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 TheraLeadTM Colorectal Cancer


TheraLeadTM CRC – Early Colorectal Cancer Detection

Colorectal Cancer, CRC, is one of the most common cancers in the industrialized world and is highly treatable and curable in 90% of cases when it is detected early.  At later stages of disease, CRC treatments are less effective and are more invasive and costly.  A variety of methodologies are available for early detection including fecal occult blood tests (FOBT) and colonoscopy.  While colonoscopy is highly effective in identifying cancer and precancerous polyps, its cost and inconvenience has led to only about 50% of 50-74 year old individuals in the US being current with recommended screening.  In Europe FOBT is the more common screening method,
colonoscopy is part of some countries screening programs, however, even though FOBT is easier and less costly to perform only about 15% of 50-74 year olds having been screened in the EU15 but with high variation between countries with more than 50% being screened in Germany and  1.3%  in Romania and  all  the other countries at  
25% or less (the Organisation for Economic Co-operation and Development, OECD)  It is well established at this point that routine screening programs for colorectal cancer improve patient outcomes and survival as well as lower treatment costs due to identifying cancers in earlier stages when they are more treatable at lower cost, however, compliance with these screening programs remains low. Studies have shown that non-invasive methodologies
for CRC screening can improve adherence (Arch Intern Med. 2012 Apr 9;172(7):575-82.) and that among non-invasive methodologies that a blood test would be preferable to stool based methodologies where the stool is collected by the patient (Taber, et.al., Abstract: American Society of Preventative Oncology 2012).



Clinicogen has developed a blood based Real Time PCR molecular assay, TheraleadTM CRC.   In clinical studies of both CRC and healthy patients the assay has been shown to be highly sensitive (92%) and highly specific (95%) when directly compared to colonoscopy results.

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