Natera Inc, San Carlos, Calif, has entered into a research collaboration with Imperial College London and the University of Leicester to evaluate use of the company’s Signatera research-use-only circulating tumor DNA (ctDNA) technology for detecting disease recurrence in women breast cancer patients. Signatera 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 researchers funded by Cancer Research UK to help identify the optimal biomarkers for prediction of disease progression among women with breast cancer after their surgery and adjuvant therapy. The study is being led by principal investigators Charles Coombes, MD, PhD, professor of medical oncology at Imperial College London and director of the Imperial CRUK Cancer Centre, and Jacqui Shaw, PhD, professor of translational cancer genetics at the University of Leicester Cancer Research Center.

 Jacqui Shaw, PhD, University of Leicester Cancer Research Center.

Jacqui Shaw, PhD, University of Leicester Cancer Research Center.

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

The collaborators will retrospectively evaluate ctDNA levels among 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 4 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. Study results are expected in 2018.

“We look forward to working with Drs. Coombes and Shaw to characterize ctDNA as a potential biomarker for breast cancer progression,” says Jimmy Lin, MD, PhD, MHS, chief scientific officer for 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 differs from currently available liquid biopsy technology, which tests for a generic panel of genes independent of an individual’s tumor. It provides a customized blood test tailored to match the mutations found in an individual’s tumor tissue, maximizing 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 showed the value of Natera’s customized ctDNA analysis for use in cancer research. The study 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.1

For more information, visit Natera.


  1. Abbosh C, Birkbak NJ, Wilson GA, et al. Phylogenetic ctDNA analysis depicts early-stage lung cancer evolution. Nature. 2017;545(7655):446–451; doi: 10.1038/nature22364.