Genomic Prediction Class Action Lawsuit Claims IVF Testing Is Inaccurate, Unreliable

Lawsuit claims company misrepresented accuracy of embryo screening technology, potentially impacting IVF decisions for hopeful parents.

A new class action lawsuit alleges a genetic testing company misled patients and fertility clinics about the accuracy of its embryo screening technology, raising concerns that IVF families may have made critical reproductive decisions based on flawed or unproven results.

The complaint (PDF) was filed by Adrian Anderson, Amanda Malkin and Maureen Ewing in the U.S. District Court for the District of New Jersey on March 19, naming Genomic Prediction Inc. as the defendant. 

The lawsuit claims the company marketed its preimplantation genetic testing for aneuploidy (PGT-A) as a scientifically validated method for identifying which embryos are better suited for implantation, despite a lack of sufficient clinical evidence to support those claims.

IVF is a widely used assisted reproductive technology that involves fertilizing eggs outside the body and selecting embryos for implantation. In recent years, advances in genetic testing have allowed clinics to screen embryos for certain abnormalities and other inherited conditions, which may affect the embryos’ implantation rates.

However, the new class action complaint alleges that Genomic Prediction’s PGT-A screening goes beyond established practices by attempting to predict complex traits and risks using scoring methods that remain controversial within the scientific community. Plaintiffs warn this may have led prospective parents to discard viable embryos and suffer significant financial and emotional strain.

IVF Testing Concerns

Genomic Prediction’s embryo screening relies on implantation risk scores that are calculated using large datasets to estimate the likelihood of an embryo’s healthy implantation. While such methods have been used in research settings, plaintiffs argue that their application in embryo selection is premature and not sufficiently validated for clinical use.

According to the complaint, the company failed to adequately warn patients and providers that the predictive accuracy of these tests is limited, particularly when applied to embryos. Unlike testing for single-gene disorders or chromosomal abnormalities, PGT-A screening involves complex statistical models that may not reliably translate into real-world outcomes.

Plaintiffs claim that by presenting the testing as a meaningful tool for improving IVF success, the company created a false impression that the results could be relied upon when making decisions about which embryos to implant. The lawsuit alleges that in reality the differences in predicted risk between embryos are often minimal and may not be clinically significant.

The complaint further indicates that patients may have discarded or deprioritized viable embryos based on these test results, potentially reducing their chances of achieving a successful pregnancy. In some cases, individuals may have undergone additional IVF cycles, incurring significant financial costs and emotional strain, based on misleading information about the benefits of the testing.

In addition, the lawsuit raises concerns about the lack of regulatory oversight for this type of testing, suggesting that the company took advantage of a gap in federal regulation to bring the product to market without sufficient scrutiny. Plaintiffs argue that the marketing of the tests outpaced the underlying science, exposing patients to unnecessary risks.

“Plaintiff and the Class members would not have purchased PGT-A from Defendants had they known that it was unproven, inaccurate, incapable of providing information claimed, and unreliable.”

— Adrian Anderson et al v. Genomic Prediction Inc.

The complaint raises allegations of breach of warranty, fraud, unjust enrichment, and violations of California’s Unfair Competition Law and Consumer Legal Remedies Act, as well as Florida’s Deceptive and Unfair Trade Practices Act and Pennsylvania Consumer Protection Laws.

It seeks class certification to represent individuals who paid for or used Genomic Prediction’s PGT-A screening services, as well as those who made reproductive decisions based on the test results, in addition to compensatory damages, restitution and other relief, including potential changes to how the tests are marketed and disclosed to consumers.

Sign up for more legal news that could affect you or your family.