Researchers at the Centers for Disease Control and Prevention (CDC) developed a low-cost technology to rapidly detect HIV-1 drug resistance (HIVDR) in plasma and dried blood spot (DBS) samples with 95.8% genotyping sensitivity. CDC’s partners at Life Technologies Corporation (“LifeTech”) have licensed, further developed, and incorporated the technology into a commercialized product. Life Tech’s HIV-1 Genotyping Kit provides a cost-effective assay, scalable workflow, easy-to read sequencing results, and robust test performance. The technology delivers high efficiency in genotyping diverse HIV-1 group M strains circulating globally from plasma samples and DBS with substantial reagent cost savings. The DBS testing capability removes a huge barrier for many resource limited areas where the World Health Organization (WHO) recommends HIVDR surveillance and monitoring, but where storage and timely transportation of plasma samples from remote locations remain challenging. The American Type Culture Collection (ATCC) first licensed CDC’s technology in 2013 and partnered with Life Tech. CDC’s Technology Transfer Office handled the first patent applications, agreements, and licensing. The CDC Team at the National Institute of Allergy and Infectious Diseases (NIAID) Technology Transfer and Intellectual Property Office (TTIPO) oversaw licensing and patenting on CDC’s behalf beginning in October 2015. TTIPO negotiated with Life Tech later and signed a non-exclusive patent license agreement in January 2017 for commercializing the technology. CDC researchers collaborated with partners and authored or co-authored 39 publications. The elimination of HIV is one of CDC’s “Winnable Battles,” which are public health priorities in which CDC and its partners can make significant progress in a relatively short time.

This technology transfer supports the Winnable Battle in monitoring HIVDR for optimal HIV treatment and viral load suppression. As antiretroviral therapy (ART) scale-up continues, HIVDR surveillance is vital to ensuring sustained effectiveness of ART regimens and preventing transmission of drug-resistant HIV to newly infected persons. Importantly, in 2017, WHO issued guidelines recommending using alternative first-line regimens in countries for which pretreatment HIVDR to non-nucleoside reverse-transcriptase inhibitors exceed 10% of HIV infected population initiating ART. Since 2017, the Thermo Fisher kit has been sold to 47 customers, including distributors in 27 countries.