Non-invasive early detection of cancer four years before conventional diagnosis using a blood test

Early detection has the potential to reduce cancer mortality, but an effective screening test must demonstrate asymptomatic cancer detection years before conventional diagnosis in a longitudinal study. In the Taizhou Longitudinal Study (TZL), 123,115 healthy subjects provided plasma samples for long-term storage and were then monitored for cancer occurrence. Here, we report the preliminary results of PanSeer, a noninvasive blood test based on circulating tumor DNA methylation, on TZL plasma samples from 605 asymptomatic individuals, 191 of whom were later diagnosed with stomach, esophageal, colorectal, lung or liver cancer within four years of blood draw. We also assay plasma samples from an additional 232 cancer patients, plus 200 primary tumor and normal tissues. We show that PanSeer detects five common types of cancer in 88% (95% CI: 80-93%) of post-diagnosis patients with a specificity of 96% (95% CI: 93-98%). We also demonstrate that PanSeer detects cancer in 95% (95% CI: 89-96%) of asymptomatic individuals who were later diagnosed, though future longitudinal studies are required to confirm this result. These results demonstrate that cancer can be non-invasively detected up to four years before current standard of care.

Xingdong Chen, Jeffrey Gole, Arthurva Gore, Qiye He, Ming Lu, Jun Min, Ziyu Yuan, Xiaorong Yang, Yanfeng Jiang, Tiejun Zhang, Chen Suo, Xiaojie Li, Lei Cheng, Zhenhua Zhang, Hongyu Niu, Zhe Li, Zhen Xie, Han Shi, Xiang Zhang, Min Fan, Xiaofeng Wang, Yajun Yang, Justin Dang, Catie McConnell, Juan Zhang, Jiucun Wang, Shunzhang Yu, Weimin Ye, Yuan Gao, Kun Zhang, Rui Liu, Li Jin