Genetic testing company Natera has announced positive results from the clinical validation study of its circulating tumour DNA (ctDNA) test for the detection of bladder cancer.
According to the findings the ctDNA test, known as Signatera, was able to identify cancer recurrence up to 8.2 months earlier than existing clinical standards. The test is said to have demonstrated 100% sensitivity and 98% specificity.
The test is designed for molecular treatment monitoring and molecular residual disease (MRD) assessment. It offers customised testing tailored to match the clonal mutations present in individual patients’ tumour tissue.
In the prospective study, Signatera was used to detect ctDNA in 656 blood samples obtained from 68 muscle invasive bladder cancer patients at Aarhus University, Denmark.
The samples were collected at diagnosis, during chemotherapy, before cystectomy and serially during the investigation period.
Data indicated that a positive Signatera result was a highly prognostic marker of disease recurrence and long-term patient outcomes, compared to all other risk factors.
At diagnosis, ctDNA-positive patients experienced a recurrence rate of 46% versus 3% in ctDNA-negative patients. Following cystectomy, ctDNA-positive patients had a 93% recurrence rate, compared with no recurrence in participants who tested negative for ctDNA.
Furthermore, serial ctDNA analysis found that Signatera could correctly identify all patients with metastatic disease progression up to 8.2 months earlier than radiographic imaging.
The study results have been published in the Journal of Clinical Oncology.
Natera oncology medical director Alexey Aleshin said: “This study shows Signatera’s power to predict which patients are at highest risk for recurrence, and to detect metastatic disease sooner to guide earlier medical interventions.
“Until now, it has been clinically difficult to evaluate which muscle invasive bladder cancer patients have benefited most from chemotherapy. Now, we have a precise tool that is much more predictive of treatment response.”
Signatera, which is currently available for research use only (RUO), is expected to be launched for clinical use in the coming months.
Recently, the US Food and Drug Administration (FDA) granted breakthrough device designation for the use of the test in post-surgical detection and quantification of ctDNA in patients who were previously diagnosed with certain types of cancer and in combination with certain drugs.