Illumina filed a complaint in U.S. District Court for the District of Delaware against BillionToOne, alleging infringement of multiple patents covering non-invasive prenatal testing technologies. The patents cited involve methods and compositions for determining fetal nucleic acid fractions in maternal samples and quantification approaches that use massively parallel sequencing. BillionToOne’s Unity platform includes several prenatal assays, including products such as Fetal Risk Screen, Aneuploidy Screen, and Confirm, which uses intact circulating fetal cells isolated from maternal blood. The company’s platform includes Quantitative Counting Templates, which uses synthetic DNA standards to enable fetal fraction calculation with higher multiplexing. Both companies are pressing IP claims as competition in NIPT expands beyond traditional workflows and into assays that aim to reduce paternal-sample dependencies and broaden clinical scope.