“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. Some said the blood screenings that look for the rarest conditions are good for little more than bolstering testing companies’ bottom lines. 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. Years before the first prenatal testing company opened, another start-up, Theranos, made claims that it could run more than a thousand tests on a tiny blood sample, before it collapsed amid allegations of fraud. This isn’t the first time Silicon Valley technology has been used to build a business around blood tests. Others base their claims on studies in which only one or two pregnancies actually had the condition in question. Some of the companies offer tests without publishing any data on how well they perform, or point to numbers for their best screenings while leaving out weaker ones.
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