Sequenom and NAFTNet to Conduct Fetal Rhesus D Study in Collaboration with Baylor College of Medicine
Sequenom, Inc. announced that the Company will conduct a multi-center fetal Rhesus D (RhD) genotype study at centers affiliated with the North American Fetal Therapy Network (NAFTNet), a nonprofit research network with expertise in the care for pregnancies at high risk of complex fetal disorders. RhD testing will be conducted at Baylor College of medicine, Medical genetics Laboratory using a Laboratory Developed Test (LDT) with Sequenom's MassARRAY(R) system and SEQureDx(TM) Technology.
The prospective, multi-center study, which will enroll 550 pregnant women who are RhD negative, has two primary goals. First, Baylor College of Medicine intends to use Sequenom's SEQureDx Technology to validate its LDT assay for RhD for use as a clinical service offering. Second, samples collected from this study will later be used in clinical studies to support Sequenom's planned regulatory application to the U.S. Food and Drug Administration (FDA).
The study's principal investigator, Dr. Kenneth Moise, Professor of Obstetrics and Gynecology and Director of the Division of Maternal-Fetal Medicine at Baylor College of Medicine in Houston, commented, "This study will initially involve the enrollment of RhD-negative pregnant women from eight to 10 member institutions throughout the NAFTNet system. The ability to make an early diagnosis is the key that opens the door for the treatment of RhD incompatibility and other birth defects before a child is born."
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