The prospective, multicenter study enrolled 130 patients with stage I–III colorectal cancer from
Results demonstrated that the Signatera test detected molecular recurrence up to 16.5 months earlier than standard-of-care radiologic imaging (average 8.7 months). Serial testing picked up 14 out of 16 relapses (patient-level sensitivity 88 percent), and among patients who did not relapse, 455 out of 456 post-surgical blood samples correctly tested negative (test-level specificity 99.8 percent).
The study also found that MRD status was the most significant predictor of relapse after adjusting for all other known risk factors, including disease stage and lymph node status. Signatera MRD-positive patients who did not receive treatment relapsed in 93 percent of cases. Among patients who remained MRD-negative, the relapse rate was 3 percent. These results underscore the potential of MRD status to risk stratify patients more accurately after surgery to determine which patients need additional therapeutic interventions and which could be safely monitored.
"Our study showed unequivocally that
"This study highlights Signatera's potential to change post-operative management of colorectal cancer," said
With 1.3 million newly diagnosed cases each year worldwide, colorectal cancer is the third most common cancer and the second leading cause of cancer-related deaths.2 Despite implementation of screening and advances in treatment regimens, the five-year mortality rate remains high at about 40 percent.2-4
The study also reported the first published demonstration of
The study, titled Analysis of Plasma Cell-Free DNA by Ultradeep Sequencing in Patients With Stages I to III Colorectal Cancer, can be found here.
Signatera is the first custom-built circulating tumor DNA (ctDNA) test for molecular treatment monitoring and molecular residual disease (MRD) assessment. The test is available for research use only (RUO) until its clinical launch planned for Q2 2019. The Signatera methodology differs from currently available liquid biopsy tests, which test for a fixed panel of therapeutically relevant genes. Signatera provides each individual with a customized blood test tailored to match the clonal mutations found in that individual's tumor tissue. This maximizes accuracy for detecting the presence or absence of MRD in a blood sample, even at levels down to a single mutant molecule in a tube of blood. Signatera also allows researchers to track additional mutations of interest, up to several hundred mutations, for clinical studies.
The body of evidence on the utility of Signatera is growing, with multiple studies demonstrating the Signatera RUO method's ability to detect molecular residual disease, measure treatment response, and identify recurrence months or years earlier than the standard of care for a variety of cancer types, including breast cancer, early stage non-small cell lung cancer, bladder cancer, and colorectal cancer.1, 5-8 Based on numerous studies across multiple cancer types, a positive Signatera RUO result without further treatment has predicted clinical relapse over 98 percent of the time.1, 5-8
All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that
This test was developed by
- Reinert T, Henriksen T, Christensen E, et al. Analysis of plasma cell-free DNA by ultradeep sequencing in patients with stages I to III colorectal cancer. JAMA Oncol. 2019.
- Ferlay J, Soerjomataram I, Dikshit R, et al. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015;136(5):E359-E386.
- Iversen LH, Green A, Ingeholm P, Østerlind K, Gögenur I. Improved survival of colorectal cancer in
Denmarkduring 2001-2012 - The efforts of several national initiatives. Acta Oncol. 2016;55 Suppl 2:10-23.
- Osterman E, Glimelius B. Recurrence risk after up-to-date colon cancer staging, surgery, and pathology: Analysis of the entire Swedish population. Dis Colon Rectum. 2018;61(9):1016-1025.
- Christensen E, Birkenkamp-Demtröder K, Sethi H, et al. Early detection of metastatic relapse and monitoring of therapeutic efficacy by ultra-deep sequencing of plasma cell-free DNA in patients with urothelial bladder carcinoma. J Clin Oncol. 2019. DOI:10.1200/JCO.18.02052.
- Coombes RC, Page K, Salari R, et al. Personalized detection of circulating tumor DNA antedates breast cancer metastatic recurrence.
Clin Cancer Res. 2019.
- Magbanua M, Brown-Swigart L, Hirst G, et al. Personalized serial circulating tumor DNA (ctDNA) analysis in high-risk early stage breast cancer patients to monitor and predict response to neoadjuvant therapy and outcome in the I-SPY 2 TRIAL. Data presented at spotlight session: San Antonio Breast Cancer Symposium;
December 5, 2018. Abstract 1259.
- Abbosh C, Birkbak NJ, Wilson GA, et al. Phylogenetic ctDNA analysis depicts early-stage lung cancer evolution. Nature. 2017; 545(7655):446–451.
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