NEW YORK – Australian rapid diagnostic device firm Atomo Diagnostics announced Wednesday an agreement with Access Bio to commercialize two rapid COVID-19 antibody tests.
Atomo will supply its rapid diagnostic test devices to Access Bio for use with Access' rapid test strip to detect COVID-19 antibodies. After the necessary regulatory approvals have been obtained, a test for professional use and a self-test, cobranded by the two companies, will be launched in the US, Canada, and Mexico, they said.
Access Bio will also have non-exclusive rights to sell the tests globally, excluding Europe, Australia, and Southeast Asia. Under the agreement, Access must sell at least 2 million tests by Sept. 30, 2021, to maintain exclusive rights in North America. Access would also need to make a payment to Atomo for the number of units short of the 2 million threshold.
If that threshold is achieved, the rights will extend to Sept. 30, 2022 and on, as long as Access continues meeting the minimum sales requirements.
Atomo will receive a percentage of the gross revenue from all sales of the tests.
The firms are submitting the test and Atomo's device to the US Food and Drug Administration for Emergency Use Authorization for professional use later this quarter, with plans to submit for regulatory approval in Canada and Mexico in Q4.
Access Bio offers a blood-based IgG/IgM test for detecting antibodies against SARS-CoV-2, which received EUA from the FDA last week.
Atomo and Access Bio currently have partnerships for HIV and Hepatitis C rapid diagnostic products.