Dr. Ken Pritzker, a globally respected pathologist, made significant strides in medical innovation as the Chief of Pathology at Toronto’s Mount Sinai Hospital from 1986 to 2008. With a career rich in leadership, over 290 scientific publications, and expertise spanning genomics, biomaterials, and cancer diagnostics, Pritzker co-founded Proteocyte AI in 2011. This was a pivotal moment in oral cancer diagnostics, as the company launched Straticyte™, a predictive test that has transformed early prognosis and patient management.
The Birth of Straticyte™
Straticyte™ stemmed from groundbreaking research by Dr. Ranju Ralhan and Michael Siu, who identified that the accumulation of the S100A7 biomarker indicated a higher risk of oral lesions developing into cancer. Given the high mortality rate (50%) of oral cancer, often due to late diagnoses, this discovery was crucial. Traditional histopathological evaluations of biopsies are prone to observer variation and frequently do not correlate well with cancer risk. Straticyte™ addressed these shortcomings by combining immunohistochemistry (IHC) with digital morphometry to provide more consistent, objective, and reliable results.
Why Straticyte™ is a Game-Changer
The test’s sensitivity of 96% and negative predictive value (NPV) of 95% are substantially higher than conventional dysplasia grading, which stands at 75% and 59%, respectively. Straticyte™ enables clinicians to predict the probability of dysplastic lesions progressing to cancer within five years, guiding more effective monitoring and timely intervention. For patients with low Straticyte™ values, it provides reassurance and allows them to return to regular life, while those with elevated values receive close follow-up to prevent potential cancer development.
Visiopharm’s Role in Straticyte™’s Success
Visiopharm’s advanced software plays an integral role in Straticyte™’s workflow. Dr. Pritzker and his team had a long-standing relationship with Visiopharm, leveraging its cutting-edge digital analysis to quantify biomarkers and assess cellular morphology. This collaboration has ensured that Straticyte™ can be seamlessly integrated into diagnostic processes, delivering precise and reproducible results. The software’s adaptability allowed Proteocyte AI to build applications that streamline the process from initial tissue detection to score calculation.
Straticyte™ in Practice
Physicians already collect biopsies from patients with potential pre-cancerous oral lesions. If the initial pathology suggests the possibility of pre-cancer, the samples are sent to Proteocyte’s partner labs, where IHC staining is performed. The digital images are then analyzed by Proteocyte, and a detailed and individualized, report is sent back, aiding doctors in decision-making and ensuring high-risk patients are properly monitored.
Validation and Expansion
Starting with data from 250 Canadian patients, Proteocyte expanded its research to multiple sites, including locations in the U.S. and Ireland. This extensive database of over 600 cases, with documented follow-up data, is unmatched globally. Such a broad dataset allowed Proteocyte to fine-tune Straticyte™ and validate its effectiveness across various demographics and healthcare settings, underscoring the test’s robustness and global applicability.
With ongoing efforts to refine their product, Proteocyte AI continues to push the boundaries of what’s possible in cancer diagnostics, demonstrating the power of innovation, collaboration, and clinical insight in transforming patient outcomes.