Rapid, Instrument-free and High Sensitivity Over-the-counter Urine Fentanyl Testing

Project Summary Fentanyl is the leading cause of overdose deaths in the United States. The majority of fentanyl-related overdoses are caused by illicit fentanyl and/or fentanyl analogs, either alone or in combination with other narcotics. Rapid identification of fentanyl as the contributing drug is crucial for clinical management of overdose patients, who may undergo respiratory depression in minutes. Even in the case of adulteration of fentanyl with any other opioid, the detection of fentanyl is important for the appropriate dosage and frequency of naloxone. Despite the clinical and public health needs, there is currently no rapid and instrument-free fentanyl detecting diagnostic cleared by FDA. Central clinical laboratory screening tests rely on expensive instrumentation and report results hours after urine sample is submitted for testing. Mass spectrometry-based methods for fentanyl are only available from selected hospital labs as lab-developed tests, and report results days after sample is collected. Neither existing method is useful for immediate clinical management, nor widely accessible to the populations who are most affected by fentanyl and emerging drug threats. Current commercially available fentanyl strips do not have the sensitivity to meet the clinically meaningful 1 ng/mL cutoff required by FDA. Instanosis has developed a rapid screening strip called InstaStrip-Fentanyl that uniquely meets the 1 ng/mL cutoff requirement. The entire test is completed in 3 simple steps within minutes. After urine collection, the user transfers urine to a reagent tube, mixes, then places the strip into the tube. Visual results can be read in 5 min. We have reached agreement with FDA in a presubmission meeting on proposed 510(k) regulatory pathway and studies required for clearance. In this fast-track proposal, Instanosis proposes to finalize the development and commercialize InstaStrip-Fentanyl as the first 510(k)-cleared, rapid, instrument-free and high sensitivity over-the-counter (OTC) fentanyl screening test. In Phase I, Instanosis will work on finalizing the test design with cutoff of 1 ng/mL under Quality Management System (QMS) and conduct clinical validation. In Phase II, Instanosis will partner with an FDA-registered contract manufacturer to manufacture three different test lots, conduct verification and validation studies, including analytical, accuracy flex and method comparison studies. We will also enroll users in an OTC usability study to evaluate and document the usability of the device. These studies will generate data for 510(k) submission. After completion of the fast-track project, the immediate next step is the submission of 510(k) application to FDA for OTC clearance, to allow marketing and distribution in both the professional healthcare and consumer markets. Although the project focuses on fentanyl, the infrastructure, resources and workflow built during this project will serve as a blueprint for Instanosis to rapidly adapt to diagnostics for other emerging drug threats, which are being developed in our pipeline.