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Sequenom Announces Launch of SensiGene Fetal(XY) (Fetal Sex Determination) Test
Date:2/16/2010

tic arsenal by providing for safe and accurate noninvasive fetal testing."

"I am very excited about the launch of the SensiGene Fetal(XY) test," added Shawn M. Marcell, vice president, molecular diagnostics. "Being able to offer physicians an advanced molecular diagnostic test with excellent performance is an important step in helping their patients focus on the positive nature of their pregnancy. Offering this test through a physicians' office should give mothers confidence in the test and assist doctors in the care of their patients."

About the SensiGene Fetal(XY) (Fetal Sex Determination) Test

The new SensiGene Fetal(XY) test is designed to detect circulating cell-free fetal (ccff) DNA in maternal blood. The test interrogates male specific targets on the Y chromosome. In addition to quality control metrics to ensure accuracy it also incorporates a fetal identifier control to facilitate the distinction between maternal and female fetal DNA. The test is performed using Sequenom’s proprietary MassARRAY® system, which allows direct mass measurement of nucleic acids.

As with the recently launched SensiGene Fetal RHD Genotyping test, more than 500 clinical samples were tested during the course of feasibility, optimization, verification and validation. The final blinded validation study, in which over 200 samples were evaluated, was performed in conjunction with the Fetal Medicine Foundation, and un-blinding was performed by Dr. Arnold Cohen, chairman of obstetrics and gynecology at the Albert Einstein Medical Center, in Philadelphia. In this validation study the SensiGene Fetal Sex Determination test demonstrated:

  • Sensitivity of 97.9% (92.5% – 99.4% at a 95% confidence interval).
  • Specificity of 100% (96.9% – 100% at a 95% confidence inter
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SOURCE Sequenom, Inc.
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