Natera announces publication of study on Signatera MRD test
Natera announced the publication of a clinical validation study demonstrating that its Signatera molecular residual disease, or MRD, test was highly prognostic of recurrence in patients with bladder cancer, and it identified recurrence up to 8.2 months earlier than current clinical standards with 100% sensitivity.1 Results were published in the May 2019 issue of the Journal of Clinical Oncology. The prospective study analyzed 656 blood samples from 68 patients with muscle invasive bladder cancer from Aarhus University in Denmark. The study used Natera's Signatera research-use-only test, a personalized, tumor-informed method for detecting molecular residual disease, to evaluate circulating tumor DNA, or ctDNA, in plasma samples collected at diagnosis, during chemotherapy, before cystectomy, and serially during the surveillance period. Results demonstrated that a positive Signatera test result was the strongest prognostic marker of disease recurrence and long-term patient outcomes, relative to all other risk factors. At time of diagnosis (pre-treatment), ctDNA-positive patients had a recurrence rate of 46%, compared with 3% for ctDNA-negative patients. During surveillance after cystectomy, ctDNA-positive patients had a recurrence rate of 93%, compared with no recurrence for ctDNA-negative patients.