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 | DTTR January 2009 (full PDF issue) |
| TOP OF THE NEWS
Genentech petitions FDA
Rosetta Genomics launches first test
BUSINESS NEWS
Invitrogen/Applied Biosystems merger closes
LabCorp inks agreement with NJH
Diagnoplex, Generation Health secure funding
SCIENCE/TECHNOLOGY
HHS report examines molecular medicine
ACP releases HIV screening guidelines
Special Focus: Cancer Diagnostics
New breast cancer study findings
Gene networks linked to leukemia prognosis
FDA approves BD imaging system
Protein levels predict colorectal cancer death
Clarient offers new colorectal cancer test
Gene Express partners with BioTrove
REGULATORY NEWS
Roche gets CE mark for viral load tests
Tom Daschle nominated for top HHS post
Abaxis gets CLIA waiver for POC panels
FINANCIAL NEWS
Esoteric testing fuels growth at LabCorp
IVD stocks down 6%
G-2 INSIDER
Learn from leaders in molecular diagnostics
Full Article |
| Rosetta Genomics Launches First Test |
| On December 11, Rosetta Genomics (Rehovot, Israel; Jersey City, N.J.; Philadelphia) announced the commercial launch of its first diagnostic test. Known as miRview squamous, the test uses a single microRNA (miRNA) to differentiate non-small-cell lung cancer (NSCLC) patients with squamous cell carcinoma from those with non-squamous carcinomas.
Full Article |
| Genentech Files Petition with FDA Urging Regulation of Lab-Developed Tests |
| As the diagnostic and clinical laboratory industries await the United States Food and Drug Administration (FDA)’s final guidance on the regulation of in vitro diagnostic multivariate index assays (IVDMIAs), Genentech (South San Francisco, Calif.) has filed a citizen petition urging the government regulatory agency to hold in vitro diagnostic tests developed by clinical laboratories for in-house testing to the same standards as those tests developed and sold as test kits. FDA currently regulates tests sold in kit form but not laboratory-developed tests (LDTs).
Full Article |
| HHS Report Examines Potential of Molecular Medicine |
| On November 14, Health and Human Services Secretary Michael Leavitt released the second report from his Initiative on Personalized Health Care, which examines the potential of a molecular-based understanding of health and disease to improve the quality and cost-effectiveness of health care.
Full Article |
| Invitrogen, Applied Biosystems Close on $6.7 Billion Merger Deal |
| Invitrogen (Carlsbad, Calif.) and Applied Biosystems (Norwalk, Conn.) have completed the $6.7 billion strategic merger announced in June. Headquartered in Carlsbad, the new company is called Life Technologies Corporation and began trading on the NASDAQ on November 24.
Full Article |
| LabCorp, National Jewish Health to Collaborate on Molecular Diagnostics |
| The nation’s second largest provider of laboratory testing will partner with National Jewish Health (NJH; Denver) to develop, market, and commercialize a range of molecular diagnostic tests, LabCorp (Burlington, N.C.) announced on December 10.
Full Article |
| American College of Physicians Releases Guidance on HIV Screening |
| On December 2, the American College of Physicians (ACP; Philadelphia) released guidelines urging physicians to begin routine HIV screening among patients at age 13, regardless of whether they engage in risky behaviors. The recommendations did not include an upper age limit because 20 percent of people living with HIV are older than age 50. The guidelines will be published in the January 20 issue of the Annals of Internal Medicine.
Full Article |
| New Study Findings May Aid in Breast Cancer Diagnosis, Treatment Selection |
| The results of several new scientific studies have significant implications for the diagnosis and treatment of breast cancer. The findings include the discovery of a protein that appears to be responsible for causing breast cancer to spread, a new link between HER2 status and treatment response, and insight into how to improve tools for calculating risk of mortality and disease recurrence.
Full Article |
| BD Receives FDA Approval for Cervical Cancer Screening System |
| BD Diagnostics, a segment of Becton, Dickinson and Company (BD; Burlington, N.C.) has received U.S. Food and Drug Administration (FDA) premarket approval for its BD FocalPoint GS Imaging System. This new system is designed to enhance cervical cancer screening for cytology laboratories, using the BD SurePath Pap test slides to detect evidence of squamous carcinoma, adenocarcinoma, and their usual precursor conditions.
Full Article |
| Gene Networks May Predict Leukemia Growth Rate |
| Groups of genes may be more reliable than individual markers in determining the clinical course of chronic lymphocytic leukemia (CLL), according to findings presented on December 8 at the annual meeting of the American Society of Hematology in San Francisco.
Full Article |
| Protein Levels Indicate Risk of Death in Colorectal Cancer Patients |
| A study published online in the Journal of Clinical Oncology on December 8 found that in people who have undergone surgery for colorectal cancer, the levels of two insulin-related proteins predicted their chances of dying from the cancer or from other conditions.
Full Article |
| Clarient Introduces Second Genetic Test for Colorectal Cancer |
| Anatomic pathology and molecular diagnostics company Clarient (Aliso Viejo, Calif.) has launched its new BRAF gene mutation test. The laboratory-developed test is for use as a predictive molecular biomarker for patients with colorectal cancer (CRC).
Full Article |
| Esoteric Testing Fuels 11% Q3 Revenue Growth at LabCorp |
| In the economically challenging third quarter of 2008, esoteric testing helped LabCorp (Burlington, N.C.) to outpace Quest Diagnostics (Madison, N.J.) in revenue and volume growth. LabCorp saw revenues grow by 11.2 percent to $1.1 billion, and volumes increase 10.6 percent. Quest, the nation’s lab testing leader, saw smaller gains, with revenue growth of 3.4 percent to $1.8 billion and volumes up by 0.7 percent.
Full Article |
| Tom Daschle Nominated for HHS Secretary |
| President-Elect Barack Obama has formally nominated former Senate majority leader Tom Daschle to the position of Secretary of Health and Human Services. Daschle has also been tapped to serve as director of the new White House Office of Health Care Reform. "He will be responsible not just for implementing our health care plan, he will also be the lead architect of that plan," said Obama, at a December 11 press conference announcing his decision.
Full Article |
| Roche Gets CE Mark for New HIV, HBV Viral Load Tests |
| Roche Molecular Diagnostics (Pleasanton, Calif.) has received CE Mark certification for its new viral load tests for HIV and hepatitis B virus (HBV), allowing the tests to be sold for clinical use in the European Union. Both tests are for use on the COBAS AmpliPrep / COBAS TaqMan system, Roche’s fully automated, real-time PCR platform that was CE Mark certified in 2005.
Full Article |
| Gene Express, BioTrove to Co-Market Lung Cancer Test |
| Gene Express Inc. (Wilmington, N.C.) and BioTrove Inc. (Woburn, Mass.) will team up to test market a genetic profiling test for lung cancer risk. The test will be marketed to reference laboratories and independent laboratories as well as community hospitals.
Full Article |
| Abaxis Gets CLIA Waiver for Point-of-Care Test Panels |
| The U.S. Food and Drug Administration (FDA) has granted waived status under CLIA regulations for two additional analytes, creatine kinase (CK) and phosphorus (Phos), used with the Piccolo and Piccolo Xpress point-of-care analyzers manufactured by Abaxis (Union City, Calif.). The waivers affect Abaxis’s Renal Function and MetLyte 8 test panels.
Full Article |
| Diagnoplex, Generation Health Close on Funding Rounds |
| Two startup companies focused on molecular diagnostics have managed to raise capital in difficult economic conditions. Diagnoplex (Epalinges, Switzerland), a developer of molecular diagnostics for cancer, has raised CHF10 million (approximately $8.6 million at current exchange rates) in a Series A round led by Novartis Venture Fund and NeoMed, with Initiative Capital Romandie acting as co-investor. Generation Health (Saddle River, N.J.), a genetic testing benefit management company, raised nearly $5 million in Series A funding. Its backers include Highland Capital Partners, Correlagen Diagnostics, D2Hawkeye, and company management.
Full Article |
| IVD Stocks Down 12%; Affymetrix Falls 30% |
| The 17 stocks in the G-2 Diagnostic Stock Index fell an average of 12 percent in the five weeks ended December 5, with 15 stocks down in price and two up. The G-2 index is down 40 percent for the year, while the S&P 500 and the Nasdaq have plummeted 39 percent and 42 percent, respectively.
Full Article |
| Learn From Leaders in Molecular Diagnostics |
| Harness the power of molecular diagnostics for your laboratory . . . Learn how to best apply the emerging science, novel business models, and consumer demand of molecular diagnostics to grow your lab at Business & Financial Strategies for Molecular Diagnostics 2009. This Washington G-2 Reports conference will take place Feb. 2 to 4, 2009, at the Hyatt Regency Pier Sixty-Six in Ft. Lauderdale, Florida. A roster of experts will provide insight and advice on how laboratories can and are successfully integrating molecular diagnostics into their business strategies, given the current regulatory and business environment. Scheduled sessions include:
Full Article |
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