Minomic to Register MiStat(TM) ELISA Prostate Cancer Test for CE Mark Approval
, May 27, 2014
/PRNewswire/ -- Australian
biotechnology company Minomic International Limited will register its MiStat ELISA prostate cancer test for CE Mark approval in the latter part of 2014.
Achieving CE approval will be a key commercial milestone for the company, allowing it to sell and market its early detection diagnostic technology in the 33 member countries within the European Union (EU). All medical devices marketed in the EU have been required to have CE approval since 1998.
The company has appointed a high calibre German consulting firm, MT ProMedt Consulting, to assist the registration process, which is expected to be completed by the fourth quarter of 2014.
MT Promedt is well regarded internationally for providing analytical and strategic services to the international health care industry.
Minomic Chief Executive Officer Dr Brad Walsh said CE Mark approval would be a critical milestone in the commercialisation of the MiStat diagnostic technology, which remains on track for a 2015 global launch.
He commented, "We are strategically and aggressively pursuing commercialisation of this important prostate cancer testing technology.
"In our endeavour, we are ensuring all regulatory requirements are met in key regions to bring the product to market. We look forward to a satisfactory outcome in the near term as we embark on the CE approval process."
All data to date suggests Minomic's MiStat test - a blood or urine test for the proprietary MIL-38 biomarker found on prostate cancer cells - is almost twice as specific as the PSA (Prostate Specific Antigen) diagnostic technology, which is the current gold standard globally. PSA has been controversial, largely due to the high number of false positive results delivered. Current PSA tests have a 40% specificity; MiStat has a demonstrated specificity of 76%.
There are currently 200 million PSA tests performed annually around the world.
Minomic International Ltd is an Australian owned biomarker discovery company specialising in in-vitro-diagnostics (IVD), diagnostic imaging and therapeutics for prostate cancer. Minomic has developed an in vitro diagnostic test called MiStatTM 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 proof-of-concept clinical study on 125 Australian patients demonstrating good sensitivity and specificity for discriminating prostate cancer patients from those with benign prostatic hyperplasia or no disease the test is about to enter a multi-centre clinical validation in mid-2014.
Minomic is interested in partnerships or collaborations with larger pharmaceutical/diagnostic global partners able to produce, register and distribute the MiStat ELISA test and collaborate through clinical validation, registration and commercialisation of future diagnostic imaging and therapeutic applications of the MIL-38 antibody for prostate cancer.
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SOURCE Minomic International Limited