Medical diagnostics technology company Rhythm Biosciences (ASX: RHY), has received some much-needed wind in its commercial sails after the company was granted a highly important European patent for its core product ColoSTAT for 13 jurisdictions until July 14, 2031.
The company’s lead product, ColoSTAT, detects instances of colorectal cancer in either a first-step screening test or as a method for confirming existing test results.
The product is also a viable alternative for patients that are unable to undergo standard screening programs.
Being developed to be an affordable and effective diagnostic, ColoSTAT has the potential to play an important role in reducing morbidity, mortality and healthcare costs associated with colorectal cancer.
As of today, Rhythm has been granted a patent for its antibody-based blood test targeting the accurate and early detection of colorectal cancer in Austria, Belgium, Denmark, Finland, France, Germany, Luxembourg, Netherlands, Norway, Sweden, Switzerland, Liechtenstein and the United Kingdom.
The European patent claims are geared towards the diagnosis or detection of colorectal cancer with a method comprising assessing the presence and/or level of selected combinations of up to 31 biomarkers.
In addition to its commercial intentions across Europe, the company has already been granted patents in Australia, China and Japan with patent applications still pending in the US, Brazil and India.
Within the biotech industry, the granting of patents is typically a precursor for the company to obtain the necessary regulatory approvals from its target markets to be able to sell their products to consumers. Given the non-invasive nature of Rhythm’s ColoSTAT product, such approvals are likely to be relatively expedient.
Following the culmination of Rhythm’s two-year research and development program of ColoSTAT, the focus for its first round of funding will be the lodgement of applications to the European Commission for a CE mark as well as to the Therapeutic Goods Administration (TGA) in Australia.
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,” according to Rhythm.
“In balancing coverage against costs, Rhythm elected to file this pivotal patent family in countries with both significant populations and health care systems that are supportive of cancer preventive strategies,” said Dr Trevor Lockett, managing director of Rhythm Biosciences.
Rhythm Biosciences chairman Shane Tanner said that the patent grant marks an important milestone for the company that will serve as a springboard for future commercial development.
“With patent rights secured, Rhythm will now begin developing its commercialisation strategy for ColoSTAT in the UK and on the continent,” declared Mr Tanner.
How ColoSTAT works
ColoSTAT uses antibodies to measure the levels of several proteins in the blood. The concentrations of these proteins in blood have been shown to vary in the presence or absence of colorectal cancer.
When these concentration values are combined using a proprietary algorithm the resultant cancer risk index is compared to a pre-determined threshold value.
An index value above the threshold suggests the patient should progress to colonoscopy for a definitive diagnosis and further intervention as indicated.
If below, the subject is advised to screen again in two years’ time.
Rhythm’s methodology of using antibodies was given a strong boost earlier this week, after the diagnostics company confirmed the first phase in the development of two new antibody reagents had been successfully completed, following the completion of Rhythm’s research contract with the Commonwealth Scientific and Industrial Research Organisation (CSIRO), Australia’s federal government agency responsible for scientific research.
On Monday this week, Rhythm said that four independent mixed monoclonal antibody preparations had now been identified and had passed all three preliminary screening tests.