A urine test (CellDetect) was able to detect disease recurrence in bladder cancer patients, with a reported sensitivity of 84.4% and specificity of 82.7%.
A noninvasive test (CellDetect urine test) was able to detect disease recurrence in bladder cancer patients, with a high sensitivity for advanced- and early-stage tumors, according to results of a new study.
“The study results are encouraging,” said Ofer Yossepowitch, MD, head of the uro-oncology service at Rabin Medical Center, in a statement. “The accuracy of this novel assay appears to be superior over any available noninvasive test, suggesting a potential to supplant some or all of the cystoscopies required for bladder cancer surveillance. This is indeed great news for patients with history of bladder cancer, which may change their management.”
In a blinded clinical trial involving nine medical centers in Israel, researchers studied urine samples from 217 participants (96 bladder cancer patients and 121 healthy patients). Urine sample results using the CellDetect test were compared with results from biopsy or cystoscopy.
Investigators reported that the urine test detected cancerous cells in patients who previously had bladder cancer with a sensitivity of 84.4% and a specificity of 82.7%. The negative predictive value was 98.5%.
By comparison, the study found that the sensitivity for detecting bladder cancer with other noninvasive tests was 68.8% (BTA stat), 50% (urine cytology), and 17.4% (NMP22 BladderChek).
“We are extremely pleased with these clinical results showing CellDetect’s high sensitivity and specificity,” said Susana Nahum Zilberberg, BioLight’s chief executive officer, in a press release.
The company plans to submit data from this trial to regulatory agencies in Europe and to the US Food and Drug Administration.
“There is a clinical need for a better test for the up to 80% of patients with bladder cancer whose cancer recurs, since many of the currently available tests are clinically suboptimal, invasive, or expensive,” said Zilberberg.
Bladder cancer is the fourth most prevalent cancer among men in the United States, and due to high rates of recurrence it is among the most expensive to diagnose and treat.
Anywhere from 50% to 80% of patients with bladder cancer will have disease recurrence, the highest rate of any cancer. Guidelines recommend patients undergo multiple tests during the first 2 years post-treatment, followed by one test annually after that, to monitor for recurrence of disease.