A recent licensing agreement between Vita Genomics and Affymetrix will put Vita in a position to create pharmacogenomic diagnostics based on Affy's FDA-cleared GeneChip technology.
Affy granted a license to Vita and its subsidiary, Shanghai GeneCore BioTechnologies, under the auspices of its "Powered by Affymetrix" program, making it one of a short list of firms that hope to earn US Food and Drug Administration clearance for GeneChip-related tests. Other participants in the program include Roche, Veridex, BioMerieux, PathWork Informatics, and ArraDx.
In Vita's case, the diagnostic under development — called HepaType — is intended to identify responders to ribavirin-interferon combination treatment for hepatitis B and C viruses, as well as those patients at risk for adverse reactions, according to a company official. The company is also working on an AsthmaType diagnostic to estimate the risk of children to develop asthma.
"Vita Genomics will seek FDA's approval [for HepaType] in the near future," John Gu, senior vice president and chief business officer of the Taipei, Taiwan-based company, wrote to Pharmacogenomics Reporter last week in an e-mail. "Currently, we are working with other [national] regulatory agencies for approvals in those regions … we expect to gain a first approval within months in one of the regions we are currently working in."
Asked whether Vita was partnering with a pharmaceutical company to create companion diagnostics linked to HCV and HBV treatment, Gu said the firm is "actively talking to potential partners and working with collaborators for co-marketing these products," but he declined to name the companies.
The company's marketing strategy will differ by region, depending on the prevalence of each virus, said Gu. Citing the World Health Organization, Gu said HCV predominates in the Americas, while HBV is more common in Asia.
The US Centers for Disease Control and Prevention estimate that 3.9 million Americans, or 1.8 percent of the population, have been infected with HCV, while 2.7 million are chronically infected. In the case of HBV, the agency estimates that 1.25 million Americans are chronically infected, with approximately 73,000 new infections each year.
The UN World Health Organization estimates that 170 million people are chronically infected with HCV worldwide, while 3 millions to 4 million people are newly infected each year. The organization estimates that 2 billion people worldwide have been infected with HBV, with more than 350 million carrying chronic infections.
Concerning the market share Vita hopes to reach, Gu said, "We hope [that] with our products, interferon treatment will reach 10 percent of the infected population in the next five years, and more people will enter treatment."
There appear to be few companies developing tests to help predict interferon response, but it may be safe to count Celera Diagnostics among them. The company recently presented a research poster at the Nov. 11 American Association for the Study of Liver Diseases meeting in San Francisco entitled, "Predictive Value of Gene Expression of Host Factors at 12 Weeks of Pegylated Interferon-alpha Plus Ribavirin Treatment in Hepatitis C Patients."
Celera spokesperson David Speechly told Pharmacogenomics Reporter in an interview this week that research into patient response to interferon treatments was "under development" at the company, but he declined to say whether the company planned to produce a diagnostic product in the area.
HepaType will incorporate "a few dozen SNPs on a handful of genes," with the ability to predict the interferon-ribavirin treatment outcome of about 80 percent of patients, Gu said. Vita is already offering the test as a service through its partners and subsidiaries, he added.
— Chris Womack ([email protected])