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Evaluating Expanded Noninvasive Prenatal Screening.

Michelle J Bayefsky1, Arthur L Caplan, Iffath A Hoskins

  • 1Department of Obstetrics & Gynecology, NYU Langone Health, and the Division of Medical Ethics, NYU Grossman School of Medicine, New York, New York.

Obstetrics and Gynecology
|June 8, 2022
PubMed
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Noninvasive prenatal screening (NIPS) for rare genetic conditions is widely available but has low positive predictive value. Public health criteria should assess NIPS risks and benefits before widespread adoption.

Area of Science:

  • Genetics
  • Public Health
  • Medical Screening

Background:

  • Commercial noninvasive prenatal screening (NIPS) for rare genetic conditions is increasingly available.
  • Concerns exist regarding the low positive predictive value (PPV) of these tests.
  • Patient education on screening versus diagnostic testing is crucial for managing false-positive results.

Purpose of the Study:

  • To evaluate the readiness of expanded noninvasive prenatal screening as a public health tool.
  • To advocate for the application of established public health criteria to NIPS.
  • To address the need for regulation of NIPS accuracy and marketing claims.

Main Methods:

  • Review of public health criteria for screening tools.
  • Analysis of the risks and benefits of expanded noninvasive prenatal screening.

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  • Assessment of current commercial NIPS against established standards.

    • Main Results:

    • Expanded noninvasive prenatal screening may not meet established public health criteria for screening tools.
    • The low PPV of NIPS raises concerns about its suitability for widespread screening.
    • Current promotional claims and accuracy may require regulatory oversight.

    Conclusions:

    • Noninvasive prenatal screening requires rigorous evaluation using public health standards before widespread implementation.
    • Governmental agencies should consider regulating the accuracy and marketing of commercial NIPS.
    • Ensuring NIPS meets established benchmarks is vital for patient safety and effective healthcare.