The use of cell-free DNA to improve the diagnosis, management, and treatment of cancer patients is an ever-expanding field of study. Recently, Natera Inc. launched a nationwide multicentre study called BESPOKE, which is aimed at stage II–III colorectal cancer (CRC) patients.

This new study will measure the effectiveness of serial testing of patients with Natera’s Signatera, an in vitro diagnostics device. Signatera is a customisable circulating tumour DNA test that provides individuals with a test tailored to the mutations present in their specific tumour. The goal of the Signatera device is to detect and quantify residual cancer, and to detect recurrence early. Due to its customisable nature, the Signatera test can be applied to multiple different cancer types and has so far been validated in CRC, non-small cell lung carcinoma, breast cancer, and bladder cancer.

In May 2019, a study published in JAMA Oncology demonstrated that serial monitoring with the Natera Signatera device identified CRC recurrence up to 16.5 months earlier than alternative standard-of-care options, such as radiological imaging. The Signatera device also successfully identified CRC patients who were more likely to relapse. The study, which involved 130 patients, demonstrated that cell-free DNA has the potential to enable risk stratification of CRC patients and allow for early relapse detection. CRC is the second most common cause of cancer death, with early diagnosis of recurrent disease constituting an important unmet clinical need.

Following these positive clinical trial results, Natera announced earlier this month that it had achieved $55M cumulative total contract value in 2019, thus exceeding its goal of $40–50M. The company also obtained eight additional oncology patents last year.

The newly launched BESPOKE study will include much larger sample size, prospectively enrolling 1,000 or more CRC patients between 2020 and 2023. Over 1.8 million people are diagnosed with CRC each year, making it the third most common cancer in men and the second most common cancer in women. This study has the potential to take vital steps toward improving management and treatment outcomes for these patients.