Simple, Rapid, and Sensitive Real-Time PCR Assays for Detecting Drug Resistance of HIV

This novel assay features real-time PCR reagents and methods for detecting drug-resistance related mutations in HIV, for newly diagnosed patients and those individuals currently receiving antiretroviral therapies. As the use of antiretroviral compounds to treat HIV infection proliferates, viruses adapt and evolve mutations limiting the efficacy of these drugs and disrupting the success of treatment. To address this problem, CDC researchers have developed this RT-PCR assay, intended for diagnosis of different point mutations in patient samples at an achievable sensitivity of 1-2 log greater than conventional point-mutation sequencing methods. More specifically, this assay measures the differential amplifications of common and mutation-specific reactions that target specific codons of interest. Given its low cost, simplicity, high-throughput capability, and tremendous diagnostic sensitivity, this assay will be useful for detection and surveillance of drug resistance-associated mutations and will aid in the clinical management of HIV infection.

Potential Commercial Applications: Competitive Advantages:
  • Clinical management of HIV infected patients
  • Pre-treatment evaluation baseline HIV infection to tailor appropriate drug combinations
  • Monitor the spread of resistant viruses
  • Blood donation screening
  • Research tool to study emergence and biology of drug resistance mutations
  • Cost-effective
  • Sensitive and rapid
  • Capable of resistance mutation detection in both subtype B and non-B subtypes of HIV -1, and in HIV-2
  • Easily formatted for use in kits
  • High-throughput capable

Development Stage:
In vitro data available


Jeffrey Johnson (CDC)  ➽ more inventions...

Walid Heneine (CDC)  ➽ more inventions...

Jonathan Lipscomb (CDC)  ➽ more inventions...

Intellectual Property:
US Pat: 10,519,518 issued 2019-12-31
US Pat: 8,043,809 issued 2011-10-25
US Pat: 8,318,428 issued 2012-11-27
PCT Pat: 8,592,146 issued 2013-11-26
US Pat: 9,476,103 issued 2016-10-25
US Pat: 9,879,317 issued 2018-01-30
US Pat: 10,793,902 issued 2020-10-06
US Application No. 14/059,085 filed on 2013-10-21
US Application No. 13/985,499 filed on 2013-08-14
US Application No. 60/577,696 filed on 2004-06-07
PCT Application No. PCT/US2012/025638 filed on 2012-02-17
PCT Application No. PCT/US2014/040514 filed on 2014-06-02
US Application No. 61/443,926 filed on 2011-02-17
US Application No. 15/848,555 filed on 2017-12-20

Johnson JA, et al. PMID 17653265
Johnson JA, et al. PMID 18666824
Li JF, et al. PMID 21257741
Nishizawa M, et al. PMID 24358257
Wei X, et al. PMID 21130027

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

OTT Reference No: E-198-2013-0
Updated: Mar 12, 2018