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Sequenom Collaborates With Obstetrix Medical Group For LDT Validation Study

Sequenom collaborates with Obstetrix Medical Group to provide the Sequenom Center for Molecular Medicine (SCMM) with samples for a study to further evaluate its noninvasive prenatal Down syndrome (Trisomy 21) test. The test is based on its circulating cell-free fetal (ccff) nucleic acid SEQureDx technology. The prospective multi-center feasibility study is entitled Noninvasive Screening for Fetal Aneuploidy: A New Maternal Plasma Marker. It is designed as a Laboratory Developed Test (LDT) validation study and will evaluate up to 5,000 samples. Sequenom to facilitate the LDT validation of the SEQureDx Trisomy 21 Test will be collaborating with physicians practicing as part of Obstetrix as well as other maternal-fetal medicine practices. According to the study protocol, Obstetrix will collect clinical maternal plasma samples before performing an amniocentesis or chorionic villus sampling (CVS) procedure. Then later SCMM will compare results for the detection of Down syndrome using its prototype test of maternal blood samples to the related CVS or amniocentesis results.