Despite a robust national cancer screening program, colorectal cancer remains the second most common cause of cancer death (after lung cancer) in Australia.

Under the National Bowel Cancer Screening Program, Australians are invited to complete a faecal occult blood test to screen for the disease every two years from the age of 50-74. Evidence shows there is a precancerous stage to bowel cancer before polyps acquire mutations and become invasive lesions. Early screening detects these early stages, allowing for early intervention and reducing mortality.

Non adherence is a major issue, with 130 million people worldwide remaining unscreened each year. To create easier, effective methods of screening, diagnostics company Rhythm Biosciences (ASX: RHY) created ColoSTAT®, a simple blood test for bowel cancer diagnosis that is more accurate than the current gold standard screening test. The test is designed for global mass market detection of colorectal cancer and can be seamlessly added to a panel of bloods.

As part of their clinical trial program the Company has been carrying out ongoing testing on ColoSTAT® which has performed well and consistently outshone the current market standard faecal test. The confirmatory testing on the tech has followed on from studies that confirmed high accuracy, sensitivity and specificity. The Company believes this provides “high confidence” in their diagnostics technology.

Rhythm is progressing their test through clinical trials and is working through the approval process with the Therapeutic Goods Administration (TGA) to gain regulatory approval. The Company is also on track to gain regulatory approval in Europe with CE Mark approval expected by the end of the calendar year.

The current round of testing will be included in a final study report which is due to be completed in 1H CY22, concurrent with the expected time for the test to enter the market. Rhythm estimates that the cancer screening market for colorectal cancer exceeds $38 billion with a global targetable population of over 800 million people.

CEO of Rhythm, Glenn Gilbert said: “Our visible path to market is emerging as our ongoing testing program continues to provide the Company with confidence moving through the regulatory phase. The high accuracy of our cancer diagnostics technology has the potential to deliver positive outcomes for millions of people around the world. This is an exciting time for all stakeholders as we focus on the massive global market opportunity ahead of us.”