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

For Immediate Release:

Today, the 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.

“The ability to rationally select treatments for patients about to start or already taking antiviral therapy provides another tool in our ongoing fight against HIV” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “Today’s authorization offers health care providers a new tool in helping to select treatment options for their patients. The right combination of antivirals can lower viral loads, or the amount of virus in the blood stream, and help keep patients with HIV healthy for many years. However, according to a recent report from the Centers for Disease Control and Prevention and the World Health Organization, the percentage of people living with HIV around the world that have resistance to some HIV drugs has increased from 11% to 29% since 2001. Today’s authorization can help health care providers better tailor drug treatment for patients who are beginning antiviral therapy and also for those who have developed resistance to HIV drugs by helping to identify mutations in the HIV-1 virus that can impact the effectiveness of certain drugs.”

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.

“As a public health agency, the FDA is keenly aware of the threat of drug resistant infections and we’re focused on facilitating the development of safe and effective new treatments to give patients more options to fight life-threatening infections,” said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. “This diagnostic provides a new way to select effective treatment options. The FDA remains committed to helping to make available to Americans more innovative medical products that help us face the challenges of managing HIV infection.”

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.

The FDA granted marketing authorization of the Sentosa SQ HIV Genotyping Assay to Vela Diagnostics USA Inc.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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