FDA Gives Aytu OK To Distribute Rapid COVID-19 Test, Company Expects To Receive 100,000 Tests This Week
Shares of Aytu Bioscience Inc (NASDAQ: AYTU), which announced earlier this month a deal to distribute a COVID-19 test, were rallying Monday after the company announced FDA approval for distribution of the test.
The Engelwood, Colorado-based specialty pharma company said it has received confirmation from the FDA that it may begin distribution of its COVID-19 IgG/IgM Rapid Test throughout the U.S.
The test, according to Aytu, is intended for professional use and delivers results in 2-10 minutes at the point-of-care.
It is a solid phase immunochromatographic assay used in the rapid, qualitative and differential detection of IgG and IgM antibodies to the new coronavirus in human whole blood, serum or plasma.
"This point-of-care test has been validated in a 126-patient clinical trial and is CE marked," according to Aytu.
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Aytu said it expects to receive its first shipment of 100,000 tests at a Colorado warehouse this week. The company said it is in talks with health care distributors, health care institutions, medical practices and government agencies to quickly begin distributing the tests into the U.S. health care supply chain.
"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," CEO Josh Disbrow said in a statement.
The stock was trading 25% higher at $1.70 at the time of publication.
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