Minomic to seek CE Mark for prostate cancer test
Minomic International plans to file for CE Mark approval for its MiSat ELISA prostate cancer test in late 2014.
The company expects to complete the registration process by the fourth quarter. It has appointed German consulting firm MT ProMedt Consulting to assist with the process.
A CE Mark would allow Minomic to sell and market its early-detection diagnostic technology throughout the European Union’s 33 member countries.
Minomic CEO Dr Brad Walsh said filing for a CE Mark would be a key milestone in the commercialisation of the company’s MiSat diagnostic technology. Minomic aims to launch the technology globally in 2015.
“We are strategically and aggressively pursuing commercialisation of this important prostate cancer testing technology,” he said.
MiSat is a blood or urine test that involves detecting MIL-38, a biomarker found on prostate cancer cells.
Trials suggest that the test is almost twice as specific as the Prostate Specific Antigen (PSA) diagnostics technology, which is the current global gold standard.
Minomic is currently testing the technology in US trials, in collaboration with uro-oncology trials management organisation CUSP Group.
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