GBC Blog

Dutch diagnostics company Inbiome has secured the EU’s In Vitro Diagnostic Regulation (IVDR) certification for its rapid bacterial identification system. This certification allows for the commercial deployment of the system across the European region. The system is designed to identify the bacteria in samples of cerebrospinal fluid, tissue biopsies, and synovial fluid. It utilises a…

SECAUCUS, N.J., April 9, 2025 /PRNewswire/ — Quest Diagnostics (NYSE: DGX), a leader in diagnostic information services, including advanced diagnostics for brain health, today announced the launch of a new laboratory blood test designed to help physicians confirm amyloid brain pathology due to Alzheimer’s disease (AD) in patients with mild cognitive impairment (MCI) or dementia. The laboratory-developed…

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Washington, D.C.— The American Clinical Laboratory Association (ACLA) and its member company, HealthTrackRx, today announced a victory in its legal challenge to the U.S. Food and Drug Administration’s (FDA) Final Rule that would have regulated virtually all laboratory developed testing services as medical devices. The U.S. District Court for the Eastern District of Texas has vacated the Final Rule in its…

BERKELEY, US – MAINZ, Germany – March 27, 2025 — Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today the first patient has been enrolled in eAArly DETECT 2, a feasibility study to evaluate the Company’s next-generation colorectal cancer (CRC) test. The…

NEW YORK – Guardant Health announced Tuesday that its Shield blood test for colorectal cancer screening has received Advanced Diagnostic Laboratory Test (ADLT) status from the US Centers for Medicare and Medicaid Services. The test will be reimbursed at the price of $1,495 per test for Medicare patients during the initial nine-month ADLT period starting…

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “E6(R3) Guideline for Good Clinical Practice.”  The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).  The draft guidance outlines modernized Good Clinical…

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NEW YORK, Aug 8 (Reuters) – Recursion Pharmaceuticals (RXRX.O), opens new tab, a biotech firm which uses artificial intelligence to discover new drug candidates, has agreed to buy smaller rival Exscientia (EXAI.O), opens new tab for $688 million in an all-stock deal, according to a statement seen by Reuters. The deal, which is expected to be announced as…

Researchers at the Fred Hutchinson Cancer Center have unveiled a new type of blood test used to detect colorectal cancer, with high hopes not only in its ability to reduce barriers to testing for this particular disease, but also potentially pave the way for many other types of cancer screenings. The study, published last week in the…