The Rhythm Biosciences Ltd (ASX: RHY) share price is pushing higher on Tuesday.
In afternoon trade, the predictive diagnostics company's shares are up 8.5% to $1.14.
Why is the Rhythm Biosciences share price racing higher?
Investors have been bidding the Rhythm Biosciences share price higher today after the release of a positive update.
According to the release, the Therapeutic Goods Administration (TGA) has formally accepted Rhythm's manufacturers evidence documentation. This documentation is required for the approval of its ColoSTAT product in Australia and completes the first step for regulatory approval in the country.
ColoSTAT is aimed to be a globally marketed, low-cost, simple blood test for the early detection of colorectal cancer for mass-market screening.
What now?
With step one of the TGA submission process complete, the company will now push ahead with the filing of an Australian Register of Therapeutic Goods (ARTG) listing.
The ARTG listing will contain further comprehensive documentation. This includes the product technical files, clinical evaluation reports, and similar documentation.
Rhythm's CEO, Glenn Gilbert, commented: "Progress for regulatory approval in Australia has commenced and it is pleasing to have received the TGA's acceptance of our Manufacturers Evidence."
"Our expectation remains that patient recruitment for the clinical trial (Study 7) is to be completed in the near term. Again, the application for a CE Mark for European approval is independent of both the clinical trial being completed and TGA application. CE Mark filing remains on track for late this calendar year," he added.
Investors appear excited that this product could soon be generating revenue and saving lives. The company estimates that over 850,000 people die from colorectal cancer each year. It also notes that there is a market opportunity of more than $6.5 billion per year in the US, EU, and Australian markets.
The Rhythm Biosciences share price is up 24% over the last 30 days.
