Skip to main content
Premium Trial:

Request an Annual Quote

More NIPT Data Needed

Better oversight of noninvasive prenatal genetic screens is needed, according to an editorial appearing in Scientific American.

The editors there say that regulation hasn't kept up with technological advances. They note that genetic screens such as the ones from Ariosa, Progenity, and Sequenom and are considered lab tests and, because of that, their makers only have to show that the results they give fall within a certain accepted errors range. The screens don't, they add, have to show that their results are clinically meaningful.

Such standards, the editorial argues, may have been OK when blood tests mostly measured individual compounds, but genetic tests that rely on significant DNA amplification and cast a wide net are a bit more complicated than that.

Because of that, the Scientific American editors argue that the US Food and Drug Administration should alter the rules so that test makers have to provide more clinically oriented data, such as the tests' predictive values. At the same time, they add that the companies that make noninvasive prenatal screens should better explain to patients the possible downsides to such testing.

"And expectant parents should think carefully about whether they want to undergo these screenings in the first place, particularly because new blood tests that supposedly provide a glimpse into the entire fetal genome — including possible predispositions to heart disease, cancer or diabetes — are just around the corner," the editorial adds.