Sunday, January 23, 2022

Go read this NYT investigation on the inaccuracy of prenatal blood tests

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Blood tests on pregnant folks that search for uncommon and devastating developmental circumstances in fetuses are sometimes fallacious, in response to an investigation from The New York Times.

The blood testing expertise, referred to as noninvasive prenatal testing (NIPT), works very nicely for extra widespread issues like Down syndrome. But The New York Times reported {that a} overview of information from a number of research confirmed that when NIPT is used to check for unusual issues like Wolf-Hirschhorn syndrome (which is present in one in 20,000 births) or Cri-du-chat syndrome (which is present in one in 15,000 births), constructive outcomes are fallacious 80 p.c of the time or extra.

These tests, made by corporations like Natera and Sequenom, have develop into extra common in recent times. Estimates of the dimension of the market method billions of {dollars}. Positive outcomes on the tests are alleged to set off extra intensive (and correct) follow-up testing, however these tests are costly, invasive, and infrequently can’t be finished till it might be too late for a authorized abortion. Many sufferers don’t find yourself getting these follow-up tests, and a few terminate pregnancies based mostly on the preliminary info.

The investigation highlights the statistical problem of testing for issues which are extraordinarily uncommon. Even a check that’s extremely correct would nonetheless discover tons of false positives if it was used on 1000’s of individuals to attempt to discover a situation that’s solely really there .005 p.c of the time (like Wolf-Hirschhorn syndrome). It’s very tough to create tests for uncommon circumstances which are so good that they received’t have a excessive quantity of false positives.

But, as The New York Times reporting discovered, that challenge wasn’t adequately defined to sufferers who have been bought the tests. Companies growing NIPTs used language like “highly accurate” and “total confidence.” Many corporations didn’t publish information on their tests’ efficiency total, or solely pressured information from tests which are extra correct. “I think the information they provide is misleading,” Alberto Gutierrez, the former director of a Food and Drug Administration (FDA) workplace overseeing medical tests, informed The New York Times.

Many NIPTs don’t need to be cleared or reviewed by the FDA earlier than they’re used for sufferers — they fall underneath a class referred to as lab-developed tests, that are in a position to skirt some regulatory oversight. Despite the lack of scrutiny, they’re in a position to promote to sufferers and tout the restricted information they’ve in advertising supplies, even when it’s deceptive.

Read the full investigation right here.

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