KNOXVILLE, TN – 28 Oct, 2015 – 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.
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements contained in this release that are not historical facts, including, without limitation, statements that relate to the Company’s expectations with regard to the future impact on the Company’s results from new products in development, may be deemed to be forward-looking statements. Words such as “expects”, “intends”, “plans”, “may”, “could”, “should”, “anticipates”, “likely”, “believes” and words of similar import also identify forward-looking statements. These statements are subject to risks and uncertainties. Forward-looking statements are based on current facts and analyses and other information that are based on forecasts of future results, estimates of amounts not yet determined and assumptions of management. Readers are urged not to place undue reliance on the forward-looking statements, which speak only as of the date of this release. Except as may be required under applicable law, we assume no obligation to update any forward-looking statements in order to reflect any event or circumstance that may arise after the date of this release.
Company Name: EDP Biotech
Name: Lisa Jensen-Long – Director of Marketing
Phone: (520) 247-6228
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Company Name: EDP Biotech
Contact Person: Kimberly Schmitz
Phone: (520) 247-5778
Country: United States