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

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A proposed class action lawsuit alleges that Genomic Prediction, Inc. and its clinical laboratory prey on “vulnerable and unsuspecting” women seeking pregnancy assistance by touting as accurate and reliable preimplantation genetic testing for aneuploidy (PGT-A) that, in truth, is unproven, highly inaccurate and can even reduce the chance of a viable pregnancy.

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The 96-page lawsuit contends that Genomic Prediction deceptively promotes its LifeView PGT-A product as the “most advanced genetic screening available” despite decades of research demonstrating the considerable likelihood of false positives and negatives for the testing.

Per the case, Genomic Predication’s PGT-A testing, which purportedly determines which embryos are best suited for implantation and which are abnormal and thus unsuitable, is sold primarily as an add-on to in vitro fertilization (IVF). The suit relays that the testing is touted as capable of increasing pregnancy rates, lowering miscarriage rates, cutting the number of IVF cycles needed, and reducing the risk of bearing a child with birth defects or disabilities, among other benefits.

The class action lawsuit alleges, however, that Genomic Prediction’s representations of PGT-A are false and/or misleading and deceptive in light of the omission of certain material information, including the fact that, per the complaint, there exists no difference between IVF cycles utilizing PGT-A and those that do not.

Related Reading: PGT-A IVF Testing Lawsuits

Though the PGT-A testing is advertised as having a 98- to 99-percent accuracy rate, the lawsuit alleges that this figure is substantially lower. In addition, many insurance companies, including UnitedHealthcare, the largest insurer in the United States, consider PGT-A “unproven and not medically necessary” due to “insufficient evidence of efficacy.”

The case asserts that PGT-A is not backed by any truly “randomized, properly structured, non-commercial trials” to support the defendant’s efficacy claims, and instead cites numerous peer-reviewed studies demonstrating issues with the procedures.

The filing alleges that Genomic Prediction has known “for years” that its representations of PGT-A are false and deceptive.

“Defendants have acted to mislead customers with their false and deceptive marketing and advertising statements, and material omissions, in exchange for the opportunity to reap millions of dollars in profit each year from selling PGT-A tests,” the suit claims.

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Per the complaint, between 2005 and the present, dozens of researchers have flagged that preimplantation genetic screening lowers live birth rates for women of advanced maternal age, may have a false positive rate of up to 55 percent, may not represent the full genetic composition of an embryo in total, and that it may be “biologically impossible” to accurately ascertain an embryo’s viability with a single biopsy of the embryo’s outer layer at the blastocyst stage, five to nine days after fertilization, as is done in LifeView testing.

“Despite these findings, Defendants 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 complaint argues.

Any studies promoted by Genomic Prediction claiming results to the contrary are small, limited, not randomized and not peer-reviewed, the suit claims.

The plaintiffs are three women residing in Ohio, Florida, and Pennsylvania who claim to have fallen victim to aggressive, predatory PGT-A marketing and were pressured to purchase the testing at IVF clinics after failing to conceive. Between July 2021 and October 2023, the case says, the three women spent approximately $3,590, $8,400, and $8,962.68 plus additional costs for their respective testing.   

As a result of deceptive advertising, the popularity of PGT-A has continually increased in recent years, with nearly 40 percent of those undergoing IVF procedures currently purchase the testing, which has allowed the industry to reap an estimated $300 to $400 million in annual revenue.

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

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