Molecular diagnosis is performed at the gene level with nucleic acids as the object for detection, with high sensitivity and accuracy.

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

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®.

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

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.

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.