The US Food and Drug Administration (FDA) has authorised marketing approval for Sentosa SQ HIV Genotyping Assay, which helps to detect human immunodeficiency virus (HIV) Type-1 drug resistance mutations using next-generation sequencing (NGS) technology.
The Sentosa SQ HIV-1 Genotyping Assay detects HIV-1 drug resistance mutations in patients taking, or just about to start antiviral therapy. However, it is not intended to diagnose HIV infection.
The assay uses NGS technology to detect genetic mutations in genes of the HIV-1 virus collected from the blood sample of a patient.
FDA’s center for biologics evaluation and research director Peter Marks said: “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.
“The authorisation offers health care providers a new tool in helping to select treatment options for their patients.”
A recent report from the Centers for Disease Control and Prevention and the World Health Organization highlights that the percentage of people suffering from HIV around the world with resistance to some HIV drugs has increased from 11% to 29% since 2001.
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Before marketing authorisation, the FDA analysed data from performance studies, which indicated over 95% sensitivity and specificity in detecting 342 HIV drug-resistant mutations.
Currently, antiretroviral therapy (ART) is the standard treatment for patients with HIV-1.
Under this standard of care, patients are treated daily through a combination of two or more drugs. Although this therapy is considered to be a life-saving treatment, it does not provide a complete cure.
By understanding the changes in the virus, healthcare providers can offer a combination of drugs in an ART regimen, indicating drugs not considered to be effective against mutated HIV-1 virus.