Cepheid announced today that it has received FDA Clearance with Clinical Laboratory Improvement Amendments (CLIA) waiver for Xpert® Xpress MVP. This multiplex vaginal panel can now be performed in near-patient settings, enabling results within 60 minutes from a single specimen for Bacterial Vaginosis (BV), Vulvovaginal Candidiasis (VVC), and Trichomoniasis (TV). This expanded claim exemplifies Cepheid's commitment to providing expanded access to women's and sexual health by making PCR testing accessible at the point of care. The test runs on Cepheid's GeneXpert Xpress instruments and has been approved for testing women fourteen years of age and older.

Cleveland Diagnostics, Inc., a clinical-stage biotechnology company developing next-generation diagnostic tests for the early detection of cancers announced the closing of over $75M in growth capital financing. The financing was led by Novo Holdings, a leading global life sciences investor, responsible for managing the assets of the Novo Nordisk Foundation, along with participation from existing investors as well as a credit facility from Symbiotic Capital. The financing will accelerate Cleveland Diagnostics’ commercial and corporate development goals.

Just as users around the world are surely strapping on new Fitbits with an aim of tackling health-focused New Year’s resolutions, so too is Fitbit itself kicking off 2024 with its sights set on a new goal.

Agilent Technologies Inc. (NYSE: A) today announced the release of a new automated parallel capillary electrophoresis system for protein analysis – the Agilent ProteoAnalyzer system – at the 23rd Annual PepTalk Conference, being held January 16-19 in San Diego. This new platform simplifies and improves the efficiency of analyzing complex protein mixtures, a process central to analytical workflows across the pharma, biotech, food analysis, and academia sectors.

Roche announced on Tuesday that it has received CE marking for a claim extension on its Elecsys Anti-Müllerian Hormone (AMH) Plus test.

The immunoassay method involves the widest range of items among all fields of medical detection; with the development of biomedical research, especially genomics and post-genomics results (high-resolution two-dimensional electrophoresis combined with mass spectrometry) which highly promote the research on disease-related markers, more and more items will be detected via immunoassay in the medical practice.

US-based Calibre Scientific has acquired German MoBiTech for an undisclosed amount to bolster its portfolio of diagnostic services.

Ultima Genomics, a developer of a revolutionary new ultra-high throughput sequencing architecture, and Quest Diagnostics (NYSE: DGX), the nation’s leading provider of diagnostic information services, today announced a collaboration involving Ultima’s next generation sequencing (NGS) technology in oncology and other clinical areas.

Stay up-to-date with the latest happenings in the rapidly evolving field of In Vitro Diagnostics (IVD) in China.

Danaher and the Innovative Genomics Institute (IGI) have launched a collaborative research center aimed at developing CRISPR-based gene therapies for a wide array of diseases.

Rapid test maker Hangzhou Clongene Biotech and diagnostics product distributor Gold Colloid on Friday said they inked a deal to distribute Clongene's in vitro­ diagnostics products in the US.

Rapid diagnostic tests for dengue fever will be accessible at all airports across the country starting Friday, the Korea Disease Control and Prevention Agency (KDCA) said, Thursday. This comes in response to the rising number of domestic cases, where individuals have been contracting the virus through mosquito bites during their overseas travels.

A menstrual pad designed with a removable strip to collect blood samples for clinical tests has been granted clearance by the US Food and Drug Administration (FDA).

US-based Veracyte has agreed to acquire minimal residual disease (MRD) test developer C2i genomics in a deal worth up to $95m, strengthening its range of cancer diagnostic products.

The UK government on Tuesday said it has issued legislation for the implementation of new regulations governing in vitro diagnostics and medical devices.