Blood test to find sex of fetal baby SensiGene launched by Sequenom

SensiGene Fetal(XY), a simple blood test to know the sex of the fetal baby by Sequenom Inc has been launched, the company announced in a press release.

The new fetal sex determination SensiGene Fetal(XY) is a non-invasive test which requires only a simple blood sample from the mother.

SensiGene Fetal also helps the determination of the baby’s sex in the first three months (trimester) of the development of the fetus.

SensiGene allows the distinction between maternal and fetal DNA for both male and female fetuses.

“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,” stated Lee P. Shulman, MD, Professor of Obstetrics and Gynecology and Chief of the Division of Clinical Genetics at the Feinberg School of Medicine at Northwestern University.

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 that SensiGene Fetal(XY) test has a sensitivity of 97.9% and specificity of 100%.

Sequenom’s proprietary MassARRAY(R) system is a high performance matrix assisted laser desorption/ionization time-of-flight (MALDI-TOF) mass spectrometry-based nucleic acid analysis platform that quantitatively measures genetic target material and its variations in a rapid, accurate, and cost efficient manner.

Sequenom’s MassARRAY system facilitates a number of nucleic acid analysis applications including SNP genotyping and allelotyping, CNV analysis, quantitative gene expression analysis, quantitative methylation marker analysis, comparative sequence analysis of haploid organisms, SNP discovery, and oligonucleotide quality control.

Sequenom Center for Molecular Medicine (Sequenom CMM), a CAP accredited and CLIA-certified molecular diagnostics laboratory, is developing a range of advanced prenatal diagnostics.

Branded under the name SensiGene, these genetic tests provide earlier patient management alternatives for obstetricians, geneticists and maternal fetal medicine specialists.

SensiGene Fetal is the second test launched this month based on the technology. Earlier, it had launched a test to detect any incompatibilitybetween the mother’s and the fetus’ blood type.

In April last year, the company delayed the launch of a Down syndrome test and said it was no longer relying on previously announced research and development test data and results related to its SEQureDx technology.
About Sequenom

Sequenom, Inc. is a life sciences company headquartered in San Diego, California.