Progenesis Falsely Advertised PGT-A Testing as Proven, Reliable Add-On Treatment for IVF Patients, Class Action Alleges

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A proposed class action lawsuit alleges Progenesis, Inc. has for years misled consumers by failing to disclose that its preimplantation genetic testing for aneuploidy (PGT-A testing) is an unproven, inaccurate and unreliable add-on treatment for individuals undergoing in vitro fertilization (IVF).

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According to the 68-page lawsuit, PGT-A testing is a relatively new procedure that involves screening embryos created through IVF for chromosomal abnormalities before implantation. Progenesis says IVF clinics use its PGT-A testing results to determine which embryos are most suitable for transfer, since abnormalities can result in implantation failure, miscarriage or developmental issues for the child, the complaint says.

Related Reading: PGT-A IVF Testing Lawsuits

Per the filing, the defendant represents that its PGT-A testing—which is rarely covered by insurance and can set a patient back thousands of dollars—increases the chance of implantation, improves pregnancy rates, decreases the risk of miscarriage, reduces the time and costs of having a healthy baby, and benefits patients who become pregnant at 35 years or older.

However, the case charges that there exists no sufficient evidence that PGT-A testing effectively improves an individual’s chances of having a successful, healthy pregnancy. There is also a lack of sufficient evidence demonstrating that PGT-A testing improves the chances of having a baby in older women, the filing contests, noting that there have been no randomized, properly structured noncommercial trials to substantiate the defendant’s marketing claims.

In fact, the complaint says, PGT-A testing is known to carry risks for embryos that may even reduce the chances of pregnancy and live birth. As the case tells it, PGT-A testing can result in false negatives, where potentially viable embryos are misdiagnosed as unsuitable for transfer and discarded. Progenesis also fails to inform consumers that embryo biopsy, freezing and thawing—all necessary parts of the PGT-A testing process—can damage the embryo and negatively affect IVF outcomes, the lawsuit claims.

The Progenesis lawsuit says the company’s alleged misrepresentations and omissions about the accuracy of its PGT-A testing are illegal and unethical.

“[The defendant] is aware of the lengths to which individuals undergoing IVF go to create embryos, their emotional and financial investment in assuring the viability of their embryos, and their expectations that any genetic testing should not be sold in a misleading and deceptive manner,” the filing stresses.

The case claims that consumers would not have paid for the testing had they known it was unproven and does not consistently produce reliable results.

The suit looks to represent anyone in the United States who has purchased PGT-A testing from Progenesis.

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