Roche has received FDA clearance for its Elecsys pTau217 blood test, marking the first FDA-cleared, single-biomarker blood test for assessing amyloid pathology associated with Alzheimer's disease. The test, developed with Eli Lilly, is designed for use in both primary and specialty care settings for individuals aged 55 and older showing signs of cognitive decline. The assay provides positive, intermediate, and negative result categories using validated clinical cutoffs across care settings. Results support both rule-in and rule-out assessment of amyloid pathology when interpreted alongside clinical information. The test will be available across Roche's installed base of over 4,500 cobas laboratory instruments in the US, enabling broad access through existing laboratory infrastructure. This clearance represents a significant advancement in Alzheimer's disease diagnostic capabilities.

Roche has expanded its cyclospora testing portfolio with two new research-use-only molecular PCR tests to support U.S. public health response efforts. The LightMix Modular Cyclospora assay specifically detects cyclospora, whilst the LightMix OneTube Gastro Para 2 assay detects multiple parasites including Entamoeba histolytica, Giardia, and Cyclospora cayetanensis. Both tests work with LightCycler 480 and LightCycler PRO instruments. They complement an existing assay compatible with cobas 5800, 6800, and 8800 systems. The portfolio offers flexible testing options with one, three, or six targets. Roche acquired TIB MOLBIOL in December 2021 to expand its PCR-test capabilities for emerging infectious diseases. The company's testing infrastructure includes assays for hepatitis, HIV, respiratory illnesses, and vector-borne diseases.

Roche has received FDA 510(k) clearance for its cobas BV/CV assay, a molecular diagnostic test that detects bacterial vaginosis and Candida vaginitis from a single vaginal swab sample. The PCR-based test aims to improve diagnostic accuracy compared to traditional methods like microscopy and pH testing, which have misdiagnosis rates approaching 50%. Bacterial vaginosis affects approximately 27% of women of reproductive age in North America, whilst up to 75% of women experience Candida vaginitis at least once in their lifetime. The assay uses real-time PCR technology to identify specific bacteria and yeast responsible for these conditions. The test expands Roche's sexual health testing menu on its cobas 6800/8800 systems, enabling comprehensive testing for multiple conditions from a single sample. Commercial launch is expected later this year.