Atomo Diagnostics (ASX:AT1) - Managing Director, John Kelly
Managing Director, John Kelly
Source: Atomo Diagnostics
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  • Atomo Diagnostics (AT1) signs five-year commercialisation agreement with NG Biotech SAS to expand the global launch of a blood-based rapid pregnancy test
  • The test combines a “highly sensitive” test strip for pregnancy hormone hCG, manufactured by NG Biotech, with Atomo’s Pascal blood test device
  • Atomo will provide NG Biotech with Pascal devices, which NG Biotech will use to manufacture the tests
  • Atomo has exclusive distribution rights for the test in Australia, New Zealand, Canada and the USA
  • AT1 shares are up 3.5 per cent, trading at 5.8 cents at 10:18am AEDT

Atomo Diagnostics (AT1) has signed a new commercialisation agreement with NG Biotech SAS to expand the global launch of a blood-based rapid pregnancy test.

The agreement is for an initial five years, at which point it will automatically renew for another five years unless terminated by either party.

The test combines a “highly sensitive” test strip for pregnancy hormone hCG, manufactured by NG Biotech, with Atomo’s Pascal blood test device.

Atomos said detectable levels of hCG build up faster in blood than in urine, meaning this device could be more effective in detecting early pregnancy than a standard urine test.

Under the agreement, Atomo will supply NG Biotech with Pascal devices, which NG Biotech will use to manufacture the pregnancy tests under an exclusive licence.

Further, Atomo will have exclusive distribution rights for both professional and self-tested versions of the test in Australia, New Zealand, Canada and the United States.

Both companies will retain intellectual property (IP) over their individual devices.

Atomo would purchase the test from NG Biotech to sell in these markets.

The company said its main focus will be registration in Australia and New Zealand.

“We are delighted to have been able to secure a long-term strategic partnership with NG Biotech for blood-based pregnancy testing,” said Atomo’s CEO John Kelly.

“We have been investing in US market entry for the company and feel that these products represent a valuable commercial opportunity for us, with pregnancy testing being one of the largest established self-test categories, and with blood testing already utilised in the US in emergency settings to rule out pregnancy on admittance.

“NG Biotech’s professional use and self-test products have already secured CE Mark for sale in Europe, so we are confident in their performance and have received strong interest from potential channel partners in the US with earlier detection of pregnancy seen as a real competitive advantage when compared with more common urine rapid tests”.

The two companies will work together during Q3 FY23 to finalise planning and costs for securing approval from the US Food and Drug Administration (FDA).

AT1 shares were up 3.5 per cent, trading at 5.8 cents at 10:18am AEDT.

AT1 by the numbers
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