Sequenom Announces Positive Clinical Data and Performance for the Fetal Rhesus D Genotyping Assay
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Sequenom, Inc. has announced that its non-invasive fetal Rhesus D (RHD) genotyping assay demonstrated 100% concordance with routine European non-invasive Real-time PCR (RT-PCR) methods.
This data demonstrates that the research use only fetal RHD genotyping assay utilizing Sequenom's MassARRAY® technology may be a suitable alternative for clinical assessment of prenatal RHD incompatibility.
“Clinical concordance between the MassARRAY platform and the current standards employed in the European community is an important validation of our testing approach,” stated Harry Stylli, Ph.D., President and Chief Executive Officer of Sequenom.
“Our first clinical licensee Lenetix Medical Screening Laboratory, Inc. is scheduled to launch its 'home brew' application for RHD incompatibility on a RT-PCR platform this quarter and we expect a 'home brew' RHD incompatibility test on the MassARRAY platform to be introduced later this year through a CLIA-certified laboratory. We plan to continue developing non-invasive prenatal tests for other genetic markers,” Stylli said.
Preliminary studies performed by Sequenom in collaboration with Professor Tobias Legler at University Goettingen compared Sequenom's MassARRAY technology with RT-PCR for fetal RHD genotyping.
In Europe, fetal RHD genotyping by RT-PCR is routinely performed for high risk pregnancies. The Sequenom studies utilized samples collected from 100 pregnant women between 13 and 39 weeks of pregnancy (mean gestational age 26 weeks). Whole blood from each patient was processed into a plasma sample and a cellular blood component sample for fetal and maternal RHD genotyping, respectively.
RHD genotypes for maternal and fetal RHD samples generated by the MassARRAY platform were compared to the results obtained from RT-PCR. Each RHD genotype result generated by the MassARRAY platform matched the RT-PCR result obtained for the same sample--establishing 100% concordance between assay results. Overall sensitivity for both methods was 100%, with 98% specificity.
