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 (NASDAQ:NTRA), Invitae Corp (NYSE:NVTA), Myriad Genetics Inc (NASDAQ:MYGN), Agilent Technologies Inc (NYSE:A), PerkinElmer Inc (NYSE:PKI), Illumina Inc (NASDAQ:ILMN), and Roche Holdings AG (OTC:RHHBY).