2-minute COVID-19 test results? Denver-area company wants to deliver that promise
The FDA would have to give a small pharmaceutical company emergency clearance before it can distribute the rapid COVID-19 test
“A small pharmaceutical company just south of Denver is making news after announcing it secured exclusive rights to distribute a COVID-19 test that takes only minutes to get results.
“It’s a 2 to 10 minute result," Josh Disbrow, CEO of Aytu BioScience, said. "It’s a very simple test that can be performed at the point of care, so in a doctor’s office. A small drop of blood is dropped onto a disposable device. It senses the COVID-19 antibody,
The test was developed in China and has been in use for the past six weeks, Disbrow said.
The company’s stock is up more than 200% after announcing the distribution rights, however Disbrow still needs to get emergency approval on the testing kits from the Food and Drug Administration.”
I think this test will not likely be approved by the FDA as an emergency approval. It needs to have rigourous validation done by the US laboratory testing programs and likely would require a second confirmatory test. It might get approved, but I think it's more likely for something like November.
Considering major testing laboratories (Quest, LabCorp, Mayo Medical Labs, Cleveland Clinic) are not pursing blood testing for this disease, it tells me this is not a reliable test.