![]() One described a case in which the follow-up testing revealed the fetus was healthy. Three geneticists recounted more recent examples in interviews with The Times. That same year The Boston Globe quoted a doctor describing three terminations following unconfirmed positive results. A 2014 study found that 6 percent of patients who screened positive obtained an abortion without getting another test to confirm the result. The companies have known for years that the follow-up testing doesn’t always happen. Those tests can cost thousands of dollars, come with a small risk of miscarriage and can’t be performed until later in pregnancy - in some states, past the point where abortions are legal. Patients who receive a positive result are supposed to pursue follow-up testing, which often requires a drawing of amniotic fluid or a sample of placental tissue. “I think the information they provide is misleading,” he said. office that oversees many medical tests, reviewed marketing materials from three testing companies and described them as “problematic.” does not regulate this type of test.Īlberto Gutierrez, the former director of the F.D.A. The Food and Drug Administration often requires evaluations of how frequently other consequential medical tests are right and whether shortfalls are clearly explained to patients and doctors. There are few restrictions on what test makers can offer. “The chance of breast cancer is so low, so why are you doing it? I think it’s purely a marketing thing.” “It’s a little like running mammograms on kids,” said Mary Norton, an obstetrician and geneticist at the University of California, San Francisco. To evaluate the newer tests, The Times interviewed researchers and then combined data from multiple studies to produce the best estimates available of how well the five most common microdeletion tests perform. One large test maker, Natera, said that in 2020 it performed more than 400,000 screenings for one microdeletion - the equivalent of testing roughly 10 percent of pregnant women in America. Most test makers don’t say how often their microdeletion tests are being performed.īut it is clear some of the tests are in widespread use. Not every patient is screened for every condition doctors decide what to order, and most companies sell microdeletion testing as an optional add-on to the Down screening. They can have a wide range of symptoms, including intellectual disability, heart defects, a shortened life span or a high infant mortality rate. ![]() Others stem from missing or extra copies of entire chromosomes. ![]() Most are caused by small missing pieces of chromosomes called microdeletions. However, the same technology - known as noninvasive prenatal testing, or NIPT - performs much worse when it looks for less common conditions. Experts say it has revolutionized Down syndrome screening, significantly reducing the need for riskier tests. In contrast with Theranos, the science behind these companies’ ability to test blood for common disorders is not in question. ![]()
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