IVDT Insight

CVS Caremark, Generation Health Outline Pharmacogenomics Partnership

CVS Caremark and Generation Health Inc. announced they will offer an integrated Genetic Benefit Management (GBM) service utilizing the industry's first Best Test Genetics Network for coordination of testing directed at tailoring prescriptions to members based on their DNA.

The initial product offering is available to CVS Caremark pharmacy benefit management services clients and focuses on thirteen drug therapies. For medications generally dispensed through PBM services, the target medications will include: Imuran, Nolvadex, Plavix, Tabloid, Tegretol, and Ziagen. The partnership will also initially focus on seven medications dispensed through CVS Caremark's specialty pharmacy business, including Pegasys and Copegus, for treatment of hepatitis C, as well as the following oncology drugs: Gleevec, Tasigna, Sprycel, Tarceva, and Tykerb.

For each drug therapy, testing will be coordinated through the industry's first Best Test Genetics Network, a preferred provider...

June 2nd, 2010
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CombiMatrix Ceases M&A Activities

CombiMatrix Corp. announced that it has instructed its investment bankers to cease work on identification and pursuit of potential purchasers of the company or its assets. For the past several months, CombiMatrix has had discussions with parties about a sale of the company or assets of the company. The Board of Directors has determined that the company should now focus exclusively on building and growing the diagnostics services business. One component of that endeavor is the recruitment and hiring of a commercially-focused executive who will replace the outgoing CEO, Amit Kumar.

"As we have stated in previous announcements, CombiMatrix is at an inflection point in its development and needs to refocus its efforts on increasing the commercial use of its tests," stated Kumar, president and CEO of CombiMatrix. "CombiMatrix has been a scientific innovator in the molecular diagnostics field, and now seeks to become a commercial leader, as well. Often for young...

June 1st, 2010
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Hitachi Software, OriGene Technologies Announce Collaboration

Hitachi Software Engineering America Ltd. and OriGene Technologies Inc. announced a comarketing agreement to jointly promote OriGene’s multiplex assays built on Luminex xMAP/Bio-Plex technology and Hitachi Software’s MasterPlex software suite for analysis and reporting of multiplex assay data. According to the agreement, OriGene will use MasterPlex exclusively in all immunoassay and custom assay development. Customers purchasing OriGene’s assays will be offered the use of MasterPlex software product for 30 days. The agreement will also enable Hitachi Software’s clients to have easy access to information and preferred purchasing arrangements for OriGene’s broad range of assays.

The Hitachi Software MasterPlex Suite delivers a combination of analysis, quality control, and reporting tools for data sets in both research and 21 CFR Part 11-compliant labs. MasterPlex is hardware independent and offers a variety of features not commonly found in a...

May 31st, 2010
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Roche Receives FDA Approval for Qualitative Anti-HCV Immunoassay

Roche Diagnostics announced that FDA granted premarket approval for its Elecsys Antibody to hepatitis C virus (anti-HCV) assay. The Elecsys Anti-HCV assay is an IVD test for the qualitative detection of total antibodies to hepatitis C virus in human serum or plasma.

Roche received approvals for the anti-HCV test on three platforms: the stand-alone cobas e 411 analyzer for low-volume testing; and the cobas e 601 and Modular Analytics E 170 analyzers, which are modules of consolidated immunoassay/clinical chemistry systems for mid-volume and high-volume testing, respectively.

The anti-HCV assay is an 18-minute test designed for use with Roche's electrochemiluminescence (ECL) technology. Assay results, in conjunction with other laboratory results and clinical information, may be used to aid in the presumptive diagnosis of HCV infection in persons with signs and symptoms of hepatitis and in persons at risk for hepatitis C infection. The test does not determine the state...

May 28th, 2010
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Thermo Fisher Scientific Acquires Fermentas

Thermo Fisher Scientific Inc. has signed a definitive agreement to acquire Fermentas International Inc., a manufacturer and global distributor of enzymes, reagents, and kits for molecular and cellular biology research, for $260 million in cash, subject to a post-closing adjustment. With headquarters in Burlington, Ontario, and principal operations in Vilnius, Lithuania, Fermentas has approximately 500 employees. The company had full-year revenues of approximately CAD$57 million in 2009 (approximately US$54 million).

Fermentas provides a broad range of high-quality molecular and cellular biology research tools, including reagents for nucleic-acid and protein purification; restriction and modifying enzymes; molecular weight markers and other life science research and diagnostic tools. The company also offers a variety of products for polymerase chain reaction (PCR), reverse transcription PCR (RT-PCR) and quantitative real-time PCR (qRT-PCR), which will strengthen Thermo Fisher...

May 27th, 2010
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Qiagen Acquires Comprehensive Portfolio of Molecular Food Safety Tests

Qiagen has entered into an agreement with the Institute for Product Quality (ifp), pursuant to which Qiagen has acquired all rights to 70 molecular food safety tests developed by the Berlin-based specialized laboratory center for food analysis. The transaction further strengthens Qiagen's applied testing business segment, which also encompasses molecular testing systems for forensic applications, veterinary medicine and biodefense. No financial details were disclosed.

The tests acquired from ifp are based on real-time PCR technology and cover a broad range of molecular targets including genetic, bacterial, viral, and other contaminants of foodstuffs. The tests can be fully automated using Qiagen's own instruments such as the QIAsymphony and the Rotor-Gene Q. The transaction enables Qiagen to offer complete solutions for all major applications in the food safety testing segment, covering entire workflows from the processing of primary samples to the final testing result....

May 26th, 2010
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Focus Diagnostics Receives First FDA Clearance of a 2009 H1N1 Test

Quest Diagnostics Inc. announced that FDA has issued 510(k) clearance to the Simplexa Influenza A H1N1 (2009) test on the 3M Integrated Cycler. The Simplexa test, developed and manufactured by Quest Diagnostics' Focus Diagnostics business, is the first to be cleared by FDA for use as an aid in the detection and differentiation of influenza A and 2009 H1N1 influenza viral RNA.

The Simplexa Influenza A H1N1 (2009) test runs on the 3M Integrated Cycler under an exclusive global distribution agreement between Focus Diagnostics and 3M.  The test employs real-time reverse transcription (RT) polymerase chain reaction (PCR) to qualitatively detect RNA of the 2009 H1N1 flu virus (2009 H1N1) in a patient's nasal or nasopharyngeal specimens. It reports if a specimen is positive or negative for the presence of 2009 H1N1 or influenza A virus. By comparison, some flu tests, including rapid point-of-care influenza tests, can detect the presence of influenza A, but not differentiate...

May 25th, 2010
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ZyGEM Acquires MicroLab Diagnostics

ZyGEM Corp. announced that it has acquired MicroLab Diagnostics Inc., a private company developing microfluidic devices for rapid DNA testing. ZyGEM intends to market products integrating its unique DNA extraction and reagents and detection assays with the breakthrough microfluidic chip technology developed by MicroLab, which will operate as a business unit of the new company. These integrated new products will dramatically decrease the time, complexity and cost of conducting DNA testing and have transformational potential in a broad range of applications.

Data presented at a recent scientific meeting demonstrated that a prototype of the new system produced accurate DNA results in less than an hour, comparable to results obtained with current technology requiring three separate instruments and five to 10 hours. The new technology has the potential to revolutionize DNA testing for the many applications where accuracy, speed, and ease-of-use are critical,...

May 24th, 2010
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Chronix Biomedical Data Could Change Cancer Diagnosis

Chronix Biomedical reported a summary of data supporting the utility of its serum DNA blood tests for the early and accurate detection of breast cancer and prostate cancer. The testing algorithms developed by Chronix detected and correctly identified DNA fragments in the blood from dying (apoptotic) cancer cells with 92% sensitivity and 100% specificity in both prostate cancer and breast cancer. If confirmed in larger studies, these results would outperform those obtained from current diagnostics for these cancers. The new data, which were generated from 575 individuals, provide further evidence that Chronix’s serum DNA assays may represent a new diagnostic and prognostic platform that can identify cancer and other chronic diseases earlier and more accurately than is currently possible. The data will be presented in an oral session at the 2010 ASCO Annual Meeting.

A growing body of peer-reviewed data shows that the Chronix DNA-based blood tests can detect cancer...

May 21st, 2010
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House Committee Investigates Personal Genetic Testing Kits

Members of the U.S. House of Representatives Committee on Energy and Commerce (Chairman Henry A. Waxman (D-CA), Ranking Member Joe Barton (R-TX), Subcommittee Chairman Bart Stupak (D-MI), and Subcommittee Ranking Member Michael C. Burgess (R-TX)) sent letters to 23andMe, Inc., Navigenics, and Pathway Genomics Corporation in light of recent reports that at least one of the companies is seeking to sell personal genetic testing kits in retail locations, despite concern from the scientific community regarding the accuracy of test results.

The Committee is requesting information from the companies on several aspects of the tests:  How the companies analyze test results to determine consumers’ risk for any conditions, diseases, drug responses, and adverse reactions; the ability of the companies’ genetic testing products to accurately identify any genetic risks; and the companies’ policies for the collection, storage, and processing of individual genetic...

May 20th, 2010
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