REAL-WORLD ADHERENCE TO BLOOD-BASED COLORECTAL CANCER SCREENING USING A METHYLATION PARTITIONING CELL-FREE DNA TEST
DDW ePoster Library. Raymond V. 05/02/26; 4199144; Tu1367
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Abstract
Discussion Forum (0)
Background: Although the number of colorectal cancer (CRC) screening options has expanded in recent years, the proportion of individuals who are up-to-date with CRC screening in the United States remains sub-optimal. Shield is a blood-based methylation partitioning cell-free DNA (mp-cfDNA) test that received FDA approval in July 2024 for average-risk CRC screening in individuals aged 45 years or older; in a large, prospective clinical trial, this test showed 83% sensitivity for CRC and 90% specificity for advanced neoplasia. This analysis describes adherence and other laboratory outcomes for the mp-cfDNA test orders following FDA approval.
Methods: The mp-cfDNA test is performed at a single laboratory (Guardant Health, CA) and became available for clinical ordering on August 1, 2024. Orders received nationally between August 1, 2024 and September 15, 2025 were retrospectively reviewed. Orders were included for individuals aged 45–85 years who received a standard of care commercial order for the test from a US-based clinic or health system. Adherence was defined as the percentage of unique clinical orders with a unique blood sample received. This research was conducted under Institutional Review Board approval for the generation of deidentified data sets for research purposes.
Results: During the time period, 56,704 unique clinical orders were received. Mean patient age was 69 years (range, 45–85) and 73% were aged 50–75 years; 57% were female. Out of the clinical orders, 52,649 blood samples were received, for an adherence rate of 93% (Table). Demographic characteristics between patients with clinical orders and blood samples received were similar. Mean time between receiving an order and receiving a blood sample in the laboratory was 3.1 days (range, 0–188), and mean time between receiving a blood sample in the laboratory and reporting of results was 9.0 days (range, 5–55). Overall, mean time between receiving an order and reporting of results was 12.2 days (range, 5–195 days). There were 709 (1.3%) blood samples that failed quality control.
Conclusions: This analysis demonstrates real-world clinical adherence to an FDA-approved blood-based CRC screening test is 93% in more than 56,000 individuals. These data are consistent with recently reported data of 95% adherence to a laboratory developed test (LDT) version of this test in 20,000 individuals. Adherence to the blood-based mp-cfDNA test far exceeds that of colonoscopy and stool-based tests, which have reported adherence rates of between 25% to 71%. Additionally, the average time from order to results was less than 2 weeks, supporting return of results in a timely manner in real-world practice.
Methods: The mp-cfDNA test is performed at a single laboratory (Guardant Health, CA) and became available for clinical ordering on August 1, 2024. Orders received nationally between August 1, 2024 and September 15, 2025 were retrospectively reviewed. Orders were included for individuals aged 45–85 years who received a standard of care commercial order for the test from a US-based clinic or health system. Adherence was defined as the percentage of unique clinical orders with a unique blood sample received. This research was conducted under Institutional Review Board approval for the generation of deidentified data sets for research purposes.
Results: During the time period, 56,704 unique clinical orders were received. Mean patient age was 69 years (range, 45–85) and 73% were aged 50–75 years; 57% were female. Out of the clinical orders, 52,649 blood samples were received, for an adherence rate of 93% (Table). Demographic characteristics between patients with clinical orders and blood samples received were similar. Mean time between receiving an order and receiving a blood sample in the laboratory was 3.1 days (range, 0–188), and mean time between receiving a blood sample in the laboratory and reporting of results was 9.0 days (range, 5–55). Overall, mean time between receiving an order and reporting of results was 12.2 days (range, 5–195 days). There were 709 (1.3%) blood samples that failed quality control.
Conclusions: This analysis demonstrates real-world clinical adherence to an FDA-approved blood-based CRC screening test is 93% in more than 56,000 individuals. These data are consistent with recently reported data of 95% adherence to a laboratory developed test (LDT) version of this test in 20,000 individuals. Adherence to the blood-based mp-cfDNA test far exceeds that of colonoscopy and stool-based tests, which have reported adherence rates of between 25% to 71%. Additionally, the average time from order to results was less than 2 weeks, supporting return of results in a timely manner in real-world practice.
Background: Although the number of colorectal cancer (CRC) screening options has expanded in recent years, the proportion of individuals who are up-to-date with CRC screening in the United States remains sub-optimal. Shield is a blood-based methylation partitioning cell-free DNA (mp-cfDNA) test that received FDA approval in July 2024 for average-risk CRC screening in individuals aged 45 years or older; in a large, prospective clinical trial, this test showed 83% sensitivity for CRC and 90% specificity for advanced neoplasia. This analysis describes adherence and other laboratory outcomes for the mp-cfDNA test orders following FDA approval.
Methods: The mp-cfDNA test is performed at a single laboratory (Guardant Health, CA) and became available for clinical ordering on August 1, 2024. Orders received nationally between August 1, 2024 and September 15, 2025 were retrospectively reviewed. Orders were included for individuals aged 45–85 years who received a standard of care commercial order for the test from a US-based clinic or health system. Adherence was defined as the percentage of unique clinical orders with a unique blood sample received. This research was conducted under Institutional Review Board approval for the generation of deidentified data sets for research purposes.
Results: During the time period, 56,704 unique clinical orders were received. Mean patient age was 69 years (range, 45–85) and 73% were aged 50–75 years; 57% were female. Out of the clinical orders, 52,649 blood samples were received, for an adherence rate of 93% (Table). Demographic characteristics between patients with clinical orders and blood samples received were similar. Mean time between receiving an order and receiving a blood sample in the laboratory was 3.1 days (range, 0–188), and mean time between receiving a blood sample in the laboratory and reporting of results was 9.0 days (range, 5–55). Overall, mean time between receiving an order and reporting of results was 12.2 days (range, 5–195 days). There were 709 (1.3%) blood samples that failed quality control.
Conclusions: This analysis demonstrates real-world clinical adherence to an FDA-approved blood-based CRC screening test is 93% in more than 56,000 individuals. These data are consistent with recently reported data of 95% adherence to a laboratory developed test (LDT) version of this test in 20,000 individuals. Adherence to the blood-based mp-cfDNA test far exceeds that of colonoscopy and stool-based tests, which have reported adherence rates of between 25% to 71%. Additionally, the average time from order to results was less than 2 weeks, supporting return of results in a timely manner in real-world practice.
Methods: The mp-cfDNA test is performed at a single laboratory (Guardant Health, CA) and became available for clinical ordering on August 1, 2024. Orders received nationally between August 1, 2024 and September 15, 2025 were retrospectively reviewed. Orders were included for individuals aged 45–85 years who received a standard of care commercial order for the test from a US-based clinic or health system. Adherence was defined as the percentage of unique clinical orders with a unique blood sample received. This research was conducted under Institutional Review Board approval for the generation of deidentified data sets for research purposes.
Results: During the time period, 56,704 unique clinical orders were received. Mean patient age was 69 years (range, 45–85) and 73% were aged 50–75 years; 57% were female. Out of the clinical orders, 52,649 blood samples were received, for an adherence rate of 93% (Table). Demographic characteristics between patients with clinical orders and blood samples received were similar. Mean time between receiving an order and receiving a blood sample in the laboratory was 3.1 days (range, 0–188), and mean time between receiving a blood sample in the laboratory and reporting of results was 9.0 days (range, 5–55). Overall, mean time between receiving an order and reporting of results was 12.2 days (range, 5–195 days). There were 709 (1.3%) blood samples that failed quality control.
Conclusions: This analysis demonstrates real-world clinical adherence to an FDA-approved blood-based CRC screening test is 93% in more than 56,000 individuals. These data are consistent with recently reported data of 95% adherence to a laboratory developed test (LDT) version of this test in 20,000 individuals. Adherence to the blood-based mp-cfDNA test far exceeds that of colonoscopy and stool-based tests, which have reported adherence rates of between 25% to 71%. Additionally, the average time from order to results was less than 2 weeks, supporting return of results in a timely manner in real-world practice.
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