By Turna Ray

The American Medical Association's Current Procedural Terminology Editorial Panel has approved Vermillion's application for a Category 1 CPT code for its OVA1 test.

According to a published summary of the panel's February meeting, the AMA "accepted establishment of code 814XX1 to describe the OVA1 test." The OVA1 test will also be listed in a new appendix for multi-analyte assays with algorithmic analysis, a subset of tests also known as in vitro diagnostic multivariate index assays.

The AMA decided a few months back that it would grant Category 1 codes to MAAAs that its CPT panel has vetted and found to meet a certain set of criteria. In addition to being listed under Category 1 codes, these tests will also be listed in a special section for MAAAs, called Appendix X. MAAAs that the AMA has not reviewed or that have not met coding criteria under Category 1 will only be listed in Appendix X. Tests in this appendix will be referenced by their proprietary names (PGx Reporter 11/9/2011).

At the February meeting, AMA's CPT panel added a new Category I subheading and guidelines in the "pathology and laboratory" section for MAAAs; established codes (ie. 81499X) to describe unlisted MAAAs with algorithmic analyses; established three new MAAA codes for listing in Appendix X; and revised its chemistry guidelines to include instructions for reporting unlisted MAAA codes.

Other than OVA1, the other two MAAAs that will be listed in Appendix X include a qualitative serum test that uses an algorithm to combine the results of two analytes and women's menopausal status into a numeric score, and a "diabetes pre-diagnostic risk screen" that analyzes multiple analytes to give a single risk score correlated with the probability of developing the disease.

The new MAAA codes will be effective Jan. 1, 2013.

According to Vermillion, in order to garner approval from the AMA for a Category 1 code, the company submitted several peer-reviewed publications on OVA1. Furthermore, the company said the fact that the test has been accepted for coverage by other payers, including Medicare contractor Highmark Medicare Services, also helped. "The new CPT code is a critical step in advancing the commercialization of OVA1, as we believe it will help streamline claims processing and accelerate further coverage and adoption by private payers," Vermillion CEO Gail Page said in a statement.

Currently there are three types of CPT codes payors use to process claims: Category I, II, and III. Many sponsors of IVDMIAs are currently using unlisted or miscellaneous codes under Category I to garner reimbursement for performed tests.

For example, Genomic Health's Oncotype DX is reimbursed with a miscellaneous CPT code and Agendia's MammaPrint uses the CPT code 84999 for "an unlisted chemistry procedure." Some MAAA providers claim to have good reimbursement through this process, but most have acknowledged that reimbursement agreements for tests with miscellaneous or unlisted codes have to be secured payor by payor, which is a costly and time-consuming process.

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AMA Approves Vermillion MAAA Category 1 Code for OVA1; Will it Improve Reimbursement?

GIA announces the release of a comprehensive global report on Biochips markets. Global market for Biochips is projected to reach US$4.6 billion by the year 2017. A promising market on the growth curve, Biochips are opening up new avenues for research and science, owing to the trend towards miniaturisation, parallelisation and the high alacrity of analysis. Besides genome analysis, Biochips are increasingly finding use in areas such as protein, diagnostics, toxicological, and biochemical research applications.

San Jose, CA (PRWEB) March 09, 2012

As stated by the new market research report on Biochips, the US continues to remain the largest regional market, with its technological superiority. Segment-wise, DNA Chips constitute the largest market. Despite plummeting market share, the segment is likely to continue its dominance in the biochip products market through 2017. Global Protein Biochips market is set for robust growth driven by anticipated rise in demand from proteomics and gene expression profiling applications. Gene expression profiling is expected to continue as the leading application area for biochips, while pharmacogenomics is expected to register robust growth.

Major players in the marketplace include Affymetrix Inc., Agilent Technologies., Bio-Rad Laboratories Inc., Caliper Life Sciences Inc., Cepheid Inc., Fluidigm Corporation, GE Healthcare Ltd., Illumina, Inc., and Life Technologies Corporation, among others.

The research report titled "Biochips: A Global Strategic Business Report" announced by Global Industry Analysts, Inc., provides a comprehensive review of trends, issues, strategic industry activities, and profiles of major companies worldwide. The report provides market estimates and projections (US$ Million) for the years 2009 through 2017 across global and regional markets for product segments including DNA Chips, Protein Chips, and Lab Chips. Geographic markets analyzed include the US, Canada, Japan, Europe, and Rest of World.

For more details about this comprehensive market research report, please visit

http://www.strategyr.com/Biochips_Market_Report.asp

About Global Industry Analysts, Inc.

Global Industry Analysts, Inc., (GIA) is a leading publisher of off-the-shelf market research. Founded in 1987, the company currently employs over 800 people worldwide. Annually, GIA publishes more than 1300 full-scale research reports and analyzes 40,000+ market and technology trends while monitoring more than 126,000 Companies worldwide. Serving over 9500 clients in 27 countries, GIA is recognized today, as one of the world's largest and reputed market research firms.

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Global Biochips Market to Reach US$4.6 Billion by 2017, According to New Report by Global Industry Analysts, Inc.

DUBLIN--(BUSINESS WIRE)--

Research and Markets (http://www.researchandmarkets.com/research/aa887c/molecular_diagnost) has announced the addition of the "Molecular Diagnostics: Market Segmentation and Opportunities - 4th Edition" report to their offering.

Molecular diagnostics (MDx) are a class of in vitro diagnostic (IVD) tests that identify nucleic acids, such as DNA. MDx tests may identify nucleic acids that are the genetic material of foreign organisms (e.g., HIV genotyping, MRSA screening) or the genetic markers of an individual patient (e.g., Her-2 overexpression for breast cancer, Factor V Leiden for coagulation). MDx tests continue to be the fastest growing segment within the IVD space, driven by high sensitivity, fast turnaround time, easy workflow and relatively low-cost compared to other techniques, such as culture-based or immune-based tests.

MDx involves platforms and assays that leverage multiple technologies to identify genetic variations. Technologies utilized include; PCR (e.g., HBV qualitative screening; Roche) qPCR (e.g., MRSA screening; Cepheid), TMA (CT/GC screening; Gen-Probe), FISH (PathVysion Her-2; Abbott), capillary electrophoresis (CE) sequencing (e.g., BRAC 1/2 testing; Myriad Genetics), next generation sequencing (Trisomy21 test; Sequenom), microarrays (Amplichip, Roche) and a host of other methods (e.g., pyrosequencing, bDNA, hybrid capture, hybridization beads, kPCR, electrochemical detection).

Analysis from this report indicates that the -$5.9B MDx market (2011E) is expected to grow at >15% p.a. over the next 4 years, reaching $10.9B by 2015. MDx growth is expected to continue to be driven by increased incidence of chronic diseases due to an aging population, increased availability of various tests, and the further adoption of Pharmacogenomics / personalized medicine.

This report reviews the market size, growth, segments and trends of the MDx industry from 2007 through 2015. The market is segmented to provide insights on specific growth opportunities by therapeutic area (infectious diseases, oncology, HPV, others), technology (PCR, qPCR, TMA, hybrid capture, CE Sequencing, NGS, FISH, other), analytes tested (low and high plex level), test rationale (predisposition, screening, diagnosis, therapy selection, monitoring), test location (reference labs, academic hospitals, blood banks, other) and geography (U.S., Europe, Japan, rest of the world). Growth and growth drivers for each segment are quantified and reviewed.

Major competitors shaping the industry include BioPharma (e.g., Abbott, Roche), IVD/MDx pure-play companies (e.g., Myriad Genetics, Cepheid, Gen-probe) or research tool companies (e.g., Illumina, Life Technologies). Major competitors are reviewed along with their key platforms and underlying technologies.

MDx is a highly regulated space. IVD instruments/assays are treated as medical devices and often require 510(k)/IVD clearance to gain full adoption in the marketplace. We briefly review the various level of clearance for MDx tests.

Finally, this report explores opportunities and challenges in the MDx industry. In this fourth edition, we place an emphasis on NGS and its emerging adoption in clinical settings, as well as other emerging technologies (e.g., dPCR, CGH).

Key Topics Covered:

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Research and Markets: Molecular Diagnostics: Market Segmentation and Opportunities - Emphasis on NGS and Its Emerging ...

OMAHA, Neb.--(BUSINESS WIRE)--

Transgenomic, Inc. (OTCBB: TBIO.OB - News) today reported financial results for the year ended December 31, 2011 and provided a business update.

Transgenomic enjoyed a landmark year in 2011, with revenue growth quarter-over-quarter and year-over-year as well as an attention to expense management translating into positive modified EBITDA for both the fourth quarter and full year 2011 periods, said Craig Tuttle, President and Chief Executive Officer. Our year-over-year top line increase of 59%, to $32 million in revenue for 2011, reflects growth in both our clinical reference labs and pharmacogenomics lab businesses. These encouraging top- and bottom-line results were achieved without compromising our investment in the development of groundbreaking new technologies. Supporting our strategic direction, and adding substantially to shareholder equity, was a $22 million private placement financing executed last month with a number of top-tier life sciences investors.

Mr. Tuttle continued: 2012 promises to be yet another important year for growth and value creation, as we look to build momentum behind our recently launched products, including our proprietary clopidogrel response panel, expand on our growing position as a key partner in cancer research and develop the markets where our products and services are available. As always, we will continue to focus on the successful integration of new products and technologies and expansion into new markets, all while managing toward the bottom line.

Recent Corporate and Business Events

Fourth Quarter and Fiscal Year Financial Results

Total revenue for the fourth quarter 2011 was $8.6 million, an increase of 68 percent compared with $5.1 million for the same period of 2010. Revenues for the fourth quarter of 2011 included $4.6 million in sales related to the Clinical Labs business, $0.5 million in revenue related to the Pharmacogenomics Services Unit (Pharma which supports Clinical Trials) and $3.5 million in revenue related to the Diagnostic Tools unit.

For the year ended December 31, 2011, revenues were $32.0 million, an increase of 59 percent compared with $20.0 million for the same period of 2010. This included $16.0 million in net sales related to the Clinical Labs, $2.3 million in Pharma revenues and $13.7 million in revenues related to the Diagnostic Tools unit.

Gross profit was $5.3 million, or 62 percent of net sales during the fourth quarter of 2011, compared with gross profit of $2.4 million, or 47 percent of net sales during the comparable period of 2010. Gross profit was $18.4 million, or 58 percent of net sales for 2011, compared with gross profit of $9.8 million, or 49 percent of net sales for 2010. The improvement in gross margin for the fourth quarter and full year is attributable to improvement in our Lab Services and Pharmacogenomic margins. The improvement in our Lab Services is due to the revenue from the FAMILION acquisition and successful consolidation of operations and reduction of overhead costs. Our Pharmacogenomics margins have improved due to the revenue increase quarter-over-quarter and year-over-year as the costs in that segment are relatively fixed.

Operating expenses were $5.4 million during the fourth quarter of 2011, compared to $3.7 million during the same period of 2010. Operating expenses increased primarily due to the acquisition of the FAMILION business, including non-cash charges totaling $0.3 million related to the amortization of the acquired intangibles. Operating expenses for the year ended December 31, 2011 were $21.4 million, compared with $13.4 million for 2010. Operating expenses increased primarily due to the acquisition of the FAMILION business, including non-cash charges for amortization related to the acquired intangibles of $1.2 million. We also recorded non-cash charges for stock option expenses of $1.0 million and bad debt expense of $1.7 million.

Excerpt from:
Transgenomic Reports Fiscal Year 2011 Financial Results

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) Transgenomic today reported 69 percent revenue growth year over year for the fourth quarter.

For the period ended Dec. 31, 2011, the Omaha, Neb.-based firm posted $8.6 million in revenues, up from $5.1 million a year ago. The Clinical Labs business recorded $4.6 million in revenue, Diagnostic Tools saw $3.5 million in revenues, and Pharmacogenomics had $500,000 in revenues.

Its R&D costs increased 60 percent to $568,000 from $354,000 a year ago, and SG&A costs rose 48 percent to $4.9 million from $3.3 million.

A net loss of $767,000, or $.02 per share, in Q4 2010 was turned into a profit of $263,000, or break-even on a per-share basis, in Q4 2011.

For full-year 2011, Transgenomic saw revenues climb to $32 million, up 60 percent year over year from $20 million in 2010. Clinical Labs revenue came in at $16 million, Diagnostic tools had $13.7 million, and Pharmacogenomics had $2.3 million.

Transgenomic decreased R&D spending 4 percent year over year to $2.2 million from $2.3 million but increased SG&A spending 76 percent to $19.2 million from $10.9 million.

The company had a net loss of $9.8 million, or $.22 per share, compared to a net loss of $3.1 million, or $.06 per share, in 2010. Transgenomic attributed the increase in net loss to an interest expense of $1 million and non-cash charges for preferred-stock valuation of $6.1 million, as well as amortization related to acquired intangibles and stock option expenses.

The firm ended 2011 with $4.9 million in cash and cash equivalents.

In a statement, Transgenomic President and CEO Craig Tuttle said that the year-over-year growth in 2011 reflected improvement in the firm's clinical reference lab and pharmacogenomics lab businesses.

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Transgenomic's Q4 Revenues Increase 69 Percent

By Turna Ray

Based on promising Phase II results, Generex Biotechnology is planning to meet with the US Food and Drug Administration about its investigational cancer immunotherapy for breast patients who have tumors that express low to intermediate levels of the HER2 protein, the company said this week.

Generex's HER-2/neu peptide vaccine, called AE37, is being developed as an adjuvant therapy for the 50 percent of breast cancer patients who express low to intermediate levels of HER2, and as a result, don't have HER2 expression levels high enough to be eligible for Roche/Genentech's Herceptin, according to the company.

However, although the AE37 immunotherapeutic is for a molecularly defined patient population, Generex is not currently planning to develop the drug with a new companion diagnostic to gauge HER2 expression in the intent-to-treat patient population.

"At the moment we are not working to set up a separate diagnostic test" for AE37, Eric von Hofe, CEO of Generex subsidiary Antigen Express, told PGx Reporter. AE37 is the first product Generex is developing using Antigen Express's Ii-Key Hybrid technology platform.

"There is currently the Dako HercepTest that can be used for scoring tumor tissue HER2 1+, 2+ or 3+; with low to intermediate expressing tissue being 1+ or 2+," Von Hofe said. "There are other tests, as well, that are available that claim to be more quantitative."

Patients who end up receiving AE37 will likely be those who were initially being considered for Herceptin treatment and, as such, were already tested with one of several FDA-cleared HER2 tests and found to have low to intermediate HER2 expression. This may be one reason why Generex expects it will not have to develop a companion test for its product.

The FDA has indicated that when a drug requires the aid of a molecular diagnostic to determine which patients should receive it, the test, in most cases, must be approved by the agency. "An IVD companion diagnostic device is an in vitro diagnostic device that provides information that is essential for the safe and effective use of a corresponding therapeutic product," the FDA states in its draft companion diagnostics guidance, released last year.

The FDA-approved labeling for HercepTest notes that it is indicated "as an aid in the assessment of patients for whom Herceptin treatment is being considered." Given the rationale for how a breast cancer patient might become eligible to receive AE37, it is unclear whether the agency will require a separate FDA-cleared companion diagnostic to market the drug for a subset of the HER2 population.

Meanwhile, Dako and other firms marketing FDA-cleared HER2 tests that are supporting an additional indication for Herceptin or that are intended to be used with a new HER2-targeted therapy have had to seek approval for their tests in these new settings (PGx Reporter 6/2/2010; 2/8/2012).

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Generex to Meet with FDA about AE37 HER2 Peptide Vaccine; Companion Dx Path Still Unclear

By Turna Ray

After the Patient-Centered Outcomes Research Institute held a meeting this week to gather public input on its comparative effectiveness research priorities, personalized medicine stakeholders are still uncertain to what degree the institute will fund studies that aim to define how well drugs work in molecularly distinct patient groups or if it will mostly fund research to gauge how interventions work in the general population.

Another unknown as PCORI further defines its CER framework is whether "patient-centered research" a term the institute has been working to define with public input will explicitly mention personalized medicine principles. Whether it does or not could signal whether comparisons of genomic medicine to the standard of care will be a major focus of PCORI's CER efforts.

PCORI, a non-profit organization formed by the 2010 Patient Protection and Affordable Care Act, has issued a draft document outlining the research areas in which it wants to conduct studies comparing the safety and efficacy of medical interventions, healthcare delivery models, and infrastructure. The findings from such CER, PCORI hopes, will help drive informed healthcare decision making, improve patient outcomes, and reduce unnecessary spending in healthcare.

The public was invited to discuss the preliminary research agenda with PCORI and key stakeholders at a meeting this week. PCORI is also accepting written comments on its draft research agenda until March 15.

PCORI is planning to spend $122 million for research activities in 2012, and it's possible that some of this money may go toward funding CER on molecularly targeted personalized medicine products. According to PCORIs statutory purpose, the research the institute supports must consider how disease can be prevented, diagnosed, and treated in patient subpopulations, which could include groups defined by molecular subtypes.

Regardless, some believe that the focus areas outlined in PCORI's draft research agenda are too broad, and personalized medicine principles, which are still new and evolving, can very easily get lost in the mix.

"PCORI was designed to address specific, practical questions of national importance," Amy Miller, vice president of public policy for the advocacy organization Personalized Medicine Coalition, said at the meeting according to prepared comments provided to PGx Reporter. "However, the broad and vague drafting of the research priorities is more appropriate for traditional, investigator-driven research, which may or may not address the types of questions PCORI must answer."

In addition, "since broad drafting does not allow for an examination of individual research proposals, topics, or research questions, it is not possible to say whether PCORIs work will support personalized medicine or not," Miller said.

Since PCORI was formed, the PMC has been trying to remind the institute's leaders that their charge isn't just to look at whether most people respond better to one drug over another, but to investigate how and why treatments work best in some people with a unique set of characteristics. "It is not enough, in the PMCs opinion, to say that one therapy works for most people in the aggregate," Miller said. "To enable personalized medicine, research must explain why a therapy works and for what types of patients."

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Will PCORI's Patient-Centered Comparative Effectiveness Research Track with Personalized Rx?

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) Vermillion's shares soared 92 percent to $2.56 in mid-afternoon trade on the Nasdaq today after the firm announced that a panel of the American Medical Association approved the company's application for a Category 1 CPT code for its OVA1 ovarian cancer test.

The new code assigned to OVA1 becomes effective Jan. 1, 2013.

Category I codes pertain to procedures that are consistent with current medical practice and are commonly performed. Tests and/or procedures coded as Category 1 have met certain criteria, such as approval by the US Food and Drug Administration, and have proven and documented clinical efficacy.

Gail Page, president and CEO of the Austin, Texas-based molecular diagnostics firm, called the decision by AMA's Current Procedural Terminology Panel "a major achievement for OVA1 and an endorsement for the unmet clinical need addressed by this important triage test."

The panel's decision was supported by several peer-reviewed publications and a decision by the Centers for Medicare and Medicaid Services to cover the test for Medicare, she added.

"The new CPT code is a critical step in advancing the commercialization of OVA1, as we believe it will help streamline claims processing and accelerate coverage and adoption by private payers," Page said.

OVA1 was launched in March 2010 following 510(k) clearance from FDA in September 2009.

The AMA issued its OVA1 CPT coding decision as it moves to revamp the coding structure for tests known as in vitro diagnostic multivariate index assays, or IVDMIA, as GenomeWeb Daily News sister publication Pharmacogenomics Reporter reported in the fall. IVDMIAs are now dubbed multi-analyte assays with algorithmic analysis, or MAAAs, by the AMA.

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Vermillion's OVA1 Test Assigned Category 1 CPT Code; Stock Jumps

ROCHESTER, N.Y.--(BUSINESS WIRE)--

ACM Global Central Lab, the central laboratory that continually defines the customer-service standard with its flexible approach, today announced the launch of its complimentary workshop series, Navigating Global Clinical Trials with Your Central Lab, designed for global pharmaceutical and biotechnology companies and contract research organizations (CROs) interested in managing global clinical trials testing. The first workshop, Ensuring Patient Safety through Efficient Specimen Lifecycle Management, will take place Thursday, March 15, 2012, from 2:00 5:00 p.m. PST at Hotel Vitale in San Francisco.

In many clinical trial scenarios, there may only be one chance to collect, ship, test and analyze a patients specimen. These often time-sensitive snapshots into a patients progression in a study are critical not only to the overall study results, but ultimately the safety of patients undergoing treatment. The lifecycle of a specimen, which starts at collection and ends at database lock, can be prone to human error along each step of the testing process, particularly when conducting global clinical trials in more remote ends of the world. Sponsors need to ensure the integrity of the specimen throughout this process, while balancing the relative cost of logistics.

There are many considerations when it comes to conducting global studies, said Tracy Hendershott, vice president of clinical trials at ACM Global Central Lab. As a central lab devoted to clinical trials testing, we wanted to develop a workshop series to support the clinical trials community by helping them navigate the many hurdles and offer some new approaches that can improve efficiencies along the way.

Executives from ACM Global Central Lab, Cryoport and Dorevitch Pathology will be discussing the scientific, financial and logistical factors that should be considered to ensure patient safety and will offer innovative, yet cost-effective methodologies and solutions for maintaining specimen integrity. During interactive presentations and a networking reception, attendees will have the opportunity to hear from ACM Global Lab and its partners on their insights on monitoring and oversight on patient safety, safeguarding sample integrity, and good business sense, based on lessons learned from managing global clinical trials testing.

To register for ACM Global Central Labs complimentary workshop, please click here. Registrants will automatically qualify to be entered into a drawing for a Sunset Sailing Experience for Two around the San Francisco Bay.

About ACM Global Central Lab ACM Global Central Lab offers a flexible approach and a focus on precision to keep clinical research studies on schedule. ACMs services extend to more than 60 countries with all tests conducted and managed from central lab facilities with seamless data management providing a single database. The organization performs 13 million tests each year, featuring more than 1,500 individual tests spanning all medical disciplines, including pathology, microbiology, flow cytometry and pharmacogenomics. Combining comprehensive safety, efficacy and pathology testing from a single lab ensures clients receive consistent, analyzable test results with faster and cleaner reporting.

For more information, visit http://www.acmgloballab.com and our Central Labs in Focus blog atwww.acmgloballab.com/blog.

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ACM Global Central Lab Launches Workshop Series to Share Expert Insights on Navigating Global Clinical Trials with a ...

CHICAGO--(BUSINESS WIRE)--

Fitch Ratings today published 'Navigating the Drug Channel - Pharmaceutical Manufacturers: At the Source,' the second of seven reports analyzing the U.S. drug channel. This newest report focuses on headwinds and tailwinds faced by drug makers, as well as their role in the U.S. drug channel and Fitch's take on certain considerations on the horizon.

Drug makers are plagued by unprecedented and now-accelerating drug patent expirations, which will continue through 2015. Fitch believes the impact of the so-called 'patent cliff' apply to each pharma manufacturer on an individual basis, with issuers such as Bristol-Myers Squibb Co.; Eli Lilly & Co., Inc.; and Pfizer Inc. most affected.

The industry's R&D pipelines were productive in 2011, positioning several drug makers to benefit from a solid recovery of a portion of lost revenues and profits; albeit delayed from the greatest impact of patent expiries. Due to their position at the beginning of the drug channel, pharmaceutical manufacturers' productivity is directly related to the longer-term viability of the channel as a whole.

Labor conditions in the U.S. are not expected to materially improve over the next few years, likely leading to continued treatment avoidance and a further pressuring of prescription drug trends. Nevertheless, Fitch expects the effects from an aging U.S. population and the expansion of Medicaid coverage in 2014 from the Patient Protection and Affordable Care Act to backstop the dampening effect on overall prescription demand from prolonged poor macroeconomic conditions.

Fitch believes that stubbornly high unemployment, constrained third-party reimbursement growth, and very large drug patent expiries will clash with favorable demographic trends and an anticipated one-time addition of about 30 million potential new patients to result in annual U.S. drug spending growth of 3% or less over the next couple of years.

Considerations on the horizon include the introduction of biosimilars into the U.S. drug channel, the rapid growth of specialty pharmaceuticals, and the growing importance of pharmacogenomics. The report discusses Fitch's take on each of these very vital issues.

The full report, 'Navigating the Drug Channel - Pharmaceutical Manufacturers: At the Source,' is available at 'www.fitchratings.com.' This is the second in a series of seven reports that Fitch will publish during the first half of 2012. The expected schedule for future reports can be found on the first page of previously published reports, including this one.

Additional information is available at 'www.fitchratings.com'.

Applicable Criteria and Related Research: Navigating the Drug Channel Pharmaceutical Manufacturers: At the Source

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Fitch: Drug Makers Continue to Face Challenges at the Beginning of the Drug Channel

New research report Future US Hematology and Flow Cytometry Market Outlook prepared by Venture Planning Group has been recently published by Market Publishers Ltd. The report reveals that commercialization of innovative products is likely to drive the future growth in the market, and the US will remain the biggest market for hematology.

London, UK (PRWEB) February 28, 2012

The world hematology market is likely to grow over the forecast period, driven by the development in bench-top high throughput hematology analyzers and in high sensitivity point-of-care (POC) tests. Commercialization of innovative products is also likely to drive the future growth in the market. The US is the biggest market for hematology, contributing around 50% towards the global market share.

New research report Future US Hematology and Flow Cytometry Market Outlook prepared by Venture Planning Group has been recently published by Market Publishers Ltd.

Report Details:

Title: Future US Hematology and Flow Cytometry Market Outlook

Published: February, 2012

Pages: 275

Price: US$ 9,500

http://marketpublishers.com/report/medicine_pharmaceuticals_biotechnology/healthcare_equipment_services/future_us_hematology_n_flow_cytometry_market_outlook.html

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US Hematology & Flow Cytometry Market Future Discussed in New Report Published at MarketPublishers.com

By Monica Heger

One major hurdle in bringing next-generation sequencing into the clinic is how it will be received by payors and hospitals.

In a webinar hosted by Illumina this week, Trisha Brown, vice president of clinical affairs at Medco subsidiary DNA Direct, said that demonstrating the technology's cost effectiveness will be key to gaining reimbursement and encouraging hospital uptake.

Currently though, there is broad variability among payors and hospitals in both their general knowledge about genomics and their readiness to incorporate the technology into health care, Brown said.

Cost-Effectiveness Data

With regards to health plans, it is the "wild, wild West," Brown said, and there is a broad spectrum of plans from those that will not deal with genetic or genomic information at all, to plans that mention whole-genome or whole-exome sequencing — although none that state specifically that those tests will be covered. There are even some plans that say they don't cover genetic tests, said Brown, but actually do without realizing that the tests they are covering are genetic.

Brown said that a study conducted by DNA Direct found that of 200 publicly available health plans, about one-third have coverage policies on genetics or genomics tests, with policies naming up to 150 specific tests. Additionally, three plans specifically mention whole-genome sequencing, but "all state that it's experimental and not covered."

Nevertheless, she said, there have been cases where whole-genome sequencing has been covered. For instance, Howard Jacob, director of the Human and Molecular Genetics Center at the Medical College of Wisconsin, has said that two insurance companies have agreed to reimburse for whole-genome sequencing of pediatric patients with rare, undiagnosed diseases (CSN 8/24/2011).

As of June, Illumina had also received reimbursement for two cases that used genome sequencing to diagnose disease (CSN 6/15/2011).

"Sometimes it doesn't matter what the policies are" of the specific health plans, said Brown. "If you're able to make a good case for why whole-genome sequencing is going to benefit this member and potentially improve outcomes, there's a good chance they're going to cover it," she said.

The more that whole-genome sequencing proves to be cost-effective, the more likely that health insurance companies will reimburse for it, she said.

Health insurance plans are "ready to embrace genomics as soon as the return on investment is there," she said.

However, not everyone agrees. For instance, in November, a Medicare official indicated that the Centers for Medicare and Medicaid Services had no plans to consider reimbursement for whole-genome sequencing-based tests any time soon because it would be difficult to convince CMS that whole-genome sequencing has value in helping physicians make patient decisions (CSN 11/9/2011).

Employers may help accelerate the reimbursement of genomic tests, said Brown. Because employers' goals are to keep their employees healthy and productive, they have a different return on investment than health plans, said Brown. And individual employers can negotiate with providers to cover genetic tests for their employees that wouldn't otherwise be covered.

Driving Hospital Revenue

While the main driver for payors to reimburse for genomic tests will be cost-effectiveness demonstrations, for hospitals, genomic tests have the potential to increase revenues.

While spending for esoteric testing currently represents only about 2 percent of all health care spending, in 2012 molecular genetic testing is estimated to be about a $4 billion market, said Brown, with next-gen sequencing poised to potentially capture half that.

As reported by Clinical Sequencing News sister publication PCR Insider, consulting firm DeciBio has estimated that the global molecular diagnostics market, which is currently valued at $5.9 billion, is expected to hit nearly $11 billion by 2015, with next-generation sequencing-based testing experiencing the highest rate of growth over the next four years, at around 100 percent growth per annum.

While next-gen sequencing is currently a very small portion of the molecular diagnostic market, by 2015 it is expected to be between $700 million and $1.1 billion.

Hospitals, which are looking for new ways to drive revenue, stand to benefit, said Brown. The model for hospitals has changed such that they no longer make the bulk of their money from "heads on beds," said Brown. Rather, hospitals are making money from outpatient services such as colonoscopies and mammograms, and genomic tests are another outpatient service that hospitals could bring on board.

While many genomic tests currently in use at hospitals are based on PCR, arrays, or other technology, a number of hospitals are developing next-gen sequencing-based tests.

The Mayo Clinic, for instance, is working on sequencing-based hereditary colon cancer and mitochondrial disease tests, and is studying how to integrate whole-genome sequencing into patient care (CSN 2/15/2012).

Mount Sinai Hospital in New York is developing a sequencing-based pharmacogenomic test that it wants to make accessible via patients' electronic medical records (CSN 12/14/2011).

Pharmacogenomics will perhaps be how most hospitals make their first entrance into genomics testing, said Brown, because it is appealing to payors, employers, and physicians alike since it has already demonstrated that it is cost-effective, will reduce employee sick time, and the data can be readily used by physicians in patient care.

From her survey of 200 health plans, she said that 40 pharmacogenomic tests are already mentioned in health plans.

For clinical applications of next-gen sequencing, "pharmacogenomics is at the top of the list," said Brown. While whole-genome sequencing to diagnose rare disease and to help guide treatment of cancer has recently made headlines, using next-gen sequencing in pharmacogenomics is applicable to a larger number of people. "There's a lot of potential for pharmacogenomics," she said.

Going forward, the adoption of next-gen sequencing in the clinic still has a number of hurdles, she said. Analysis is still expensive and complicated, particularly for whole-genome sequencing, and acceptance by the US Food and Drug Administration is a "hurdle that has to be overcome."

Among other things, it will require that researchers and clinicians "demonstrate that the information you're getting out of next-generation sequencing or any kind of genomic analysis is going to provide a benefit greater than the cost that you put into it."

"We have a lot of work to do to make that happen," she said

Have topics you'd like to see covered by Clinical Sequencing News? Contact the editor at mheger [at] genomeweb [.] com.

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Demonstrating Cost Effectiveness of Clinical NGS is Key to Payor Reimbursement, Hospital Uptake

Last Updated on Sunday, February 26, 2012 10:27 PM Written by The Darien Times
Monday, February 27, 2012 06:00 AM

Darien High School students took home first place honors in five out of eight categories at the 12th Annual Southern Connecticut Invitational Science & Engineering Fair in Woodbridge on Feb. 4.

More than 600 students, judges and community members were joined by Dr. Dan Riskin, host of Animal Planet's Monsters Inside Me, at the fair, which was held at Amity Regional High School. Completed projects and research proposals were presented by students from Darien, Amity, Convent of the Sacred Heart, Joel Barlow High School, Hamden High School, Newtown High School and Staples High School.

Each student was required to create an exhibit, make a presentation, and participate in a question and answer session. Volunteer judges evaluated entries — both completed projects and research proposals — in four categories: behavioral sciences, environmental sciences, health sciences and physical sciences.

Darien student Reed Morgan took first place for his behavioral science proposal called, "Ethnogenesis and State Formation in the Mycenaean Hither State of Pylos: A-pu2/Iklaina as a Diagnostic for Expansion of the Core Zone." Katherine Ferguson won first place for her environmental science proposal, "Quantifying the Effect of Lionfish and Other Stressors on Coral Reef Ecosystems off the Coast of Southern Mexico." Jeffrey Sload tied for first place in the health science proposal category his work, "Elucidating Warfarin Pharmacogenomics in African Americans: A Genome-Wide Association Study on Warfarin Dose Response in a Cohort of African American Individuals." Brooke Davis won first place for her completed behavioral science project, "Use of Formant Values in Classifying Vocalizations of Beluga Whales (Delphinapterus leucas)," and Amanda Sommi took first place for her completed environmental science project, "The Effect of Rising Sea Level on the Elevation of Salt Marshes Throughout Long Island, NY."

Darien students Oscar Barbour, Leah Hotchkiss, Caroline Wetterauw, Grace Brandon, Mark Kaminski and Andrew Fletcher also earned awards for their science projects. Sacred Heart junior Lauren Wood also lives in Darien and was awarded a second place prize for her project.

State Rep. Tony Hwang, a Democrat who represents Fairfield and Trumbull, was a first time judge at the event. "The quality of each exhibit was impressive and the enthusiastic and energetic presentation by each young science/engineering scholar gave hope that our community and country will ably compete in the global marketplace into the future," Hwang said. "The tireless work of board members and volunteers made this event an incredible success. They are the true heroes in advocating science/engineering education for our kids."

Celebrity scientist Riskin delivered a speech called, "Should I Really Consider a Career in Science?" An internationally known evolutionary biologist, Riskin told the story of his own career path, how it led him to become an expert on bat locomotion and then a TV host. Among his many lessons, he urged the students to question what they see and what others have told them, and then to question themselves before drawing any conclusions. He said science is about following one's passion, and that it's an intellectual pursuit but "cool and awesome," too.

The science foundation is actively encouraging future participation by additional schools for the science fair competition, part of this effort being to subsidize participation by science teachers in a program on teaching science research at the high school level offered by the State University of New York.

The Sexauer Foundation is a major funding source of the fair and this year's prizes were sponsored by Laticrete International of Bethany. The fair is sponsored by the Southern Connecticut Science & Engineering Foundation.

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Darien High Schoolers fare well at science fair

MOUNTAIN VIEW, Calif. (TheStreet) -- By day, Joseph Lee is a graduate student pursuing a PhD in pharmaceutical sciences and pharmacogenomics. By night, he's the "FDA Panel Whisperer" -- the creator of FDATracker.com, a unique web site that predicts outcomes of FDA advisory committees based on the historical voting records and behavioral analysis of participating panelists. Lee has crunched the data on the 22 panel members who will sit in judgment of Vivus(VVUS) and its obesity drug Qnexa tomorrow and he's not encouraged. His prediction: 10 experts will vote to recommend Qnexa approval but the remaining 12 will vote against. That's a very close vote, made more so by Lee's acknowledgement that one or two votes could swing in either direction, according to his analysis. Guessing the outcome of any FDA advisory panel is a big challenge; Vivus' panel is even more difficult to handicap because FDA invited eight experts who have not previously participated in any of the obesity panels held last year. For that reason alone, I wouldn't necessarily take Lee's Vivus analysis to the bank, but his research is thorough and a compelling read if you're at all interested in following tomorrow's Qnexa presentations and the volatile deliberations that will undoubtedly follow. Assessing the risk of birth defects caused by the topirimate component of Qnexa is likely to be the focal point of Wednesday's FDA panel debate. FDA invited Suzanne Gilboa from the National Center on Birth Defects and Development Disabilities at the CDC to present at Wednesday's panel. Her testimony could prove to be influential on the final vote. Of the eight "new" votes on the Qnexa panel, Lee has three experts voting yes and five voting no. Twelve experts on Wednesday's panel also participated in the last Qnexa panel. They voted 5-7 against the drug previously. This time, Lee has only one of these experts changing to a positive vote, bringing the tally in this group to a 6-6 tie. Two additional experts invited to review Qnexa tomorrow participated in FDA panels for the two other obesity drugs last year from Arena Pharmaceuticals(ARNA) and Orexigen Therapeutics(OREX). Lee predicts these two experts will split their votes on Qnexa. That's how Lee comes up with his prediction for a 10-12 vote against the weight-loss drug. It's hard to get a solid read on a consensus Wall Street expectation for the Qnexa panel, but FDA's review of the drug released Friday revealed few surprises. This seems to have left investors leaning toward predicting a positive vote, although almost everyone predicts a split/close vote. Vivus shares rose 7% Friday after the FDA release of its briefing documents but the stock was down 3% Tuesday to $11.64 per share. I encourage you to read Lee's breakdown on how each of the panel members may vote on Qnexa based on their voting record from past obesity drug panels or statements made at other FDA panels. Tomorrow night, we'll learn if the "FDA Panel Whisperer" is accurate or not. FDA panel members predicted to vote for Qnexa's approval, according to Lee: Melanie Coffin, Eric Felner, Allison Goldfine, Jessica Henderson, Sanjay Kaul, Michael Rogawski, Robert Smith, Myrlene Staten, Abraham Thomas, Susan Yanovski. FDA panel members predicted to vote against Qnexa's approval, according to Lee: Erica Brittain, Ken Burman, David Capuzzi, Robert Clancy, Janet Cragan, Katherine Flegal, Ed Gregg, Mike Lauer, Elaine Morrato, Sonja Rasmussen, Lamont Weide, Almut Winterstein. --Written by Adam Feuerstein in Boston. >To contact the writer of this article, click here: Adam Feuerstein. >To follow the writer on Twitter, go to http://twitter.com/adamfeuerstein. >To submit a news tip, send an email to: tips@thestreet.com. Follow TheStreet on Twitter and become a fan on Facebook.>To order reprints of this article, click here: Reprints

Excerpt from:
A Negative Vote for Vivus Obesity Drug, Says 'FDA Panel Whisperer'

Small changes in the molecules might cause diseases and discovering new drugs through molecular research was the only solution to address the problem, said Prof V.N. Rajasekharan Pillai, Executive Vice- President and Principal Secretary, Science and Technology Department, Kerala State Council for Science Technology and Environment.

Prof Pillai was inaugurating the two-day international conference on molecular medicine that began at Sree Buddha College of Engineering (SBCE) at Pattoor near Pandalam on Thursday.

Traditionally, diagnostics has been quite distinct from therapeutic development. Molecular medicine is changing that paradigm, as molecular markers become increasingly important for understanding disease biology, selecting and validating targets, and assessing the efficacy and safety of compounds under development, said Prof Pillai.

According to him, molecular research, diagnostics and medicine have a much greater role in patient care.

Prof Pillai said molecular diagnostic technologies were likely to have a strong impact on the drug treatment of many major illnesses. Now, a wealth of genomic data is enabling researchers to predict a patient’s response to therapy based on the genetic make-up of a tumor (in the case of cancer), or the viral genotype.

Potential applications for emerging molecular diagnostics tests include viral genotyping for drug resistance, cancer diagnosis and prognosis, disease susceptibility and prediction, diagnosis of inherited genetic disorders, prediction of drug response, and forensic (identity) testing, he said.

Prof Pillai said a slight change in the DNA molecule might lead to diseases like Sickle Cell Anaemia. However, the Sickle Cell Anemia patients were also found to have been resistant to Malaria, he added. Inter-disciplinary interaction among officers, chemists, biotechnologists, medical doctors, etc, was inevitable to address various problems in the field of molecular medicine and research, he said.

Dr Somi Sebastian, college principal, presided over the inaugural function.

Prof K. Sasikumar, Sree Buddha Educational Society chairman; Prof V. Prasad, secretary and Dr Seema Nair, head of the Department of Biotechnology, also spoke.

Delivering the keynote address on Pharmacogenomics, Dr C. Adithan, head of ICMR Centre for Advanced Research in Pharmacogenomics in Puducherry, said each drug was likely to interact in the body with numerous proteins that determine the absorption, distribution, excretion, targeting to the site of action, and pharmacological response of drugs. Hence the presence of multiple polymorphisms in these genes could affect the drug levels which in turn could affect the drug response, he added.

Dr Adithan says pharmacogenomics research is an emerging discipline that focuses on genetic determinants of drug response at the levels of entire human genome. The goal of pharmacogenomic research is to evaluate genetic variations in an individual genome to predict how a patient may respond a particular therapy or dose, he adds.

Dr Min-Tze Liong from the School of Industrial Technology, Universiti Sains Malaysia in Penang, delivered the plenary lecture on Probiotics Cholesterol and Blood, later.

Dr D. Karunagaran of Department of Biotechnology at Indian Institute of Technology in Chennai spoke on Role of micro RNAs in cancer and Dr Annie John from Sree Chitra Tirunal Institute for Medical Sciences and Technology in Thiruvananthapuram delivered a lecture on Regenerative Medicine, later in the afternoon.

Invited Lectures on Molecular Medicine for Disease Diagnosis and Biomaterials for Regenerative Engineering will be held on Friday forenoon. Dr K. Sudesh Kumar from School of Biological Sciences, Universiti Sains Malaysia in Penang will talk on ‘Fabrication of Electrospun Polyhydroxyalkanoate and its application in Medicine and Environmental Conservation’, later, in the afternoon.

Original post:
International meet on molecular medicine begins at SBCE

25-01-2012 21:19 The OncTerm for the day is Pharmacogenomics. OncTerm is the NCI defintion of a specific term used in Oncology. This word is brought to you by Courtney Mullen from our Molecular Pathology Department.

The rest is here:
OncTerm- Pharmacogenomics - Video

SANTA CLARA, Calif.--(BUSINESS WIRE)--

Affymetrix, Inc. (NASDAQ:AFFX - News) today announced that its GeneChip® System 3000Dx v.2 (GCS 3000Dx v.2) has been approved by China's State Food and Drug Administration (SFDA) for in vitro diagnostic use. The GCS 3000Dx v.2 is the first microarray instrument system to be granted SFDA registration for array-based diagnostics for enabling personalized medicine. China has more than 2,000 clinical centers that will now have access to the only SFDA-cleared microarray platform for clinical testing.

The molecular diagnostic market in China is the fastest growing in the world and represents a significant growth opportunity for Affymetrix in Asia. “We are delighted to be the first SFDA-cleared microarray platform, as this will enable us to expand into the clinical diagnostics applications,” says Chris Barbazette, Vice President, Commercial Operations International Markets at Affymetrix.

The GCS 3000Dx v.2 microarray platform has a proven record of successful development and commercialization through partnership via the Powered by Affymetrix™ (PbA) program. A number of companies are developing molecular diagnostic tests in cancer, cardiovascular diseases, and inherited disorders based on the Affymetrix GeneChip platform. More than ten tests are in the pipeline for regulatory clearance. Two FDA-cleared tests (Roche AmpliChip® CYP450 Test and Pathwork® Diagnostics' Tissue of Origin Test) and three CE-IVD marked tests, including Skyline Diagnostic’s AML test, are currently on the market. These tests and Affymetrix’ own solutions for cytogenetics, cancer, and pharmacogenomics are part of an increasing menu of clinical applications that can be run on the SFDA-cleared GeneChip System.

“Having an SFDA-cleared system and a wide-range of clinical tests will enable physicians in China to bring personalized medicine to their patients faster,” says Dr. Ming Zhang at Hangzhou Bio-San Biochemical Technologies Company.

“This registration clearance is a significant accomplishment for Affymetrix and supports our global clinical strategy. It connects us more closely to physicians in China wanting to utilize clinically relevant genomic biomarkers that improve their patients’ health and wellness,” said Andy Last, Executive Vice President of Genetic Analysis and Clinical Applications Business Unit at Affymetrix.

The GCS 3000Dx v.2 microarray System is cleared for in vitro diagnostic use in the United States, Japan, CE-IVD marked in Europe, and is also available in Canada, Singapore, Australia, India, and Saudi Arabia.

In addition to the GCS 3000Dx v.2, Affymetrix also offers a Clinical Toolkit, which contains the US FDA-cleared and CE-IVD marked Gene Profiling Reagents and the Gene Profiling Array cGMP U133 P2, the cGMP-manufactured version of the widely cited GeneChip® Human Genome U133 Plus 2.0 Array. The Affymetrix® Clinical Toolkit provides a proven path to market, enabling test developers to save time and money while reducing regulatory risks.

About Affymetrix

Affymetrix technology is used by the world's top pharmaceutical, diagnostic, and biotechnology companies as well as leading academic, government, and nonprofit research institutes. About 2,200 systems have been shipped around the world, and more than 25,000 peer-reviewed papers have been published using the technology. Affymetrix is headquartered in Santa Clara, CA, and has manufacturing facilities in Cleveland, Ohio, and Singapore. The company has about 900 employees worldwide and maintains sales and distribution operations across Europe, Asia, and Latin America. For more information about Affymetrix, please visit http://www.affymetrix.com.

Forward-looking statements

All statements in this press release that are not historical are "forward-looking statements" within the meaning of Section 21E of the Securities Exchange Act as amended, including statements regarding Affymetrix' "expectations," "beliefs," "hopes," "intentions," "strategies" or the like. Such statements are subject to risks and uncertainties that could cause actual results to differ materially for Affymetrix from those projected, including, but not limited to: risk relating to the Company’s ability to successfully commercialize new products, risk relating to past and future acquisitions, including the ability of the Company to successfully integrate such acquisitions into its existing business; risks of the Company's ability to achieve and sustain higher levels of revenue, higher gross margins and reduced operating expenses; uncertainties relating to technological approaches, risks associated with manufacturing and product development; personnel retention; uncertainties relating to cost and pricing of Affymetrix products; dependence on collaborative partners; uncertainties relating to sole-source suppliers; uncertainties relating to FDA and other regulatory approvals; competition; risks relating to intellectual property of others and the uncertainties of patent protection and litigation. These and other risk factors are discussed in Affymetrix' Annual Report on Form 10-K for the year ended December 31, 2010, and other SEC reports. Affymetrix expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Affymetrix' expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

PLEASE NOTE: Affymetrix, the Affymetrix logo, GeneChip, and all other trademarks are the property of Affymetrix, Inc.

Excerpt from:
China Clears Its First Microarray Platform for in Vitro Diagnostics to Accelerate Personalized Medicine

By Turna Ray

The clinical laboratory testing market will take a Medicare payment hit, according to provisions in a bill that both houses of Congress passed last week and sent off to President Barack Obama for enactment.

The American Clinical Laboratory Association decried the 2 percent decrease in Medicare reimbursement to clinical labs included in the "Middle Class Tax Relief and Job Creation Act of 2012," or the so-called payroll tax deal. ACLA said the reduced payments will hurt the lab testing industry, with particular implications for the small but rapidly growing personalized medicine sector.

The new cut adds to reductions that the lab industry already faces from the healthcare reform law, known formally as the Patient Protection and Affordable Care Act, which includes provisions to reduce Medicare reimbursement for lab services by 19 percent over 10 years. The payroll tax bill, which legislative experts are saying the President will likely sign into law, decreases the payment amount to clinical labs by an additional 2.4 percent.

ACLA criticized the bill for forcing the lab industry to "bear a vastly disproportionate share," or around 13.5 percent, of the $20 billion needed to cushion the 27 percent Medicare payment cut that doctors would have had to bear this year. In the payroll tax deal, Congress decided to delay the reimbursement decrease for doctors for another year.

The Centers for Medicare & Medicaid Services has frozen or reduced payments to labs through the clinical lab fee schedule between 2003 and 2012. Comparatively, Medicare payments for physicians have increased during that time, according to ACLA.

Although lab tests comprise a very small portion of Medicare spending, industry observers have often noted that such tests influence the majority of healthcare decisions in the US. "Doctors use laboratory test results to make 70 percent of their treatment decisions," ACLA said in a statement. "But lab services represent only 1.6 percent of Medicare spending ($8.1 billion in 2010.)"

Wall Street's reaction to the reimbursement cuts doesn't bode well for two of the largest clinical labs in the US. "We believe that these potential unexpected cuts highlight ongoing pricing risk to the US clinical lab industry in an environment centered on austerity and reducing healthcare costs," Goldman Sachs analyst Isaac Ro wrote in a note last week. Ro maintained a "sell" rating on Quest and the Laboratory Corporation of America.

Given these "unexpected" events, Ro said Goldman Sachs would keep a "cautious view" on the clinical lab industry relative to the life sciences tools and diagnostics market.

Medicare currently reimburses few molecular diagnostics used in personalized medicine settings, but that segment of the broader lab testing market is expected to grow. As a result, ACLA believes that slashing reimbursement for a nascent segment of the industry may have ill effects for job creation and investments. Citing figures from a study prepared by Battelle Memorial Institute on its behalf, ACLA noted that the genetic testing industry created 116,000 jobs, accounting for $6 billion in income, for US workers in 2009. The same year, the industry contributed $16.5 billion in national economic output.

Have topics you'd like to see covered in Pharmacogenomics Reporter? Contact the editor at tray [at] genomeweb [.] com.

Originally posted here:
ACLA Says Cuts in Medicare Lab Payments Could Hurt Nascent Personalized Dx Segment

By Turna Ray

Under a collaboration with personalized medicine-focused bioinformatics company MolecularHealth, the US Food and Drug Administration will evaluate software that will allow the agency to analyze and predict drug safety issues caused by a variety of factors, including pharmacogenomic interactions.

After evaluating the Molecular Analysis of Side Effects, or MASE, software the FDA will likely use a version of the system to gauge safety issues with marketed drugs. "The immediate plans are to use [MASE] in the post-market setting," an agency spokesperson told PGx Reporter.

MASE is a software-as-a-service offering that MolecularHealth is marketing to a variety of end users, including drug developers and payors. As reported by PGx Reporter sister publication BioInform, the company launched MASE last month (BI 1/20/2012).

MASE allows users to assess drug safety by analyzing data on therapeutic mechanisms of action, treatment-treatment interactions, as well as associations between molecular markers, diseases, and drugs in published literature. The software also includes visualization and analytical features that enable users to explore drug safety issues from a statistical or molecular perspective.

The capabilities of MASE are aligned with the FDA's expressed intent to detect and analyze drug safety issues at a mechanistic level. "The FDA Predictive Safety Team has been meeting with Molecular Health … for over a year," the agency spokesperson said, noting that the project builds on work FDA has been doing internally "for years" to mine its Adverse Event Reporting System — a computerized system to monitor drug-related adverse events — to understand mechanisms of drug toxicity.

Adverse reactions are often not detected for several years after a drug has been approved. In recent years, however, as genetic testing firms and bioinformatics companies have begun to amass large databases of molecular and phenotype data on individuals treated with a variety of drugs, the FDA has expressed a desire to use this information to detect treatment-related toxicities faster and with more precision.

The commercially available version of MASE combines patients' drug-related clinical and molecular data with information from a publicly available version of FDA's AERS. MolecularHealth has said that MASE users can use the system to analyze mechanism-based safety data for all drugs currently on the market, as well as identify potential adverse events for drugs under development.

According to the FDA spokesperson, MolecularHealth has created a new version of MASE that the company will present next month to multiple offices in the Center for Drug Evaluation and Research.

"Specific projects for collaboration will be discussed at next month's meeting," the agency spokesperson said. "The Predictive Safety Team has interest in hepatotoxicity and cardiotoxicity. Other areas of interest will likely include some focus areas related to the Sentinel Initiative."

In 2008, the FDA launched the Sentinel Initiative, under which the agency is implementing a proactive, electronic system for tracking adverse events associated with drugs, biologics, and medical devices that the agency has approved for marketing. Under this effort, the agency hopes that with a more refined mechanistic understanding of drug safety it can pick up on potential toxicity signals associated with investigational drugs and ink risk-mitigation strategies with sponsors to avoid adverse events when the drug goes on the market.

In 2010, the FDA's Advisory Committee for Pharmaceutical Science and Clinical Pharmacology held a meeting to discuss plans to build a predictive safety system that integrates pharmcogenomics, chemical structure data, and systems biology approaches to predict drug-induced adverse events before they happen (PGx Reporter 3/24/2010).

Then, last year the FDA held several drug safety workshops in which the agency discussed its intent to develop a mechanism-based drug safety assessment and prediction program. MolecularHealth's collaboration with the FDA around the MASE system evolved during that time.

MASE is exactly the type of technology that FDA has described, according to Jeffrey Marrazzo, MolecularHealth's chief business officer. "It supports not only the ability to look at adverse event information from a statistical basis, but it allows you to link understanding of how drugs work in the human system, thereby allowing you to identify, either proactively or even afterwards, safety signals with a drug," Marrazzo told PGx Reporter.

In its meeting with the FDA, MolecularHealth discussed how it could launch MASE commercially but also garner input from the agency. Marrazzo said the FDA will likely tweak the system for its own purposes.

"MASE will continue to use only the publically available AERS data at this time," the FDA spokesperson explained. "Internally, we may perform our own data-mining analyses using the in-house AERS data as a quality-control assessment."

According to the agency, its collaboration with MolecularHealth is one of several public-private partnerships focused on improving its adverse event predictive capabilities through better understanding of mechanistic-based drug safety issues. "The goal of the Predictive Safety Team is to bring together expertise from within the FDA, academia, and pharmaceutical sponsors," the agency spokesperson said. "The FDA has other Research Collaboration Agreements in place and is looking to create new RCAs."

According to the spokesperson, the agency is interested in inking additional drug safety collaborations around ontologies, cheminformatics, bioinformatics, and systems biology.

Have topics you'd like to see covered in Pharmacogenomics Reporter? Contact the editor at tray [at] genomeweb [.] com.

Read more from the original source:
FDA Evaluating MolecularHealth's MASE for Analyzing Post-Market Drug Safety

NEW YORK, Feb. 16, 2012 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Future US Nucleic Acid Testing Market Outlook

http://www.reportlinker.com/p0773583/Future-US-Nucleic-Acid-Testing-Market-Outlook.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=NoCategory

Highlights

Comprehensive 880-page market segmentation analysis of the US NAT market. Major issues pertaining to the US NAT laboratory practice, as well as key economic, regulatory, demographic, social and technological trends with significant market impact during the next ten years. An extensive review of DNA probe and biochip technologies, test formats, detection methodologies, trends in testing automation and amplification methods. Ten-year test volume and reagent sales forecasts for the following categories:

                 - Infectious Diseases

                 - Cancer

                 - Forensic Testing

                 - Genetic Diseases

                 - Paternity Testing/HLA Typing

Review of testing methodologies and instrumentation technologies. Feature comparison of automated and semiautomated analyzers. Sales and market shares of leading suppliers. Over 60 specific opportunities for NAT instruments, test systems, IT and auxiliary products. Profiles of major suppliers, and emerging market entrants, including their sales, product portfolios, marketing tactics, technological know-how, new products in R&D, collaborative arrangements and business strategies. Alternative market penetration strategies. Potential market entry barriers and risks. Business planning issues and concerns.

Contains 880 pages and 37 tables

Table of ContentsIntroduction

Worldwide Market And Technology Overview

A. DNA Sequencing

1. Introduction

2. Sequencing Methods

3. Autoradiography

4. The Human Genome Project

5. Sequencing Automation

6. Image Scanners

7. Fluorescent Detection

8. Gene Profiling

9. Gene Expression

10. Polymorphism Screening

11. Protein Interaction Networks

B. DNA And RNA Probe Technology

1. Basic Principles

2. Probe Preparation

3. The DNA Probe Test

a. Sample Preparation

b. Hybridization

c. Separation

d. Detection/Measurement

4. Test Formats

a. Filter Hybridization

b. Southern Blot

c. Northern Blot

d. In Situ Hybridization

e. Others

5. Labeling Techniques

6. Amplification Methods

O Polymerase Chain Reaction

- Temperature Cyclers

- PCR Variations* Immuno-PCR* QC-PCR* DAP-PCRO Strand Displacement ActivationO TMAO Ligase Chain ReactionO Branched DNA- Hybridization Protection AssayO Nucleic-Acid Sequence-Based AmplificationO Self-Sustained Sequence ReplicaseO Others- Ampliprobe- CAR- CAS- CPT- Dendritic Polymer Technology- ISO-CR- LAT- Probe Networks- RAMP- Repair Chain Reaction- Rolling Circles- Sequence Independent Gene Amplification- Sequence Initiation Reaction- SISPA- Solid Phase AmplificationC. Detection Technologies1. Radioactive Methodsa. Overviewb. Major IsotopesO P-32O S-35O H-3O I-1252. Non-Isotopic Methodsa. Enzymatic Labelsb. Chemical LabelingO Indirect Chemical LabelingO Direct Chemical Labeling

c. Fluorescence

d. Chemiluminescence

e. Electrical Conductivity

D. Instrumentation Review

1. Abbott LCx

2. Beckman Coulter/Biomek FK

3. Becton Dickinson SDA

4. Bio-Rad GeneScope

5. Gen-Probe Tigris

6. Roche Cobas Amplicor

7. Tecan LS Series

E. Biochips: Genosensors, Microarrays, and

Labs-on-the-Chip

- Liquid Transportation and Mixing

- Separation

- Reaction

- Detection

F. Pharmacogenomics

G. Major Applications

1. Microbiology/Infectious Diseases

a. Overview

b. Major Infectious Diseases

* AIDS

O Structure and Composition

O Classification

O AIDS Origins

O Animal Lentivirus Systems

O Virus Receptors

O HIV Infections in Humans

- Pathogenesis and Pathology

O CD4T Lymphocytes and Memory Cells

O Monocytes and Macrophages

O Lymphoid Organs

O Neural Cells

O Viral Coinfections

- Clinical Findings

O Plasma Viral Load

O Pediatric AIDS- Neurologic Disease- Opportunistic Infections- CancerO Immunity- Virus Isolation- Serology- Viral Nucleic Acid/Antigen DetectionO Epidemiology- Worldwide Spread of AIDS- United States- Routes of TransmissionO DNA Probes- Overview- Quantitative PCR- In Situ PCR- Needed ImprovementsO Viral Load/Drug Resistance TestingO Genotype and Phenotype TestingO Blood Banking Considerations* AdenovirusO BackgroundO Diagnostic TestsO Vaccines and DrugsO Adeno-Associated Viruses (AAV)* Anthrax/Bacillus AnthracisO BackgroundO Diagnostic TestsO Vaccines and Drugs* BabesiosisO Background* BEA and Other Bartonella DiseasesO BackgroundO Diagnostic TestsO Vaccines and Drugs* Chagas DiseaseO Background

* Campylobacter

O Background

O Diagnostic Tests

- Culture Identification

O Vaccines and Drugs

* Chlamydia

O Background

- Chlamydia psittaci

- Chlmaydia pneumoniae

- Chlamydia trachomatis

O Diagnostic Tests

O Vaccines and Drugs

* Creutzfeldt-Jakob's Disease

O Background

O Blood Transmission

O Diagnostic Tests

O Major Commercial and Academic Players

- Bayer

- Disease Sciences/Bio Tec Global

- Imperial College School of Medicine

- Ortho-Clinical Diagnostics

- Pall

- ProMetic Life Sciences

- Proteome Sciences/Idexx

- Q-One Biotech

- Serono

- U.S. Agricultural Research Service

O Drugs

O Vaccines

* Cytomegalovirus

O Background

- Chorioretinitis

- Gastrointestinal

- Central Nervous System Disease

O Diagnostic Tests

O Vaccines and Drugs

* Ebola Virus

O Background

- Epidemiology

- Clinical Syndromes

O Diagnostic TestsO Vaccines and Drugs* EchoVirusO Background- Acute Aseptic Meningitisis- Encephalitis- Exanthems- Respiratory Disease- Myopericarditis- Neonatal InfectionsO Diagnostic TestsO Vaccines and Drugs* EncephalitisO BackgroundO Diagnostic TestsO Vaccines and Drugs* EnterovirusesO BackgroundO Diagnostic Tests- Viral Isolation and Identification- Antibody TestsO Vaccines and Drugs* Epstein-Barr VirusO BackgroundO Diagnostic TestsO Vaccines and Drugs* GonorrheaO BackgroundO Diagnostic TestsO Vaccines and Drugs* HepatitisO Hepatitis AO Hepatitis B- Structure and Composition- ReplicationO Hepatitis CO Hepatitis D (Delta)O Hepatitis EO Hepatitis GO Hepatitis Infections PathologyO Clinical FindingsO Laboratory Tests

- Hepatitis A

- Hepatitis B

- Hepatitis C

- Hepatitis D

- Hepatitis E

O Virus-Host Immune Reactions

O Epidemiology

- Hepatitis A

- Hepatitis B

- Hepatitis C

- Hepatitis D (Delta)

O Vaccines and Drugs

* Herpes Simplex Virus

O Background

O Diagnostic Tests

O Vaccines and Drugs

* Legionella

O Background

O Diagnostic Tests

O Vaccines and Drugs

* Lyme Disease

O Background

- Clinical Description

- Clinical Case Definition

- Laboratory Criteria for Diagnosis

- Case Classification

O Diagnostic Tests

O Vaccines and Drugs

* Malaria

* Mycoplasma

O Background

- Ureaplasma Urealyticum & Mycoplasma

Hominis

O Diagnostic Tests

O Vaccines and Drugs

* Papillomaviruses/HPV

O Background

- HPV in Cancer

- Cervical Neoplasm

O Diagnostic Tests

O Vaccines and Drugs

- Prevention* Parvovirus B19O Background- Microbiology- Epidemiology- Clinical Syndromes- Erythema Infectiosum (Slapped Cheek)- Adult Polyarthropathy- Transient Aplastic Crisis- Transient Pancytopenia- Red Cell Aplasia in Immunocompromised- Perinatal InfectionsO Diagnostic TestO Vaccines and Drugs* PneumoniaO BackgroundO Diagnostic TestsO Vaccines and Drugs* PolyomavirusesO BackgroundO Diagnostic TestsO Vaccines and Drugs* SalmonellosisO BackgroundO Diagnostic TestsO Vaccines and Drugs* ShigellosisO BackgroundO Diagnostic TestsO Vaccines and Drugs* StreptococciO BackgroundO Diagnostic TestsO Vaccines and Drugs- Group A Streptococci- Group B Streptococci* ToxoplasmosisO BackgroundO Diagnostic TestsO Vaccines and Drugs

* Tuberculosis

O Background

O Diagnostic Tests

- Microscopic Characteristics

- Cultural Characteristics

- Skin Tests

- MDRTB

O Vaccines and Drugs

* West Nile Virus

O Background

- Clinical Syndromes

O Diagnostic Tests

O Vaccines and Drugs

* Yersinia

O Background

O Diagnostic Tests

O Vaccines and Drugs

c. Antibiotic Susceptibility

2. Cancer Testing

a. Overview

b. Major Cancer Types

* Prostate

* Lung

* Colon and Rectum

* Breast

* Skin

* Uterine

* Leukemia

* Oral

c. Oncogenes

O Abl/abl-bcr

O AIB1

O BCL-2

O BRCA1

O CD44

O C-fos

O C-myb

O C-myc

O CYP17

O Erb-B

O HPC1

O N-mycO P40O P51O P53O PIK3CAO PTI-1O RasO RegO SisO Src3. Genetic Diseasesa. Overviewb. Nucleic Acid Amplificationc. Chromosome Imagingd. Genomics Technologiese. Proteomics Technologiesf. Current Pharmacogenomic Testsg. Future Pharmacogenomic Testingh. Major Diseases* Achondroplasia* Autosomal Dominant Polycystic KidneyDisease* Cancer* Cosmetogenomics* Cystic Fibrosis* Down's Syndrome* Duchenne and Becker Muscular Dystrophy* Factor V (Leiden)* Factor IX Deficiency* Fragile X Syndrome* Heart Disease* Hemochomatosis* Hemophilia* Huntington's Disease* Maternal-Fetal Incompatibility* Multiple Endocrine Neoplasia* Phenylketonuria (PKU)* Polycystic Kidney Disease (PKD)* Prenatal Screening* Retinitis Pigmentosa* Retinoblastoma* Sickle Cell Anemia

* Spinal Muscular Atrophy

* Vitamin B12 Metabolism

i. Social Issues and Concerns

4. Forensic Testing

a. Overview

b. Multilocus and Single Locus Probes

* Multilocus Probes

* Single Locus Probes

* PCR and RFLP

c. The FBI

d. DNA Profile Data Banks

* U.S.A.

* U.K.

e. Judicial Implementation

f. Major Crime Categories

g. Factors Contributing to the DNA Probe

Market Expansion

* Technology Availability

* Use of Hair as Evidence

h. Wildlife Forensics

5. Paternity Testing/HLA Typing

6. Other Applications

a. Disease Susceptibility Testing

b. Cardiovascular Diseases

c. Diabetes

d. Alzheimer's Disease

e. Periodontal Disease

f. Plasma Purification

g. Organ Transplantation

h. Water Contamination

i. Other

H. Competing/complementing Technologies

1. Monoclonal Antibodies/Immunoassays

2. RNA Probes

3. Two-Dimensional Electrophoresis

4. Flow Cytometry

I. Worldwide Market Overview

1. Business Environment

2. Market Structure

3. Market Size and Growth

USAA. Executive SummaryB. Business EnvironmentC. Market StructureD. Market Size, Growth And Major Suppliers'Sales And Market SharesMajor Product Development OpportunitiesA. InstrumentationB. Reagent Kits and Test Systems/panelsC. Computers, Software and AutomationD. Auxiliary ProductsDesign Criteria For Decentralized Testing ProductsAlternative Market Penetration StrategiesA. Internal DevelopmentB. Collaborative ArrangementsC. University ContractsD. Distribution Strategies For Decentralized TestingMarkets1. Marketing Approaches2. Product Complexity3. Customer Preference4. Established Suppliers5. Emerging Suppliers6. Major Types Of Distributors7. Market SegmentationPotential Market Entry Barriers And RisksA. Market MaturityB. Cost ContainmentC. CompetitionD. Technological Edge And LimitationsE. Patent ProtectionF. Regulatory ConstraintsG. Decentralized Testing Market Challenges

Competitive Profiles

- Abbott

- Affymetrix

- Agilent

- Applied Gene Technologies

- Arca

- Beckman Coulter/Danaher

- Becton Dickinson

- Biokit

- BioMerieux

- Bio-Rad

- Biotest

- Caliper

- Cepheid

- Decode

- Diadexus

- Eiken

- Enzo

- Exact Sciences

- Fujirebio

- Gen-Probe

- Hologic

- Illumina

- Innogenetics/Solvay

- Kreatech

- Li-Cor Biosciences

- Life Technologies

- Monogram Biosciences

- Myriad Genetics

- Nanogen/Elitech

- Novartis

- Orchid CellMark

- Ortho-Clinical Diagnostics

- Proteome Sciences

- Qiagen

- Roche

- Scienion

- Sequenom

- Shimadzu

- Siemens

- Sierra Molecular

- Takara Bio

- Tecan Group

AppendixesAppendix I: Major Universities and Research Centers

Developing NAT Technology

Appendix II: Glossary of Terms

Appendix III: Currency Exchange Rates

List of TablesMajor Companies Developing or Marketing AIDS NAT

And Other Direct Identification Tests

Major Companies Developing or Marketing Adenovirus

NAT And Other Direct Identification Tests

Major Companies Developing or Marketing Campylobacter

NAT And Other Direct Identification Tests

Major Companies Developing or Marketing Chlamydia

NAT And Other Direct Identification Tests

Major Companies Developing or Marketing CMV Molecular

Diagnostic And Other Direct Identification Tests

Major Companies Developing or Marketing EBV Molecular

Diagnostic And Other Direct Identification Tests

Major Companies Developing or Marketing Gonorrhea

NAT And Other Direct Identification Tests

Major Companies Developing or Marketing Hepatitis

NAT And Other Direct Identification Tests

Major Companies Developing or Marketing Herpes

NAT And Other Direct Identification Tests

Major Companies Developing or Marketing Legionella

NAT And Other Direct Identification Tests

Major Companies Developing or Marketing LymeDisease NAT And Other Direct Identification TestsMajor Companies Developing or Marketing MycoplasmaNAT And Other Direct Identification TestsMajor Companies Developing or Marketing PapillomaVirus NAT And Other Direct Identification TestsMajor Companies Developing or Marketing PneumoniaNAT And Other Direct Identification TestsMajor Companies Developing or Marketing SalmonellaNAT And Other Direct Identification TestsMajor Companies Developing or Marketing ShigellaNAT And Other Direct Identification TestsMajor Companies Developing or Marketing StreptococciNAT And Other Direct Identification TestsMajor Companies Developing or Marketing ToxoplasmosisNAT And Other Direct Identification TestsMajor Companies Developing or Marketing TuberculosisNAT And Other Direct Identification TestsOncogenes Potential Application in Cancer DiagnosisMajor Companies Developing or Marketing CancerNAT Tests

Major Companies Developing or Marketing NAT Assays

For Genetic Diseases

Summary Table U.S.A., NAT Test Volume

And Sales Forecast by Major Application

U.S.A., Laboratories Performing

DNA Sequencing by Market Segment

U.S.A., NAT Market, Potential

Laboratory Universe by Market Segment

U.S.A., NAT Test Volume Forecast By Major Application

U.S.A., Major Infectious Disease NAT Test Volume Forecast

U.S.A., Infectious Disease Screening

NAT Volume by Test Forecast

U.S.A., NAT Market Forecast By Major Application

U.S.A., Infectious Disease Screening Nat Reagent

Market Forecast by Test

U.S.A., NAT Market by Major Supplier

U.S.A., HIV/Hepatitis C NAT Market Reagent Sales

By Major Supplier

U.S.A., West Nile Virus NAT Market Reagent Sales

By Major Supplier

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Nicolas Bombourg
Reportlinker
Email: nbo@reportlinker.com
US: (805)652-2626
Intl: +1 805-652-2626

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Future US Nucleic Acid Testing Market Outlook