Advancement of a Point-of-Need (PoN) platform device for accurate and destigmatized detection of recent cannabis use

Ricovr Healthcare Inc., Princeton NJ

Investigators

Abstract

Project Summary Cannabis use has continued to rise, leading to an increase of individuals with Cannabis Use Disorder (CUD). Further, legalization of recreational cannabis in States across the U.S. is associated with additional public health concerns including increased workplace injuries, vehicle accidents, and cannabis induced psychosis. Despite these trends, there is not yet an effective and scalable product for detecting recent cannabis use at the point-of- need (PoN) to mitigate these harms. Ricovr Healthcare is developing its plasmonic fiber optic absorbance biosensor (P-FAB) technology to create a PoN device that can accurately quantify Δ-9-tetrahydrocannabinol (THC) in saliva for determining recent cannabis consumption with an automated, easy to use workflow that decouples the stigma associated with current drugs of abuse (DoA) screening methods. Ricovr Healthcare provides significant advances for DoA detection compared to existing tools that have deficient sensitivity and accuracy, are not amenable to PoN use, and are prohibitively expensive. Coupled with administrator intervention, XALIVA® will eliminate the burden of stigma in monitoring processes at workplaces, roadsides, and healthcare settings to improve outcomes for both users and administrators. Ricovr Healthcare has developed its innovative P-FAB technology into an automated PoN diagnostic device that can quantitatively measure analytes at ultrasensitive concentrations from 1 fg/mL to 1 ug/mL. The platform is comprised of an automated reader device and a disposable microfluidic cartridge that performs an automated immunoassay using gold nanoparticle conjugates that can be easily operated at the PoN. Ricovr has demonstrated measurement of THC in authentic oral fluid using P-FAB with a limit of quantification of 2 ng/mL; this is more sensitive than the guidance from the United States Substance Abuse and Mental Health Services Administration (HHS/SAMHSA) and Department of Transportation (DOT) for a 4 ng/mL THC cut-off for a screening test. The use of saliva to detect recent cannabis consumption has distinct advantages over other matrices such as urine, blood, or breath; both the SAMHSA and DOT have endorsed saliva as the preferred matrix for drug testing programs. Ricovr Healthcare believes that there is a high significance and commercial potential for this product. This proposal is to build on the current SBIR Phase I project and participate in the NIH I-Corps program to test the Ricovr Healthcare team’s current hypotheses for market needs and target customers. The successful completion of the project will refine Ricovr Healthcare’s commercial plan and position the team for a successful SBIR Phase II proposal involving clinical trials to validate the effectiveness of XALIVA® for determining recent cannabis consumption. Commercialization of the assay will enable safe, fair, drug-free workplaces and roadways and provide new tools for healthcare workers in treating patients with CUD while de-stigmatizing the drug screening process.