Rhythm Biosciences goes out of tune


Cancer test developer Rhythm Biosciences’ shares plunged on the ASX yesterday when the company withdrew an application for registration with the Therapeutic Goods Administration of its ColoSTAT test for colorectal cancer.

The company’s shares closed down 38 percent to 36.5 cents last night after the company announced its response to its application for an Australian Register of Therapeutic Goods listing from the TGA which required a number of questions to be answered.

Rhythm said it was in a position to answer the majority of questions posed by the TGA which reviewed its 1,300 page application.

However some questions required analytical testing of three separate batches of test kits made by its overseas contract manufacturer.

Logistical and supply chain timing was an additional issue in answering the questions.

The company said: “This would prevent RHY (Rhythm Biosciences) from being able to receive these commercially made test kits and answer the minority of questions raised by the TGA.

“In recent discussions with the TGA, in line with their normal policies, they have advised that they would be reluctant to provide an extension beyond the 20 business days.”

ColoSTAT is a simple, minimally invasive blood test for those currently unwilling or unable to utilise traditional screening methods for the disease.

The blood test is approved for sale in a number of jurisdictions, including most recently New Zealand.

Rhythm said it would submit a new application to the TGA ‘to bettewr meet their feedback and questions posed’.

this could occur this calendar year.

Picture: Rhythm Biosciences

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