North Carolina startup gets approval for COVID-19 test that works in 15 minutes

MORRISVILLE, N.C. (WTVD) -- The Old North State is rich in history, and a biotechology startup is adding its name to that history with one a COVID-19 breakthrough.

BioMedomics, Inc., a small research and development firm in Research Triangle Park, created one of the world's first rapid tests to detect COVID-19, the disease caused by the novel coronavirus. The test only requires a small blood sample and can deliver results within 15 minutes.

"I think this type of test certainly is a game changer," Kent Lupino, Director of Marketing & Product Management, tells ABC11. "Antibody-based rapid tests like ours are well-suited for initially screening patients at the point-of-care, because they are fast and don't require any laboratory equipment to conduct the test."

How it works is a big part of why it's fast: instead of trying to detect the virus' genetic signature, or RNA, the BioMedomics test measures how the patient's body is reacting to the virus. In other words, it checks whether the body's immune system is reacting to the virus - or something else.

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"It's something that can help alleviate the burden on the laboratories that are doing testing right now because if you know someone tests negative with our test out in the field, perhaps they're not as high priority to test even though they're presenting symptoms," Lupino adds. "If someone tests negative, then you don't have to waste that resource, that valuable resource of that laboratory test on someone who probably doesn't have COVID-19."

The rapid test has already proven valuable overseas, as sales to China's CDC has topped 500,000 units since January; the company is also shipping tests to South Korea, Thailand, India, Latin America, Europe and Africa.

In the United States, only this month have federal regulators amended guidelines to allow BioMedomics to market the rapid test nationwide.

The demand has been so high that the company temporarily halted taking new orders for the COVID-19 tests to ensure it could fulfill existing orders and ramp up raw material procurement and manufacturing capacity.

"We're going as fast as we can and hope to turn on orders again soon," Lupino said.

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BioMedomics' success is also a credit to one of its key investors, the North Carolina Biotechnology Center. The non-profit has given more than $40 million to 200 companies, including $275,000 to BioMedomics since its founding in 2006.

"In a crisis like this, to have a company like BioMedomics have a test that is so critically necessary in order for clinicians to properly treat and evaluate patients, that right there speaks to the innovation that we see across the companies we've got in North Carolina," Greta Brunet, the Center's Senior Director of Investments, said.

Brunet said the Center is now advising BioMedomics on how to address the challenges of being a small startup being asked to produce a product like a multi-billion dollar conglomerate.

"It's going to take a little bit for that infrastructure to get in place, in terms of staffing, logistics, sales, manufacturing, packaging, labeling," she explains. "(BioMedomics') goal is to help people and they will do whatever they have to - to try to meet the need, get capacity up and running, and get this test out to people."