The FDA has cleared Aptitude’s next-generation Metrix COVID Test, which the company says offers 3-fold higher sensitivity and 30% faster results compared to its EUA version.
Co-Diagnostics has submitted a Dual 510(k) and CLIA waiver application to the FDA for its PCR-based flu and RSV test, aiming to enable point-of-care use on the Co-Dx PCR Pro instrument.
The funding will support regulatory certification and the commercial launch of rapid tests for Lyme disease and sexually transmitted infections.
Roche has developed a rapid PCR assay for the rare Ebola Bundibugyo virus, enabling research-use detection within six days to support outbreak response in Central and East Africa, according to the company.
The system simultaneously detects RSV, influenza A and B, and SARS-CoV-2 from a nasal swab in under 10 minutes.
QIAGEN’s FDA-cleared QIAstat-Dx panel detects Cyclospora cayetanensis, addressing a surge of over 1,600 confirmed US cases since May 2026.
A randomized trial found Cepheid’s Xpert Xpress MVP test improved appropriate treatment rates for vaginitis within 24 hours compared to standard diagnostic methods.