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Diagnostic Testing & Technology Report contains up-to-the-minute information and unique perspectives on where diagnostic testing is headed, covering every innovation, new product, manufacturer, market and end-user application. Each monthly issue provides an unbeatable blend of news, analysis, statistics, and forecasts.
Keep up with the latest trends in esoteric lab testing and what the hottest new tests are worth to your bottom line. Plus, find out about the strategies that individual companies are implementing now to win the fight for specific local markets and which sector has the most potent resources and best game plan for the long term.
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 | DTTR October 2008 (full PDF issue) |
| TOP OF THE NEWS
Myriad Genetics may spin off pharma biz
FDA clears AlloMap test
BUSINESS NEWS
Nanogen to merge with Elitech Group
Meridian Bioscience inks Canadian distribution deal
Pathwork Diagnostics raises $20 million
Pall Corp. acquires GeneSystems
INSIDE DIAGNOSTICS INDUSTRY
Interview with Nanogen’s David Ludvigson
SCIENCE/TECHNOLOGY
New gene variant linked to prostate cancer risk
Protein variant predicts chemotherapy response
REGULATORY NEWS
Physicians frustrated by CMS’s quality reporting initiative feedback
FINANCIAL NEWS
IVD stocks down 6%
G-2 INSIDER
Biomarker for soft tissue sarcoma
Full Article |
| FDA Clears Third IVDMIA: XDx’s AlloMap |
| The U.S. Food and Drug Administration (FDA) has cleared for marketing the AlloMap test developed by XDx (Brisbane, Calif.). The multi-gene, multi-pathway gene expression test can be used to assist physicians in managing heart transplant patients for potential organ rejection. AlloMap is the third in vitro diagnostic multivariate index assay (IVDMIA) cleared by the FDA. IVDMIAs are medical devices that combine the values of multiple variables to yield a single, patient-specific result.
Full Article |
| Myriad Genetics May Spin Off Pharma Business |
| By this time next year, Myriad Genetics (Salt Lake City) may be two separate companies: one focusing on the company’s pharmaceutical business and the other on the diagnostics business. Spinning off the pharmaceutical division from the molecular diagnostics division—best known for its BRACAnalysis test for breast cancer—is one of the "strategic alternatives" now being reviewed by Myriad’s board of directors, the company announced on September 11.
Full Article |
| Nanogen to Merge With French Diagnostics Company |
| Molecular diagnostics-focused Nanogen (San Diego, Calif.) has entered an agreement to combine with the privately held Elitech Group (Paris, France) in an all-stock deal valued at approximately $98 million. With estimated first-year revenues of $150 million, the combined company will encompass molecular and point-of-care diagnostics as well as clinical chemistry and molecular biology. Structured as a reverse acquisition of Nanogen by Elitech, the deal has been approved by the boards of both companies and is expected to close by the end of the first quarter of 2009.
Full Article |
| Meridian Bioscience Inks Canadian Distribution Deal |
| Meridian Bioscience (Cincinnati) is making good on its promise to expand its business outside of the United States. On September 10, the developer, manufacturer, and distributor of rapid diagnostic tests announced that it has entered into a new exclusive Canadian distribution agreement with Somagen Diagnostics (Edmonton, Alberta), a specialty distributor of clinical laboratory products.
Full Article |
| Inside the Diagnostics Industry: Nanogen’s David Ludvigson on Mergers, Markets, and Microarrays |
| Nanogen (San Diego, Calif.) recently agreed to combine with the privately held Elitech Group (Paris, France) in a deal valued at approximately $98 million (see p. 2). The combined company will encompass the molecular, point-of-care, clinical chemistry, and microbiology diagnostics and will have estimated first-year revenues of more than $150 million. DTTR recently talked with David Ludvigson, president and chief operating officer of Nanogen, to get his view on what makes the companies a good match, what the deal means for Nanogen’s pipeline, and on the possibly intersecting futures of Nanogen’s two key markets: molecular and point-of-care diagnostics.
Full Article |
| Protein Variant Predicts Chemotherapy Response |
| Researchers at the Moores Cancer Center at the University of California, San Diego (UCSD) in La Jolla have found evidence to explain the varying responses of cancer patients to cisplatin, a common chemotherapy drug that is the first-line therapy for testicular and ovarian cancers. Findings published online on September 3 in the Proceedings of the National Academy of Sciences demonstrated that when a variant version of a key protein that normally causes cell death is active, patients may be resistant to the cancer-killing drug.
Full Article |
| New Gene Variant Linked to Prostate Cancer Risk |
| A novel gene variant may contribute to the risk of developing prostate cancer. Scientists have discovered a second independent site within the prostate cancer gene HNF1B, which is located on chromosome 17. The finding was reported in a study published online in Nature Genetics on August 31.
Full Article |
| Pall Corporation Acquires GeneSystems |
| Pall Corporation (PLL; East Hills, N.Y.), which specializes in filtration, separation, and purification for industrial and life sciences applications, has purchased privately held GeneSystems (Bruz, France), an eight-year-old biotechnology company that has developed a real-time polymerase chain reaction (PCR)-based molecular diagnostics platform. Financial terms of the deal were not disclosed.
Full Article |
| Pathwork Diagnostics Raises $20 Million |
| Oncology-focused molecular diagnostics company Pathwork Diagnostics (Sunnyvale, Calif.) has closed on a $20 million funding round led by Abingworth, a venture capital firm that specializes in early-stage life sciences and biomedical companies. Other investors included Prospect Venture Partners and Advent Venture Partners. This is Pathwork’s second funding round.
Full Article |
| Physicians Frustrated by CMS’s Quality Reporting Initiative Feedback |
| Physicians are not satisfied with the information on improving patient care obtained from their 2007 Physician Quality Reporting Initiative (PQRI) feedback reports prepared by the Centers for Medicare & Medicaid Services (CMS), according to survey results released September 8 by the Medical Group Management Association.
Full Article |
| IVD Stocks Down 6%; OraSure, Luminex Only Gainers |
| The 17 stocks in the G-2 Diagnostic Stock Index fell an average of 6 percent in the five weeks ended September 5, with 15 stocks down in price and two up. The G-2 index is down 11 percent so far this year, while both the Nasdaq and the S&P 500 are down 14 percent.
Full Article |
| Biomarker for Soft Tissue Sarcoma |
| New biomarker could translate to prognostic test for soft tissue sarcoma. . . A gene linked to susceptibility for a retinal cancer (retinoblastoma) may be the first independent prognostic biomarker in cases of soft tissue sarcoma (STS), according to a study published in the August 1 issue of Clinical Cancer Research. Researchers found that a reduction in the expression of the tumor suppressor gene pRb2/p130 can mean a higher risk of recurrence and death from STSs. A member of the retinoblastoma family of genes, pRb2/p130 regulates a portion of the cell cycle.
Full Article |
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