Project Summary Fentanyl is a major contributor to the Opioid Epidemic. Rapid identification of the causative drug as fentanyl is critical for prompt and appropriate administration of naloxone, and the right level of clinical care. From the public health perspective, rapid identification of fentanyl is also key to overdose surveillance, outbreak recognition and communication among healthcare professionals. The global market for point-of-care (POC) drug of abuse testing, fueled by the continued growth of illicit drug use worldwide, especially fentanyl and its derivatives, is estimated to be $3.8 billion in 2023, growing at a compound annual growth rate (CAGR) of 5.4%. Oral fluid drugs of abuse testing market is estimated at $38.8 million in 2023. However, there is currently no FDA-approved or cleared rapid diagnostic for fentanyl screening at the POC. In this phase I STTR proposal, Instanosis Inc will partner with University of Pennsylvania to develop and commercialize a rapid onsite screening diagnostics (sFENTANYL) that can be deployed at the patient’s side to quickly identify fentanyl in saliva. In sFENTANYL, saliva is collected using swabs, quickly extracted and applied to the saliva lateral flow assay (sFENTANYL) strip that can effectively detect 0.1 ng/mL fentanyl in saliva within 5 min. Readout is visual with naked eyes, with no need for external instruments. This rapid diagnostic tool meets the clinical needs of fentanyl detection at the POC: rapid, sensitive, portable and low cost, and can be used in many settings, including first response vehicles, emergency departments, detoxification clinics, drug treatment clinics and patient homes. In Phase I, we will develop sFENTANYL with the needed analytical sensitivity and readout time, and conduct preliminary validation using deidentified clinical saliva samples.