The Rhythm Biosciences Ltd (ASX: RHY) share price is on the run following the company's strategic update to FY22.
During early morning trade, Rhythm shares are swapping hands for $1.045, up 8.8%.
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Rhythm moves ahead with strategic plans
Investors appear to be pleased with the company's progress to commercialise its cancer detection technology, ColoSTAT, driving Rhythm shares higher.
In its announcement, Rhythm highlighted a number of activities that it is moving forward to launch ColoSTAT into global markets.
The first of its listed strategic initiatives is to accelerate United States market entry for ColoSTAT. The company has incorporated a wholly-owned entity to cement its foothold in the country to carry operations out smoothly. The initial pathway stages to obtain market approval from the United States Food and Drug Administration (FDA) has already commenced.
In addition, Rhythm has expanded its platform by setting up an Australian entity to hold its technology within. The company validated initial data that its lead biomarker has a global market opportunity for cancer diagnostics.
Regulatory entry in both Europe (CE Mark) and Australia is advancing ahead of completion in its ColoSTAT Study 7. CE Mark filing is slated for late 2021, and the Australian Therapeutic Goods Administration (TGA) has begun the regulatory approval process.
Lastly, the company is looking at further market entry strategies in Europe, Australia, New Zealand, China, and broader Asia. Further updates in regards to this are expected to be released to the ASX in the coming months.
Notably, the company is targeting its first revenue for late 2022.
Comments from the CEO
Rhythm CEO, Mr. Glenn Gilbert commented:
Following the exceptional ColoSTAT performance results from Study 6 and the LRF algorithm enhancement work, this has given the company confidence to now accelerate the execution of our commercial strategy, focusing on our path to market activities.
ColoSTAT will transform the global mass-market cancer diagnostic market, with exciting and positive impacts at a social and economic level.
About the Rhythm share price
The Rhythm share price has been one of the best performers over the last 12 months, rising more than 1,000%. The company's shares were trading at 6.3 cents in June before accelerating later that year.
It's worth noting that the Rhythm share price is trading just below its all-time high of $1.675, reached in March.
