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Aptitude Medical Gets FDA EUA for Over-the-Counter COVID Saliva MDx

This article has been updated from a prior version which incorrectly described the technology used to read out the assay.

NEW YORK – The US Food and Drug Administration said on Tuesday that it has issued an Emergency Use Authorization to Aptitude Medical for an over-the-counter saliva-based COVID molecular test. It is the first OTC molecular test to use saliva as a sample.

Called the Metrix COVID-19 Test, the Aptitude Medical assay is a single-use test authorized for nonprescription home use to detect the SARS-CoV-2 virus. It uses real-time loop-mediated isothermal amplification (RT-LAMP) paired with an electrochemical reporting technology that monitors the amplified cDNA in real time. The electrochemical signal is analyzed automatically with a paired reader, providing a result in 30 minutes or less.

The Metrix test requires self-collected saliva or nasal swab samples from people 14 years and older, and is also authorized for use in people ages 2 years and older whose samples are collected by an adult. It is for use in people with reason to suspect COVID-19 infection who are either symptomatic or asymptomatic.

Cofounded by University of California, Santa Barbara researcher Scott Ferguson and based in Goleta, California, Aptitude Medical specializes in using aptamers for diagnostic testing, according to its website.