Preventative diagnosis of fatty liver disease

P.O. Box 265
Lewisburg, PA 17837
ph: (800) 970 - 0294

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Hepgen is a molecular diagnostics company helping overweight patients and their caregivers evaluate treatment options for potential life-threatening liver diseases. 

Our flagship product now under development — HepGen Fibrosis Test — is the first accurate non-invasive standard blood test for non-alcoholic steato hepatitis (NASH).  The Fibrosis Test will assist treatment planning by qualifying invasive liver biopsies and treatment options for NASH and obesity. 

We also provide Fibrosis Test as a useful tool to support clinical trials for NASH and other obesity and liver related drugs.

  

                                                  
 

 

What We Do


The NASH epidemic is growing, tied to obesity:  Approximately 40 million obese Americans have NASH, with 8 million having fibrosis and 400,000 having cirrhosis.  There are an estimated 70,000 to 140,000 transplantations per year related to liver disease with a mortality rate of 25% (1 in 4 die).  Our tests will help guide differentiated and targeted medical management with reduced liability, including invasive but necessary liver biopsy procedures, bariatric surgery, weight loss therapy and interventions, and pharmacological treatments.  By preventing the onset of cirrhosis, our treatment will save lives and expensive transplantation procedures with high mortality rates. 

 

                                                 
 

 

Current Diagnosis Methods Do Not Work:  Currently, the gold standard of NASH diagnosis is the liver biopsy, required for pharmacological interventions and follow-up bariatric surgery and other interventions.  However, the liver biopsy [VIDEO] is rarely used (1 in 1,000) because of the liability associated with its invasiveness.  Patients who do get biopsied usually do so after a positive screen for NASH.  However, current pre-biopsy screen methods are only about 15% accurate.  These tests, known as liver function tests (or LFTs) are used broadly to screen for NASH but not very useful because of poor accuracy, sensitivity and specificity at identifying NASH patients. 

 

                                            

 

Our Solution:  We are developing better non-invasive pre-biopsy diagnostics with high accuracy, specificity and sensitivity.  Our test consists of a set of proprietary blood-based biomarkers identified and validated in clinical trials as accurately diagnosing liver scarring (fibrosis) in NASH and cirrhosis.  Preventative medicine will save lives, increase quality of care and reduce or eliminate unnecessary healthcare costs.

                                

 

Did you know..?

 

  • There are 50 million obese Americans with BMI over 30

 

  • There are 40 million people with NASH; 8 million with fibrosis (scarring) and 400,000 with end-stage cirrhosis

 

  • The liver function test pre-biopsy diagnostic fails to predict as many as 8 in 10 NASH patients.

 

  • The biopsy is recommended as the gold standard, but no accurate non-invasive pre-biopsy test exists today.  Liver biopsies cause complications or death in 5 out of 1,000 obese patients, and as a result, few physicians order the test (1 in 1,000)

 

  • There is asymptomatic phase (inflammation and fibrosis) prior to morbidity/mortality (cirrhosis)

 

  • Safe bariatric surgery, emerging therapies, and weight loss clinical interventions at the stage of fibrosis will likely prevent the onset of cirrhosis, which could result in death without transplant

 

  • HepGen's new NASH test will enable clinicians to catch NASH at the fibrosis stage, where there are few or no symptoms, and rule out certain therapies that would otherwise endanger the NASH patient

P.O. Box 265
Lewisburg, PA 17837
ph: (800) 970 - 0294