Transformative cancer diagnostics technology company, Rhythm Biosciences Ltd (ASX: RHY) has confirmed another milestone toward commercialisation of its colorectal cancer blood test, with the announcement of the final ColoSTAT clinical trial site closure.
The closure of all ColoSTAT clinical trial sites signifies the finality of clinical trial operations, which follows the recent announcement confirming ColoSTAT delivers very high accuracy for the detection of colorectal cancer, recording a sensitivity1 of 81% and a specificity of 91%.
The company is now in the process of completing remaining regulatory submission activities. Near-term activities ahead of the market release of ColoSTAT later this year, include:
- Final clinical study report completion;
- Partnering / commercialisation deals (Domestic and International);
- International country submissions / registration updates; and
- Submission with the Therapeutic Goods Administration (TGA).
The successful closure of the operational aspects of our clinical trial program places the Company into a critical phase to deliver ColoSTAT into the market later this year. We look ahead with confidence that our lifesaving cancer detection technology will make a meaningful difference to millions of people around the world,” Rhythm CEO and Managing Director, Glenn Gilbert, said.
ColoSTAT is a simple, low-cost, blood test for global mass market detection of colorectal cancer. Worldwide, colorectal cancer is the third most common cancer in men and the second most common in women, accounting for an estimated 1.9 million new cases and 935,000 deaths annually.
In an effort to reduce the global burden, many countries have implemented screening programs aimed at early detection. These programs are predominantly administered with a faecal immunochemical test (FIT) for the assessment of colorectal cancer risk, with a positive result referred for a colonoscopy.
FIT only analyses the presence of blood in faeces, which can occur for several reasons other than cancer, therefore it is not designed as an accurate test for cancer. Many people simply don’t take the test for fear of an unnecessary colonoscopy procedure, unpleasantness, difficulty, or for religious/cultural reasons.
There is currently no appropriate blood test alternative. Rhythm aims to transform the global mass-market for colorectal cancer detection with ColoSTAT its simple, lowcost blood test that is fit for purpose, meaning that it is designed to actually detect colorectal cancer.
Since listing on the ASX in 2017, the company has run a successful multi-year research and development program that has delivered technical validation of the core biomarker technology, being reproducible and stable.
The ColoSTAT test-kit was manufactured in 2021 and delivered performance testing that outperforms the current market standard faecal immunochemical test (FIT) utilising Rhythm’s proprietary algorithm.
The company is currently finalising its clinical trial for ColoSTAT, and is progressing regulatory, manufacturing and scale up activities ahead of market entry in 2022.
