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RANDOX LABORATORIES

Non-Invasive Urine Test Detects Prostate Cancer

By Labmedica International staff writers
Posted on 15 Mar 2018
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Image: The CellDetect platform is the only histochemical solution providing color discrimination between normal, pre-cancer and cancer cells alongside morphological examination (Photo courtesy of Micromedic Technologies).
Image: The CellDetect platform is the only histochemical solution providing color discrimination between normal, pre-cancer and cancer cells alongside morphological examination (Photo courtesy of Micromedic Technologies).
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 USA for 2018 there will be about 165,000 new cases of prostate cancer and about 29,000 deaths from prostate cancer.

Prostate cancer is initially diagnosed by digital rectal exam and if the doctor finds any abnormalities in the texture, shape or size of the gland, the patient may need further tests. The Prostate-specific antigen (PSA) test is used to analyze a blood sample for a substance that is naturally produced by the prostate gland.

A clinical study carried out by scientists at Kaplan Medical Center (Rehovot, Israel) 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. 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.

The team found that 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%.

Guy Lerner, MBA, CEO of Micromedic, said, “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. 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.”

Related Links:
Kaplan Medical Center



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