Lenetix Reports Submission of Clinical Data for the Commercial Launch of Non-Invasive Prenatal Rhesus D Incompatibility Test
Sequenom, Inc. and Lenetix Medical Screening Laboratory, Inc. announced that Lenetix has submitted a clinical package to the New York State Department of Health to support its application for a clinical laboratory permit to perform a non-invasive prenatal Rhesus D (RhD) incompatibility test, the first non-invasive prenatal test based on Sequenom's Fetal Nucleic Acid Technology. The prenatal RhD incompatibility test will be marketed as a "home brew" and performed on a real-time PCR (RT-PCR) platform. In preparation for New York State approval, Lenetix is preparing marketing and scientific materials to commercialize the RhD incompatibility test throughout the United States.
Lenetix's RhD application of Sequenom's proprietary Fetal Nucleic Acid Technology detects a fetus' RhD status from the mother's blood sample without invasive procedures that typically pose risk to the health of the mother and baby in utero.
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