The FDA has cleared Cepheid’s Xpert Hemorrhagic Fever Panel, a multiplex PCR test that detects four hemorrhagic fever viruses and delivers results in about an hour on GeneXpert Dx systems, according to the company.
A new federal directive tasks HHS with launching rapid diagnostic R&D for vector-borne diseases, emphasizing decentralized molecular testing as part of a broader strategy to improve local pathogen surveillance.
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.
Alveo Technologies and UTMB have partnered to develop point-of-care diagnostics for Lassa fever, deploying molecular sensing platforms at clinical sites in Nigeria and Sierra Leone to support real-time pathogen detection.
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 resource provides information on contamination sources, symptoms, and next steps to customers whose qPCR stool tests detect the intestinal parasite.
HHS has allocated $4 million to expand rapid syphilis testing in emergency departments and nontraditional settings, aiming to address a 700% rise in congenital syphilis cases over the past decade, according to agency data.