NEW YORK –The Biomedical Advanced Research and Development Authority (BARDA) announced last week that it has awarded OraSure Technologies and InBios International total funding of up to $27 million for biothreat assay development. BARDA is part of the US Department of Health and Human Services' Administration for Strategic Preparedness and Response (ASPR).
The companies will develop diagnostic tests, seek regulatory approval, conduct rapid response manufacturing capability studies, and complete technology transfer for manufacturing, according to a statement from ASPR.
The awards are the first to be granted by the Rapid Response Partnership Vehicle (RRPV) — a 10-year, multipurpose acquisition mechanism and consortium partnership funded by BARDA and managed by Advanced Technology International — as part of the BARDA's Diagnostics Rapid Response Initiative (DxR2).
"Through these awards, we are establishing long-term partnerships to develop diagnostic tests rapidly, using existing domestic manufacturing facilities, to create a more sustainable response to future health security threats," said Gary Disbrow, BARDA director and deputy assistant secretary for preparedness and response, in a statement.
The contract to OraSure supports the development of a US Food and Drug Administration-cleared point-of-care lateral flow viral antigen assay for the detection of Marburg virus infection. It will be a single-use test for people with epidemiological risk factors for infection as well as for deceased individuals suspected to have died from Marburg.
The initial contract award to OraSure is valued at approximately $7.5 million in the base period, with a potential value of up to $11 million, the RRVP said.
OraSure previously collaborated with BARDA to develop its InteliSwab COVID-19 test as well as its 510(k)-cleared OraQuick Ebola assay.
The award to InBios International, meanwhile, totals $16.5 million and aims to build on the firm's existing Active Melioidosis Detect Plus device design. The goal is to finalize the operational workflow and test algorithm, RRPV said in a statement, as well as to obtain FDA clearance for identification of capsular polysaccharide in patients with Burkholderia pseudomallei infection.