The specialty pharma company said it has signed an exclusive distribution agreement with Hong Kong-based L.B. Resources to commercialize a clinically validated and commercially used COVID-19 IgG/IgM Rapid Test in the U.S. for three years. The agreement also provides for three-year autorenewals thereafter.
The test is meant for professional use and delivers clinical results in 2-10 minutes at the point of care, Aytu said.
L.B. Resources had licensed the test from product developer Zhejiang Orient Gene Biotech.
The test has been validated in a 113-patient clinical trial and has received CE marking, Aytu said.
The company said it will now pursue regulatory clearance in the U.S. as it looks to engage with the FDA for qualifying the test under FDA's Emergency Use Authorization.
Aytu expects to receive an initial product shipment in three to four weeks.
The stock was jumping 317.93% to $1.45 at the time of publication Tuesday.