Predictive cancer diagnostics company Rhythm Biosciences (ASX:RHY) has achieved a major milestone rounding off recruitment for its clinical trial for detecting colorectal cancer.

The company has enlisted 815 patients across 11 Australian sites for its clinical trial for lead product coloSTAT, a low-cost, simple blood test to early detect colorectal cancer, which is aimed at mass-market screening.

Rhythm will work with its Clinical Research Organisation (CRO) Accelagen and its analytical testing partner Sonic Clinic Trials (SCT) to progress the next stages in finalising the trial, before completing the final clinical study report.

As part of the validation process, the ColoSTAT test-kit will be loaded and tested on SCT’s testing platforms to provide further information on ease of integration into the routine process flows of pathology labs globally.

The final clinical study report for this clinical trial is targeted for completion in in the first half of 2022, and is a key component for the TGA registration package.

Current colorectal cancer detection methods problematic

Colorectal cancer is the third biggest cause of cancer-related deaths globally. More than 935,000 people die from the disease world-wide annually.

Colorectal cancer is typically diagnosed at a later stage where there is poor prognosis for long-term survival. However, if detected early colorectal cancer is also one of the most curable.

A major problem has been there currently no simple or easy detection methods for diagnosing colorectal cancer.

Many patients are put off by the faecal immunochemical test (FIT) or undergoing a colonoscopy. Rhythm’s business pursuit is centred upon technology originally developed by the CSIRO with its lead product coloSTAT addressing problems of current detection methods.

In that context, RHY said its coloSTAT blood test for the detection of bowel cancer for the global mass market is expected to be comparable to, if not better, than the FIT at a lower cost.

The new coloSTAT blood screening test would provide an alternative for those who choose not to or are unable to undergo current diagnosis methods for colorectal cancer with hopes it will detect the disease at an early stage, when patients have more treatment options, the company said.

Bowel cancer screening globally

The market for annual unscreened 50-74-year-olds is estimated at more than 800 million people globally with this market alone estimated to be worth more than $38 billion.

Rhythm CEO Glenn Gilbert told Stockhead coloSTAT had enormous potential to save lives on a global scale.

“The faecal test only detects blood in the stool which could be for a range of reasons that aren’t cancer related such as haemorrhoids or irritable bowel syndrome,” Gilbert said.

“The difference is the coloSTAT blood test is specific for colorectal or bowel cancer and it will reduce unnecessary colonoscopies which cost the healthcare system significant dollars.”

Gilbert said Rhythm’s goal is to ultimately replace the FIT and transform the way colorectal cancer is detected globally.

“Most of the world uses the faecal test as the standard of care and we know that A no-one likes to do it and B it’s not as accurate as an alternative like ours,” he said.

“We see our test fitting into the standard GP panel of tests where a patient goes for full bloods, liver function, thyroid, cholesterol and tick another box and have coloSTAT as well.”

ColoSTAT on track for critical approval in Australia and Europe

September has been a good month for Rhythm with the Therapeutic Goods Administration (TGA) formally accepting its manufacturers evidence documentation, which is required for the approval of ColoSTAT in Australia.

With the first step in the TGA submission process complete, Rhythm will now push ahead with the filing of an Australian Register of Therapeutic Goods (ARTG) listing.

The ARTG listing will contain further comprehensive documentation, including product technical files, clinical evaluation reports, and similar documentation.

Furthermore, Gilbert said Rhythm’s CE Mark certification for Europe is independent of the clinical trial activity being completed, with filing still on track for late 2021 opening the region for marketing and sales.

“This is huge because we are so close to getting European CE Mark certification and TGA approval,” he said.

“It will actually make a difference to patients, their families and healthcare systems worldwide.”

Rhythm Biosciences was trading up 4.24% in afternoon trade on today’s news at $1.23.