Point of Care Detection of HPV and P16 in Saliva

ABSTRACT Oropharyngeal squamous cell carcinoma (OPSCC) is the sixth most common cancer globally, with its incidence rising due to high-risk HPV infections, particularly HPV16. Current screening methods are primarily observational, and diagnostic procedures for observable lesions are invasive and time-consuming, often leading to delayed diagnosis and treatment. This project aims to improve human health by developing Recognize™- OPSCC, a saliva-based, point-of-care diagnostic test that offers rapid (within 30 minutes), non-invasive, and accurate detection of OPSCC. Recognize™-OPSCC integrates a reusable, ultraportable, AI-enabled device with a test kit that includes an FDA-approved saliva collection device and a disposable diagnostic cartridge containing lyophilized reagents for simultaneous detection of genotypic and phenotypic markers of OPSCC. The innovation lies in its multiomics approach, which simultaneously detects genotypic markers (such as HPV16 and HPV18) and phenotypic cancer progression markers of OPSCC, along with a reference gene, directly at the point of care in doctors’ offices. The long-term goal of this project is to establish Recognize™-OPSCC as a reliable, non- invasive alternative to biopsy, enhancing early detection and enabling timely treatment of OPSCC, thereby improving patient outcomes. The specific aims of Phase II are: (1) to optimize the device's optical detection system to improve sensitivity and enhance accuracy, (2) to use clinical specimens to validate the test's accuracy, sensitivity, and specificity in detecting OPSCC compared to gold-standard standard of care methods, and (3) to evaluate the stability and performance of lyophilized reagents under various conditions. The Phase II objectives include pilot manufacturing of devices under GMP/GLP standards and conducting clinical validation studies at multiple partner sites. Recognize™-OPSCC represents a significant commercial opportunity as it provides a much-needed solution for an accurate and rapid alternative to painful OPSCC detection, potentially replacing invasive diagnostic procedures and allowing routine screening by healthcare providers in primary care and dental settings using saliva. The successful development and validation of this test will advance the standard of care for OPSCC, align with the NIH mission to improve human health, and address a critical unmet need in cancer diagnostics.