Carlsbad, Calif.-based Reliable-LFC is touting its V-Chek as an affordable, high-performance, easy-to-use, rapid, point-of-need nasal coronavirus antigen test.
Part of the company’s mission is to turn venue-specific sampling centers into real-time testing centers with results provided on-site in 10 minutes. The company plans to charge $20 or less for its over-the-counter test, which will include a cassette and reader. Results will be securely relayed to tested individuals from Reliable’s Bluetooth-enabled reader to paired smart devices (phones, tablets) then to remote public health servers to enable contact tracing, according to the company.
Reliable submitted V-Chek to the FDA for an emergency use authorization, but will have to resubmit with more information on how the samples were handled between the time they were collected and tested, according to CEO Bill Pagels. He expects to enroll up to 200 patients in a second trial “in a very short number of weeks” and has a site selected.
Pagels told Medical Design & Outsourcing that he believes that testing more frequently with what may be less-sensitive antigen tests that produce quick results will help contain the spread of SARS-CoV-2 better than testing less frequently with expensive, super-sensitive PCR (molecular) tests. There are only 15 antigen tests on the U.S. market and 252 molecular tests, he noted.
“Most people will say that the state-of-the-art as far as the best results available are these PCR tests,” Pagels said. “More of them are done in a laboratory and they’re expensive and they take a while to get the test results back.”