ACLA Statement on Clinical Use of Non-invasive Prenatal Screenings (NIPS)

April 20, 2022 Categories: ACLA News, ACLA Press Releases, Regulatory Issues

Washington, D.C. – In response to recent interest in non-invasive prenatal screenings (NIPS) and their use by patients and health care providers, ACLA has issued the following statement:

“Health care providers rely on a variety of tools to help guide them through the diagnostic process. Screenings are used throughout a patient’s lifetime to detect potential health conditions, even if the patient currently is not exhibiting any symptoms of disease. A screening test provides information about the chance a person may be affected with a condition, whereas diagnostic tests are used to confirm the presence or absence of a condition.

NIPS is a screening test, not a diagnostic test, and does not provide definitive results for any genetic condition. NIPS is a non-invasive method to provide a preliminary assessment of potential risk for certain health issues and is not equivalent to, nor intended to be used as, a diagnostic test for specific fetal conditions. Ultimately, choices about prenatal screening are made by patients in close consultation with their health care provider.

The results of these screening tests can help health care providers including genetic counselors develop appropriate medical management plans with their patients. Chromosomal abnormalities can have profound consequences on the life and health of a child. Detecting this information early on in pregnancy can help families prepare and allow health care providers to recommend specialized care, before and after delivery.”

For more information on NIPS, you can see a fact sheet here on ACLA’s website.


The American Clinical Laboratory Association (ACLA) is the national trade association representing leading laboratories that deliver essential diagnostic health information to patients and providers. ACLA members are at the forefront of driving diagnostic innovation to meet the country’s evolving health care needs and provide vital clinical laboratory tests that identify and prevent infectious, acute and chronic disease. ACLA works to advance the next generation of health care delivery through policies that expand access to lifesaving testing services.

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