- The withdrawal comes after the company received feedback from the TGA and concluded it wouldn’t be able to answer all questions about the application within the 20-day timeframe allowed by the regulator
- The company says it will need to produce three batches of ColoSTAT tests from overseas to complete the testing required to answer some of the questions
- RHY first applied for ColoSTAT approval from the TGA on May 12, 2022
- The company is now planning to submit a new application for ColoSTAT this calendar year
- RHY shares are tumbling 42.71 per cent lower and trading at 55 cents at 1:55 pm AEDT
Cancer diagnostics technology company Rhythm Biosciences (RHY) has withdrawn its application for an Australian Register of Therapeutic Goods (ARTG) listing for its ColoSTAT technology.
The withdrawal came after the company received feedback from the TGA and concluded it would not be able to answer all questions about the application within the 20-day timeframe allowed by the regulator.
RHY first applied for TGA approval on May 12, 2022, for ColoSTAT — a simple, low-cost blood test for detecting colorectal cancer.
A few questions required new internal analytical testing by RHY, meaning the company needed to produce three different batches of commercially-made ColoSTAT test kits from its overseas-based manufacturer.
Supply-chain and logistics constraints mean this could not be done within the 20-day limit.
The company is now planning to submit a new application that will better meet the feedback and questions posed by the Australian Therapeutic Goods Administration (TGA).
This application is planned to be made in the current calendar year, with a subsequent announcement to be released to the ASX at the time of submission.
The company said the delay in the Australian application did not affect its proposed market entry activities into other CE Mark-conforming territories and additional international markets, including the US.
“Following the TGA’s most recent feedback, both written and verbal and management/board review, we believe that time constraints imposed result in a better opportunity for the company to submit a new and strengthened application in line with the questions raised in the TGA application review,” Otto Buttula, Executive Chairman of RHY, said.
“Hence, with a new submission to be completed in line with the questions raised by the TGA, we believe we have a better blueprint to follow in framing our new application.
“Therefore, I remain confident of a TGA registration for ColoSTAT in the future.
“Whilst Australia, as our home, remains important, it represents one of the smaller markets in our global aspirations, and the company has always intended to build the majority of its revenues in overseas territories.”
RHY shares tumbled 42.71 per cent to 55 cents at 1:55 pm AEDT.
