To date, there are no known conventional means of treating or stopping the coronavirus disease (COVID-19). All that remains in the limelight is that it causes respiratory failure and/or secondary infections, which results in death. However, there are more than sixty COVID-19 antibody tests, and one of them is from Aytu Bioscience Inc. (NASDAQ:AYTU)
The company is the sole distributor of the COVID-19 IgG/IgM rapid test cassette. According to a publication in Business Insider, it is one of the few tests with 100% sensitivity and specificity in identifying SARS-CoV-2 IgM antibodies.
The approval of using COVID-19 IgG/IgM Rapid Test Cassette
Aytu BioScience has been on a long journey of commercializing innovative products that address large pediatric and primary care markets. The two categories have a large portfolio of prescription products, a majority of which have the FDA’s approval.
The emergency use of COVID-19 IgG/IgM Rapid Test Cassette was initially given to Healgen Scientific, LLC, and a subsidiary of Zhejiang Orient Gene Biotech, Limited. Aytu BioScience would later strike a distribution deal to distribute the rapid test.
According to the CEO of Aytu BioScience, Josh Disbrow, the company is confident about the robust performance characteristics of the test. The anticipation is to use the product to identify persons with an adaptive immune response to SARS-CoV-2. However, Disbrow did confirm that they would continue observing and seeking opinions from independent studies to keep the public informed about any disparities in its performance.
Aytu BioScience Secures a TGA Approval of ZolpiMist
The company has made yet another milestone of securing approval of ZolpiMist by the Therapeutic Goods Administration (TGA) in Australia. The approval was obtained through SUDA Pharmaceuticals Ltd, a sublicensee of ZolpiMist, and has only opened a wider market for oral spray.
Other beneficiaries include SUDA’s current ZolpiMist sublicensees such as MTP Korea, Mitsubishi Tanabe Pharma Singapore as well as Teva Pharmaceuticals.
Partnering is vital for the growth of any business. Hence Aytu continues to explore other alliances to strengthen its product portfolio. This is in addition to the acquisition of enhanced therapeutics, devices, and diagnostic technologies to aid in the improvement of the current therapies.