EDP Biotech Achieves ISO 13485 Certification

KNOXVILLE, TN--(Marketwired - October 28, 2015) -

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EDP Biotech, a privately-held company providing in-vitro diagnostic test kits for the detection of colorectal cancer, has achieved ISO 13485 and Canadian Medical Device Regulations Certification. The certification includes the design, development and production of its first product, the ColoMarker® ELISA kit, an enzyme immunoassay in vitro diagnostic test kit to aid in the detection of colorectal cancer in patients 50-75 years of age.

To earn this internationally recognized quality certification, an organization must establish it has effectively implemented a quality management system which demonstrates its ability to provide medical devices and related services that consistently meet customer and regulatory requirements. A medical device manufacturer's quality management system is the foundation for maintaining regulatory compliance, driving improvement, increasing efficiency and achieving stakeholder confidence in the manufacturer and its products.

"The achievement of the ISO 13485 and CMDCAS certification demonstrates EDP Biotech's commitment to quality and attention to detail in the development and provision of ColoMarker brand products, laying a solid foundation for the future growth of EDP's clinical diagnostics business," stated Dennis Forbush, Director of Quality Assurance and Regulatory Affairs at EDP Biotech.

"This is a milestone achievement for EDP Biotech. It demonstrates to the international community that we are passionate about providing exceptional quality in all aspects of our business in order to improve early diagnosis of diseases, including colorectal cancer," said Eric Mayer, CEO of EDP Biotech.

About EDP Biotech
Based in Knoxville, Tenn., EDP Biotech is dedicated to the development and commercialization of innovative cancer diagnostics, including simple, cost-effective, and accurate ELISA-based colon cancer technology. For more information on EDP Biotech, EDPbiotech.com. ColoMarker received CE Mark approval in late 2014 and is not currently approved for clinical use in the United States.

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