A New Liver Disease Diagnostic and Prevention Approach

July 25, 2022 - According to the Cleveland Clinic, approximately 1 in 10 people in the United States have liver disease. Current diagnostic methods for liver disease have proven ineffective in early diagnosis. Oncoustics is one of many companies looking to improve and develop new diagnostic and prevention approaches.  

The product they are investigating is an AI software to be used with ultrasound technology for liver disease diagnosis.  

Beth Rogozinski, MBA and CEO of Oncoustics, has spent most of her career advising healthcare companies, and in an interview with PharmaNewsIntelligence, she explained that traditional methods of diagnosing liver disease are invasive and are not consistently accurate. 

“Traditionally, liver disease is diagnosed via multiple referrals. If a primary care doctor suspects a patient has liver disease, the physician will usually start with blood tests, which aren't highly accurate,” she said.  

This procedure is notoriously inaccurate. “There's a whole group of people that are trying to rename liver function tests because these tests don’t really say anything about the function of the liver. As a matter of fact, over 70% of patients with full-blown cirrhosis will have normal liver enzymes. That’s a scary number,” Rogozinski told Xtelligent Healthcare Media.  

In addition to accuracy limitations, the process of liver disease diagnosis has multiple steps, making it more difficult to obtain care.  

“If a doctor suspects something is going on, they'll refer that patient to a hepatologist. The hepatologist can do a number of exams, including a fibroscan. Sometimes it might be in the office, or they'll refer that patient to radiology. So, the whole process takes multiple referrals, high-end imaging, or highly invasive biopsy,” she explains.  

She highlights the 16-gauge needle used for the biopsy and the day-long process associated with the procedure.  

Cost Efficiency  

Rogozinski explains that the plan for this device is to enable point-of-care doctors with devices as small as an ultrasound wand. Despite not producing the actual device, the software created by Oncoustics will allow for reduced cost and increased access to liver disease diagnostics.  

“We're leveraging the rise of these low-cost systems that many are probably familiar with, like a Butterfly or Exo, these things that cost under $4,000, and then we can pair it with our smartphone app. At the primary care office, a quick scan of the liver can be done to have a much deeper understanding of where a patient is at with liver disease,” said Rogozinski.  

This device will mitigate time barriers allowing patients to receive care more readily. On top of time, another benefit of this product is reduced cost.  

Rogozinski says, “A biopsy can cost upward of $10,000, and not all of that is covered. MR and MRE, magnetic resonance elastography, range between $1,500 and $1,200. A fiber scan is a big machine that costs $300,000–$350,000 and costs $10,000 a year, every six months, to recalibrate.” 

“By comparison, we're going to be able to deploy a system to the clinics at a very low cost. We're working already with some of these ultrasound OEMs to help to deploy those types of systems, and then we're looking to charge a per scan fee.” 

Rogozinski anticipates that Oncoustics AI diagnostics will be covered by insurance, pending the approval and universal use of the software. She outlines existing CPT codes, which could align with this diagnostic tool.  

Accessibility  

In addition to alleviating liver disease's temporal and financial burden, Oncoustics anticipates that this device will improve global access to diagnostic tools.  

Rogozinski describes Oncoustic’s goal as an unmet market. She cites data from the University of California Los Angeles, which states that approximately 46% of Americans are at risk for liver disease.  

During the interview, Rogozinski acknowledges that the social determinants of health play a role in increased risk and lower diagnosis rates. “A lot of patients in the black and brown community aren't getting those kinds of referrals. They don't live near a high-end MR magnet and the like.” 

The company is already beginning to consider ways in which it can improve health equity by implementing different approaches to deploy the software globally.  

“Our company is planning to deploy some systems for a clinical study at UCSD. One of the doctors there is Latina. She's got a clinic near the border. There are huge issues in Latinx populations because there's a genetic allele that increases these patients’ risk of fatty liver disease and all liver diseases, but in particular fatty liver disease. If patients get these fatty infiltrates, steatosis infiltrates into their liver,” stated Rogozinski.  

In collaboration with other organizations, Oncoustics is looking at how they can implement their devices more broadly.  

“With one group that we're starting work with, Liver Care Canada, right now, they put a big machine in a van. They're looking at how we can deploy these with nurses to go village to village outside of the cities in Canada. It's like many places; not a lot of medical care in these rural areas. We are also starting a study with the VA and looking at that as well.” 

While the initial FDA application is for adult use, the Oncoustics team hopes to apply for usage in pediatric settings later. Rogozinski outlines that the company doesn’t make any changes to existing devices. Instead, they implement their software so the device is as safe as it always was.  

Moreover, this device can potentially be used beyond liver disease. The company has collected data on its use for detecting other diseases and multiple types of cancer.  

“Our approach is a platform approach, where we can work on any anatomical area of the body that the ultrasound can image. But philosophically, we're really looking at where there are gaps that we can fill with this,” she exclaimed.  

Overall, this software shows promise in improving healthcare accessibility globally. The organization’s goals to fit unmet needs are essential for closing the healthcare gap and providing more equitable care.  

Rogozinski noted that one of the company’s main aims is to develop products to address unmet needs while decreasing costs, increasing access, and allowing for early diagnosis and intervention.  

As the investigational use of Oncoustics progresses, providers will await approval and consider how they may implement the product in their daily practices. 

Editor's Note: This article has been edited to reflect accurate names, locations, and additional information.