HepGen services include molecular diagnostics for medical management of NASH patients, clinical trial laboratory services in the NASH field and consulting, sponsored / contracted research and development through industry and government partnerships.  Our laboratory is a fully certified independent diagnostics reference laboratory, compliant with regulations and standard operating procedures.  As of today, we are a full-service reference laboratory and central laboratory for clinical trials, licensed under current guidelines and regulations. 

For physicians and patients, the HepGen NASH test is a first-line diagnosis for preventative care of liver disease.  Our test is highly accurate and specific to NASH, unlike liver function tests (LFTs) which measure enzyme levels and liver damage.  The HepGen NASH test will provide exquisite supportive evidence to determine if an invasive liver biopsy should be ordered, or determine if the biopsy is unnecessary. 

For pharmaceutical and biotechnology partners wishing to incorporate biomarker assays into the drug development process, Niche Genomics provides consultation and access to proprietary markers through a non-exclusive license arrangement in the stages of clinical trial preparation. We also help our partners with study design, testing parameters, and specimen collection and handling.  HepGen’s NASH test may be used in every stage of clinical drug development programs for NASH, from R&D to preclinical research, and through each phase of clinical trials testing.

HepGen also provides sponsored and contracted research and development services to industry and government partners. 

Why HepGen? 

Non-alcoholic steato hepatitis (NASH) is a disease of the liver associated with obesity.  An estimated 2-5% of all Americans have NASH (9 to 15 million), and most of the 50 million obese people (body mass index over 30) are at risk for NASH.  NASH progresses from inflammation to steatosis (small pockets of fatty tissue in liver) to fibrosis (large fatty fibers in liver) to cirrhosis (liver scarring), and end-stage cirrhosis (liver failure due to scarring) which requires transplantation.  Exhibit 1 below displays progressive onset of NASH. 

Picture above: Progression of Non-Alcoholic Steato Hepatitis (NASH) to

End Stage Cirrhosis

NASH ranks third behind alcohol and hepatitis viruses as the leading causes of cirrhosis in the U.S.  To properly treat NASH, it is important to catch the disease early.  Proper treatment is guided primarily by a liver biopsy (Exhibit 2) [VIDEO].  However, the procedure is practically difficult and invasive, especially in obese patients.  Due to complications or death resulting from biopsy (5 in 1,000 cases), most physicians are unwilling to order a biopsy unless pre-biopsy tests mitigate the liability. 

Thus, there is a well-understood market need for accurate, non-invasive tests.  The predominant pre-biopsy test today is a set of non-invasive blood tests for liver damage known as liver function tests (LFTs).  LFTs catch about 15% of all NASH cases.  If a patient tests positive for liver damage, the chance of having NASH is about 80%.  However, the vast majority of NASH cases go undetected because pre-biopsy LFTs “miss” the rest. 

Picture above: The biopsy procedure involves insertion of a needle into a patient’s abdomen to extract tissue.  The tissue is analyzed under a microscope for disease.

The physician is paid a professional fee for the procedure (about $100 to $200).  While the professional fee should not be considered a primary incentive, it is the reality of the current reimbursement system.  Proper testing would lead to prevention of late stage NASH through weight control, bariatric surgery and other surgical procedures aimed at weight control, and currently used and emerging therapeutics.  Preventative measures can eliminate the need for costly treatment, morbidity and mortality associated with end stage cirrhosis.

Treatment of liver fibrosis is currently a large and rapidly growing market, chiefly due to the increase in fatty liver disease sufferers in the developed world as a consequence of the rising prevalence of obesity.  Further, recent evidence supports treatment during the reversible presymptomatic stage to open treatment options earlier (Friedman, 2003). It is apparent that, in order to interfere with this multi-step process, therapeutic intervention is required at different disease stages, ideally simultaneously.

Testimonial:

Christopher Still, DO

Director of Weight Management

Geisinger Medical Center

Danville, PA

"The HepGen NASH test will be appropriate as a first line diagnostic against NASH, and replace liver function tests as the de facto pre-biopsy measure. 

For all stages of therapy to control obesity with hypocaloric diet and physical exercist.

Because hypocaloric diets and physical activity as weight loss therapies are NOT effective over the long-term in over 90% of patients, the second line of treatment is therapeutics.  These will be selected on a case-by-case basis depending upon clinical factors.  For example, patients with simple steatosis, if there are no other symptoms due to the fatty liver, will not be treated with drugs unless they also have insulin resistance and/or hyperlipidemia.  If liver inflammation and/or fibrosis is present, then pharmacological therapy will likely be prescribed.

Alternative treatments in development/clinical trials.  Progression of NASH may not respond to the therapies described above.  Alternative treatments currently include anti–TNF-antibodies, antibiotics, probiotics, cytoprotective agents and antioxidants, reduction of peripheral resistance to insulin, and reduction of liver iron content.  Currently, at least 15 NIH monitored clinical trials are ongoing to assess various alternative treatments for NASH.

With inflammation or NASH, patients will be withdrawn from treatment with potentially hepatotoxic drugs such as amiodarone, perhexiline maleate, and tamoxifen, and will be counseled to minimize exposure to hepatotoxic environmental agents, including alcohol and certain solvents and chemicals. 

With fibrosis or cirrhosis, bariatric surgery will be considered as a weight loss alternative. 

Once NASH has progressed to cirrhosis, a variety of complications may ensue including fluid accumulation, infections, and portal hypertension and varices (increased pressure in the blood vessels of the abdomen causing swelled veins that can cause life-threatening bleeding).  These complications also require treatment, much like a chronic medical condition.  For example, drugs that remove fluid from the body will be prescribed and antibiotics will be used for infections.  For portal hypertension, blood pressure medications such as beta-blockers will be used and if varices bleed, procedures to tie off or bypass the bleeding veins will be performed (such as a transjugular intrahepatic portosystemic shunt). 

When complications from cirrhosis cannot be controlled or when the loss of liver function becomes life-threatening, a liver transplant is necessary to replace the diseased organ can replace long-term hospitalization.