NEW YORK – Atomo Diagnostics and NG Biotech said Wednesday the firms had inked a deal to collaborate on manufacturing and distributing blood-based pregnancy tests for use in homes and clinical settings.
The test will combine France-based NG Biotech's assay for human chorionic gonadotropin (hCG) levels with Australian medical device maker Atomo's integrated Pascal blood testing instrument. Under the agreement, Atomo will provide the Pascal instruments and an exclusive license for NG Biotech to use the devices to manufacture rapid pregnancy tests. The deal has an initial period of five years and automatically renews unless terminated by either party.
Atomo also secured exclusive rights to distribute the tests in Australia, Canada, New Zealand, and the United States. Atomo will seek regulatory approval of the Atomo-branded test in Australia and New Zealand. The partners plan to collaborate during the fiscal third quarter of 2023 to finalize plans for securing US Food and Drug Administration authorization to market the tests in the United States.
Financial and other terms of the deal were not disclosed.
Atomo CEO John Kelly said in a statement his company has been investing toward entering the US market, and blood-based pregnancy tests provide a valuable opportunity because of their use in emergency settings to rule out pregnancy on hospital admission. He said that the agreement also lets NG Biotech prioritize commercialization efforts in Europe and Brazil and expand into other markets in the coming year.
“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 said.