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Natera Prenatal Tests High Rate of False Positives Class Action

Natera, Inc. offers noninvasive prenatal tests (NIPTs) that can help alert pregnant women to chromosomal disorders in the fetus, such as Down syndrome. Natera advertises these tests as being the most reliable available. But the complaint for this class action alleges that Natera’s tests, while effective for screening for Down syndrome, give a high number of false positives for other conditions. The complaint alleges they are “incorrect 85 percent of the time or more—up to 98 percent.”

The class for this action is all those who bought Natera’s NIPT testing services, including consumers who paid out-of-pocket, through health insurance, or throught any other collateral source. An Ohio subclass has also been defined, for those in the above class who bought Natera’s testing services in Ohio.

Prenatal tests are meant to identify disorders in the fetus, which can have serious consequences, such as mental disability, a short life, and other problems.

The complaint quotes Natera as saying that its Panorama NIPT test is “the most reliable way of noninvasively assessing a baby’s health” and that Panorama is “overall the most accurate NIPT commercially available in the United States.” Natera’s website, the complaint claims, calls the test “the most rigorously validated NIPT” and says its tests are “validated with >99% sensitivity & specificity.”

When a test comes back positive, expecting parents must decide what to do, the complaint alleges, including have invasive further tests, getting counseling, and consulting with doctors who know about high-risk pregnancies. According to the complaint, NIPT testing is done early in a pregnancy, meaning that follow-up tests may not be available immediately to confirm the results.

The complaint alleges, “In some states, diagnostic testing may not become available until after the period when a pregnancy may be legally terminated, meaning some expectant parents must rely entirely on the results of the NIPT testing to make an extremely difficult decision on whether to proceed with the pregnancy.”

In addition, the complaint claims, “even if it is available, follow-up testing is highly invasive and carries the risk of causing a miscarriage.”

While Natera does well in screening for Down syndrome, the complaint alleges, “there is a precipitous drop in the positive predictive value of NIPT.”

According to the complaint, a January 2022 New York Times investigation “reported widespread misrepresentations on the accuracy of NIPT. The Times’ analysis found that positive results from tests screening for rare chromosomal microdeletion disorders such as DiGeorge and Prader-Willi syndromes were incorrect approximately 85% of the time.”

The Food and Drug Administration (FDA) does not regulate NIPTs. The Times quoted a former FDA official who reviewed marketing from three companies as saying that the materials were “problematic.” The complaint says, “According to the New York Times investigation, some expectant mothers have even terminated a viable pregnancy based on a false positive from NIPT testing.”

The counts include fraudulent concealment, breach of implied warranty, and unjust enrichment.

Article Type: Lawsuit
Topic: Consumer

Most Recent Case Event

Natera Prenatal Tests High Rate of False Positives Complaint

February 17, 2022

Natera, Inc. offers noninvasive prenatal tests (NIPTs) that can help alert pregnant women to chromosomal disorders in the fetus, such as Down syndrome. Natera advertises these tests as being the most reliable available. But the complaint for this class action alleges that Natera’s tests, while effective for screening for Down syndrome, give a high number of false positives for other conditions. The complaint alleges they are “incorrect 85 percent of the time or more—up to 98 percent.”

Natera Prenatal Tests High Rate of False Positives Complaint

Case Event History

Natera Prenatal Tests High Rate of False Positives Complaint

February 17, 2022

Natera, Inc. offers noninvasive prenatal tests (NIPTs) that can help alert pregnant women to chromosomal disorders in the fetus, such as Down syndrome. Natera advertises these tests as being the most reliable available. But the complaint for this class action alleges that Natera’s tests, while effective for screening for Down syndrome, give a high number of false positives for other conditions. The complaint alleges they are “incorrect 85 percent of the time or more—up to 98 percent.”

Natera Prenatal Tests High Rate of False Positives Complaint
Tags: Deceptive Advertising, Fraudulent Concealment, Unjust Enrichment