Atomo Diagnostics Limited announced the signing of a new agreement with its long-term partner NG Biotech SAS (NG Biotech), covering the manufacture and distribution of rapid blood-based pregnancy tests for professional use and at-home self-test use in key global markets. The rapid test product combines a highly sensitive hCG test assay manufactured by NG Biotech and Atomo's integrated Pascal blood test device. It is acknowledged that detectable hCG levels typically build up quicker in blood than in urine, making the test potentially suited to early detection of pregnancy.

Under the new agreement, Atomo will continue to supply NG Biotech with assembled Pascal devices and grant an exclusive licence for NG Biotech to utilise in the manufacture of finished rapid pregnancy tests for both professional use and at-home self-testing. The agreement, which has an initial period of five years and automatically renews for a further five years unless terminated by either party, sees Atomo retain ownership of all IP related to its Pascal device and NG Biotech retain ownership of all IP related to its rapid hCG test strip. As noted in Atomo's most recent quarterly activity report, NG Biotech reordered Pascal cassettes to support the launch of its products, both of which are CE Marked in Europe and marketed by NG Biotech under their own brand.

NG Biotech also recently purchased an initial quantity of Pascal cassettes to support product launch in Brazil. Under the agreement Atomo has secured exclusive distribution rights for both professional and self-test versions of the product in Australia, New Zealand, Canada and the United States, and can purchase finished tests from NG Biotech for sale in these markets. Atomo will prioritise registration activities in Australia and New Zealand as product sponsor of Atomo branded versions of the test.ial quantity of Pascal cassettes to support product launch in Brazil.

Under the agreement, Atomo and NG Biotech will also work together during Third Quarter Fiscal year 2023 to finalise planning and associated costs related to securing US market regulatory approvals from the US Food & Drug Administration (FDA) for US market opportunities, including seeking over-the-counter (OTC) home use approval. If Atomo approves NG Biotech's proposed work plan and costs for US regulatory approval, which will be shared by the parties, then the United States is included in the exclusive distribution territory for finished tests under the agreement. Although the Company is unable to quantify the revenue impact at this stage, the new agreement is considered to be strategically material as the Company seeks to grow its global footprint, expand its rapid test portfolio beyond infectious diseases and leverage its opportunities in the US market.