Noninvasive prenatal tests (NIPTs) have taken a lot of flak recently and now a new report is throwing more dirt on the marketing side of these tests. The Hastings Center Report study, released on March 9, assessed all English-language brochures for consumers of NIPTs that could be found, concluding that the information they contain “substantiate[s] concerns about bias and inaccuracy in the promotion of these screening tests.”
NIPTs are screening tests used to determine the chance a baby will be born with specific genetic abnormalities, and accuracy varies with the condition they are predicting. Women receiving a “high-risk” result can go on to have further diagnostic testing to confirm these screening results, though these methods are more invasive and do carry a small risk of miscarriage.
For their study, the authors compared the material found in the brochures to guidance produced by the Nuffield Council on Bioethics on how information about NIPTs should be communicated. When communicated poorly, information about NIPTs can damage the ability of consumers to make informed decisions, the authors state.
After comparing the brochures to recommendations from the council on how to properly market NIPTs, the authors found:
- None of the material studied followed all of the Nuffield Council on Bioethics’ recommendations
- Over half of the brochures incorrectly described NIPTs as diagnostic tests, rather than screening tests, which may cause some women to terminate their pregnancies based only on results from their NIPT
- Companies didn’t supply evidence to support claims about test performance
- Much of the information presented consumers’ own health care providers as authorities on NIPTs—an issue because research shows physician knowledge of these tests is limited and evidence exists that some physician-researchers have been paid by NIPT companies to do validation studies on their tests, raising conflict of interest issues
This isn’t the only time NIPTs have come under fire. Most recently, a January 2022 New York Times (NYT) story highlighted that the true accuracy of these tests often doesn’t match manufacturer claims, leading women to get unnecessary, invasive follow-up tests and causing them additional stress. Natera, one NIPT manufacturer whose Panorama NIPT was included in the NYT article, is now facing two class-action lawsuits related to the marketing of that test and its stock has nosedived as a result.
Noting that the marketing of NIPTs is not currently regulated, the authors of the Hastings Center Report study stress the continued need for such oversight, and until that goal is realized, it is important for both consumers and physicians to look at marketing materials from these companies with a critical eye.