Proteocyte AI: The Value of the STRATICYTETM Test Oral Cancer Risk Score

“Doctor, Will this Precancerous Lesion become CANCER?”

When a patient comes into the dental office with a white or red lesion inside the mouth, everyone wants to know, “Is it Cancer?”  Currently an office biopsy, the standard of care for diagnosis, only tells doctors and patients that a lesion is cancerous or precancerous but does not inform about the future behavior of a precancerous lesion.  These precancerous lesions are very common, affecting an estimated 14,000,000 people in North America annually.  Affecting the soft tissue lining the mouth, treatment of precancerous lesions has changed little in 40 years.

With the 5-year survival rate for oral cancer hovering near 60%, the need for early detection, prognosis and management is evident. Moreover, oral cancer advances silently, without producing pain or symptoms in many cases.  Traditional histopathological assessments of dysplasia grade, often used for prognostication, are subjective and inadequate, leading to undiagnosed patient risks and escalating late-stage treatment costs. In the face of these challenges, Proteocyte AI stands at the forefront of innovation, pioneering advanced diagnostic lab tests to predict patient risk of developing cancer. Founded in 2011, the company identified a critical need within the healthcare industry—to provide healthcare professionals with objective and quantifiable information that could significantly improve patient outcomes. Proteocyte AI’s groundbreaking approach combines personalized medicine with AI-driven technology, offering a new paradigm in cancer diagnosis and treatment.

Proteocyte AI has developed a groundbreaking solution—STRATICYTE—a prognostic test designed to accurately predict the progression of premalignant oral lesions to invasive oral cancer, offering healthcare professionals and patients alike a reliable tool for early prognosis and effective management. The company recognizes that over 70% of patients seek treatment only after the cancer has progressed to late stages, limiting treatment options and compromising patient outcomes. “Specifically focused on predicting the progression of premalignant lesions (OPMD) to invasive oral cancer, STRATICYTE offers high confidence prediction with 96% sensitivity and negative predictive value (NPV), outperforming traditional methods,” explains Dr. Anthony Morlandt, Chief Medical Officer-USA, Head and Neck Surgeon / Oral Oncology, University of Alabama, Birmingham.

Cancer developing from the mucosal lining of the mouth, called Oral Squamous Cell Carcinoma (OSCC), accounts for most oral cancer cases. Virtually all OSCCs develop from a pre-existing lesion called OPMD (Oral Potentially Malignant Disorder). There are several conditions comprising the WHO OPMD classification system, some with malignant transformation rates as high as 36%. At this point, the STRATICYTE test utilizes a protein biomarker (S100A7) and advanced digital pathology to produce a 5-year individual risk score of developing oral cancer. By seamlessly integrating into clinical practice as an adjunct to dysplasia grading, STRATICYTE enhances confidence and consistency in the management of OPMD patients. The test utilizes patient tissue from the original biopsy, streamlining the process and providing actionable insights for physicians and patients alike. In a nutshell, STRATICYTE represents a significant leap forward in oral cancer diagnosis and management. By accurately distinguishing between low and elevated risk lesions, the test enables early intervention and treatment, ultimately saving lives, improving quality of life, and reducing healthcare costs.

Proteocyte AI has invested over 12 years in research and development to create a proprietary prognostic software platform-based technology. This innovative platform digitally analyzes specific biomarkers, known as predictive proteomics, leveraging artificial intelligence to predict an individual’s progression to cancer accurately and objectively. By harnessing the power of AI, Proteocyte AI has revolutionized cancer prognosis, providing healthcare professionals with invaluable insights to guide patient care.


At the heart of Proteocyte AI is a team of highly experienced and dedicated professionals from diverse backgrounds. Comprising oral surgeons, head and neck surgeons, otolaryngologists, medical pathologists, oral pathologists, and health research scientists, the Proteocyte team is united by a common goal—to improve the early detection and treatment of cancer through innovative technology and collaboration.

Proteocyte AI has recently been recognized in the Global Excellence Awards 2023 with Best Innovative Prediction Platform, 2023 – Canada. “As a company, Proteocyte AI hopes to continue making a positive impact on the lives of patients at risk of oral cancer, as well as increasing its reach to clinicians and patients globally, reducing the mortality, morbidity, and the financial burden of oral cancer,” Mark Hammar, CEO Proteocyte AI.

As Proteocyte AI continues to innovate and expand its suite of prognostic solutions, the company remains committed to its mission of transforming cancer prognosis and management. Through cutting-edge technology, collaborative research, and a relentless pursuit of excellence, Proteocyte AI is shaping the future of healthcare, one patient at a time. With STRATICYTE leading the way, Proteocyte AI is poised to make a profound impact on oral cancer management, providing hope and healing to patients and healthcare professionals around the world.

Proteocyte AI

Dr. Barrie Renick, Chief Medical Officer

“Early detection is the key to saving lives and improving outcomes related to oral cancer. Straticyte is an innovative new test that can help us to better risk stratify patients and personalize their treatment.” Deepak Kademani, MD, DMD, FACS, Associate Professor, Department of Oral and Maxillofacial Surgery, University of Minnesota