NEW YORK (GenomeWeb News) — Maternal fetal medicine company Obstetrix Medical Group will provide Sequenom with samples that it will use to evaluate its prenatal screening test for Down syndrome, Sequenom said today.
The Sequenom Center for Molecular Medicine will evaluate up to 5,000 samples in a multi-center feasibility study for a non-invasive test using a maternal plasma marker. The test will assess Down syndrome using Sequenom's circulating cell-free fetal nucleic acid technology, the SEQureDx Trisomy 21 test.
Sequenom will collaborate with doctors practicing as part of Obstetrix, which is affiliated with Pediatrix Medical Group, to collect clinical maternal plasma samples prior to performing an amniocentesis or chorionic villus sampling procedure. SCMM will compare the results from these tests in order to detect Down syndrome using its prototype test.
“This test could produce results that are more accurate than current early-stage serum screening methods, thus reducing the need for invasive tests, such as amniocentesis or CVS, which pose a certain level of risk for mother and fetus,” Thomas Garite, of Obstetrix Medical Group, who will oversee the study, said in a statement.
Sequenom President and CEO Harry Stylii said the company completed “a rigorous” study over the past year, and it initiated this validation study to “obtain extensive clinical data” to support the program. It also is sponsoring the RNA Noninvasive Aneuploidies study, which is a multi-center prospective investigation involving up to 10,000 samples from first and second trimester pregnancies.