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FDA authorizes marketing of first next-generation sequencing test for detecting HIV-1 drug resistance mutations

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U.S. Food and Drug Administration authorized marketing of a test to detect human immunodeficiency virus (HIV) Type-1 drug resistance mutations using next generation sequencing (NGS) technology. The Sentosa SQ HIV Genotyping Assay is the first HIV drug resistance assay that uses NGS technology that the FDA has authorized for marketing in the U.S.

When untreated, HIV infection can lead to acquired immunodeficiency syndrome (AIDS). It is transmitted through direct contact with HIV-infected bodily fluids such as blood, and the majority of HIV infections in the U.S. are from HIV-1. According to the CDC, there were more than 1 million Americans living with HIV in 2016.

The current standard of care for patients with HIV-1 is antiretroviral therapy, also known as ART, the daily use of a combination of drugs to treat HIV by suppressing the virus. According to the National Institutes of Health, it is a lifesaving treatment that can let patients with HIV lead long and healthy lives but it is not a cure.

Traditionally, monitoring a patient’s viral load has been done to evaluate the effectiveness of treatments. Increasing viral loads indicate that the virus may have mutated and that a patient’s current regimen is no longer effective at suppressing the virus. Once the virus has mutated and drug resistance develops, a person generally must change medications as different drugs will be needed to keep the virus from multiplying.

The Sentosa SQ HIV-1 Genotyping Assay detects HIV-1 drug resistance mutations in patients taking or about to start antiviral therapy. This assay detects mutations in genes of the HIV-1 virus from a sample of a patient’s blood using NGS. Understanding the mutations in the virus can help healthcare providers select an effective combination of drugs in an ART regimen and indicate which drugs may no longer be effective against the mutated HIV-1 virus. The FDA reviewed data from performance studies, which demonstrated a greater than 95% sensitivity and specificity in detecting 342 HIV drug resistant mutations and determined the Sentosa SQ HIV-1 Genotyping Assay provides a reasonable assurance of safety and effectiveness for its intended use.

The Sentosa SQ HIV Genotyping Assay is for use only in patients with HIV-1 who are about to start or already taking antiviral therapy and is not intended for diagnosing infection with HIV. Results of this test are intended to be used in conjunction with clinical observations, patient history and other laboratory evidence to make patient management decisions.

The FDA reviewed data for the Sentosa SQ HIV Genotyping Assay through the de novo premarket review pathway, a regulatory pathway for devices of a new type. Along with this authorization, the FDA is establishing criteria, called special controls, the requirements that test developers must meet for demonstrating accuracy, reliability and effectiveness of tests intended to identify virus mutations. These special controls, when met along with general controls, provide a reasonable assurance of safety and effectiveness for tests of this type. This action also creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA’s 510(k) pathway, whereby devices can obtain clearance by demonstrating substantial equivalence to a predicate device.

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