Atomo Diagnostics Limited and Access Bio, Inc. Renegotiate Supply Agreements
October 05, 2021 at 12:43 am
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Atomo Diagnostics Limited (Atomo) and Access Bio LLC (Access Bio) announced a restructuring of their commercial relationship to reflect the evolving structural changes in the COVID-19 diagnostics market. Under the new agreement, which has immediate effect and expires on 31 December 2022, Atomo will receive from Access Bio a one-off fee considered by Atomo to be material and replacing any payments due to Atomo under the existing agreements. The new agreement also provides Atomo the right, but not the obligation, to purchase at a fixed price per unit up to 10 million COVID-19 Rapid Antigen tests1 (Atomo branded) between now and the end of CY22, for use in professional settings in Australia and New Zealand only. This test was listed
on the ARTG by the TGA in October 2020, following the announcement of Atomo's supply agreement with Access Bio for rapid antigen testing dated 29 September 2020, and is currently
being sold by Atomo in the Australian market in a number of channels. Further, Atomo has the right, but not the obligation, to purchase at a fixed price per unit up to 10 million (Atomo branded) COVID-19 Rapid Antigen Self-Tests during CY22 for sale in the Australian market only. Access Bio's self-test has received Emergency Use Authorization (EUA) from the US FDA and will be delivered to Atomo as an Atomo branded product. Atomo intends to now make an application to the TGA for this self-test to be listed on the ARTG for self-test use in Australia (subject to TGA approval). Conditional on Access Bio meeting the one-off fee obligation and certain product supply requirements under the new agreement, the existing antibody agreement between Access Bio and Atomo announced to ASX on 28 July 2020 (for supply of Atomo's Galileo devices to Access Bio) and the existing OEM agreement between the parties dated 22 December 2017
(related to Access Bio commercialising their own HIV professional use test for LMIC global health markets) will both terminate.
Atomo Diagnostics Limited is an Australia-based medical device company. The Company supplies integrated rapid diagnostic test (RDT) devices to the global diagnostic market. The Companyâs patented devices simplify testing procedures, enhance usability and improve reliability across rapid point-of-care (POC) and at-home testing applications. The Company has commercialized a number of products across international markets and has supply agreements in place for testing applications targeting infectious diseases, including COVID-19, HIV, viral vs bacterial differentiation and female health. Its products include Atomo HIV Self-Test, AtomoRapid HIV (1&2) and ATOMONOW Pregnancy Test. Its Atomo HIV Self-Test is an integrated, blood-based rapid diagnostic test (RDT) for HIV screening, which provides results in 15 minutes. Its AtomoRapid HIV (1&2) integrates multiple test components into the device platform. AtomoRapid HIV (1&2) needs a small drop of blood to give results in 15 minutes.
ATOMO DIAGNOSTICS LIMITED 
