Toronto, ON; March 17, 2022 – Proteocyte AI, a company dedicated to producing a range of technological solutions that predict a patient’s risk of developing oral cancer, has reached an important milestone in the regulatory process for Straticyte™, its first commercial offering.
The company successfully completed the American Association for Laboroaty Accreditaiton (A2LA) evaluation process, and is now recognized for technical competence in the field of clinical testing. Accreditation has been granted to Proteocyte to allow its laboratory to perform certain types of testing on human samples, in accordance with ISO 15189:2012 (Medical Laboratories – Requirements for Quality and Competence).
“This is a very important milestone for us,” says Proteocyte CEO Mark Hammar. “It allows for full commercialization in Canada and opens the door to the US market as well, pending CLIA certification. We hold our products to the highest clinical standards, and regulatory certificaiton is central to creating a safe and effective oral cancer product like Straticyte.”
The American Association for Laboratory Accreditation (A2LA) is among the largest accreditation bodies in the world and the only independent, 503(c)3, non-profit, internationally recognized accreditation body in the United States that offers a full range of comprehensive conformity assessment accreditation services.
Proteocyte is a personalized medical diagnostics company located in MaRS Centre, Toronto, ON. Proteocyte’s product helps 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.