Some non-invasive prenatal tests (NIPT) to screen for genetic abnormalities in the fetus may generate false results, and should not be used for diagnostic purposes, the US Food and Drug Administration (FDA) warned on Tuesday.
The growing – and sometimes inappropriate – use of these tests prompted the warning, according to FDA.
These tests, which fall under the category of laboratory-developed tests (LDTs), are not subject to premarket review by FDA and are accorded enforcement discretion under the Medical Device Amendments of 1976.
“While genetic non-invasive prenatal screening tests are widely used today, these tests have not been reviewed by the FDA and may be making claims about their performance and use that are not based on sound science,” said Jeff Shuren, director of the FDA Center for Devices and Radiological Health (CDRH). “Without proper understanding of how tests should be used, people may make inappropriate health care decisions regarding their pregnancy. We strongly urge patients to discuss the benefit and risk of these tests with a genetic counselor or other health care providers prior to making decisions based on the results of these tests.”…
