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Sequenom, NAFTNet Studying Rhesus D Test

NEW YORK (GenomeWeb News) – Sequenom will evaluate its Rhesus D genotype test in a multi-center study conducted at North American Fetal Therapy Network centers, the company announced today.
The company plans to enroll 550 RhD-negative, pregnant women in the study of its non-invasive, prenatal laboratory-developed test for RhD blood group incompatibility, which relies on Sequenom’s MassARRAY system and SEQureDx technology. Their goals are to not only validate the test, but also to collect data for an anticipated regulatory application to the US Food and Drug Administration.
Between eight and 10 of NAFTNet’s 18 medical center affiliates are expected to participate in the study. NAFTNet specializes in caring for pregnancies deemed at high risk for fetal disorders. Baylor College of Medicine’s Medical Genetics Laboratory in Houston will carry out the testing.
Approximately 10 to 15 percent of Americans are RhD negative. But 60 percent of RhD-negative women give birth to RhD-positive children. In some cases, this incompatibility between maternal and fetal blood causes the mother’s body to produce antibodies against her fetus’ RhD antigens, leading to RhD disease in the unborn child. These high-risk pregnancies can result in jaundice, anemia, brain damage, heart failure, and even death.
“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 children are born,” Baylor College obstetrician and gynecologist Kenneth Moise, principal investigator of the study, said in a statement.
Sequenom intends to file a submission with the US Food and Drug Administration for a non-invasive prenatal test for Rhesus D incompatibility. Lenetix Medical Screening Laboratory, Sequenom’s CLIA-certified, nonexclusive licensee, currently offers a home-brew version of the test to customers.

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