point-of-care testing

This post is one of a series in the #Innovate4Health policy research initiative.

Innovate4Health By Alex Summerton & Nick Churchill

Africa’s predominantly rural characteristic and limited medical infrastructure are among the region’s greatest challenges to implementing effective healthcare programs and policies for its residents. The high costs for patients associated with diagnosis and treatment in terms of money, time, and travel, along with cultural barriers, often result in individuals failing to seek treatment or only making initial consultations before abandoning the matter. Coupled with poor infrastructure, inadequate facilities, substandard equipment, and insufficient personnel, it is not difficult to see why Africa is still recognized as the setting for the world’s most difficult health crises by the World Health Organization (WHO).

hands taking a blood test One solution to these problems is to effectively move clinics to the patients through point-of-care technologies. Daktari Diagnostics, located in Cambridge, Massachusetts, is an innovator in this field focusing on microfluidic techniques. These techniques allow the company to develop products that do not require large scale manipulation of high volumes of blood or other biological products. Thus, diagnostic technologies can be made smaller and used anywhere they are needed. Its slogan “Anywhere. Care.” underscores its commitment to developing a cheap, and lightweight, portable diagnostic device to detect HIV, Hepatitis C Virus (HCV), and sickle cell disease.

Efforts eradicating disease are two-part, regardless of where it occurs: diagnosis and treatment. No matter how much time, effort, money, and technology are spent on improving the treatment phase, failures to accurately and affordably diagnose can undermine even the greatest plans. For a rural populace, diagnosis can be frustrated by a number of factors. Many rural clinics do not have the facilities and equipment to conduct diagnostic tests. Reaching a medical clinic with laboratory services may require hours of travel by foot, and many patients fail to return for their results.

Africa is particularly susceptible to these problems. There exists a need for low cost, portable, and durable systems that can be used to facilitate immediate and accurate diagnosis of diseases that commonly affect the population. Lightweight point-of-care diagnostic platforms aim to meet WHO’s “ASSURED” criteria, a set of aspirational guidelines for creating diagnostics tools to meet the socioeconomic challenges of developing regions such as Africa.

However, developing point-of-care technology is costly, and attracting investors requires a reasonable expectation of return on their investments. The developing world is not often considered a lucrative market for the development of medical products. Developing technology that can meet the need of an effective point-of-care testing system and securing funding for the endeavor is a significant challenge.

Daktari Diagnostics machine Daktari (Swahili for “Doctor”) Diagnostics is working on the development of a point-of-care testing platform that meets the ASSURED standards. Daktari’s portable point-of-care platform, Daktari Virology, uses microfluidic techniques to test for both HIV and HCV. Microfluidic devices offer a number of advantages that directly address Africa’s challenges, including small sample sizes, low production costs, fast sampling and processing, and low power consumption. Using a single drop of blood, a microfluidic testing chip prepares the raw sample and performs the tests in one compact system.

For HIV testing, the technology uses a novel microfluidic technique to capture a key cellular indicator for the management of antiretroviral therapy in a patient’s blood. The device then uses nonoptical detection to count them. The effect is rapid testing that can give an accurate assessment of a patient’s HIV viral load in approximately half an hour.

To secure rights in its microfluidics technology, Daktari has been diligently working to assemble a patent portfolio around its innovations. Its website lists over 20 patents already granted internationally and even more applications pending. Leveraging these rights has helped Daktari overcome the challenges associated with conducting expensive R&D for the developing world by securing several rounds of funding. Daktari is using this capital to develop its microfluidics assaying technology for other diseases. In January, Daktari met a funding milestone in a partnership with Merck by completing the design of a prototype HCV point-of-care system suitable for commercial production. Recently, Daktari licensed its technology for integration into a connectivity platform that enables healthcare providers to assist global health officials by monitoring and reporting disease data in real time.

Point-of-care testing is a realistic approach to overcoming challenges in improving diagnostic and monitoring technologies in developing countries, where space, money, time, and training are often limited. Utilizing its intellectual property rights, Daktari continues to develop the technologies that can address some of the world’s most pressing health needs and connect its innovations with the communities that need them.

CPIP has previously discussed the benefits of point-of-care testing in its profile of Fydor Biotechnologies’ Urine Malaria Test, a device enabled by patented technology licensed from John Hopkins University, and ITIF has highlighted a public-private partnership that created the Visitect CD4 point-of-care HIV test.

#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 jhartli2@gmu.edu.

This post is one of a series in the #Innovate4Health policy research initiative.

Innovate4Health By Jaci Arthur

Every year, more than 200 million cases of malaria are reported worldwide. It can often be mistaken for a less serious malady, as symptoms include “fever, chills, and flu-like illness.” If quickly identified, the disease is treatable. Yet more than 655,000 people, mostly children in sub-Saharan Africa, died from malaria in 2016.

Expeditious diagnosis of the disease can result in faster treatment and lower mortality rates. The patented Urine Malaria Test (UMT) developed by Dr. David Sullivan, a Johns Hopkins Bloomberg School of Public Health professor and microbiologist, addresses this global challenge by offering a rapid, accurate, more convenient, and less expensive alternative to traditional laboratory testing. The UMT is also the first point-of-care (POC) test for malaria that does not require the use of trained personnel or a blood sample.

90% of all malaria-related deaths in 2015 occurred on the African continent. Much of this can be attributed to a lack of access to health services and personnel due to poverty, remoteness, and a general lack of healthcare infrastructure. According to a 2011 report, about 31% of Ethiopians live on less than $1.25 a day. Even when health services are free of charge, trips to medical facilities are quite costly for the average, rural African because patients will often have to take an entire day off from work to travel.

In Niger, a patient may have to walk more than four hours to receive medical treatment at an overcrowded, ill-equipped facility. Many people turn to presumptive diagnosis or self-medication at the first sign of a fever, resulting in widespread drug resistance and more expensive treatments. Meanwhile, others gamble on the chance it is simply a virus that will pass, never seeking diagnosis or treatment.

On average, there are 1.15 health workers for every 1,000 people in sub-Saharan Africa, with numbers as low as 0.4 physicians for every 10,000 people in countries like Chad. The few laboratories in rural areas that can identify diseases such as malaria are underfunded, short-staffed, and ill-equipped. Although there are several POC tests for malaria, most of them require trained personnel taking a blood sample. Having a proper diagnosis within twenty-four hours of the onset of symptoms can reduce the mortality rate, but such diagnosis is difficult for most Africans. All these factors lead to a deadly combination, especially for those in rural Africa.

Maryland-based Fyodor Biotechnologies was founded in 2008 by Nigerian biotechnologist Eddy Agbo specifically to address these problems. In 2009, the company was granted an exclusive worldwide license from Johns Hopkins University to research, develop, and commercialize the UMT.

As its name suggests, the UMT tests a patient’s urine, rather than blood, for “novel Plasmodium proteins,” and it provides results in less than twenty-five minutes, thus abating fears, eliminating the need for presumptive diagnosis, and reducing costly, lengthy, and unnecessary trips. Unlike other tests for malaria, the UMT can be taken at home and is as easy to use as an at-home pregnancy test. The UMT is currently priced at about two dollars each; however, Dr. Agbo intends for the price to be reduced once production increases.

Preclinical studies were conducted by researchers at Johns Hopkins University, and the UMT is currently in clinical validation. Fyodor intends to seek concurrent regulatory clearance from both the Nigerian National Agency for Food and Drug Administration and Control (NAFDAC) and the US Food and Drug Administration (FDA).

Initial commercialization efforts will be focused in Dr. Agbo’s home country of Nigeria before expanding to other areas significantly affected by malaria. Nigeria accounts “for 25% of all malaria cases in the African region.” Testing is also currently underway at Fyodor Biotechnologies for a “second generation broad-based Urine Malaria Test (UMT-Broad),” which will be useful for detecting other types of infection.

Fyodor Biotechnologies stepped onto the global market specifically to meet the needs of people in malaria endemic regions and reduce the mortality rate associated with this treatable disease. The company relies heavily on its exclusive license to Johns Hopkins University’s patent, as research, development, and production of the UMT are currently its sole function.

Fyodor’s two-dollar, at-home test is the perfect counter to claims that intellectual property rights, specifically patents, result in expensive healthcare and a lack of access to necessary medical services. Intellectual property rights have made quick, efficient, low-cost, and convenient testing for malaria a reality.

The UMT provides an ideal example of how patented innovation can conquer global challenges. It is a reasonable, rapid, efficient, convenient, economical alternative to a system that cannot meet the needs of the rural poor. And it is a reminder that innovation and intellectual property rights can work together for the common good.

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