PGT-A IVF Testing Lawsuits: False Positive, Success Rate Controversy?

Several lawsuits have been filed alleging that an add-on to the in vitro fertilization (IVF) process called preimplantation genetic testing for aneuploidy (PGT-A) is misleadingly advertised—and attorneys are now looking to speak with more people who had PGT-A to help strengthen the litigation and potentially file new lawsuits.

Specifically, the lawsuits allege that PGT-A, which is used to screen embryos for chromosomal abnormalities, is falsely advertised as a proven and accurate method to increase the success of IVF, decrease the chance of miscarriage, reduce the time to pregnancy, and increase live birth rates, among other claims. In reality, the cases allege, the advertised benefits of PGT-A are not supported by conclusive scientific evidence, and the genetic testing may even reduce a patient’s chances of having a baby through IVF due to false positives.

The lawsuits claim that if consumers had known the truth about PGT-A testing’s accuracy and risks, many of them would not have gone through with the testing, which can cost thousands of dollars out of pocket.

IVF Genetic Testing Controversy

The use of PGT-A during the IVF process has been a subject of controversy in the field of reproductive medicine. While the clinical use of other types of preimplantation genetic testing—preimplantation genetic testing for monogenic disorders (PGT-M) and preimplantation genetic testing for structural rearrangements (PGT-SR)—has been “firmly established,” some experts have voiced concern about the broad marketing of PGT-A to IVF patients without a clear explanation of its limitations.

Preimplantation genetic testing for monogenic disorders (PGT-M), previously known as preimplantation genetic diagnosis, is a customized test for a specific genetic mutation when there is a known risk that one or both biological parents may pass down a genetic abnormality. Similarly, preimplantation genetic testing for structural rearrangements (PGT-SR), is used to test an embryo for chromosome gains and losses when one or both parents have structural chromosomal abnormalities.

On the other hand, PGT-A (previously known as preimplantation genetic screening) is used to identify possible chromosomal abnormalities in an embryo—i.e., whether the cells have missing or extra chromosomes—when there is no known risk of inherited disorders. The American Society for Reproductive Medicine stated in its 2024 practice guidance that scientific studies have not established the value of PGT-A as a routine screening test for IVF patients and that more research is needed to determine the best use of the genetic test.

PGT-A Lawsuits: Misleading Success Rate, Accuracy Claims

Several lawsuits have been filed against companies that sell PGT-A tests—specifically, Natera, Progenesis, Reproductive Genetic Innovations and CooperGenomics—claiming they have misled consumers about the tests’ benefits while failing to disclose their limitations and risks.

According to the lawsuits, PGT-A testing companies market their products as a proven and reliable method to increase IVF success rates, reduce the risk of miscarriage, reduce the amount of time it takes to become pregnant, and increase live birth rates. The cases claim, however, that studies have shown no difference in pregnancy, miscarriage and live birth rates between IVF cycles utilizing PGT-A and those not utilizing PGT-A.

The lawsuits state that as of 2024, there have been no randomized, properly structured, non-commercial trials to support claims that preimplantation genetic screening improves implantation rates, increases pregnancy and live birth rates and reduces miscarriages. In fact, a meta-analysis conducted in 2011 found that preimplantation genetic screening actually lowers the live birth rate for women of advanced maternal age.

The lawsuits also claim that PGT-A test sellers have overstated the accuracy of the tests, some of which are advertised as up to 99% accurate. Per the suits, a small 2016 study that retested embryos that had previously been deemed aneuploid (i.e., containing an abnormal number of chromosomes and thus not suitable for implantation) suggested a false positive rate of nearly 55%. Eight transfers of embryos that had been initially reported as aneuploid resulted in five chromosomally normal pregnancies, four of which delivered and one of which was ongoing at the time the results were published. The researchers concluded that although the study was too small to draw statistically significant conclusions, the results “raise concerns” about the rate of false positive diagnoses during preimplantation genetic screening and the risk that testing may actually reduce patients’ pregnancy chances by causing them to discard “potentially perfectly normal embryos.”

The author of a 2017 study analyzing the clinical reliability of PGT-A results estimated that as many as 40% of chromosomally normal embryos are discarded based on false positive PGT-A test results, the lawsuits state.

A 2021 study observed that term placentas, which form from the tissue used in PGT-A biopsies, are inherently mosaic, meaning they contain both euploid cells (chromosomally normal) and aneuploid cells, even if the fetus is completely euploid. Per the lawsuits, this finding conflicts with the representation that a biopsy during PGT-A can adequately predict how the entire embryo will develop.

The lawsuits claim that although PGT-A test sellers are well aware of the body of scientific literature questioning the use and accuracy of PGT-A, they have not included this critical information in their marketing and advertising.

According to the lawsuits, the defendants’ misleading claims have had “severe consequences” for patients, many of whom have paid thousands of dollars out of pocket for PGT-A genetic testing based on potentially false or incomplete information. PGT-A is rarely covered by insurance, the suits say, and several major insurers have noted that the genetic testing is “unproven” and not medically necessary due to “insufficient evidence” of its efficacy.

Patients Voice Concern Over False Positive, False Negative Results

IVF patients have turned to online forums such as Reddit for advice on whether PGT-A testing is worth it, with some expressing concern over the rate of false positive or false negative results. In response, others have detailed their own experiences with PGT-A testing, noting that it can be wrong and suggesting that the success rate varies.

Below is a sampling of posts from Reddit users warning of the possible risks of PGT-A [sic throughout]:

I had a miscarriage with a PGT-A tested embryo. I was told it was euploid, but after the miscarriage, the testing proved that it was not. I have DOR and I've done multiple retrievals and it was my one golden ‘euploid’ embryo. For me, there will always be a bit of doubt and wondering. Did I discard embryos that could have resulted in a live birth? I'll never know. … I think doctors in the US push for the testing, but it is expensive and not a guarantee.”
— MrsXYZ123, Reddit.com

My RE had recommended against testing but I still went with it. Fast forward, I just miscarried a highly graded euploid, . It was obvious on the us that it had a severe abnormality. They test only a few cells so there are many false negatives and falls positives. This test is not reliable even though they claim its accuracy close to 98 %”
— Correct-Opening3567, Reddit.com

This is just word of mouth, but has anyone else heard about false positives on PGT-A testing coming back as abnormal embryos? I was told the stats on it coming back as false positive were very low and I’m pretty sure I remember reading about it once, but I have recently been informed by doctors in another country that there is more to that story … Have I been misled into paying for PGT-A for nothing (I was 26yo at the time of ER) and have I allowed my clinic to discard potentially fine embryos? I am extremely distraught because I had two abnormal embryos my clinic refused to store/that they discarded even though I tried to push back on this.”
— ARIT127, Reddit.com

Out of 4 retrievals, tested for 2, didn’t test for 2. No children from the cycles we tested the embryos for, and 2 healthy kiddos from the rounds we didn’t. Also, one of the cycles we tested on the lab came back later and told us they mistakenly reported one of our embryos as aneuploid that was actually euploid.”
— Prim_and_Polished, Reddit.com

I am definitely in the minority, but I regret testing my embryos. I am 33 and have DOR but quality eggs. Out of my two IVF cycles, I only got 5 mature eggs but 3 genetically normal embryos (1 embryo was abnormal). Our doctor was thrilled and make it seem like we were in a great position for 2 children. Welp, we had two failed transfers and one embryo that didnt even survive the thaw. A big part of me is convinced they were damaged in the freezing processing or my body just doesnt love a frozen embryo. So now we are moving forward doing a fresh transfer with my next cycle. Many doctors make it seem that genetically testing embryos is the sure fire way to bring home a healthy baby, but the reality is not always the case.”
— ekaps17, Reddit.com

We had a successful IVF transfer and just recently went for a 12w ultrasound. We had PGT-A testing performed before the transfer and no abnormalities were found. Our lab results after the 12w have been returned with high risk (1:16) for Down syndrome. We now understand PGT is not a guarantee as it only samples a small number of cells.”
— wags25, Reddit.com

How Could a Lawsuit Help?

If successful, a class action lawsuit could help IVF patients get back some of the money they spent on PGT-A.

The lawsuits that have already been filed are also seeking orders requiring the defendants to properly disclose “the true nature” of PGT-A testing and prohibiting them from misleading or deceiving consumers going forward.

What You Can Do

After you get in touch, an attorney or legal representative may reach out to you directly to ask you some questions and explain how you may be able to help the investigation. It doesn’t cost anything to fill out the form or speak with someone, and you’re under no obligation to take legal action.

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