UNC Analysis Finds Beta1-AR Alleles Impact Survival in Patients Treated with Beta-Blockers

By Turna Ray

CHICAGO A recent analysis of genotype and clinical data from more than 700 heart failure patients found that individuals who are homozygous for the wild-type allele Ser49 in the beta 1-adrenergic receptor gene experienced prolonged survival when they received treatment with beta-blockers compared to Ser49 homozygotes who didn't receive such treatment.

The study, led by researchers from the University of North Carolina, Chapel Hill, also found that carriers of one or two copies of the Gly49 allele in the beta1-AR gene did not experience a survival advantage when treated with beta-blockers compared to Gly49 carriers who didn't receive such drugs.

Beta-blockers inhibit beta-adrenergic substances that regulate the nervous system of the heart and are often prescribed to control high blood pressure, to manage irregular heart rhythms, and to treat heart failure patients. There are several beta-blockers on the market approved by the US Food and Drug Administration, including AstraZeneca's Toprol XL and GlaxoSmithKline's Coreg.

Based on data from past studies, UNC researchers Jasmine Talameh, Kirkwood Adams, and others hypothesized that Ser49 allele status "will be associated with beta-blocker survival benefit in a large, heterogeneous, US heart failure population," said Talameh, who presented data from this study at the American College of Cardiology meeting here this week.

Study investigators reviewed beta-blocker use and survival for heart failure patients enrolled in the United Investigators to Evaluate Heart Failure Biomarker Registry from 2000 to 2002. The current analysis involves more than 700 patients in the registry for whom there was information on beta-blocker use, survival, and genotype.

"The UNITE-HF DNA Registry was started by Kirkwood in 1999 as a way to promote clinical registry, biomarker, and genomic research in heart failure," Talameh said during her presentation. "These prospective, multicenter, observational registries were designed to study medication use, long-term outcomes, and the genomics of heart failure patients seen in US heart failure specialty clinics."

Patients in the registry had a history of heart failure and could have been asymptomatic at the time they were enrolled. According to Talameh, the majority of patients in the registry had received Coreg and Toprol.

Study investigators used mass spectrometry to genotype patients for the Gly49 and Ser49 alleles in the lab of Howard McCleod, director of UNC's Institute for Pharmacogenomics and Individualized Therapy. During the follow-up period, researchers collected patients' clinical information at the study sites and then periodically with the Social Security Death Index.

Among the study participants, 68 percent were Ser49 homozygous and 32 percent were Gly49 carriers. Using the Social Security Death Index, researchers found that more than 340 patients died after an average follow up of seven years, of which 52 percent were Gly49 carriers and 47 percent were Ser49 homozygous.

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UNC Analysis Finds Beta1-AR Alleles Impact Survival in Patients Treated with Beta-Blockers

PGx Highlights from American College of Cardiology Annual Meeting

The annual meeting of the American College of Cardiology held this week in Chicago featured a number of pharmacogenomically guided studies related to treatments for cardiovascular disease.

The following is a roundup of some of the meeting's pharmacogenomics highlights.

Lack of Association in SLCO1B1 Polymorphisms and Clinical Myalgia after Crestor Treatment

Researchers led by Jacqueline Suk Danik from Brigham and Women's Hospital investigated whether individuals who are carriers of SCLCOB1 rs4363657C and rs4149056C have increased incidence of myopathic complaints when taking AstraZeneca's Crestor (rosuvastatin) compared to non-carriers. In past studies, researchers have seen a similar influence in patients taking Merck's Zocor (simvastatin).

Danik et al. retrospectively genotyped patients receiving Crestor in the JUPITER trial. The original study randomized 4,400 people without heart disease or diabetes to Crestor or placebo. "Among those allocated to active rosuvastatin, there was no difference in [the] rate of myalgia among carriers of the rs4363657C allele or the rs4149056C allele when compared to non-carriers," the researchers found. The researchers had similar findings even after expanding their definition of myalgia to include complaints of muscle weakness, stiffness, or pain.

"In contrast to data for simvastatin, there appears to be no increased risk of myalgia among users of rosuvastatin who carry the rs4363657C allele or the rs4149056C allele in the SLCO1B1 gene," Danik et al. concluded.

AstraZeneca, the National Cancer Institute, and the National Heart, Lung, and Blood Institute provided funding for this study.

Impact of CYP2C19 and CYP3A5 Genotypes in Patients Undergoing Stent Procedures, Treated with Maintenance Dose Plavix

Studies have shown that patients with high platelet reactivity after being treated with Bristol-Myers Squibb's Plavix (clopidogrel) may be at increased risk of stent thrombosis after undergoing a stent procedure. Researchers led by Tadasuke Chitose of Kumamoto University examined CYP2C19 and CYP3A5 genotypes, as well as platelet aggregation, in 62 patients. Platelet reactivity was measured twice, after patients received a loading dose (300 mg/day) of Plavix, and then after they received a maintenance dose (75 mg/day) of the drug.

In the study, 31 percent, 42 percent, and 27 percent of patients were extensive metabolizers, intermediate metabolizers, and poor metabolizers, respectively. After patients received 300 mg/day of Plavix, platelet reactivity was 4,069 +/-1,383; 4,407 +/-1,755; and 5,301 +/-807 AU*min in the extensive, intermediate, and poor metabolizer groups, respectively. After receiving the maintenance dose of Plavix, platelet reactivity levels were 2,948 +/-1,427; 3,068 +/-1,656; and 4,465 +/-1,557 AU*min in the extensive, intermediate, and poor metabolizer groups, respectively.

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PGx Highlights from American College of Cardiology Annual Meeting

Perkins Chain Hires New CEO

VOL. 127 | NO. 62 | Thursday, March 29, 2012

Mike Murphy Builders LLC has filed a construction loan for three lots in Germantowns Enclave planned development, phase 3, through Financial Federal Savings Bank for $1.1 million. The sizes of the financed lots are 6,759 square feet fronting Enclave Hollow Lane East, 7,032 square feet fronting Terrene Lane and 6,760 square feet fronting Enclave Green Lane West.

Enclave phase 3 is on the north side of Wolf River Boulevard northwest of the dead end of Forest Hill-Irene Road. The plat was originally filed with the Shelby County Register of Deeds in 2008. It shows 50 lots on about 16 acres.

Source: The Daily News Online & Chandler Reports

Daily News staff

A Sterne, Agee & Leach analyst on Wednesday upgraded shares of First Horizon National Corp., parent company of First Tennessee Bank, saying the regional banks loan portfolio is stabilizing and it may return more money to shareholders this year.

Todd Hagerman lifted his rating on First Horizons shares to Neutral from Underperform.

Shares of the Memphis-based bank closed at $10.48 on Tuesday, and have nearly doubled since hitting a 52-week low of $5.38 on Oct. 4.

Still, Hagerman sees limited potential for the shares to rise significantly. The benefit to the bank from improving credit trends will moderate this year and next year, he said. He kept intact his 2012 and 2013 earnings estimates.

The Associated Press

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Perkins Chain Hires New CEO

Collecting Cancer Data

The Broad Institute and Sanger Institute announced yesterday (March 28) details from their separate cancer cell line databases, the largest such repositories of genomic and drug profiling data to date. With preliminary results published in two Nature papers, the databases should help researchers identify which drugs to use against which cancers to streamline drug development efforts.

This continues to move us towards cancer being understood as a molecular disease instead of an anatomical disease, said Eileen Dolan, who studies pharmacogenomics at the University of Chicago and was not involved in either study. It will help us understand our existing drugs, as well as new drugs, to make more informed decisions in phase I and phase II trials.

In recent years, researchers have become increasingly aware that whether a tumor will respond to a given drug treatment depends on its genomic profile. But because of the vast number of cell lines and variety of drug options, researchers in smaller labs often dont have the resources to identify the best fit for the cancer type or drug theyre studying.

For any variety of cancer drugs that are being developed, we cant necessarily know in advance which cancers are going to be vulnerable, said Levi Garraway, a cancer biologist at the Dana Farber Cancer Institute who spearheaded the Broad project. If you have a large collection of cell lines that are deeply annotated genetically and molecularly, you can probe the biology linked to many types of genetic alterations of interest.

Four years ago, Garraway and his colleagues began a massive screen of 947 cancer cell lines, sequencing cancer-associated genes, profiling drugs, collecting RNA expression data using microarrays, and combing the cancer genomes for repeated regions. And they werent too far along when they learned of a parallel project at the Sanger Institute, led by genomicist Mathew Garnett.

The projects arent identical; they screen different genes and different drugs using slightly different methods. For this reason, Garnett views the two databases as complementary. There was sufficient non-overlap that it was possible to make different observations, agreed Garraway. (See table for details.)

Plus, having two separate databases rather than pooling the data, as previous databases have done, could lend more weight to certain findings. I think having two independent resources is a good thing, said Jian Ma, a computational genomicist at the University of Illinois, who did not participate in the research. If two different groups have the same result for one cell line, it would be more reliable.

The two Nature papers, submitted as a pair, describe how the data for each project were collected, and include confirmatory experiments to demonstrate how the databases could enhance cancer drug development. Garnetts project, called the Cancer Cell Line Encyclopedia, identified a mutation in Ewings sarcoma cells that is highly sensitive to PARP inhibitors, for example. Meanwhile, Garraways database, the Genomics of Drug Sensitivity in Cancer project, includes data suggesting that MEK inhibitors, a class of cancer drugs that target the RAS oncogene, may have increased efficacy in cancers with a mutation in another gene, AHR.

The ultimate hope is that the databases will be used to help people with cancer by better matching a cancer type to a drug, and identifying which patients to enroll in clinical trials based on their genetic flavor of cancer. Often, drugs fail [in clinical trails] simply because theyre not tested in the right people, said Garnett. A better understanding of how drugs respond to genetic mutations, helped by the databases, could help clinicians single out what populations are most likely to respond.

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Collecting Cancer Data

Genoptix Says NGS Melanoma Test Will Not Be Used to Place Patients in Trials for Parent Novartis

By Molika Ashford

Genoptix, the medical laboratory within Novartis's molecular diagnostics unit, has launched a targeted sequencing-based test for mutations in BRAF, NRAS, and c-KIT to help physicians tailor treatment for metastatic melanoma patients.

The NexCourse Melanoma sequencing profile, offered through Genoptix's CLIA lab, is the company's first sequencing-based test service and is already being ordered by physicians, according to the firm. Genoptix's President Tina Nova declined to provide details on how the test is being used so far but did tell PGx Reporter in an e-mail that the panel is not being used to place patients into clinical trials for Novartis drugs.

The company sees the service as a tool to help inform treatment decisions for patients with metastatic melanoma by screening for clinically relevant mutations in three genes associated with different prognoses and potential responses to targeted treatments.

However, the NGS profile is "not intended as a test for any specific drugs;" is not linked to any drugs in Novartis' pipeline targeting BRAF, NRAS or c-KIT mutations; and the company is not using the NGS profile to place patients into clinical trials involving drugs in development, "nor do we have any plans to do so," Nova wrote.

And although the service will assess BRAF mutations including V600E and V600K mutations it is not intended to guide treatment with Roches Zelboraf, which is indicated for BRAF V600E mutation-positive metastatic melanoma. The US Food and Drug Administration approved the drug in August alongside Roche's internally developed companion test, the Cobas 4800 BRAF V600 Mutation Test.

"Our focus in Genoptix is on providing physicians with the most relevant clinical information. We believe that NGS technology is going to factor heavily in the diagnosis and treatment of patients in the future," Nova said.

Novartis acquired Genoptix in January 2011 and the business falls within Novartis Molecular Diagnostics, a unit formed around three years ago. The primary focus of the Novartis MDx business is companion diagnostics, but the company is also pursuing a "complementary diagnostics" strategy, which includes tests that don't require extensive coordination between drug and diagnostic development arms or simultaneous drug/test approval by the FDA (PGx Reporter 12/7/2011).

Nova did not detail Genoptixs hopes for the testing service beyond offering a more comprehensive test than currently available single-gene assays to help physicians tailor treatment for each patient.

"The NGS profile provides us with a much more comprehensive picture of the tumor than with assays that target specific point mutations, she said.

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Genoptix Says NGS Melanoma Test Will Not Be Used to Place Patients in Trials for Parent Novartis

St. Jude's Evans Receives Pharmacists Assn. Award

VOL. 127 | NO. 62 | Thursday, March 29, 2012

Mike Murphy Builders LLC has filed a construction loan for three lots in Germantowns Enclave planned development, phase 3, through Financial Federal Savings Bank for $1.1 million. The sizes of the financed lots are 6,759 square feet fronting Enclave Hollow Lane East, 7,032 square feet fronting Terrene Lane and 6,760 square feet fronting Enclave Green Lane West.

Enclave phase 3 is on the north side of Wolf River Boulevard northwest of the dead end of Forest Hill-Irene Road. The plat was originally filed with the Shelby County Register of Deeds in 2008. It shows 50 lots on about 16 acres.

Source: The Daily News Online & Chandler Reports

Daily News staff

A Sterne, Agee & Leach analyst on Wednesday upgraded shares of First Horizon National Corp., parent company of First Tennessee Bank, saying the regional banks loan portfolio is stabilizing and it may return more money to shareholders this year.

Todd Hagerman lifted his rating on First Horizons shares to Neutral from Underperform.

Shares of the Memphis-based bank closed at $10.48 on Tuesday, and have nearly doubled since hitting a 52-week low of $5.38 on Oct. 4.

Still, Hagerman sees limited potential for the shares to rise significantly. The benefit to the bank from improving credit trends will moderate this year and next year, he said. He kept intact his 2012 and 2013 earnings estimates.

The Associated Press

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St. Jude's Evans Receives Pharmacists Assn. Award

EMERGE Network Launches Publicly Available Database of Phenotype Identification Algorithms

By Uduak Grace Thomas

SAN FRANCISCO, Calif. The Electronic Medical Records and Genomics Network has launched an open resource, dubbed the Phenotype KnowledgeBase, which offers access to validated algorithms for identifying patients with specific disease phenotypes based on data in their electronic medical records.

Joshua Denny, an assistant professor in the biomedical informatics and medical departments at eMERGE participant Vanderbilt University, described the new resource at the American Medical Informatics Association's Summit on Translational Bioinformatics here this week.

PheKB currently includes 12 algorithms developed by members of the eMERGE consortium, though others are welcome to contribute their tools, Denny told BioInform.

The algorithms use natural language processing techniques to mine EMR data for patients with particular conditions of interest to researchers, such as cataracts, Alzheimers disease, low levels of high-density lipoprotein, type II diabetes, among others.

These algorithms make their selections using various search criteria, such as ICD9 codes, current procedural terminology codes, laboratories, and medications, according to the website.

Scientists from the consortium have been using the algorithms for a number of projects, including a study published last April in which they mined data from five institutions to find patients in each of five disease groups (BI 04/22/0011).

Denny explained that the consortium developed the database so that its tools could be better disseminated to other research efforts that are also studying disease phenotypes such as the Pharmacogenomics Research Network.

Initially, the eMERGE algorithms were made available through the consortiums Wikipedia page, but that method did not allow the kind of interactivity the researchers were looking for, Denny said.

Through PheKB, users can share their own tools as well as any updates that they make to existing algorithms on the website, he said.

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EMERGE Network Launches Publicly Available Database of Phenotype Identification Algorithms

Prospective Outcomes Trial Shows Agendia's MammaPrint Safely Reduces Chemo Use in Low-Risk Patients

By Turna Ray

A study involving Agendia's MammaPrint test has shown that physicians may be able to use the test results alongside other clinical data to withhold chemotherapy for patients with a low risk of recurrence without impacting their five-year survival.

According to Agendia, the study marks the first prospectively designed outcomes trial to gauge whether the use of a molecular diagnostic can impact breast cancer survival by avoiding unnecessary and toxic treatment. Past data on MammaPrint and other breast cancer recurrence diagnostics have shown that such tests impact treatment decisions and can impact survival, but in those investigations, researchers performed genomic analysis retrospectively on samples from patients previously enrolled in large studies.

Data from the Microarray Prognostics in Breast Cancer, or RASTER, study showed that the use of MammaPrint led to a 20 percent reduction in adjuvant chermotherapy use in patients whom the test determined to be at low risk of recurrence.

"Based on our data, the use of the genomic test could lead to a reduction of nearly 30 percent in the use of adjuvant chemotherapy without compromising patient outcomes," lead study investigator Sabine Linn of the Netherlands Cancer Institute said in a statement. In clinical practice, "this percentage may vary somewhat due to different guidelines used in different countries."

In RASTER, between 2004 and 2006, researchers collected fresh tumor samples from 427 women who were younger than 61 years and had breast cancer that hadn't yet spread to the lymph nodes. The researchers then analyzed these samples with MammaPrint, a microarray-based test that measures the expression of 70 genes.

Those patients deemed by MammaPrint to be at high risk of cancer recurrence were provided adjuvant chemotherapy. In the case of patients deemed to be at low risk, physicians considered both the MammaPrint results and clinical factors to decide whether they could avoid receiving such treatment. After patients were treated, study investigators followed them for five years to gauge outcomes.

Within the 219 patients in the low-risk group, 85 percent avoided chemotherapy while the remainder received it because their clinical factors suggested they might benefit from it, Bastiaan van der Baan, VP of sales and marketing at Agendia, told PGx Reporter.

In the high-risk group, meanwhile, 81 percent of 208 patients received chemotherapy.

The low risk group experienced a five-year distant disease-free survival rate of 96 percent versus a DDFS rate of 90 percent in the high-risk group.

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Prospective Outcomes Trial Shows Agendia's MammaPrint Safely Reduces Chemo Use in Low-Risk Patients

Abbott Challenges 'Incorrect Assumptions' in Cost-Effectiveness Study of Xalkori PGx Testing

By Turna Ray

Abbott Molecular plans to contact the British Journal of Cancer to contest the conclusions of a recently published cost-effectiveness analysis involving its Vysis ALK Break Apart FISH Probe Kit.

According to Stafford O'Kelly, president of Abbott Molecular, the authors of the study published in BJC last month based their economic analysis on two erroneous assumptions: the list price charged by labs for the ALK test and the prevalence of ALK rearrangements in the advanced non-small cell lung cancer population. As such, the modeling performed by the researchers to determine the circumstances under which the pharmacogenetic test is cost effective is flawed and should not be considered by healthcare providers and payors, Abbott maintained.

"If clinicians were to act on this article, patients will suffer," O'Kelly told PGx Reporter. "The whole premise of the paper is based fundamentally on very incorrect assumptions."

In the BJC paper, University of Colorado researchers Adam Atherly and Ross Camidge modeled the health economics of administering Pfizer's non-small cell lung cancer drug Xalkori to patients whose tumors are ALK mutation-positive. They found that broadly testing all advanced NSCLC patients in order to identify the small subset of ALK-positive individuals who should be treated with Xalkori did not meet a cost-effectiveness bar of less than $100,000 per quality-adjusted life year gained.

The US Food and Drug Administration last August simultaneously approved Pfizer's Xalkori and Abbott's Vysis ALK Break Apart FISH Probe Kit. The drug costs more than $115,000 per year. The $1,400 price tag for FISH-based ALK testing cited in the BJC analysis was established by "expert opinion" gathered by the researchers.

"Prices for the different tests vary depending on the payer and system. In the US, for example, different insurers reimburse charges at different rates. To limit this complexity, we have therefore taken charges, not reimbursements, as our base values," the study authors detail in the BJC article. "We estimated costs for pathological testing, including both technical and professional fees, utilizing Medicare list prices and the associated University of Colorado charges."

Assuming testing costs within a range of $600 to $1,400 per patient, Atherly and Camidge found that PGx testing for Xalkori is not cost-effective because ALK rearrangements occur in less than 5 percent of advanced NSCLC patients. However, the researchers demonstrated that by applying enrichment strategies to narrow the NSCLC population receiving testing for example, if physicians only tested those NSCLC patients who have adenocarcinoma histology, are non-smokers, and are known to have EGFR and KRAS wild-type tumors payors could potentially more than double the "mean health gain" to around 0.29 QALYs gained per person from 0.013 QALYs gained per person if all advanced NSCLC patients were genetically tested (PGx Reporter 3/21/2012).

In O'Kelly's view, the researchers should not have based their economic modeling on the list price labs charge for the test, but should instead have pegged the analysis to payor reimbursement rates. As the manufacturer, Abbott said it charges labs less than $170 per patient for the ALK FISH test kit. The laboratory then factors in costs associated with performing the test when billing for it.

The lab costs of between $600 and $1,400 cited in the study are "highly exaggerated," O'Kelly asserted. Furthermore, the list price doesn't accurately reflect what payors are reimbursing for the test, which in his view is the most important number when it comes to calculating what a medical intervention costs the healthcare system.

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Abbott Challenges 'Incorrect Assumptions' in Cost-Effectiveness Study of Xalkori PGx Testing

Research and Markets: Bioinformatics Market Outlook to 2015

DUBLIN--(BUSINESS WIRE)--

Research and Markets (http://www.researchandmarkets.com/research/132bc6/bioinformatics_mar) has announced the addition of the "Bioinformatics Market Outlook to 2015" report to their offering.

During the past decade, the bioinformatics market has significantly evolved across the globe on back of rising genomics industry. The increasing application of genomics in biotech and pharmaceutical research and development has created a huge commercial market for bioinformatics worldwide. As per our latest research report's estimation, the global bioinformatics market, which reached the mark of around US$ 3 Billion in 2010, will expand at a CAGR of around 25% during 2012-2015 as the declining cost of human genome sequencing and increasing public and private sector investment will give a significant boost to the industry.

According to Bioinformatics Market Outlook to 2015, the content market that includes specialized and generalized databases was the biggest segment of the global bioinformatics industry in 2010, followed by analysis software & services and IT infrastructure. As per our analysis, the software segment is likely to exhibit strong performance in future, improving its share in the overall market. On the other hand, content/database market will suffer the downturn due to the increasing popularity of innovative analysis software. We have also discussed in the report how the free databases would impact the sales of the paid ones. Our report analyzed the wide application of bioinformatics in genomics, proteomics and pharmacogenomics. A further in-depth study of the market revealed that genome studies have completely transformed cancer research in the past few years and oncology has become the leading therapeutic area supported by bioinformatics. We also observed that small firms in the field are opting for outsourcing route to expand their presence. The other key trends and drivers pushing the market have also been elaborated in the comprehensive research study.

Read more inside Bioinformatics Market Outlook to 2015

Companies Mentioned:

For more information visit http://www.researchandmarkets.com/research/132bc6/bioinformatics_mar

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Research and Markets: Bioinformatics Market Outlook to 2015

Quest Launches MDx that May Predict Kidney Transplant Rejection Earlier than Current Methods

By Turna Ray

Quest Diagnostics has launched a renal transplant rejection test that the company claims can help doctors figure out if their patients are rejecting their new kidneys "weeks before" clinical symptoms or other standard tests can detect such events.

Kidney transplant rejection is a costly and common occurrence. Quest believes that its blood-based, non-invasive Renal Transplant Monitoring test, if widely adopted, can save the healthcare system money by obviating the need for the more expensive tests currently in use.

Quest developed the laboratory test in collaboration with Beth Israel Deaconess Medical Center and Weill Cornell Medical College. The company claims that it is the first commercial molecular diagnostic for kidney transplant rejection.

The real-time PCR-based test gauges several RNA markers, including FoxP3, GZMB, and PRF1, which Quest exclusively licensed from Beth Israel and Weill.

Terry Strom, co-director of The Transplant Institute at Beth Israel, along with Manikkam Suthanthiran, chairman of the Department of Transplantation Medicine at Weill, have published data showing that biomarkers such as FoxP3 and others are useful in detecting acute cellular rejection of renal transplants.

Researchers from Weill Cornell and elsewhere have published studies in several peer-reviewed journals demonstrating an association between the RNA markers in Quest's panel and renal transplant rejection. Rises in blood RNA levels "often occur before a rise in blood levels of serum creatinine," Quest said in a statement. As such, the Renal Transplant Monitoring test may allow doctors to predict earlier that their patients are at risk of transplant rejection and take action to prevent this from happening.

Wendy Bost, director of media relations at Quest, told PGx Reporter that the company "validated the test in the performing laboratory prior to release."

In 2009, there were nearly 17,000 renal transplant procedures performed, making the kidney the most routinely transplanted organ. However, based on 2010 figures from the US Organ Procurement and Transplantation Network and the Scientific Registry of Transplant Recipients, 70 percent of kidney transplants from a deceased donor fail within five years.

Current standard procedures for assessing whether a patient is rejecting a kidney transplant involve checking serum creatinine levels to gauge renal function and performing biopsies of the kidney, which can result in bleeding, graft injury, or loss.

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Quest Launches MDx that May Predict Kidney Transplant Rejection Earlier than Current Methods

Pharmacogenomics – Video

13-03-2012 12:01 Pentucket Medical cardiologists Sunny Biliazarian and Sunny Srivastava discuss the influence of our genetics impacts the our response to different medications. To speak with a Pentucket Medical cardiologist, please call: Haverhill, MA: (978) 521-3288 RiverWalk in Lawrence, MA: (978) 557-8900 Newburyport, MA: (978) 499-7400

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Pharmacogenomics - Video

PanGenX Takes Semantic-based Approach to Data Integration, Analytics for Personalized Medicine

By Uduak Grace Thomas

Bioinformatics startup PanGenX is betting that its semantic approach to data integration will ultimately help drug developers and diagnostic firms develop more personalized treatments.

The firm, based in Auburndale, Mass., intends to help pharma and diagnostic customers integrate proprietary and public data in "meaningful ways" and then run analyses that reveal information on individuals' responses to treatment, Jeremy Sohn, PanGenX's chief operating officer, explained to BioInform this week

The company markets the PanGenX Knowledge Base, which uses a linked data approach to aggregate pharmacogenetic data, results from peer-reviewed literature, health outcomes, and claims data. It relies on a set of proprietary ontologies that specify scientific, clinical, and business concepts and relationships to structure that data for querying and analysis.

Among the data included in the knowledgebase is a version of the National Center for Biotechnology Information's Single Nucleotide Polymorphism Database, or dbSNP, that improves on the publicly available resource, according to PanGenX.

The company's version, dubbed LD-SNP, offers a cleaner, normalized version of the public resource, which makes it possible to find additional variants that aren't currently associated with some genes in dbSNP, Sohn explained.

For example, he said, dbSNP's record of the DPYD gene which encodes for the dihydropyrimidine dehydrogenase enzyme that is involved in a metabolic pathway reports about 6,000 variants for the gene, while PanGenX's approach identified nearly 12,000 variants.

This data, combined with the company's semantic-based approach to analysis, makes it possible to map and compare polymorphisms between different individuals as well as calculate distributions of variants from a gene, drug, or disease perspective, PanGenX said.

The product also includes so-called PURL (Persistent Uniform Resource Locator) Nexus, or Plexus, technology, which lets the system combine data from the knowledgebase with remote customer data.

Currently, PanGenX offers two versions of its knowledgebase under a software-as-a-service business model: PanGenx-KB, priced at $250,000 per year for a site license, is geared toward pharma and diagnostic companies; while PanGenX-KB Professional, priced at $35,000 per year, is meant for academic and commercial research groups and labs.

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PanGenX Takes Semantic-based Approach to Data Integration, Analytics for Personalized Medicine

With MDx Usage and Costs on the Rise, UnitedHealthCare Urges Reimbursement Reform

By Turna Ray

Amid rising adoption and costs of molecular diagnostics to personalize treatment decisions, insurer UnitedHealthCare is calling for improvements in the medical claims coding system that will enable accurate test utilization tracking.

In a working paper released this week by its Center for Health Reform & Modernization, UnitedHealthcare also advocates payor-supported clinical utility studies to demonstrate that molecular tests are improving patient outcomes and reducing healthcare costs.

"Reimbursement approaches used today, which involve setting an initial rate and subsequent indexing for inflation, may not reflect appropriately the value to the delivery system of a new technology and its continued use," UHC states in the report. "They also may contribute to the rising costs of new and complex tests. New approaches are needed and the working paper discusses some of the options."

In the paper, the insurer reports that its health plan participants racked up nearly $500 million in genetic and molecular diagnostic testing costs in 2010, a 14 percent increase on a per-person basis since 2008. Overall, national spending on genetic tests and molecular diagnostics "may have reached around $5 billion" in 2010 and could reach as high as $25 billion by 2021, according to the report.

The report also includes the results of a survey of consumers and physicians to gauge their attitudes about genetic testing. A poll of more than 1,200 physicians showed that more than 75 percent of doctors identified the cost of tests and reimbursement issues as the most difficult barrier to incorporating genetic tests in their practice.

Given that the US healthcare system is spending more on molecular diagnostics that will likely get more complex with advancing knowledge about the human genome, UHC makes a number of recommendations that could help payors ensure that they are paying for tests that are robustly validated, improve patient outcomes, and ultimately reduce healthcare costs.

"A new coding system could be a foundation for better analytics, evidence development and coverage," UHC states. "Such a system would assign specific codes to individual genetic tests and genetic testing services."

UHC's recommendations come amid a number of ongoing efforts to update the molecular diagnostic coding system.

The American Medical Association has created a two-tier current procedural terminology coding system for single analyte molecular diagnostics that will likely move into use next year. The AMA has also begun issuing Category 1 codes for multi-analyte, algorithm-based assays, such as Vermillion's OVA1 ovarian cancer test (PGx Reporter 3/7/2012).

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With MDx Usage and Costs on the Rise, UnitedHealthCare Urges Reimbursement Reform

WSU recruits geneticists in new research venture

Washington State University is recruiting two genetics researchers to its Spokane campus to launch a $15 million enterprise that will add 135 pharmaceutical scientists.

It's a bold research and job creation that relies, in part, on leveraging a $1.2 million investment of local tax dollars with federal, state and private funds.

"These are people and projects that can be a real catalyst for Spokane," said Susan Ashe, acting executive director of the Health Sciences & Services Authority of Spokane County.

Called the HSSA, the authority was established several years ago to capture a sliver of the local-option sales taxes collected in the Spokane area to help pay for projects designed to create a thriving research cluster here.

If successful, the projects will turn into either sustained research facilities that create jobs, or they will produce ideas or goods that can be commercialized.

Philip Lazarus, a professor and researcher at Penn State University's College of Medicine, has been offered a position to erect a new academic and research program at WSU, a rare opportunity that WSU is dangling as a recruitment tool along with a generous financial package.

The authority is contributing $500,000 over two years to help bring Lazarus to Spokane and set up his program.

"This is pretty exciting stuff. An opportunity in academic research to really create something with your stamp on it," said Gary Pollack, WSU vice provost for health sciences.

Lazarus would work as WSU's chairman of pharmaceutical sciences at the Spokane campus starting in 2014.

His area of expertise is molecular genetics. Specifically, Lazarus is interested in pharmacogenomics. He would bring his independent, federally funded research with him.

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WSU recruits geneticists in new research venture

Bioinformatics Market Outlook to 2015

NEW YORK, March 15, 2012 /PRNewswire/ --Reportlinker.com announces that a new market research report is available in its catalogue:

http://www.reportlinker.com/p0795432/Bioinformatics-Market-Outlook-to-2015.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Genomics

During the past decade, the bioinformatics market has significantly evolved across the globe on back of rising genomics industry. The increasing application of genomics in biotech and pharmaceutical research and development has created a huge commercial market for bioinformatics worldwide. As per our latest research report's estimation, the global bioinformatics market, which reached the mark of around US$ 3 Billion in 2010, will expand at a CAGR of around 25% during 2012-2015 as the declining cost of human genome sequencing and increasing public and private sector investment will give a significant boost to the industry.

According to "Bioinformatics Market Outlook to 2015", the content market that includes specialized and generalized databases was the biggest segment of the global bioinformatics industry in 2010, followed by analysis software & services and IT infrastructure. As per our analysis, the software segment is likely to exhibit strong performance in future, improving its share in the overall market. On the other hand, content/database market will suffer the downturn due to the increasing popularity of innovative analysis software. We have also discussed in the report how the free databases would impact the sales of the paid ones.

Our report analyzed the wide application of bioinformatics in genomics, proteomics and pharmacogenomics. A further in-depth study of the market revealed that genome studies have completely transformed cancer research in the past few years and oncology has become the leading therapeutic area supported by bioinformatics. We also observed that small firms in the field are opting for outsourcing route to expand their presence. The other key trends and drivers pushing the market have also been elaborated in the comprehensive research study.

The market has witnessed the launches of key bioinformatics products and services in various areas, and we have evaluated these on the basis of their companies and countries in our report. The research includes country-level analysis and looks into the recent developments that may impact the industry's future performance in a significant manner. By providing a brief profile of key market players like Accelrys and Affymetrix and evaluating their recent activities in the study, we have presented the industry's competitive landscape. Overall, the report aims at providing an in-depth knowledge about the global bioinformatics market to clients and investors.1. Analyst View2. Research Methodology3. Key Industry Trends and Drivers3.1 Increasing Bioinformatics R&D Efforts by Players3.2 Strategic Collaborations Aimed at Enhancing Innovations3.3 Financial Support by Governments Strengthening Bioinformatics Research3.4 Oncology Research - Leading Therapeutic Area Being Aided by Bioinformatics3.5 Small Firms Enlarging Presence through Bioinformatics Outsourcing3.6 IT and Internet Growth Boosting Usage of Bioinformatics Tools4. Market Overview4.1 By Segment4.1.1 Analysis Software & Services4.1.2 Content/Database4.1.3 IT Infrastructure4.2 By Application4.2.1 Genomics4.2.2 Proteomics4.2.3 Pharmacogenomics5. Prominent Country Profile5.1 US5.2 UK5.3 Japan5.4 India5.5 China5.6 South Korea5.7 Taiwan5.8 Singapore5.9 Australia6. Recently Commercialized Products and Services7. Key Players7.1 Accelrys, Inc.7.2 Affymetrix, Inc.7.3 Compugen Ltd.7.4 IBM Life Sciences7.5 Kinexus

List of Figures:

Figure 4-1: Global - Cost of Genome Sequencing (US$), 1990 to 2015Figure 4-2: Global - Bioinformatics Market (Billion US$), 2010-2015Figure 4-3: Global - Bioinformatics Market by Segment (%), 2010Figure 4-4: Global - Analysis Software & Services Market (Million US$), 2010-2015Figure 4-5: Global - Content Market (Million US$), 2010-2015Figure 4-6: Global - IT Infrastructure Market (Million US$), 2010-2015Figure 4-7: Global - Bioinformatics IT Infrastructure Market by Segment (%), 2010Figure 4-8: Global - DNA Sequencing Market (Billion US$), 2010-2015Figure 4-9: Global - Proteomics Market (Billion US$), 2010-2015Figure 4-10: Global - Pharmacogenomics Market by Segment (%), 2009Figure 5-1: UK - Bioinformatics Market (Million US$), 2010-2015Figure 5-2: India - Bioinformatics Market (Billion INR), 2010-2015Figure 5-3: South Korea - Bioinformatics Market (Million US$), 2010-2015

List of Tables:

Table 4-1: Key Molecular Dynamics SoftwareTable 4-2: Key Molecular Modeling SoftwareTable 4-3: Key Open Source Bioinformatics SoftwareTable 4-4: Types of Generalized DatabasesTable 4-5: Types of Specialized DatabasesTable 4-6: Top Countries for High Content Analysis ResearchTable 4-7: Growth in Key Bioinformatics Databases (Dec 2010 & Dec 2011)Table 4-8: Top Countries for DNA Sequence Analysis ResearchTable 4-9: Key Genome Interpretation Databases and ResourcesTable 4-10: Available Data Sources and Gene Prioritization ToolsTable 4-11: Single Nucleotide Variants Interpretation ToolsTable 4-12: Top Countries for Proteomics ResearchTable 4-13: Mass Spectrometry E-ProgramsTable 4-14: 2-DE E-DatabasesTable 4-15: Key Pharmacogenomic DatabasesTable 4-16: Top Ten PharmGKB Gene, Drug, Disease and Pathway Pages (2009)Table 5-1: Top Countries for Bioinformatics ResearchTable 6-1: Recently Commercialized Bioinformatics ProductsTable 6-2: Recently Commercialized Bioinformatics Services

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Bioinformatics Market Outlook to 2015

Research and Markets: Stephens' Detection and Evaluation of Adverse Drug Reactions: Principles and Practice (6th …

DUBLIN--(BUSINESS WIRE)--

Research and Markets (http://www.researchandmarkets.com/research/831b19/stephens_detectio) has announced the addition of John Wiley and Sons Ltd's new book "Stephens' Detection and Evaluation of Adverse Drug Reactions: Principles and Practice (6th Edition)" to their offering.

Written with practitioners in mind, this new edition of Stephen's Detection of Adverse Drug Reactions: Principle and Practice continues to be one of the corner stones of the pharmaceutical medicine list. The classic text covers the issues and problems involved in the detection of adverse drug reactions (ADRs) throughout the life cycle of a medicine from animal studies through to clinical trials, its introduction to the market, followed by wide clinical use, and eventual decline in use or withdrawal. The sixth edition is completely revised and updated including five new chapters on pharmacogenomics, ADRs with herbal medicines, safety of medical devices, safety issues with oncology drugs, and economic aspects of ADRs. All tables and web information needed in order to practice are included to make this sixth edition a complete primer for the new practitioner and a reference for the more experienced.

Key Topics Covered:

Authors:

John Talbot, Senior Lecturer, University of Hertfordshire, UK. Formerly Director, Global Drug Safety, AstraZeneca R&D Charnwood, Loughborough, Leicestershire, UK

Jeffrey Aronson, Reader in Clinical Pharmacology, University of Oxford, Oxford, UK and President Emeritus of the British Pharmacological Society

For more information visit http://www.researchandmarkets.com/research/831b19/stephens_detectio

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Research and Markets: Stephens' Detection and Evaluation of Adverse Drug Reactions: Principles and Practice (6th ...

WSU venturing into pharmacogenomics – Tue, 13 Mar 2012 PST

March 13, 2012 in City Researchers wooed to organize $15 million researchcenter

The HSSA was established several years ago to capture some of the local-option sales taxes collected in the Spokane area to help pay for projects designed to create a thriving research cluster in thearea.

Washington State University is recruiting two genetics researchers to its Spokane campus to launch a $15 million research enterprise that will add 135 pharmaceuticalscientists.

Its a bold research and job-creation effort announced Monday that relies in part on leveraging a $1.2 million investment of local tax dollars with federal, state and privatefunds.

These are people and projects that can be a real catalyst for Spokane, said Susan Ashe, acting executive director of the Health Sciences & Services Authority of SpokaneCounty.

Called the HSSA, the authority was established several years ago to capture a sliver of the local-option sales taxes collected in the Spokane area to help pay for projects designed to create a thriving research clusterhere.

If successful, the projects will turn into either sustained research facilities that create jobs, or they will produce ideas or goods that can becommercialized.

Philip Lazarus, a professor and researcher at Penn State Universitys College of Medicine, has been offered a position to erect a new academic and research program at WSU, a rare opportunity that WSU is dangling as a recruitment tool along with a generous financial package. The HSSA is contributing $500,000 over two years to help bring Lazarus to Spokane and set up hisprogram.

This is pretty exciting stuff. An opportunity in academic research to really create something with your stamp on it, said Gary Pollack, WSU vice provost for healthsciences.

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WSU venturing into pharmacogenomics - Tue, 13 Mar 2012 PST

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

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.