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.

Competitive Advantages:

• 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.

Commercial Applications:

• 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.