Sequenom Announces New York State Approval of a Noninvasive Prenatal Test for Rhesus D Incompatibility
Sequenom, Inc. announced the New York State approval of the first noninvasive prenatal test based on Sequenom's SEQureDx(TM) Technology for Cell Free Fetal Nucleic Acid assessment. The Laboratory Developed Test (LDT) performed on a real-time PCR (RT-PCR) platform to detect Rhesus D (RhD) incompatibility will be marketed by Sequenom's nonexclusive licensee, CLIA-certified, New York State Permitted laboratory Lenetix Medical Screening Laboratory, Inc., Mineola, New York.
"This will be the first commercially introduced noninvasive prenatal test in the United States to utilize the SEQureDx(TM) Technology and represents a significant step in our strategy to build a proprietary global portfolio of noninvasive prenatal products. RhD is our pioneering test and will serve in assisting in preparing us in developing and launching other tests such as FetalXY and Down syndrome," said Harry Stylli, Ph.D., Sequenom's President and Chief Executive Officer. "Genetic-based noninvasive prenatal testing could complement and potentially present a paradigm shift from current invasive testing procedures such as amniocentesis. Tests based on our SEQureDx Technology can be performed from a simple maternal blood sample, which could allow obstetric and fetal maternal specialists to successfully intervene early in the pregnancy to improve outcomes."
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