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California Court Temporarily Stops State From Barring Other Labs Performing Trisomy Screenings

This story has been updated from a previous version posted Nov. 1 to clarify that BillionToOne is a stakeholder in the case but not a plaintiff. 

NEW YORK ­– The Superior Court of California last week granted a preliminary injunction filed by Myriad Genetics and Laboratory Corporation of America, preventing California's Department of Public Health (CDPH) from enforcing a requirement that only labs contracting with CDPH be allowed to perform trisomy screening for California residents.

The CDPH had recently amended one of its regulations to read that "only Department approved birth defects screening laboratories" would be able to offer trisomy screening or prenatal screening for neural tube defects as part of the department's prenatal screening (PNS) program for California residents.

The plaintiffs asked for an injunction, arguing that the amendment effectively cuts them out of California's market while favoring labs that have joined the CDPH PNS program. Additionally, BillionToOne released a statement implying that it, too, would be impacted by the regulation.

In its injunction order, the court wrote that the plaintiffs are "likely to prevail on the merits at trial" and due to the harm that not issuing an injunction is likely to cause to the companies while the matter is settled.

The companies claim that CDPH failed to consult the public or experts before amending its regulations, which the court document said CDPH did not dispute.

According to the order, CDPH had argued that it did not need to consult the public or experts, relying instead on statutes allowing it to enact "emergency regulations." Myriad Genetics and Labcorp, however, pushed back, saying that cell-free DNA screening has been performed for decades in California and that CDPH failed to cite any crisis that might support the use of emergency regulations.

The injunction will remain in force until the case is settled.

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