Signatera is the first ctDNA test custom-built for each patient based on the unique mutations in an individual patient's tumor. Signatera has been shown in numerous clinical studies, across non-small cell lung, bladder, breast and colorectal cancers, to identify molecular residual disease significantly earlier (up to two years earlier) than standard imaging.1-5 Studies have also shown that Signatera test status is the most significant predictor of long-term patient outcomes after surgery and treatment, relative to all other clinical and pathological factors.1-5
"This Breakthrough Device designation is a significant step forward in our commercial strategy, helping to clear the path for
"We are delighted to work with the
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 MRD, 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 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
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
- 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
- Birkenkamp-Demtröder K, Christensen E, Sethi H, et al. Sequencing of plasma cfDNA from patients with locally advanced bladder cancer for surveillance and therapeutic efficacy monitoring. Poster presented at: European Society for Medical Oncology Annual Congress;
October 20, 2018; Munich, Germany. Abstract 86P.
- 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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