The Rhythm Biosciences Ltd (ASX: RHY) share price was a very strong performer on Wednesday.
The predictive diagnostics company's shares ended the day 12% higher at $1.32.
This means the Rhythm Biosciences share price is now up 550% over the last 12 months.
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Why did the Rhythm Biosciences share price surge higher today?
Investors were bidding the Rhythm Biosciences share price higher today following the release of a milestone announcement.
According to the release, the company has completed recruitment for its clinical trial (Study 7) for ColoSTAT.
ColoSTAT is a globally marketed, low-cost, simple blood test for the early detection of colorectal cancer aimed at mass-market screening.
The release explains that Rhythm Biosciences has now successfully recruited 815 patients across 11 Australian clinical trial sites. This was deemed to be an adequate number of patients following a detailed consultation with leading industry professionals and the company's biostatisticians and Clinical Research Organisation (CRO).
Management notes that the recruitment phase is a highly involved and resource intensive component of the clinical trial. Therefore, it feels the completion of this phase represents a significant milestone towards the final completion of the clinical trial study.
What's next?
The good news for the Rhythm Biosciences share price is that ColoSTAT could be generating revenue in the not so distant future.
The company will now commence testing the collected blood samples, finalise and lock the patient database, and other routine associated works. It will also progress the next stages in finalising the trial, before completing the final clinical study report.
If all goes to plan, the clinical trial is targeted for completion in the first half of calendar year 2022. After which, it is hoping for approval to market ColoSTAT within Australia later that year.
European trials are ongoing as well, with a filing expected to be made before the end of the year.
Management commentary
Rhythm's CEO, Glenn Gilbert, said: "With the recruitment target now met for the ColoSTAT clinical trial, the Company remains fully focused on working with our partners to progress through the remaining phases for trial completion."
"In the context of market conditions made extremely difficult by COVID-19, I am proud of the achievement by the entire Rhythm team, our trial sites, CRO, operations and laboratory partners. This milestone should not be understated, considering the recruitment phase is typically the most resource, logistically challenging and cost intensive component of completing a clinical trial," he added.
Management estimates that ColoSTAT has a $6.5 billion market opportunity across the US, European, and Australian markets.
