Patients are suing over an embryo screening technology that wasn't as accurate as promised
Many reproductive technologies are sold to patients before there is strong evidence about how well they work. How much evidence is enough? The question is now before an Australian court.
3 minute read
Before May 2019, people who wanted to screen an embryo before using it had no choice but to let scientists pluck a few cells and send them off for testing. It's called "preimplantation genetic testing for aneuploidy" (PGT-A) and its purpose is to make sure an embryo has the right number of chromosomes.
That month, however, Monash IVF, a leading fertility group based in Australia, announced another option. Called "cell-free PGT-A" or "non-invasive PGT-A" (niPGT-A), it did not test an embryo's cells directly, but rather, tested DNA that had been secreted into the nutrient solution, known as "culture medium," in which the embryo was growing.
A press release at the time called the new offering "revolutionary," and said it would make embryo testing more widely available. That's because it could be used on more embryos, including ones not hardy enough to be biopsied. Monash IVF's medical director, Luk Rombauts, was quoted saying, "Older patients who would benefit the most were missing out because most or all of their embryos were not suitable for the embryo biopsy — with this new breakthrough these embryos can be screened, improving their chance of successful pregnancy." It was also a much cheaper procedure, costing around $500, according to the press release. Standard PGT-A can cost a few thousand.
According to a chart on a fact sheet handed out to clinic patients, the new test had 95 percent accuracy, whereas the standard test had 96 percent. The factsheet also said: "Our in-house studies have demonstrated that non-invasive PGT results are identical to the embryo biopsy PGT results in 95% of the cases. Therefore, it is important to note that this method is not 100% accurate."
The technology was used some 13,000 times, according to an estimate in the Sydney Morning Herald.
But in October 2020, Monash abruptly withdrew the non-invasive option. In a letter to patients, they wrote, "There are some new findings about cell-free PGT-A that are inconsistent with the original clinical trial results that need to be further understood. In preliminary investigations the proportion of abnormal embryos classified (aneuploid) appears to be marginally higher than what was observed in the initial clinical trial, suggesting the cell-free testing has erred on the side of caution in its identifications."
In other words, embryos were being classified as abnormal that might not have been. This is a problem. People were making decisions based on those false classifications — decisions to go through IVF yet another time, for instance, decisions to opt for donor gametes, or decisions to give up altogether.
On December 22, 2020, a patient brought a class action suit against Monash IVF and an affiliated clinic. The group now numbers more than 170 — and counting. Michel Margalit, the lawyer representing the patients, believes that as many as a thousand people may end up joining.
The lead plaintiff, Danielle Bopping, first sought treatment in July 2017, when she was 39 years old. After four transfers that did not lead to a child, in November 2019 Bopping decided to test an embryo using the non-invasive procedure. The results came back as abnormal, and the embryo was discarded.
Margalit's clients have told her that doctors suggested the non-invasive testing was preferable, because it didn't disrupt the embryo. Doctors are influential, she says: "At the end of the day, if the doctor recommends something, you just do it."
The statement of claim says that what Monash IVF told Bopping about the technology was "false, misleading and deceptive."
The key issue is whether adequate research was done before offering this as a product to patients. According to court filings, the technology relied on results from a clinical trial of 73 people. The results of that trial, says Margalit, have never been published and were not scrutinized by other professionals, a process known as peer review. The non-invasive test, she says, "should not have been introduced."
Monash has not responded to requests for comment.
Note: This story originally stated that using PGT-A improves the odds of a live and healthy birth. This has now been refuted.
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