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Blood test may serve as noninvasive alternative to colonoscopy
A study underway in West Virginia is designed to evaluate a novel blood test that may prove a more acceptable alternative for patients unwilling to undergo a screening colonoscopy.
Richard M. Goldberg, MD, FACP, FASCO, director of West Virginia University Cancer Institute and Mary Babb Randolph Cancer Center, and colleagues are using the Epi proColon test (Epigenomics) to detect methylated Septin9, considered a promising biomarker for colorectal cancer screening.
“Early detection is the key to optimal survival for virtually every cancer,” Goldberg told HemOnc Today. “Anything that we can do to increase screening rates will improve the health of West Virginians, and we hope this Septin9 test will be broadly applicable across the world should this method prove feasible.”
West Virginia is a sparsely populated state, and many residents live in rural communities that lack access to providers who can offer all endorsed options for colorectal cancer screening.
Epi proColon — an FDA-approved proprietary DNA methylation biomarker test — will be offered to women who meet screening guidelines but have not been screened.
The test will be performed by the staff who operate Bonnie’s Bus, a mobile unit that provides mammograms to women at rural health clinics.
Blood draws will take place in the rural clinics where the bus parks during screening visits, and samples will be stored on the mobile unit until testing can be performed.
Women who test positive for Septin9 will receive a recommendation from a health care provider for a colonoscopy.
Researchers will compare results from the blood test and colonoscopy to assess the sensitivity and specificity of the less-invasive approach.
Epigenomics will pay for colonoscopies for individuals who test positive for Septin9 but do not have insurance that will cover the cost.
The study’s target enrollment is 300 women, and 100 have been enrolled so far.
Colonoscopies rank among the cancer screenings most frequently recommended by medical societies and other professional organizations. However, many individuals opt not to undergo the procedure.
“People delay or do not screen for a number of reasons, including fear, access to care, lack of insurance that covers the test, travel, time and lack of awareness for the need of colorectal cancer screening,” Stephenie Kennedy-Rea, director of cancer prevention and control at West Virginia University, said in a press release. “We need to shine the light on the need for colorectal cancer screening and the fact that there are a number of evidence-based screening options available to patients.”
The researchers hope women who undergo mammography screening through Bonnie’s Bus represent a subset of individuals who are predisposed to consider health promotion, making them more willing to accept a recommendation for a blood test to screen for colorectal cancer.
Accrual is expected to be completed in 18 to 24 months, with study results available within 3 months of closure.
“The genomic revolution is changing not just the way we diagnose patients, but also the way we treat them,” Goldberg said. “Next-generation sequencing has now become much less expensive and increasingly automated. We are looking at new applications of these innovations and trying to figure out how best to exploit the new knowledge.” – by Joe Gramigna
For more information:
Richard M. Goldberg, MD, FACP, FASCO, can be reached at P.O. Box 9300, 1805 Health Sciences Center, South Morgantown, WV 26506; email: richard.goldberg@hsc.wvu.edu.
Disclosure: Goldberg reports no relevant financial disclosures.