Screening tests that use human genome sequencing technology to detect the health of fetuses have been a booming business for years and have led pregnant women and their doctors to make some very difficult decisions. The tests are more accurate than traditional blood tests and ultrasounds, but they’re not as accurate as they have been billed, according to the New England Center for Investigative Reporting, which published the findings of a three-month investigation into the tests this weekend at the Boston Globe.
“There is a crucial difference between a test that can detect a potential problem and one reliable enough to diagnose a life-threatening condition for certain. The screening test only does the first,” wrote the Center’s Beth Daley in her report.
Daley says the manufacturers of the tests are overselling the accuracy of their product and “doing little to educate expecting parents or their doctors about the significant risks of false alarms.”
She continues: [blockquote]Two recent industry-funded studies show that test results indicating a fetus is at high risk for a chromosomal condition can be a false alarm half of the time. And the rate of false alarms goes up the more rare the condition…
The [tests] are not subject to approval by the Food and Drug Administration. Because of a regulatory loophole, the companies operate free of agency oversight and the kind of independent analysis that would validate their accuracy claims. Doctors often get that information from salespeople[/blockquote]
It’s another chilling tale of the power the medical-industrial complex exerts in shaping our most intimate decisions and the crucial role oversight plays in protecting the public interest.
A fight to boost regulation on the tests is ongoing. Meantime, doctors say patients should seek out counseling on the genetic prenatal screenings, how they work, what they mean and how to interpret the results.
Read the whole story at the New England Center for Investigative Reporting.