Biocurious: Rhythm gets into the groove of predicting and preventing cancer

News.com.au

5 hours ago

Rhythm Biosciences has expanded its original remit of bowel cancer to diagnosing other cancers early in the piece
The company late last year acquired the Genetype platform from the administrators of Genetic Technologies
Rhythm is developing its blood-based bowel cancer assay Colostat as a laboratory test
Cancer diagnostics house Rhythm Biosciences (ASX:RHY) goes by the age-old seamstress lore that a stitch in time saves nine.
In the case of common cancers, treating them later is much more expensive than if they are detected early.
'Without screening, cancers are diagnosed at late stage, by which time the cost of treatment is much greater,' says Rhythm CEO Dr David Atkins.
In the case of bowel cancer, Australians aged between 50 and 75 are eligible for a free biennial test, delivered to their door.
One problem is fewer than half of the 'poo tests' – more formally known as faecal occult tests (FOTs) – are returned.
The program is costly to run.
Another is that the disease increasingly is being detected in the under 50s, which account for 20% of all cases.
The reasons are unclear. One hypothesis is exposure to a particular e-coli toxin in early childhood, possibly more prolific because of antibiotics use, caesarean births or probiotics.
Others blame wheat-based diets.
'We have good screening programs, but the economics are such that we can't really go below 50 years old,'' Atkins says.
Getting into the Rhythm
Rhythm is working on a double-banger solution to early detection not just of bowel cancer – its original remit – but other tumours as well.
The company has been developing Colostat, a minimally invasive blood-based test that detects certain protein biomarkers. The tech had its origins from within the hallowed halls of the CSIRO, more than two decades ago.
'Our goal is to provide a simple inexpensive lab-based test that will be equivalent to the stool-based test for the symptomatic patient,' Atkins says.
Late last year Rhythm acquired a testing platform, Genetype, from the administrators of the failed listed Genetic Technologies.
Genetype tests an individual's genetic propensity to get cancer.
'The two platforms work hand in hand,' Atkins says.
'Genetype is the earliest possible point at which you can detect disease, while Colostat is able to detect disease once it has actually formed.'
For many people, FOT is not the right fit
Many recipients are unwilling to carry out the FOT test for religious or cultural reasons – or simply squeamishness.
Requiring two samples over two days, the test is somewhat cumbersome.
But Atkins says Colostat is unlikely to replace FOTs for routine screening.
'Screening tests anywhere take a long time to be adopted and authorities would be reluctant to disturb the status quo'.
Rather, Colostat is likely to be an 'adjunct or alternative to the current standard of care' for the symptomatic population.
In other words, the test would be used by GPs on doctors on the small minority of patients that present with symptoms.
'Unfortunately, in Australia most of the circa 15,000 cases diagnosed annually results from patients going to their doctor with symptoms,' Atkins says.
'Doctors need a solution to determine whether they can send the individuals for a colonoscopy, or send them home.'
The clinicians obtain a result within 24 hours, rather than a week or more for the FOT test.
The flipside of effective detection is avoiding overservicing. If the patient goes home safely, that's a big plus for the health system.
Atkins notes that Australian clinics carry out one million colonoscopies annually. Given the detection figure of 15,000 patients, many are unnecessary and 'result in unnecessary cost and stress.'
Clinical tests have shown that Colostat is more effective at detecting cancer than a FOT test, which detects blood in the stools. But this could also be a sign of polyps, ulcers, or hemorrhoids.
That said, Rhythm is happy with mere equivalency. After all, the Colostat test always will be more effective than an unused poo test.
Pursuing the lab-based route
On March 6, 2023, Rhythm shares tumbled 45% after the company withdrew its 1300-page marketing application to the local Therapeutic Goods Administration (TGA).
The company felt it was unable to provide the information the agency requested within the requisite 20 business days.
Initially, Rhythm planned to resubmit to the TGA, but now plans to commercialise Colostat via the laboratory-developed test route.
'Lab based' refers to the common path of shipping the test to an appropriately certified lab, which acts as the quality gatekeeper.
Certification means National Association of Testing Authorities accreditation.
The lab-based route obviates the need for TGA approval for general dispersal.
'Most new diagnostics go down the lab path,' Atkins says.
'It's rare for a new diagnostics company to put an assay in a box and try to get TGA approval, which is an expensive and difficult path.'
In the case of Colostat, one or two labs nationally could handle the processing, so the lab route is not that arduous.
'We're not going to need hundreds of labs running our assays in future, but we will need more than one.'
Atkins, who joined Rhythm a year ago says: 'We have focused on taking the work the previous team has done and leveraging that so we can get a high-quality product to market.'
This work includes reformulating the protein biomarkers that Colostat detects, using a single simplified assay.
'We are finalising the verification validation for the assay to ensure it does what it says on the label.'
Predicting cancer risk
The Genetype tests are a mix of genomic data and clinical and demographic history.
'The selling point for Genetype is that it gives insights into individuals' risk profiles that they otherwise wouldn't get,' Atkins says.
The Genetype acquisition transforms Rhythm from development stage to a revenue-generating business,
Rhythm paid $625,000 for Genetype – less these days than a house in Darwin or Hobart.
Atkins says Genetic Technologies spent 'comfortably more' than that on developing Genetype over more than a decade.
In the year to June 2024 Genetic Technologies derived $134,085 of revenue from Genetype, 200% higher than the previous year.
Atkins says Rhythm primarily has acquired the know-how behind Genetype – seven key staff members stayed on – as well as a watertight patent portfolio and US and local lab licences.
Rhythm also obtains the medical history of several thousand patients which it ultimately could use for R&D.
"This is incredibly valuable," Atkins says.
Won't make the same mistake
Atkins says Genetic Technologies tried to sell Genetype directly to consumers. In reality, physicians need to request the test.
'We are focused on partners who either are GP networks or have GPs within their system. For example, employee management groups, insurers, clinical networks and laboratories.'
Health insurers could carry out the test routinely, as part of health checks.
Atkins says there's a sizeable market of consumers willing to pay out of pocket for the test, ranging from 'worried well' those already deemed high risk.
Nonetheless, the company is exploring reimbursement.
Atkins says while the US is the obvious market, Europe and China are also challenging but appealing.
'We are not ignoring Australia – the tenth biggest global health wellness market based on out-of-pocket payments,' he says.
'GPs tell us there is a real appetite for individuals to invest in their own health.'
Meanwhile, Rhythm expects Colostat revenue to flow from 2026.
Following that, the company hopes to expand the assay to six other tumours, including lung cancer.
'The next 12 to 18 months for Rhythm should be truly transformational,' Atkins says.