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

H.U. Group Holdings Inc. and its wholly owned subsidiary Fujirebio today announced that Health Canada has issued Class II Medical Device Licenses (MDL) for the Lumipulse G NfL Blood and the Lumipulse G pTau 217 Plasma assay for use on the fully automated LUMIPULSE® G immunoassay platform in the Canadian market.

Quest Diagnostics (NYSE: DGX), a leader in diagnostic information services, today announced two new developments for its Quest AD-Detect® portfolio of blood-based biomarker tests for Alzheimer's disease, with the goal of broadening access to quality blood tests for evaluating symptomatic patients for Alzheimer's disease.

The U.S. Food and Drug Administration has cleared Roche (ROPC.S), opens new tab and partner Eli Lilly's (LLY.N), opens new tab blood test to help ​identify signs of Alzheimer's disease in people aged ‌55 and older with cognitive decline.

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

The U.S. FDA has approved Freenome's (FRNM.O), opens new tab blood-based colorectal cancer ​screening test for older adults, paving the way for partner ‌Abbott (ABT.N), opens new tab to launch it in the U.S. this fall, the companies said on Monday.

Beckman Coulter Diagnostics, a global leader in clinical diagnostics and a Danaher company, today announced it received CE Mark under IVDR for its Access p-Tau217 assay, a blood test designed to support clinical evaluation of amyloid pathology in patients with signs and symptoms of cognitive decline. The company also introduced its high-specificity Access BD-pTau217 Research Use Only (RUO) assay at the Alzheimer's Association International Conference (AAIC) 2026 in London.

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.

According to the network statistics, market size of China’s blood group reagent was RMB 2.55 billion in 2024, which is expected to achieve RMB 2.86 billion in 2025 with growth rate of 12.3%.

Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, today announced that its Personalis EDTA Blood Collection Kit and Personalis cfDNA Blood Collection Kit have obtained Class A CE-IVD marking in compliance with the European Union’s In Vitro Diagnostic Regulation (IVDR).