Minomic Completes Prospective Clinical Study Using MiCheck® to Assist in Diagnosis of Prostate Cancer
May 17 2018 - 12:14AM
Business Wire
- 58% Fewer patients proceed to
Biopsy
- US Rollout well advanced
Australian immuno-oncology company Minomic International Ltd is
pleased to announce the completion of its prospective clinical
trial of the company’s novel prostate cancer diagnostic test,
MiCheck®. The trial demonstrated utility identifying patients with
elevated PSA who did not require a biopsy. The prospective trial
demonstrated that using MiCheck® could reduce the number of
patients (with a clinically elevated PSA) proceeding to biopsy by
up to 58%.
The trial was a prospective, non-randomized case-control study,
with a primary endpoint of detecting prostate cancer vs no cancer
and a secondary endpoint, differentiating between aggressive and
non-aggressive cancer. Twelve US research centers located across
the US, all part of the CUSP Uro-Oncology Network, provided samples
from 384 patients.
Both endpoints were met, demonstrating competitive sensitivity
and specificity in both the identification of prostate cancer and
differentiating aggressive from non-aggressive cancer.
Minomic’s CEO, Dr. Brad Walsh, noted “We are very pleased with
these results. MiCheck® has continued to show significant utility
in assisting clinicians to decide whether patients require biopsy.
This has major health economic benefits, reducing the need for
biopsy, a costly and invasive procedure, as well as obvious patient
benefits.”
The results from the trial also provide a strong foundation for
the US rollout of MiCheck® as a Laboratory Developed Test (LDT).
Minomic is well advanced in discussions with a number of potential
laboratory partners with a view to making the test available as
soon as possible.
Dr. Neal Shore, Director of Carolina Urologic Research Center,
who is the trial’s Principal Investigator, commented “New biomarker
tests such as MiCheck® will assist clinicians in selecting and
optimizing a more precise clinical pathway for both the diagnosis
and treatment of prostate cancer.”
About Minomic
Minomic International Ltd is an Australian immuno-oncology
company specialising in therapeutics and diagnostics for solid
tumors, including prostate, bladder and pancreas. Minomic has
developed an in vitro diagnostic test called the MiCheck® test for
the detection of prostate cancer. Minomic is preparing to globally
launch the MiCheck® test, which has been shown to be more than
twice as specific as the existing gold standard Prostate Specific
Antigen (PSA) screening technology. This means that MiCheck®
delivers only 1.5 false positives from every ten samples, compared
to 6 false positive results in every 10 samples using the standard
PSA test. The MiCheck® technology uses Glypican-1, a recently
identified biomarker and other biomarkers never previously used in
prostate cancer diagnosis. 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 commercialization of
future diagnostic imaging and therapeutic applications of the
MIL-38 antibody for prostate cancer.
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version on businesswire.com: https://www.businesswire.com/news/home/20180516006628/en/
Minomic International LtdBrad Walsh, Ph.D., +61 413-231-296Chief
Executive Officer