NEW YORK — UK-based molecular diagnostics firm Yourgene Health said on Monday that it has signed on Immuno-Biological Laboratories (IBL-America) as a nonexclusive US distributor of its Elucigene DPYD chemotoxicity assay and certain other reproductive health tests.
Under the terms of the deal, Spring Lake Park, Minnesota-based IBL-America will distribute in the US Elucigene DPYD, which identifies cancer patients with an enzyme deficiency that can result in serious side effects from 5-fluorouracil treatment, as well as Yourgene's PCR-based tests for cystic fibrosis, male factor infertility, and invasive aneuploidy.
Yourgene said the tests will initially be sold by IBL-America for research use only to research groups and CLIA labs for in-house validation prior to clinical use. Yourgene said that it may pursue FDA registration of the tests depending on customer demand.
Additional terms of the deal were not disclosed.
"The appointment of IBL-America is an important pillar within our plans to penetrate the largest diagnostics market in the world with our full portfolio across the whole genomic testing lifecycle," Yourgene CEO Lyn Rees said in a statement.
In August, Yourgene agreed to acquire Canadian sample prep technology firm Coastal Genomics for up to $13.5 million.