Federal Agencies Reach Out to Manufacturers to Ramp Up COVID-19 Testing Supply Chain

Supply chain and logistics have bedeviled COVID-19 testing efforts on a national basis since the pandemic began. On Feb. 5, the federal government took steps to address the supply chain challenge via collaboration of key agencies. The first move: publication of an Area of Interest (AoI) notice soliciting proposals for the funding of projects designed to streamline, expand and scale the manufacture and distribution of diagnostic testing equipment and personal protective equipment (PPE). The Federal Collaboration Four federal government agencies with direct ties to the diagnostics supply chain are participating in the new initiative, including:

• The Department of Health and Human Services (HHS) (Office of the Assistant Secretary (OASH));
• The Biomedical Advanced Research and Development Authority (BARDA);
• The National Institute of Health (NIH) Rapid Acquisition of Diagnostics (RADx)); and
• The U.S. Air Force (USAF).

The mission of the collaboration is to understand and improve the diagnostics industry’s capability “to rapidly mature and scale specific manufacturing capabilities within the diagnostic testing supply chain.” The AoI solicitation targets different stakeholders in the testing supply chain, such as sample collection and consumables makers, suppliers of raw materials and components, and developers of equipment, asking them to propose projects to expand manufacturing capacity and/or increase test throughput. Projects eligible for federal funding encompass a wide scope of products, including 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. Who and How to Respond to the AoI The AoI also provides general response guidelines and procedures. The agencies are seeking proposals from vendors that have developed or are developing products relevant to COVID-19 diagnostic tests, but also have potential for future use in diagnostics related to other pathogens and testing requirements, such as blood product testing. The supply chain products must also support in vitro diagnostics that have or are expected to receive Emergency Use Authorization (EUA) from the FDA by March 31, 2021. Submissions should provide line of site from their manufactured items to the COVID-19 diagnostic activity they support or are integrated with. Although respondents don’t necessarily have to be U.S.-based companies, all expansion of manufacturing efforts supported by the AoI must be carried out within the U.S. and/or U.S. territories. The agencies will accept proposals until March 7, 2021, with evaluations expected to have begun within 48 hours of the posting of the AoI. Interested companies should submit cost estimates with their proposals, and a USAF contracting team will respond to questions from developers directed to a dedicated email address. All questions concerning the AoI must be sent to the following email: supplychain.cso.dafact@afwerx.af.mil