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RHYTHM BIOSCIENCES LIMITED

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A medical diagnostics technology company
Rhythm Biosciences is interested in developing and commercialising Australian medical diagnostics technology for sale to national and international markets.
For Rhythm Biosciences, ColoSTAT™ is the first proposed product-in-development, intended as a test for the accurate and early detection of colorectal cancer.


Whether used as a ‘first-step’ screening test or in the triage of persons with a positive FIT to colonoscopy, ColoSTAT™ could play an important role in reducing the morbidity, mortality and healthcare costs associated with colorectal cancer.

ColoSTAT™ is envisaged as a simple, affordable and effective diagnostic ‘first step’ test to augment any national, state or philanthropic screening programs. This test may be of value to those people who are at risk of developing colorectal cancer, particularly those who choose not to participate in standard screening programs for various reasons.
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Colorectal cancer is a growing concern in Australia, United States and Europe
Colorectal cancer is currently the 2nd largest cause of cancer death in Australia, Europe (EU) and the United States (US), and the 3rd largest cause of cancer-related deaths globally.
The seriousness of the colorectal cancer problem and benefits of early detection have been recognised. A number of countries around the world have introduced screening programs targeted at reducing the morbidity, mortality and healthcare costs associated with colorectal cancer. In Australia for example, the National Bowel Cancer Screening Program was developed to detect colorectal cancer early to enable early intervention, improve treatment outcomes and rein in associated health costs with treating the disease in its later stages.
It’s estimated there are around 250 million people aged between 50 and 75 years for whom regular screening is recommended, yet the majority remain under-screened.


Early detection has the potential to improve treatment outcomes and save lives
Disease progression of colorectal cancer
Colorectal cancers arise in the epithelial cells that line the large bowel. The systems that normally control cell growth and survival have stopped working properly. These cells become cancerous after acquiring genetic changes that make them divide excessively and become long-lived. Colorectal cancers most often develop within precancerous overgrowths of epithelium called adenomas.

Survival is highly dependent on how advanced the cancer is at time of diagnosis. At the earliest stage, cancerous lesions can be removed during a colonoscopy and survival rates can be 90% or even higher. Late stage treatment protocols become more invasive, are expensive and lengthy. Early detection and treatment of this disease increases treatment options and has the potential to save lives.
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Doctors currently use diagnostic tests such as colonoscopies and histological analysis of biopsy samples to detect the presence and determine the stage of the colorectal cancers and what kind of treatment is best.

Patients with cancers at the earliest, most treatable stage of colorectal cancer, generally have no physical disease symptoms. These cancers bleed less, both in quantity and frequency, than more advanced cancers making them more difficult to detect with the most commonly used faecal screening test.

The risk of the cancer spreading increases progressively by stage. At each stage the cancer grows deeper into the layers of the bowel wall and beyond, increasing the risk of cancerous cells metastasizing. As the cancerous cells break away from the primary tumour they typically spread first to the lymph nodes, then to other target organs and tissues such as the liver, lungs, bones and brain.
At these later stages, the primary cancer is easier to detect with current laboratory diagnostic tools. But, the patients will often require more invasive treatments which may also include chemotherapy.

More effective detection of early-stage cancers and their timely treatment may save lives and reduce the invasiveness of treatment required.
Many people between 50 – 74 years remain unscreened
The Faecal Immunochemical Test (FIT) is an inexpensive pre-assessment of colorectal cancer risk. This test looks for surrogate markers of cancer (blood in the faeces) to identify whether a colonoscopy is needed for a clear diagnosis and to initiate appropriate treatment.
This test is offered to people aged between 50 – 74 years in Australia and most of Europe. In the US, the recommended testing includes sigmoidoscopy and colonoscopy.


Despite the efforts of screening programs to date, out of approximately 250 million people between 50-74 years of age in Australia, EU and US, around 132 million people are not screened as recommended for colorectal cancer.

As a simple blood test, the envisaged ColoSTAT™ has the potential to improve screening rates and augment existing screening programs.
Click here to read more
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Development of a simple blood test for screening
The ColoSTAT™ technology has the potential to become the new, first step screening test for people, who for personal, cultural or clinical reasons, elect to not participate in the existing screening programs for colorectal cancer.
ColoSTAT™ is designed to be a simple blood test:

  • Cost effective
  • Minimally invasive
  • Another option for those currently unwilling to screen
  • Easily run by laboratories, with minimal training or need for new infrastructure
Comparable to, if not better than, the current FIT tests in detecting early stage colorectal cancers
The in-development ColoSTAT™ blood test is anticipated to achieve greater patient participation and compliance than faecal tests. It could also be used as a triage for FOBT/FIT positive results to prioritise urgency for colonoscopy follow-up.


The ColoSTAT™ technology
The proposed ColoSTAT™ blood test has the potential to efficiently detect colorectal cancer at all stages, including the early ones. The test is to be an immunoassay – a biochemical test that measures the presence or concentration of multiple protein biomarkers for colorectal cancer.
This search for suitable biomarkers began in 2003. Since then, CSIRO scientists have identified 68 proteins reported to vary in concentration in the blood of patients with and without colorectal cancer.


Assisted by funding from the National Health and Medical Research Council, CSIRO evaluated these 68 biomarkers across five studies and reduced it to a lead panel of just a few. The studies found that when certain combinations of these protein biomarkers are measured in a blood sample, and their concentrations weighted using an algorithm, a colorectal cancer risk score can be determined. It is this patented process that forms the basis for the ColoSTAT™ technology.
Rhythm Biosciences is now working towards turning this technology into an in-market product.


Taking Australian technology to the world
Rhythm Biosciences is focussed on commercialising this Australian technology to reduce the impact of colorectal cancer globally. From research labs into an in-market product, this potentially life-saving technology could benefit people globally.

ColoSTAT™: A proposed simple blood test to save lives
ColoSTAT™ has the potential to reduce the impact of colorectal cancer globally. To achieve the realisation of a cost effective, simple blood test, easily adoptable into current clinical practices with minimal training, is a driving force for the next stage of development.
ColoSTAT™ is designed to be minimally invasive, cost effective and provide another option for those currently unwilling or unable to participate in current screening programs, estimated to be over 100 million people just in Australia, Europe and the United States.


If patient participation can be improved, and early detection achieved as comparable to, if not better than, the standard faecal test, there is an opportunity to save lives and reduce the significant impact this disease.
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The Company’s Board currently comprises four Directors. The Board has an experienced multidisciplinary management and advisory team with a strong, proven record of developing and successful product commercialisation.

Shane Tanner Chairman
An experienced, accomplished and highly-respected professional in the Australian Healthcare sector, Shane has orchestrated and been responsible for numerous small and large scale acquisitions. He also has helped to establish and guide a number of significant businesses where he was deeply involved in growth and management upskilling.
Shane has considerable experience at both senior executive and board level, being Chairman of ASX listed Paragon Care Limited and Zenitas Healthcare Limited, two successful healthcare businesses where he was the Co-Founder of each. Shane is also Chairman of ASX listed Funtastic Limited. Previously, Shane was CEO of Symbion Health (formerly Mayne Nickless Diagnostic Services), one of Australia’s largest diagnostic businesses, CFO of Mayne Group and Chairman of Vision Eye Institute.


Trevor Lockett CEO and Managing Director
A molecular biologist by trade, Trevor Lockett received his PhD in biochemistry from the University of Adelaide and postdoctoral experience at the Rockefeller University in New York. With over 30 years of research experience, predominantly at the CSIRO, Trevor has led large, multidisciplinary research efforts in the areas of prostate cancer gene therapy, colorectal cancer prevention and the promotion of gastrointestinal health. In his role as Theme Leader, Colorectal Cancer and Gut Health, Trevor oversaw the research efforts leading to the technology that is to become ColoSTAT™.
Trevor is an inventor of seven active patent families, all of which have been licensed. Trevor has previously served on the leadership executive team of business units within CSIRO and has a strong commitment to improving human health and wellbeing through the translation and commercialisation of scientific discovery into innovative products and services.


Lou Panaccio Non-Executive Director
A chartered accountant with extensive management experience in business and healthcare services. He is currently on the boards of ASX listed companies Sonic Healthcare Limited, Genera Biosystems Limited and Avita Medical Limited. Lou is also on the board of Unison Housing Limited.
Lou has more than twenty years’ experience as a board member of both public and private, for profit and not for profit companies. Previously, Lou was the CEO of Melbourne Pathology and Monash IVF, and also executive Chairman of Health Networks Australia.


David White Non-Executive Director
Based in the United States, David is a current Senior Consultant with Planet Innovation where he leads the business development efforts for the Lumos Diagnostics Division. David has over 18 years of in-depth experience covering strategic and tactical marketing, medical device sales and the commercialisation of diagnostic products.
David has previously spent three years as the Group Marketing Manager of Advanced Staining for Leica Biosystems based in Chicago. David orchestrated the integration and strategic growth of newly acquired Vision BioSystems products within Leica’s US business unit. This was followed by three years in molecular sales for GenMark Dx where he initially covered 11 states in the US Midwest and grew his start-up territory by over 100% year on year. David’s network and contacts within the US diagnostics market can accelerate the path to commercialisation in this key geography.
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