Israeli breakthrough in noninvasive prostate cancer test

New-generation cytopathological staining platform could be a reliable diagnostic tool to help determine whether and when to perform a prostate biopsy.

Keren Gueta Milshtein, director of R&D Micromedic Technologies in Ramat Gan, examining slides from the prostate cancer screening study. Photo: courtesy

Scientists at Kaplan Medical Center in Rehovot, Israel, have reported a breakthrough of successfully detecting prostate cancer cells with high sensitivity using Micromedic Technologies’ CellDetect noninvasive diagnostic test, developed at Kaplan over the past two years.

The news comes less than a week after British actor and comedian Stephen Fry revealed he is being treated for prostate cancer, which afflicts nearly one adult male in nine sometime during his lifetime. Among many other celebrities who have battled prostate cancer are Robert De Niro, Mandy Patinkin, Harry Belafonte and Frank Zappa.

Current screening tests for prostate cancer deliver a high rate of false positive results (as low as 25% specificity), leading to unnecessary invasive diagnostic tests such as biopsies. In fact, for the past 10 years many experts have discouraged men without symptoms from undergoing an annual prostate-specific antigen (PSA) test, commonly used for screening in the United States since 1994.

Trials of CellDetect, a new-generation cytopathological staining platform for accurate cancer detection, demonstrated successful detection of prostate cancer cells in urine samples with 91.3% sensitivity and 75% specificity.

CellDetect previously was proven effective for diagnosing cervical and bladder cancer in multiple clinical studies and it is expected 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 stages in the United States and Europe, ISRAEL21c was told by biochemist Keren Gueta Milshtein, director of R&D at Micromedic Technologies. For the prostate cancer indication, a blinded study is planned next.

More reliable results

Prof. Dan Leibowitz, chief of urology at Kaplan and the study’s principal investigator, said the results of the CellDetect trial for prostate cancer “are very important for demonstrating the use of a reliable diagnostic tool that will help us in determining whether and when to perform, or avoid a prostate biopsy.”

For the clinical study conducted at the medical center, 59 urine samples — 28 positive prostate cancer patients and 31 healthy subjects — were collected and examined by a cytopathologist using the CellDetect color marker derived from proprietary plant extract and generic dyes.

A definite diagnosis was made in 80% of those samples. The results of the positive prostate cancer patients were compared to biopsy results that these patients had undergone prior to the clinical study.

“While prostate cancer is the second most common cancer in men worldwide, the currently available diagnostic testing is known to be unreliable,” said Guy Lerner, Micromedic’s CEO.

“With these clinical study results, we have the potential to transform prostate cancer diagnostics, offering patients a noninvasive, accurate and reliable test, and one that could improve the healthcare system through considerable cost savings.”

According to the company, CellDetect dramatically enhances the diagnostic accuracy of early-stage tumors that may be missed by standard staining techniques. The technology is applicable to both urine specimens and cervical smears, and labs can use standard processes to examine the samples.

Prostate cancer is the second most common cancer (after skin cancer) among men worldwide and is the third-leading cause of death in men worldwide.

The disease is very treatable if found early, and in some cases the cancer grows very slowly and does not need treatment. However, each year there are about 29,000 deaths from prostate cancer in the United States and 70,000 in Europe.