A proposed class action alleges the Prequel genetic prenatal screening tests sold by Myriad Genetics provide incorrect results roughly 85 percent of the time.
The 23-page suit says that although Myriad touts its pricey prenatal screening tests as accurate, the products, which are used by pregnant women to screen for chromosomal and genetic conditions that can affect a baby’s health, regularly return incorrect results that indicate a genetic disorder.
According to the complaint, Myriad’s genetic tests, a type of non-invasive prenatal testing, are worth far less than their market price and, due to the false results, often cause expecting mothers to be unnecessarily subjected to further, “very invasive” diagnostic testing, genetic counseling and even the erroneous termination of a viable pregnancy.
Cited in the filing is a New York Times investigation that found that for every 15 times a non-invasive prenatal screening correctly identified a fetal disorder, the testing is wrong 85 times, meaning that the far majority of all positive results are false positives, the lawsuit states.
“Despite this inaccurate testing, Defendant falsely advertises their findings as reliable, accurate and offering peace of mind for patients regarding the viability of their pregnancies,” the case says. “These false positives can lead to devastating personal consequences and painful decisions that are premised upon this wrong information.”
The lawsuit states that a non-invasive prenatal screening test such as Myriad’s Prequal product analyzes DNA from the blood of a pregnant woman to estimate the risk that a fetus will be born with certain genetic abnormalities. In 2020, Myriad launched its proprietary “Amplify” technology, which the company claimed increased the performance of the Prequel test and thereby reduced the rate of false positive and false negative results, the case says. The NYT investigation, however, has cast substantial doubt on the “highly accurate” Prequel tests and similar products, the suit relays.
In particular, Prequel and other non-invasive prenatal tests are unable to accurately discover microdeletions like the ones Myriad Genetics claims its test can correctly detect, the lawsuit says. According to the case, microdeletions can come with a wide range of symptoms, including intellectual disability, a shortened life span and a high infant mortality rate.
“Consumers are therefore paying hundreds of dollars for testing that is inaccurate and untrustworthy,” the complaint alleges.
The lawsuit looks to cover all persons in the United States who purchased a Prequel prenatal test.
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