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Neonatal Opioid Screening Using Aptamers and Compensated Interferometry

使用适体和补偿干涉测量法进行新生儿阿片类药物筛查

基本信息

批准号：
10226376
负责人：
George W Jackson
金额：
$ 55.99万
依托单位：
BASE PAIR BIOTECHNOLOGIES, INC.
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-03-01 至 2023-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10226376
关键词：
Address Affect Affinity Archives Base Pairing Binding Biological Assay Biotechnology Birth Blinded Blood capillaries Buprenorphine Cessation of life Clinic Clinical Collaborations Computer software Continuous Intravenous Infusion Country DNA Data Analyses Development Devices Diagnostic Drug Prescriptions Early Intervention Engineering Epidemic Fentanyl Frequencies Goals Gold Health Hospitals Hour Hydrocodone Incidence Individual Infant Infrastructure Interferometry Intervention Label Laboratories Legal patent Libraries Mass Spectrum Analysis Measurement Medical Medical Device Methadone Methodology Methods Monitor Morphine Neonatal Neonatal Abstinence Syndrome Neurologic Effect Newborn Infant Noise Operative Surgical Procedures Opioid Optical Readers Optics Overdose Oxycodone Pain Pain management Patients Performance Pharmaceutical Preparations Phase Positioning Attribute Probability Protocols documentation Randomized Rapid screening Reader Readiness Rest Risk Sampling Scientist Signal Transduction Small Business Innovation Research Grant Specificity Symptoms Syndrome Technology Testing Training Translating Translations Treatment Cost United States Universities Urine Work addiction aptamer assay development base carfentanil clinically relevant commercialization cost design detection limit economic impact experience improved instrument laboratory experience nanolitre nanomolar neonate novel operation opioid abuse opioid epidemic opioid use pain reduction patient population point of care prescription opioid programs prototype screening social success urinary

项目摘要

Project Summary/Abstract 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.

项目概要/摘要美国正在经历规模空前的阿片类药物流行病。超过6出目前，10 例药物过量与阿片类药物相关，导致每天约 90 人死亡。经济影响据估计，该流行病的费用每年超过 $75B，主要来自健康和社会成本与处方阿片类药物的使用相关[Pain Med。 2011； 12（4）：657-67。 2013年； 14（10）：1534-47]。新的可能会采取立法行动来解决危机。新生儿戒断综合症是由母亲在出生前使用阿片类药物引起的当今美国出生的新生儿中约 6% 患有这种严重疾病，由于这种流行病，发病率正在迅速增加。快速筛选测试的可用性可以在护理点对所有新生儿进行管理，以便进行早期干预，降低治疗费用，减少弱势群体的痛苦和折磨患者群体。此外，出生后不久就需要手术的新生儿通常会忍受持续静脉输注吗啡或相关化合物，导致发育患有同样的综合症，因为这些婴儿也对他们的处方药物上瘾。提供一个平台来准确监测这些药物及其代谢物的实际水平这些患者可以更好地控制使用这些疼痛管理治疗，根据新生儿个体的需求进行个性化，减少成瘾的可能性由此产生的并发症，包括有害的神经系统影响。 FastTrack SBIR 项目的目的是扩展我们的初步结果并为商业化做准备。我们已经证明了后向散射干涉测量法可与高选择性 DNA 适体结合使用，以灵敏地检测准确检测一微升尿液中的阿片类药物及其主要尿代谢物样品引入我们的设备后不到一分钟。在本期节目中，我们将通过 (i) 修改仪器以降低每次测试和许可的成本来改进该平台多路复用； (ii) 开发检测所有最常见的检测所需的其余检测菜单这些样本中含有滥用的阿片类药物及其代谢物； (iii) 测试新的护理点仪器和分析与金标准质谱实验室测试相比，使用真实的从目标患者人群中获取的样本。经验丰富的协作团队，包括核酸适体和检测开发 Base Pair Biotechnologies 的科学家、范德堡大学反向散射干涉测量专家大学、BioTex, Inc. 医疗设备工程师、范德比尔特大学临床医生健康中心和具有转化/商业化经验的新生儿科医生将发挥作用共同实现这些目标。监管专家将就检测、软件和用于医院、诊所和其他可能进行此类测试的场所的仪器设计被部署。