“The Department of Health and Human Services has chosen its first COVID-19 coronavirus diagnostic testing solution to support development as the agency ramps up testing, detection and prevention efforts to combat the virus.”
“HHS’s Office of Assistant Secretary for Preparedness and Response announced its Biomedical Advanced Research and Development Authority will support a molecular diagnostic test from Hologic, which is developing a diagnostic system for COVID-19 that can process up to 1,000 tests in 24 hours…”
“Although the pilot system is in development, it uses a preexisting system used widely across U.S. laboratories that leverages “sample-to-result automation” and offers “a broad menu of FDA-cleared tests to detect common respiratory infections,” HHS reported. Updating these systems already in the supply chain to detect COVID-19, therefore, would allow for a rapid scale-up of testing.”
“BARDA anticipates that the final system will be completed “in a manner of weeks,” after which the Food and Drug Administration will consider granting an emergency-use authorization — which enables the availability and use of needed medical products during public health emergencies — for diagnostic testing.”
“Although HHS has chosen its first technological solution to support for rapid testing of COVID-19, it is still seeking more solutions that are faster, accurate and portable. In a March 9 solicitation, BARDA said it is still seeking handheld diagnostic testing devices that are easy to use at the point of care…” Read the full article here.
Source: HHS Backs Development of Rapid COVID-19 Diagnostic Testing System – By Melissa Harris, March 11, 2020. GovernmentCIO.
