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 NTRAInvitae Corp NVTAMyriad Genetics Inc MYGNAgilent Technologies Inc APerkinElmer Inc PKIIllumina Inc ILMN, and Roche Holdings AG RHHBY.
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