Issuance by the European Patent Office means that coverage of the company’s granted European patent EP 2829881 has been confirmed in 13 countries.
As well as the UK, the countries are Austria, Belgium, Denmark, Finland, France, Germany, Luxembourg, Netherlands, Norway, Sweden, Switzerland and Liechtenstein.
Managing director Dr Trevor Lockett said: “In balancing coverage against costs, Rhythm elected to file this pivotal patent family in countries with significant populations and health care systems supportive of cancer preventive strategies.”
The patent claims are geared towards diagnosis or detection of colorectal cancer with a method comprising assessing the presence and/or level of selected combinations of up to 31 biomarkers.
It also relates to diagnostic kits comprising reagents for determining the presence and/or level of selected biomarkers and methods of detecting or diagnosing colorectal cancer.
The European patent’s expiry is July 14, 2031.
Colorectal cancer is the second largest cause of cancer death in Australia, Europe and the US, and the third largest cause of cancer-related deaths globally.
ColoSTAT is intended to provide the accurate and early detection of colorectal cancer, acting as either a ‘first-step’ screening test or within the triage of persons with a positive faecal immunochemical test (FIT) or colonoscopy.
As well as being of value to those with colorectal cancer risk factors, ColoSTAT provides an alternative for those who choose not to or are unable to be assessed using standard screening programs.
Chairman Shane Tanner said: “This is an important milestone for the company.
“With patent rights secured, Rhythm will now begin developing its commercialisation strategy for ColoSTAT in the UK and on the continent.”
Rhythm has previously been granted patents directed towards the diagnosis of colorectal cancer in Australia, China and Japan.
Further patents pending
It has patent applications pending in the US, Brazil and India, and a divisional patent application pending in China.
The culmination of Rhythm’s two-year R&D program, the focus for its first funding round, will be lodgement of applications to the European authorities for a CE mark for ColoSTAT.
Rhythm will also make application to the TGA in Australia for listing of ColoSTAT on the Australian Register of Therapeutic Goods.
Success with these regulatory approvals will allow the company to sell the product in Europe, the UK and Australia via the activation of regionally tailored commercialisation plans.