Home testing firm LetsGetChecked announced on Tuesday that its ImPress lancing device has received 510(k) clearance from the US Food and Drug Administration for professional use.

Foundation Medicine, Inc., a genomics company committed to transforming cancer care, today announced a collaboration with Sumitomo Pharma America, Inc. (SMPA) to develop the FoundationOne®Heme platform as a companion diagnostic to identify patients with acute leukemia with a KMT2A rearrangement, also known as mixed lineage leukemia (MLL) rearrangement, or NPM1 mutations for potential treatment with SMPA’s enzomenib (DSP-5336), an investigational menin inhibitor.

Mindray’s Second Headquarters to Fully Launch Mindray’s Second Headquarters, located in Wuhan’s Optics Valley Bio-City, is set to be fully operational. As one of the world’s leading an..

bioMérieux, a company specializing in in vitro diagnostics, announced the launch of GENE-UP TYPER, a real-time PCR solution for rapid pathogen detection root cause analysis in the food industry.

The number of workers terminated by the Trump administration at the National Institutes of Health has been revised to 1,165, according to an NIH internal email seen by Reuters on Sunday, down from an initial 1,500.

Bio-Rad Laboratories, Inc. (NYSE: BIO and BIO.B), a global leader in life science research and clinical diagnostics products, today announced that the company has entered into a binding offer to purchase all equity interests in Stilla Technologies (“Stilla”). The acquisition remains subject to consultation with relevant employee representatives, regulatory approvals, and other customary closing conditions, and is expected to close by the end of the third quarter of 2025.

Bio-Rad Laboratories, Inc. (NYSE: BIO and BIO.B), a global leader in life science research and clinical diagnostics products, today announced financial results for the fourth quarter and full year ended December 31, 2024.

Roche announced today that the Roche Elecsys® sFlt-1/PlGF ratio for preeclampsia has received 510(k) clearance from the United States Food and Drug Administration (FDA). The ratio is a prognostic test intended to stratify hospitalized pregnant women with hypertensive disorders of pregnancy into low- and high-risk categories for developing severe preeclampsia within two weeks of testing. Identifying patients at high risk for severe preeclampsia can lead to better prediction, earlier interventions and reduced adverse outcomes.

GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, and Quest Diagnostics (NYSE: DGX), a leading provider of diagnostic information services, today announced the initial phase of a program to improve provider access to GRAIL’s Galleri® multi-cancer early detection (MCED) test. Providers can now order the Galleri test directly from GRAIL through the Quest Diagnostics connectivity system. The Quest Diagnostics connectivity system enables providers in the United States to order and receive reports of laboratory tests electronically through Quest’s Quanum laboratory portal and more than 900 electronic health record (EHR) systems. More than 500,000 providers used the Quest connectivity system last year.

Original from: QuidelOrtho Fourth Quarter and Full-Year 2024 Results (all comparisons are to the prior year period) Fourth quarter 2024 revenue was $708 million, as reported · Non-respira..

The Nasdaq Hearings Panel has decided to delist T2 Biosystems common stock after the firm failed to meet the stock exchange's requirements for the minimum bid price and market value of listed securities, T2 Biosystems said in a form filed Tuesday with the US Securities and Exchange Commission.

bioMérieux, a world leader in the field of in vitro diagnostics, today announces that its BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel Mid has obtained clearance from the U.S. Food and Drug Administration (FDA). This midplex molecular panel tests for 11 of the most common bacteria, viruses, and parasites associated with gastroenteritis — all from one sample, with results available in approximately one hour.

Wantai and UNOPS Partner to Advance Global Tuberculosis Prevention and Control In December 2024, the United Nations Office for Project Services (UNOPS) and Wantai officially signed a long-..

3.4 Genetic Disease Molecular Diagnostic Reagents 3.4.1 Preimplantation Screening Reagent In vitro fertilization embryos are prone to chromosomal aneuploidy abnormalities. Chromosome aneuploidy ref..

Original from: business wire Ibex Medical Analytics (Ibex), the leader in AI-powered cancer diagnostics, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for ..