Q&A: Noninvasive liquid biopsy test could be ‘game changer’ for NASH, liver fibrosis
Click Here to Manage Email Alerts
A noninvasive liquid biopsy test diagnosed the presence and severity of nonalcoholic steatohepatitis and liver fibrosis more reliably than liver biopsy, according to research published in Gut.
In a multicenter study, researchers identified two novel protein biomarkers (PLIN2 and RAB14) that demonstrated high accuracy, sensitivity and specificity in the diagnosis of NASH and/or liver fibrosis. The proteins were tested in both primary and validation cohorts, and results were confirmed through liver biopsy. More reliable than currently used biomarkers, these proteins could aid in identifying patients who are eligible for NASH pharmacotherapy or surgery in clinical trials.
Healio spoke with Giorgio Castagneto Gissey, BSc, MSc, PhD, president and founder of Metadeq Inc., a NASH and metabolic disease diagnostics company that collaborated with study investigators on the test, about key research findings and how they might impact the care of patients with NASH and liver fibrosis.
Healio: Why did your team explore this topic?
Castagneto Gissey: The main driver for Metadeq working on this problem was the fact that there is no noninvasive and accurate blood test for NASH or liver fibrosis; the only way to diagnose both diseases is through invasive liver biopsy, which causes complications and is expensive.
About 25% of the global population has nonalcoholic fatty liver disease and can be at risk for NASH. However, there is no way to get them tested because of the issues associated with liver biopsy, which is a fundamentally unscalable technology.
We wanted to find a highly scalable, easy to perform and accurate blood test and have been able to do just that. The test will revolutionize the NASH space, saving millions of lives and helping generate much better drugs for those affected.
Healio: How was the study designed?
Castagneto Gissey: Essentially, we had a sample of 250 patients across three hospitals, including patients who had NASH and/or liver fibrosis as determined with the standard of diagnosis (liver biopsy). We compared results in terms of presence/absence and stage of the two diseases with our blood test and with liver biopsy.
Healio: What were the main takeaways?
Castagneto Gissey: Our test has impressive accuracy, sensitivity and specificity for both NASH and liver fibrosis. It has a sensitivity of 88% to 95%, a specificity of 90% to 100% and an overall accuracy of 92% to 93% for NASH.
For fibrosis, results were even better with a sensitivity of 99% to 100%, specificity of 90% to 96% and accuracy of 98% to 99%. As well as being much more accurate than all other currently available biomarkers, it is now possible to predict the stages of the diseases without invasive liver biopsy.
Healio: How will these results inform patient care going forward?
Castagneto Gissey: Patients will be able to know whether they have NAFLD, NASH or liver fibrosis — this will be invaluable for them — and it can determine the stage of liver disease, saving millions of lives before liver damage is irreversible. In fact, this is a silent disease that leads to irreversible damage (ie, requiring liver transplant or causing liver cancer or death) before the patient is aware of it.
Healio: What additional research, if any, is needed?
Castagneto Gissey: The evidence is quite conclusive and what we are now doing is bringing this to market. We have completed the research stage and are working on gaining FDA approval and entering the market. The FDA will likely require us to complete further testing, but we already have a significantly validated and most useful and needed test.
Healio: Is there anything else you would like our readers to know?
Castagneto Gissey: Metadeq’s Hepar-Q is the first ever noninvasive test that can stage the disease. Before, the only way this was possible was via invasive liver biopsy. The high cost — $3,000 or more per biopsy — which causes many complications, is the reason why 25% of the global population cannot easily be tested. The test will be a game changer for 2 billion people worldwide, as well as companies developing drugs.
Reference:
- PR Newswire. Metadeq announces breakthrough non-invasive blood test that solves NASH diagnosis problem. Available at: https://www.prnewswire.com/news-releases/metadeq-announces-breakthrough-non-invasive-blood-test-that-solves-nash-diagnosis-problem-301587569.html. Accessed: July 19, 2022.
Collapse
Angelini G, et al. Gut. 2022;doi:10.1136/gutjnl-2022-327498.
Read more about
Click Here to Manage Email Alerts