Sequenom has received New York State approval for the first noninvasive prenatal test based on its SEQureDx technology for cell free fetal nucleic acid assessment.
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The laboratory developed test performed on a real-time PCR platform to detect Rhesus D (RhD) incompatibility will be marketed by Sequenom’s nonexclusive licensee, CLIA-certified, Lenetix Medical Screening Laboratory based at Mineola, New York.
The company expects to introduce additional noninvasive prenatal tests, beginning in the first half of 2008 with a LDT application for fetal(XY)/gender screening, which may assist healthcare providers in the evaluation of high risk pregnancies with familial history of inherited disorders associated with the X chromosome.
Harry Stylli, president and CEO of Sequenom, said: “This will be the first commercially introduced noninvasive prenatal test in the US to utilize the SEQureDx technology and represents a significant step in our strategy.”
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