AUGUST 23RD, 2022 CONN HASTINGS EXCLUSIVE, ONCOLOGY, RADIOLOGY
Oncoustics, a medtech company based in Ontario, Canada, developed the OnX Liver Assessment Solution, an AI-powered ultrasound-based diagnostic system for liver disease. At present, detecting liver disease is a challenge, potentially involving high-end imaging systems, specialists, and invasive biopsies. These challenges, and the related expense, can limit patient access to such testing for those with strong indications of liver disease.
Consequently, in many cases, liver disease may not be detected until it is already quite advanced, limiting the potential for early detection and treatment. There is a clear need for a non-invasive, inexpensive, and relatively simple method to assess a patient’s liver for signs of disease. This latest technology aims to achieve this.
The OnX system is intended to offer a full liver screen from any clinician, with the test itself taking as little as five minutes. The test is based on an inexpensive point-of-care ultrasound system and the AI in the product uses both the ultrasound images and the raw data to infer the disease state of the imaged liver. The company describes the procedure as a virtual biopsy.
Medgadget had the opportunity to speak with Beth Rogozinski, CEO at Oncoustics, about the technology.
Conn Hastings, Medgadget: Please give us an overview of liver disease, its prevalence, and consequences for patients.
Beth Rogozinski, Oncoustics: The landscape of chronic liver disease (CLD) has evolved over the past decades. Despite advances in identifying and treating viral hepatitis, the rise of type 2 diabetes, metabolic syndrome and associated non-alcoholic fatty liver disease (NAFLD) have substantially increased the burden of chronic liver diseases worldwide. Today, it is estimated that 1.5 billion people globally have chronic liver disease and the numbers of at-risk patients are estimated to be significantly higher as NAFLD rates have increased due to the growing obesity epidemic. Structural and behavioral liver diseases like NAFLD that result in hepatic injury, starting with fatty liver infiltrates (steatosis) that can lead to inflammation and progressive fibrosis, are expected to drive most liver-related cancers, liver transplants and/or mortalities from end stage liver disease in the next decade. These diseases are most often asymptomatic until they reach very advanced stages when treatment options are limited. The COVID pandemic may also be contributing to the acceleration of liver diseases as a recent report by the American Psychological Association showed that, since the pandemic began, about 42 percent of U.S. adults have gained weight — 29 pounds, on average. Additionally, alcohol consumption has increased considerably in the context of COVID-19. There was a 54% surge in national alcohol sales during the first week of the pandemic and subsequent reports indicated persistent increases in rates of alcohol intake. Alcohol-associated liver disease (ALD) has increased in the population, with especially high increases in women. All of this is leading to an unprecedented increase in CLD and the manifold comorbid risks associated with this condition.
Medgadget: How is liver disease currently detected and assessed? How is this suboptimal?
Beth Rogozinski: Current preventative approaches to catch and diagnose liver disease early are complex and time consuming, with several appointments and specialists including hepatologists and radiologists. These exams can be expensive and minimally available and involve high end imaging such as MRIs, or they involve highly invasive biopsies. Due to these costs and lack of availability, many structural and morphological diseases go undiagnosed at early stages where there are far more options for patient interventions.
Medgadget: Please give us an overview of the Oncoustics virtual biopsy approach to liver disease diagnosis. What liver diseases can it detect?
Beth Rogozinski: Oncoustics applies AI to raw ultrasound signals from readily-available handheld ultrasound devices to rapidly differentiate healthy versus diseased tissues. There’s a wealth of information in these raw signals and this approach reveals novel biomarkers that can be aligned with existing standards and categorization systems. By mining the sound in ultrasound, Oncoustics can provide a quantitative and comparative score. While still for investigational use only, the OnX Liver Assessment Solution can be used to aid in the detection of fatty liver (steatosis) and fibrosis/cirrhosis. Other liver indications that are in development include NASH (non-alcoholic steatohepatitis) liver inflammation and liver cancer.
Medgadget: How does the system compare with conventional approaches and what are its advantages?
Beth Rogozinski: The OnX has been validated against the existing clinical standard for liver fibrosis screening with an approach called “vibration controlled transient elastography.” These systems cost up to $320,000 to buy and $20,000 a year to maintain. They require a trained operator and tests can require up to 10 separate measures to get an accurate reading. Results require evaluation and interpretation by a trained clinician. By contrast, the OnX will be low-cost, pocket-sized and easy-to-use and read by any frontline clinician. We’re simultaneously improving this product by validating it against the gold standard in liver diagnostics – the liver biopsy. In some of the clinics in which we’re currently deployed and collecting data many patients undergo a biopsy. This important data not only helps improve the labels of our fibrosis product, but it fuels the development of our NASH (non-alcoholic steatohepatitis) diagnostic – which today can only be determined via MR PDFF (magnetic resonance proton density fat fraction) or biopsy.
Medgadget: Do you have any plans to expand the technology to assist in the assessment of other organs?
Beth Rogozinski:Our approach is highly scalable and works across any anatomical region of the body that ultrasound can image. Oncoustics has already developed a proof-of-concept solution for prostate cancer, and we have a roadmap that includes breast and ovarian cancer, thyroid disease and more.
Medgadget: What stage is the technology at in terms of testing and regulatory approval? If all goes well, when do you anticipate that the technology could be available?
Beth Rogozinski: Our initial product, the OnX Liver Assessment Solution, is currently for investigational use only and has not been deployed into public clinical practice. We have been deployed for studies and data collections in six public clinics and are rapidly expanding. We are currently working on our initial FDA submission and expect to have this product cleared and available by mid-2023.
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