The SensiGene Fetal(XY) test is noninvasive and requires only a simple blood sample from the mother. It allows early fetal sex determination in the first trimester. The test also allows the distinction between maternal and fetal DNA for both male and female fetuses.

The 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.

Lee Shulman, professor of obstetrics and gynecology and chief of the division of clinical genetics at the Feinberg School of Medicine at Northwestern University, said: “The launch of the SensiGene Fetal(XY) test represents another successful noninvasive prenatal test demonstrating the utility of using maternal blood to determine fetal status.

“This is a great leap forward in delivering a test with a high degree of accuracy, using cutting-edge technology which has been rigorously evaluated through blinded studies, performed in collaboration with internationally recognized prenatal diagnosticians. This test adds to the physicians’ prenatal diagnostic arsenal by providing for safe and accurate noninvasive fetal testing.”

Shawn Marcell, vice president of molecular diagnostics, said: “I am very excited about the launch of the SensiGene Fetal(XY) test. 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.”