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

Abstract

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 223 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: 89-98%) 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.

Cancer methylomes characterization enabled by Rocker-meth

“…Similar results have been observed for multiple tumor types [10][11][12][13][14]. Furthermore, DNA methylation has recently gained substantial attention in the setting of liquid biopsy for early detection and for monitoring of disease evolution [15][16][17][18], further eliciting the need for robust and reliable biomarker detection approaches.…”

Towards Routine Implementation of Liquid Biopsies in Cancer Management: It Is Always Too Early, until Suddenly It Is Too Late

“…While all the respondents concluded that there are opportunities for early detection using liquid biopsies to have impact, the evidence on this application is immature. Several commercial initiatives are underway to improve early detection, with methods focused on either aberrant methylation of ctDNA such as in the GRAIL Galleri test [ 23 ] and panSEER [ 24 ] or methods based on specific gene mutations and plasma proteins such as in CancerSeek [ 22 ]. A test based on methylation patterns of ctDNA may detect a wider range of cancers.…”

“…In cancer screening and early detection, one of the first approved blood tests is the Epi ProColon for colorectal cancer screening (FDA approved in December 2016). Since then, several high-impact studies have been published investigating the use of different blood test approaches and artificial intelligence-based classifiers for early detection of up to 50 different cancers [ 22 , 23 , 24 ].…”

Impact of the COVID-19 pandemic on specialty community practices: an oncology perspective

“…There are several novel multi-cancer early detection (MCED) tests nearing commercial availability. [10][11][12] These MCED tests use sophisticated technologies to identify signals of early cancer in blood and can detect a variety of cancers, many of which are potentially lethal and currently have no recommended screening tests. The ease and convenience of cancer detection via a single blood draw is an important added advantage that could help achieve better compliance than existing single-cancer screening tests.…”