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Atomo Diagnostics expands launch of novel blood based rapid pregnancy test in key markets

19 January 2023 | News

Atomo secures exclusive distribution for Australia & New Zealand, Canada and the US

Image credit: shutterstock

Image credit: shutterstock

Australia-based Atomo Diagnostics has announced the signing of a new agreement with its long-term partner NG Biotech SAS (NG Biotech) in France, 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.

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. 

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