Portland-based Hemex Health has applied for an Emergency Use Authorization in the U.S. for a rapid test it developed for Covid-19 that gives results in just 15 minutes.
The test, which uses Hemex's Gazelle device, is as accurate as PCR tests, according to data from recent clinical studies that are under peer review. Not only that, but Gazelle gives faster results and at a lower cost, just $6-to-$8 per test, Hemex CEO Patti White said Wednesday.
The device is already used to identify hemoglobin disorders, including sickle cell disease and beta thalassemia. The Covid-19 test uses fluorescence to detect an antigen from the virus.
White said decentralized point-of-care tests will likely become more common in the U.S. and abroad, as the population ages and countries prepare for the next pandemic. The point-of-care market reached $42 billion last year.
Hemex is also developing a “mini” Gazelle that could be used with a smart phone. Meanwhile, the Gazelle Pro is intended for use by a clinic or rapid-test site. It costs about $1,300 for the device and then each test runs between $6 and $8. Hemex just began selling the device in India and White hopes to get the green light from the FDA in the coming months.
One advantage of the test is that it can detect even low levels of the virus, she said.
“The reason very excited about this technology is we’re adding other tests to it,” White said. “The idea is to make all these affordable, easy to use and accurate, so people can access testing.”
Hemex funded its research and development of the product with help from a series of grants from Business Oregon.
