Vela Diagnostics will go down in history as bringing to market the first test capable of detecting human immunodeficiency virus (HIV) Type-1 drug resistance mutations using next-generation sequencing (NGS) technology.
The Fairfield, NJ-based company submitted the Sentosa SQ HIV Genotyping Assay for FDA market authorization in March. It is the first FDA-authorized HIV drug resistance assay that uses NGS technology.
“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, MD, PhD, director of FDA’s Center for Biologics Evaluation and Research. “Today’s authorization offers healthcare 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 bloodstream, and help keep patients with HIV healthy for many years."
HIV drug resistance is a growing problem. Marks cited a recent report from the Centers for Disease Control and Prevention and the World Health Organization that found the global percentage of people living with HIV who 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," Marks said.
The standard of care for patients with HIV-1, which represents the majority of HIV infections in the United States, is antiretroviral therapy (ART). This involves 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.
FDA noted that 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, MD, 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 new assay is designed to detect HIV-1 drug resistance mutations in patients taking or about to start antiviral therapy by analyzing a sample of the patient's blood using NGS technology. 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. 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.
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, FDA noted. The agency reviewed the test through the de novo premarket review pathway, which is intended for devices of a new type.