Part 15 of IVD Hall of Fame
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HIV Genotyping Tests are used by physicians to closely monitor the emergence of drug resistance mutations, and to optimize the management of patients infected with drug resistant strains of HIV. HIV Genotyping tests are used to guide treatment for patients whose antiretroviral therapy is failing or as a baseline for those that are just starting on antiretroviral treatment. HIV Genotyping has become standard of care for many HIV-infected patients, as positive test results for certain mutations correlates with clinical resistance to some classes of antiretrovirals.
Prior to the availability of HIV Genotyping Assays, physicians monitored CD4 T-cell counts, HIV RNA viral loads and treatment history to help determine if the prescribed antiviral therapy was effective. Today, HIV Genotyping Tests are used by physicians to closely monitor the emergence of drug resistance mutations and to optimize the management of patients infected with drug resistant strains of HIV.
A Federal Register final rule reclassified HIV drug resistance genotype assays from Class III to Class II in conjunction with the release of a special control guidance for the submissions of 510(k) premarket notification, “Class II Special Controls Guidance Document: In Vitro HIV Drug Resistance Genotype Assay.” There are several FDA cleared and laboratory developed HIV-1 Genotyping tests available. The first FDA cleared test was Visible Genetic’s TRUGENE HIV-1 Genotyping Kit and OpenGene DNA Sequencing System.
The identification of the presence of mutations has provided insight into the efficacy of certain HIV drugs, which has improved the physician’s therapeutic guidance in monitoring or treating HIV-infected patients. The use of HIV Genotyping tests has helped physician’s identify antiretroviral therapies that are no longer appropriate for the HIV-infected patients, thereby improving survival rates and the overall quality of life for HIV-positive patients.