A blood test that predicts preterm birth harvests exosomes from a blood sample and looks for a specific biomarker fingerprint that indicates a high risk for preterm birth, even in women with no known risk factors.
NX PharmaGen (Louisville, KT, USA) has conducted early studies with maternal serum samples using its NeXosome Preterm Birth Assay. Two cohorts were balanced for age and subjects were asymptomatic with no known risk factors, such as hypertension, twins, or gestational diabetes. The average age was 28. In the study, a preterm birth was before 34 weeks and after 37 weeks was full-term.
As early as 15 weeks, the test could detect a risk for preterm birth. NX PharmaGen’s initial human studies also suggest the test could be used for early detection, sub-typing/staging, drug receptor presence/absence, and recurrence monitoring for cancer, including lung cancer, ovarian cancer, and brain cancer.
“If you harvest exosomes and open them up and look at their content, the protein content of a term pregnancy looks very different from a preterm pregnancy,” commented Brian Brohman, co-founder and chief business officer of NX Pharmagen.
The initial benefit of the NeXosome Preterm Birth Assay will allow doctors to move a patient from normal OBGYN care to a fetal medicine specialist.
“This is a tool to tell doctors where they should be spending extra time,” Brian Brohman said. “If you can extend the pregnancy on knowledge of a risk, you can save lots of money.”
Next steps for NX PharmaGen are assay optimization and validation. Brian Brohman said that it is too early to know which regulatory path the company will take: Clinical Laboratory Improvement Amendments a laboratory-developed test (CLIA LDT) and an US Food and Drug Administration (FDA; Silver Spring, MD, USA) approval.
The company is seeking patents on the biomarker pattern that indicates a high risk of premature birth and the method of harvesting exosomes from a blood sample.