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InnoTech Precision Medicine Awarded NIH SBIR Phase II to Advance Point-of-Care Detection of HPV-Related Oropharyngeal Cancer

August 8, 2025

InnoTech Precision Medicine is proud to announce the receipt of Phase II funding from the NIH to continue the development of Recognize™-OPSCC, a saliva-based, point-of-care diagnostic test for oropharyngeal squamous cell carcinoma (OPSCC). OPSCC is the sixth most common cancer globally, with incidence rising due to high-risk HPV infections, particularly HPV16. Current screening methods rely on observational assessment, and invasive biopsy procedures often delay diagnosis and treatment.

Recognize™-OPSCC provides a rapid (under 30 minutes), non-invasive, and highly accurate alternative. The system 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. Its multiomics approach simultaneously detects genotypic markers, phenotypic markers of cancer progression, and a reference gene, enabling reliable detection directly in clinicians’ offices.

Phase II objectives include pilot manufacturing under GMP/GLP standards and conducting clinical validation studies across multiple partner sites to ensure accuracy, sensitivity, and specificity.

Recognize™-OPSCC represents a transformative opportunity in cancer diagnostics, providing a rapid, accurate, and non-invasive alternative to traditional biopsies. By enabling early detection and routine screening, this technology has the potential to improve patient outcomes, advance the standard of care for OPSCC, and address a critical unmet need in oncology.