Next Generation Tools for Onsite Monitoring and Treatment of Drug of Abuse-Dependent Persons

Abstract
Opioid abuse disorder (OAD) affects 2.1 million of Americans annually resulting in overdoses numbering in the
tens of thousands and skyrocketing rates of mortality. In addition to its enormous social impact, OAD carries a
multi-billion-dollar price tag that includes $78.5 billion, specifically for health care and other costs related to
prescription opioid abuse and misuse. Although effective interventions exist, they are highly underutilized –
Currently less than 1-in-5 Americans with prescription OUDs receive treatment for their disorder, the $2.8 billion
spent accounting for less than 4% of the financial resources consumed by mismanagement of prescription opioid
use. As treatment programs expand to meet need, it is critical that they be able to offer comprehensive services
to best support patient recovery. Among potential treatment options for OAD, medication-assisted treatment
(MAT) for opioid addiction – typically employing methadone, buprenorphine or naltrexone – has been shown to
reduce withdrawal symptoms and is associated with reduced overdose risk and improved maternal and fetal
outcomes in pregnancy. Since the inception of medication-assisted treatment (MAT) for opioid addiction, drug
testing has provided both an objective measure of treatment efficacy and a tool to monitor patient progress,
however, current methods are ill-suited for use in drug treatment settings. Liquid chromatography–tandem mass
spectrometry (LC–MS-MS) is highly sensitive, but the method is slow to yield results and requires tedious sample
processing. Easy to use immunochromatographic test strips (ICS) are gold-standard reference methods for
point-of-care settings, but they are non-quantitative and have limited multiplexing capacity. A multiplexing tool is
desirable for monitoring MAT because patients with OUD may have multiple opioids in their system over the
course of treatment including the primary addictive opioid, treatment opioid, and less desirable substitutes for
the addictive opioid of choice. Recognizing this unmet need in addiction treatment settings for a simple, yet
sensitive, instrument that can measure multiple opioids in clinical specimens, SensoDx conceptualized a drug of
abuse testing-on-a-chip strategy that implements microfluidics technology for high-sensitivity detection of
opioids. In previous work (Phase I studies), we developed and clinically tested a triplex assay targeting
simultaneous quantitative determination of buprenorphine, cocaine and morphine in oral fluid for use in
buprenorphine-assisted treatment. This Phase II project will deliver a set of milestones – an optimized cartridge
(precision, cost, size), expanded multiplexing capabilities to detection of seven drugs (buprenorphine, morphine,
oxycodone, methadone, heroine, fentanyl, and cocaine), and pilot-scale clinical validation (in patients undergoing
MAT) that will form the foundation and proof-of-concept for a prototype SensoDx Drug ScreenTM platform ready
for design and fabrication finalization, GLP manufacturing and testing. The efforts will result in the commercial
release of analyzer instrumentation, sampling devices and customized disposables for entry into the Lab-on-a-
Chip market, valued at $4.23 Billion (in 2016) and expected to grow at a CAGR of 11% by 2022.Narrative
Opioid abuse disorder affects millions of Americans annually and its enormous social impact carries a multi-
billion-dollar price tag that includes medication-assisted treatment (MAT) for opioid addiction. Because current
opioid-testing methods to monitor patients receiving MAT are ill-suited for point-of-care use, SensoDx developed
and clinically tested (Phase I studies) a triplex assay targeting simultaneous quantitative determination of
buprenorphine, cocaine and morphine in oral fluid samples for use in buprenorphine-assisted treatment. This
Phase II project will optimize the platform technology for commercialization, expand its capabilities, and validate
its clinical efficacy in monitoring patients undergoing MAT.