Thermo Fisher Highlights New FDA-Cleared Diagnostics at ADLM 2026
The company is showcasing newly cleared tests and platforms for multiple myeloma, lung cancer, connective tissue disease, and other laboratory applications.
The company is showcasing newly cleared tests and platforms for multiple myeloma, lung cancer, connective tissue disease, and other laboratory applications.
The FDA has cleared Roche’s cobas BV/CV assay, a molecular test that detects bacterial vaginosis and Candida vaginitis from a single swab, enabling streamlined diagnosis on the cobas platform, according to Roche.
The program connects researchers with certified laboratories offering single-molecule PCR testing, technical support, and bioinformatics expertise.
The automated assay identifies latent infections in routine laboratory settings with results available in less than 24 hours.
New analysis suggests that higher-sensitivity testing could lower annual spending by more than $3 billion by reducing misdiagnosis.