NX Prenatal Announces Publication of Peer-Reviewed Study in the American Journal of Obstetrics & Gynecology for Validation of First Trimester Preterm Birth Risk Biomarkers
The findings represent the first reported multi-site validation of blood-based biomarker panels at 10-12 weeks gestation to stratify pregnant patients for the risk of preterm birth
Feb 28, 2019, 12:18 ET
LOUISVILLE, Ky. and HOUSTON, Feb. 28, 2019 /PRNewswire/ -- NX Prenatal Inc., focused on development of proprietary blood-based, early warning molecular diagnostic tests for adverse pregnancy outcomes, announced today the publication of a peer-reviewed study, "Circulating Microparticle Proteins Obtained in the Late First Trimester Predict Spontaneous Preterm Birth at Less than 35 Weeks Gestation: A Panel Validation with Specific Characterization by Parity" in the American Journal of Obstetrics & Gynecology. The publication is available online: https://doi.org/10.1016/j.ajog.2019.01.220.
First trimester blood samples were evaluated from a total of 261 pregnant patients at the Brigham & Women's Hospital, the University of Pittsburgh Magee Women's Hospital, and Seattle Children's Hospital. The trial was designed to build upon prior published biomarker discovery and verification studies by the Company and its collaborators (https://www.ajog.org/article/S0002-9378(16)00289-1/fulltext), which demonstrated an ability to use plasma-derived, exosomal proteins, obtained in the first trimester, to determine the risk of spontaneous preterm delivery later in pregnancy. Samples from 87 subjects delivering prematurely and 174 control subjects delivering at term were evaluated utilizing NX Prenatal's proprietary NeXosome® platform for exosome isolation and enrichment, followed by multiplexed, protein biomarker quantification.
In an industry first, the study defined differential biomarker panels for "first-time moms" and for those moms who had one or more prior pregnancies. "Exosomes are known to play many important roles in pregnancy, including a role in the adaptive immunity of the fetus, and this appears to be reflected in differences we see in the biomarker signatures based on the parity status of the mother," commented Dr. Kevin P. Rosenblatt, Chief Medical and Scientific Officer of NX Prenatal. The patent-pending, multiplexed biomarker panels were developed via machine learning statistical techniques. In a striking finding, the panel for first-time moms correctly identified preterm delivering patients with specificity (86%) and sensitivity (63%) levels that provide a higher predictive power than historically utilized risk measures, such as a prior history of preterm birth or a short cervix in the second trimester. "The first-time mom group is particularly difficult for physicians to risk-stratify; so, this finding may be of particularly high value in almost 40% of pregnancies in the US, and even higher proportions in certain other regions of the world."
"Currently, there are no first trimester, early warning tests for the risk of spontaneous preterm birth. Effectively utilized biomarker signatures such as this could lead to a new era of personalized medicine in pregnancy," commented Dr. Thomas McElrath of Brigham & Women's Hospital, and principal investigator for the study. Preterm birth has been reported as the number one cause of neonatal mortality, of chronic childhood medical conditions, and of million-dollar medical cases in the US.
About NX Prenatal
NX Prenatal Inc. is a private, US-based molecular diagnostics company. The company's proprietary NeXosome® platform is being utilized to develop enabling, early warning systems for pregnancies that may result in spontaneous preterm birth, preeclampsia and other adverse outcomes. NX Prenatal has demonstrated the clinical utility of its biomarker panels for prenatal risk assessment as early as 10 weeks gestation. This technology exploits biologically active and stable microparticles, such as exosomes, from the maternal bloodstream, to provide a real-time and non-invasive view of changing maternal and fetal cells and tissues. For more information, please visit the company's website at www.nxprenatal.com.
SOURCE NX Prenatal Inc.