Vigilant Biosciences, Inc., marks significant milestone with ISO 13485:2003 certification

Vigilant Biosciences, Inc., an oncology company specializing in point-of-care and lab-based products that aid in the early detection and intervention of cancer, has received ISO 13485:2003 certification, an internationally recognized quality standard for medical devices. The ISO 13485:2003 certification covers the design, development, production, sales and service of Vigilant's OncAlert oral cancer-specific risk assessment products.

This certification demonstrates that Vigilant has successfully implemented a quality management system that conforms to the worldwide standard for medical device and diagnostic manufacturing, and marks a pathway to achieving a CE Mark for sale of its products in the European Union, and additional regulatory approvals needed for commercialization of its products worldwide.

“Obtaining ISO certification is a significant step forward for Vigilant as we continue our efforts to bring our oral cancer risk assessment kit to market,” says Matthew Kim, founder and CEO of Vigilant Biosciences, Inc. “As thousands continue to be diagnosed with oral cancer every year, we are committed to providing a simple, specific, and cost-effective way to aid in the detection of the disease in its earliest stages. This accomplishment will help us to achieve that goal.”

The Vigilant oral cancer risk assessment kit is formulated to detect proteins specific to oral cancer captured by an oral rinse. The test can be applied to every adult at risk, with particular emphasis on tobacco users, those who consume alcohol, and people with human papillomavirus (HPV). In a 300 patient study, the largest oral cancer study of its kind, the kit demonstrated the ability to detect tumors early and across a racially and ethnically diverse population.