Atomo Diagnostics and NG Biotech to commercialise blood-based rapid pregnancy tests
These new pregnancy tests combine NG Biotech’s manufactured “highly sensitive hCG test assay” and Atomo’s Pascal blood test device.
Under a new commercialisation agreement, Atomo Diagnostics (ASX: AT1) and NG Biotech will launch a unique blood-based rapid pregnancy tests across Australia, New Zealand, Canada and the United States.
The new pregnancy test combines NG Biotech’s manufactured “highly sensitive hCG test assay” and Atomo’s integrated Pascal blood test device.
Detectable hCG levels are known to build more quickly in blood than urine – making this new test potentially suited to early pregnancy diagnosis.
Atomo expects the “unique ease of use” and reliability of its Pascal cassette for blood testing will pave the way for entry in professional, over-the-counter and online markets.
Agreement terms
Under the deal, Atomo will provide NG Biotech with its assembled Pascal devices. NG Biotech will also be granted an exclusive licence to use the devices in manufacturing the rapid pregnancy tests, which will be available for at home testing and professional use.
The initial agreement is for five years and will auto-renew for a further five-years unless either party terminates it.
Atomo will retain all IP relating to its Pascal device, while NG Biotech will remain the owner of all IP related to its hCG test strip.
Distribution rights
As part of the agreement, Atomo will own exclusive distribution rights for both professional and self-test versions of the product throughout Australia, NZ, Canada and the US.
Atomo can purchase the finished tests for NG Biotech to sell in these markets. It will also prioritise registration activities for the product in Australia and NZ.
Over in the US market, Atomo and NG Biotech will work together in Q3 FY2023 to finalise planning and costs to secure regulatory approvals from the Food and Drug Administration.
These approvals also include securing permission for over-the-counter at-home use.
In the case of Atomo securing exclusive distribution rights to the US market, the companies need to agree on the work plan and costs, which will be shared.
Global expansion
At this stage Atomo chief executive officer John Kelly said the company is unable to quantify the revenue impact of the agreement, but considers it to be “strategically material” as it expands globally.
“We are delighted to have been able to secure a long-term strategic partnership with NG Biotech for blood-based pregnancy testing.”
“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.”
Mr Kelly noted the agreement will free NG Biotech up to pursue market entry for the products in Europe and Brazil.
“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,” he added.