Between May 2019 and October 2020, Monash IVF offered a new, non-invasive, embryo genetic screening test that has since been suspended. The world-first method had a high false-positive rate, meaning that viable embryos may have been destroyed. The test was used up to 13,000 times and thousands of people could be affected.
Michel Margalit, lead lawyer on the case, said 'I think that there is a real possibility that many, many people will question whether or not they have lost their ability to have children because of this inaccurate testing.'
Instead of procuring an embryo biopsy, the new non-invasive method involved collecting a sample from the liquid surrounding the embryo. Monash IVF told patients that the results of invasive and non-invasive testing were identical in 95 percent of cases. When genetic abnormalities were identified, patients had the choice of saving, destroying or donating the embryos for medical research. The majority of people who were informed that their embryo was abnormal chose not to keep it for use in treatment.
'What we've found out now is [the non-invasive method] perhaps didn't go through the usual robust testing systems that you'd usually expect, which would include publication of the trial data when testing this type of technology, and peer review,' Margalit said.
Monash IVF are offering free treatment to the affected patients; however, this is not feasible for some. Those affected are seeking compensation for the trauma caused and the lost opportunity to have genetically related children, in a multi-million-dollar class action. 'It's an age and time game for a lot of people in IVF,' Margalit added, 'We will be fighting for the rights of these women who have placed their trust in the hands of a medical provider and unknowingly have had devastating consequences.'