GSN receives NIH grant for non-invasive prenatal test trial in genetic abnormalities

Gene Security Network (GSN) announced today that they have received a $2 million grant from the National Institutes of Health (NIH) to conduct a clinical trial applying Parental Support™ technology for non-invasive prenatal diagnosis (NIPD).

Non-Invasive Prenatal Testing

NIPD will enable highly accurate detection of severe fetal genetic abnormalities by testing fetal DNA found in maternal blood. Currently the only testing options available to detect fetal genetic abnormalities with high accuracy are amniocentesis and chorionic villi sampling (CVS), which are invasive procedures that carry approximately a 0.5% risk for miscarriage. Maternal blood analyte screening such as "Triple" or "Quad" tests and first trimester screening using analytes and ultrasound can help identify pregnancies at higher or lower risk for fetal genetic abnormalities, but these tests miss approximately 15% of affected pregnancies and 95% of pregnancies with high risk results are actually unaffected. GSN's NIPD test is expected to be able to detect several genetic disorders including Down Syndrome with accuracy approximately equivalent to CVS. The test can be performed on a maternal blood draw in the first trimester of pregnancy prior to 12 weeks gestation.

New Technology for Genetic Testing

GSN's Parental Support testing technology is designed to deliver highly accurate and comprehensive genetic testing results from tiny quantities of DNA, as little as found in a single cell. The technology has been used successfully for preimplantation genetic diagnosis (PGD) since 2008 to diagnose chromosome and inherited genetic abnormalities in a single cell removed from a human embryo during an in vitro fertilization (IVF) cycle. In research studies the technology has also demonstrated exceptional success in diagnosing chromosome abnormalities from small traces of fetal DNA found in maternal blood.

Ronald Wapner, MD, will be Chief Investigator

Dr. Ronald Wapner, Vice Chairman of Research at Columbia University Medical Center will be the Chief Investigator for the trial.

"NIPD has been an exciting and frustrating area for over thirty years since the discovery was first made that fetal genetic material is present in maternal blood," said Dr. Wapner. "The challenge is that the amount of fetal DNA mixed within the maternal blood is so miniscule that molecular testing techniques have not been able to produce a clinically useful test. GSN's approach of pairing advanced biostatistics with molecular testing is unique and holds immense promise to achieve clinically useful results. I am looking forward to heading up this clinical trial."

Trial Funded by NIH Grant

"There are over four million births in the U.S. a year," said Matthew Rabinowitz, PhD, CEO of GSN. "Most pregnant women undergo blood analyte screening, which results in thousands of unnecessary invasive procedures like amniocentesis and still fails to detect roughly fifteen percent of babies with Down Syndrome. In the 21st century, we should be doing much better than that. We believe GSN's Parental Support technology, when applied to a simple maternal blood draw, will substantially reduce the number of invasive prenatal procedures and undetected cases of Down Syndrome. We are pleased that the NIH has chosen to support GSN's trial based on the strength of the pre-clinical data, and are equally thrilled that an industry thought leader such as Dr. Wapner is spearheading our trial."

The research phase of the clinical study is currently underway. The prospective randomized trial is scheduled to commence later this year.