The Rhythm Biosciences Ltd (ASX: RHY) share price is on the move during late morning trade on Thursday.
This comes after the medical device company provided an update in regards to its colorectal cancer test kit product, ColoSTAT.
At the time of writing, the Rhythm share price is up 10% to $1.32 apiece.
Rhythm progresses towards commercialisation of test kit
In today's release, Rhythm advised it has continued to conduct confirmatory testing on its ColoSTAT proprietary medical device.
Previously, Rhythm achieved positive results from its Study 6 findings in mid-March. It stated that the ColoSTAT prototype test kit demonstrates an accuracy of 84% sensitivity at 95% specificity.
This means the ColoSTAT blood test is 33% more accurate than the current market standard faecal tests.
Rhythm stated that it is advancing its approval process with the Therapeutic Goods Administration (TGA) for ColoSTAT. Achieving regulatory approval is the final hurdle for entering the Australian market.
In Europe, Rhythm has submitted its CE Mark application and is anticipating approval by end of the year. The company notes that the recent confirmatory testing is designed to support the criteria required to obtain a CE Mark.
A final study is underway following the completion of the patient recruitment phase last month. Rhythm expects to deliver the report in the first half of 2022.
Rhythm CEO, Glenn Gilbert, said:
Our visible path to market is emerging as our ongoing testing program continues to provide the company with confidence moving through the regulatory phase. The high accuracy of our cancer diagnostics technology has the potential to deliver positive outcomes for millions of people around the world. This is an exciting time for all stakeholders as we focus on the massive global market opportunity ahead of us.
More on ColoSTAT and colorectal cancer
ColoSTAT is an experimental test kit being trialled as a low-cost and easy-to-use blood test that detects colorectal cancer.
An estimated 850,000 people lose their lives from colorectal cancer each year.
In the United States, Europe, and Australia, more than 130 million people aged 50-74 years have not been tested for colorectal cancer. This represents an addressable market opportunity worth more than $6.5 billion.
Rhythm share price snapshot
The Rhythm share price has accelerated by 500% in the past 12 months, reflecting positive investor sentiment.
The shares reached an all-time high of $1.675 in March before some profit-taking investors swooped in.
At today's price, Rhythm presides a market capitalisation of roughly $281.9 million with 208.8 million shares on issue.
