Category Archives: Pharmacogenomics

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

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

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

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

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

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