Gentris Corporation Announces Collaboration to Study Blood Stability

MORRISVILLE, N.C., July 26, 2012 /PRNewswire/ --Gentris Corporation (www.gentris.com), a global leader in pharmacogenomics and biorepository solutions, announced today that it will begin a collaborative study with a major pharmaceutical company to test the long-term stability of DNA in whole blood samples that have been stored for five and ten years. This study will provide insight into the optimal, long-term storage of clinical samples to ensure adequate DNA integrity for future pharmacogenomics testing.

The three phase collaboration aims to investigate the effects of multiple freeze-thaw cycles on DNA from whole blood, both fresh and archived. In order to evaluate these effects, DNA will be extracted from archived whole blood samples after several freeze-thaw cycles and will undergo quantitative genotyping for specific genetic variations. Variants were chosen to evaluate both large and small deletions to assess DNA integrity. The results will be compared to genotyping data from the same samples before long-term storage and to similarly treated, freshly collected blood samples. A pharmaceutical partner will provide archived samples and the associated data. Gentris will provide freshly collected samples and perform the genotyping analysis.

The goal of this collaboration is to determine the impact of long term storage and multiple freeze-thaw cycles on the integrity of DNA from whole blood samples. With this data, Gentris will be able to determine whether archived samples would be best stored as whole blood or extracted DNA to ensure sufficient sample quality for future analysis. Maintaining high-quality samples allows pharmaceutical companies to utilize these biospecimens as needed during the entire drug development process, which typically takes several years to complete.

Related Links: http://www.gentris.com

Quotes: "We look forward to collaborating with our pharmaceutical partner to investigate an important question as more companies establish long-term archives of clinical samples," said Eric Hall, Gentris Vice President of Clinical Operations and Biorepository Services. "Because technologies are improving rapidly and the drug development process is lengthy, pharmaceutical companies can gain significant value from reanalyzing samples in order to refine later phases of clinical trials or answer questions that arise during development. Proper handling and storage of samples is the foundation for driving innovation in pharmacogenomics and personalized medicine."

About Gentris Corporation: Founded in 2001, Gentris is located in Research Triangle Park, NC, where it provides pharmacogenomics and biorepository support for all phases of clinical studies and genomic biomarker programs. The Company works with academic and industry leaders to translate innovations in pharmacogenomics into safer, more effective medicines, which can lead to accelerated drug development and improvement in patient care globally. In the past year, Gentris significantly expanded its facility and onsite biorepository to meet the increased needs of biopharma clients, while maintaining a preeminent quality system.

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Gentris Corporation Announces Collaboration to Study Blood Stability

Gentris Corporation Launches New Pharmacogenomics Services

MORRISVILLE, N.C., July 12, 2012 /PRNewswire/ -- Gentris Corporation (www.gentris.com), a global leader in pharmacogenomics and biorepository services, announced today that it has expanded its genomic biomarker services by incorporating multiple technology platforms into its 24,000 sq. ft., CLIA-certified, GLP-compliant laboratory. Gentris has integrated the Affymetrix GCS3000, Sequenom MassArray, and LifeTech Ion Torrent technologies in a continued effort to identify polymorphisms involved in drug response and adverse drug events as well as in determining somatic mutations in cancer.

Gentris has utilized Affymetrix DMET Plus analysis in a number of clinical studies, including oncology clinical trials. DMET Plus analysis allows drug developers to understand how variations in drug metabolism enzymes and drug transporters between patients affects adverse drug responses and treatment efficacy. This type of analysis has been implemented by major pharmaceutical companies in Phase I through Phase III clinical trials focused on numerous therapeutic areas. Most recently, Gentris collaborated with Dr. Howard McLeod of UNC-Chapel Hill to assess the risk of sensory neuropathy in breast cancer patients with genetic variations in drug metabolizing enzymes.

With the integration of Sequenom's MassArray, Gentris is able to design customizable, multiplex panels of genes for use in clinical trials. The Company has already designed a custom panel for a top ten pharmaceutical company. In addition, Gentris offers the iPLEX ADME PGx panel, which examines 192 of the most common variants in 36 ADME genes; the OncoCarta Panel v1.0, which is a comprehensive screen of 19 oncogenes and 238 mutations; and the Sequenom Sample ID Plus panel, which ensures that chain of custody is maintained and that there is amplifiable DNA in the sample.

The latest platform to be brought online is LifeTech's Ion Torrent Personal Genome Machine (PGM) for next generation sequencing. The Ion Torrent PGM allows for rapid, deep sequencing of large areas of the genome, which can efficiently identify both common and rare variations that may better predict the safety and efficacy of new drugs in development. Currently, Gentris is using the Ion Torrent PGM for discovery initiatives with its pharmaceutical partners as well as part of a collaboration with UNC-Chapel Hill.

Related Links: http://www.gentris.com

Quotes:

"The expansion of our services by using these platform technologies allows us to provide our clients quality and regulated services in all phases of the clinical development pipeline," said Dr. L.Scott Clark, Gentris Chief Scientific Officer. "It's very exciting to use the Ion Torrent for discovery initiatives, because the depth of coverage and resolution can reveal new SNPs and variations that may be clinically relevant. However, these results need to be verified on a second platform which Gentris can perform because of its extensive experience with real-time PCR, Sanger sequencing, and Sequenom platforms."

"The key to successfully implementing pharmacogenomics is to use the right platform to answer your specific question," said Dr. Howard McLeod, Director of the UNC Institute for Pharmacogenomics and Individualized Therapy and Gentris Chief Scientific Advisor. "By integrating multiple platforms, Gentris has the ability to address the needs of pharmaceutical clients during any stage in the clinical development of a drug. I'm excited to be working with them to discover, translate, and validate new biomarkers that will have an impact on patient care."

About Gentris Corporation:

Founded in 2001, Gentris is located in Research Triangle Park, NC, where it provides pharmacogenomics and biorepository support for all phases of clinical studies and genomic biomarker programs. The Company works with academic and industry leaders to translate innovations in pharmacogenomics into safer, more effective medicines, which can lead to accelerated drug development and improvement in patient care globally.

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Gentris Corporation Launches New Pharmacogenomics Services

Gentris Corporation Expands Headquarters, Biorepository

MORRISVILLE, N.C., Sept. 13, 2012 /PRNewswire/ --Gentris Corporation (www.gentris.com), a global leader in pharmacogenomics and biorepository solutions, announced today the completion of a significant expansion to their Morrisville, N.C. facility. The first phase of the expansion included additional office space and a large, multipurpose conference room, which will accommodate scientific training and education programs. The second phase of construction tripled the available capacity of the clinical sample biorepository in order to meet future demand.

Gentris continues to invest in capabilities and capacity to address the growing personalized medicine market. As more pharmaceutical companies pursue biomarker-driven therapeutic strategies, there is a growing need to collect and store patient samples for analysis. The expanded biorepository will ensure sufficient capacity to accommodate the sample storage and management needs of pharmaceutical clients that are implementing pharmacogenomics in clinical trials. In addition to biorepository space, Gentris has added a large conference room to host scientific training and education programs that will focus on providing up-to-date information on best practices for integrating pharmacogenomics into drug development.

Eric Hall, Gentris VP of Clinical Operations and Biorepository Services, will be chairing a session on Strategic Specimen Tracking as part of the Biorepository track at the Clinical Business Expo 2012 in Boston on September 19-20.

Related Links: http://www.gentris.com

Quotes:

"As demand for clinical sample storage grows, we needed a larger, dedicated facility for sample management and biosrepository functions," said Eric Hall, Gentris VP of Clinical Operations and Biorepository. "Pharmaceutical companies are increasingly recognizing the value of banking clinical trial samples for immediate or future testing. By tripling the size of our biorepository space, we have increased our flexibility to manage and store a large number of diverse sample types and serve our rapidly expanding client base."

"We anticipate an increased need for biorepository and pharmacogenomics testing services as pharmaceutical companies invest in personalized medicine," said Scott Clark, Gentris Chief Scientific Officer. "The recent expansion will enable us to continue providing high quality solutions to our clients as well as to host training and education programs focused on maximizing the benefits of integrating pharmacogenomics and biobanking into clinical trials."

About Gentris Corporation:

Founded in 2001, Gentris is located in Research Triangle Park, NC, where it provides pharmacogenomics and biorepository support for all phases of clinical studies and genomic biomarker programs. The Company works with academic and industry leaders to translate innovations in pharmacogenomics into safer, more effective medicines, which can lead to accelerated drug development and improvement in patient care globally.

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Gentris Corporation Expands Headquarters, Biorepository

Research and Markets: Companion Diagnostics in Personalized Medicine and Cancer Therapy

DUBLIN--(BUSINESS WIRE)--

Research and Markets (http://www.researchandmarkets.com/research/h3n97n/companion_diagnost) has announced the addition of the "Companion Diagnostics in Personalized Medicine and Cancer Therapy" report to their offering.

Companion diagnostics (CDx) refers to a particular clinical diagnostic test that is under evaluation and is specifically linked to a known drug therapy. This linkage could be important in the therapeutic application and clinical outcome of a drug, such as with personalized medicine for oncology patients. The molecular diagnostics field plays a vital part in personalized medicine and has greatly expanded over the past twenty years, expanding by more than 20% annually compared to most other laboratory procedures. Research will continue to produce an increased understanding of disease processes, and diagnostics manufacturers will continue to expand and refine the technology and automation needed for clinical testing. Companion diagnostics, although smaller at present, is one of the fastest growing segments in the in vitro diagnostic (IVD) market. And while the concept of a drug-diagnostic combination is not new, it has only recently started to generate interest with the move of healthcare towards pharmacogenomics.

This TriMark Publications report examines the use of companion diagnostics in personalized medicine and cancer therapy. The study provides a qualitative and quantitative review of the industry, including cancer biomarker tests, pharmacogenomics tests, recurrence prediction tests, blood-based technologies, proteomics and regulatory trends. Moreover, this analysis profiles the leading companies that are developing and manufacturing companion diagnostics solutions. Each company is discussed in extensive depth with a section on its history, product line, business and marketing analysis, and a subjective commentary of the company's market position. Detailed tables and charts with sales forecasts and market share data are also included.

Key Topics Covered:

1. Overview

2. Companion Diagnostics and Personalized Medicine

3. Companion Diagnostics: Qualitative and Quantitative Market Analysis

4. Trends and Overview

5. Biomarker Tests Co-developed with Cancer Therapeutics as Companion Diagnostics

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Research and Markets: Companion Diagnostics in Personalized Medicine and Cancer Therapy

Synta Announces Results from Interim Analysis of the Randomized Phase 2b/3 GALAXY Trial Evaluating Ganetespib plus …

LEXINGTON, Mass.--(BUSINESS WIRE)--

Synta Pharmaceuticals Corp. (SNTA) today announced encouraging results from a planned interim analysis of the GALAXY trial, a randomized Phase 2b/3 study designed to evaluate the efficacy and safety of the Companys lead Hsp90 inhibitor, ganetespib, in combination with standard-of-care docetaxel vs. docetaxel alone as second-line treatment for advanced non-small cell lung cancer (NSCLC).

The GALAXY trial is based on a two-stage, operationally adaptive design. The first-stage, randomized, open-label, 240-patient Phase 2b portion of the trial is designed to enroll Stage IIIB/IV NSCLC patients who have progressed following one prior line of therapy, with the goal of determining biomarkers predictive of ganetespib activity. Results will be used to guide choice of patient population for the Phase 3 stage of the trial.

Patients in the GALAXY trial are randomized 1:1 to receive ganetespib plus docetaxel or docetaxel alone. Patients in both arms receive a standard regimen of docetaxel 75 mg/m2 on day 1 of a 21-day cycle; patients in the combination arm receive in addition ganetespib 150 mg/m2 on days 1 and 15. Treatment continues until disease progression per RECIST 1.1 criteria.

The co-primary endpoints of GALAXY are PFS (progression-free survival) in patients with elevated baseline level of serum LDH (lactate dehydrogenase), and PFS in the mutant KRAS population. PFS and OS (overall survival) in all adenocarcinoma patients are key secondary endpoints. Serum LDH levels and tumor KRAS mutation status are assessed by independent central laboratories.

Elevated LDH: Elevated baseline LDH occurs in approximately one quarter to one third of advanced cancer patients in clinical trials and is prognostic of poor clinical outcomes in many cancer types, including lung cancer.[1-3] While elevated LDH can result from several conditions, in cancer patients elevated levels of LDH and its isoforms have been associated with tumor hypoxia (lack of oxygen).[4,5] Inhibition of hypoxia pathways has been shown to enhance anti-cancer activity of taxanes and other chemotherapies.[6] Recent results from trials evaluating agents that target hypoxia-related pathways, including VEGF and mTOR inhibitors, have shown correlation between elevated LDH and improved clinical activity.[7-10] In laboratory experiments, treatment with ganetespib potently suppresses HIF-1alpha, a critical regulator of hypoxic pathways[11] supporting potential application for ganetespib in combination with taxanes in this patient population.

KRAS mutation: Activating KRAS mutations, estimated to occur in 15-30% of NSCLC patients, are also associated with poor clinical outcomes and limited therapeutic options.[12,13] Hsp90 is required for the proper function of a number of key signaling proteins in the KRAS pathway, while inhibition of Hsp90 by ganetespib has shown promising activity in laboratory models of this disease.[14] Recent results from trials evaluating ganetespib monotherapy in lung, colon, and gastric cancers have further suggested promising potential in patients with KRAS mutations.

Based on a target enrollment of 240 adenocarcinoma patients, GALAXY is 90% powered to detect a PFS improvement from 6 to 12 weeks in elevated LDH patients and from 5 weeks to 10 weeks in the mutant KRAS patients. For the key secondary endpoints: in all adenocarcinoma patients, GALAXY is 88% powered to detect an improvement in PFS from 3 to 4.5 months, and 73% powered to detect an improvement in OS from 6 to 8.5 months. All powering assumptions are based on a 1-sided alpha of 0.05. An interim analysis was planned when approximately 50% of patients had been enrolled and had sufficient follow up, defined as one post-baseline scan.

GALAXY Interim Results

At the time of this interim analysis, a total of 114 adenocarcinoma and 69 non-adenocarcinoma patients had been enrolled. Following a review earlier this year that determined low likelihood of benefit in the non-adenocarcinoma population, the trial was modified to enroll only adenocarcinoma patients. Results reported below are for adenocarcinoma patients only.

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Synta Announces Results from Interim Analysis of the Randomized Phase 2b/3 GALAXY Trial Evaluating Ganetespib plus ...

Life-sciences team forms new partnerships at US event

Home national Life-sciences team forms new partnerships at US event

The Nation July 3, 2012 1:00 am

The collaborative project with the US is aimed at developing "probe capture assay" applications on next-generation DNA-sequencing technologies for HIV-1 pharmacogenomics, the most advanced of its kind in the world. It will put new tools for diagnosing both human and virus genomes in the hands of front-line physicians, and bring clear benefits to patients.

The 2012 BIO International Convention held last week in Boston, Massachusetts drew 20,000 participants including researchers, scientists, investors and businessmen from both the public and private sectors. TCELS led a team of Thai delegates from allied agencies including the Board of Investment (BoI), National Nanotechnology Centre (Nanotec) and Naresuan University. Works by Thai researchers were presented at the Thai Pavilion.

TCELS presented projects under its support including a whitening product made from natural latex extracted by Prince of Songkla University; the discovery of genes allergic to the anti-retroviral drugs Nevirapine and d4T (a world first discovery by the Pharmaco-genomics Project at Ramathibodi Hospital with Mahidol University); and other pre-clinical and clinical research developments that meet international standards. This is to prove the country's potential in research collaboration and services.

TCELS acting head Kamchorn Balangura said that over the four-day event, more than 700 visitors showed their interest and sought details about Bio-Nanotechnology investment, standard clinical research and development, as well as Thai life-science products.

Kamchorn said the event was a great success for Thailand, as the team was able to establish tie-ups with counterparts from major countries in the field like South Korea and the US. The Chuncheon Bioindustry Foundation (CBF), a South Korean regional industrial estate, is interested in integrating research in the industry, and has already signed an MoU with Thailand.

US biotechnological firm Pathogenica, which works on advanced DNA-sequencing technologies, also agreed to sign an MOU to collaborate with the TCELS-supported Pharmaco-genomics Project.

Prof Wasun Chantratita, head of the Pharmacogenomics Project, said Dr Yemi Adesokan, the chief of Pathogenica, had followed Thai research on pharmacogenomics for a while and expressed an interest in establishing a collaboration. After learning that the Pharmaco-genomics team was at the convention, talks were held and the groups agreed to work together.

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Life-sciences team forms new partnerships at US event

Healthscope to commercially launch Circadian's Cancers of Unknown Primary Diagnostic Test

MELBOURNE, Australia, June 26, 2012 /PRNewswire/ --Circadian Technologies Limited (ASX: CIR, OTCQX: CKDXY) announces that it has been advised by its development partner, Healthscope Advanced Pathology, that it will commercially launch Circadian's novel technology for aid in the diagnosis of "Cancers of Unknown Primary" (CUP), on Monday July 16 2012 in Australia, New Zealand, Singapore and Malaysia under the brand CUPGUIDE.

The diagnostic test method has been developed in collaboration between Circadian, Healthscope, the Peter MacCallum Cancer Centre, a leading specialty cancer centre, and scientists at NICTA, Australia's Information and Communications Technology (ICT) Research Centre of Excellence.

A publication in March 2012 from Healthscope reported that the CUP test was able to detect actual primary source of tumour type with 93% accuracy within the first three predictions and had 98.5% specificity across 15 different tumour types.

Healthscope, through its subsidiary Clinical Laboratories Pty Ltd, has rights to develop, clinically validate and market the test throughout Australia, New Zealand, Malaysia and Singapore. Circadian retains rights to market the test in the remainder of the world. Healthscope has paid Circadian an upfront fee, and will pay a royalty on sales of the test. Circadian, through its wholly owned subsidiary Cancer Therapeutics Limited, owns exclusive worldwide rights to the test through a licensing arrangement with the Peter MacCallum Cancer Centre and NICTA.

The CUP diagnostic methodology identifies a patient's tumour type by comparing its pattern of gene expression to a database of known tumours. It is hoped that by correctly identifying a patient's tumour type, clinicians can choose the most effective treatment strategy for the cancer. CUP is generally less well known and publicised than other cancer types. However, it is actually more common than leukaemia and is the fifth most common cause of death due to cancer in Australia. In 2007, Cancer Council Australia estimated the incidence of CUP to be around 2900 case per annum; American Cancer Society estimated USA incidence at around 32,000 per annum and Cancer Research UK estimated UK incidence at 14,000 per annum.

Robert Klupacs, Circadian Managing Director and CEO stated, "We are absolutely delighted that after all of the efforts of the collaborative partners that CUPGUIDE will now be available to oncologists and pathologists. We are extremely hopeful that CUPGUIDE will have a major impact in significantly improving the clinical diagnosis of CUP."

Dr Keith Byron, Scientific Director of Healthscope's Advanced Pathology Division said, "Healthscope is proud and excited that after the extensive development program we have undertaken with our partners that we will now be able to provide this ground breaking diagnostic technology on a commercial basis. The test is an important addition to our existing business of providing diagnostic tools for doctors throughout our 43 hospitals and the health care industry in general."

Prof David Bowtell, Head of the Cancer Genomics Program at the Peter MacCallum Cancer Centre and a co-inventor of the diagnostic methodology added, "The approach was initially developed in our lab several years ago but the assay needed to be made more generally available. Circadian and Healthscope have been critical to taking the work forward and it is very gratifying that this product of our translational research efforts will be made available to clinicians throughout the region. The concept of personalising treatments for patients based on highly specialised diagnostics is now very well accepted in oncology and has been shown to have significant patient benefit. We believe that the assay will lead to earlier diagnosis, improved treatment outcomes and enhanced quality of life for patients."

Dr Adam Kowalczyk, Leader of Diagnostic Genomics Team in NICTA's Victorian Research Laboratory, and a co-inventor of the diagnostic methodology added, "It is very satisfying that formal techniques for signal detection and pattern recognition can be utilised in practical medical applications. This diagnostic test heralds imminent arrival of many new developments bringing promises of personalised medicine and genomics, in particular, to everyday usage that benefits patients."

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Healthscope to commercially launch Circadian's Cancers of Unknown Primary Diagnostic Test

JCI early table of contents for June 25, 2012

Public release date: 25-Jun-2012 [ | E-mail | Share ]

Contact: Sarah Jackson press_releases@the-jci.org Journal of Clinical Investigation

METABOLISM The skinny on what makes us fat

Obesity is a disorder in which fat cells grow larger and accumulate. Certain proteins, called WNT family proteins, function to prevent fat cell formation. However, the activity of WNT proteins can be inhibited by secreted frizzled-related proteins (SFRPs), thus leading to fat cell generation. One of these SFRPs, SFRP5, is highly expressed during fat cell generation and increases during obesity. Dr. Ormond MacDougald and colleagues at the University of Michigan sought to determine the mechanism of SFRP5-mediated obesity and found that mice lacking SFRP5 were resistant to diet-induced obesity, despite having similar numbers of fat cells as control mice. The results from a transplantation experiment wherein fat tissue was transferred from SFRP5-deficient mice into obesity-prone mice demonstrated that the mechanism of SFRP5-mediated inhibition of fat cell generation is specific to the tissue itself and not dependent on the surrounding environment. The team also found that SFRP5-deficient mice showed increased metabolic activity compared to control mice. These findings, which were discussed in a commentary by Alexander Rauch and Susanne Mandrup at the University of Southern Denmark, shed light on the mechanism of SFRP5-mediated obesity and identify the WNT signaling pathway as a potential therapeutic target to counteract obesity.

TITLE:

Regulation of adipocyte mitochondrial biogenesis and metabolism by secreted frizzled-related protein 5 and WNT signaling

AUTHOR CONTACT:

Ormond MacDougald University of Michigan, Ann Arbor, MI, USA Phone: (734) 647-7721; Fax: 734 232-8175; E-mail: macdouga@umich.edu

ACCOMPANYING COMMENTARY

TITLE:

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JCI early table of contents for June 25, 2012

Frost & Sullivan: Expanding Sample Prep Market Supports Growth Trends in Molecular Diagnostics Markets

Biomarker validation analyses create surge in demand for formalin-fixed, paraffin-embedded sample prep solutions

MOUNTAIN VIEW, Calif., June 21, 2012 /PRNewswire-Asia/ -- Hundreds of millions of formalin-fixed, paraffin-embedded (FFPE) archive specimens available globally have piqued tremendous interest for biomarker validation studies, generating a surge in demand for FFPE sample prep solutions. FFPE archive specimens from patients with known clinical outcomes provide an economic and readily available source for the biomarker validation needed to develop clinical molecular cancer tests.

Analysis from Frost & Sullivan's (http://www.clinicaldiagnostics.frost.com( http://www.frost.com/prod/servlet/svcg.pag/HCCD )) Demand Analysis of U.S. Cancer Sample Prep Market research finds that automated sample prep systems developed specifically for FFPE provide greater sample throughput and satisfy the requirements of various end users.

If you are interested in more information on this research, please send an email to Britni Myers, Corporate Communications, at britni.myers@frost.com( mailto:britni.myers@frost.com ), with your full name, company name, job title, telephone number, company email address, company website, city, state and country.

Archived tissues are Institutional Review Board (IRB) exempt and are a feasible alternative to validating biomarkers when compared to costly prospective clinical trials. Therefore, pharmaceutical companies and research institutes are employing FFPE services for their pharmacogenomics programs.

"Translational research using FFPE archive specimens is helping to produce an expanding menu of future molecular-based cancer testing," said Frost & Sullivan Industry Analyst Winny Tan. "A Frost & Sullivan survey of molecular pathology labs in the United States reveals that nucleic acid extraction from FFPE specimens is poised for more than 20 percent volume growth in the next three years."

Molecular sample prep vendors have offered kits for FFPE specimens for the last three to five years. Process automation signals the brink of a market expansion fueled by the increased throughput. Additionally, clinical molecular tests for serine/threonine-protein kinase B-Raf (BRAF) and GTPase Kras (KRAS) gene biomarkers, as well as for epidermal growth factor receptor (EGFR), are driving the demand for the FFPE sample preps.

Sample prep for FFPE specimens that produce nucleic acid extractions of high purity and yield will become even more critical for downstream molecular testing. The clinical labs surveyed by Frost & Sullivan anticipate an inevitable integration of molecular extraction techniques with the long FFPE legacy that exists in solid tumor diagnostics.

However, growth of this market is hindered by the limited number of sites where molecular pathology is performed as well as the slow adoption of FFPE sample prep automation by hospital laboratories. Further, hospital budgets are restricted, and investments for FFPE sample prep automation compete with other top priorities, such as the implementation of electronic medical records. Despite these factors, the hospital segment is far from saturation, as it has long-term potential.

The FFPE sample prep automation market targets a variety of end user segments with different needs, applications, and perceptions; therefore, a strong understanding of relevant product specifications is critical for capitalizing on the market opportunity. Vendors must remain attentive to genomic analysis trends and emerging applications to keep pace with changing customer needs in specimen types, protocol customization and throughput.

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Gentris Corporation Partners with the Shanghai Institutes of Preventative Medicine

MORRISVILLE, N.C., June 21, 2012 /PRNewswire/ -- Gentris Corporation (www.gentris.com), a global leader in the application of genomic biomarkers to clinical studies, announced today that it has signed a Memorandum of Understanding with the Shanghai Institutes of Preventative Medicine to advance global personalized medicine. The goal of this USA-China collaboration is to create translational research and epidemiological projects, as well as training and education programs, focused on pharmacogenomics and clinical sample banking, which will drive innovation in drug development and improvements in patient care.

Through this collaboration, Gentris and the Shanghai Institutes of Preventative Medicine will work together to launch cutting-edge research projects to discover, develop, and validate new genomic biomarkers. Gentris will take the lead to identify sponsors in the United States, e.g., pharmaceutical companies, for these personalized medicine projects while the Shanghai Institutes of Preventative Medicine will seek support from Chinese organizations.

The tuberculosis drug-induced liver injury pilot (TB DILI Study), conducted between Gentris, the Shanghai Institutes of Preventative Medicine, and a non-profit research institute in Research Triangle Park (RTP) serves as a model for USA-China collaborations. In this study, investigators designed a common protocol and pooled their resources to investigate DILI among tuberculosis patients in three Shanghai hospitals. By utilizing metabolomics and pharmacogenomics, they are evaluating biomarkers for early detection. Dr. Tong Zhou, Senior Director of China Initiatives for Gentris, is Co-Principal Investigator for the TB DILI Study and has significant experience in developing and managing collaborations between the United States and China. Dr. Zhou has also drawn upon his extensive network in China to begin establishing a satellite laboratory for Gentris in Shanghai that complies with U.S. regulatory standards.

Dr. Wu Fan, Director General of the Shanghai Institutes of Preventative Medicine and the Shanghai Municipal Center for Disease Control and Prevention (Shanghai CDC), and Dr. Howard McLeod from the University of North Carolina will provide strategic scientific oversight for personalized medicine collaborations. Director Wu is recognized internationally as a leader in public health initiatives. Dr. McLeod, Chief Scientific Advisor for Gentris, has been involved in numerous global initiatives including the Pharmacogenetics for Every Nation Initiative (PGENI), which he founded. It is anticipated that combining the resources and expertise of a research institute, academic institution, and industryin both the United States and Chinawill lead to more rapid improvements in drug development and public health.

For this personalized medicine program, research studies and epidemiological projects will be designed for implementation in Shanghai based on sponsor needs. Key targeted therapeutic areas include oncology, infectious disease, and chronic disease. Training and education initiatives will also be created to bring U.S. quality standards to China including GLP, GCP, CLIA, and CAP. Gentris, the Shanghai Institutes of Preventative Medicine, and their collaborators will work with leading experts to develop workshops, courses, and a fellowship program to educate academic and industry scientists in China regarding best practices in the application of pharmacogenomics for drug development.

The Memorandum of Understanding leverages the relationships that Gentris CEO Rick Williams and Dr. Zhou have built during the past few years between North Carolina and China. While assisting a non-profit research institute in RTP, they helped to create the North Carolina-China Global Bioscience Gateway, a public-private partnership that addresses how to enhance global research innovation. Mr. Williams and Dr. Zhou are also members of the N.C. China Advisory Council, which works with the N.C. Office of the Governor and N.C. Department of Commerce to facilitate economic development between the state and China.

One of the major goals for this new agreement between Gentris and the Shanghai Institutes of Preventative Medicine is to create an expanded network of collaborators among leading universities, pharmaceutical companies, and public health organizations that leads to new pharmacogenomics discoveries, which accelerate drug development and improve patient care globally.

Related Links: http://www.gentris.com, http://www.scdc.sh.cn

Quotes:

"I have worked with the Shanghai CDC and Shanghai Institutes of Preventative Medicine for nearly four years to develop a translational research bridge between our two countries. I'm honored that Gentris now has an opportunity to work even more closely with the Shanghai Institutes of Preventative Medicine," said Rick Williams, Gentris CEO. "Gentris will take the lead to identify U.S. sponsors in the pharmaceutical industry that would like to jointly develop new research, epidemiological, and training programs in Shanghai."

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Gentris Corporation Partners with the Shanghai Institutes of Preventative Medicine

CepMed Appoints New CEO

MONTREAL, QUEBEC--(Marketwire -06/18/12)- Mr. Michel Saucier, Chairman of the Board of Directors of CepMed, the Center of Excellence in Personalized Medicine, is pleased to announce the appointment of Ms. Manon Decelles, CPA, CGA as Chief Executive Officer. Coincident with Ms. Decelles' arrival, Dr. Clarissa Desjardins, outgoing CEO, is leaving to manage a start-up biotechnology company.

Ms. Decelles has 20 years of experience in the pharmaceutical industry and a proven track record in key areas of business including finance, marketing and business development. Together with this experience Ms. Decelles brings an extensive business network that will enable CepMed in bringing together medical, scientific and business communities to promote innovation and commercialization in personalized medicine. Prior to joining CepMed, Ms. Decelles was Director of Business Development and Acquisitions at Sanofi, a global and diversified healthcare leader, where she was responsible for the Canadian affiliate's business development activities, including in and out licensing, divestitures as well as company acquisitions. In this capacity, Ms. Decelles developed and implemented a Strategic Business Development Plan and review process that guided Sanofi's Canadian strategy. Previously, Ms. Decelles held roles of increasing responsibility in finance, marketing and business development at Marion Merrell Dow, Hoechst Marion Roussel and Aventis. Ms. Decelles is an active member of the Board of Directors of the Canadian Healthcare Licensing Association.

Ms. Decelles first studied in science - microbiology at the University of Sherbrooke. She later obtained a Bachelor of Business Administration from the University of Montreal, HEC and is also a Chartered Professional Accountant (CPA).

"As Cepmed approaches its fifth year of operations, we believe that Manon's background and experience is perfectly suited to take Cepmed to the next level. Going forward, we expect to increasingly attract foreign investment in our centre for translational studies, commercialize the results of our studies and implement personalized medicine tests and strategies into our healthcare system. We welcome Manon to her new position and are confident that she can take on this challenge." - Mr. Michael Saucier, Chairman of the Board, CepMed

The Board extends its best wishes to Clarissa in her new endeavors and its deep gratitude for her contributions to CepMed and the advancement of personalized medicine in Canada. "Her leadership of our public-private partnerships and innovative knowledge translation activities including a Personalized Medicine Portal and the creation of physician's expert panels in cardiology, oncology and family medicine have created an awareness of personalized medicine and its benefits across the country." - Dr. Jean Claude Tardif, Director Montreal Heart Institute Research Centre

About CepMed

Founded by the Montreal Heart Institute and Genome Quebec in 2008, CepMed is a non-profit organization dedicated to promoting the science and practice of personalized medicine. It is a Centre of Excellence for Commercialization and Research (CECR) funded by the Canadian Government, Genome Quebec and industry partners including Pfizer, AstraZeneca, Novartis and Merck. Cepmed's initiatives are designed to promote and enable personalized medical treatment, based on the use of molecular information in clinical decision making, in particular to improve the efficacy and safety of drug therapy. Cepmed participates in several multi-million dollar public-private partnerships (PPP) in translational medicine that incorporate pharmacogenomics into Phase III clinical trials or studies of marketed drugs with partners including Roche and Servier. These partnerships leverage the expertise and capacities of The Beaulieu Saucier Pharmacogenics (PGx) Centre, The Montreal Heart Institute Coordinating Centre (MHICC) and The Montreal Heart Institute Biobank. Generating several millions of dollars in investment these partnerships have established a unique and world class centre for translational clinical research. In addition CepMed is collaborating and partnering with Canadian stakeholders in personalized medicine including physicians, patients, governments, industry and investors to enable the clinical development and implementation of personalized medicine while creating commercial opportunities for Canadian companies.

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CepMed Appoints New CEO

GenMark Diagnostics Appoints Stephen T. Worland, Ph.D. to Board of Directors

CARLSBAD, Calif.--(BUSINESS WIRE)--

GenMark Diagnostics, Inc. (NASDAQ: GNMK), a provider of automated, multiplex molecular diagnostic testing systems, announced today that Dr. Stephen T. Worland has been appointed to GenMark's Board of Directors.

Stephen Worland has extensive experience in global technology, infectious disease and healthcare businesses and is currently President and Chief Executive Officer and a director of eFFECTOR Therapeutics, Inc., a start-up stage company focused on new treatments for cancer. Dr. Worland was President and Chief Executive Officer and a director of Anadys Pharmaceuticals, Inc., a biopharmaceutical company which discovered and developed treatments for Hepatitis C and cancer, from August 2007 until the companys acquisition by Roche in November 2011. Dr. Worland joined Anadys in 2001 and served in a number of executive roles prior to being named CEO, including President, Pharmaceuticals, and Chief Scientific Officer. Dr. Worland began his healthcare industry career in 1988 at Agouron Pharmaceuticals, Inc. and remained with the company through its successful commercialization of an HIV protease inhibitor and successive acquisitions by Warner-Lambert and Pfizer. During this period he held a number of positions, including Vice President, Antiviral Research and Director, Molecular Biology and Biochemistry. Dr. Worland was a National Institutes of Health Postdoctoral Fellow in Molecular Biology at Harvard University from 1985 to 1988. He received his B.S. with highest honors in Biological Chemistry from the University of Michigan and his Ph.D. in Chemistry from the University of California, Berkeley.

"We are delighted to have Steve Worland join our Board. In addition to his extensive operational experience in the Pharmaceutical industry, both in small and large companies, Steves deep knowledge of molecular biology, specifically as it relates to infectious disease, cancer and related pharmacogenomics, will be invaluable as GenMark continues to build its own molecular diagnostics franchise in these areas. Steves skill set and experience complement an already strong Board that is focused on building a high value business in the global molecular diagnostics market, commented Christopher Gleeson, GenMark's Chairman.

ABOUT GENMARK

GenMark Diagnostics is a leading provider of automated, multiplex molecular diagnostic testing systems that detect and measure DNA and RNA targets to diagnose disease and optimize patient treatment. Utilizing GenMark's proprietary eSensor detection technology, GenMark's eSensor XT-8 system is designed to support a broad range of molecular diagnostic tests with a compact, easy-to-use workstation and self-contained, disposable test cartridges. GenMark currently markets three tests that are FDA cleared for IVD use: Cystic Fibrosis Genotyping Test, Warfarin Sensitivity Test, and Thrombophilia Risk Test. A Respiratory Viral Panel (RVP) has been submitted to the FDA for 510(k) clearance. A number of other tests, including HCV Genotyping and 2C19, versions of which are available for research use only, are in development for IVD use. For more information, visit http://www.genmarkdx.com.

SAFE HARBOR STATEMENT

This press release includes forward-looking statements regarding events, trends and business prospects, which may affect our future operating results and financial position. Such statements, including, but not limited to, those regarding continued growth in sales of our diagnostic tests, the expansion of our diagnostic test menu, the development and functionality of our products and the continued development of our technology, are all subject to risks and uncertainties that could cause our actual performance, operating results and financial position to differ materially. Some of these risks and uncertainties include, but are not limited to, risks related to our history of operating losses, our ability to successfully commercialize our products, the need for further financing and our ability to access the necessary additional capital for our business, inherent risk and uncertainty in the protection intellectual property rights, ability to maintain gross margins, regulatory uncertainties regarding approval or clearance for our products, as well as other risks and uncertainties described under the "Risk Factors" in our public filings with the Securities and Exchange Commission. We assume no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made.

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GenMark Diagnostics Appoints Stephen T. Worland, Ph.D. to Board of Directors

AMP Receives 40% Increase in Abstract Submissions

Newswise Bethesda, MD, June 13, 2012: the Association for Molecular Pathology (AMP) announced a record-breaking number of abstract submissions for the AMP 2012 Annual Meeting on Genomic Medicine, marking a 40% increase over last year. The Meeting will be held October 25-27, 2012 in Long Beach, CA. An increase in the number of meeting attendees and exhibitors is anticipated as well. "The record growth in every phase demonstrates clearly how well-recognized it is that AMP offers the meeting of the year in molecular diagnostics and genomics," stated Iris Schrijver, MD, AMP President.

Growth in recent years and the spike in this years AMP Annual Meeting participation mirror the marked growth in the field of molecular pathology. AMP has had consistent growth in the number of abstracts submitted and number of attendees at the annual meeting, but the increase this year blew the lid off even our expectations, noted Mary Steele Williams, Executive Director, The AMP 2012 Annual Meeting on Genomic Medicine promises to be jam-packed with attendees and exciting scientific exchange.

As the only organization dedicated solely to the practice and science of molecular pathology, it is natural that the AMP Annual Meeting serves as the showcase for translational research, clinical practice, and practical technical discussions in all aspects of molecular diagnostics and genomic medicine. Abstract topics submitted for this years meeting span the breadth of molecular diagnostics, including the use of next generation sequencing in a clinical setting; novel tools for the detection of infectious agents; development and validation of new molecular tests; detection and analysis of various biomarkers in cancer.

Session topics chosen for this years meeting include; integrating pharmacogenomics into health care, utility of next generation sequencing, new molecular pathology CPT codes, and many more. AMP expects a record number of poster presentations at this years AMP Annual Meeting. With 400+ posters plus more than 30 hours of educational sessions and 55 presentations, this years event is expected to be the largest to date.

ABOUT AMP: The Association for Molecular Pathology (AMP) is an international medical professional association dedicated to the advancement, practice, and science of clinical molecular laboratory medicine and translational research based on the applications of molecular biology, genetics, and genomics. For more information, please visit http://www.amp.org.

CONTACT: Mary Steele Williams mwilliams@amp.org (301) 634-7921

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AMP Receives 40% Increase in Abstract Submissions

CareCapital Grp plc – Agreement with Varigen Technologies

12 June 2012

CARECAPITAL GROUP PLC

("CareCapital" or "the Company")

Agreement with Varigen Technologies

Diagnosis and Treatment of Malignant Diseases Based on Genetic Testing, Initially Targeted at Women's Health Care

CareCapital (AIM: CARE) announces that it has signed a mutually exclusive agreement ("the Agreement") with Varigen Technologies ("Varigen") to use Varigen's expertise in the areas of genetic testing and its application to both the diagnosis and development of personalized medical treatments for patients with malignant diseases. Under the Agreement, the specialist services supplied by Varigen will initially be made available at CareCapital's planned medical centre in Folkestone (Berlin: FKO.BE - news) , dedicated exclusively to women's health. Varigen will be entitled to a share, after deduction of all operating costs, of 30% of revenues derived from the provision of the services, with CareCapital retaining the remainder.

Varigen is a company established by Mark Hoser, an expert in the field of genetic and medical diagnostics. Following the award of a PhD from St Thomas' Hospital in haematology and coagulation diagnostics, Mark subsequently held various management positions with large, international pharmaceutical companies before founding GeneForm Technologies in 2003 to exploit his patents in molecular diagnostics and pharmacogenomics. After a successful trade sale of GeneForm Technologies, he has continued his focus on personalized medicine and rapid, next generation diagnostics as well as genotyping technologies for the prediction of drug efficiency in oncology.

Commenting on the Agreement, Mike Sinclair, CareCapital's CEO, said,"The addition of Mark's expertise via this agreement with Varigen Technologies is exactly on strategy for us as we build and grow our specialist cancer services business. The services developed with Varigen will be first available at our dedicated women's health care facility but can then be rolled out more widely."

Mark Hoser of Varigen, added, "The personalisation of diagnosis and treatment are critical steps in the future of medical care and translate to best care and improved quality of life for the patient. Varigen is excited to contribute to CareCapital's endeavour's in making this a reality."

For further information, please visit http://www.carecapital.co.uk or contact:

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CareCapital Grp plc - Agreement with Varigen Technologies

Research and Markets: European Molecular Diagnostics Markets

DUBLIN--(BUSINESS WIRE)--

Dublin - Research and Markets (http://www.researchandmarkets.com/research/7m2ls7/european_molecular) has announced the addition of Frost & Sullivan's new report "European Molecular Diagnostics Markets" to their offering.

This Frost & Sullivan research service titled European Molecular Diagnostics Markets provides a comprehensive analysis of key challenges, drivers, and restraints as well as recent venue forecasts. It also examines major trends and initiatives in the molecular diagnostics market. The research covers oncology, genetic diseases, infectious diseases and pharmacogenomics segments.

Market Overview

Automation to Play Important Role in Expansion of Molecular Diagnostics Markets

The potential for enhanced clinical efficiency and reduced costs is fuelling the interest of healthcare stakeholders in personalised and preventive medicine. Molecular diagnostics is a vital tool to support this trend. Available molecular diagnostics technologies can detect diseases at very early stages and help monitor the efficacy of therapies being used in disease treatment. Technology advances, paralleled by the decreasing cost of automated systems, will boost market prospects, notes the analyst of this research. Automation, in particular, will play an increasingly important role in market expansion.

Many molecular diagnostic methods were historically based on steps of manual pipetting. Automated devices are nowadays replacing them and offer numerous advantages. These include faster turn-around time (TAT), manipulation of smaller volumes of liquids as well as more accurate and quantifiable results, compared to manual methods. Automation is currently of interest mostly among large diagnostic laboratories, but it is expected that, over time, automated systems will also be available at smaller laboratories, remarks the analyst. In small and medium-sized laboratories, if automation is implemented at all, it is likely to be based on single function automated devices rather than fully automated, comprehensive systems. However, automation of molecular diagnostics is still considered to be insufficient. This is especially the case in sample preparation and nucleic acid extraction, where the majority of work is performed manually. This leads to prolonged TAT, which is a challenge, especially when immediate results are required.

Market Sectors

Expert Frost & Sullivan analysts thoroughly examine the following market segments in this research:

- Oncology

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Research and Markets: European Molecular Diagnostics Markets

Research and Markets: Pharmacogenetics and Individualized Therapy

DUBLIN--(BUSINESS WIRE)--

Research and Markets (http://www.researchandmarkets.com/research/xp9wx4/pharmacogenetics_a) has announced the addition of John Wiley and Sons Ltd's new book "Pharmacogenetics and Individualized Therapy" to their offering.

The One-Stop Reference To Pharmacogenetics And Its Impact On Pharmaceuticals, Therapeutics, And Clinical Practices

Pharmacogenetics and Individualized Therapy offers thorough coverage of the study of the genetic determinants of drug response at the single gene leveland its impact on pharmaceuticals, therapeutics, and clinical practice. Providing an overview of the molecular basis of pharmacogenetics, the book helps readers understand the implications of genetic variability on pharmacokinetics and pharmacodynamics, as well as other aspects such as adverse drug reactions. Providing coverage of specific disease areas, including cardiovascular concerns, cancer and asthma/COPD, transplantation, and pain medication, the book also looks at the clinical practices, along with the psychiatric and ethical issues that have come to dominate conversation about pharmacogenetics.

The technological applications of pharmacogenetics, including genotyping, drug disposition (metabolism and enzymes), and the impact of this research on the pharmaceutical industry and regulatory matters are all addressed in chapters by internationally recognized leaders from both academia and industry.

Including chapters on specific therapeutic areas and clinical aspects, Pharmacogenetics and Individualized Therapy helps readers, whether they're students or researchers, to understand the implications of genetic variability on pharmacokinetics and pharmacodynamics.

Authors

ANKE-HILSE MAITLAND-van der ZEE, PhD, is Associate Professor of Pharmacogenetics

Pharmacogenomics at Utrecht University, the Netherlands.

ANN K. DALY, PhD, is Professor of Pharmacogenetics at Newcastle University, UK.

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Research and Markets: Pharmacogenetics and Individualized Therapy

Leading Anti-Cancer Drugs and Associated Market 2012-2022

NEW YORK, June 4, 2012 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Leading Anti-Cancer Drugs and Associated Market 2012-2022

http://www.reportlinker.com/p0819459/Leading-Anti-Cancer-Drugs-and-Associated-Market-2012-2022.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Drug_and_Medication

Report Details

Cancer treatments - discover which products have greatest potential

Where are cancer-treating drugs heading? Visiongain's report shows you potential revenues to 2022, with data, forecasts and discussions.

This study investigates leading drugs to treat human cancers. It lets you assess potential sales trends at world market, therapeutic submarket, product and national level to 2022.

How will 25 leading products - including Avastin, Rituxan, Herceptin and Glivec/Gleevec - perform from 2012? See potential revenues and other information. The study also assesses eight recently approved drugs.

Our investigation gives you business research and analysis with sales forecasts. You also see forecasting of five submarkets to 2022, finding potential revenues:

Traditional antineoplastic agents

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Leading Anti-Cancer Drugs and Associated Market 2012-2022

Life Technologies Showcases Leading Technologies for Companion Diagnostic Development, Cancer Research at the ASCO …

CARLSBAD, Calif., June 1, 2012 /PRNewswire/ --Life Technologies Corporation (LIFE) will exhibit platforms for companion diagnostic development and products ideal for basic, translational and clinical cancer research during the American Society for Clinical Oncology (ASCO) Annual Meeting 2012, taking place June 1 June 5, in Chicago, Illinois. In addition, several of the company's customers will present clinical research findings obtained with Life's sequencing technologies.

"Life Technologies offers platforms across the spectrum of genomics and proteomics that can be utilized in companion diagnostic development," said Ronnie Andrews, president of medical sciences at Life Technologies. "We share with our pharma partners a dedication to the movement toward personalized treatments based on the specific defects driving cancer in each individual patient."

In October 2011, Life announced a partnership with GlaxoSmithKline to develop a companion molecular test for a GSK candidate cancer immunotherapy.

Presentations:

AmpliSeq panels accurately identify more than 700 mutations in patient samples Marilyn Li, Ph.D., professor of molecular and human genetics and director of the Cancer Genetics Lab at Baylor College of Medicine, will present a poster demonstrating use of the Life Technologies Ion AmpliSeq cancer panels to sequence 12 archived tumor research samples including FFPE, bone marrow and cell line samples. The authors report that the panel accurately identified all known mutations previously detected using Pyrosequencing or Sanger sequencing and was sensitive enough to detect mutations at frequencies as low as 5% with 99% confidence. The poster will be presented June 4, Monday afternoon from 1:15 to 5:15.

AmpliSeq panels validated in CLIA lab with rapid turn-around for tumor sample sequencing Christopher Corless, M.D., Ph.D., chief medical officer of the Knight Diagnostic Laboratories at Oregon Health & Science University's Knight Cancer Institute, will present results using the Ion Torrent (Life Technologies) AmpliSeq Cancer Panel in a CLIA-licensed/CAP-certified setting. Forty-five FFPE tumor samples were sequenced, and the results matched those obtained via previous mass spec-based genotyping and revealed an additional 27 new mutations. Preliminary data from a custom AmpliSeq GI Stromal Tumor (GIST) panel will also be shown. The poster will be presented June 4, Monday afternoon from 1:15 to 5:15.

Featured Products:

Life Technologies offers cancer researchers the ability to detect mutations in cancer-associated genes using both PCR and sequencing platforms.

Ion Personal Genome Machine (Ion PGM) and Ion Proton Between the benchtop Ion PGMSequencer and the benchtop Ion ProtonSequencer, the Ion Torrent technology can cover any application. The Ion PGMSequencer is ideal for sequencing genes, small genomes, panels of genes, or performing gene expression profiling, and its speed, simplicity and scalability also make it an ideal platform to extend into diagnostics.

The Ion ProtonSequencer is ideal for sequencing both exomes regions in the DNA that code for protein and human genomes. The Ion ProtonI Chip, ideal for sequencing exomes, will be available mid-2012. The Ion ProtonII Chip, ideal for sequencing whole human genomes, will be available six months later. In addition, the Ion ProtonOneTouchsystem automates template prep and a stand-alone Ion ProtonTorrent Server performs the primary and secondary data analysis.

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Life Technologies Showcases Leading Technologies for Companion Diagnostic Development, Cancer Research at the ASCO ...

Outsourcing in Drug Discovery: The Contract Research Organization (CRO) Market, 5th Edition

NEW YORK, June 6, 2012 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Outsourcing in Drug Discovery: The Contract Research Organization (CRO) Market, 5th Edition

http://www.reportlinker.com/p0203691/Outsourcing-in-Drug-Discovery-The-Contract-Research-Organization-CRO-Market-5th-Edition.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Drug_Discovery_and_Development

The drug discovery process is long, arduous and costly, which has driven outsourcing in this field. The first phase is discovery of a lead compound, a molecule that affects biological function by binding to a target protein or nucleic acid in a way that is useful for treatment of disease. The process by which molecules are identified for their therapeutic value involves synthesis and analysis of many derivatives of the original leads. There are several steps in the drug discovery process including hit confirmation, lead generation, lead optimization, and other studies. Drug discovery is a high-cost, risky business because only a fraction of the therapeutic targets selected for study will actually yield products that achieve regulatory approval by the Food & Drug Administration (FDA).

Since the last edition of Kalorama's Report on the outsourcing of discovery of novel compounds in the pharmaceutical industry, the industry has seen dramatic change. Pharmaceutical companies facing cutbacks in R&D budgets and new demands for novel products need to outsource aspects of their operations. Core functions once kept in-house such as the discovery of potential new drugs are now commonly outsourced. Kalorama Information's Outsourcing in Drug Discovery captures this trend, offering unparalleled coverage of the drug discovery outsourcing market. It presents viewpoints from both customers and suppliers. Segments, size, and growth of the market are presented. The trend toward the increased use of offshore suppliers in China, India, Russia and Eastern Europe is covered in detail. The report also provides profiles of 23 suppliers, representative of those active in this market.

Segments covered in this report with market size estimates include:

In addition to market data and forecasts, the report covers issues such as:

This report provides an in depth look into the trends that have shaped the drug discovery outsourcing market today, and details the current and future global market.

The information for this report was gathered using both primary and secondary research including comprehensive research of secondary sources such as company literature, databases, investment reports, science, medical and business journals. Telephone interviews and email correspondence were the primary method of gathering information. For the purpose of this study Kalorama Information conducted interviews with key industry officials, consultants, and government personnel. These sources were the primary basis in gathering information specifically relating to revenue and market share data presented in this report. Specific interviews with pharmaceutical, biotechnology and contract research organizations included marketing directors, division managers, and product representatives.

CHAPTER ONE: EXECUTIVE SUMMARY

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Outsourcing in Drug Discovery: The Contract Research Organization (CRO) Market, 5th Edition

AssureRx Health Raises $12.5 Million Series C Financing

MASON, Ohio, May 30, 2012 /PRNewswire/ --AssureRx Health, Inc. today announced the closing of a $12.5 million Series C financing. The personalized medicine company, which provides clinically-relevant information to help physicians select the right drug for individual neuropsychiatric patients, will use the funds to increase commercial activities for its two flagship pharmacogenomic products, GeneSightRx Psychotropic and GeneSightRx ADHD, as well as next generation product development activities.

The financing was led by Four Rivers Group and existing investors Claremont Creek Ventures and Sequoia Capital. The financing also included participation of existing investors Cincinnati Children's Hospital Medical Center, Mayo Clinic, CincyTech, Allos Ventures, as well as new investors jVen Capital and Alafi Capital. New investors Four Rivers, jVen Capital, and Alafi Capital bring to AssureRx Health further expertise and partnering connections to help AssureRx Health continue building its leadership position in psychiatric pharmacogenomics.

"Our goal is to build the leading clinical informatics company providing pharmacogenomic and other treatment decision support products to help physicians individualize the treatment of patients with neuropsychiatric and other disorders," said James S. Burns, president and CEO of AssureRx Health. "Proceeds from the Series C financing will be used to expand sales coverage, sponsor multiple clinical studies, and develop new products to help accelerate our leadership position in psychiatric personalized medicine."

Warren Hogarth, partner at Sequoia Capital, said, "AssureRx products have the potential to change the way physicians select the appropriate medications for each of their patients. AssureRx is at the cutting edge of providing treatment decision support products for a very large global psychiatric market. We believe that AssureRx Health is building a world class company."

John Steuart, managing director of Claremont Creek Ventures said, "AssureRx has enormous potential to lead the transformation of neuropsychiatric care toward personalized patient treatment. GeneSightRx Psychotropic, GeneSightRx ADHD and future pharmacogenomic products hold the promise for faster, better patient outcomes and less costly care. We believe that AssureRx products have the potential for significant adoption by the psychiatric community, leading ultimately to incorporating pharmacogenomics into routine psychiatric practice guidelines."

From a simple cheek swab, the GeneSightRx technology measures and analyzes clinically important genetic variants that determine how a patient's unique genetic make-up affects his or her ability to tolerate or effectively respond to psychotropic medications. Patient-specific genetic information obtained through GeneSightRx can assist physicians in the process of selecting appropriate antidepressant and antipsychotic medications for individual patients.

About Claremont Creek Ventures Claremont Creek Ventures (CCV) is a seed and early stage venture firm. CCV invests in digital healthcare, energy technology, payments/commerce, and online businesses. Utilizing the firm's proprietary life-cycle venturing program, Claremont Creek Ventures also partners with entrepreneurs and institutions, including UC Berkeley, Lawrence Livermore Labs, Stanford University and UC Davis. Claremont Creek has more than $300 million in capital under management in two funds. CCV's digital healthcare investments in addition to AssureRx Health include Genalyte, GeneWeave, GigaGen, Fluxion Biosciences, Natera, Tibion and Zipline Medical. For more information, visit http://www.claremontcreek.com.

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AssureRx Health Raises $12.5 Million Series C Financing