- 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.
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