Proteocyte AI is a Canadian medtech company that uses proteomics to individually assess cancer risk in vulnerable patients. The STRATICYTE test, which assigns a five-year oral cancer risk score to patients with oral pre-cancer (OPMD), has just become commercially available after years of development and research. It has been made possible by the Proteocyte team, a very experienced, diversified, balanced, and extremely driven group that includes oral surgeons, head and neck surgeons, otolaryngologists, medical pathologists, oral pathologists, and health research scientists.
Oral cancer develops in hundreds of thousands of new patients globally each year. Unfortunately, the five-year survival rate of 50-60% has stood relatively unchanged over the past 50 years. The high mortality of this disease is due to late presentation for definitive and potentially curative treatment. Only 25% of oral cancer patients present with early disease.
Cancer developing from the mucosal lining of the mouth and 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 a number of conditions comprising the WHO OPMD classification system, some with malignant transformation rates as high as 36%.
Identifying high-risk patients and managing them appropriately should lead to diagnosis of OSCC at the earliest stages of micro-invasion, thus lowering the mortality and morbidity of this disease. Some cases of OSCC may in fact be prevented with aggressive management of high risk OPMD patients.
Clinical oral examination, even with the assistance of various dyes and lights, cannot reliably identify OSCC or OPMD high risk patients. Clinicians must biopsy suspicious lesions and have routine histopathology performed on the submitted tissue.
The “gold standard” for assessing risk of OPMD lesions that may undergo malignant transformation has been dysplasia grading. Dysplasia grading is a subjective microscopic opinion from the pathologist regarding how abnormal the biopsy tissue is. Dysplasia grading has poor reproducibility and poor cancer predictive ability, but it has governed OPMD patient management for decades.
For many years, there has been a world-wide search for a reliable biomarker that can be objectively quantified and analyzed in OMPD patients and be used to predict cancer risk. Most potential tests are still a long way away from actual clinical use.
Proteocyte AI now offers the STRATICYTE test for use in the management of OPMD patients, which has the backing of numerous key opinion leaders who have been waiting for years to have an accurate biomarker to assist with the care of these patients.
If a suspicious oral lesion is identified and biopsied by the surgeon, and a diagnosis of OPMD is rendered, unstained microscopic slides from the lab handling the original biopsy tissue are requested for STRATICYTE testing. STRATICYTE testing can be seamlessly incorporated into your practice as no additional biopsy is required. The slides are immunohistochemically stained for a cellular protein called S100A7 which is involved in cell replication and invasion in many cancers. The digitalized microscopic images are computer scanned and analyzed for S100A7 and cellular morphology and the results are compared with a large database of patients followed for many years that have or have not gone on to develop OSCC. An individualized five-year oral risk is assigned to the patient as either low or elevated, directing appropriate surveillance.
High risk patients will be monitored and treated more aggressively. Clinicians and patients can now feel confident that their care is being guided by an advanced and truly objective test.
Ultimately, it comes as no surprise that Proteocyte AI has recently been recognized in the Global Excellence Awards 2023 with Best Innovative Prediction Platform, 2023 – Canada. As the company continues to develop new products to address oral cancer as well as other human cancers, 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.
The STRATICYTE test is now commercially available to order in Canada and the US.
ORDER THE TEST. PROTEOCYTE DOES THE REST. ORDER THE STRATICYTETM TEST ONLINE! Visit proteocyte.com or call: 1-833-5-PROTEO (1-833-577-6836) Or email: [email protected]
Proteocyte hopes to see STRATICYTE available globally in the near future. The sensitivity and specificity performance of the STRATICYTE test is comparable to other cancer prediction tools such as Mammaprint and Endopredict.
“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 stratify patients and personalize their treatment.”– Dr. Deepak Kademani, DMD, MD, FACS Fellowship Director, Head and Neck Oncologic and Reconstructive Surgery, Minnesota Oral and Facial Surgery