The chair of the U.S. House Select Committee ​on China opened national security investigations into whether five drugmakers including Merck (MRK.N), opens new tab and AbbVie (ABBV.N), opens new tab have been involved in clinical trials conducted in China ‌that helped fuel the communist country's military capability.

The U.S. Department of Health and Human Services (HHS) today announced that Secretary Robert F. Kennedy, Jr. has signed determinations terminating the COVID-19 Emergency Use Authorization (EUA) declarations for drugs and biological products and for medical devices, concluding that the circumstances that justified these emergency authorities no longer exist.

bioMérieux, a world leader in the field of in vitro diagnostics, has submitted a Dual 510(k)/CLIA Waiver* application to the U.S. Food and Drug Administration (FDA) for the BIOFIRE® SPOTFIRE® Vaginitis (VG) Panel**. This automated, multiplex PCR*** test can simultaneously detect the most common causes of vaginitis in 20 minutes, directly at the point of care. With this submission, bioMérieux is intending to expand into women’s and sexual health, bringing rapid and accurate diagnostics closer to patients.

Genedrive (LSE:GDR) has entered into a collaboration agreement with Thermo Fisher Scientific to develop the Genedrive CYP2C19 HT Kit, a high-throughput pharmacogenetic in vitro diagnostic test designed for use on Thermo Fisher’s QuantStudio 5 Dx PCR platform. The new assay is aimed at centralised laboratory testing and complements the company’s existing rapid CYP2C19 ID Kit for near-patient use. Genedrive is targeting UKCA certification by the end of 2026, with the initial commercial focus on NHS genomic laboratories across the UK.

1 Status Quo of China’s Urinalysis Market The major brands in China’s urinalysis market are URIT, DIRUI, AVE, etc. URIT produced China’s first urine analyzer in 1984. And after nearly 40..

Roche Diagnostics Receives NMPA Approval for Expanded cobas® 4800 HPV Test Indications in China Roche Diagnostics recently announced that its cobas® 4800 HPV Test (PCR Fluorescence..

GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, today announced the closing of its previously announced equity financing with Samsung affiliates including Samsung C&T Corporation.

A diagnostics company behind one of the best-known rapid Covid-19 tests has put its point-of-care testing unit up for sale, aiming at a valuation of $1.5bn, as private equity buyers eye opportunities in the healthcare and life sciences sectors.

Agilent Technologies Inc. (NYSE: A) today announced the successful completion of its previously announced acquisition of Biocare Medical, a global leader in clinical pathology, from an investor group led by Excellere Partners and GHO Capital Partners LLP. Following the close of the transaction, Biocare is now part of Agilent’s Life Sciences and Diagnostics Markets Group.

Original from: Bio-Techne Corporation Merck KGaA, Darmstadt, Germany, a leading science and technology company, and Bio-Techne Corporation (NASDAQ: TECH), a Minneapolis-based global provider of life scie..

Not every assay needs the same substrate. But every assay needs the right one. Kementec’s TMB Crew is a complete portfolio of chromogenic HRP substrates developed to support different ELI..

Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced that Signatera has received regulatory approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).

Original from: Quest Diagnostics Quest Diagnostics® (NYSE: DGX), a leading provider of diagnostic information services, today announced that the New York State Department of Health's (NYSDOH) Clinica..

4.3.3 Future Status of Blood Typing Reagent Market Accompanied with further expansion of coverage of automated blood typing instrument market, promotion of newborn test, genotyping, and other new test items will..

Revvity, Inc. (NYSE: RVTY) announced the continued evolution of artificial intelligence across its Revvity Signals software business with new and expanding AI capabilities. Built natively into the Signals One™ platform, new capabilities from Signals AI help scientists transform connected R&D data into understanding, decisions and action using natural language within their existing workflows.

Original from: Masimo Masimo, a Danaher company and a specialty diagnostics solutions innovator of pulse oximetry and other patient monitoring solutions, today announced FDA 510(k) clearance for an opioi..

Original from: Fierce Biotech French biopharma Sanofi has inked a partnership deal with Pangaea Data to use its AI platform that helps detect Alpha-1 Antitrypsin Deficiency (AATD), which will be distribu..

Snibe's Clinical Chemistry Analysis System Receives CDC Certification On June 16, the Total Glycerides (TG) assay on Snibe's clinical chemistry analysis system successfully passed the CDC-CRMLN certifica..

Original from: PR Newswire Co-Diagnostics, Inc. (Nasdaq: CODX) ("Co-Dx" or "the Company"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tes..

Original from: DiaSorin Diasorin (FTSE MIB: DIA) announced today that it has received 510(k) clearance and CLIA waiver from the U.S. Food and Drug Administration (FDA) for its Group A Streptococcus (GAS)..