This post is one of a series in the #Innovate4Health policy research initiative.
By Alex Summerton
HIV/AIDS is a complex disease presenting a range of challenges for all stages of a patient’s progression. Effective detection, diagnosis, management, and monitoring are all crucial, and problems anywhere in the treatment chain can make later stages more difficult or undo the careful work of earlier stages. Significant technological improvements in healthcare have increased the effectiveness HIV/AIDS treatment in the developed world. However, many of these advances are inaccessible to developing world countries for reasons of cost, size, complexity, or infrastructure requirements.
Developments in the use of Ion Sensitive Field Effect Transistors (ISFETs) by DNA Electronics (DNAe) has resulted in a new method for monitoring the effectiveness of antiretroviral therapy (ART). Where traditional ART effectiveness monitoring techniques often require bulky, specialized equipment with a large laboratory footprint and long turnaround times, new ISFET based testing is quicker and far more discrete as the entire testing platform has been reduced to a USB stick and requires only half an hour to perform a test.
ART comprises the administering of a combination of antiretroviral drugs inhibiting HIV’s ability to infect and reproduce in healthy cells. HIV, like any pathogen, can develop resistance to the drugs used to treat it. Monitoring is crucial to ensuring ART is effective, and when treatment isn’t it becomes necessary to switch the drugs used. Several indicators can give a window into the efficacy of treatment, either by directly or indirectly monitoring the presence of HIV. The recommended method of monitoring for HIV treatment failure is testing the concentration of viral bodies in the blood stream, or the “viral load.” The World Health Organization recommends testing every 6 to 12 months to balance the cost of testing with the need to ensure the effectiveness of ART.
However, with accuracy comes costs. Testing equipment is roughly the size of a photocopier, requires support infrastructure, and takes up considerable laboratory space, limiting its deployment and making testing costly. Testing also requires preparatory work and trained support staff, further limiting where testing is carried out. For developing countries with HIV/AIDS crises, these attributes often limit monitoring technology to large urban areas. This imposes additional costs on persons living with HIV in rural areas who often must pay for a trip to test the efficacy of their ART and a return trip days later to receive the results.
Professor Christofer Toumazou of Imperial College London and DNAe have created a method for viral load testing using ISFETs to detect subtle changes in blood caused by the presence of HIV. Using ISFET technology overcomes challenges of cost, time, and complexity. DNAe has also used ISFETs to overcome the size and centralization issues by implementing its innovative testing technology on a USB stick. A USB based ISFET testing platform boasts several advantages over traditional equipment that decrease the cost and burden imposed by testing. Dramatically smaller size means increased portability and reduced power demand, untethering testing from the lab and allowing it to travel to patients. ISFET testing technology also operates far more quickly than current testing methods. Current tests take days to perform. DNAe’s USB test returns an accurate result in 20 minutes, allowing patients to receive results in a single visit. Furthermore, USB implementation reduces the complexity of testing and consequently the need for extensive training to perform tests.
Genealysis, DNAe’s underlying ISFET technology, operates by detecting changes in pH caused by the reaction of HIV genes on a specialized microchip. The change in pH is sufficient to change the electrical state of the chip and turn it on. Thus, Genealysis uses these pH changes to identify the presence or absence of HIV in the blood by measuring pH changes related to HIV RNA and monitoring if the ART is working.
Professor Toumazou formed DNAe to commercialize his innovations in DNA analysis with a mission “to bring dramatic, life-changing improvements to healthcare and beyond with fast, simple and scientifically sound products.” The patented ISFET technology serves as the backbone of DNAe’s business operations, allowing it to secure the necessary funding for further research and development. Genealysis is currently being adapted for a sepsis diagnosis platform with the same improvements in testing time, accuracy, and cost ISFETs have shown for HIV testing. DNAe’s intellectual property rights have allowed it to secure over $70 million in investment from the U.S. Department of Health and Human Services for research and development to expand its diagnostic technology to other innovative, life-saving applications, including rapid detection of biothreat agents, antimicrobial resistant infections, and influenza. DNAe has also used its patents to increase the speed of innovation and adoption of this important technology by granting non-exclusive licenses to certain life science companies.
HIV is a disease for which treatment lasts a lifetime. Technological improvements at all stages of a patient’s progression, detection, diagnosis, treatment, and monitoring help lessen the burden HIV imposes. ISFET technology is a promising avenue to reduce the burden ART monitoring imposes on persons living with HIV in the developing world, and DNAe is poised to adapt its patented innovations for other life-saving applications.
#Innovate4Health is a joint research project by the Center for the Protection of Intellectual Property (CPIP) and the Information Technology & Innovation Foundation (ITIF). This project highlights how intellectual property-driven innovation can address global health challenges. If you have questions, comments, or a suggestion for a story we should highlight, we’d love to hear from you. Please contact Devlin Hartline at firstname.lastname@example.org.