TEL AVIV, Israel, Feb. 20, 2018 /PRNewswire/ -- Micromedic Technologies (TASE: MCTC) ("Micromedic"), announced successful results of a clinical study designed to detect prostate cancer cells in urine specimens using its CellDetect® technology. The study successfully detected cells originated from the prostate in urine samples. Micromedic's product is designed to allow for the first time, by a simple and non-invasive method, for direct and accurate detection of malignant prostate cells in urine samples.
The clinical study was conducted in the Kaplan Medical Center in Israel. The study included 59 urine samples (28 positive prostate cancer patients and 31 healthy subjects) that were collected and examined by a cytopathologist using the CellDetect® unique color marker. Of the 59 samples tested, a high rate of 80% of the samples received a definite diagnosis, and accordingly, included in the clinical study results. The results of the positive prostate cancer patients were compared to biopsy results that these patients had undergone prior to the clinical study.
The study results demonstrated that Micromedic's product successfully detected prostate cancer cells in urine samples, in a high sensitivity of 91.3% and specificity of 75%.
"We are very pleased with the results from this clinical study, which indicates the potential we see in the CellDetect® technology to dramatically improve prostate cancer diagnostics," commented Guy Lerner, Micromedic's CEO. "While prostate cancer is the second most common cancer in men worldwide, the currently available diagnostic testing is known to be unreliable. With these clinical study results, we are confident that our product has the potential to transform prostate cancer diagnostics, offering patients a non-invasive, accurate and reliable test, and one that could improve the healthcare system through considerable cost savings."
The successful study results are considered breakthrough in the development and commercialization of Micromedic's product as a simple and accurate diagnostic test compared to the current used tests. To the best of the Company's knowledge, the accuracy and effectiveness of current used tests are questionable, mainly due to a high rate of false positive results (as low as 25% specificity), resulting in unnecessary invasive diagnostic tests such as biopsies.
Prof. Dan Leibowitz, the study Principal Investigator and the Head of the Urology Department at Kaplan Medical Center, said that, "The results of the successful trial are very important for demonstrating the use of the Micromedic's product as a reliable diagnostic tool that will help in determining whether and when to perform a prostate biopsy or if such prostate biopsy can be avoided."
About Prostate Cancer
Prostate cancer is the second most common cancer among men worldwide. About one man in nine will be diagnosed with prostate cancer during his lifetime. It is estimated that in the United States for 2018 there will be about 165,000 new cases of prostate cancer and about 29,000 deaths from prostate cancer.
The CellDetect® is a new-generation cytopathological staining platform for accurate cancer detection. It offers proprietary diagnostic solutions based on unique combination of color and morphology. The CellDetect® efficacy was proven for cervical and bladder cancer in multiple clinical studies, and it is estimated that the technology can be implemented for use in additional cancer detection indications. Both the cervical and bladder cancer diagnostic products are in initial commercial stage.
Itai Bar-Natan, CFO
SOURCE Micromedic Technologies