Vigilant Biosciences, Inc. Marks Significant Milestone with ISO 13485:2003 Certification
Company Advances Towards CE Mark and Commercialization of its OncAlert™ Oral Cancer Risk Assessment Kit
MIAMI, Dec. 10, 2014 /PRNewswire/ -- Vigilant Biosciences, Inc. ("Vigilant"), an oncology company specializing in point-of-care and lab-based products 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-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.
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 oral cancer risk assessment kit 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 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) – 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 World Health Organization, there are over 600,000 new cases of head and neck cancer and 300,000 deaths each year worldwide. In the United States, more than 54,000 individuals will be diagnosed with head and neck cancers in 2014, with 13,500 deaths from the disease. Historically the death rate associated with this cancer is particularly high due to late-stage diagnosis and intervention. Early diagnosis of oral cancer results in a cure rate of up to 90 percent.
About Vigilant Biosciences, Inc.
Vigilant Biosciences, Inc. is an oncology company specializing in point-of-care and lab-based products that aid in the early detection and intervention of cancer. The company's initial product development initiatives are aimed at overcoming the oral cancer challenge – identifying more cancers at an earlier stage and thereby improving overall survival rates while minimizing healthcare costs. For more information, visit www.vigilantbiosciences.com.
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SOURCE Vigilant Biosciences, Inc.
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