NEW YORK – A collaborative effort involving various agencies in the federal government is soliciting proposals intended to dramatically scale up the US testing supply chain.
The collaboration includes the Office of the Assistant Secretary (OASH) of the Department of Health and Human Services (HHS), HHS' Biomedical Advanced Research and Development Authority (BARDA), the National Institute of Health Rapid Acquisition of Diagnostics (RADx) program, and the United States Air Force.
The supply chain solicitation came as an Area of Interest document that was posted online on Feb. 5. The document was further updated Feb. 11 to emphasize that the solicitation is not intended to procure test kits, but rather to procure the components and materials supporting test production.
On Wednesday this week, hosts of the US Food and Drug Administration's weekly town hall for developers presented a slide describing the support.
Toby Lowe of the Center for Devices and Radiological Health explained that the AoI enables developers of materials to "request investment funding for capacity expansion, and provide price quotes for raw materials, test components, and supplies for COVID-19 point-of-care tests and other IVDs."
On the call, Lowe noted that the expedited process is coordinated by HHS, OASH, and the US Department of Defense "to support the government's COVID-19 response to rapidly increase manufacturing capabilities within the diagnostics supply chain."
The solicitation specifically seeks submissions from testing supply chain stakeholders, such as sample collection and consumables makers, suppliers of raw materials and components, and developers of equipment, among others, to expand manufacturing capacity or increase test throughput.
A representative at HHS' COVID-19 Testing and Diagnostics Working Group noted in an email the solicitation is part of a Commercial Solutions Offering, which is a DoD mechanism for soliciting proposals.
Interested companies should submit cost estimates with their proposals, the representative confirmed, and a USAF contracting team will respond to queries from developers directed to a dedicated email address.
As noted in the AoI, the collaboration is looking to understand the diagnostics industry's ability "to rapidly mature and scale specific manufacturing capabilities within the diagnostic testing supply chain." The scope includes raw materials, resources, components, and equipment for the production of analyzers, reagents, test kits and other preanalytical, analytical, and post-analytical diagnostic materials for COVID-19 testing.
The desired respondents are vendors that have developed or are developing products relevant to COVID-19 diagnostic tests, but have potential for future use in diagnostics related to other pathogens and testing requirements such as blood product testing, the AoI states.
"Submissions should provide line of site from their manufactured items to the COVID-19 diagnostic activity they support or are integrated with," and need not be from US-based companies, but "all expansion of manufacturing efforts must be done within the US and/or its territories."
The supply chain products must also support in vitro diagnostics with Emergency Use Authorization or expected to receive EUA by March 31.
The AoI states that proposals will be accepted until March 7, 2021, with evaluations expected to have begun within 48 hours of the posting of the AoI.