Feb 5 2010
Sequenom, Inc. (Nasdaq: SQNM) today announced the launch of the SensiGene™ Fetal RHD Genotyping test by Sequenom's CAP accredited and CLIA-certified laboratory, Sequenom Center for Molecular Medicine (Sequenom CMM). This is the company's first laboratory developed test powered by its SEQureDx™ technology.
In the United States, there are approximately 528,000 pregnancies in Rhesus D (RhD) negative women every year, and almost all of these women could benefit from an assessment of the RhD type of the fetus. RhD type can be determined by an invasive procedure, such as amniocentesis or chorionic villus sampling (CVS), but both procedures involve risk to the fetus. Currently in the United States, most RhD negative women are managed without knowing the fetal RHD status.
The benefits of the noninvasive SensiGene Fetal RHD Genotyping test include:
- Aid to physicians in creating a more informed strategy to manage the care of pregnant RhD negative women.
- Reduction in need for invasive procedures, such as amniocentesis or CVS.
- First trimester detection.
- Fetal identifiers – a control to confirm the presence of fetal DNA thus ensuring that a RHD negative result for a female fetus is due to the measurement of fetal rather than maternal nucleic acid in the sample.
"The introduction of this test is an important development in improving patient care for pregnant women in both the United States and in Europe," said Dr. Wolfgang Holzgreve, director at the University Hospital, Freiburg and Sequenom clinical advisory board member. "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. 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."
"Launching the first test based on our SEQureDx technology is an important milestone for Sequenom and our CLIA lab - the Sequenom Center for Molecular Medicine," stated Shawn M. Marcell, vice president, molecular diagnostics. "We believe this test represents a significant and important advancement for prenatal care. Our ability to launch this test and bring it to patients is, in no small part, directly related to the strong support of the Fetal Medicine Foundation, UK, which supplied clinical samples to us."