Shaun P. Forbes, PhD, Victoria Raymond, MS, Nicole Zhang, MPH, Amar K. Das, MD, PhD Guardant Health, Palo Alto, CA
Introduction: A blood-based CRC screening test can improve screening adherence, most importantly in those who have deferred or delayed screening due to inherent barriers with existing options, especially those aged 45-49 and those from diverse racial/ethnic communities who are disproportionally impacted. Leveraging a real-world evidence (RWE) clinical claims database, we report the demographics and screening history of individuals who underwent blood-based CRC screening.
Methods: Shield is a qualitative Laboratory Developed Test (LDT) validated in a CLIA/CAP-accredited laboratory (Guardant Health, CA) for the detection of colorectal neoplasia associated biomarkers, intended for average risk screening in individuals age 45+. Anonymized results from consecutively tested patients (May 2022 to February 2023) were linked, using a secure and HIPAA-compliant methodology, to a de-identified encounters database containing medical and pharmacy claims to provide a view of patients’ demographics and clinical journeys, including prior screening history and real-world clinical outcomes.
Results: A cohort of 8,057 tested individuals was identified in the RWE platform as having verifiable insurance coverage at any time. Median age: 60 years (16%, 45 – 49; 53%, 50 – 64; 32%, 65+). 61% were female. Race/ethnicity were recorded for 63% of the cohort, 17% were of Hispanic/Latino ancestry. Of those with non-Hispanic/Latino ancestry, 9% were Asian or Pacific Islander, 11% Black or African-American, 70% White, 10% multiple or other race. 18% of the cohort had active medical insurance coverage for 3+ years prior to test date and did not have any claims suggesting above average CRC risk. 89% of this subcohort did not have any claims for CRC screening (direct visualization, imaging, or stool-based) for 3+ years prior to the test date, confirming no recent screening. In this subcohort, race and ethnicity was recorded as 17% Hispanic/Latino, and non-Hispanic: Asian, 8%, Black/African-American 9%, White, 57%, and multiple or other race, 8%. Data are maturing to evaluate clinical follow-up after blood-based test results.
Discussion: In over 8,000 people screened for CRC using a blood-based test, demographics were consistent with US demographics, highlighting broad uptake of the test. Where data were available, 89% of tested average risk individuals did not have any recent CRC screening, demonstrating blood-based testing’s ability to address the unscreened population.
Disclosures:
Shaun P. Forbes: Guardant Health – Employee, Stock-publicly held company(excluding mutual/index funds).
Victoria Raymond: Guardant Health – Employee, Stock Options, Stock-publicly held company(excluding mutual/index funds).
Nicole Zhang: Guardant Health – Employee, Stock-publicly held company(excluding mutual/index funds).
Amar K. Das: Guardant Health – Employee.
Shaun P. Forbes, PhD, Victoria Raymond, MS, Nicole Zhang, MPH, Amar K. Das, MD, PhD. P0171 - Evaluation of Real-world Clinical Use of a Blood-based Colorectal Cancer Screening Test Using a Real-World Evidence Platform, ACG 2023 Annual Scientific Meeting Abstracts. Vancouver, BC, Canada: American College of Gastroenterology.
