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Aytu BioScience Licenses US Rights to Point-of-Care Coronavirus Test

NEW YORK — Specialty pharmaceutical firm Aytu BioScience said on Tuesday that it has exclusively licensed the US distribution rights for a point-of-care SARS-Cov-2 immunoassay developed by China's Zhejiang Orient Gene Biotech.

Englewood, California-based Aytu licensed the US rights to the test from Hong Kong's LB Resources, which holds the test's North American rights. Aytu has right to distribute the test in the US for three years with three-year autorenewals thereafter.

According to Aytu, the COVID-19 IgG/IgM Rapid Test is a solid phase immunochromatographic assay designed for the rapid, qualitative, and differential detection of SARS-CoV-2 IgG and IgM antibodies in human whole blood, serum, or plasma.

In a 113-patient clinical study, the test showed a sensitivity of 87.9 percent and specificity of 100 percent for IgM antibody detection when compared to RT-PCR, and a 97.2 percent sensitivity and 100 specificity for IgG antibody detection during patients' convalescence period, Aytu said.

The test, which provides results in two to 10 minutes, is CE marked, and Aytu said it intends to pursue its clearance with US Food and Drug Administration and plans to talk with the agency about getting Emergency Use Authorization for the test. An initial shipment of the test is expected within three to four weeks.