Dutch diagnostics firm Inbiome said Friday that it has received certification under the EU's In Vitro Diagnostic Regulation for a PCR-based test to aid the identification of more than 200 bacterial species from patient samples, with results within five hours.

BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for BD Phoenix™ M50 and BDXpert™ System on the BD Synapsys™ Informatics Solution, leveraging rapid identification (ID) and antimicrobial susceptibility testing (AST) algorithms to assist in the interpretation of complex diagnostic data to help ensure accurate and reliable diagnoses related to antimicrobial resistance (AMR).

More than 200 biotech leaders have penned a letter voicing concerns over the FDA’s capacity after mass federal layoffs, specifically for small biotechs that depend on investor backing to meet agency standards.

The World Health Organization on Thursday issued the first global guidelines for meningitis diagnosis, treatment, and care.

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.

Oxford Nanopore Technologies, the company behind a new generation of sequencing-based molecular analysis technologies, and Cepheid, a leading molecular diagnostics company, today announced a strategic collaboration to develop and commercialize a seamless end-to-end workflow that combines Cepheid's GeneXpert system for pre-sequencing sample and library preparation with Oxford Nanopore's rapid, information-rich molecular analysis platform.

Boditech Med, a global leader in point-of-care diagnostics, announced on the 7th that it held a successful completion ceremony for its new manufacturing facility located in Jhajjar, India. The new plant is a key part of the company’s strategy to strengthen its presence in the Indian, South Asian, and Middle Eastern markets through local production and enhanced cost competitiveness.

· Q1 2025 preliminary net sales rise 7% CER and adjusted diluted EPS results of at least $0.55 CER both above outlook despite challenging macro environment · Full-year 2025 adjusted diluted EPS outlook raised to about $2.35 CER (prior outlook about $2.28 CER) · On track to exceed 31% CER adjusted operating income margin ahead of 2028 mid-term target

Tecan Group (SIX Swiss Exchange: TECN) today announced an agreement to acquire certain assets relating to key ELISA immunoassay products from Cisbio Bioassays SAS, a subsidiary of the global life sciences and diagnostics company, Revvity Inc. The asset purchase includes the manufacturing process of four ELISA kits – two in vitro diagnostic (IVD) products for specialty diagnostics and disease monitoring, and two research-use-only (RUO) kits.

QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that the U.S. Food and Drug Administration (FDA) has cleared the QIAstat-Dx Gastrointestinal Panel 2 Mini B for clinical use, further strengthening its syndromic testing portfolio in the United States.

Revvity, Inc. (NYSE: RVTY), today announced the launch of EUROIMMUN’s CE-marked Anti-Measles Virus ELISA 2.0 (IgG) to support the diagnosis of a measles virus infection or to determine the immune status against measles virus. EUROIMMUN’s Anti-Measles Virus ELISA 2.0 (IgG) is the first of several assays in development expanding EUROIMMUN’s serological infection diagnostics portfolio with validation for dried blood spots (DBS) as sample material in addition to serum and plasma.

Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced its financial results for the fourth quarter and year ended December 31, 2024.

Dutch diagnostics firm MRC Holland said Friday that two of its blood-based assays for spinal muscular atrophy (SMA) have been certified under Europe's In Vitro Diagnostic Regulation (IVDR).

Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, today reported financial results for the fourth quarter and full year ended December 31, 2024, and provided recent business highlights.

Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, today reported its financial results for the fourth quarter and full year ended December 31, 2024.