The Rhythm Biosciences Ltd (ASX: RHY) share price is on fire on Tuesday morning.
At the time of writing, the cancer diagnostics technology company's shares are up 15% to $1.90.
This means the Rhythm Biosciences share price is now up an impressive 68% in 2021.
Why is the Rhythm Biosciences share price rocketing higher today?
Investors have been bidding the Rhythm Biosciences share price higher today following the release of an update relating to its ColoSTAT product.
ColoSTAT is a simple, low-cost, blood test for global mass market detection of colorectal cancer. The company notes that colorectal cancer is the third most common cancer in men and the second most common in women globally, accounting for an estimated 1.9 million new cases and 935,000 deaths annually.
According to today's release, the company has achieved a major regulatory milestone for the commercialisation of ColoSTAT. The product has been granted CE Mark and fully conforms with the European Directives for IVD Medical Devices.
Management highlights that this critical regulatory achievement is a result of robust and stringent analytical testing and adherence to design and development procedures.
Rhythm Biosciences' CEO, Glenn Gilbert, said: "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. 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."
What's next?
The company notes that being granted CE Mark was a critical component in its commercial plan and priority market entry strategy. It allows Rhythm to commercialise, market and sell ColoSTAT in a significant global market across Europe and other countries which recognise CE.
Management estimates that this customer market currently represents an addressable screening population of over 231 million people, with a combined value of US$12 billion.
