-- High calibre German consulting company appointed to assist CE Mark registration process
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
The company has appointed a high calibre German consulting firm,
MT Promedt is well regarded internationally for providing analytical and strategic services to the international health care industry.
Minomic Chief Executive Officer Dr
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(TM) 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(TM) has a demonstrated specificity of 76%.
There are currently 200 million PSA tests performed annually around the world.
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(TM) 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.