SUNNYVALE, Calif., Oct. 15 — Cepheid (Nasdaq: CPHD) today announced the U.S. Food & Drug Administration (FDA) categorized Cepheid’s Xpert(TM) MRSA/SA Skin and Soft Tissue Infection (SSTI) test as “Moderate Complexity” under the Clinical Laboratory Improvement Amendments (CLIA). The new test is designed for on-demand detection of Methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA), […]
Celera (NASDAQ:CRA) today announced the appointment of Christopher Hall as Chief Business Officer of Berkeley HeartLab (BHL), effective immediately. Mr. Hall succeeds Frank Ruderman, the former Chairman and CEO of BHL, who is leaving the company to pursue other interests following the successful integration of BHL into Celera. Mr. Ruderman will consult for Celera during […]
REYKJAVIK, Iceland, Oct 08, 2008 — Enables women to understand whether they may benefit from more intensive screening, monitoring or preventive drug therapy deCODE genetics today announced the launch of deCODE BreastCancer(TM), a new tool for assessing risk of the common forms of breast cancer. For the first time, a woman concerned about breast cancer […]
Luminex Corporation (NASDAQ: LMNX), the worldwide leader in multiplexed solutions, today announced that it has received clearance from Health Canada for its xTAG(TM) Respiratory Viral Panel (RVP). xTAG RVP is a unique, groundbreaking test that, from one patient sample, simultaneously detects the 18 respiratory viruses and subtypes that are responsible for the majority of respiratory […]
SUNNYVALE, Calif., Oct. 7 — Cepheid (Nasdaq: CPHD) today announced the release of Xpert(TM) vanA/vanB as a European CE IVD Mark product under the European Directive on In Vitro Diagnostic Medical Devices. The test delivers rapid detection of vanA and/or vanB genes, the genes most commonly associated with vancomycin-resistant enterococci (VRE) — one of the […]
Strengthening the Company’s Leading Position in the Molecular Diagnostic Market in China Increasing the Company’s High Margin Recurring Revenues Expecting Accretion to Adjusted Earnings per ADS for FY2009 and Significantly Higher Accretion thereafter BEIJING, Oct. 7 /Xinhua-PRNewswire-FirstCall/ — China Medical Technologies, Inc. (the “Company”) (Nasdaq: CMED), a leading China-based medical device company that develops, manufactures […]
One Hour Test is Cepheid’s Second FDA Cleared Diagnostic Test in 2008; Test Improves Time-to-Result by More Than Twenty-Four Hours Over Conventional Methods SUNNYVALE, Calif., Oct. 1 — Cepheid (Nasdaq: CPHD – News) today announced it has received clearance from the U.S. Food & Drug Administration (FDA) to market its Xpert(TM) MRSA/SA Blood Culture (BC) […]
Richmond, California – October 1, 2008 – Lumiphore, Inc., a biotechnology leader in the development of new proprietary fluorescent metal-lanthanide technology for use in high-value applications, announced that it has signed an exclusive agreement with Biophor Diagnostics, Inc., Redwood City, California to apply Lumiphore products in diagnostic tests for drugs of abuse. Under the agreement, […]
Applied Biosystems Inc. (NYSE:ABI) today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration for its new 7500 Fast Dx Real-Time PCR Instrument for use with the new CDC Human Influenza Virus Real-time RT-PCR Detection and Characterization Panel (rRT-PCR Flu Panel) from the U.S. Centers for Disease Control and Prevention. […]
MUKILTEO, Wash., Sept. 30, 2008 — CombiMatrix Corporation (NasdaqGM:CBMX -News) announced today the launch of two new array-based diagnostic tests, adding to its leading and growing portfolio of tests. These new tests augment each other and demonstrate levels of multiplexing and personalization that are unprecedented in the industry. The tests will be operated out of […]
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IBO (Instrument Business Outlook) is a twice-monthly newsletter aimed at providing decision-makers with the latest and most complete information available on the life science and analytical instrument industry, and lab product markets. IBO delivers the latest curated industry news, information and trends, as well as SDi data and analysis to deliver the maximum in industry insight with a minimum time investment for executives and investors.
