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3EO Health At-Home Molecular COVID-19 Test Nabs FDA EUA

NEW YORK – 3EO Health has received Emergency Use Authorization from the US Food and Drug Administration for its over-the-counter at-home molecular COVID-19 test, the agency announced last week. 

According to the authorization letter posted on the agency's website, the 3EO Health COVID-19 Test uses reverse transcription loop-mediated isothermal DNA amplification technology to qualitatively detect SARS-CoV-2 RNA in anterior nasal swab samples. The assay is authorized for nonprescription home use by people aged 2 years or older with signs or symptoms of COVID-19, the agency noted. 

The test includes the reusable 3EO Cube device, the single-use 3EO Key sample cartridge, and the 3EO Swab. The test returns results in about 30 minutes. In a clinical study conducted in the US in April, the test correctly identified 95 percent of 40 positive samples and 100 percent of 155 negative samples compared to an FDA-authorized molecular laboratory test, according to the test's fact sheet released by the FDA.

Last year, the Beverly, Massachusetts-based company announced that it had signed an exclusive, worldwide licensing agreement to market an at-home PCR-grade test system developed at the Wyss Institute for Biologically Inspired Engineering at Harvard University.