Visible Genetics is the manufacturer and marketer of a kit-based sequencing assay.
GENERAL INFORMATION
Assay Name
TRUGENE™ HIV-1 Genotyping Kit
Collaborators/Distributors
AML, Applied Science, Gladstone-UCSF, RDL, Los Angeles County, USC
Availability
Commercially available.
Regulatory Status
FDA approved for marketing in September 2001.
Proficiency Testing Programs
Virco
Clinical Trials
Visible Genetics is currently enrolling patients in Vigilance II, an observational study being performed under an FDA-approved IDE.
For more information about this study call:
1-877-590-0893
Financial Assistance
A Patient Assistance Program is available on a limited case-by-case basis as part of VGI's Vigilance II observational study being performed under an FDA-approved IDE (investigational device exemption). More information about this program may be obtained by phoning the TRUGENE™ Help Line at 1-888-244-2633
ASSAY INFORMATION
Genotype
Codons Interrogated
Turnaround time
Sensitivity
RT
PI
Full sequence assay
40–247
1–99
7-14 days
1000 copies/mL
*
Turnaround time depends on when and how often assays are performed at specific laboratories using this kit-based assay.
METHODOLOGY
The TRUGENE™ HIV-1 Genotyping Kit utilizes RT-PCR and CLIP™ sequencing technology to sequence the entire protease and up to codon 247 in the reverse transcriptase genes of HIV-1.
REPORT INFORMATION
Report
Drug Resistance Interpretation
Genotype
Yes
A rules-based algorithm, the GuideLines™ Rules, is used for interpretation of the entire pattern of mutations. This algorithm was developed by the VGI Consensus Panel, which is composed of independent experts in the field of antiretroviral resistance. The Consensus Panel uses information available in the peer-reviewed literature, clinical drug trials, and from the pharmaceutical industry. A final interpretation, with details for each mutation, is developed. This interpretation reports three levels of resistance for 15 FDA approved antiviral drugs and 2 available in expanded access programs: "No evidence of resistance", "Possible resistance" and "Resistance." An interpretation of "Insufficient Evidence" is provided when there is inadequate direct or indirect evidence to determine susceptibility. The report lists rules used and types of data [Evidence Basis] used for each drug to make the resistance interpretation.
1000 copies/mL