Diasorin (FTSE MIB: DIA) today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the LIAISON PLEX® Gram-Positive Blood Culture Assay, the final syndromic blood culture panel for the microbiological diagnosis of bloodstream infections on the LIAISON PLEX®.

New data published in JAMA Internal Medicine on Friday from MD Anderson Cancer Center researchers found that mail-in self-collection kits for human papillomavirus testing more than doubled cervical cancer screening participation among never- and under-screened patients.

Burning Rock Biotech Limited (NASDAQ: BNR, the “Company” or “Burning Rock”), a company focused on the application of next generation sequencing (NGS) technology in the field of precision oncology, today reported financial results for the three months ended March 31, 2025.

Fujirebio, a leading innovator in in-vitro diagnostics, today announced a collaboration with Stanford Medicine (Location: Palo Alto, California, USA) to advance research and innovation in the field of infectious disease testing. This collaboration aims to accelerate the adoption of ultrasensitive immunoassays that incorporate single-molecule counting technology developed by Fujirebio’s Silicon Valley wholly-owned subsidiary, Fluxus, Inc. Greater test sensitivity can better inform treatment decisions in the clinic, as well as accelerate studies towards therapeutics and preventive strategies against infectious disease threats worldwide.

Randox Laboratories announced that the U.S. Food and Drug Administration (FDA) has approved the De Novo application for the company’s first Companion Diagnostic (CDx). This is a major achievement for Randox following over 3 years of innovative development and collaboration with Novo Nordisk. The Companion Diagnostic was developed as a new option for determining the amount of medication a patient with hemophilia has received.

Cepheid today announced that Health Canada has issued Cepheid a medical device licence for Xpert® HIV-1 Viral Load XC, a next-generation extended-coverage (XC) test intended to aid in assessing HIV viral load levels, which are used to monitor effectiveness of antiretroviral treatment.

China's drug regulator has approved the country's first domestically developed 9-valent human papillomavirus (HPV) vaccine, ending over a decade of foreign dominance in the market.

Technical Platform POCT technology has gradually evolved from classical immunochromatography to more sensitive platforms hosting multiple detection technologies, such as luminescence and molecular detection. ..

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that its Shield multi-cancer detection (MCD) test has been granted Breakthrough Device designation from the U.S. Food and Drug Administration (FDA). The Shield MCD test is a methylation-based blood test for the multi-cancer screening of multiple cancer types including bladder, colorectal, esophageal, gastric, liver, lung, ovarian and pancreas cancer in individuals aged 45 or older who are at typical average risk for cancer.

QuidelOrtho Corporation (Nasdaq: QDEL) (the "Company" or “QuidelOrtho”), a global provider of innovative in vitro diagnostic technologies designed for point-of-care settings, clinical labs and transfusion medicine, today announced a refocusing of its molecular diagnostics strategy. This strategy includes the intent to acquire full ownership of LEX Diagnostics after 510(k) clearance by the U.S. Food and Drug Administration ("FDA") for consideration at closing of approximately $100 million and plans to discontinue the Company's Savanna platform development.

PathAI, a leading provider of AI-powered pathology solutions, and Northwestern Medicine, Chicago’s premier integrated academic health system, today announced a strategic collaboration to transform pathology diagnostics through artificial intelligence. This multi-year collaboration will see Northwestern Medicine implement PathAI’s AISight digital pathology image management system with the goal of driving efficiency and quality in pathology operations. In addition to the digital innovation efforts, this joint effort establishes a broad framework for joint research initiatives, clinical innovation programs, and co-development of new AI-powered diagnostic tools aimed at improving patient outcomes.

QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the expansion of its oncology diagnostics portfolio with two strategic partnerships to advance the use of minimal residual disease (MRD) testing in clinical trials to support pharma co-development projects for companion diagnostics. The new collaborations with Tracer Biotechnologies and Foresight Diagnostics expand QIAGEN’s reach in MRD testing and cover solid tumors and hematological cancers.

From May 21-23, 2025, Lei Haichao, Director of the National Health Commission of the P.R.C, led a delegation on an official visit to France.

Introduction Point-of-care testing (POCT) is a subfield of in vitro diagnostics (IVD), where portable analytical instruments and supporting reagents are used to obtain test results quickly at the sampling site. P..

Illumina Inc. (NASDAQ: ILMN) today announced an expanded clinical oncology portfolio, unlocking the next new solutions to advance precision oncology and improve the standard of care. The company's broad range of clinical offerings will accelerate access to precision oncology for more patients with cancer. Illumina tumor profiling and in vitro diagnostic (IVD) solutions will be on display at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.