NX Prenatal Announces Key Clinical Validation Trial of its Exosome-Based Blood Test for Preterm Birth Risk in Collaboration with Indiana University School of Medicine
Samples from more than 2,300 pregnant patients will be evaluated to support commercialization of the Company's new maternal blood test targeted for use at 10-12 weeks of pregnancy; information at this early time point provides actionable results to the physicians aimed at improving outcomes for the mom and baby while providing significant savings to the health care system
HOUSTON and LOUISVILLE, Ky., Oct. 24, 2018 /PRNewswire/ -- NX Prenatal Inc., a privately held women's healthcare molecular diagnostic company, announced today that it has entered into a collaboration with Indiana University School of Medicine to further validate its early pregnancy biomarker panels that predict Spontaneous Preterm Birth (SPTB) and to further develop its biomarker panels for Preeclampsia (PE). "The collaboration builds upon published data in which NX Prenatal has demonstrated that the enrichment of exosome and microvesicle particles from maternal blood and subsequent biomarker analysis enables risk stratification of preterm birth and preeclampsia as early as 10-12 weeks into the pregnancy. This 'early detection' result has not been realized by other approaches," commented Dr. Kevin Rosenblatt, Chief Medical and Scientific Officer of NX Prenatal.
The collaboration is part of an ongoing research collaboration with David M. Haas, MD1, Vice Chair of Research for IU School of Medicine Department of Obstetrics and Gynecology2, who commented, "the scope of the study will allow for the clinical validation of previously identified first trimester biomarker panels, and will uniquely utilize the exosome-enrichment strategy to uncover vast new proteomic and genomic information in a number of adverse pregnancy outcomes. This technology holds the promise of enabling clinicians to identify early in pregnancy which patients are at greatest risk for conditions such as SPTB and PE and that may benefit from more personalized care and tailored interventions."
Blood samples from more than 2,300 women will be evaluated at first trimester and second trimester time points. The samples were prospectively collected at more than 20 hospitals affiliated with 8 clinical research centers across the US, including IU School of Medicine. Extensive medical data, demographic data, outcomes, and follow-up data were collected according to standardized protocols3. All of the women in the study are "nulliparous," meaning they had not previously given birth, so there was no history of a preterm birth. As such, this is a low-risk population that is the most difficult for physicians to risk-stratify and manage. The size of the study will allow for the evaluation of co-risk factors like age, body mass index, nutrition and socio-economic factors.
"In our most recent studies, there are two striking findings. We have identified a panel of markers that preferentially discriminate SPTB in first-time moms. We have also recently confirmed that our exosome-based approach yields markers of PE at the same week 10-12 time point. As a result, the opportunity to fully define the clinical value of our exosome-based approach across a large and valuable resource such as the nuMoM2b repository has significant breakthrough potential," commented Dr. Rosenblatt.
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.