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：
10216688
负责人：
George W Jackson
金额：
$ 58.25万
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 2022-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10216688
关键词：
Abstinence Syndrome 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 Detection Development Devices Diagnostic 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 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 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.

项目摘要/摘要美国正经历着前所未有的范围的阿片类药物流行。超过6个现在，阿片类药物相关的10种药物过量药物中有约90例死亡。经济影响据估计，该流行病的估计超过$ 75B/年，主要来自健康和社会成本与处方阿片类药物的使用有关[止痛药。 2011; 12（4）：657-67。 2013; 14（10）：1534-47]。新的立法行动可能会采取解决危机。新生儿禁欲综合征是由产妇在出生前使用的阿片类药物引起的，是一个严重的状况使大约6％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所有新生儿的护理点进行管理，将允许早期干预，降低治疗成本，减轻这种脆弱和无助的痛苦和痛苦患者人数。此外，在出生后不久需要手术的新生儿经常忍受连续静脉注射吗啡或相关化合物，这导致发育同一综合征，因为这些婴儿也沉迷于处方药。提供一个平台，以准确监测这些药物的实际水平及其代谢物这样的患者将允许更好地控制这些疼痛管理治疗，对个体新生儿的需求进行个性化，从而减少了成瘾的可能性产生的并发症，包括有害神经系统作用。这个FastTrack SBIR项目的目的是扩展我们的初步结果和准备商业化。我们已经证明了反向散射干涉法可以与高度选择性的DNA适体结合使用以敏感并准确检测一个微量尿液中的阿片类药物及其主要的泌尿代谢物样品在样本引入我们的设备后不到一分钟之内。在这个程序中，我们将通过（i）修改仪器以降低每次测试成本和许可证来改善该平台多路复用；（ii）开发最常见的所有测定菜单所需的其余部分在这些样品中滥用阿片类药物及其代谢产物；（iii）测试新的护理点使用REAL 从目标患者人群获得的样本。一个经验丰富的协作团队，包括适合和测定开发基本对生物技术的科学家，范德比尔特的反向散射干涉法专家大学，范德比尔特大学临床医生Biotex，Inc。的医疗设备工程师健康中心和具有转化/商业化经验的新生儿学家将有效共同实现这些目标。监管专家将就测定，软件和用于在医院，诊所和其他可能需要进行的医院，诊所和其他场所使用的仪器设计部署。