SAN FRANCISCO (CN) — A genetic testing company’s “highly accurate” prenatal tests give false positives about 85% of the time, causing pregnant women to suffer anxiety, endure invasive exams and sometimes end their pregnancies for no reason, according to a federal lawsuit filed Friday.
The proposed class action claims Salt Lake City-based Myriad Genetics has deceptively marketed its Prequel Prenatal Screen tests as reliable, even though a recent New York Times investigation found 85 false positives in a review of 100 positive tests.
“Defendant is a national genetics laboratory that specializes in genetic testing and therefore knew the tests would provide an unnecessarily high number of false positive results,” the lawsuit states. “Nonetheless, defendant continued to sell its worthless tests to unsuspecting consumers.”
Named plaintiff Ashley Carroll of Menlo Park, California, paid $295 out of pocket for a Prequel test. When making the purchase, Carroll said she relied on Myriad’s representations that the test “has the lowest test failure rate in the industry” and that it “reduces the chances you’ll need an unnecessary invasive follow-up test,” according to her 23-page complaint.
But false positives had led many women to undergo additional invasive tests such as amniocentesis, which involves using a needle to remove amniotic fluid from the uterus. Another procedure called CVS requires a catheter or needle to extract placental cells that contain the same genetic material as the fetus. Both tests can slightly increase the risk of miscarriage, according to the Mayo Clinic.
Some women have also chosen to end their pregnancies after getting potentially inaccurate positive test results, according to the lawsuit. Six percent of patients who tested positive for potential genetic abnormalities chose abortion without undergoing additional testing, according to a 2014 study in the American Journal of Obstetrics & Gynecology.
Like other companies that offer noninvasive tests to identify potential genetic disorders, Prequel screens fetal DNA in maternal blood and looks for missing pieces of chromosomes and other abnormalities that can cause conditions like Down syndrome or Edwards syndrome.
According to a New York Times report published last month, Myriad removed language from its website that advertised “total confidence in every result” after the Times inquired about the accuracy of its tests.
The lawsuit filed Friday seeks punitive damages for false advertising, fraud, unjust enrichment, breach of warranty and violations of California consumer protection laws. It also seeks a court order to require Myriad stop advertising its prenatal tests as “highly accurate.”
Timothy Fisher of Bursor & Fisher in Walnut Creek, California, represents Carroll and the proposed plaintiff class.
Myriad spokeswoman Megan Manzari said the company would not comment on pending litigation.
This isn’t the first time a biotechnology company has faced legal trouble over allegedly false statements regarding the accuracy of medical tests. A federal jury recently found Theranos founder Elizabeth Holmes guilty of four counts of fraud and criminal conspiracy for deceiving investors and the public about the accuracy of her company’s revolutionary mobile blood tests.
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