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 | DTTR June 2009 |
| TOP OF THE NEWS
H1N1 flu outbreak puts focus on testing
ACLU suit challenges
BRCA gene patents
BUSINESS NEWS
Nanogen files for bankruptcy
MDx revenues up 47% at Myriad Genetics
Genetix buys SlidePath
Thermo Fisher to acquire Biolab
INSIDE DIAGNOSTICS INDUSTRY
Testing for H1N1 flu
REGULATORY NEWS
CMS proposal would limit Medicare coverage for warfarin testing
‘Comparative effectiveness’ is Obama priority
SCIENCE/TECHNOLOGY
Combination test can predict ESRD
JAMA study links albumin levels to blood clot risk
Prometheus partners with Rosetta Genomics
FINANCIAL NEWS
IVD stocks up 6%
G-2 INSIDER
Personnel changes at FDA
Full Article |
| ACLU Suit Challenges Breast Cancer Gene Patents |
| In a lawsuit filed on May 12 in U.S. District Court for the Southern District of New York, the American Civil Liberties Union (ACLU; New York City) and the Public Patent Foundation (New York City) charge that patents on BRCA1 and BRCA2, genes associated with hereditary breast and ovarian cancer, stifle valuable medical research.
Full Article |
| H1N1 Outbreak Puts Focus on Lab Testing Capability |
| The outbreak of a novel influenza A (H1N1) flu virus of swine origin that was first detected in April sent the world clamoring for effective diagnostics. The Centers for Disease Control and Prevention (CDC; Atlanta) promptly developed a polymerase chain reaction (PCR)-based diagnostic test kit to detect H1N1, secured FDA clearance for the test, and has now distributed test kits to all states in the United States, the District of Columbia, and Puerto Rico. The test kits are also being shipped internationally.
Full Article |
| Myriad Sees MDx Revenues Rise 47%, Launches Seventh Test |
| As Myriad Genetics (Salt Lake City) moves forward with the previously announced plan to spin off its pharmaceutical business to focus exclusively on molecular diagnostics, the company continues to see strong revenue growth. On May 4, Myriad reported record quarterly revenue of $87.5 million, compared with $61.8 million in the prior-year period, and a net profit of $25.3 million, compared with a net loss of $4.6 million in 2008. Molecular diagnostic revenues rose 47 percent to $86.5 million from $59 million last year.
Full Article |
| Nanogen Files for Chapter 11, Agrees to Sell Assets |
| Molecular and point-of-care diagnostics company Nanogen (San Diego) has filed for Chapter 11 bankruptcy and entered a deal to sell its assets, the company announced on May 14. Lacking the cash required to continue running its business, Nanogen has agreed to sell nearly all of its assets to diagnostics company the Elitech Group (Paris) for $25.7 million. The sale is subject to customary closing conditions, as well as the approval of the bankruptcy court and an auction process in which the company may seek competing bids to achieve the highest price for its assets.
Full Article |
| Inside the Diagnostics Industry: FDA Clears CDC Test for H1N1, Companies Race to Develop Own Tests |
| The U.S. Food and Drug Administration (FDA) has given the green light to public health and other qualified laboratories to make emergency use of the Swine Influenza Virus Real-time RT-PCR Detection Panel (rRT-PCR Swine Flu Panel) for the presumptive diagnosis of the new H1N1 strain. The panel is authorized for use in “individuals who have been diagnosed with influenza A caused by a virus not subtypeable by currently available FDA-cleared devices.”
Full Article |
| CMS Proposal Would Limit Medicare Coverage for Warfarin Response Testing |
| On May 4, the Centers for Medicare & Medicaid Services (CMS) proposed that pharmacogenomic testing to predict how a beneficiary responds to the anticoagulant warfarin will not be covered by Medicare, unless the beneficiary is enrolled in a clinical trial that meets specific guidelines.
Full Article |
| JAMA Study Links Albumin Levels to Blood Clot Risk |
| Preliminary research published in the May 6 issue of the Journal of the American Medical Association suggests that higher than normal levels of the protein albumin in urine is associated with an increased risk for blood clots in the deep veins of the legs or lungs (venous thromboembolism; VTE).
Full Article |
| Combination Test Can Predict End-Stage Renal Disease |
| Assessing kidney function by measuring glomerular filtration rate and urinary albumin levels can help determine which patients with chronic kidney disease (CKD) will develop end-stage renal disease (ESRD), according to a study published in the May 2009 issue of the Journal of the American Society Nephrology. This combination test could help physicians to identify patients at high risk of serious kidney trouble and allow them to intervene at an early stage.
Full Article |
| Genetix Acquires SlidePath to Expand in Digital Pathology |
| Imaging and diagnostics company Genetix (New Milton, United Kingdom) is looking to expand its presence in the rapidly growing digital pathology market. On April 30, the company announced its acquisition of privately held SlidePath (Dublin, Ireland), which offers products for analysis, management, and viewing of tissue and cellular samples via the Web.
Full Article |
| Prometheus Partners With Rosetta Genomics on Molecular Tests for Cancer |
| Pharmaceutical and diagnostic manufacturer Prometheus Laboratories (San Diego, Calif.) has entered into a license and collaboration agreement with Rosetta Genomics (Philadelphia and Rehovot, Israel) to market tests and undertake research and development activities. Prometheus develops and markets molecular diagnostic testing services and therapies related to gastrointestinal disease, and this partnership signals Prometheus’s move into molecular diagnostics for cancer.
Full Article |
| Thermo Fisher to Acquire Alesco’s Biolab Division for $120 Million |
| Thermo Fisher Scientific (Waltham, Mass.) has agreed to buy Biolab, the scientific and medical division of Alesco (Sydney, Australia), for AUD $175 million (approximately $120 million, at current exchange rates). The transaction is expected to close by the end of May.
Full Article |
| ‘Comparative Effectiveness’ Is New Buzzword in Washington |
| As the world waits for President Obama’s comprehensive health care legislation, activity is focused around “comparative effectiveness.” A priority of the Obama administration, comparative effectiveness research (CER) got a $1.1 billion boost under the American Recovery and Reinvestment Act of 2009 (ARRA). The aim of CER is to evaluate affordable health care tests and treatments to determine their significant advantages or disadvantages.
Full Article |
| IVD Stocks Up 6%; Quidel Soars 43% on Swine Flu Outbreak |
| The G-2 Diagnostic Stock Index gained an average of 6 percent in the five weeks ended May 8, with 11 stocks up in price and five down. The G-2 index is up 6 percent so far this year, while the Nasdaq is up 11 percent and the S&P is up 4 percent.
Full Article |
| G-2 Insider: Personnel Changes at FDA |
| New acting director for FDA OIVD . . . Donald St. Pierre has been named acting director of the United States Food & Drug Administration’s Office of In Vitro Diagnostic Device Evaluation and Safety (FDA OIVD). St. Pierre previously served as the deputy director of the office under the OIVD’s former director, Steve Gutman, Ph.D., until his retirement late last year. A permanent director is expected to be named by August.
Full Article |
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