Development of an automated, point of care DNA methylation cartridge blood test for colorectal cancer detection in LMICs- an academic-industrial partnership

ABSTRACT Colorectal cancer (CRC) is diagnosed at advanced stages in many low- and middle-income countries (LMICs). The lack of knowledge of CRC signs and symptoms by patients and community health practitioners frequently leads to delayed presentation with Stage 3-4 disease. This initial delay, paired with limited colonoscopy facilities,

leads to prolonged diagnostic delays. The result is a 5-year mortality rate in LMIC up to 5 times higher than that in USA. An innovative solution to this problem could be an affordable, easily deployable, “point of care” molecular test to identify and prioritize patients likely to have a malignancy for expedited colonoscopy and pathology review

leading to better outcomes. Continuing our established collaboration with our industrial partner, Cepheid, we propose to build on our strong published data on hypermethylated markers in CRC to develop an affordable,