Natera Selected for Circulating Tumor DNA Study in Bladder Cancer

Natera has entered into a research collaboration with Denmark's Aarhus University to leverage the company's Signatera (RUO) personalized liquid biopsy technology to evaluate circulating tumor DNA (ctDNA) as a useful biomarker in the diagnosis and treatment of bladder cancer. Signatera was recently launched for research use only (RUO) for oncology researchers and biopharmaceutical companies, and is not for use in diagnostic procedures. It is expected to be available for clinical use next year.

The study will evaluate over 400 prospectively obtained plasma samples from patients who underwent treatment for bladder cancer, and whose blood was collected serially through chemotherapy and surgery. Sequencing data from each patient's tumor will be provided by Aarhus University and run through the Signatera proprietary ctDNA bioinformatics pipeline, resulting in custom ctDNA assays being designed for each patient. Personalized ctDNA analysis will be performed at multiple time points per patient to correlate ctDNA levels with clinical outcomes.

"Aarhus University's significant expertise in bladder cancer research, as well as its extensive repository of longitudinal patient tumor and blood samples, make it an ideal partner," said Jimmy Lin, MD, PhD, MHS, Chief Science Officer, Oncology, at Natera. "We expect that this study, plus additional research efforts in other cancer types, will help us build toward clinically validating Signatera. If validated, Signatera could enable earlier diagnosis, more precise monitoring, better determination of prognosis, and individualized treatment of disease."

Signatera differs from currently available liquid biopsy tests, which test 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, which maximizes sensitivity and specificity. Signatera also allows researchers to track additional mutations of interest, up to several hundred mutations, for clinical studies. A recent study of patients with early stage non-small cell lung cancer (NSCLC) showed the value of Natera's customized ctDNA analysis for use in cancer research. The study, which was featured on the cover of the journal Nature, demonstrated Signatera's potential to detect residual disease, measure treatment response, and identify recurrence up to 11 months earlier than the standard of care.