Improving diagnostic tests

Two TDR Clinical R&D Career Development Fellows are honing their skills in operational research to close the gap between innovation and implementation. Citizens of Kenya and Swaziland, they are working with the Foundation for Innovative New Diagnostics (FIND) on the development, evaluation and implementation of novel malaria and tuberculosis rapid diagnostic tools.

Dr Magoma Mwancha-Kwasa from Kenya

Dr Magoma Mwancha-Kwasa was destined for a career in medicine. “My mother would always tell us that we had to be doctors,” she recalls of her childhood in Kenya, and nearly everyone obeyed. Of her seven siblings, she says, 5 entered the field and 2 became physicians, giving her proud parents a grand total of 3 MDs. “So I always kind of knew that that’s what I would do.”

It wasn’t until her internship at a provincial hospital, though, that Mwancha-Kwasa knew exactly what kind of doctor she wanted to be. “When I arrived, I was surprised to find so many basic things missing,” she says. “We at times didn’t have basic drugs and other supplies such as sutures, and I began to think that it wasn’t just our patients who needed a doctor but the health system itself.” That experience moved Mwancha-Kwasa to keep her job as a medical officer in Kenya’s Ministry of Health, where her focus is on health service management, and, two years later, to apply for a TDR Clinical R&D Career Development Fellowship (CDF).

A one-of-a-kind program, the CDF affords developing country researchers the rare opportunity to develop skills not readily available in academic centers through 12 months of on-the-job training at a relevant company partner. In Mwancha-Kwasa’s case, that partner was the Foundation for Innovative New Diagnostics (FIND), a non-profit organization headquartered in Geneva, where as the Malaria Clinical Fellow, she’s been involved with projects under the purview of the group’s Malaria & Acute Febrile Syndrome (AFS) program.

"We are a developing country and research training is one area where we are quite weak. Magoma’s TDR fellowship is a way for Kenya to address this gap, to develop our human resources and strengthen our research capacity around diseases like malaria and tuberculosis that affect large numbers of Kenyans. So for us, this is a critical initiative."

Dr Wycliffe Mogoa, deputy director of medical services in Kenya’s Ministry of Health

“FIND has been a perfect fit,” says Mwancha-Kwasa, who, among other projects, coordinated a proof-of-concept study looking at the use of LAMP (loop-mediated isothermal amplification), a promising new technique for the detection of malaria parasites. “I was lucky because my advisors had already laid out a plan for me,” she says. “They knew my background, and they put me on projects that would give me hands-on experience ̶ I could write the protocol and then go into the field to see the study I’d designed in action, and to collect and analyze the data,” she says. “In Kenya, we do a lot of good things, but, as in many developing countries, we don’t evaluate the impact, so we don’t really know whether our strategies are effective, or if they’re as effective today as they were when we first started. Working at FIND, I’ve learned how to ask the right questions and to design a study that can answer this question, and I think that’s important.”

Last October, Mwancha-Kwasa attended the 6th MIM Pan African Malaria conference in Durban, South Africa and in November the 6th Moving Forward in Diagnostics Forum in Annecy, France, organized by BioMérieux and the London School of Hygiene and Tropical Medicine (LSTMH). A first for the young researcher, the forum allowed Mwancha-Kwasa to engage with a broad spectrum of stakeholders—“scientists, policy-makers, manufacturers and even government regulators, all in one room,” she says. “It was great to be able to see these different players interact and to hear lessons learnt from other national lab programs.”

Dr Welile Sikhondze from Swaziland

Dr Welile Sikhondze is also a TDR Career Development fellow, who joined FIND in June of 2013. She has also transitioned from patient care to public health, putting aside long harbored dreams of becoming a neurosurgeon and deciding instead to concentrate on tuberculosis (TB) clinical research in Swaziland, her home country, which has the highest TB and HIV incidence rates globally. Dr Sikhondze is currently completing her Master of Public Health (Clinical Epidemiology) degree at the University of Cape Town in South Africa.

“The decision to train in public health instead of specializing in neurosurgery was spurred on by my experience working in a rural hospital in Swaziland,” she says recalling the many challenges patients faced in gaining access to rapid and accurate clinical diagnosis and appropriate treatment. “I focused on improving patient clinical outcomes, particularly of tuberculosis.” After earning her MD, Dr Sikhondze went on to work as a sub-investigator on TB vaccine clinical trials at the University of Cape Town (UCT) before moving over to the university’s division of medical microbiology as a clinical research fellow on TB diagnostic clinical trials. “That’s when I really developed an interest in conducting high quality clinical research, from product development to implementation,” she says.

Going from clinical trial to impact

When it comes to TB diagnostics, she says, the clinical trial is but one aspect of the product development pipeline. “I have developed an interest in understanding the best methods required to support successful integration of novel technology into existing health systems—what needs to be done in terms of health system strengthening in preparation for new diagnostic technology. ” In her 6 months at FIND, Welile has been addressing that challenge through her work in FIND’s TB clinical trials unit and downstream activities programme.

Welile attended the 44th Union World Conference on Lung Health in Paris last year, which she says was “highly beneficial in assisting her to gain insight into the direction and development of future TB research questions”. Together with Dr Mwancha-Kwasa, she also attended the 6th Moving Forward in Diagnostics Forum in Annecy France organized by BioMérieux and the London School of Hygiene and Tropical Medicine (LSTMH). Both Fellows found the Diagnostic Forum to be extremely useful, with Dr Sikhondze adding, “It helped me better understand the different aspects of the diagnostic pipeline and the importance of an interdisciplinary approach to developing new diagnostic tools.”

Within her first few months at FIND, Sikhondze has already had an impact on the organization, say her supervisors. “Welile’s arrival coincided with a period of organizational change,” says Pamela Nabeta, a medical officer at FIND. “Yet despite this she managed to establish a place for herself on the TB team,” using her previous experience in data management and data analysis to fill a gap left by the departure of FIND’s former data manager. “She was able to facilitate the smooth continuation of projects,” says Nabeta, calling Sikhondze’s contributions “crucial to our work.”

Returning home to reduce barriers to new tools

Following the fellowship, Sikhondze says she’ll return to Swaziland where she’ll utilize her training in TB diagnostics to conduct operational research that can improve the challenges and barriers to the successful implementation of novel diagnostic tools. She also plans to conduct impact assessments on successfully implemented tests. “Hopefully, the findings can be used in advising policy-makers and global health partners on the end-user requirements of point-of-care tools for TB diagnosis.”

Mwancha-Kwasa, too, is keen to apply what she’s learned during her training at FIND to strengthening the health system in her home country. “I knew that as a rookie researcher, I had a lot to learn, so I approached everything with a very open mind and really embraced every opportunity,” she says, adding that her advisors at FIND— David Bell, Mark Perkins, Sandra Incardona and Iveth Gonzales—have done much to shape her plans going forward. “They turned this doctor into a clinician researcher,” she says.

"My experiences have been extremely helpful to better understand the different aspects of the diagnostic pipeline and the importance of an interdisciplinary approach to developing new diagnostic tools."

Dr Welile Sikhondze, TDR Career Development Fellow from Swaziland

“We feel very strongly that what Magoma is learning at FIND will be of great benefit to public health in Kenya,” says Dr. Wycliffe Mogoa, deputy director of medical services in Kenya’s Ministry of Health. “We are a developing country and research training is one area where we are quite weak. Magoma’s TDR fellowship is a way for Kenya to address this gap, to develop our human resources and strengthen our research capacity around diseases like malaria and tuberculosis that affect large numbers of Kenyans. So for us, this is a critical initiative.”

“Magoma has been involved in nearly every step required to develop new and improved diagnostics for malaria,” says Incardona, a technical officer at FIND specializing in malaria RDT lot testing. “We’re very confident that this experience will help her in carrying out research studies in Kenya, and that with her strong motivation and her willingness to work hard, she’ll succeed in adding a stone to this edifice.”

For more information, contact

Pascal Launois (launoisp@who.int)

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