Rhythm Biosciences (ASX: RHY) is a step closer to commercialising their bowel cancer detection test, having submitted documents to the Australian Therapeutic Goods Administration (TGA) for approval. The filing is a significant milestone for the Company who are hoping to launch their product to market later this year. 

Rhythm’s test offers a convenient and non-invasive method of cancer detection via blood test, The current standard test is the faecal occult blood test which is designed to detect traces of blood in the stool. Definitive diagnosis of bowel cancer is only achieved via colonoscopy where a physician can visualise adenomas or tumours in the bowel. 

With bowel cancer being the third most common cancer in both men and women in Australia, the government instituted the National Cancer Screening Program. The Program provides faecal  testing kits to Australians on their 50th birthday and encourages testing every two years after to promote early detection of disease. However, adherence is appallingly low with only 43.5% of people returning their testing kits in 2018-2019. 

Rhythm is offering an easier method of testing that has actually outperformed the market standard in clinical trials. The ColoSTAT test has a high level of specificity and sensitivity when it comes to detecting the biomarkers of cancer. 

The filing of documents for entry into the Australian Therapeutic Goods Register is an important step for the Company as they approach commercialisation. The test is already patented in multiple jurisdictions and has received the CE mark for use in Europe. 

“This is an exciting time for all Rhythm stakeholders and indeed global cancer diagnostics markets,” said Glenn Gilbert, CEO and Managing Director of Rhythm. “The team continues to diligently execute on our plans as we target ColoSTAT revenues in late CY’22. 

“We are very close to being in a unique position to transform and revolutionise the colorectal diagnostics market with our lifesaving cancer detection technology.” 

Rhythm anticipates the market opportunity for ColoSTAT and similar biomarker cancer detection tests to exceed USD $38 billion, with the potential to reach over 771 million people to screen for colorectal cancer. 

The TGA review process is expected to take between three to six months, during which time Rhythm will focus on preparing their key logistics and administrative capabilities as they work towards market entry.