Monoclonal Antibody to Detect the Antiretroviral Drug Emtricitabine – for HIV Drug Adherence Monitoring


The U.S. Food and Drug Administration and World Health Organization (WHO) approved the antiretroviral drug emtricitabine (FTC)/ tenofovir disoproxil fumurate (TDF) combination for HIV pre-exposure prophylaxis (PrEP) in high risk populations. Efficacy of PrEP depends strongly on adherence to taking the FTC/TDF pill daily. In the US, the Centers for Disease Control and Prevention (CDC) estimates that 1.2 million Americans will benefit from PrEP. FTC is also a key component of antiretroviral therapy (ART) regimens of HIV-infected persons and significantly associated with adherence. According to reports from the WHO, 21.7 million HIV-infected persons worldwide were receiving ART by the end of 2017. Currently, laboratories use costly, complex, and time- consuming mass-spectrometry blood tests to monitor compliance in patients receiving PrEP and ART treatment.

CDC recently developed a monoclonal antibody (mAb) that specifically reacts with FTC. An enzyme immunoassay (EIA) test developed from the mAb could potentially maximize efficacy in PrEP users. The competitive EIA has clinically relevant sensitivity and specificity to FTC in urine. The mAb is also able to detect FTC in a lateral flow assay. These FTC assays may also aid ART management in HIV-infected persons to optimize treatment efficacy and maximize viral suppression.

Potential Commercial Applications: Competitive Advantages:
  • Development of plate-based enzyme immunoassays (EIAs) for a manufactured diagnostic kit and lateral flow assays for Point-of-care (POC) rapid diagnostics for antiretroviral drug emtricitabine (FTC) treatment adherence
  • Testing to monitor at-risk populations for HIV on PrEP
  • Testing to monitor HIV-infected populations on ART
  • Testing in surveillance programs and clinical research (e.g., clinical trials)
  • Use of assays and monoclonal antibody in laboratory research, in vitro and in vivo (e.g., animal models)
 
  • The mAb has high sensitivity and specificity to FTC – does not react with naturally occurring similar molecules in humans
  • Does not require costly mass spectrometry equipment and complex processing
  • The technology can be used by a variety of healthcare providers
  • Rapid results vs. a few weeks for standard lab results
  • No need for blood collection or finger stick by healthcare workers – reducing risk of HIV exposure
  • Pain-free, non-invasive testing of urine specimens


Inventors:

Timothy Granade (CDC)  ➽ more inventions...

Ae Saekhou Youngpairoj (CDC)  ➽ more inventions...

William Switzer (CDC)  ➽ more inventions...

Walid Heneine (CDC)  ➽ more inventions...

Chou-Pong Pau (CDC)  ➽ more inventions...

HaoQiang Zheng (CDC)  ➽ more inventions...

Jan Pohl (CDC)  ➽ more inventions...


Intellectual Property:
US Application No. 62/696,751
PCT Application No. PCT/US2019/041195

Collaboration Opportunity:

The CDC Technology Transfer Office (TTO) is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize: - Monoclonal Antibody to Detect the Antiretroviral Drug Emtricitabine – for HIV Drug Adherence Monitoring. For collaboration opportunities, please contact CDC TTO at tto@cdc.gov or 1-404-639-1330.


Licensing Contact:
Jeremiah Mitzelfelt,
Email: jeremiah.mitzelfelt@nih.gov
Phone: 301-443-8518

OTT Reference No: E-134-2018-0
Updated: Apr 12, 2019