Aggregated News
NEW YORK (GenomeWeb) – Results from an undercover performance test of five commercial noninvasive prenatal testing laboratories suggest a need for better quality standards, as three of the labs reported normal results in samples from women who were not even pregnant.
The assessment, which involved just two samples and was conducted by Tamara Takoudes and Benjamin Hamar, maternal-fetal medicine specialists based in Massachusetts, was reported in a Letter to the Editor in Ultrasound in Obstetrics & Gynecology this week. One of the commercial testing labs, Ariosa Diagnostics, provided financial support for the study but its laboratory was not informed about the samples it received.
Critics have called the study flawed because it used samples from women who were not pregnant, subjects they said the tests are not designed to analyze.
All NIPT relies on the presence of cell-free fetal DNA in the mother's blood, though companies differ in how they measure and analyze the DNA to find chromosomal abnormalities, such as trisomies or microdeletions.
The relative amount of free fetal DNA compared to maternal DNA, called fetal fraction...