Roche enhances its lineup of IT solutions for the professional medical laboratory and today unveils cobas IT middleware, a software suite for fully automated workflow management. Enabling laboratory managers to easily link multiple laboratory systems and software with their IT infrastructure, cobas IT middleware takes over autonomous coordination of laboratory routine processes. More than a […]
AUSTIN, Texas, — Luminex Corporation (NASDAQ: LMNX) announced today that it has received FDA clearance for its xTAG Gastrointestinal Pathogen Panel (GPP), the first comprehensive molecular diagnostic assay that tests for greater than 90% of bacterial, viral, and parasitic causes of infectious gastroenteritis in a single assay. The xTAG GPP assay can be an important […]
Franklin Lakes, NJ – BD Medical, a segment of BD (Becton, Dickinson and Company) (NYSE:BDX), a leading global medical technology company, today announced that the U.S. Food and Drug Administration (FDA) has cleared the BD PhaSeal™ Closed System Transfer Device (CSTD) under the newly created ONB code. The BD PhaSeal System is the first and […]
FOSTER CITY, CA –– Silicon Valley Biosystems (SV Bio), a diagnostics company founded to provide rapid, accurate, and turnkey clinical interpretation of comprehensive genomics data at the point of care to improve the health and outcomes of patients, was launched today. Backed by Sequoia Capital, a premier venture capital firm that helped to build Apple, […]
Hilden, Germany, and Germantown, Maryland, — QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced submission of its therascreen® EGFR RGQ PCR Kit (therascreen EGFR test) to the U.S. Food and Drug Administration (FDA) as a proposed companion diagnostic to guide treatment with afatinib, a new investigational oncology compound developed by Boehringer Ingelheim. Afatinib […]
SUNNYVALE, Calif., — Cepheid (NASDAQ: CPHD) today announced the U.S. Food & Drug Administration (FDA) has categorized Cepheid’s Xpert® CT/NG test as ‘Moderate Complexity’ under the Clinical Laboratory Improvement Amendments (CLIA). Xpert CT/NG is a qualitative in vitro molecular diagnostic test for the detection and differentiation of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG). The […]
FREMONT, Calif — Thermo Fisher Scientific Inc., the world leader in serving science, today announced that its Thermo Scientific QMS Everolimus Assay Kit has been CE marked for sale in the European Union for a third application, namely liver transplants. This new indication allows laboratories to monitor blood levels of everolimus, the active ingredient in […]
WALTHAM, Mass. & REDWOOD CITY, Calif — PerkinElmer, Inc. (NYSE: PKI) and Verinata Health, Inc., today announced a strategic agreement for expanding access to Verinata’s verifi® test, the most comprehensive non-invasive prenatal test (NIPT) currently available for high-risk pregnancies. The verifi® test, which is performed at Verinata’s CLIAcertified, California laboratory, uses a single maternal blood […]
SUNNYVALE, Calif., –Ahead of its presentation at the JP Morgan Healthcare Conference in San Francisco later today, Cepheid (Nasdaq: CPHD) this morning shared an update on Xpert test availability, highlighting that significant progress towards a return to normal manufacturing operations was achieved despite higher than anticipated demand for a number of Xpert test products during […]
The Novocastra™ HD menu for head and neck pathology comprises six antibodies[#], each selected following extensive customer research and independent evaluation* by external QA. The menu is the second portfolio of antibodies to launch from the new Novocastra HD range, following on from the introduction of the Novocastra HD menu for breast pathology in October […]
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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.
