If you tuned in to FDA’s weekly Virtual Town Hall Meeting on February 10th, 2021 you would have seen a short presentation by Toby Lowe (CDRH/OHT-7) describing a recent funding announcement from HHS OASH, Office of Assistant Secretary for Health, and the DoD. This “Area of Interest” (AOI) funding announcement is a call for proposals from industry.
you may request investment funding for capacity expansion and provide price quotes for raw materials, test components, supplies, et cetera for COVID-19 point-of-care tests and other IVDs. This is an expedited process that’s coordinated by HHS and OASH and DoD to support the government’s COVID-19 response to rapidly increase manufacturing capabilities within the diagnostic supply chain.
This funding announcement is not a unique occurrence, in fact, there is a whole group at HHS with a mandate to expand testing supplies and testing capacity through targeted investments. The COVID-19 Testing and Diagnostic Working Group (TDWG) has been built around four central goals:
Understand the diagnostic supply chain, including projected production and potential constraints and bottlenecks;
Work with state public health and laboratory leadership, diagnostics manufacturers, and commercial labs throughout the country;
Provide technical assistance to leverage existing testing infrastructure and resources based on available tests; and
Distribute certain testing supplies, focusing primarily on point-of-care technologies, to support states’ testing goals.
This funding announcement is yet another indication, in a string of recent public statements and actions on the part of FDA, that the federal government is shifting time, energy, and resources from the CLIA Lab base testing to testing in non-laboratory settings, like Point-of-Care and people’s homes. HPM recently released a blog post on FDA’s changing priorities (“Beware EUA Deprioritization”).