Plans to Secure CE Mark for a European Launch of the Non-Invasive Test and Submit a Pre-IDE to the U.S. FDA in 2015
BioLight Life Sciences Investments Ltd. (OTC: BLGTY, TASE: BOLT), a firm that invests in, manages and commercializes biomedical innovations in ophthalmology and cancer diagnostics, announced today that a blinded, multi-center clinical study of the CellDetect® non-invasive test for detecting bladder cancer in urine, successfully achieved the study's primary endpoint for effectively detecting the recurrence of bladder cancer in subjects with a history of the disease. 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 CellDetect® technology is being developed by Micromedic Technologies (TASE: MCTC), BioLight's cancer diagnostics subsidiary, and allows an accurate diagnosis of cancerous and precancerous cells, based on a unique combination of color and morphology by utilizing a proprietary kit containing unique extract and dyes. 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. Food and Drug Administration (FDA).
"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," noted Susana Nahum Zilberberg, BioLight's Chief Executive Officer. "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."
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.
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.
The secondary endpoint showed that the sensitivity of other non-invasive comparator tests, urine cytology, BTA stat and NMP22 BladderCheck, was 50.0%, 68.8% and 17.4%, respectively. These findings further underscore the potential of the CellDetect® test as an accurate, reliable and a non-invasive tool for monitoring the recurrence of bladder cancer.
Micromedic also plans to utilize reimbursement existing codes for monitoring bladder cancer recurrence and will continue to advance the CellDetect® technology for the diagnosis of additional cancer indications.