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Sequenom on Track for June Launch of Prenatal Test

NEW YORK (GenomeWeb News) – Sequenom announced last night that it is on track to launch this June its non-invasive, RNA-based, SEQureDx test for assessing fetal aneuploidy in maternal blood.

Sequenom President and CEO Harry Stylli said in a statement that the company has completed R&D studies on its RNA-based trisomy 21 detection test. He said the company will now transfer the technology to the Sequenom Center for Molecular Medicine for the remaining development and validation steps prior to the June launch.

The announcement follows the completion of a prospective clinical trial that the company says yielded positive data. The firm tested 459 samples using Sequenom's RNA-based test and reportedly detected all eight first trimester Down syndrome samples with no false positives or negatives, as well as 14 of 15 second trimester Down syndrome samples. One second trimester Down syndrome sample could not be resolved using the test, but was verified by other methods, and another second trimester sample yielded a false positive result.

Sequenom also is pursuing a DNA-based approach for simultaneously testing for trisomy 21 (Down syndrome) and other trisomies, such as trisomy 18 (Edwards syndrome) and trisomy 13 (Patau syndrome).

Earlier this week, Artemis Health announced that it licensed co-exclusive worldwide rights from Stanford University to develop a non-invasive, DNA-based test of its own for detecting fetal trisomies in maternal blood. Fluidigm holds co-exclusive rights to the same DNA-based approach, developed in Stephen Quake's lab at Stanford University.

After seeing its shares fall to as low as $19.95 during the day, Sequenom's shares closed up 1 percent at $22.73 on the Nasdaq.

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