China’s NMPA has approved Quanterix and Innovita’s HD-X and SR-X immunoassay platforms and four blood-based neurology biomarker tests, expanding access to Alzheimer’s diagnostics in the Chinese clinical lab market.
USC researchers report that two blood tests, Lumipulse G p-tau217/β-Amyloid 1-42 and PrecivityAD2, can accurately detect Alzheimer’s pathology in patients with Down syndrome.
The insurer will provide coverage for the multi-analyte test starting July 2026, following new data showing parity with mass spectrometry.
The certification verifies that the automated immunoassay provides results equivalent to the gold standard method for measuring total testosterone.
VolitionRx reports its lateral flow prototype can detect nucleosomes in finger-prick blood samples from sepsis patients, enabling rapid, point-of-care testing outside centralized labs, according to company data.
The assay is CE marked under the European Union In Vitro Diagnostic Regulation and identifies resistance genes to help prevent hospital-acquired infections.