The U.S. Food and Drug Administration has requested comments from the public on a proposed Framework for Regulatory Oversite of Laboratory Developed Tests.

The Jerome Lejeune Foundation has a great concern with the lack of oversight of so-called noninvasive prenatal tests (NIPT), a simple blood test given at 10 weeks into a pregnancy that claims near 100% accuracy for the detection of Down syndrome and other disabilities. A recent report published by the New England Center for Investigative Reporting showed the effect these tests are having on families who receive an innacurate positive or negative result. In one report, 22 of 356 women chose to abort on the basis of one these screening tests, encouraged by the claims of their accuracy. In another report from Stanford University, 3 women who chose to abort based on a positive NIPT result later found out their children did not have Down syndrome after all. One had even followed the product recommendation and had an amniocentesis to confirm the result. Her amniocentesis was negative, but she aborted anyway because she couldn't believe the NIPT was wrong.

It is anticipated that the market for NIPT will grow 37.6% annually to a market value of $3.62 billion by 2019. The four companies that manufacture the tests are in constant litigation over patent rights, and yet because of a loophole in federal regulation, laboratory developed tests such as these are currently not required to be regulated by the FDA.

You can follow this link to read our comments that were submitted to the FDA on January 26, 2015.