Aytu BioScience Inc. (AYTU:NASDAQ) announced today that "it signed an exclusive distribution agreement for the right to commercialize a clinically validated and commercially used coronavirus 2019 (COVID-19) IgG/IgM Rapid Test." The company reported that the test has been licensed from a privately held Hong Kong firm L.B. Resources Ltd., which in turn licensed North American rights from China-based product developer Zhejiang Orient Gene Biotech Co. Ltd. The agreement provides Aytu BioScience with exclusive rights to distribute the product in the U.S. for three years and allows for subsequent three-year automatic renewals.
The company advised that the Rapid Test is only intended for professional use and is a simple time saving procedure that produces results in 2-10 minutes at the point of care. The test requires only very small serum/plasma or whole blood specimens.
The firm stated that "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 and that this point-of-care test has been validated in a 113 patient clinical trial and has received CE marking."
Aytu advised that it expects to pursue commercial use of its qualifying test under the U.S. Food and Drug Administration's Emergency Use Authorization. The firm expects to receive an initial product shipment in 3-4 weeks depending on the speed of regulatory, customs and importation activities.
The company's CEO Josh Disbrow commented, "The safety and health of every American is of paramount importance to the company as we face the threat of the coronavirus. We are excited to be able to work with U.S. regulatory authorities, and we will work to make this important test available in the U.S. as soon as possible. Coronavirus is a major global health concern, and we are proud to be in a position to help clinicians address this very serious public health concern."
Aytu BioScience is a commercial-stage specialty pharmaceutical company based in Englewood, Colo. The company markets a portfolio of prescription products addressing large primary care and pediatric markets. The primary care portfolio includes Natesto®, a nasal formulation of testosterone for men with hypogonadism, ZolpiMist™, an oral spray prescription sleep aid and Tuzistra® XR, a 12-hour codeine-based antitussive syrup. The firm also markets a portfolio of pediatric medicines.
Aytu BioScience started the day with a market capitalization of around $9.7 million with approximately 27.83 million shares outstanding. AYTU shares opened nearly 275% higher today at $1.30 (+$0.952, +273.56%) over yesterday's $0.348 closing price. The stock has traded today between $0.92 and $2.99 per share and is currently trading at $2.01 (+$1.66, +476.44%).[NLINSERT]
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