The United States is experiencing an opioid epidemic of unprecedented scope. More than 6 out of 10 drug overdoses are now opioid-related, resulting in ~90 deaths/day. The economic impact of the epidemic has been estimated to exceed $75B/year, primarily from health and social costs related to prescription opioid use [Pain Med. 2011; 12(4):657-67. 2013; 14(10):1534-47]. New legislative actions are likely to be taken to address the crisis. Newborn Abstinence Syndrome, which results from maternal opioid drug use prior to birth, is a serious condition that afflicts approximately 6% of all neonates born today in the U.S. and which is increasing rapidly in incidence because of this epidemic. Availability of a rapid screening test that can be administered at the point of care to all neonates would allow for early intervention, reducing costs of treatment and reducing pain and suffering for this vulnerable and helpless patient population. In addition, neonates who require surgery shortly after birth often endure continuous intravenous infusion of morphine or related compounds, which result in development of the same syndrome, as these infants also become addicted to their prescribed medications. Providing a platform to accurately monitor actual levels of these drugs and their metabolites in such patients would allow better-controlled use of these pain management treatments, personalized to the needs of the individual neonate, reducing the probability of addiction and resulting complications, which include deleterious neurological effects. The purpose of this FastTrack SBIR project is to expand upon our preliminary results and prepare for commercialization. We have already demonstrated that backscattering interferometry can be used in combination with highly-selective DNA aptamers to sensitively and accurately detect opioids and their primary urinary metabolites in one microliter urine samples, in less than a minute after sample introduction into our device. In this program, we will improve this platform by (i) modifying the instrument to reduce cost per test and permit multiplexing; (ii) develop the rest of the assay menu needed to detect all the most commonly abused opioid drugs and their metabolites in these samples; and (iii) test the new point of care instrument and assays versus gold-standard mass spectrometry lab-based tests, using real samples obtained from the target patient population. A highly experienced, collaborative team that includes aptamer and assay development scientists at Base Pair Biotechnologies, backscattering interferometry experts at Vanderbilt University, medical device engineers at BioTex, Inc., a clinician from Vanderbilt University Health Center, and a neonatologist with translational/commercialization experience will work together to achieve these goals. A regulatory expert will advise on assay, software and instrument design for use in hospitals, clinics and other venues in which such tests are likely to be deployed.
Public Health Relevance Statement: Project Narrative The United States is experiencing an opioid epidemic of unprecedented scope. More than 6 out of 10 drug overdoses are now opioid-related, resulting in ~90 deaths/day. The economic impact of the epidemic has been estimated to exceed $75B/year, primarily from health and social costs related to prescription opioid use [Pain Med. 2011; 12(4):657-67. 2013; 14(10):1534-47]. Newborn Abstinence Syndrome, which results from maternal opioid drug use prior to birth, is a serious condition that afflicts approximately 6% of all neonates born today in the U.S. and which is increasing rapidly in incidence because of this epidemic. Availability of a rapid screening test that can be administered at the point of care to all neonates, would allow for early intervention, reducing costs of treatment and reducing pain and suffering for this vulnerable and helpless patient population. The purpose of this project is to expand upon and commercialize our preliminary results, which showed that backscattering interferometry can be used in combination with highly-selective DNA aptamers to sensitively and accurately detect opioids and their primary urinary metabolites in one microliter urine samples in less than a minute after sample introduction. In the near term, the proposed technology will have the largest impact in regions of the country that are most affected by the current epidemic those lacking the infrastructure for expensive centralized laboratories.
NIH Spending Category: Bioengineering; Biotechnology; Brain Disorders; Drug Abuse (NIDA only); Opioid Misuse and Addiction; Opioids; Pain Research; Pediatric; Perinatal Period - Conditions Originating in Perinatal Period; Preterm, Low Birth Weight and Health of the Newborn; Substance Abuse
Project Terms: Abstinence Syndrome; addiction; Address; Affect; Affinity; aptamer; Archives; assay development; base; Base Pairing; Binding; Biological Assay; Biotechnology; Birth; Blinded; Blood capillaries; Buprenorphine; carfentanil; Cessation of life; Clinic; Clinical; clinically relevant; Collaborations; commercialization; Computer software; Continuous Intravenous Infusion; cost; Country; Data Analyses; design; Detection; Development; Devices; Diagnostic; DNA; Early Intervention; economic impact; Engineering; Epidemic; experience; Fentanyl; Frequencies; Goals; Gold; Health; Hospitals; Hour; Hydrocodone; improved; Incidence; Individual; Infant; Infrastructure; instrument; Interferometry; Intervention; Label; Laboratories; laboratory experience; Legal patent; Libraries; Mass Spectrum Analysis; Measurement; Medical; Medical Device; Methadone; Methodology; Methods; Monitor; Morphine; nanolitre; nanomolar; Neonatal; Neonatal Abstinence Syndrome; neonate; Neurologic Effect; Newborn Infant; Noise; novel; off-patent; operation; Operative Surgical Procedures; Opioid; opioid abuse; opioid epidemic; opioid use; Optical Readers; Optics; Overdose; Oxycodone; Pain; Pain management; pain reduction; patient population; Patients; Performance; Pharmaceutical Preparations; Phase; point of care; Positioning Attribute; prescription opioid; Probability; programs; Protocols documentation; prototype; Randomized; Reader; Readiness; Rest; Risk; Sampling; Scientist; screening; Signal Transduction; Small Business Innovation Research Grant; social; Specificity; success; Symptoms; Syndrome; Technology; Testing; Training; Translating; Translations; Treatment Cost; United States; Universities; urinary; Urine; Work
