ACOG Statement on FDA Warning on Genetic Non-Invasive Prenatal Screening Tests

Washington, DC – The following is a statement from Christopher Zahn, MD, chief of Clinical Practice and interim chief of Health Equity and Quality for the American College of Obstetricians and Gynecologists (ACOG):

“The American College of Obstetricians and Gynecologists (ACOG) acknowledges the content of the warning issued by the U.S. Food and Drug Administration alerting patients about the risks of inappropriate use and inappropriate interpretation of results from cell-free DNA tests or non-invasive prenatal tests (NIPT) and has incorporated these same issues in its current guidance. It is critical for patients to understand the limitations of these screening tests, the difference between a screening and diagnostic test, and the likelihood of, and risks associated with, false results.

“ACOG’s clinical guidance on NIPT explains the need for nuanced, patient-centered counseling from genetic counselors or obstetric care professionals when making the decision to screen for fetal chromosomal abnormalities. Cell-free DNA is the most sensitive and specific screening test for common fetal aneuploidies; however it is not equivalent to diagnostic testing and has the potential for false-positive and false-negative results.

“The risk of fetal chromosomal abnormalities should be discussed along with the relative benefits and limitations of the available screening and diagnostic tests. When a screen positive test result is obtained, patients should be counseled regarding their revised risk of carrying a fetus with a chromosomal abnormality. Information regarding the characteristics of the condition should be reviewed to aid decision making. Patients with a positive screening test result for fetal aneuploidy should undergo genetic counseling and a comprehensive ultrasound evaluation with an opportunity for diagnostic testing to confirm results. Because of inherent limitations, screening test results should not be used as the sole basis on which to make critical clinical decisions.

“Counseling should be performed in a clear, objective, and nondirective fashion, allowing patients sufficient time to understand and make informed decisions regarding testing. All patients, regardless of maternal age or baseline risk, should be offered both screening and diagnostic tests and all testing for chromosomal abnormalities should be an informed patient choice based on provision of adequate and accurate information, the patient’s clinical context, accessible health care resources, values, interests, and goals.”