FDA Clears Roche Respiratory Panel with Expanded Pathogen Coverage
New cobas eplex RP3 panel detects up to 19 respiratory pathogens, including Bordetella pertussis, with results available in under two hours.
New cobas eplex RP3 panel detects up to 19 respiratory pathogens, including Bordetella pertussis, with results available in under two hours.
Roche Diagnostics has supplied two molecular testing systems and is training laboratory staff in the Democratic Republic of Congo to expand PCR testing capacity for Bundibugyo virus amid rising Ebola testing demand.
A nine-lab network evaluated four Bundibugyo virus PCR assays from two manufacturers in two weeks during the 2026 outbreak, establishing new reference standards, according to a study in The Lancet Infectious Diseases.
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.
Roche has launched two new research PCR assays for Cyclospora cayetanensis detection, expanding lab testing options amid a US outbreak and adding flexibility for gastrointestinal pathogen research.
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.