Coronavirus: Colorado pharma company's test kits that give results in JUST two minutes still awaiting FDA approval
All coronavirus testing solutions in use at the moment yield results anywhere between 2 to 3 days. The wait to find out if a person is at risk of contracting the new virus is long, and anxiety-inducing. Not to mention, many people have been turned down from getting tested simply because clinics have run out of equipment to carry out tests.
This is where AYTU Bioscience comes in. The Colorado-based pharmaceutical company said it has a COVID-19 testing solution that determines results in a matter of minutes.
Josh Disbrow, CEO, AYTU, calls refers to the test as "a game-changer". AYTU Bioscience partnered with a Hong-Kong based manufacturer to produce a test kit that takes anywhere between two to ten minutes to provide results. But it awaits approval from the Food and Drug Administration (FDA) for public use.
"Very few tests have been FDA-approved despite the big need. Tests are getting approved but rapid point-of-care tests have not yet been approved. So if this can get approved, it would be among the first, if not the first," said Disbrow.
The company has placed an order for over 100,000 test kits to be distributed across the US. The kits bear similarities to those that have been in use in China for the past weeks and have helped detect confirmed cases by plenty.
"The FDA does have a provision whereby products like this and in times like this can go through emergency use authorization and we’ll pursue that angle," Disbrow added. He hopes that the FDA will speed up the approval process. Though, even with the approval, the company would require a week or two to ship the test kits to the U.S.
This speedy kit requires a small blood sample from a finger prick in order to determine the COVID-19 antibodies in the person's system.
Currently, the US is using nasal swabs to test Americans for the virus, which takes 48 hours to process results.
Stressing on the importance of the testing procedure, Disbrow said " The idea [is] that you could get something as quickly as 2-10 minutes to very quickly get sequestered, get quarantined, potentially get treatment. But really, detection is the critical piece right now and time is of the essence."
He also affirmed that the test yields 90 percent accurate results and the screenings can be undertaken in a doctor's clinic.
Trump in his statement at the Rose Garden news conference on Friday, March 13, declared a state of emergency for the US. He also said his administration was partnering with testing clinics and kit providers to offer seamless testing procedures for the public.
A Swiss pharmaceutical, Roche, is one such company that will test and detect potential coronavirus patients with its FDA approved automated test machines. These have been made available in at least 100 laboratories across the US, and are capable of testing up to 4,000 people per day, and provide results within 4 hours.