News | April 21, 2015

Australian Prostate Cancer Screening Technology Achieves Positive Results in U.S. Pilot Study

Blood test found to more than double diagnostic specificity, drastically reduce false positives

blood test, prostate cancer, PSA, Australia, U.S., MiCheck, Minomic

April 21, 2015 — 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 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-randomized 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 Neal Shore, M.D., FACS, medical director, CPI, Atlantic Urology Associates, South Carolina, found MiCheck had a demonstrated specificity of 85 percent, compared to just 40 percent for existing PSA screening technology. It also demonstrated 60 percent sensitivity.

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

International urology expert Prof. David Gillatt, who is based at Macquarie University Hospital, Sydney, Australia said it was globally recognized 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 six 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 1,200 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 U.S. Food and Drug Administration for regulatory approvals.

For more information: www.minomic.com

Related Content

Check-Cap Initiates U.S. Pilot Study of C-Scan for Colorectal Cancer Screening
News | Colonoscopy Systems | April 15, 2019
Check-Cap Ltd. has initiated its U.S. pilot study of the C-Scan system for prevention of colorectal cancer through...
Deep Lens Closes Series A Financing for Digital AI Pathology Platform
News | Digital Pathology | April 09, 2019
Digital pathology company Deep Lens Inc. announced the closing of a $14 million Series A financing that will further...
Uterine Fibroid Embolization Safer and as Effective as Surgical Treatment
News | Interventional Radiology | April 05, 2019
Uterine fibroid embolization (UFE) effectively treats uterine fibroids with fewer post-procedure complications compared...
News | Biopsy Systems | March 29, 2019
Dune Medical Devices has just completed the first in-man cases for Smart Biopsy, its percutaneous soft tissue biopsy...
Artificial Intelligence Can Improve Emergency X-ray Identification of Pacemakers
News | X-Ray | March 29, 2019
A research team from Imperial College London believes a new software could speed up the diagnosis and treatment of...
Interventional Radiology Treatment for Tennis Elbow Reduces Pain and Inflammation

Image courtesy of Yuji Okuno

News | Interventional Radiology | March 29, 2019
Tennis elbow, a painful chronic condition that affects up to 3 percent of U.S. adults, can be effectively treated...
NIH Study of Brain Energy Patterns Provides New Insights into Alcohol Effects

NIH scientists present a new method for combining measures of brain activity (left) and glucose consumption (right) to study regional specialization and to better understand the effects of alcohol on the human brain. Image courtesy of Ehsan Shokri-Kojori, Ph.D., of NIAAA.

News | Neuro Imaging | March 22, 2019
March 22, 2019 — Assessing the patterns of energy use and neuronal activity simultaneously in the human brain improve
Houston Methodist Hospital Acquires Focal One High-Intensity Focused Ultrasound System
News | Focused Ultrasound Therapy | March 19, 2019
EDAP TMS SA announced that Houston Methodist Hospital, one of the first hospitals in the U.S. to offer Ablatherm...
Older Biologic Age Linked to Elevated Breast Cancer Risk
News | Women's Health | March 19, 2019
Biologic age, a DNA-based estimate of a person’s age, is associated with future development of breast cancer, according...
HeartFlow Analysis Successfully Stratifies Heart Disease Patients at One Year
News | CT Angiography (CTA) | March 19, 2019
Late-breaking results confirm the HeartFlow FFRct (fractional flow reserve computed tomography) Analysis enables...