- Cancer diagnostic technology company Rhythm Biosciences (RHY) achieves CE Mark certification for ColoSTAT
- This certification indicates Rhythm’s products comply with the EU’s IVD Directives, which are a series of legislative requirement to ensure product safety
- The ColoSTAT test measures the presence and concentration of protein markers seen in colorectal cancer and determines whether the patient has it or not
- According to CEO Glenn Gilbert, the company is currently assessing its commercialisation options to market ColoSTAT into Europe
- Shares in Rhythm are up 15.8 per cent on the market and are trading at $1.91
Cancer diagnostic technology company Rhythm Biosciences (RHY) has achieved CE Mark certification for ColoSTAT.
CE Mark indicates that a company’s products comply with the EU’s IVD Directives, which are a series of legislative requirements in place to ensure product safety on the European market.
ColoSTAT is a biochemical test that measures the presence and concentration of multiple protein markers seen in colorectal cancer.
The patient is first recommended for a ColoSTAT test by their doctor, before they give a blood test and the results are analysed.
If it reveals the patient has colorectal cancer then they will go in for a colonoscopy as soon as possible.
CEO Glenn Gilbert commented on the milestone.
“The achievement of this regulatory milestone continues to validate our commercial pathway into significant global markets, with Europe alone representing a massive addressable population of over 231 million people,” Mr Gilbert said.
“This significant achievement represents an initial step change in the company and is a testament to the dedication and commitment of the entire Rhythm team.”
“Rhythm is currently assessing its commercialisation options to market ColoSTAT into Europe.”
Shares in Rhythm were up 15.8 per cent on the market and were trading at $1.91 at 11:33 an AEDT.