Real-Time PCR Assay for HIV-1 Subtype Diagnosis and Global Surveillance of Drug Resistance

CDC researchers have developed a patented set of RT-PCR and sequencing primers based on HIV-1 group M sequences. Evaluation of the primers using samples collected around the world demonstrated broad detection capacity for multiple HIV-1 group subtypes and predominant circulating recombinant forms. Commercially available HIV-1 drug resistance (HIVDR) genotyping assays are expensive and have limited ability to detect non-B subtypes. This optimized assay is broadly sensitive in genotyping HIV-1 group M viral strains and more sensitive than other assays in detecting mixed viral populations. This technology can be used in resource-limited settings where HIVDR surveillance is recommended to minimize the development and transmission of HIVDR.

  • Utility for HIV-1 sub-typing detection, evaluation of anti-HIV therapeutic efficacy, and HIV drug resistance (HIVDR) surveillance and monitoring
  • Rapid, accurate, and cost-effective technology easily adapted as a kit

Potential Commercial Applications: Competitive Advantages:
  • HIV-1 sub-typing diagnostic
  • Evaluation of efficacy of anti-HIV therapeutics
  • HIV drug resistance (HIVDR) surveillance and monitoring
  • Cost-effective
  • Simple to implement
  • Rapid, accurate and objectively conclusive
  • Easily implemented as a kit
  • Assay could be applicable to HIVDR genotyping in both ART-naive and ART-experienced populations


Chunfu Yang (CDC)  ➽ more inventions...

Nicholas Wagar (CDC)  ➽ more inventions...

Joshua Devos (CDC)  ➽ more inventions...

Zhiyong Zhou (CDC)  ➽ more inventions...

Intellectual Property:
US Pat: 10,053,741 issued 2018-08-21
US Pat: 9,040,244 issued 2015-05-26
PCT Application No. PCT/US2012/045523 filed on 2012-07-05
US Application No. 61/504,522 filed on 2011-07-05

Zhou Z, et. al. PMID 22132237
Yang C, et al. PMID 20660209

Collaboration Opportunity:

The Centers for Disease Control and Prevention (CDC) is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize Real-time PCR Assay for HIV-1 Subtype Diagnosis and Global Surveillance of Drug Resistance. For collaboration opportunities, please contact CDC TTO at or 1-404-639-1330.

Licensing Contact:
Jeremiah Mitzelfelt,
Phone: 301-443-8518

OTT Reference No: E-259-2013-0
Updated: Sep 16, 2019