Cancer diagnostics company pulls TGA application

Australian cancer diagnostics technology company has withdrawn its application to the Therapeutic Goods Administration (TGA), after receiving feedback from the regulator and concluding it would not be able to answer all questions about the application for its blood test for colorectal cancer within the 20-day timeframe allowed by the regulator.

Rhythm Biosciences believed it was in a position to be able to answer the majority of questions within the required timeframe, however a minority of the questions required new internal analytical testing, which require three different production batches of commercially made ColoSTAT test-kits from their overseas based manufacturer Biotem. Coupled with the logistical and supply chain timing, this has prevent the company from being able to receive these commercially made test-kits and answer the questions raised by the TGA.

While the company is sorting out the local regulatory issues, the New Zealand regulator Medsafe approved ColoSTAT in November 2022, paving the way for the company to market the product and commence partnership discussions.

This local withdrawal does not impede the company’s proposed market entry activities into other CE Mark conforming territories and additional international markets, including the US.

Otto Buttula, Executive Chairman of Rhythm Biosciences, commented “Having decided to withdraw the current TGA submission for ColoSTAT is clearly disappointing for all stakeholders. Nonetheless, we appreciate the thorough review undertaken and meaningful dialogue with the TGA. Following the TGA’s most recent feedback, both written and verbal and management and 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.

“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 ColoSTA in the future.”

He added “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.”

Rhythm Biosciences intends to submit a new TGA application for ColoSTAT later in the current calendar year.

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