3EO Health has received an Emergency Use Authorisation (EUA) from the US Food and Drug Administration (FDA) for its SARS-CoV-2 molecular test.
Its patented biochemistry facilitates a preparation-free ‘sample to test’ workflow, thereby helping avoid the use of expensive equipment, microfluidics and cumbersome steps.
The company plans to start distributing these molecular products to physicians and consumers in November of this year.
3EO Health CEO Jeremy Schubert said: “Our healthcare system faces many challenges and is constantly in pursuit of simultaneously improving outcomes while reducing cost.
“Unfortunately, many times the pathways to those goals are in opposition. With this recent authorisation of our new platform and SARS-CoV-2 test, we are pleased to bring to physicians and consumers a technology that no longer places them in the cost versus quality conundrum.”
Compared to existing point-of-care molecular tests, the company’s new technology enables savings of up to 70%.
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The company intends to lower inequities and expand access to molecular testing for all by offering it at a market price of less than $20 per test.
3EO Health research head Thomas Schaus said: “Our vision was to leverage breakthrough biochemistry to provide molecular performance at antigen pricing.
“Our patented technology has delivered on this vision and paves the way to enable more people to benefit from molecular testing.”
This project is receiving federal funds from the Department of Health and Human Services, the Administration for Strategic Preparedness and Response and the Biomedical Advanced Research and Development Authority.