London, UK — MRC Technology, a technology transfer organisation, announced today it has entered into collaboration with Renishaw Diagnostics Ltd (RDL), developer of the RenDx® multiplex assay system, to identify and design novel clinical diagnostic tests for infectious disease. The agreement will benefit from the combination of RDL’s proprietary multiplex screening technology and expertise in […]

SAN DIEGO — Sequenom, Inc. (NASDAQ: SQNM), a life sciences company providing innovative diagnostic testing and genetic analysis solutions, today announced that it has submitted Premarket 510(k) Notifications to the United States Food and Drug Administration (FDA) for its IMPACT Dx™ System and its IMPACT Dx™ Factor V Leiden and Factor II Genotyping Test. The […]

INDIANAPOLIS –– Beckman Coulter Life Sciences has received 510(k) clearance from the U.S. Food and Drug Administration and an Import Medical Device Registration Certificate from the China Food and Drug Administration for the in vitro diagnostic use of the Navios flow cytometry system. In the U.S., the Navios flow cytometer is intended for immunophenotyping in […]

SAN DIEGO — Trovagene, Inc. (NASDAQ: TROV), a developer of cell-free molecular diagnostics, today announced availability of the first urine test for cancer mutation monitoring through the company’s CLIA laboratory. The robustness of Trovagene’s ultra-sensitive assay procedure has been demonstrated for detection of the BRAF V600E mutation from cell-free DNA in urine. This mutation commonly […]

NEW YORK — Exosome Diagnostics today announced that it has selected Cedars-Sinai Medical Center to participate in an early technology access program for use of exosome RNA biofluid extraction kits for biomarker discovery in neo-natal and other disease settings. “The ability to monitor patients, particularly extreme premature infants, using real-time biofluid based genetics tests, may […]

OMAHA, Neb. — Transgenomic, Inc. (OTCBB: TBIO), a global biotechnology company advancing personalized medicine in cardiology, oncology, and inherited diseases through diagnostic tests as well as clinical and research services, today announced that Paul Kinnon has been named President, Chief Executive Officer and a Director, replacing Craig J. Tuttle, effective today. Mr. Kinnon brings over […]

LENEXA, Kan. — Analytical sensitivity data shows Thermo Fisher Scientific’s Remel Xpect Flu A&B assay is able to detect cultured avian influenza A (H7N9), A/Anhui/1/2013 virus. Analytical reactivity testing for this novel strain is in line with the FDA reclassification proposal for assessing detection of emerging viruses that could potentially cause a public health emergency. […]

LEXINGTON, Mass. — T2 Biosystems, a company developing direct detection products enabling superior diagnostics, today announced that it will provide demonstrations of its flagship test, T2Candida®, for the rapid and sensitive identification of species-specific Candida directly from whole blood, on its T2Dx® instrument at Booth #922 at IDWeek 2013, October 2-6, 2013, in San Francisco, […]

CARLSBAD, Calif. — Life Technologies Corporation (NASDAQ: LIFE) and Advanced Cell Diagnostics, Inc. (ACD), a leader in the field of molecular pathology and developer of cell and tissue-based analysis tools, today announced a global distribution agreement by which Life will distribute ACD’s fluorescent RNAscope® portfolio of probes and kits to the research market through its […]