NTRA - FDA issues warning on potential false results from noninvasive prenatal screening tests
The U.S. FDA is warning that non-invasive prenatal screening (NIPS) tests may provide false results, such as stating a fetus may have a genetic abnormality when in actuality the fetus was healthy. The agency noted that these tests, which are also known as noninvasive prenatal tests (NIPT), have not been approved, adding they are designed to inform an individual of the risk of an abnormality. 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 the results of a genetic prenatal test. Many companies offer NIPS/NIPT screenings. They include Natera (NTRA), Invitae (NYSE:NVTA), Myriad Genetics (MYGN), Agilent Technologies (NYSE:A), PerkinElmer (PKI), Illumina (NASDAQ:ILMN), and Roche (OTCQX:RHHBY). Seeking Alpha's Quant Rating views Natera (NTRA) as a strong sell.
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FDA issues warning on potential false results from noninvasive prenatal screening tests