Israeli diagnostic device company Micromedic Technologies, a subsidiary of BioLight Life Science Investments Ltd., has seen a successful outcome from its blinded, multi-center clinical study of the CellDetect® non-invasive test for detecting bladder cancer in urine. The test successfully achieved the study’s primary endpoint for effectively detecting the recurrence of bladder cancer in subjects with a history of the disease.
Bladder cancer is the fourth most prevalent cancer among males in the U.S. and the seventh most prevalent among males worldwide, with nearly 430,000 new case of the disease diagnosed globally in 2012. The rate of recurrence is the highest of all cancers and ranges from 50% to 80%. According to U.S. clinical guidelines, patients with a history of urinary bladder cancer are required to undergo three to four tests per year to monitor disease recurrence in the first two years immediately following treatment, and one test annually in the years that follow. Because of high recurrence rates, the cost of diagnosing and treating bladder cancer is among the highest of all cancers. As such it remains something of an open door for a company that can deliver improved test accuracy.
Micromedic’s CellDetect® technology allows an accurate diagnosis of cancerous and precancerous cells, based on unique combination of color and morphology. The technology may be implemented in screening tests and monitoring tests of disease recurrence in cancer patients after being treated. Micromedic has already demonstrated the product’s efficacy in diagnosing cervical cancer and bladder cancer in the framework of clinical trials, and estimates that the technology underlying the products may be implemented for use in additional cancer indications.
In the newly announced study results, the CellDetect® urine test successfully identified cancerous cells in urine samples in patients with a history of the disease, 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 in Israel, 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 CellDetect® urine test were compared with results from biopsy or cystoscopy, in cases where biopsies were not taken. The results also indicated that the CellDetect® urine test’s negative predictive value (NPV), defined as the probability that a patient having a negative result doesn’t suffer from the disease, 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. These findings indicate that the method is adequately sensitive for the purpose of accurate and early detection of the recurrence of the disease.
As a result of these successful study results, Micromedic plans to secure CE mark approval for a European launch of the non-invasive test later this year, as well as to submit a Pre-IDE to the U.S. FDA.
Prof. Ofer Yossepowitch. M.D., Head of the Uro-Oncology Service at Rabin Medical Center: “The study results are encouraging. 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 cystoscopies required for bladder cancer surveillance. This is indeed great news for patients with history of bladder cancer, which may change their management.”
Susana Nahum Zilberberg, BioLight’s CEO said ;”We are extremely pleased with these clinical results showing CellDetect’s high sensitivity and specificity and believe that they provide a foundation upon which regulatory approval can be secured and be a second indication for use of the CellDetect® technology platform”
“There is a clinical need for a better test for the up to 80 percent of patients with bladder cancer whose cancer recurs, since many of the currently available tests are clinically suboptimal, invasive or expensive. Based on these strong clinical results, we believe that CellDetect® is a promising solution for the millions of patients with bladder cancer, and has the potential for diagnosing additional cancer indications.”
Source: BioLight Life Science Investments Ltd.