DeZwarteRidder schreef op 23 maart 2020 11:50:
Company Expects to Seek Regulatory Clearance Under Health Canada and COFEPRIS Expedited Clearance Procedures
ENGLEWOOD, CO / ACCESSWIRE / March 19, 2020 / Aytu BioScience, Inc. (AYTU), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs announced today that it extended its distribution right to commercialize the clinically validated and commercially used coronavirus 2019 (COVID-19) IgG/IgM Rapid Test. The test has been licensed from L.B. Resources, Limited (a Hong Kong Corporation). The COVID-19 IgG/IgM Rapid Test is intended for professional use and delivers clinical results between 2 and 10 minutes at the point-of-care. This amendment expands Aytu's commercial rights and grants Aytu the right to distribute and commercialize the COVID-19 test in North America, specifically including the United States, Canada and Mexico.
The Company expects to pursue expedited regulatory clearance of the product with Health Canada and COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios), the regulatory agencies in Canada and Mexico, respectively.
Josh Disbrow, Chief Executive Officer of Aytu BioScience, commented, "We have to be progressive in doing our part in combatting the spread of the COVID-19 virus. We need to ensure that screening is available across North America and providing broad access to screening tests has to be among our highest priorities as we collectively fight the coronavirus outbreak. With COVID-19 now designated as a global pandemic, we believe we should expand our efforts to assist healthcare providers with faster point-of-care detection."
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 113 patient clinical trial and is CE marked.
About Aytu BioScience, Inc.