The prospective national study funded by
In the study, Signatera (RUO) detected 16 of 18 (89 percent) relapses, with a median lead time 8.9 months earlier than the current standard of care. Among 31 patients that did not relapse, Signatera reported zero false positives across 156 plasma samples tested, with an overall specificity of 100 percent. In the study, this translates to a positive predictive value of 100 percent.
The study concludes that early recurrence detection with Signatera (RUO) may provide a critical window of opportunity for additional therapeutic intervention. Furthermore, tumor analysis showed that one third (33 percent) of all patients had no actionable hotspot mutations, indicating the validity of Signatera's personalized, tumor-informed approach to circulating tumor DNA (ctDNA) monitoring.
"The study showed that Signatera is an effective tool for the early detection of breast cancer recurrence, which occurs in up to 30 percent of certain patient groups," said
"Standard technologies for the detection of cancer recurrence have always been imprecise," said R Charles Coombes, Professor of Medical Oncology at
Breast cancer is the second leading cause of cancer death in women.2 Approximately 250,000 women are diagnosed with invasive breast cancer every year in
The study, titled Personalized Detection of Circulating Tumor DNA Antedates Breast Cancer Metastatic Recurrence, 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.
- A 2017 study demonstrated the Signatera (RUO) method's ability to detect MRD, measure treatment response, and identify recurrence up to 11 months earlier than the standard of care for early stage non-small-cell lung cancer with 93 percent sensitivity and zero false positives.6
- I-SPY 2 study results presented at the 2018
San Antonio Breast Conferencedemonstrated Signatera (RUO) as able to predict neoadjuvant treatment response and clinical outcomes (p<0.001) based on ctDNA positive/negative status in a cross-section of breast cancer patients, including those who were HER-2 positive, hormone receptor-positive, and triple negative. Failure to clear ctDNA after neoadjuvant treatment correlated with poor clinical outcomes. ctDNA levels were also associated with tumor burden as determined by imaging (p<0.01).7
- Data presented at the
European Society for Medical Oncology2018 Congressshowed successful results from bladder and colorectal cancer studies, including median detection points of MRD that were 3.3 and 7.9 months, respectively, ahead of clinical relapse detection.8,9
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.1,6-9
Cancer Research UKis the world's leading cancer charity dedicated to saving lives through research. Cancer Research UK'spioneering work into the prevention, diagnosis and treatment of cancer has helped save millions of lives. Cancer Research UKreceives no government funding for its life-saving research. Every step it makes towards beating cancer relies on vital donations from the public. Cancer Research UKhas been at the heart of the progress that has already seen survival in the UKdouble in the last forty years.
- Today, 2 in 4 people survive their cancer for at least 10 years.
Cancer Research UK'sambition is to accelerate progress so that by 2034, 3 in 4 people will survive their cancer for at least 10 years. Cancer Research UKsupports research into all aspects of cancer through the work of over 4,000 scientists, doctors and nurses.
- Together with its partners and supporters,
Cancer Research UK'svision is to bring forward the day when all cancers are cured. Cancer Research UKhas extensive expertise in drug discovery and development as established through the charity's Therapeutic Discovery Laboratoriesand Centre for Drug Development. The organisation also has access to large scale clinical trial capabilities through the Experimental Cancer Medicine Centre (ECMC) network.
About Imperial College London
Imperial College London is one of the world's leading universities. The College's 16,000 students and 8,000 staff are expanding the frontiers of knowledge in science, medicine, engineering and business, and translating their discoveries into benefits for society. Founded in 1907, Imperial builds on a distinguished past—having pioneered penicillin, holography and fibre optics—to shape the future. Imperial researchers work across disciplines to improve health and wellbeing, understand the natural world, engineer novel solutions and lead the data revolution. This blend of academic excellence and its real-world application feeds into Imperial's exceptional learning environment, where students participate in research to push the limits of their degrees. Imperial collaborates widely to achieve greater impact. It works with the NHS to improve healthcare in West London, is a leading partner in research and education within the
About the University of Leicester
The University of Leicester is led by discovery and innovation—an international centre for excellence renowned for research, teaching, and broadening access to higher education. It is among the top 25 universities in the
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 Res2019. American Cancer Society. About Breast Cancer, 2017. https://www.cancer.org/cancer/breast-cancer/about/how-common-is-breast-cancer.html. Accessed April 14, 2019 World Cancer Research Fund. American Institute for Cancer Research. https://www.wcrf.org/dietandcancer/cancer-trends/breast-cancer-statistics. Accessed April 14, 2019.
- Brewster AM, Hortobagyi GN, Broglio KR, et al. Residual risk of breast cancer recurrence 5 years after adjuvant therapy. J Natl Cancer Inst 2008; 100:1179.
- Dent R, Trudeau M, Pritchard K, et al. Triple-negative breast cancer: clinical features and patterns of recurrence.
Clin Cancer Res2007; 13: 4429-4434.
- Abbosh C, Birkbak NJ, Wilson GA, et al. Phylogenetic ctDNA analysis depicts early-stage lung cancer evolution. Nature. 2017; 545(7655):446–451.
- 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 Conference 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.
View original content to download multimedia:http://www.prnewswire.com/news-releases/new-publication-validates-clinical-performance-of-signatera-for-recurrence-monitoring-and-mrd-assessment-in-breast-cancer-300832940.html