3EO Health, a diagnostics company focused on the development of high-performing low-cost molecular diagnostics for both point-of-care and at-home testing, announced today the receipt of an FDA emergency use authorization (EUA) for its SARS-CoV-2 molecular test.

Born out of Harvard’s Wyss institute, 3EO delivers a true low-cost, high-performing, easy-to-use platform. “Our vision was to leverage breakthrough biochemistry to provide molecular performance at antigen pricing,” says Thomas Schaus, MD, PhD, head of Research at 3EO Health. “Our patented technology has delivered on this vision and paves the way to enable more people to benefit from molecular testing.” 

At a market price of less than $20 per test, 3EO aims to reduce inequities and expand access to molecular testing for all.

“Our healthcare system faces many challenges and is constantly in pursuit of simultaneously improving outcomes while reducing cost,” says Jeremy Schubert MBA, MPH, chief executive officer of 3EO Health. “Unfortunately, many times the pathways to those goals are in opposition. With this recent authorization 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.”

3EO Health’s patented biochemistry enables a dilution free “sample to test” workflow eliminating the need for cumbersome steps, microfluidics, or expensive equipment. 3EO expects to begin distributing products to physicians and consumers in November of this year.

Further reading: NIH Study Informs Antigen Testing for COVID

This project is being funded in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under contract number 75A50122C00062.

“Delivering a high-performing low-cost product is not easy,” said Peter Honkanen MSM, BSEE, Chief Technology officer of 3EO Health. “Our patented and novel technology coupled with our unique engineering has enabled breakthroughs in ease of use, reliability, and cost. We achieved clinical accuracy of 99% while simultaneously reducing the price per test up to 70% versus existing providers.”

Featured image: 3EO’s novel technology enables up to 70% savings versus existing point-of-care molecular tests, offering a preparation-free “sample to test” workflow eliminating the need for cumbersome steps, microfluidics, or expensive equipment. 3EO expects to begin distributing products to physicians and consumers in November of this year. Photo: Business Wire