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Redefining Liver Health Through Early Detection and Monitoring: A Paradigm Shift

HeparDx: A blood test for MASH and Liver Fibrosis focused on detecting lobular inflammation and hepatocyte ballooning

In June 2023, the American Diabetes Association Recommended that all Type 2 Diabetes patients are screened for MASLD (NAFLD).

In June 2023, the multinational liver societies AASLD, EASL and ALEH announced a change in nomenclature for the diseases formerly described as NAFLD and NASH. Nonalcoholic fatty liver disease (NAFLD) is now metabolic dysfunction-associated steatotic liver disease (MASLD); metabolic dysfunction-associated steatohepatitis (MASH) is the replacement term for nonalcoholic steatohepatitis (NASH).

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What Makes Us Different?
High Accuracy
Published Clinical Data
Simple Blood-based Test
The Need for Simple and Accurate Non-invasive Testing for MASH and Liver Fibrosis

>25% of US adults have MASLD (~62m), with ~20% progressing to MASH (~13m)

Source: Int J Mol Sci, 2019

MASH has been estimated to grow to a $26bn market by 2035 (ROTH•MKM)

HeparDx is a novel liquid biopsy solution to accurately diagnose, stage and monitor MASH

Peer-reviewed and published clinical data in 250 patients

We Address the Challenges of Diagnosing MASH and Liver Fibrosis

Currently, MASH needs to be diagnosed with an ultrasound-guided liver biopsy – which has significant drawbacks

 
 
 
Out-patient procedure
Intra-user variability affects accuracy
Expensive and non-scalable
Sample quality issues
Invasive procedure with risks
Out-patient procedure
Intra-user variability affects accuracy
Expensive and non-scalable
Sample quality issues
Invasive procedure with risks
The Diagnosis Problem
Diagnosis of MASH
Currently, MASH needs to be diagnosed with an ultrasound-guided liver biopsy, which extracts a piece of the liver.
 
Risks to the Patient
This procedure can cause organ damage, pain, and in most cases, bleeding, and intrinsically has high rates of sample error.
 
 
High Cost
The procedure is high cost (~$6,000 per diagnosis in the US) and is usually performed in an out-patient setting.
 
Improving Clinical Trials
Liver biopsy for drug testing has an 80% screen failure rate, wasting money and harming patients. Many MASLD, MASH, and liver fibrosis drugs need better diagnostics.
Addressing the Need
Accurate, scalable and reproducible non-invasive tests are needed to replace liver biopsies for diagnosis & monitoring and drug discovery.
Diagnosis of NASH
Currently, NASH needs to be diagnosed with an ultrasound-guided liver biopsy, which extracts a piece of the liver.
Risks to the Patient
This procedure can cause organ damage, pain, and in most cases, bleeding, and intrinsically has high rates of sample error.
High Cost
The procedure is high cost (~$6,000 per diagnosis in the US) and is usually performed in an out-patient setting.
Improving Clinical Trials
Liver biopsy for drug testing has an 80% screen failure rate, wasting money and harming patients. Many NAFLD, NASH, and liver fibrosis drugs need better diagnostics.
Addressing the Need
Accurate, scalable and reproducible non-invasive tests are needed to replace liver biopsies for diagnosis & monitoring and drug discovery.

Our Solution

Metadeq Diagnostics has developed HeparDx – a blood test that, based on a multi-center prospective study, can accurately diagnose and stage MASH and liver fibrosis

Why HeparDx?

  • HeparDx can accurately diagnose and stage MASH with high accuracy, with the goal to aid physicians in replacing liver biopsy procedures

  • The test has high accuracy of >95% vs. liver biopsy in diagnosing the presence or absence of MASH. In comparison, other tests are below the 90% threshold

  • Clinical data from a prospective multi-center trial in 250 patients undergoing liver biopsies has been peer-reviewed and published in a leading hepatology journal, and correlates two blood biomarkers with MASH activity and fibrosis in the liver

  • The March 14, 2024 FDA approval of Madrigal Pharmaceuticals’ Rezdiffra™ (resmetirom) for the treatment of non-cirrhotic MASH with moderate to advanced liver fibrosis (F2-F3 stages) will require a faster and more accurate way for patient diagnosis and monitoring, to aid physicians, as well as payors, in monitoring drug response

  • Abstracts presented at EASL 2024 show that HeparDx can accurately detect inflammation and ballooning as individual components.

  • Over the next 3+ years, as additional therapeutics are approved by the FDA, diagnosis of MASH by the primary care physician is crucial

Key Messages

  • Published clinical trial data in high-impact peer-reviewed journal from a 250-patient multi-center prospective study
  • Potential competitive advantage in MASH with accuracy >95% using a single biomarker
  • Identifiable path to FDA approval via a 510(k); breakthrough device designation
  • Potential for point-of-care testing to expand the treating physician base beyond hepatologists

Clinical Data & FDA

  • The approval of Rezdiffra™ (resmetirom) and subsequent near-term MASH therapeutics will need an accurate, non-invasive companion diagnostic
  • Clinical trial results continue to be slowed by high screen failure rates
  • Total MASH addressable market (TAM) >$23 billion

In June 2023, the American Diabetes Association updated their guidelines to emphasize the importance of early detection of MASLD (NAFLD) in people with Type 2 Diabetes

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The CDC estimates that 37.3M people in the US have diabetes 
(By the Numbers: Diabetes in America | Diabetes | CDC)
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Diabetes and liver disease are closely linked, and it is essential that healthcare professionals have the most current information to effectively detect and manage this disease.

- Nuha ElSayed, MD MM Sc, the overseer of the ADA standards of care guidelines and chair of the professional practice committee
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