Proteocyte is a privately owned med-tech company located on Hospital Row in downtown Toronto, Canada, focused on developing advanced diagnostic lab tests to predict patient risk of developing cancer. Specifically, the company uses proteomic assays to predict future cancer risk, thus identifying patients at high-risk of developing cancer. This information can then be used to direct more effective patient management. STRATICYTE is the first commercial product launch from Proteocyte to receive accreditation for clinical use in both Canada and USA, specifically focused on oral cancer prediction.

STRATICYTE is the 1st commerical launch specifically focused on predicting the risk of developing ORAL CANCER using a protein biomarker (S100A7) and advanced digital pathology to produce a 5-year risk score of developing oral cancer. STRATICYTE is a proteomic based test that predicts the 5-year risk of oral cancer development in someone who has had an intra-oral biopsy which was diagnosed as an oral potentially malignant disorder (OPMD). Identification of the high-risk patient is essential in effective long-term management.

A diagnosis of OPMD by conventional histopathology is an absolute pre-requisite to perform the STRATICYTE test. OPMD diagnoses defined by the WHO include: unexplained leukoplakia, (hyperkeratosis), erythroplakia, oral lichen planus, lichenoid mucositis, dyskeratosis congenita, graft vs host reaction, proliferative verrucous hyperplasia, oral submucous fibrosis, actinic cheilitis (keratosis), oral lupus erythematosis, and palatal lesion of reverse smoking.

The STRATICYTE test is performed using tissue sections from the original biopsy. The tissue sections are immunohistochemically stained for the cancer associated protein biomarker S100A7. It is then digitized, analyzed, and a STRATICYTE score is generated, with the help of computer-assisted digital pathology. This score is compared to our patient cohort of known clinical outcomes to generate an individualized, 5-year oral cancer transformation risk.

In a recent study of 302 patients tested with STRATICYTE, the test had a sensitivity of 95%, meaning that 95% of those patients that will develop cancer will be identified as high-risk.

The test must be ordered by a licensed health care provider. The test requisition form is completed and submitted. Simply order the test, we do the rest. The current early adopter cost of the test is $500 USD or $650 CDN. The fee is collected by our intermediary Patient Care Solutions. A receipt and documents for potential reimbursement will be issued to the patient. An individualized, personal STRATICYTE report will normally be issued in approximately 3 weeks to the ordering clinician.

Please consult our website https://proteocyte.com for more information. Our website also provides contact details to communicate with a Proteocyte representative directly.