Natera Inc. announced a research collaboration with the Institut Jules Bordet, a multidisciplinary cancer reference center in Belgium, using the company’s Signatera research-use-only circulating tumor DNA assay to evaluate molecular response and minimal residual disease in women with early stage breast cancer.
Natera will analyze approximately 300 plasma specimens prospectively collected and banked from 80 patients diagnosed with non-metastatic breast cancer, who all received neoadjuvant chemotherapy followed by surgery, and who were then monitored for recurrence with serial imaging.
The study will correlate results of the Signatera assay with clinical outcomes, including pathological response and event-free survival. With sample collection initiated in 2011, the study is led by Michail Ignatiadis, attending physician in the Medical Oncology Department of Institut Jules Bordet and assistant professor at the Université Libre de Bruxelles.
This is the third breast cancer collaboration Natera has announced in the past 18 months. Breast cancer is the second leading cause of cancer death in women in the United States. While the overall survival rate for breast cancer has improved, recurrence remains an important clinical concern, with 5-year recurrence rates estimated to be as high as 33 percent.
Signatera is the first ctDNA assay custom-built for treatment monitoring and MRD assessment. The Signatera methodology differs from currently available liquid biopsy assays, which test for a panel of genes independent of an individual’s tumor.
Signatera provides each patient with a customized blood test tailored to match the mutations found in that individual’s tumor tissue, which maximizes sensitivity and specificity. Signatera also allows researchers to track additional mutations of interest, up to several hundred mutations, for clinical studies.
In a recent study, the Signatera customized ctDNA assay demonstrated the method’s ability to detect residual disease, measure treatment response, and identify recurrence up to 11 months earlier than the standard of care for early stage non-small cell lung cancer.
Additional research presented at the 2018 American Association for Cancer Research meeting showed successful results from bladder and colorectal cancer studies, including median detection points of ctDNA that were 4.3 and 7.9 months ahead of clinical relapse detection, respectively.
