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.

Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced that Signatera has received regulatory approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).

Quest Diagnostics® (NYSE: DGX), a leading provider of diagnostic information services, today announced that the New York State Department of Health's (NYSDOH) Clinical Laboratory Evaluation Program (CLEP) has approved the company's Haystack MRD® test, a circulating tumor DNA (ctDNA) liquid biopsy test, for use in identifying residual or recurring disease in patients with a range of solid tumor cancers.

Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today the European Union In Vitro Diagnostic Regulation (IVDR) approval of several label expansions for the VENTANA® MMR RxDx Panel, an immunohistochemistry (IHC) companion diagnostic test that aids in identifying a cancer patient’s mismatch repair (MMR) status. MMR is a process that scans a person’s genetic code and fixes errors to prevent mutations that can lead to cancer. The test evaluates a panel of MMR proteins in tumours to provide this important treatment information to clinicians.

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that the U.S. Food and Drug Administration (FDA) has approved Guardant360® CDx as a companion diagnostic (CDx) for Boehringer Ingelheim’s HERNEXEOS® (zongertinib tablets), the first targeted therapy for adults with HER2 (ERBB2)-mutant advanced non-small cell lung cancer (NSCLC) as an initial treatment option.

Myriad Genetics Inc., (NASDAQ: MYGN), a leader in molecular diagnostic testing and precision medicine, today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved the use of the MyChoice® Test for prostate cancer patients as a companion diagnostic for Lynparza® (olaparib). With this approval, clinicians can now order the MyChoice Test to determine homologous recombination deficiency (HRD) status for patients with ovarian cancer, and BRCA1/2 status for breast and prostate cancers.

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

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

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received CE mark for its Elecsys® Dengue Ag test – a high-throughput, fully automated immunoassay to be used as an aid in the diagnosis of an acute dengue virus infection. This milestone promises to set a new standard for efficiency and reliability in tackling the growing global challenge of dengue fever.

Riken Genesis Co., Ltd. (Riken Genesis) and Burning Rock Biotech Limited (NASDAQ: BNR, “Burning Rock”) today announced that the OncoGuide™ OncoScreen™ Plus CDx System based on OncoScreen™ Plus to be used as a companion diagnostic for AstraZeneca’s capivasertib has received Manufacturing and Marketing Approval from Japan’s Ministry of Health, Labour and Welfare (MHLW).