Natera Lawsuit Alleges PGT-A IVF Testing Is Falsely Marketed As Accurate, Reliable

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A proposed class action lawsuit claims that Natera has deceptively marketed its Spectrum preimplantation genetic testing for aneuploidy (PGT-A) as an accurate, reliable way to improve in vitro fertilization (IVF) outcomes, despite decades of scientific research and medical guidance that contradict the purported benefits touted by the company.

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The 68-page complaint contends that although Natera has promoted its pricey Spectrum PGT-A screenings as more than 99 percent accurate and capable of increasing implantation and live birth rates while reducing miscarriage risks for women undergoing IVF, the company has deceptively suppressed the material fact that science does not support its marketing claims.

According to the filing, PGT-A is an optional add-on procedure that involves removing a small sample of cells from an embryo’s trophectoderm, the tissue that later develops into the placenta, and analyzing those cells for chromosomal abnormalities before implantation. The testing costs roughly $5,000 per IVF cycle and is rarely covered by insurance, the case says.

The lawsuit alleges that although Natera has marketed Spectrum as a tool to identify embryos most likely to result in a successful pregnancy and birth, the company has failed to disclose mounting evidence that a trophectoderm biopsy may not reliably represent the embryo as a whole. Per the suit, scientific literature has increasingly suggested that embryos can have a mixture of normal and abnormal cells, may self-correct abnormalities over time, and, in some cases, can result in healthy births despite being classified as abnormal by PGT-A.

Overall, studies show that for clinical pregnancy, miscarriage, or live-birth rates, there is no difference between cycles that utilize PGT-A and cycles that do not, and that the accuracy rating for PGT-A is “significantly lower than advertised or disclosed,” the lawsuit says.

“Defendant has known for years that there is insufficient evidence of efficacy of PGT-A, and that PGT-A does not improve pregnancy rates, reduce the chance of miscarriage, increase the success of IVF, or increase the chances of a healthy baby,” the complaint charges. “Despite that, Defendant has to aggressively promote PGT-A to vulnerable and unsuspecting consumers.”

Related Reading: PGT-A IVF Testing Lawsuits

The lawsuit references a plethora of studies spanning decades that found no meaningful improvement in pregnancy outcomes from PGT-A. Among the studies are a 2011 meta-analysis of randomized trials that found no evidence that preimplantation genetic screening improved live birth rates compared to IVF alone, and a 2021 study in the New England Journal of Medicine that concluded conventional IVF treatment resulted in a higher cumulative live-birth rate than IVF utilizing PGT-A in women with a good prognosis for a live birth.

The suit also highlights guidance from major medical organizations such as the American Society for Reproductive Medicine and the American College of Obstetricians and Gynecologists, which have stated that evidence supporting routine PGT-A use remains insufficient.

Related Reading: PGT-A Lawsuit Claims ‘Experimental,’ ‘Unproven’ Genetic Testing Falsely Touted as Accurate and Reliable

According to the complaint, studies have likewise failed to demonstrate clear benefits for some of the patients typically targeted by PGT-A marketing, including women of advanced maternal age and those with recurrent implantation failure or prior pregnancy complications.

“Despite these findings, Defendant continued to advertise and misrepresent non-existent benefits of PGT-A that are not supported by science to vulnerable consumers, while at the same time omitting material information concerning the efficacy of PGT-A,” the filing asserts.

The complaint says that despite Natera’s claims, the company has failed to conduct any “randomized, properly structured, non-commercial trials to support the basis of its marketing” as of 2024. Instead, the case contends, a 2018 Natera-promoted study frequently cited in its marketing materials in support of Spectrum’s efficacy had significant limitations, was not randomized, and by the researchers’ own admission, was insufficient to establish the screening’s overall impact on IVF outcomes.

Further, the lawsuit alleges that these challenged representations helped transform PGT-A into a multi-million dollar global industry with sustained domination of the preimplantation genetic testing market, with an estimated 40 percent of IVF cycles in the United States utilizing the screening.

Natera discontinued Spectrum in December 2025, the suit mentions.

The Natera PGT-A class action lawsuit looks to represent all individuals in the United States who have purchased PGT-A testing from Natera.

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