Sydney-based Atomo Diagnostics (ASX: ATI) has signed a binding agreement with US-based diagnostics specialist Access Bio Inc. under which the Australian company will supply its unique, integrated rapid diagnostic test (RDT) devices for use with its rapid test strip for detection of antibodies to COVID-19.
Atomo co-founder and CEO John Kelly said finished products being commercialised under this agreement include a COVID-19 rapid antibody test for professional use and a COVID-19 rapid antibody test for self-test use.
Once relevant regulatory authorisations or approvals are obtained, the Products will be launched in the United States, Canada and Mexico, co-branded by both Access Bio and Atomo, with Access Bio as the listed manufacturer.
Access Bio will also have non-exclusive rights to sell the Products in the rest of the world with the exception of Europe, Australia/NZ and South-East Asia where Atomo already has contractual arrangements in place.
Under the agreement, Access Bio is obliged to sell a minimum of two million Products by September 30, 2021. If this threshold is not achieved by Access Bio within the timeframe, Access Bio is obliged to make a payment for that number of units short of two million and Access Bio’s exclusive rights under the agreement in the United States, Canada and Mexico automatically become non-exclusive.
If the sales threshold is achieved, Access Bio’s exclusive rights in the United States, Canada and Mexico will be automatically extended until September 30, 2022 with the same obligations and threshold as for the first year. The agreement will automatically renew for subsequent one year periods, provided that Access Bio continues to meet the minimum sales threshold in each year.
Mr Kelly said Atomo is currently undertaking a scale up of its production capacity, with the increased capacity sufficient for Atomo to meet its volume obligations under the agreement. In consideration for supplying the Galileo cassettes to Access Bio, Atomo will receive a percentage of the gross revenue from all sales of the Products.
Access Bio’s newly developed blood-based IgG/IgM diagnostic test detects antibodies produced in response to infection by COVID-19.
Access Bio’s standard test kit format received an Emergency Use Authorisation1 (EUA) by the US Food & Drug Administration (FDA) in July 2020. Access Bio’s standard IgG/IgM COVID-19 rapid test uses a separate lancet to generate a blood sample and a separate manual pipette to collect and deliver blood to the test strip, unlike the Products that utilise Atomo’s RDT device, where these steps are integrated.
The test strip used in the multi component standard test is identical to the test strip being used in the Products. Atomo and Access Bio are working together to complete the Product dossier required to make a submission later this quarter to the FDA for EUA for the Products.
This is an exciting development for Atomo, and we are proud to be partnering with Access Bio on this project,” Mr Kelly said.
“Access Bio is a leading manufacturer in rapid diagnostics, with strong ties to US markets and as a long-standing trusted partner of Atomo having existing partnerships for HIV and Hepatitis C, is a natural fit for the next phase of our expansion in the COVID-19 market.
“Our companies believe that blood-based rapid diagnostic testing is an essential component of the global fight against COVID-19. Given the increasing urgency of the situation in the US, we are delighted to be able to play our part in attempting to defeat this pandemic.”