The Rhythm Biosciences Ltd (ASX: RHY) share price has opened higher on Tuesday after the successful completion of Study 6 for its ColoSTAT product. At the time of writing, the Rhythm share price is trading at $1.60, up 6.33%.
Let's take a closer look at this announcement and what it means for the Rhythm share price.
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Why the Rhythm share price opened higher on Tuesday
The Rhythm share price has surged. Climbing from a low of 3.5 cents 12-months ago to a high of $1.675 on 2 March. The company continues to hit significant milestones. In particular, for the commercialisation of its simple, affordable, and effective ColoSTAT blood test. This test focuses specifically on the early detection of colorectal cancer, the third-largest cause of cancer-related deaths globally.
Today, the company announced the successful completion of Study 6 for ColoSTAT. Study 6 confirmed that the third-party commercially manufactured ColoSTAT prototype test-kid demonstrated a high level of accuracy for the detection of colorectal cancer via a simple blood test.
This test utilised a third-party, commercially developed test-kit which proved that the test was reproducible, salable and consistent. Study 6 demonstrated an increase in performance over Rhythm's earlier testing results announced in November 2020.
The company will now progress to Study 7, which involves a ~1000 patient clinical trial across ten clinical trial sites. The newly appointed sites will provide geographical diversity across four states. These trials will ultimately support regulatory submissions. In particular, for the Conformitè Europëenne (CE) Mark and the Therapeutic Goods Administration (TGA) in Australia.
Rhythm share price eyes global opportunity
Rhythm highlights the growing burden of colorectal cancer in the US. The US Preventative Services Task Force currently recommends the screening age to be reduced from 50 to 45 years. This would increase the targeting screening population in the US to ~144 million people, up from 94 million. The US Centres for Medicare and Medicaid Services has also released a draft decision outlining the criteria for reimbursement of current and future blood-based colorectal cancer screening tests. Rhythm also notes that its ColoSTAT testing kid would be able to meet the requirements for reimbursement eligibility in the US. This comment was based on the Study 6 performance.
Comments from the CEO
Rhythm CEO, Glenn Gilbert is pleased with the company's results today and eyes future opportunities to commercialise the ColoSTAT test:
We continue to target ColoSTAT® as a disruptive cancer detection technology for the global mass screening market to address the growing burden of colorectal cancer. The completion, increase in performance and generally positive outcome of Study 6, is a critical milestone for the Company as we progress our clinical trial, and importantly, how we now consider our entry plans for the global markets, including the US.
Additionally, in Rhythm's half-year results, the company notes that it remains fully funded to execute its development plan. Furthermore, Rhythm ended the December 2020 period with a cash balance of $6.02 million.
