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Natera Hit With Multiple Class Action Suits Over 'Unreliable' NIPT Results

NEW YORK – Natera is facing two new class action suits, which allege damages suffered due to results returned by the company's Panorama noninvasive prenatal testing assay.

In a complaint filed Thursday in the US District Court for the Northern District of California, plaintiff Amanda Law alleged that Natera "falsely advertises their findings as reliable, accurate and offering peace of mind for patients regarding the viability of their pregnancies. These false positives can lead to devastating personal consequences and painful decisions that are premised upon this wrong information."

The complaint alleged that Natera also engaged in deceptive and unfair business practices, among other claims.

In a separate suit filed last week in the same court, plaintiff Amanda Davis alleged that "Natera marketed and sold Panorama NIPT tests that it knew to be unreliable and failed to take sufficient steps to ensure the reliability of such tests" and that it "made misleading partial representations and did not fully and truthfully disclose to its customers and their physicians that its NIPT tests cannot accurately and reliably detect rare disorders such as DiGeorge syndrome."

In a statement, Natera said, "We believe the complaints' allegations are meritless. We intend to vigorously defend our company in this matter and believe we will prevail, should this case proceed.

"Natera is proud of the performance of its tests, which have been the subject of over 100 published, peer reviewed publications," the Austin, Texas-based firm added. "For our NIPT, we offer complimentary information sessions with board-certified genetic counselors, both pre- and post-test. Our test report is explicit that our NIPT is a screening test rather than a diagnostic, and includes our performance data, with citations to the published, peer-reviewed source."

Both lawsuits referenced a recent story in the New York Times about high incidence of incorrect results for rarer chromosomal abnormalities found with NIPT, especially microdeletions. The story identified Natera, as well as Laboratory Corporation of America and Quest Diagnostics, as NIPT providers.

The complaints follow a class action suit filed against Natera in November, alleging deceptive and unfair billing practices for NIPT and carrier genetic screening tests.

Law claimed she paid for the Panorama test out of pocket because it was not covered by her insurance. "The results showed a 'High Risk' for Triploidy, Trisomy 18, or Trisomy 13," the complaint said. "Due to the 'High Risk' finding, Plaintiff suffered emotional distress, stress, and anxiety throughout her pregnancy. Plaintiff ultimately gave birth to a healthy baby girl who did not suffer from any chromosomal abnormalities."

Law alleged that "she would not have purchased the Panorama test on the same terms had she known that Defendant’s representations about accuracy and trustworthiness were not true, or at least would have paid significantly less for the Panorama Test."

Similarly, Davis alleged that her Panorama results showed an "atypical finding," which led her to make "extra medical appointments with a high-risk pregnancy specialist doctor."

Davis alleged she paid approximately $3,000 out of pocket for these additional doctors' appointments as well as approximately $100 out of pocket for the portion of the Natera test not covered by insurance. She eventually gave birth to a healthy baby.

Both plaintiffs asked the court to certify class as defined in the respective complaints, to award damages and attorneys' fees, and to order jury trials. Law's complaint also suggested she would pursue an injunction from the court "requiring Defendant to stop advertising, and to instruct its resellers to stop advertising, any NIPT test as being highly accurate."