The new molecular diagnostic tests are expected to offer lab-quality results in 15-30 minutes. Credit: PRNewswire / Aptitude Medical Systems.

Aptitude Medical Systems (Aptitude) has received a grant of up to $53.7m from the Biomedical Advanced Research and Development Authority (BARDA) to support the development of over-the-counter molecular diagnostic tests.

BARDA is part of the Administration for Strategic Preparedness and Response within the US Department of Health and Human Services.

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Aptitude will use $19.6m to leverage advancements attained by its Metrix testing platform for the development and validation of at-home COVID-19 and COVID/Flu tests.

The remaining $34.1m will be used for the creation of additional multiplex tests to identify other types of infectious diseases.

The new molecular diagnostic tests are expected to offer lab-quality results in 15 to 30 minutes with costs that are comparable to antigen tests. 

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Aptitude CEO and co-founder Scott Ferguson said: “We are honoured that BARDA has selected Aptitude as a partner. We expect to bring these best-in-class products to the market to address the ongoing need for diagnostics for Covid and other disease threats.

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“More broadly, we are excited to work together to drive a new generation of healthcare where individuals, doctors and pharmacies can leapfrog the lab to get timely diagnostic information to limit the spread, prescribe treatments and improve health outcomes.”

The funding will provide support to the development of these products through US Food and Drug Administration’s (FDA) 510(k) clearance.

The first product based on the Metrix platform is the Metrix COVID-19 Test, which was granted emergency use authorization by the FDA.

Products in the pipeline include the Metrix COVID/Flu Test and software to integrate patients, providers, payers and public health and other products targeting different health and wellness conditions.