Visby Medical, the at-home diagnostics company, today announced U.S. Food and Drug Administration (FDA) clearance for the Visby Medical Flu and COVID-19 Test, the first multi-viral at-home PCR test. This marks Visby’s second over-the-counter PCR test and expands the company’s growing portfolio of rapid molecular diagnostics designed for home use.

Cytiva Localizes Production of Automated Industrial Chromatography Columns in China Cytiva, a Danaher operating company, has announced the local production of its automated industrial chro..

We are proud to announce that Hartwig Medical Foundation has received CE certification under the European In Vitro Diagnostic Regulation (IVDR) for Hartwig Medical OncoAct (OncoAct), our software solution for cancer diagnostics based on Whole Genome Sequencing (WGS) in solid tumors.

Today, the World Health Organization (WHO) has added the first molecular diagnostic test for Bundibugyo virus (BDBV) to its Emergency Use Listing (EUL). The test detects the virus by identifying its genetic material in blood samples, helping confirm infection rapidly and accurately.

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced its Shield™ blood test for colorectal cancer screening (CRC) is now covered for eligible UnitedHealth Group (UHG) members, making it the first major commercial insurer to provide coverage for adults 45 or older amid rising CRC rates for adults under 65 and mortality for younger adults as the leading cause of cancer death for those under 50.

CareDx, Inc. (Nasdaq: CDNA), a leading precision medicine diagnostics company in transplant, specialty oncology, and cell therapy today announced the successful completion of its previously announced acquisition of Naveris, following the satisfaction of all closing conditions. The transaction terms were disclosed at the time of announcement in April 2026.

altona Diagnostics today announced that its FlexStar® STI panel has obtained CE marking under Regulation (EU) 2017/746 (IVDR). This completes the IVDR transition for the company’s modular and adaptive STI testing portfolio, enabling laboratories to configure customizable multiplex panels for up to 7 sexually transmitted pathogens in a single sample.

CareDx, Inc. (Nasdaq: CDNA) — The Transplant Company™, a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high‑value healthcare solutions for transplant patients and caregivers, today announced the closing of the previously announced sale of its Lab Products business to Eurobio Scientific. The transaction closed on June 30, 2026 following receipt of required Swedish regulatory clearance.

The chair of the U.S. House Select Committee ​on China opened national security investigations into whether five drugmakers including Merck (MRK.N), opens new tab and AbbVie (ABBV.N), opens new tab have been involved in clinical trials conducted in China ‌that helped fuel the communist country's military capability.

The U.S. Department of Health and Human Services (HHS) today announced that Secretary Robert F. Kennedy, Jr. has signed determinations terminating the COVID-19 Emergency Use Authorization (EUA) declarations for drugs and biological products and for medical devices, concluding that the circumstances that justified these emergency authorities no longer exist.

bioMérieux, a world leader in the field of in vitro diagnostics, has submitted a Dual 510(k)/CLIA Waiver* application to the U.S. Food and Drug Administration (FDA) for the BIOFIRE® SPOTFIRE® Vaginitis (VG) Panel**. This automated, multiplex PCR*** test can simultaneously detect the most common causes of vaginitis in 20 minutes, directly at the point of care. With this submission, bioMérieux is intending to expand into women’s and sexual health, bringing rapid and accurate diagnostics closer to patients.

Genedrive (LSE:GDR) has entered into a collaboration agreement with Thermo Fisher Scientific to develop the Genedrive CYP2C19 HT Kit, a high-throughput pharmacogenetic in vitro diagnostic test designed for use on Thermo Fisher’s QuantStudio 5 Dx PCR platform. The new assay is aimed at centralised laboratory testing and complements the company’s existing rapid CYP2C19 ID Kit for near-patient use. Genedrive is targeting UKCA certification by the end of 2026, with the initial commercial focus on NHS genomic laboratories across the UK.

1 Status Quo of China’s Urinalysis Market The major brands in China’s urinalysis market are URIT, DIRUI, AVE, etc. URIT produced China’s first urine analyzer in 1984. And after nearly 40..

Roche Diagnostics Receives NMPA Approval for Expanded cobas® 4800 HPV Test Indications in China Roche Diagnostics recently announced that its cobas® 4800 HPV Test (PCR Fluorescence..

GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, today announced the closing of its previously announced equity financing with Samsung affiliates including Samsung C&T Corporation.