Sequenom, Inc. has 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® system and SEQureDx™ 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).
"We are combining the expertise of Baylor College of Medicine's Genetics Laboratory with the medical and research focus of the NAFTNet organization's multi-center members to demonstrate our SEQureDx RhD Genotype System's effectiveness as a clinical model for future noninvasive prenatal tests currently in development by our organization," stated Harry Stylli, PhD., President and Chief Executive Officer of Sequenom.
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."
Sequenom Noninvasive Prenatal Diagnostics Sequenom holds exclusive worldwide license rights to develop and commercialize noninvasive prenatal tests for genetic screening and diagnostic testing, including genetic expression and epigenetic-based assays and tests, using free fetal nucleic acids from maternal serum or plasma.
Sequenom's license rights are platform independent, allowing for development of noninvasive prenatal screens and tests using the Company's MassARRAY platform or other systems the Company deems appropriate.