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Ed. Note: This post is part of Innovate4Health, a joint project of GMU’s Center for the Protection of Intellectual Property and the Information Technology and Innovation Foundation providing case studies on how IP-driven innovation is tackling some of the world’s toughest health issues.
Health care providers face daunting challenges in diagnosing HIV in remote, resource-poor areas of developing countries. First, the gold-standard process for testing people’s blood requires expensive lab equipment and well-trained technicians, which means it is often centralized in major cities. Additionally, after someone has tested positive for the virus, they should be retested every six months during treatment which creates further challenges. The lack of alternative diagnostic options has become a major roadblock to getting more people with HIV on the path to treatment. But an innovative new product may finally do this.
This product—Visitect CD4—will make HIV diagnosis quicker, cheaper, and more accessible. And intellectual property, which can play a role in improving healthcare outcomes in developing countries, has been one key part of the long, complex, and difficult process involved in developing it.
Testing for the number of CD4 T-cells—which are a critical part of the body’s immune system—is a vital step for the management and care of people with HIV. It is required to prioritize people for treatment and encourage rapid linkage to care and treatment, especially antiretroviral treatment (ART). Early detection is critical as HIV can destroy so many of the body’s CD4 T-cells that it can’t fight off infections and disease, such as malaria, bacterial infections, toxoplasmosis and pneumocystis pneumonia. Furthermore, testing is not a one off. The World Health Organization (WHO) recommends patients be tested at least every 6 months thereafter to monitor their health during ART.
The problem is that the current way to make this diagnosis—flow cytometry—requires expensive laboratory-based equipment, well-trained laboratory technicians, power, clean water, regular maintenance, and cold chain storage for reagents, which results in centralized testing locations. Most laboratories and clinics in countries most affected by HIV and AIDS are unable to monitor T-cells, particularly in remote and rural settings.
The Visitect CD4 is a point-of-care test that uses a format similar to a pregnancy test where a sample line of blood is checked against a test line to give a visual treat or no-treat result. Visitect CD4 uses a small amount of blood from a finger-prick with results available after 40 minutes at a cost of approximately $5, half the cost of a regular CD4 test. Furthermore, it shortens the diagnosis and treatment timeframe; a standard process would involve a visit to a clinic, a referral for CD4 testing, a visit to a laboratory for blood to be drawn, and an additional clinic visit to receive a CD4 test result and counselling.
This product could increase the number of people on ART and reduce the number of people whose health is negatively affected due to delays associated with centralized laboratory-based testing and in getting follow up treatment. Indicative of the potential positive impact, a U.S. Centers for Disease Control and Prevention (CDC) and Kenya Medical Research Institute study showed that carrying out a point-of-care CD4 count immediately after a person was diagnosed with HIV by home-based testing doubled the rate of linkage to HIV care. It also showed that, even where HIV treatment performs best in Africa, around one in five people entered HIV care in 2014 or 2015 when their CD4 cell counts had already fallen below a critically low threshold (100 cells/mm3).
Intellectual property has played an important role in bringing Visitect CD4 to market. Visitect was initially developed by the Burnet Institute in Melbourne, Australia, a not-for-profit research institution which focuses on accelerating the translation of research, including through licensing, into health solutions, especially for vulnerable communities. The Burnet Institute has already developed a number of rapid point of care diagnostic tests for use in developing countries, including for hepatitis E, hepatitis A and Active Syphilis tests. However, developing the technology involved risks, costs, and time investment.
It took the Burnet Institute six years to develop Visitect CD4. In 2012, the Burnet Institute entered into a licensing agreement with Omega Diagnostics to commercialize CD4 for use worldwide. A licensing agreement is a key way for research institutions, such as the Burnet Institute, to translate its work into real-world impact as it can leverage a private company’s manufacturing and distribution networks and resources and expertise on product development. Omega Diagnostics Group is one of the United Kingdom’s leading companies in the fast-growing area of immunoassay and has a global presence in over 100 countries worldwide. Working to ensure the organization’s intellectual property is widely protected, in 2013, the Burnet Institute applied for and received a U.S. Patent, which builds on earlier patents granted in South Africa and to the members of the African Intellectual Property Organization.
However, indicative of the risks involved in bringing new discoveries to market, subsequent testing showed discrepancies (due to temperature changes) between laboratory and field tests. Omega had to put the device through additional testing at hospitals in the United Kingdom (where it is based), which ultimately resulted in it having to redesign the product and to simplify the manufacturing process. This extended the cost and timetable to reach commercialization. To further test the performance of the Visitect CD4, the Burnet Institute is leading a field study using the product among 175 HIV-infected pregnant women attending four antenatal care clinics in Kenya and South Africa. The risks and costs highlight the crucial role that intellectual property plays in incentivizing and protecting inventions and in facilitating product development, manufacturing, and distribution.
Furthermore, Visitect CD4 shows how intellectual property and public-private partnerships can work together to ensure the development and deployment of healthcare innovations for developing country markets. In 2014, UNITAID (a global non-profit financed by an airline ticket tax in ten countries, along with other donations, including by the Bill and Melinda Gates Foundation) gave the Burnet Institute a grant that it, in part, passed onto Omega to allow it to build up an inventory of products and for it to establish a second manufacturing facility in India. In early 2017, Omega manufactured a pilot batch of 10,000 units, tested these at three British hospitals, and finalized the design for large-scale manufacturing at its plants in India and the UK. Locating the plant in India will also greatly improve access to life-saving anti-HIV drugs for potentially hundreds of thousands of HIV-positive citizens in India.
While Visitect CD4 has the potential to have a significant impact on helping people with HIV in developing countries, it only addresses one specific issue, which may otherwise be undermined or negated by broader weaknesses in a country’s healthcare system. A recent large study in South Africa showed that linkage to care after testing HIV positive is the biggest weakness in its treatment program in trying to achieve UNAID’s 90-90-90 goal (to achieve 90 percent of people with HIV diagnosed, 90 percent of people diagnosed on treatment, and 90 percent of people on treatment with undetectable viral loads). Visitect CD4 may make diagnosis quicker, easier, cheaper, and more accessible, however, its potential to improve an individual person’s health will ultimately depend on the developing country’s overall healthcare system. The potential benefits of Visitect CD4 will be largely determined by the developing country’s ability to connect the person to treatment, and the health system’s ability or inability to provide supplies, personnel, training, and funding.
Visitect CD4’s history highlights the long, complex, uncertain, and potentially expensive path from invention, licensing, and delivery, to use. It is also an example of the intersection of how a public health issue is both a problem and a market, and how intellectual property can work as part of public-private partnerships that together seek to bring innovations to markets in countries around the world. However, the risks of failure and in product development, manufacturing, and distribution demonstrates the essential role that intellectual property plays in incentivizing and protecting innovation. Weakening intellectual property protections will only slow down the potential for further progress. Without the ability to earn returns on investment, there isn’t an incentive to invest in further research, or in the case of Omega, for it to negotiate future licensing agreements and to invest in further product development. Intellectual property is a key part, though just one of many, in what is a complex and difficult process of improving healthcare outcomes.