Virco Resistance Testing FAQ
- What types of clinical studies have been conducted with your products?
- What is Virco doing to keep its HIV resistance database up to date?
- Are Virco's products FDA approved?
- How are Virco's products distributed?
What types of clinical studies have been conducted with your products?
A. Studies of Resistance testing: Three European prospective clinical studies (Mazotta et al., 'Real versus Virtual Phenotype to guide treatment in heavily pretreated patients: 48- week follow up of the Genpherex trial'; Perez Eliz et al., 'Phenotype or Virtual Phenotype for Choosing Antiretroviral therapy after failure; a Prospective randomized Study' {RealVirFen}, Antivir. Ther. 8 (2003), 577-584) and Saracina et al Selection of Antiretroviral Therapy Guided by Genotypic or Phenotypic Resistance Testing An Open-Label, Randomized, Multicenter Study (PhenGen), (J Acquir Immune Defic Syndr 2004; 37:1587-1598) demonstrated the effectiveness of virco® TYPE HIV-1 in guiding the construction of a new regimen in failing patients. Each study proved that virco® TYPE HIV-1 was as effective as conventional phenotyping in guiding the construction of an effective antiretroviral regimen. Yet the virco® TYPE HIV-1 test is significantly less expensive than traditional phenotyping and is available in less than half the time it takes to complete the traditional method.
A prospective clinical study was conducted using the Antivirogram® test. This study (C. Cohen et al., 'A randomized trial assessing the Impact of Phenotypic resistance testing on Antiretroviral therapy', AIDS 16 (2002), 579-588) proved that a conventional phenotype (Antivirogram®) assay was more effective than the standard of care at the time in helping physicians design a new regimen for patients failing their current antiretroviral regimen.
B. Studies of Antiretroviral drugs utilizing resistance testing: In addition, Virco provides resistance testing services to different pharmaceutical companies involved in antiretroviral drug development programs (i.e. tirpanavir, Boheringer Ingelheim). Virco also provides resistance testing support to several ACTG- and CPCRA-sponsored studies.
What is Virco doing to keep its HIV resistance database up to date?
Virco continually updates and refines assay-specific clinical cut-offs for the optimal interpretation of phenotypic resistance. New data and samples are constantly being added to the database through Virco's routine clinical testing and through testing for clinical trials. These samples come mainly from North America and Europe. In addition, Virco has established a separate research program called the Leading Edge Initiative (LEI) to make sure the database stays at the leading edge of the HIV epidemic. Under the LEI, Virco is actively seeking specific sample types (specific mutational patterns) that are currently under-represented in the database. Virco establishes separate research collaborations with clinical centers that are willing to contribute these specific types of samples. In exchange, Virco provides free genotyping and phenotyping information. In this way, Virco will always have the most up-to-date and most complete HIV resistance database in the field.
Are Virco's products FDA approved?
The resistance testing services offered by Virco are currently not regulated by the FDA. They are covered by the Clinical Laboratory Improvements Amendments Act. All of Virco's resistance testing assays are performed in laboratories that are accredited by CLIA, CAP, and several states in the U.S.
How are Virco's products distributed?
Virco uses a network of distributors to provide its products and services to large commercial clinical laboratories and direct to hospital laboratories worldwide. In the U.S, Virco has distribution agreements with several commercial reference labs and large hospital labs. In Europe, Canada, Japan, Thailand, Hong Kong and India, Virco has partnerships with several large HIV clinical centers or core centers. For more information please visit: www.vircolab.com > about virco > strategic partnerships.