Preterm Birth Risk, Preeclampsia Exosome Tests Enter Clinical Validation

NEW YORK (GenomeWeb) – NX Prenatal said today that it has entered a collaboration with Indiana University School of Medicine to further validate its early pregnancy biomarker panels that predict spontaneous preterm birth and to continue developing its biomarker panels for preeclampsia. 

"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 to 12 weeks into the pregnancy," Kevin Rosenblatt, NX Prenatal's chief medical and scientific officer, said in a statement. Early detection results of this nature have not been realized by other approaches, he added.

NX Prenatal's NeXosome 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.

The new study will allow for the clinical validation of previously identified first trimester biomarkers and will use an exosome-enrichment strategy "to uncover vast new proteomic and genomic information in a number of adverse pregnancy outcomes," said David Haas, vice chair of research for IU School of Medicine's Department of Obstetrics and Gynecology.

Blood samples from more than 2,300 women will be evaluated at time points during the first and second trimesters. The samples have been prospectively collected at more than 20 hospitals affiliated with eight 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 protocols.  All women in the study had not previously given birth. As such, this is a low-risk population that is the most difficult for physicians to risk-stratify and manage, according to NX Prenatal. The size of the study will allow for the evaluation of co-risk factors such as age, body mass index, nutrition, and socioeconomic factors.    

Rosenblatt said that in its most recent studies, the firm identified a panel of markers that preferentially discriminate spontaneous preterm birth in first-time mothers.