A proposed class action alleges Natera’s prenatal tests are not as reliable as the company claims.
The 22-page lawsuit alleges Natera has known for years that its non-invasive prenatal tests, which are touted as able to detect chromosomal disorders in a fetus, are susceptible to false positives, yet has continued to promote the tests as accurate. The complaint also alleges Natera claims that its non-invasive prenatal tests produce fewer false positives than competing products while failing to reveal the extent to which pregnant women and their doctors may be induced to make health decisions based on inaccurate test results.
The case stresses that a false positive on a prenatal test can cause expecting parents to experience unnecessary anxiety and anguish about their child’s health and potentially make decisions based on inaccurate data. Moreover, Natera prenatal screening test users may incur additional medical costs related to further diagnostic testing, which can be more invasive and dangerous to an unborn fetus, the suit adds.
Cited in the complaint is a January 2022 New York Times report that found that positive prenatal test results for rare genetic conditions are incorrect 85 percent of the time or more.
According to the suit, Natera processes upward of 400,000 non-invasive prenatal tests each year, equating to roughly one test for every 10 pregnant women in the United States. When a prenatal screening test provides accurate information, it can reveal whether a pregnancy is non-viable or whether the newborn may have structural abnormalities, intellectual disabilities or a shortened lifespan, the case relays. Per the suit, a screening test differs from a diagnostic test in that it is far less invasive, requiring only a blood sample, and can be performed at a much earlier stage in pregnancy.
“A pregnant patient whose child has one of these conditions faces serious questions about risks in continuing the pregnancy, the viability of the pregnancy, and the prognosis and quality of life for any surviving newborn,” the complaint states. “Some patients choose to terminate a pregnancy that has chromosomal abnormalities.”
Although Natera has marketed its prenatal screening tests to patients and doctors as the “most rigorously validated” non-invasive prenatal tests and offering “greater accuracy,” among other representations, the products are among those at the center of the NYT investigation released earlier this year.
The lawsuit looks to represent all purchasers of Natera’s non-invasive prenatal testing services, including consumers who paid out-of-pocket, through health insurance or through any other collateral source.
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