The prospective study analyzed 656 blood samples from 68 patients with muscle invasive bladder cancer from
Results demonstrated that a positive Signatera test result was the strongest prognostic marker of disease recurrence and long-term patient outcomes, relative to all other risk factors. At time of diagnosis (pre-treatment), ctDNA-positive patients had a recurrence rate of 46 percent, compared with 3 percent for ctDNA-negative patients. During surveillance after cystectomy, ctDNA-positive patients had a recurrence rate of 93 percent, compared with no recurrence for ctDNA-negative patients.
In addition, serial ctDNA analysis following cystectomy revealed that Signatera correctly identified all patients with metastatic disease progression up to 8.2 months (245 days) ahead of radiographic imaging with 100 percent sensitivity and 98 percent specificity.
"This study shows Signatera's power to predict which patients are at highest risk for recurrence, and to detect metastatic disease sooner to guide earlier medical interventions," said Alexey Aleshin, M.D., MBA,
An estimated 549,000 cases of bladder cancer are diagnosed worldwide each year,2 and it is the sixth most common cancer in men.2 The overall five-year survival rate is 77 percent, but the five-year survival rate for locally advanced bladder cancer is just 35 percent.3
The study, titled 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, can be found here.
Signatera is the first circulating tumor DNA (ctDNA) test custom-built 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, 4-7 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, 4-7
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
- 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.
- Bray F, Ferlay J, Soerjomataram, I, et al. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. Cancer J Clin. 2018;68:394–424
- Bladder cancer statistics. https://www.cancer.net/cancer-types/bladder-cancer/statistics. Accessed
May 6, 2019
- Coombes RC, Page K, Salari R, et al. Personalized detection of circulating tumor DNA antedates breast cancer metastatic recurrence.
Clin Cancer Res. 2019. DOI:10.1158/1078-0432.
- 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
- Reinert T, Henriksen TV, Rasmussen MH, et al. Serial circulating tumor DNA analysis for detection of residual disease, assessment of adjuvant therapy efficacy and for early recurrence detection in colorectal cancer. Poster presented at: European Society for Medical Oncology Annual Congress;
October 21, 2018; Munich, Germany. Abstract 456PD.
- 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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