According to the Complaint, Myriad is a molecular diagnostic company that develops and markets predictive, personalized, and prognostic medicine tests worldwide. Myriad offers, among other products, GeneSight, a DNA genotyping test to aid psychotropic drug selection for depressed patients; and Foresight, a prenatal test in the expanded carrier screening market for future parents to assess their risk of passing on a recessive genetic condition to their offspring.
The Complaint alleges that throughout the Class Period, Defendants made materially false and misleading statements regarding the Company’s business, operational and compliance policies. Specifically, the Complaint alleges Defendants made false and/or misleading statements and/or failed to disclose that: (i) GeneSight lacked evidence or information sufficient to support the tests in their current form, including their purported benefits; (ii) the U.S. Food and Drug Administration had requested changes to GeneSight and questioned the validity of the test’s purported benefits; (iii) Myriad had been in ongoing discussions with the FDA regarding the FDA’s requested changes to GeneSight; (iv) Myriad’s acquisition of Counsyl—and thereby, Foresight—caused the Company to incur the risk of suffering from lower reimbursement for its expanded carrier screening tests, which had the potential to, and actually did, materialize into a material negative impact on the Company’s revenue; and (v) as a result, the Company’s public statements were materially false and misleading at all relevant times.
On December 23, 2019, the Court issued an Order appointing Lead Plaintiff and Counsel. Lead Plaintiff filed an amended Complaint on February 21, 2020.