FDA authorizes next-generation test for drug resistance mutations

[Jim Allen]

Read this, I could not find in any articles or new releases what the VL limitations were so I had a dig around and found the package insert. 

Intended use;
"The Sentosa® SQ HIV-1 Genotyping Assay is a next-generation sequencing (NGS)-based in vitro diagnostic (IVD) test intended for use in detecting HIV-1 genomic mutations (in the protease, reverse transcriptase and integrase regions of the pol gene), as an aid in monitoring and treating HIV-1 infection. This test is used in adjunct to the therapeutic management of patients diagnosed with HIV-1 Group M infection with viral loads of at least 1,000 RNA copies per mL in EDTA plasma specimens[/b]" https://www.fda.gov/media/132293/download

Anyhow, the press release by FDA:
https://www.fda.gov/news-events/press-announcements/fda-authorizes-marketing-first-next-generation-sequencing-test-detecting-hiv-1-drug-resistance

In Short:

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"

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.