The US Food and Drug Administration (FDA) wants to clarify rules to make it explicit that all laboratory-developed tests are within its jurisdiction, the New York Times reports.
Non-invasive prenatal testing (NIPT) is used by a third of pregnant women in the USA, but some test results, or the way they are marketed can mislead patients.
The NHS offers NIPT as part of its prenatal screening programme for pregnancies at higher risk of trisomies, but patients are advised that a positive result is not diagnostic and should be confirmed using either amniocentesis or chorionic villus sampling (CVS).
