Sequenom, Inc. unveiled its plans to conduct a multi-centre fetal Rhesus D (RhD) genotype study at centres 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-centre study, which will enrol 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 US 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-centre members to demonstrate our SEQureDx RhD Genotype System's effectiveness as a clinical model for future noninvasive prenatal tests currently in development by our organisation," stated Harry Stylli, PhD., president and chief executive officer, Sequenom.

The study's principal investigator, Dr. Kenneth Moise, Professor of Obstetrics and Gynaecology and Director of the Division of Maternal-Fetal Medicine at Baylor College of Medicine in Houston, said, "This study will initially involve the enrolment 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."

During pregnancy, RhD disease can occur when the blood of an RhD-negative expectant mother is incompatible with her unborn child. Approximately 10 per cent to 15 per cent of the population in the United States and Europe is RhD negative. The routine prenatal determination of fetal RhD is useful in the management of pregnancies of RhD-negative women, as up to 60 per cent of these pregnancies bear an RhD-positive foetus. In the United States and Europe, an estimated 40,000 RhD-negative pregnancies may progress to "high-risk" status annually and can lead to jaundice, anaemia, brain damage, heart failure and death.

The North American Fetal Therapy Network (NAFTNet) is a nonprofit, voluntary association of 18 medical centres in both the United States and Canada that perform advanced in-utero fetal therapeutic procedures. The primary mission of NAFTNet is to provide a cooperative clinical research network to study the natural history of fetal disease and to develop therapeutic prenatal interventions to improve pregnancy outcomes. NAFTNet provides an umbrella organization to assist the various medical centres that practice fetal medicine, promote cooperation between these centres and foster research in the field of fetal therapy.