Bio-Rad Receives U.S. FDA Clearance for the IH-Reader 24, Expanding the Company’s Offering for the Blood Typing Market

Date: 10/29/2018 HERCULES, Calif.–Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb), a global leader of life science research and clinical diagnostic products, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the IH-Reader 24, a semi-automated blood typing instrument designed for medium- to small-volume laboratories. A combination centrifuge and... Read more

Agena and DaRui Biotechnology Announce China FDA Clearance of MassARRAY® Technology for Diagnostic Use in China

23 October 2018 San Diego, CA and Guangzhou, China, Wednesdy, October 24, 2018 – Agena Bioscience (Agena) and DaRui Biotechnolog (DaRui) announced today that the MassARRAY® System has formally passed the registration application of Guangdon Food and Drug Administration, becoming the first CFDA approved MALDI-TOF mass spectrometry system to directly detect nucleic acids for in vitro diagnostics in... Read more

NML transfers to ISO17034 accreditation for reference material production

22 OCT 2018 Tags:  Measurement, National Measurement Institute LGC is pleased to announce that the UK’s National Measurement Laboratory (NML) at LGC has successfully completed the transition from ISO Guide 34 to ISO 17034:2016 accreditation after assessment by the United Kingdom Accreditation Service (UKAS). The NML develops internationally-recognised measurement standards that are used as benchmarks in analytical laboratories. Our... Read more

Luminex Corporation to Acquire MilliporeSigma's Flow Cytometry Portfolio

AUSTIN, Texas, Oct. 18, 2018 /PRNewswire/ — Luminex Corporation (NASDAQ: LMNX) today announced that the company has signed a definitive agreement to acquire MilliporeSigma’s flow cytometry portfolio for $75 million, consisting of approximately $69.9 million to be paid under a Stock and Asset Purchase Agreement and approximately $5.1 million in committed inventory purchases. The deal... Read more

DNAnexus Granted Authority to Operate by Health and Human Services (HHS) for FedRAMP Moderate

Government agencies can now easily integrate biomedical data management and informatics into their research and services. October 17, 2018 05:00 AM Pacific Daylight Time MOUNTAIN VIEW, Calif.–(BUSINESS WIRE)–DNAnexus Inc. announced today it has been granted an Authority to Operate (ATO) under the Federal Risk and Authorization Management Program (FedRAMP) for the management and analysis of biomedical... Read more

BD Launches Molecular Test For Detecting Tuberculosis And Multi-Drug Resistant TB

BD MAX™ MDR-TB Panel Obtains CE-IVD Status in Europe FRANKLIN LAKES, N.J., Oct. 16, 2018 /PRNewswire/ — BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced the availability of the BD MAX™ MDR-TB panel in Europe. Clinicians can use the test to simultaneously detect bacteria that cause tuberculosis (TB) and determine if the bacteria... Read more

OCREVUS (ocrelizumab) data show early initiation of treatment reduces disability progression over five years in relapsing and primary progressive multiple sclerosis

Basel, 10 October 2018 OCREVUS (ocrelizumab) data show early initiation of treatment reduces disability progression over five years in relapsing and primary progressive multiple sclerosis People with relapsing MS (RMS) treated sooner with OCREVUS had earlier reduction in disease activity and less disability progression vs. those who switched from interferon beta-1α People with primary progressive... Read more

European Society of Radiology and GE Healthcare announce exclusive artificial intelligence partnership for ECR 2019

Vienna, Austria – October 9th, 2018 – The European Society of Radiology (ESR) and GE Healthcare are partnering on artificial intelligence (AI) for the upcoming European Congress of Radiology (ECR) on February 27-March 3, 2019 in Vienna, Austria. The partnership includes joint sessions on artificial intelligence and a 300 m² dedicated space on GE Healthcare’s 850... Read more

Thermo Fisher Scientific Announces Sixth Licensing Agreement for B•R•A•H•M•S PCT

Thermo Fisher Scientific Announces Sixth Licensing Agreement for B•R•A•H•M•S PCT Siemens Healthineers Recent FDA Clearance of the Atellica IM B•R•A•H•M•S PCT Assay Extends Access of Procalcitonin to More U.S. Laboratories WALTHAM, Mass., Oct. 2, 2018 /PRNewswire/ — Thermo Fisher Scientific Inc., today announced the sixth licensing agreement for its B·R·A·H·M·S PCT (procalcitonin) biomarker that provides information... Read more

PerkinElmer Receives FDA Clearance for NeoBase™ 2 Non-Derivatized Tandem Mass Spectrometry Kit

In vitro diagnostic solution tests newborn babies for a variety of metabolic disorders with a single dried blood spot card WHAT: PerkinElmer, Inc., a global leader committed to innovating for a healthier world, today announced that its NeoBase™ 2 Non-Derivatized MSMS Kit has received 510(k) clearance from the U.S. Food & Drug Administration (FDA). Used with... Read more