Cohen & Malad, LLP class action attorneys are investigating claims that non-invasive prenatal test (NIPT) makers failed to provide accurate data regarding birth defects in unborn babies. A New York Times investigation recently reported an alarming fact – several brands of prenatal NIPT tests returned false positive results 85% of the time. That means expectant parents were incorrectly told their unborn child had a serious genetic condition when, in fact, no genetic problem existed. While these expensive tests were marketed to provide peace of mind, these defective tests had the opposite result. Some experts who spoke with New York Times investigators said that NIPT blood screenings that look for the rarest of conditions are good for little more than bolstering test companies’ bottom lines. Natera, one of the largest NIPT test makers reported revenue of $391 million in 2020 and projects its 2021 revenue will exceed $615 million.
The investigation analyzed NIPT prenatal tests manufactured by Natera, Quest, Labcorp, Roche, and Myriad and found inconsistent reporting by these companies regarding the number of false positive results the tests generated. Some companies provided a handful of data points regarding test efficacy while others offered little to no data regarding the reliability of the test results. Worse, there is little protection for patients as the U.S. Food and Drug Administration does not regulate these tests or the marketing materials these companies provide.
Pregnant women rely on prenatal tests to provide accurate results regarding their unborn baby. False positive results can force patients to make difficult decisions and possibly undergo additional testing that can be both expensive and invasive to their unborn child. Tests can run between a few hundred to a few thousand dollars. If you or someone you know paid for a NIPT prenatal test, contact us. Our class action attorneys would like to gather additional information about the test you paid for and discuss your legal rights and options.