New Tool: ProSource
Check out our packaging and processing solutions finder, ProSource.

FDA to Regulate Prenatal Tests

New regulations are in the works as the FDA seeks to address issues with concerns over false positives.

Daniel Reche
Daniel Reche via Pexels

A recent New York Times article said the FDA plans to regulate the prenatal testing market amid concerns about false positive results and potentially misleading marketing. The regulations would target noninvasive prenatal tests that use a small blood sample to screen for genetic abnormalities during the first trimester. While these tests are accurate for common genetic disorders like Down syndrome, they often provide incorrect positive results for rare abnormalities. 

The misleading language used by companies to describe the tests can lead to significant distress for parents and even result in the termination of pregnancies based on false positives. The FDA's concerns extend beyond prenatal screenings and include tests for heart disease and autism that may lead to improper treatments. The agency aims to address these issues through new regulations and a pilot program for laboratory-developed tests used in cancer drug trials. However, legal challenges from test manufacturers who dispute the FDA's authority to regulate such products are expected.

Discover Our Content Hub
Access Healthcare Packaging's free educational content library!
Read More
Discover Our Content Hub
Test Your Supply Chain Smarts
Take Healthcare Packaging's supply chain quiz to prove your knowledge!
Read More
Test Your Supply Chain Smarts