Rhythm Biosciences (ASX: RHY) has appointed French company Biotem as the global manufacturer of its ColoSTAT test-kit.
The company said it chose Biotem following a due diligence process to select a manufacturer capable of executing on its ambition to address the global unmet need for the early detection of colorectal cancer.
Rhythm said the initial design and broader core technology transfer is currently underway. It is
expected that small-scale manufacturing of ColoSTAT prototype test-kits will have commenced by the end of 2020.
The initial batches of test-kits will undergo quality assurance and ongoing product verification testing by Rhythm.
The initial batch will be used for testing on cancerous and healthy blood samples, forming Study 6, which is on track for completion by early 2021.
“The opportunity to partner with Rhythm to manufacture the ColoSTAT® test-kit really appealed to us in the context of being part of a lifesaving diagnostic test. We understand the cancer screening opportunity and look forward to leveraging our history in developing and manufacturing antibody diagnostic tests to make ColoSTAT a success,” said Biotem CEO and CSO Clarence Deffaud.
Rhythm CEO, Mr Glenn Gilbert, said, “Following our recent completion of the ColoSTAT prototype test-kit, the appointment of Biotem as our global manufacturer now sets a clear pathway to bring ColoSTAT® to the market. We are focused on an exciting few months ahead as we scale up our development plan activities.”