NEW YORK (GenomeWeb News) – Shares of Sequenom were up around 7 percent at $4.36 in mid-afternoon trade on the Nasdaq, after the firm announced the launch of its SensiGene Fetal RHD Genotyping test.
The test will be offered through Sequenom's CAP-credited and CLIA-certified lab, the Sequenom Center for Molecular Medicine.
Sequenom said that the test is designed to detect circulating cell-free fetal DNA from maternal blood and examine multiple regions of the gene that are known to be the most common genetic basis of RhD negative phenotypes. It interrogates four targets within three exons located on the RHD gene on chromosome one and incorporates male-specific targets on the Y chromosome.
A validation study, which evaluated more than 220 samples, was conducted at the Albert Einstein Medical Center in Philadelphia. Researchers found that the SensiGene test had sensitivity of 97.2 percent and specificity of 96.9 percent.
"Fetal RhD genotyping utilizing real-time PCR has been widely used in Europe for over a decade, and has led to better patient management and is even considered for reduction of unnecessary treatment with Anti-D immune globulin," Wolfgang Holzgreve, director at the University Hospital, Freiburg, and a Sequenom clinical advisory board member, said in a statement. "Based upon Sequenom's validation study, the SensiGene Fetal RHD Genotyping test appears to offer a higher level of sensitivity and specificity compared with the real-time PCR methodology."
The new test runs on Sequenom's MassArray system.
The firm estimates that roughly 528,000 pregnancies in RhD negative women each year in the US, "and almost all of these women could benefit from an assessment of the RhD type of the fetus."