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 | DTTR April 2008 (full PDF issue) |
| TOP OF THE NEWS
JAMA study questions value of MRSA screening
Immucor to acquire BioArray
BUSINESS AND DEAL NEWS
Third Wave’s clinical revenue up 25% in 2007
PerkinElmer buys newborn screening lab
Quest signs onto Google Health EHR
SCIENCE/TECHNOLOGY
NEJM study probes pharmacogenomics of warfarin metabolism
New bioimaging system promises improved HER2 testing
Abbott to co-develop pharmacogenomic test for lung cancer drug
Beckman Coulter launches new workstation
INSIDE DIAGNOSTICS INDUSTRY
Inside Ikonisys: DTTR interviews CEO Petros Tsipouras, M.D.
REGULATORY
Quidel RSV test gets CLIA waiver
ACLA presses SACGHS for clarification on genetic testing oversight
FINANCIAL NEWS
IVD stocks down 7%
G-2 INSIDER
Allegro Diagnostics raises $4 million
Full Article |
| Immucor Bets on Blood Genotyping |
| Pretranfusion diagnostics company Immucor (Norcross, Ga.) has agreed to acquire privately held BioArray Solutions (Warren, N.J.) for $117 million. BioArray is a molecular diagnostics company that has developed a novel BeadChip platform for nucleic acid and protein analysis. Immucor will focus on BioArray’s genotyping tests for blood donors and transfusion recipients.
Full Article |
| JAMA Study Sends Chill Through IVD Market |
| The publication of the JAMA study sent a chill through the in vitro diagnostics industry and prompted Cepheid CEO John Bishop to post a letter to his company’s Web site addressing the study and affirming Cepheid’s financial guidance for 2008. Cepheid has built its business on the GeneXpert molecular diagnostics platform and its MRSA screening test. Last year, revenues for the clinical product sales segment of Cepheid’s business, which accounted for 52 percent of total 2007 product sales of $116.5 million, were primarily driven by the U.S. market launch of the Xpert MRSA test in April 2007.
Full Article |
| Third Wave Sees Clinical Revenue Grow 25% in '07 |
| Molecular diagnostics company Third Wave Technologies (Madison, Wis.) reported clinical molecular diagnostic revenue of $26.3 million in 2007, an increase of 25 percent from 2006. Total 2007 revenues were up 11 percent to $31.1 million, which includes $4.6 million in research revenue. The company reported a net loss of $16.8 million in 2007, compared to last year’s net loss of $18.9 million.
Full Article |
| NEJM Study Probes Pharmacogenomics of Warfarin Metabolism |
| A study published in the March 6 issue of the New England Journal of Medicine sheds new light on how genetic variation affects patients’ initial response to the common blood thinner warfarin (Coumadin). The finding could help doctors determine the optimal dose of warfarin more quickly and precisely through genetic screening and could reduce the incidence of side effects from the drug, particularly severe bleeding.
Full Article |
| New Bioimaging System Promises Improved HER2 Testing |
| A novel biomaging system may improve the detection of HER2-positive breast cancer, according to a paper published online in the International Journal of Cancer. Researchers at the National Institute of Standards and Technology (NIST), the National Cancer Institute (NCI), and the scientific research firm SAIC found that a chicken immunoglobulin Y (IgY) antibody created against the HER2 protein could be tagged with tiny, intense light sources known as "quantum dots" to more reliably detect the HER2 biomarker than existing diagnostic tests that use mammalian antibodies tagged with conventional fluorescent dyes. Overall, the improvement in sensitivity to the HER2 biomarker was about 40 percent to 50 percent.
Full Article |
| PerkinElmer Acquires Pediatrix’s Newborn Screening Lab |
| PerkinElmer (Waltham, Mass.) has completed its acquisition of the newborn metabolic screening business of Pediatrix Medical Group (Sunrise, Fla.) for an undisclosed cash sum. The deal gives PerkinElmer Pediatrix’s reference laboratory, as well as its StepOne screening test for inherited disorders and other genetic screening products. The lab provides neonatal screening and consultative services to five states and the District of Columbia and also to hospitals and medical groups.
Full Article |
| Ikonisys Boosts Automated FISH Platform with New Reference Lab |
| This year will be a busy one for cell-based diagnostics company Ikonisys (New Haven, Conn.). After closing a $30 million Series E funding round led by Goldman Sachs last fall, the company started 2008 with a CLIA inspection for its new clinical laboratory and expects to receive FDA clearance for three new tests by the end of the year.
Full Article |
| Quidel RSV Test Gets CLIA Waiver |
| The U.S. Food and Drug Administration (FDA) has granted a CLIA waiver for the QuickVue respiratory syncytial virus (RSV) test manufactured by Quidel (San Diego, Calif.). The test qualitatively detects RSV, the leading cause of pneumonia and bronchiolitis among children two years of age and younger. The test is intended for use as an aid in the diagnosis of acute RSV viral infections for symptomatic pediatric patients.
Full Article |
| Quest Diagnostics Signs Onto Google Health EHR |
| Patients who want to access their lab test results may soon be able to simply Google them. Quest Diagnostics (Madison, N.J.) has announced that it will collaborate with the Internet giant on Google Health, a pilot electronic health record (EHR) system that will allow users to manage their health information online. Google Health was launched last month at the Health Information Management Systems Society trade show. In addition to Quest, Google Health’s future partners include Aetna, Wal-Mart, the University of California at San Francisco, the American Medical Association, and Cedars-Sinai Medical Center.
Full Article |
| Abbott to Co-Develop Pharmacogenomic Test for Lung Cancer Drug |
| The molecular diagnostics business of Abbott (Abbott Park, Ill.) has entered a collaboration with Genentech, Roche, and OSI Pharmaceuticals to develop a molecular test that will assess the clinical benefit of erlotinib (Tarceva), an orally-administered drug that is used to treat patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen.
Full Article |
| Beckman Coulter Launches High-Volume Testing System |
| Beckman Coulter (Fullerton, Calif.) has released a new workstation that combines chemistry and immunoassay testing for high-volume laboratories. The UniCel DxC 880i Synchron Access clinical system combines Beckman Coulter’s chemistry system (the UniCel DxC 800) and its high-throughput immunoassay system (the UniCel DxI 800). Laboratories that have installed either of those 800-level systems can upgrade to the new 880i configuration.
Full Article |
| ACLA Presses SACGHS for Clarification on Genetic Testing Oversight |
| The American Clinical Laboratory Association (ACLA) is urging a top federal panel to clarify its explanation of the oversight of genetic tests. The industry group recently submitted its comments to the HHS Secretary’s Advisory Committee on Genetics, Health, & Society (SACGHS).
Full Article |
| IVD Stocks Fall 7%; Inverness Plummets 33% |
| The 18 stocks in the G-2 Diagnostic Stock Index dropped an average of 7 percent in the five weeks ended March 7, with 15 stocks down in price and three up. The S&P 500 has lost 11 percent so far this year, and the Nasdaq is down 15 percent.
Full Article |
| Lung Cancer-Focused Allegro Diagnostics Raises $4 Million |
| Allegro Diagnostics (Boston) has completed a $4 million Series A financing round led by Kodiak Venture Partners and joined by Catalyst Health Ventures and Boston University. Founded in 2006, Allegro is a molecular diagnostics company focused on developing and commercializing products based on gene expression technology developed by Jerome Brody, M.D., and Avrum Spira, M.D., at the Boston University School of Medicine. Brody was recently appointed chief scientific officer of the company.
Full Article |
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