Frankfurt / Richmond, Calif. – Nanostart holding Lumiphore announced the European launch of three diagnostic tests by its partner ThermoFisher Scientific Clinical Diagnostics using Lumiphore’s time-resolved fluorescent reporter technology. ThermoFisher Clinical Diagnostics has launched three CE-marked in vitro diagnostic tests in countries of the European Economic Area (EEA), consisting of the 27 Member States of […]
FRAMINGHAM, Mass. – AB SCIEX, a global leader in life science analytical technologies, today announced that it has achieved ISO 13485 certification for its quality management system. ISO 13485 is an international standard that requires a manufacturer to demonstrate a comprehensive and compliant quality management system suitable for the design and manufacturing of medical devices. […]
London, UK and Ann Arbor, MI – NextGen Group Plc (AIM: NGG), an AIM listed company providing biomarker discovery and testing services has completed the establishment of its new diagnostics subsidiary company (NextGen Sciences Dx Inc.). The board of NextGen believes that the creation of the diagnostics business as a separate corporate entity is an […]
ANN ARBOR, Mich. and AMSTERDAM, Rubicon Genomics, Inc., a company developing and commercializing sample-specific pre-analytical processes to improve the capabilities and performance of DNA and RNA analytical platforms, today announced a clinical supply agreement with molecular diagnostics firm Agendia for its TransPLEX® whole genome RNA amplification technology. Agendia will incorporate Rubicon’s TransPLEX kits into the […]
REDWOOD CITY, Calif., Verinata Health, Inc., a privately-held company dedicated to maternal and fetal health, announced today that it has commenced an action against Sequenom, Inc. and its wholly-owned subsidiary, Sequenom Center for Molecular Medicine, LLC (“Sequenom CMM”), in federal court. The action, filed in the Northern District of California, seeks a declaratory judgment that […]
SEATTLE – Integrated Diagnostics (InDi®), an emerging leader in molecular diagnostics, today announced that the company has made substantial progress in its diagnostic programs, triggering a $10 million third tranche of its Series A financing. The company will use the funds to complete clinical development of its in vitro proteomic-based diagnostics programs and prepare for […]
PLEASANTON, Calif., Roche and Life Technologies Corporation (LTC) announced today that they have entered into two license agreements to allow LTC to expand its PCR offerings for diagnostics applications. Under these two agreements, Roche has granted LTC an in vitro diagnostics product license to all of Roche’s patents for real-time PCR (polymerase chain reaction) as […]
NEW YORK, NY, Enzo Biochem, Inc. (NYSE:ENZ) today announced that the New York State Department of Health has approved Enzo Clinical Labs’ use of the ColonSentry™ test for providing an assessment of a patient’s risk of having colorectal cancer. The ColonSentry™ test was originally developed by GeneNews (TSX: GEN) and requires only a small blood […]
Austin, Texas, Asuragen, Inc. announced today the immediate availability of the miRInform® Pancreas Test in its CAP-accredited CLIA Laboratory. miRInform® Pancreas was developed to aid physicians in the diagnosis and management of pancreatic ductal adenocarcinoma (PDAC) when cytology is inconclusive. The test evaluates expression levels of seven miRNAs in Fine Needle Aspirate (FNA) specimens of […]
SANTA CLARA, Calif., Affymetrix, Inc. today announced that its GeneChip® System 3000Dx v.2 (GCS 3000Dx v.2) has been approved by China’s State Food and Drug Administration (SFDA) for in vitro diagnostic use. The GCS 3000Dx v.2 is the first microarray instrument system to be granted SFDA registration for array-based diagnostics for enabling personalized medicine. China […]
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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.
