NX Prenatal Inc., a privately held women's healthcare molecular diagnostic company, announced today that the American Journal of Perinatology has published the results of a blinded, retrospective study of 48 asymptomatic, healthy pregnant women that demonstrates the feasibility of assessing biomarkers associated with blood based microvesicles/exosomes for spontaneous preterm birth (SPTB) risk. The study describes a new library of statistically valued biomarkers for prenatal risk assessment that were identified at week 15-17 of gestation.
"The use of circulating extracellular microparticles as biomarkers is being intensely examined in multiple diseases. This study reflects the first in-depth proteomic evaluation of microparticle biomarkers as potential early warning signals of SPTB," said lead author Alan M. Ezrin, Ph.D. "A key finding was a common subset of differentiating biomarkers identified in both first pregnancy and second pregnancy subgroups, which opens the potential for use in a broad group of patients." The blinded study identified 18 such proteins of priority interest, with various multiplex combinations of markers accurately correlating 41-47 of the 48 cases to the respective SPTB or term-delivering cohort, at varying probability of error values of p<0.05 or better. NX Prenatal has undertaken further studies that may enable the clinical use of such markers for early risk stratification, understanding the pathophysiology of SPTB, and possibly the development of effective prevention strategies.
"A non-invasive test that can reliably provide enhanced preterm birth risk information prior to the week 16-20 optimal intervention initiation period would be a significant new tool for physicians and pregnant moms," commented co-author Dr. Baha Sibai, of the University of Texas Health Science Center at Houston. These findings are of importance relative to addressing the global problem of preterm birth which affects one in eight U.S. women and 15 million women globally each year – accounting for 75% of perinatal deaths and over 1 million newborn deaths each year.