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Other Diseases
Monogram has developed and is developing new drug resistance tests for hepatitis C virus (HCV) and hepatitis B virus (HBV) by building on the foundation of its PhenoSense™ and GeneSeq™ technologies. Hepatitis infection is a leading cause of liver disease and liver cancer, and affects hundreds of millions of people worldwide. We believe drug resistance testing can play an important role in both the development of new HBV and HCV drugs and in guiding the use of therapies in the future.
Hepatitis C
We have applied our GeneSeq technology to develop a test to analyze HCV drug resistance. An estimated four million people in the US are currently infected with HCV, making it much more common than HIV. Current first-line therapy for HCV is treatment with pegylated interferons plus ribavirin, which provides a cure for approximately 50 percent of patients. Unfortunately, those who do not respond to this first-line therapy, known as non-responders, do not have an acceptable alternative treatment.
HCV replicates and mutates at extremely high rates inside an infected patient, much like HIV. Complex combinations of drugs may therefore be required for successful treatment. As a result, a number of major pharmaceutical companies are discovering and developing new drugs for HCV that target many different phases of the virus' life cycle. For example, companies are developing HCV protease inhibitors as well as drugs that block the replication of the genetic material of HCV or the production of HCV proteins.
Monogram's HCV genotypic test is currently being used by pharmaceutical customers in the research and development of new HCV drugs. As more HCV drugs are developed and put into use, these tests may provide useful information to healthcare providers making treatment decisions.
Hepatitis B
We have applied our GeneSeq technology to develop a test to analyze HBV drug resistance. HBV infection is a leading cause of liver disease and liver cancer.
As with HIV, drug resistance is a problem when treating HBV. Effective therapy for chronic HBV infection will likely require complex combinations of anti-viral drugs. As more drugs become available, it will be increasingly difficult for healthcare providers to select the most appropriate drug combinations for HBV patients. Therefore, Monogram believes drug resistance testing may play an important role in guiding HBV treatment.
The FDA has approved three drugs (alpha interferon, lamivudine, and adefovir) for the treatment of HBV infection and more than 15 drugs are estimated to be in preclinical or clinical stages of development. Many of these drugs target HBV reverse transcriptase, which acts in a manner similar to HIV reverse transcriptase, preventing the virus from copying its genes. Research efforts are ongoing to discover drugs that target other aspects of HBV's life cycle, such as the assembly of HBV viruses, or the entry of HBV into liver cells.
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