FDA approves rapid coronavirus test created in Colorado

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WESTMINSTER, MARYLAND – MARCH 16: Dawn Canova, clinical manager for outpatient wound care at Carroll Hospital, handles a sample from a person tested for the coronavirus at a drive-thru station in the hospital’s parking garage March 16, 2020 in Westminster, Maryland. Not open to the general public for testing, the station was set up to take samples from people who had spoken with their doctors and received explicit direction to get a test for the novel coronavirus called COVID-19. (Photo by Chip Somodevilla/Getty Images)

ENGLEWOOD, Colo. (KDVR) — Aytu BioScience, Inc. announced Monday that the company may begin the distribution of the first 100,000 COVID-19 IgG/IgM Rapid Tests throughout the country this week. The test delivers results between 2 and 10 minutes at the point of care and are for professional use only.

Josh Disbrow Aytu BioScience’s Chief Executive Officer, said , “We are moving as quickly as we can to bring the COVID-19 IgG/IgM Rapid Test to the U.S. professional medical community. With product now in transit to our warehouse in Colorado we’re optimistic that we can have test kits ready for sale in the very near term. In the two short weeks since signing our distribution agreement, we have ordered our first 100,000 tests and have received confirmation from FDA that we may begin distribution. We are optimistic that we’re now just days away from placing these COVID-19 test kits into the hands of healthcare professionals.”

The COVID-19 IgG/IgM Rapid Test is used in detection of the 2019 Novel Coronavirus antibodies in human whole blood, serum or plasma. This point-of-care test has been validated in a patient clinical trial.

Aytu BioScience is a commercial-stage specialty pharmaceutical company. Aytu recently acquired exclusive U.S. distribution rights to the COVID-19 IgG/IgM Rapid Test.

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