Thursday March 26, 2020 0 comments
ENGLEWOOD -- Aytu BioScience, Inc. (NASDAQ:AYTU), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs, announced it has received confirmation from the U.S. FDA that the company may begin distribution of its Coronavirus Disease 2019 ("COVID-2019") IgG/IgM Rapid Test throughout the United States.
The COVID-19 Rapid Test is intended for professional use and delivers results between 2 and 10 minutes at the point-of-care.
Aytu said it expects delivery of its first shipment of 100,000 tests this week. The company has been in discussions with healthcare distributors, healthcare institutions, medical practices, and government agencies and is working quickly to begin distribution into the U.S. healthcare supply chain.
"We are moving as quickly as we can to bring the COVID-19 IgG/IgM Rapid Test to the U.S. professional medical community,” said John Disbrow, Aytu’s CEO.
“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 a solid phase immunochromatographic assay used in the rapid, qualitative and differential detection of IgG and IgM antibodies to the 2019 Novel 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.