New Australian Prostate Cancer Screening Technology Achieves "Outstanding" Results on Key US Pilot Study

SYDNEY, April 20, 2015 /PRNewswire/ --  A NEW prostate cancer screening technology developed by Australian scientists could be available to men by the end of this year, after being shown to be more than twice as accurate as existing Prostate Specific Antigen (PSA) screening technology.

The simple blood test, known as MiCheck™, has been in development at private Australian biotechnology company Minomic International Ltd for almost eight years.

It works by screening for a proprietary biomarker known as the MIL-38 antigen. This biomarker is present on the surface of prostate cancer cells. In addition, Minomic scientists have now identified two other biomarkers never previously used in prostate cancer diagnosis, to further improve the test.

In the latest trial, scientists tested 300 patient samples sourced from 10 major urology centres across the United States. The non-randomised pilot study was designed to further verify the accuracy and reliability of the technology in differentiating normal, benign and prostate cancer samples.

Researchers led by Principal Investigator Dr Neal Shore MD FACS, Medical Director, CPI, Atlantic Urology Associates, South Carolina, USA, found MiCheck™ had a demonstrated specificity of 85%, compared to just 40% for existing PSA (prostate specific antigen) screening technology. It also demonstrated 60% sensitivity.

This means that MiCheck™ delivers 1.5 false positives for every ten samples, compared to 6 false positive results in every 10 samples using standard PSA diagnostic technology.

Minomic Chief Executive Officer Dr Brad Walsh described the results as "outstanding" and said this was a significant step towards the test being commercially available to men in Australia and around the world.

"We are delighted with these results, which provide further confirmation of our approach in developing an improved prostate cancer screening tool," he said.

"MiCheck™ has been examined for reliability, accuracy and specificity in detecting the presence of prostate cancer and has passed this important clinical development stage with flying colours."

International urology expert Professor David Gillatt, who is based at Macquarie University Hospital, Sydney, Australia said it was globally recognised that new tools were required to more accurately detect the presence of prostate cancer.

He said the PSA test remained the gold standard prostate cancer-screening tool globally, but was well known for delivering a large number of false positive results.

"PSA readings can be elevated by simple activities like riding a bike," he said. "We know PSA will give a false positive reading in 6 out of 10 cases. This means men around the world are sent off for invasive biopsies and further medical investigations when in fact there was no need (in 6 out of 10 cases)."

A final trial of the MiCheck™ technology will be launched in the United States later this year, with scientists screening 1200 patient samples to provide final stage validation. These results, combined with results from this 300 patient study, will be included in a comprehensive package submitted to the US Food and Drug Administration for regulatory approvals.

Prostate cancer is the most commonly diagnosed cancer in Australian men, but has one of the best survival rates, with more than 80% of men diagnosed surviving longer than five years.

Dr Walsh commented: "This survival rate has been steadily increasing for three decades and demonstrates that early detection is crucial. We hope and expect the innovative MiCheck™ technology will further help physicians to reliably diagnose the condition at an early stage of disease and save lives."

Further Interviews:

Dr Brad Walsh, Minomic:  +61 413 231 296

About Minomic

Minomic International Ltd is an Australian privately owned biomarker discovery company specialising in in-vitro-diagnostics, diagnostic imaging and therapeutics for prostate cancer. Minomic has developed the in vitro diagnostic test called MiCheck^TM for the early detection of prostate cancer.  The key reagents, including the MIL-38 antibody and antigen and related applications are protected by international patents.

Following a successful 300 patient clinical study demonstrating good specificity of 85% for discriminating prostate cancer patients from those with benign prostatic hyperplasia or no disease, the test is about to enter final stage validation trials.

Minomic is interested in partnerships or collaborations with larger pharmaceutical/diagnostic global partners able to produce, register and distribute the MiCheck™ test and collaborate through registration and commercialisation of future diagnostic imaging and therapeutic applications of the MIL-38 antibody for prostate cancer.

SOURCE Minomic International Limited