Preimplantation genetic testing for aneuploidy (PGT-A) is now one of the most promoted add-ons in IVF treatment. Clinics present it as a way to select the “best” embryos before transfer. Marketing often promises higher pregnancy rates, fewer miscarriages, and a faster path to a live birth. Many patients are told that it is a proven step toward success. In reality, medical experts say the science is far from settled. Independent studies have found no consistent evidence that PGT-A improves live birth rates for the general IVF population.
The test is expensive, often costing thousands of dollars per cycle. Most insurance plans do not cover it. Many patients pay out of pocket based on the belief that it will improve their odds. The lawsuits claim these patients were misled. Court filings argue that the benefits of PGT-A were overstated while the risks were downplayed. Some evidence suggests that the test may even harm outcomes by causing the disposal of embryos that could have resulted in healthy babies. Patients who relied on PGT-A say they lost time, money, and in some cases, their only chance at biological parenthood.
What PGT-A Does
PGT-A screen embryos for missing or extra chromosomes before they are transferred to the uterus. The process starts after eggs are fertilized in an IVF cycle. A small sample of cells is taken from each embryo and sent to a genetic testing lab. Doctors review the results and label embryos as “euploid” if the chromosomes appear normal. Embryos labeled “aneuploid” show abnormalities that may reduce the chance of implantation or increase the risk of miscarriage.
Clinics often recommend transferring only embryos labeled as euploid. The goal is to improve pregnancy outcome and avoid the emotional and physical toll of failed cycle. In theory, this selection process should help patients achieve a healthy birth faster. In practice many scientists and doctor question whether the test delivers on it promises. The classification relies on a tiny sample of cell which may not represent the entire embryo. This can lead to false result and the potential loss of viable embryos.
Why Lawsuits Were Filed
Patient across the United States have filed class action lawsuit against several major genetic testing companies. The defendant include CooperGenomics, Natera, Progenesis Reproductive Genetic Innovations Ovation Fertility and Igenomix. These companies market PGT-A as a proven tool to increase IVF success. The lawsuits claim that this marketing misrepresented both the accuracy and the benefits of the test.
Court documents say patients were not told about the risk of false positives. A false positive can label a healthy embryo as abnormal. Once labeled many clinics refuse to transfer these embryos. This mean patients may discard embryos that could have resulted in a healthy child. The suits argue that companies knew about these risks yet continued to promote PGT-A as highly reliable.
The filings also point to the financial impact. PGT-A costs thousands of dollars per cycle and is rarely covered by insurance. Patient say they paid out of pocket based on incomplete or misleading information. Some plaintiff allege they lost their only chance at having a biological child because their healthy embryos were discarded after PGT-A testing.
Scientific Dispute
Medical bodies such as the American Society for Reproductive Medicine (ASRM) have stated that evidence does not prove PGT-A improve outcome for all IVF patients. Studies show no clear difference in pregnancy or live birth rates between IVF cycle with and without PGT-A. A 2011 meta analysis even found lower live birth rates for older women who used the test.
Small studies have raised concerns over accuracy. One 2016 study retested embryos labeled abnormal and found that many were normal. In some cases, these embryos resulted in healthy births. Experts say this suggests a high false positive rate. Estimates suggest that up to 40% of viable embryos may be discarded due to inaccurate results.
Patient Stories
Many IVF patients have shared personal experiences online. Some reported miscarriages from embryos labeled as normal. Others found that embryos initially marked abnormal later tested normal. Several patients said they had healthy children from embryos PGT-A would have rejected. These stories highlight a growing distrust in the test’s reliability.
One woman discovered her “abnormal” embryo was actually healthy after participating in a research trial. She now has a healthy son. Another patient found that her clinic stored embryos labeled as abnormal then re tested them and found they were normal. This left her feeling misled and emotionally drained.
Financial and Industry Impact
PGT-A costs thousands of dollars and is rarely covered by insurance. Clinics and labs profit from the test, which can make up a large part of their revenue. Some clinics reportedly require patients to use it, especially in markets where insurance reduces overall IVF profit margins. Critics say these financial incentives have fueled overuse.
The lawsuits could reshape the fertility industry. Reduced PGT-A use may cut clinic profits and lower the value of private equity-owned fertility groups. This could trigger broader changes in how IVF add-ons are marketed and sold.
Expert Opinion
Supporter of PGT-A argue that it helps select the best embryos reduce the number of transfer and lowers miscarriage risk. Doctors at major fertility centers say their patients see better outcomes with it. They also point to research showing benefits for older women and those with repeated pregnancy losses.
Skeptics argue that testing only a few cell from the embryo may not reflect its true genetic health. Mosaicism where embryos have both normal and abnormal cell add to the uncertainty. Some embryos with abnormalities can self correct and lead to healthy birth. Critics warn that clinics discarding such embryos could be eliminating viable pregnancy chance.
Past Legal Cases Abroad
An Australian class action against Monash IVF settled for $56 million. Patients alleged that PGT-A results wrongly labeled embryos as unviable. The clinic used a newer, non-invasive method (niPGT-A) that studies found less accurate than standard testing. Some U.S. clinics already offer this method despite its accuracy concerns.
What the Lawsuits Seek
U.S. plaintiffs are asking the courts to award refunds for the money they spent on PGT-A. Many paid thousands of dollars out of pocket for testing they now believe was unnecessary or harmful. They also seek compensation for emotional distress and the loss of embryos they will never be able to use. Some say this loss has permanently ended their chances of having a biological child.
The lawsuit aim to force genetic testing companies to change how they market PGT-A. Plaintiff want clear, accurate information about the limit of the test. They are asking for warning about false positives, false negative and the lack of proven benefit for many patient. The legal teams also want injunction that would prohibit companies from making unverified claim in advertising.
Lawyers involved in the case believe more companies may be added as new evidence come to light. The suit could expand to include additional testing lab IVF clinics and any parties found to have profited from misleading patient about PGT-A.
The Road Ahead
The lawsuit are still in the early stage. Several companies have filed motions to dismiss but the case remain active in multiple court. Legal expert say the process could take year before any settlements or judgments are reached. Even so the filings have already triggered debate within the fertility industry. Doctor scientists and patient advocate are reexamining whether PGT-A should be used as widely as it is today.
Industry observer believe these lawsuits could change how IVF clinics present add on service. A ruling against the testing companies might force clinics to stop promoting PGT-A as a guaranteed path to better outcome. It could also push regulators to require stronger evidence before such test are marketed.
Patient who are considering PGT-A should take time to ask detailed question at their clinic. They should learn about the test limitation possible error rate and overall cost. Understanding the science and the risk can prevent financial losses and emotional setback. Informed patient are better equipped to decide whether PGT-A fit their personal circumstance and goal for building a family.
