ViroSeq HIV-1 Genotyping System

Intended Use
The ViroSeq HIV-1 Genotyping System is intended for use in detecting HIV genomic mutations that confer resistance to specific types of antiretroviral drugs, as an aid in monitoring and treating HIV infection. Specifically, the ViroSeq HIV-1 Genotyping System can be used to:

• Detect HIV-1 Subtype B viral resistance in plasma samples collected in EDTA with a viral load ranging from 2000 to 750,000 copies/mL
• Genotype the entire HIV-1 protease gene from codons 1-99 and two-thirds of the reverse transcriptase (RT) gene from codons 1-335

Indication for Use
The indications for use encompass the following populations:

• HIV-1 infected individuals at drug therapy failure (with increased viral load) before therapy switch
• HIV-1 infected individuals at initial presentation, before initial drug therapy

High Throughput Processing with Automated Sequencing

• Integrated systems including sample preparation, RT-PCR, cycle sequencing module, and positive controls
• Autoloading of samples provides walkaway processing

Targeted Therapy, Now a Reality

• Software converts continuous sequenced data for entire protease and 1 - 335 codons in reverse transcriptase to patient report
• Comprehensive drug resistance interpretation algorithm.
• Software provides interpretive resistance report to aid in treatment decisions

In - Depth Understanding for Targeted Treatment Decisions

• Integrated system from sample prep to final report
• Unattended hands-free capillary electrophoresis
• Powerful analysis software provides comprehensive drug resistance reports to assist with treatment decisions