March 31 2015
EDP Biotech Signs Distribution Partnership Agreements for ColoMarker® Abroad
ColoMarker®is a simple, sensitive blood test that aids in detection of earlystage colorectalcancer.
Knoxville, Tenn. – (March 31, 2015) – EDP Biotech Corporation (EDP), a global in vitro diagnostic innovator of a simple blood-based cancer diagnostic test, announces it has entered into distribution agreements with more than twenty-five market leading distribution channel partners throughout Europe, Asia, and South America. EDP plans a multiphase roll out of ColoMarker®, a blood test that aids in detection of early stage colorectal cancer, in 2015 to gain experience and data in conjunction with KOLs and distributor partners. These new partnerships continue to broaden EDP’s global presence.
ColoMarker enables clinicians to use a simple blood sample to quickly detectCA11- 19™, a biomarker that is highly correlated to early stages of colorectal cancer.EDP expects that ColoMarker’s superior test performance, convenience, and cost effectiveness will significantly improve compliance withcolonoscopy-basedcancer screenings, when compared to existing fecal testing options. EDP’sColoMarker test provides patients a new choice in detecting and fighting colorectal cancer in its early stage, when the disease is most treatable. For moreinformation about ColoMarker, please visitwww.ColoMarker.com.
“We are excited to team up with our IVD distribution partners that can systematically help accelerate our commercialization ability to introduce the ColoMarker blood test. We looked exhaustively at companies that had the expertise and acumen to meet our very demanding needs,” said Alan Jernigan, CEO of EDPBiotech. “Our 25 new distribution partners are keen to begin launch activities. We feel confident that ColoMarker will result in increased patient compliance, reductions in healthcare expenditures and saved lives. With our extensive network of distributor partners we are truly becoming a global company prepared to meet the needs of clinicians who provide treatment to colon cancer patients and those patients seeking non-invasive solutions to early detection. Additionally, this market experience will put us in a great position to meet our goal of FDA submission later thisyear.”
ColoMarker has been tested in multiple sites with a large number of sampleshaving both known and unknown stages of colorectal cancer (stages I-IV). In a recent multi-center study, clinicallyverified ColoMarker results demonstrated a sensitivity approaching 100% for early stage colorectal cancer (stages I-II) and an overall cancer detection rateof around 98% with a specificity of 84%. Dr HerbertFritsche, Professor Emeritus of Laboratory Medicine and Chief of Clinical Chemistry atMD Anderson Cancer Center and Consultant to EDP states that “Routine colonoscopy isthe best way to detect colon cancer and high risk polyps, but many people arenot compliant. A simple blood test will be a welcomed option to the current fecaloccult blood- and DNA-based assays for a directedcolonoscopy.”
Colon cancer is the third most diagnosed cancer and second leading cause ofcancer- related deaths in the US and is expected to cause nearly 50,000 deaths in2015. However, colon cancer is one of the most treatable cancers and if detected early,the five-year survival rate is nearly 90%. Unfortunately, only about 40% of peopleare diagnosed at this early stage when treatment is most likely to be successful and 1 in3 people over 50 years of age are not screened at all. Abnormal growths called polypsare very common in the colorectal tract yet some can become cancerous over time.While there are currently several options available for cancer screening, people are oftennot screened due to lack of awareness, the high cost, inconvenience and invasivenessof current testingoptions.
About EDP BiotechCorporation
EDP Biotech is dedicated to the development and commercialization ofinnovative cancer diagnostics that are simple, accurate and cost-effective includingthe ColoMarker® ELISA kit for detection of early stage colorectal cancer. EDP Biotechhas research, license or commercialization agreements with leading institutions, includingGI Associates and Covenant Health. ColoMarker is not cleared for clinical use in theUS. For more information on EDP Biotech, visit our websites: www.ColoMarker.comor www.EDPbiotech.com.
This release contains forward-looking statements within the meaning of the PrivateSecurities Litigation Reform Act of 1995. Statements contained in this release that are not historicalfacts, including, without limitation, statements that relate to the EDP’s expectations with regard tothe future impact on the EDP’s results from new products in development, may be deemed tobe forward-looking statements. Words such as “expects”, “intends”, “plans”, “may”,”could”, “should”, “anticipates”, “likely”, “believes” and words of similar import also identifyforward- 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 basedon forecasts of future results, estimates of amounts not yet determined and assumptionsof management. Readers are urged not to place undue reliance on theforward-looking statements, which speak only as of the date of this release. Except as may be requiredunder applicable law, we assume no obligation to update any forward-looking statements in orderto reflect any event or circumstance that may arise after the date of thisrelease.