FDA Warns About Genetic Noninvasive Prenatal Screening Tests – Consumer Health News

FRIDAY, April 22, 2022 (HealthDay News) — Noninvasive prenatal screening (NIPS) exams might yield false outcomes or inappropriate interpretations of outcomes, in keeping with a security communication issued by the U.S. Food and Drug Administration. NIPS exams, the FDA warns, should not approved, cleared, or accepted, and the accuracy and efficiency of those exams haven’t been evaluated by the FDA. The FDA says it’s conscious of instances the place a screening check reported a genetic abnormality and a confirmatory diagnostic check later discovered that the fetus was wholesome.The FDA issued the next suggestions: (1) sufferers ought to talk about the advantages and dangers of NIPS exams with a genetic counselor or different well being care supplier earlier than deciding to get these exams; (2) sufferers ought to talk about NIPS check outcomes with a genetic counselor or different well being care supplier earlier than making any selections about their being pregnant; and (3) well being care suppliers ought to concentrate on the dangers and limitations of utilizing these screening exams. Results from NIPS exams alone shouldn’t be used to diagnose fetal chromosomal (genetic) abnormalities or problems, the FDA says.”While genetic NIPS exams are broadly used at present, these exams haven’t been reviewed by the FDA and could also be making claims about their efficiency and use that aren’t based mostly on sound science,” Jeff Shuren, M.D., J.D., director of the FDA Center for Devices and Radiological Health, stated in a press release. “Without correct understanding of how these exams must be used, individuals might make inappropriate well being care selections relating to their being pregnant.” More Information


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