Natera Chosen for Longitudinal Circulating Tumour DNA Study in Breast Cancer

Natera, Inc., (NASDAQ: NTRA), a global leader in cell-free DNA testing, has entered into a research collaboration with Imperial College London and the University of Leicester, U.K., to leverage the company’s Signatera™ (RUO) personalised circulating tumour DNA (ctDNA) technology to evaluate retrospectively the use of ctDNA to detect disease recurrence in women breast cancer patients. Signatera™ (RUO) was recently launched for use by oncology researchers and biopharmaceutical companies, and is expected to be available for clinical use next year.

Natera will partner with Cancer Research UK-funded researchers to help identify the optimal biomarkers for prediction of disease progression in women with breast cancer after their surgery and adjuvant therapy. The study is being led by Principal Investigators Dr. Charles Coombes, Professor of Medical Oncology, Imperial College London and Director of The Imperial CRUK Cancer Centre, and Dr. Jacqui Shaw, Professor of Translational Cancer Genetics at the University of Leicester Cancer Research Centre.

“We believe circulating tumour DNA may provide a meaningful guide to predict disease progression before scans for patients with breast cancer,” Prof. Shaw said. “We are pleased to partner with Natera to explore this exciting new biomarker.”

Breast cancer is the second leading cause of cancer death in women.[1] Approximately 250,000 women are diagnosed with invasive breast cancer every year in the United States.[1] While the overall survival rate for breast cancer has improved, recurrence is an ongoing problem, with 5 year recurrence rates estimated to be as high as 33%.[2],[3]

The collaborators will evaluate ctDNA levels in breast cancer patients who have completed chemotherapy and are at risk for disease recurrence. Patients were monitored with blood tests and physical exams for up to four years. The primary objective of the study is to determine the sensitivity, specificity, lead time, and utility of ctDNA analysis for the early detection of breast cancer recurrence. The study results are expected to read out in 2018.

“We look forward to working with Drs. Coombes and Shaw to characterize ctDNA as a potential biomarker for breast cancer progression,” said Jimmy Lin, MD, PhD, MHS, Chief Scientific Officer,Oncology, at Natera. “They are experts in using ctDNA for disease monitoring in breast cancer.This is an excellent application of the Signatera™ technology.”

Signatera™ (RUO) differs from currently available liquid biopsy technology, which tests for a generic panel of genes independent of an individual’s tumour. It provides a customised blood test tailored to match the mutations found in each individual’s tumour tissue, which maximises sensitivity and specificity. Signatera™ also allows researchers to track up to several hundred additional mutations of interest for clinical studies. A recent study of patients with early stage non-small cell lung cancer (NSCLC) showed the value of Natera’s customised ctDNA analysis for use in cancer research. The study, which was featured on the cover of the journal Nature, demonstrated the method’s potential to detect residual disease, measure treatment response, and identify recurrence up to 11 months earlier than the standard of care.[4]


[1] American Cancer Society. About Breast Cancer, 2017. Accessed Oct. 27, 2017.

[2] 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.

[3] Dent R, Trudeau M, Pritchard K, et al. Triple-negative breast cancer: clinical features and patterns of recurrence. Clin Cancer Res 2007; 13: 4429-4434.

[4] Abbosh C. et al. Phylogenetic ctDNA analysis depicts early-stage lung cancer evolution. Nature 545,446–451 (2017)