The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to Aptitude Medical Systems’ Metrix Covid/Flu multiplex test for over-the-counter (OTC) use.
The decision makes the test accessible for at-home testing and in Clinical Laboratory Improvement Amendments (CLIA)-waived point-of-care setting.
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This test can reportedly concurrently identify and differentiate influenzas A or B, as well as SARS-CoV-2 in 20 minutes.
In partnership with Sekisui Diagnostics, the company and its distribution partners have made the test available across the US.
According to Aptitude, the development of the Metrix Covid/Flu test has been partially funded by the Department of Health and Human Services, Biomedical Advanced Research and Development Authority; Administration for Strategic Preparedness and Response, under contract number 75A50123C00013.
It is the second molecular test on the platform to receive FDA authorisation, following the Metrix Covid-19 Test, which can be used without professional supervision for at-home use with saliva or swab samples.
Aptitude Medical Systems CEO Scott Ferguson said: “We built Metrix to dramatically expand the reach of molecular diagnostics by breaking cost and accessibility barriers.
“Our Metrix Covid/Flu test empowers individuals to get their own lab-quality results on the spot in their homes and enables healthcare providers to upgrade from existing molecular and antigen testing platforms while lowering total cost of care.”
A “deep-tech” healthcare company, Aptitude is focused on detecting and treating infectious diseases.
Last month, the company secured a grant of more than $10m from the Bill & Melinda Gates Foundation.
This funding aims to expedite the development and release of new point-of-care and OTC tests for sexually transmitted infections on the Metrix diagnostics platform, including chlamydia, gonorrhoea, and trichomoniasis.
In April 2023, the company obtained a grant of up to $53.7m from the Biomedical Advanced Research and Development Authority (BARDA) for the development of OTC molecular diagnostic tests.
