The objective of this study is to evaluate the performance of Sequenom's noninvasive test
for fetal RHD genotype. The test uses MALDI-TOF mass spectrometry to detect DNA. The
study is specifically designed to determine whether RHD typing using free fetal DNA in
maternal circulation can accurately predict the neonatal RhD phenotype at birth.

A Noninvasive Test for Fetal RHD Genotype

Rhesus D Genotype

In the United States and Canada, routine obstetrical care includes a blood test to
determine the blood type of the mother (ABO and RhD). An antibody screen for anti-red
cell antibodies in the mother's serum is also performed.

Postpartum prophylactic treatment of RhD negative women with anti-D immunoglobulin to
prevent "RhD Disease", or hemolytic disease of the fetus/newborn, was initiated in the
1960's. In the mid 1980's, the routine administration of antenatal anti-D immunoglobulin
became the standard of care as well. Although these treatments have dramatically reduced
the incidence of RhD Disease, approximately 40% of all RhD negative pregnancies continue
to receive unnecessary injections of antenatal anti-D immunoglobulin.

Genotyping platforms such as MALDI-TOF mass spectrometry allow for precise and sensitive
detection of fetal-specific (paternally derived) alleles in maternal plasma. In this
study, Sequenom's MassARRAY technology will be used to assess a noninvasive test for
fetal RHD genotyping in a clinical setting.

Evaluation Of The Performance Of A Noninvasive Test For Fetal RHD Genotype On The Sequenom MassARRAY System

Obstetrix Medical Group of Phoenix

Wayne State University

Columbia University

Mt. Sinai School of Medicine

University of North Carolina

Good Samaritan Hospital

Ohio State University

Thomas Jefferson

Baylor College of Medicine

Evergreen Hospital

University of British Columbia

McGill University

A Noninvasive Test for Fetal RHD Genotype

About this trial

Study ID

Status

Type

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

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