News | April 21, 2015

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

News | PET Imaging

October 19, 2021 — Blue Earth Diagnostics, a Bracco company and recognized leader in the development and ...

Time October 19, 2021
arrow
News | Digital Pathology

October 18, 2021 — Histolix, a leading developer of direct-to-digital read pathology solutions, announced it has ...

Time October 18, 2021
arrow
News | Women's Health

October 11, 2021 — Electrical engineering professor Magda El-Shenawee’s effort to develop a more accurate and less ...

Time October 11, 2021
arrow
News | Prostate Cancer

September 24, 2021 — Scientists have identified two subtypes of metastatic prostate cancer that respond differently to ...

Time September 24, 2021
arrow
News | Digital Pathology

September 22, 2021 — The U.S. Food and Drug Administration authorized marketing of software to assist medical ...

Time September 22, 2021
arrow
News | Women's Health

September 22, 2021 — Radiation therapy is an effective and widely used treatment for breast cancer. While the benefits ...

Time September 22, 2021
arrow
News | Radiopharmaceuticals and Tracers

September 17, 2021 — Blue Earth Diagnostics, a Bracco company and recognized leader in the development and ...

Time September 17, 2021
arrow
News | PET Imaging

September 13, 2021 — Lantheus Holdings, Inc. and RefleXion Medical, Inc., today announced a development and ...

Time September 13, 2021
arrow
News | Breast Imaging

September 9, 2021 — Laws designed to help women with increased risk for missed breast cancer diagnoses may help catch ...

Time September 09, 2021
arrow
News | PET Imaging

September 8, 2021 — A new study from scientists at the UCLA Jonsson Comprehensive Cancer Center found that emerging ...

Time September 08, 2021
arrow
Subscribe Now