Micromedic Technologies Ltd., has announced the results of a blinded, multi-center clinical study using the Cell Detect non-invasive technology to detect bladder recurrence in patients with a history of the disease. The Cell Detect test successfully identified cancerous cells in urine samples, with reported sensitivity of 84.4% and specificity of 82.7% for the study's primary endpoint. The blinded clinical study was conducted in nine medical centers, where urine samples from 217 subjects with a history of bladder cancer were tested. The study population included 121 healthy subjects and 96 patients currently suffering from the disease.
The results of the Cell Detect urine test were compared with results from biopsy or cystoscopy, in cases where biopsies were not performed. The results also indicated that the negative predictive value (NPV) was 98.5%. In addition to its high sensitivity for advanced stage tumors and high-grade malignancy, the test was also found to exhibit high sensitivity for early stage tumors and low-grade malignancies which are difficult to identify using other non-invasive tests currently available on the market.
The secondary endpoint showed that the sensitivity of other non-invasive comparator tests, urine cytology, BTA stat and NMP22 Bladder Check, was 50.0%, 68.8% and 17.4%, respectively. These findings indicate that the method is adequately sensitive for the purpose of accurate and early detection of the recurrence of the disease.
Following these successful study results, the company plans to secure a CE mark approval for a European launch of this non-invasive test later this year as well as to submit a Pre-IDE to the U.S. Food and Drug Administration (FDA).
"We are tremendously pleased with the results of the study that confirm the high performance of the CellDetect(R) urine test in accurately monitoring recurrence of bladder cancer," Steven Eitan, Micromedic's CEO, said. "By administering this test, millions of bladder cancer patients may be able to forego numerous costly and invasive tests, starting to receive treatment faster if their cancer is likely to recur. Following these successful results, we are also planning to conduct the required activities to quickly broaden the intended use to the early detection diagnostic market for additional millions of patients. The Cell Detect technology has the potential for diagnosing additional cancer indications."The accuracy of this novel assay appears to be superior over any available non-invasive test, suggesting a potential to supplant some or all of the cystos copies required for bladder cancer surveillance. This is indeed great news for patients with history of bladder cancer, which may change their management."