FDA Authorizes HIV-1 drug
The FDA has approved the for marketing the Sentosa SQ HIV Genotyping Assay, which is the first HIV drug-resistant assay used in next-generation sequencing technology.
The capability to logically choose therapies for patients ready to start or already taking antiviral treatment offers an additional device in our ongoing fight versus HIV,” said Peter Marks, M.D., Ph.D., supervisor of the FDA’s Facility for Biologics Examination and Research Study. “Today’s consent offers healthcare providers a brand-new tool in helping to choose treatment choices for their patients.
The best combination of antivirals can lower viral tons, or the quantity of virus in the bloodstream, and also aid keep patients with HIV healthy for several years. Nonetheless, according to a recent record from the Centers for Disease Control and also Avoidance and also the World Health Organization, the percent of individuals dealing with HIV around the globe that have resistance to some HIV medications has boosted from 11% to 29% given that 2001.
FDA Authorizes HIV-1 drug – What Causes AIDS?
When HIV infection is untreated, it can cause acquired immunodeficiency syndrome (AIDS) disease. It is transmitted through direct contact with Human Immunodeficiency Virus-infected bodily fluids such as blood, and the majority of Human Immunodeficiency Virus infections in the U.S. are from Human Immunodeficiency Virus-1.
According to the Center for Disease Control, there were more than 1 million Americans with Human Immunodeficiency Virus in the year 2016.
The present standard of care for patients with Human Immunodeficiency Virus-1 is ART, also known as antiretroviral therapy, the daily combined usage of drugs to treat Human Immunodeficiency Virus by suppressing it.
Traditionally, monitoring a patient’s viral lots has been done to evaluate the effectiveness of therapies. Increasing viral loads indicate that the virus might have mutated and that a patient’s present regimen is not effective at suppressing the virus. Once the virus has mutated or altered, and drug resistance develops, a person should generally change medications intake as different drugs will help to keep the virus from multiplying.
FDA Authorizes HIV-1 drug- Why Did FDA Approve It?
Food and Drug Administration Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., said the public health agency, the FDA is precise, aware of the danger of drug-resistant infections and are focused on facilitating the development of safe and effective new treatments to give patients more options to fight life-threatening infections. This diagnostic provides a new way to select effective treatment options, he added.
The Sentosa SQ Human Immunodeficiency Virus-1 Genotyping Assay detects Human Immunodeficiency Virus-1 drug resistance mutations in patients taking to start antiviral treatment. This assay will detect mutations in genes of the Human Immunodeficiency Virus-1 virus from a sample of a patient’s blood using New Generation Sequencing or NGS technology. Understanding the mutations in the virus will help healthcare providers to select a very useful combination of drugs in an ART regimen and indication in which drugs may no longer be effective against the mutated HIV-1 virus.
The US FDA reviewed data from performance studies, which demonstrated a greater than 95 percent 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.
FDA Authorizes HIV-1 drug- The Research Data
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 Food Drug and Administration or FDA have 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 Food Drug and Administration is establishing criteria, called special controls, which is the requirement that test developers must meet for demonstrating accuracy, reliability, and effectiveness of tests intended to identify the virus mutations.
These unique controls, when met along with general controls, provide a reasonable assurance of efficacy and safety for tests of this type. This action will also create a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the Food and Drug Administration’s 510(k) pathway, whereby devices can obtain clearance by demonstrating substantial equivalence to a predicate device.
The Food Drug and Administration agreed on marketing authorization of the Sentosa SQ HIV Genotyping Assay to Vela Diagnostics USA Inc.