BillionToOne, Inc., Secures Landmark Win in Lawsuit Against CDPH’s PNS Program in Order to Maintain Patient and Provider Choice Regarding Cell-free DNA Screening for Trisomy 21, 18, and 13

BillionToOne, alongside other laboratories, has triumphed in a lawsuit against the California Department of Public Health (CDPH) contesting a regulation (California Code of Regulations, title 17, section 5623(e)) that prevented licensed clinical laboratories from offering cell-free DNA (cfDNA) screening for trisomies outside the Prenatal Screening Program (PNS Program). The lawsuit commenced in September 2022, and the final decision was filed with the Superior Court of California on April 28, 2023.

The Court determined that the CDPH’s enforcement of exclusivity exceeded its authority. On November 2, 2022, a preliminary injunction temporarily suspended CDPH’s enforcement of exclusivity, and this new ruling solidifies that suspension indefinitely. This verdict allows physicians and patients in California to have open and enduring access to cfDNA screening for trisomy 21, 18, and 13 by any licensed clinical laboratory in California, including BillionToOne. The outcome of this lawsuit provides critical preservation of patient and provider choice. 

Click here to read the entire filing.