- Rhythm Biosciences’ (RHY) share price more than doubles after securing regulatory approval for its colon cancer detection blood test in the UK
- The UKCA mark certification has been granted for ColoSTAT – an affordable and user-friendly blood test designed to detect colorectal cancer
- With this certification, Rhythm can market and sell ColoSTAT within the United Kingdom
- Rhythm says this regulatory milestone is a crucial step in its strategic plan for commercialisation and market entry, opening up a customer market of around 24 million individuals
- RHY shares were up 103 per cent, trading at 71 cents at 1:45 pm AEST
Rhythm Biosciences’ (RHY) share price has more than doubled, following the regulatory approval of its colon cancer detection blood test in the United Kingdom.
The company has been granted UK conformity assessment (UKCA) mark certification for ColoSTAT, a cost-effective and user-friendly blood test designed to detect colorectal cancer.
This certification now permits Rhythm to market and sell ColoSTAT within the United Kingdom.
Introduced as the new mandatory product marking in the UK post-Brexit, the UKCA mark has replaced the previous CE mark for most products.
According to Rhythm Biosciences, obtaining this certification is a vital milestone in its strategic plan for commercialisation and market entry.
The company estimates the UK customer market for ColoSTAT encompasses a screening population of approximately 24 million individuals.
“The achievement of this regulatory milestone continues to validate our commercial pathway into global markets, with the UK alone representing an addressable population of approximately 24 million people,” Rhythm Chief Commercial Officer Elena Deak said.
“Importantly, over time we expect the market size to continue expanding, as various bodies encourage earlier age screening.”
Rhythm Biosciences anticipates further progress in its UK market entry by the end of the current calendar year.
RHY shares were up 103 per cent, trading at 71 cents at 1:45 pm AEST.