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Aptitude Medical Systems Wins $54M BARDA Contract for At-Home COVID, Flu Assays

NEW YORK – Aptitude Medical Systems said on Thursday that it has won a contract worth up to $53.7 million from the Biomedical Advanced Research and Development Authority (BARDA), which is part of the US Department of Health and Human Services' Administration for Strategic Preparedness and Response.

The contract will support the development and validation of at-home molecular diagnostic assays for COVID-19 and influenza.

Specifically, Santa Barbara, California-based Aptitude aims to develop over-the-counter molecular diagnostics capable of delivering lab-quality results in 15 to 30 minutes at a cost approaching that of rapid antigen tests. The assays will use Aptitude's testing platform, called Metrix, that incorporates real-time loop-mediated isothermal amplification (RT-LAMP) and electrochemical reporting technology.

"Metrix disrupts point-of-care testing by eliminating reliance on a bulky, expensive instrument and delivers a low-cost consumable simultaneously," said JP Wang, Aptitude's CSO and cofounder, in a statement. "This unlocks molecular testing in more settings [including] pharmacies, physician offices, and homes."

Metrix can use multiple sample types, including swabs, saliva, blood, and urine, and can be highly multiplexed to support syndromic panels, according to the firm.

Aptitude received Emergency Use Authorization from the US Food and Drug Administration for its over-the-counter saliva-based Metrix COVID-19 assay last October.

The BARDA award includes $19.6 million in funding to develop and validate at-home COVID and COVID/flu tests as well as up to $34.1 million for options to develop additional multiplex tests for other infectious diseases. It will support development of these products through FDA 510(k) clearance.