Vigilant Biosciences, Inc. (“Vigilant”), a leading developer of solutions that aid in the early detection and intervention of cancer, today announced that it 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 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.
For Vigilant, the certification 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 OncAlert technology to market,” said Matthew Kim, founder and chief executive officer 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 OncAlert Oral Cancer product line 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) – collectively representing a $3.9 billion United States market and $10.2 billion worldwide market. 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.
According to the Oral Cancer Foundation, there are over 640,000 new cases of oral cancer each year worldwide. In the U.S., close to 48,250 individuals will be diagnosed with oral or pharyngeal cancer this year, with 9,575 deaths from the disease, killing roughly one person per hour, 24 hours per day. Historically the death rate associated with this cancer is particularly high due to late-stage diagnosis and intervention. Currently, the vast majority of patients are detected through a visual exam and/or are symptomatic, at which point they are likely late stage. As a result, oral cancer often goes undetected to the point of metastasizing. Early diagnosis of oral cancer results in a cure rate of up to 90 percent.
About Vigilant Biosciences, Inc.
Vigilant Biosciences is a leading innovator and developer of solutions that aid in the early detection and intervention of cancer. Vigilant’s OncAlert Oral Cancer product line includes rapid and lab-based products that are simple, accurate and cost-effective, and empower healthcare practitioners to improve lives through earlier intervention. The OncAlert Oral Cancer product line is not yet available for sale in the U.S. For more information, visit www.vigilantbiosciences.com.