Medical diagnostics technology company Rhythm Biosciences (ASX: RHY) is continuing the development of its novel test for colorectal cancer, named ColoSTAT.
As part of this work, the company says it has achieved a major technical achievement by isolating four cell lines that produce monoclonal antibodies.
Rhythm said that its development of reagents is currently “ahead of schedule” and that their development is another critical step towards ensuring the company has a reliable, long-term source of key reagents for its “simple and effective” ColoSTAT blood test.
ColoSTAT uses antibodies to measure the levels of several proteins in the blood. The concentrations of these proteins in blood have been shown to vary in the presence or absence of colorectal cancer.
When these concentration values are combined using a proprietary algorithm the resultant cancer risk index is compared to a pre-determined threshold value. An index value above the threshold suggests the patient should progress to colonoscopy for a definitive diagnosis and further intervention as indicated. If below, the subject is advised to screen again in two years’ time.
Once clinically proven and approved, Rhythm’s goal is to establish ColoSTAT as an important tool in the diagnosis and treatment of colorectal cancer, augmenting existing tools such as faecal immunochemical tests (FITs) and colonoscopies.
ColoSTAT has the potential to reduce colorectal cancer rates – as long as people complete regular screening.
“Colorectal cancer is the third highest cause of cancer death worldwide yet it is quite treatable if diagnosed in the early stages so we really want to enable doctors to order a simple blood test as soon as we practically can,’’ said Rhythm CEO, Dr Trevor Lockett.
“In Europe, Australia and the US combined there are 250 million people between ages 50 and 75 years who should be screening for colorectal cancer but 130 million of these don’t,” said Dr Lockett.
Dr Lockett added that the team is focused on seeing the fruits of their labour translated into robust laboratory tests that can be clinically evaluated in Study 6, currently on track to start in late 2018.
As part of this development phase that has been ongoing for over a decade by both Rhythm and the CSIRO, the next stage is clinical trials.
One of Rhythm’s substantial shareholders Merchant Group has increased its equity stake from 5% to 7% earlier this month.
The Merchant Opportunities Fund is a specialist life sciences fund recognised as a successful and long-term investor in companies close to commercialisation.
The added investment could be indicative that Rhythm’s ColoSTAT test is well on its way to becoming an established method in detecting colorectal cancer and reaping significant commercial upside in the years to come.
“The CSIRO and the Rhythm teams have worked hard and done an excellent job of screening and cloning these antibody-producing cell lines putting Rhythm in a strong position to develop quality assay kits for this the third biomarker of its lead ColoSTAT biomarker panel,’’ said Dr Lockett.