Spokane-based GenPrime develops COVID-19 rapid test reader system
A Spokane-based company has developed new technology it believes will provide quick and accurate COVID-19 testing.
Biotechnology company GenPrime says the GenPrime Reader is designed for use in point-of-care settings, such as hospitals and urgent care and retail clinics.
The device, which is available in hand-held mobile and benchtop versions, allows for COVID-19 test results to be quickly interpreted within minutes, then submitted to an electronic database and sent back to patients, physicians, clinics and regional health departments.
The GenPrime Reader is an extension of the company’s software-based lateral flow test screening system developed in 2012 for pre-employment drug screening, said Buck Somes, GenPrime’s CEO and co-founder.
Lateral flow test strips are most commonly used in home pregnancy tests but are also used in infectious disease and drug testing, among other things.
“We were cruising along, partnering with another company and developing a new method for doing that and COVID-19 hit earlier this year, and some of our partners started talking to us about COVID-19 tests that use similar technology,” Somes said. “So, we said, ‘Why don’t you send us some of your tests and we might be able to adapt our technology to be able to read those devices as well?’ ”
GenPrime is partnering with a couple of U.S. diagnostic companies that make COVID-19 tests to gain approval under the U.S. Food and Drug Administration’s emergency use authorization in order to sell the tests and readers as a packaged system for nonlaboratory use.
The FDA, under its emergency use authorization, is able to expedite approval of products that can be used during a public health emergency.
Last week, the FDA authorized the first point-of-care diagnostic test in which results can be read directly from a testing card. Illinois-based Abbott Diagnostics Scarborough Inc. received approval for its BinaxNow COVID-19 Ag Card, an antigen test that collects samples via a nasal swab and provides coronavirus infection results within 15 minutes.
Somes said it’s difficult to predict when the FDA will approve GenPrime’s Reader for point-of-care diagnostic testing, but the company hopes to receive a decision within the next couple of months.
“Once the FDA says go ahead … we are going to be ready with our mobile reading application that will help manage the data, results and disseminate that information to the correct authorities to get it to the CDC, so we can do better tracking and tracing of where infections are, or what level immunity there is in our regional area,” Somes said.Amy Edelen can be reached at (509) 459-5581 or at amye@spokesman.com.