New study demonstrates the potential of NX Prenatal blood-based biomarker panel to identify risk of premature birth as early as week 10 of pregnancy

LOUISVILLE, Ky.March 22, 2016 – NX Prenatal, Inc. announced today that the American Journal of Obstetrics and Gynecology (“AJOG”) published a manuscript entitled, “Evaluation of proteomic biomarkers associated with circulating microparticles as an effective means to stratify the risk of spontaneous preterm birth,” from a clinical study evaluating blood-based biomarkers in pregnant mothers. In the study, candidate biomarker panels comprised of exosome-associated proteins evaluated at week 10-12 of gestation were shown to effectively differentiate groups women who go on to deliver spontaneously at less than 34 weeks versus term delivering controls (≥ 37 weeks).

This optimization study enrolled 75 patients (25 spontaneous preterm cases by 50 matched full-term controls) from the prospectively collected LIFECODES cohort at Brigham & Women’s Hospital (BWH). Results indicated that:

  • The candidate protein biomarkers identified are primarily involved in interrelated biological networks linked to coagulation, fibrinolysis, immune modulation, and the complement system, which in turn, are believed to have an interaction with adaptive immunity and the mediation of inflammatory processes necessary to sustain a successful pregnancy.
  • Linear multiplex models were evaluated to assess the clinically relevant performance, and the variables were limited to possible combinations of 3 proteins or less to assure proper statistical evaluation of the sample set.
  • Various candidate 3-plex panels exhibited a specificity of 83% with a fixed sensitivity of 80% with median area under the curve of 0.89.
  • With further validation, there is strong potential of multivariate model development for informative SPTB risk stratification as early as week 10 of gestation based on this approach.

Dr.David Cantonwine, Perinatal Epidemiologist with the Division of Maternal Fetal Medicine at BWH, commented, “Multiple other peer-reviewed publications have now identified important roles that exosomes play in mediating maternal-fetal crosstalk. To our knowledge, this is the first report that shows the potential to exploit this phenomenon for clinically useful SPTB risk stratification in the late first trimester.”

Based on these encouraging data, NX Prenatal is conducting further studies which are powered to validate a multiplex panel comprised of up to 10 biomarkers associated with clinically relevant biological processes which have consistently shown unique expression profiles across its discovery and optimization cohorts.

Cantonwine DE, Zhang Z, Rosenblatt K, Goudy KS, Doss RC, Ezrin AM, Page G, Brohman B, McElrath TF. (2016) Evaluation of proteomic biomarkers associated with circulating microparticles as an effective means to stratify the risk of spontaneous preterm birth. Am J Obstet Gynecol [Epub ahead of print]. [abstract]

About NX Prenatal
NX Prenatal Inc. (NXPN) is a private US based molecular diagnostics company located in Louisville, KY. The company’s NeXosome® Preterm Birth Risk Assay is positioned to be an enabling early warning system for pregnancies that may result in spontaneous preterm birth. Using its proprietary NeXosome Platform, NXPN has demonstrated the potential utility of a new library of biomarkers 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 tissues.

Source – PRNewswire

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