Toronto, ON; June 29, 2026 – Proteocyte AI is pleased to announce that it has obtained a California Out-of-State Clinical Laboratory License authorizing the Company to perform STRATICYTE® testing on patient specimens originating in the State of California. This achievement represents a significant milestone in Proteocyte AI’s U.S. commercialization and market expansion strategy.
“This approval opens access to one of the largest healthcare markets in the United States and expands the availability of STRATICYTE® to clinicians and patients throughout California,” said Mark Hammar, Chief Executive Officer of Proteocyte AI. “We are excited to bring advanced oral cancer risk assessment to a broader population and support healthcare providers with actionable prognostic information that can improve patient management.”
With both CLIA certification and California licensure now in place, Proteocyte AI is positioned to offer STRATICYTE® testing to healthcare providers across California.
STRATICYTE® is the first clinically validated prognostic test designed to predict an individual’s personalized five-year risk of malignant transformation in Oral Potentially Malignant Disorders (OPMD). Utilizing proprietary artificial intelligence-driven biomarker analysis and advanced digital pathology, STRATICYTE® delivers objective risk stratification that complements conventional histopathologic assessment, helping clinicians make more informed surveillance, treatment, and surgical management decisions.
The addition of California licensure represents another important step in Proteocyte AI’s mission to improve oral cancer prevention through precision diagnostics and personalized patient care.
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About Proteocyte
Proteocyte AI is a precision diagnostics company headquartered in the MaRS Discovery District in Toronto, Canada. The Company is focused on transforming oral cancer prevention and management through innovative molecular diagnostics and artificial intelligence. Its flagship test, STRATICYTE®, addresses the uncertainty surrounding oral potentially malignant disorders by providing individualized risk assessment for malignant transformation. Developed from the discovery and validation of more than 811 protein biomarkers and supported by over a decade of research and development, STRATICYTE® is positioned to redefine risk assessment and clinical decision-making in oral dysplasia and oral cancer care worldwide.
www.proteocyte.com
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For more information please contact:
Todd Conrad
Director, Sales & Marketing
416-779-4806
[email protected]
