MISSOULA, MONTANA, August 31, 2022 – Newborns develop Neonatal Opioid Withdrawal Syndrome (NOWS) when the mother is exposed to opioids and passes exposure to their unborn child. NOWS cases surged from 1.5 per 1,000 hospital births in 2004 to 8 per 1,000 in 2014. Symptoms of NOWS in newborns range from mild and temporary to prolonged hospitalization with complications. Variability in the presentation of signs has led to delayed treatment decisions until the onset of withdrawal symptoms. Yet, delays in pharmacologic interventions lead to the risk of increased infant morbidity.
FYR Diagnostics has partnered with the laboratories of Dr. Rajesh C. Miranda, Ph.D. from Texas A&M College of Medicine, and Dr. Ludmila Bakhireva, MD, Ph.D., MPH from the University of New Mexico Health Sciences Center to develop a diagnostic test for NOWS. This collaboration will demonstrate the feasibility of a rapid and quantitative tool based on non-invasive microRNA (miRNA) biomarkers in umbilical cord blood that proactively predicts the presence and severity of NOWS before the onset of physical withdrawal symptoms. This test will also differentiate NOWS patients that need immediate pharmacological intervention from those requiring extended hospitalization and monitoring of symptoms, leading to more effective treatments for NOWS patients and increased positive patient outcomes compared to the current standard of care.
“NOWS is a notable example of a burdensome disease with an unmet need for a cutting-edge diagnostic that will improve health outcomes for infants,” says Dr. Katie Havranek, a Senior Researcher at FYR Diagnostics. “Our team is excited to advance this promising NOWS diagnostic test.”
“It is a privilege to participate in transforming a basic science finding into a clinical diagnostic test that will improve healthcare delivery and the lives of infants,” says Dr. Miranda.
“My hope is that this novel diagnostic approach will continue to demonstrate high accuracy in rigorous clinical studies we are conducting and be available to clinicians caring for these vulnerable newborns,” says Dr. Bakhireva.
This research is funded by the National Institute of Drug Abuse through a three-year Fast-Track Phase I/II SBIR award 1R44DA054017-01.
About FYR Diagnostics
FYR (pronounced “Fire”) Diagnostics is a Montana-based company focused on developing, commercializing, and implementing novel technologies for diagnostics and testing in human health. FYR Diagnostics is currently developing non-invasive liquid biopsy diagnostic solutions that utilize innovative classes of biomarkers for an array of diseases with unmet clinical needs, such as cancers and neurological disorders. For more information, visit fyrdiagnostics.com.
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