Launch of the CE-IVD-Marked HIV-1 Treatment-Resistant Strain Assay by Thermo Fisher Scientific


Thermo Fisher Scientific, a global leader in providing scientific services, today announced the release of its CE-IVD marked Applied Biosystems TaqPath Seq HIV-1 Genotyping Kit, a Sanger sequencing-based assay that analyses HIV-positive samples to find genetic variants that may resist conventional antiretroviral therapies.

The test’s results can be used to inform epidemiological and genetic surveillance studies to follow the virus’s continuous evolution as well as to monitor and treat people who have HIV. The assay is made to examine genomic alterations in the protease, reverse transcriptase, and integrase sections of the HIV-1 pol gene across nine subtypes of global relevance using HIV RNA isolated from plasma or dried blood spots.

Testing for antiretroviral medication resistance is necessary since more than 10% of people who have never had therapy and almost half of babies who have just been diagnosed exhibit resistance to first-line drug classes. Resistance is also developing against the more recent class of integrase inhibitor-based medications, posing a threat to the continued efficacy of these life-saving treatments.  In order to manage the overall evolution of HIV care and research as well as public health measures in support of the UNAIDS 2030 Fast Track targets, the improved assay design helps provide worldwide clinical and public health laboratories with a standardized, cost-effective instrument.

“Resistance to antiretroviral therapy is an important concern when providing care to people living with HIV”, “This assay, along with its ability to use either plasma or dried blood spots specimen, fulfills an unmet clinical need that can help better manage people living with HIV with the aim of having them receive more effective therapies.”

Dr. Manoj Gandhi, senior medical director of genetic testing solutions at Thermo Fisher Scientific

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