Natera is facing a class action lawsuit alleging misleading marketing of its preimplantation genetic testing for aneuploidy (PGT-A) through its Spectrum PGT-A test. Plaintiffs Melissa Klein and Valerie Griffeth filed the case in US District Court for the Northern District of California, asserting false and misleading advertising under New York and Illinois consumer protection laws and fraud claims. The complaint alleges that Natera marketed Spectrum PGT-A as proven and reliable to decrease miscarriage risk and increase the chance of giving birth to a healthy baby despite evidence questioned by plaintiffs and several professional guidance documents. The filing cites assertions that PGT-A does not meaningfully change pregnancy, miscarriage, or live birth outcomes compared with IVF cycles without it. Natera discontinued its Spectrum PGT-A test before the filing, but the lawsuit seeks to hold the company accountable for prior claims tied to IVF decision-making. The complaint also points to insurance denials from UnitedHealthcare and Aetna and highlights a 2018 committee opinion from the American Society for Reproductive Medicine and Society for Assisted Reproductive Technology and a 2020 ACOG opinion noting insufficient evidence for routine use. The case matters for the reproductive genomics market because regulatory ambiguity around clinical utility can rapidly translate into reputational, legal, and reimbursement risk—especially where consumer-facing claims are at issue.
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