Sequenom to Begin Clinical Assessment of Noninvasive Screening Technology for Down Syndrome
Sequenom, Inc. announced the approval of a protocol by the Institutional Review Board (IRB) at San Diego-based Sharp HealthCare, clearing the way to commence patient enrollment in a screening study to clinically assess the Company's noninvasive cell free fetal nucleic acid SEQureDx(TM) Technology for the detection of fetal aneuploidy, including Down syndrome, using a laboratory developed test (LDT).
According to the company, Sequenom's SEQureDx Technology, to be evaluated in this screening study, provides a direct genetic assessment of Down syndrome using a noninvasive maternal blood sample collected in the first or second trimester of pregnancy. The expected benefits of this approach are to improve current detection rates, while reducing the number of patient referrals (false positives) to the invasive procedures and fetal losses due to the procedures, which are currently employed in prenatal screening programs throughout the U.S.
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