Rhythm Biosciences: A look at development in medical diagnostics technology

An ASX-listed healthcare company, Rhythm Biosciences Limited (ASX: RHY) is striving to develop and commercialise medical diagnostics technology to reduce the impact of colorectal cancer through improved diagnosis. The company possesses global patent rights to the technology, creating an enviable position and an ideal platform to make a global difference.

ColoSTAT™ outlines the company’s first proposed product-in-development, which is designed as a first step screening test for the accurate and early detection of colorectal cancer, the third biggest cause of cancer-related deaths globally. The company has directed over 13 years of research towards the ColoSTAT™ technology and is now applying the significant product development and commercialisation expertise, seeking to take the potentially life-saving technology from the research laboratory into an in-market In Vitro Diagnostic (IVD) medical device.

Image: Path to ColoSTAT™ technology commercialisation (Source: RHY’s 2018 Annual Report)

With this technology, Rhythm Biosciences is targeting to develop first minimally invasive and cost-effective step screening test for people who elect not to participate in the existing standard screening programs for colorectal cancer.

In March 2019, the company recruited its first patient for the 1,000-patient prospective clinical trial (Study 7) for ColoSTAT®, at Lyell McEwin Hospital in Adelaide. This follows the ethics approval granted by the Central Adelaide Local Health Network’s (CALHN) Human Research Ethics Committee (HREC) to Rhythm Biosciences for a 1,000-patient prospective clinical trial of its blood test ColoSTAT® for the early detection of colorectal cancer. The approval marked the first key milestone in the commencement of ColoSTAT® clinical trial, which would further allow the inclusion of additional trial sites in Adelaide and Melbourne as required.

Colorectal cancer is reported as the 2nd most prevalent in Australia, Europe and the United States, and the 3rd largest cause of cancer-related deaths globally. RHY has observed that the risk of developing colorectal cancer rises dramatically above the age of 50, but the majority of this elevated-risk section of the population remains under-screened.

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(Source: RHY’s 2018 Annual Report)

The company believes that if colorectal cancer is detected early, cure rates could be as high as 90%. To capture this market opportunity, Rhythm Biosciences is focusing on the development and commercialisation of ColoSTAT®, which is anticipated to achieve greater patient participation and compliance than faecal tests.

ColoSTAT® could play an important role in reducing the morbidity and mortality rates and healthcare costs associated with colorectal cancer. It is expected to be comparable to, if not better than the current standard of care, the faecal immunochemical test (FIT), at a lower cost. The company informed that ColoSTAT® could also be used as a triage for FOBT/FIT positive results to prioritise urgency for colonoscopy follow-up.

Under Study 7, the clinical trial reportedly involves a prospective, cross-sectional, multi-centre examination to evaluate the diagnostic performance of ColoSTAT® for detecting colorectal cancers and advanced adenomas relative to colonoscopy, as well as related comparisons to the currently used Faecal Immunochemical Test. As per the company’s information, Study 7 is expected to be completed by Q4 2019.

RHY stock closed the day’s trade at $0.170 as on 17 May 2019. The stock has returned a decent YTD return of 21.43%, with an attractive upside of 9.68% recorded in the past six months.


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