Why is PGT-A Testing Under Scrutiny and Litigation?
Justice Law Collaborative, along with co-counsels Constable Law, and Berger Montague, filed class action lawsuits in the United States against multiple genetic testing companies for misleading consumers about the efficacy of Preimplantation Genetic Testing for Aneuploidy (PGT-A).
What is PGT-A?
PGT-A is advertised as a genetic test that purports to analyze the chromosomal makeup of fertilized human embryos and screens them for chromosomal abnormalities. The add-on test (not included in most IVF treatment plans) typically costs thousands of dollars and is rarely covered by health insurance.
The lawsuits, filed against CooperGenomics, Inc., CooperSurgical, Inc., The Cooper Companies, Inc., Reproductive Genetic Innovations, LLC., Progenesis, Inc., and Natera, Inc., allege that these companies are engaged in deceptive marketing practices by overstating PGT-A testing benefits including:
- Significantly increases the success of IVF.
- Decreases the chance of miscarriage.
- Improves pregnancy rates.
- Is highly accurate and reliable.
Litigation around PGT-A has further spurred questions and concerns in the medical, science, and human reproduction industries. In fact, a large randomized trial published in the New England Journal of Medicine, challenged the widespread use of PGT-A, suggesting that it does not significantly improve IVF outcomes and may even have unintended negative consequences, such as the destruction and discarding of potentially viable embryos. Further, a just-published study in the Journal for Assisted Reproduction and Genetics (JARG; January 2025) reported no outcome benefits from higher utilization of preimplantation genetic testing for aneuploid (PGT-A) of embryos during in vitro fertilization (IVF) but demonstrated increased utilization of PGT-A with non-medical ownership of IVF clinics. The study reveals that the increased usage of PGT-A does not lead to better IVF treatment outcomes.
The study also correlated a concerning connection in that IVF clinics owned by private equity (i.e. no longer owned by medical interests) had a significantly higher PGT-A utilization than either hospital/medical-school- or physician-owned clinics.
IVF attorney and JLC co-founder Paula Bliss said, “Along with increased attention on IVF from political circles and the incumbent administration exists the need for greater protections for patients pursuing a family through IVF treatment. The desire to start a family, combined with unexpected, monumental hurdles to achieving that family, creates emotional and financial hardships that cannot be overstated. As attorneys, we must not only be aware of the constantly changing IVF landscape, we find ourselves in the position to potentially frame new legislation that protects fellow citizens from bad actors seeking to line their pockets at their expense."
Those undergoing IVF treatment are encouraged to research and select fertility treatment centers associated with medical teams that provide access to multiple specialists so that you can obtain a range of perspectives and support through the process. For more information about the pending litigation, visit this link.
Source: Center for Human Reproduction