Anne Bucher  |  February 23, 2022

Category: Legal News

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In this photo illustration a Natera logo seen displayed on a smartphone
( Photo Credit: rafapress/ Shutterstock)

Natera Prenatal Test Class Action Lawsuit Overview:

  • Who: Plaintiff Amanda Davis has filed a class action lawsuit against Natera Inc.
  • Why: The Natera noninvasive prenatal tests are allegedly unreliable and show healthy fetuses as having serious disorders.
  • Where: The lawsuit was filed in California federal court.

Natera Inc. is facing a class action lawsuit alleging its noninvasive prenatal tests, or NIPTs, are unreliable and falsely show healthy fetuses as having serious birth defects, according to a class action lawsuit filed Feb. 17 in California federal court.

Prenatal testing is often used to determine whether a fetus has a chromosomal disorder that may be linked to shortened lifespans, intellectual disabilities or other serious complications. Based on the results of these tests, expectant mothers may choose to make potentially life-altering decisions, including deciding whether to terminate the pregnancy.

Diagnostic testing such as amniocentesis is highly invasive, whereas NIPTs require only a blood sample and can be conducted much earlier during a pregnancy.

Plaintiff Amanda Davis alleges Natera has known for years that its NIPT tests are prone to false positives but continues to market the tests as a reliable detector of rare chromosomal abnormalities.

Specifically, Natera markets its Panorama NIPT as “overall the most accurate NIPT commercially available in the United States,” according to the class action lawsuit. Natera also allegedly touts that its NIPT test produces fewer false positives than other prenatal tests.

The Natera NIPT tests are generally effective at screening for Down syndrome, according to the lawsuit. However, a January 2022 investigation by the New York Times allegedly found that positive test results for some rare genetic conditions are incorrect more than 85% of the time. 

Natera False Positives May Lead Parents to Make Life-Altering Decisions

False positives on prenatal tests can have significant consequences for expecting parents, the Natera class action lawsuit says. Not only do they cause stress and anxiety about the health of their baby, but the pregnant woman will also likely be subjected to invasive diagnostic testing, genetic counseling and consultations regarding high-risk pregnancies.

Because NIPT testing is often completed early in the pregnancy, diagnostic testing is not always available immediately to confirm the results. In some cases, diagnostic testing may not be an option until after the period in which a pregnancy may be legally terminated. In these situations, parents may be forced to rely exclusively on the results of the NIPT testing to decide whether or not to proceed with the pregnancy

Unfortunately, the New York Times reports that some women have terminated a viable pregnancy based on a false positive from NIPT testing.

According to the prenatal testing class action lawsuit, Natera tests approximately one in 10 pregnant women in the United States. 

“Each patient is led to believe that they will receive accurate results,” the class action lawsuit says. “Users of Natera’s NIPT test, however, have not received what they paid for given the numerous problems that have come to light and many–including Plaintiff–have been subjected to unnecessary stress and anxiety, and additional medical costs due to false positive indications of rare disorders.”

Davis filed the Natera class action lawsuit on behalf of herself and a proposed class of purchasers of Natera’s NIPT testing services.

What do you think about the claims that Natera prenatal tests are incorrect 85% of the time for some genetic conditions? Join the discussion in the comments below!

Davis is represented by Adam E. Polk, Trevor T. Tan and Nina R. Gliozzo of Girard Sharp LLP.

The Natera Prenatal Defect Test Class Action Lawsuit is Amanda Davis v. Natera Inc., Case No. 3:22-cv-00985-AGT, in the U.S. District Court for the Northern District of California.


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8 thoughts onNatera Class Action Says Prenatal Tests Give False Positives

  1. Caitlin Ross says:

    I did the Natera NIPT and my daughter was flagged high risk for Monosomy X, Turners syndrome. I did an amniocentesis because I wanted to get specialists picked out if she needed them. The NIPT was wrong per amniocentesis. She does not have Turners syndrome and is a completely normal/healthy almost two year old. During my experience with Natera, the genetic counselors speak to you as if its a fact your child has the disorder because their lucrative test flags your child as high risk. They did not admit there was a high chance of getting a false positive result. It was absolutely awful-the emotional distress, the entire experience, everything about it. I will never ever do a NIPT/NIPS again.

  2. Chelsey says:

    I’ve been through hell with the NIPT testing. I wanted to know the sex, and with that came some genetic testing. I was never told they weren’t reliable, just that it’s better to know etc. so I moved forward thinking it was a legit test. A week went by, I found out I was having a girl … and she had a 78 percent chance of having turners. Reluctant to get the amniocentesis (because of the risk of miscarriage), I asked for another test with a different lab (not knowing both labs are in bed with each other), and I got back an inconclusive. I was then sent to talk to a genetic counselor who knew nothing about turners except the baby would have a 2 percent chance of surviving pregnancy.
    I decided to try again on the blood test, if positive I would do aminocentisis if negative I would move on. Final test came back positive! Next day I did the aminocentisis by myself (partner was out of town), I was so terrified I almost passed out and then spent the next three days in bed crying my eyes out preparing to abort my baby. I was about 2 weeks from the “cut off time”. Absolutely horrible.

    I then got a call from my doctor and they said, looks like you’re all in the clear. She’s negative for turners syndrome.

    Look I’m happy. But I should of never of been put through this roller coaster, I had a baby who was totally normal and healthy. Even her sonorgrams were perfect but they still insisted I move forward with the procedure which could of killed my baby.

    These tests need to be pulled off the market. I’m fighting for the women who don’t have the 5-7k to do the aminocentiis and end up aborting a perfectly fine baby. I’m fighting for women to be able to enjoy their pregnancy instead of holding back announcing their Baby, and spend all their time googling rare disorders.

    This is a scam. And this needs to end.

  3. Ashley Jones says:

    I was harassed my my Dr and a certain nurse after signing a paper stating I did not want genetic testing. Was asked 7 times and told how important it was. That if something was wrong I might want to abort( their words). Ended up getting the non invasive. Results came back high . They scheduled amnio( to be sure) because I’m their piv I could abort if something was wrong ( atthistimei did Not believe in abortion. So had an amniocentesis, which caused a slow leak ended up having g my daughter at 23 weeks. She survived! Now is 10. Such hell I went through. Oh yeah . The first test was a FALSE positive and didn’t get results back in time enough to abort if I had wanted too. Such bullshit and lies.

  4. Jodee fisk says:

    What about the prenatal paternity tests? Are these equally unreliable? I just got one that only has the final page of the report. It doesn’t show any of the lab work or genetic markers. Nothing but the interpretation was sent to me. They said that they get rid of files x amount of time old so I had to get the result and they didn’t even send the whole thing. Their website also says that you get results for prenatal tests in “different ways” than the regular paternity tests and to call a number to understand your results. Should I be concerned this test is invalid ?

  5. Taylor says:

    This company has flagged me for having a 68% chance of my baby girl having trisomy 13, the ultrasound findings of my baby aren’t consistent with this particular genetic abnormality, my high risk doctor wants to believe this is a false positive and if it is I’m going to be very upset that I am sitting here crying my eyes out wondering how much time I’ll get with my daughter.

    1. Heather Long says:

      What ever happened?? I literally just received the same result yesterday. Were you okay?? I am meeting with the genetics specialist tomorrow. I am also 68%. That seems odd??

  6. Anni says:

    The results are very generic and generalized. The notation of singleton/twins is not determine via blood sample. The emotional rollercoaster we went on as a result of their generalized results should not be allowed to continue.

  7. Heather says:

    Add me

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