FDA Warns Against Relying On Screening Tests For Prenatal Diagnosis

The U.S. FDA is warning that noninvasive prenatal screening (NIPS) tests may provide false results, such as stating a fetus may have a genetic abnormality when the fetus was healthy.
FDA issues warning on possible false results from noninvasive prenatal screening tests.
The agency noted that these tests, also known as noninvasive prenatal tests (NIPT), have not been approved.
They are designed only to tell the risk of the fetus having certain genetic abnormalities. Diagnostics tests are needed to confirm or deny a suspected abnormality.
The FDA said it is aware of reports of women who ended pregnancies following a genetic prenatal test.
The FDA said it is aware of cases where a screening test reported a genetic abnormality and a confirmatory diagnostic test later found that the fetus was healthy.
Companies offering NIPS/NIPT screenings include Natera Inc NTRA, Invitae Corp NVTA, Myriad Genetics Inc MYGN, Agilent Technologies Inc A, PerkinElmer Inc PKI, Illumina Inc ILMN, and Roche Holdings AG RHHBY.