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).

MedMira Inc. (MedMira) (TSXV: MIR) announced today that it has received approval from Health Canada for its Reveal® TP (Syphilis) Antibody Test (Reveal® TP) – the fastest standalone screening device for syphilis in Canada.