Implementation of blood-based colorectal cancer screening: real-world adherence and outcomes

The overall CRC screening adherence rate remains suboptimal, with only 58% of screen-eligible individuals in the United States up to date with screening. This analysis reports on real-world adherence, test outcomes, and turnaround times for the initial large-scale clinical implementation of a blood-based CRC screening test. Providers ordered the commercially-available, blood-based Shield laboratory developed test (Guardant Health) in their clinics, based on an intended use population of individuals at average risk for CRC, aged 45 years or older. Retrospective review of laboratory orders and test turnaround times for the first 20,000 age-eligible patients was conducted; adherence rate was defined as the number of unique blood samples received out of the number of unique clinical test orders. For the first 20,000 age-eligible patients with a test order, 61% were female individuals; median age was 59 years (range = 45–99). From 20,000 patients, 18,901 provided a blood sample, resulting in 94.5% adherence. Test positivity rate was 9.2%. Median times from placement of an order to blood sample receipt in the testing laboratory and from blood sample receipt in the testing laboratory to a results report were 1 day (range = 0–182) and 15 days (range = 0–83), respectively. Real-world adherence to a blood-based CRC screening test was 95% for the first 20,000 patients, with short median turnaround times for test completion by the patient and results return. These results support the ability of blood-based options to improve adherence.

结直肠癌（Colorectal Cancer, CRC）筛查的整体依从率仍未达理想水平，美国仅58%符合筛查条件的个体完成了规范的最新筛查流程。本分析针对首次大规模临床落地的血液法CRC筛查检测，报告了其真实世界中的筛查依从性、检测结果与周转时长。临床医师基于针对45岁及以上CRC平均风险人群的预期使用人群定位，在其诊所内订购了商业化的血液型Shield实验室自研检测（Guardant Health）。本研究对首批20000名符合年龄条件的患者的实验室检测订单与检测周转时长进行了回顾性分析；依从率定义为实际接收的有效血液样本数与有效临床检测订单数的比值。在首批20000名持有检测订单的符合年龄条件的患者中，61%为女性，患者年龄中位数为59岁（范围45~99岁）。20000名患者中共计18901人提供了血液样本，对应依从率为94.5%；本次检测的阳性率为9.2%。从检测订单下达至检测实验室收到血液样本的中位时长为1天（范围0~182天），从实验室收到血液样本至出具检测报告的中位时长为15天（范围0~83天）。本研究涉及的首批20000名患者中，血液法CRC筛查的真实世界依从率达95%，患者完成检测与报告返回的中位周转时长均较短。上述结果证实，血液法筛查方案可有效提升结直肠癌筛查的依从性。