MaRS Discovery District, Toronto, ON; January 18, 2021 – Proteocyte AI, a personalized medicine and diagnostics company located in MaRS Center, Toronto ON, announces today that the first Clinical Advisory Board (CAB) meeting with some of the most renowned global key opinion leaders in oral cancer was hosted today.
The members convened virtually to frame the Company’s strategic steps to commercialization, the upcoming post-marketing surveillance (PMS) study, and current observational study, now registered on ClinicalTrials.gov. A complete list of the new Clinical Advisory Board can be found here.
During the meeting, members discussed the dominant clinical unmet need among dysplasia patients and the high risk, of up to 30%, of precancerous oral dysplasia progressing to oral cancer. According to the American Cancer Society, oral cancer carries a high mortality – 35% of patients die within 5 years of diagnosis. When compared to breast, prostate, and thyroid cancers with greater than 90% of patients surviving 5 years, oral cancer carries one of the worst prognoses.
Dr. James Melville of University of Texas at Houston, highlighted the unique value proposition of the Straticyte test:
“The majority of patients care about their health. If I can tell the patients that there is a test that can give you an actual quantifiable number to further stratify a dysplastic lesion for better management and planning, many patients would likely agree to take the test. Since a biopsy is already taken and the same biopsy is used for the additional test, a potential barrier is removed since the patient would likely not want to undergo an additional procedure.”
Though it is difficult to calculate an exact number, the Proteocyte CAB estimates nearly 2 million oral biopsies are performed in the USA and Canada each year. This number represents a fraction of the 2.5 – 5% of the population with oral lesions – white or red patches – on the tissues of the tongue, gums, or palate. The specific addressable market for the test is any patient, with any lesion of the mouth. Performance characteristics for the test, however, have not been established.
“Evidence-based results are key. When the patients know that a device/test works, they will lobby for inclusion of it into the standard of care, which is key for reimbursement. And if the device/test that is offered is the only one available, you don’t have any choice or options, except to use that one device/test.”
The company plans its next CAB meeting, centering around the launch of the pivotal PMS study in April of 2021.
Proteocyte AI is a personalized medicine and diagnostics company located in MaRS Center, Toronto, ON. Proteocyte’s products help tackle the uncertainty surrounding oral cancer care, one of the most aggressive human cancers. The company’s oral dysplasia predictive test, Straticyte, was developed from a panel of 811 protein biomarkers, leverages over 10 years of R&D, and is positioned to disrupt oral dysplasia and cancer care worldwide.