Diagnostic Marker for Improving Treatment Outcomes of Hepatitis C

The National Cancer Institute (NCI) Division of Cancer Epidemiology and Genetics (DCEG)  Immunoepidemiology Branch is seeking statements of capability or interest from parties interested in collaborative research to further co-develop a gene-based diagnostic for Hepatitis C virus (HepC, HCV).

NCI Researchers have discovered Interferon-lambda 4 (IFNL4), a protein found through analysis of genomic data. Preliminary studies indicate that this protein may play a role in the clearance of HCV and may be a new target for diagnosing and treating HCV infection.

One of the unfortunate aspects of (HCV) infection is that the majority of infected individuals will develop a chronic HCV infection. Not all patients respond to current treatments, which themselves can cause severe adverse effects. IFNL4-ΔG is a novel genetic polymorphism in the newly discovered gene that is a better predictor of clinical outcome for treatment in people of African descent than the currently available diagnostic test, while the predictive value in HCV-infected Caucasians and Asians is comparable to current diagnostics. In addition, IFNL4-ΔG can predict the likelihood of a whether a person who is acutely infected with HCV infection will spontaneously clear the infection or develop chronic infection.

Potential Commercial Applications: Competitive Advantages:
  • Novel target for treatment of HCV infection 
  • Diagnostics for detection of IFNL4 mRNA or protein
  • Biological reagents for detection of IFNL4 – expression assays, antibodies and protein.
  • IFNL4 is not an essential protein and its functional inactivation may be well-tolerated.
  • Better than current ‘IL28B’ based diagnostics for predicting response to current HCV treatments for people of African descent.
  • Comparable predictive capabilities to current ‘IL28B’ based diagnostics for response to current HCV treatments in Caucasians and Asians.

Development Stage:
Pre-clinical (in vivo)

Related Invention(s):


Ludmila Prokunina (NCI)  ➽ more inventions...

Thomas O'Brien (NCI)  ➽ more inventions...

Brian P. Muchmore (NCI)  ➽ more inventions...

Raymond P. Donnelly (FDA)  ➽ more inventions...

Intellectual Property:

Prokunina-Olsson L, et al. A variant upstream of IFNL3 (IL28B) creating a new interferon gene IFNL4 is associated with impaired clearance of hepatitis C virus PMID: 23291588

Collaboration Opportunity:

Licensing and research collaboration

Licensing Contact:
John Hewes, Ph.D.
Email: John.Hewes@nih.gov
Phone: 240-276-5515

OTT Reference No: E-217-2011
Updated: Apr 20, 2018