NEW YORK – Startup Revna Biosciences is on a mission to bolster the genomics landscape in sub-Saharan Africa — and ultimately improve patient care locally — by increasing access to personalized medicine. The Accra, Ghana-based company recently established partnerships with Diatech Pharmacogenetics and Qiagen. It plans to address knowledge and care gaps by supporting clinical trials, creating a biobank, and offering molecular diagnostic testing services for oncology therapy selection.
According to Derrick Edem Akpalu, the startup's CEO and cofounder, Revna's name highlights its mission. The word is shorted from the Greek "erevna," which means research or inquiry, Akpalu said in a recent interview.
"One of the things that we wanted to debunk very quickly was the notion that commercial biomedical sciences couldn't happen on the continent," Akpalu said. "We wanted a name that reminded us constantly that we are a research entity," he said.
People from Africa are underrepresented in global genomics studies, and fewer than 2 percent have had their genomes sequenced and deposited in global databases, Akpalu said. Yet, the continent also happens to be among the most diverse and genetically rich regions of the world, so an abundance of genetic insights are likely being missed.
"It's not an African problem, it's a global problem," Akpalu said.
Penetration of molecular diagnostics in sub-Saharan Africa is low, and the vast majority of treatments are initiated without an associated molecular test, according to Akpalu. When testing is performed, it is often part of a clinical trial from outside of Africa, and data sharing is limited, he said.
Akpalu formerly served as a clinical research coordinator at the Morehouse School of Medicine in Atlanta, and returned to Ghana to help coordinate clinical studies that required shipping patient samples to the US. He also served as a clinical scientist at Johnson & Johnson's Janssen subsidiary, now named J&J Innovative Medicine.
"With drug development getting more and more personalized, you begin to realize that molecular profiling and genetic testing have become essential," he said. "None of these things are happening in West Africa, so how do we address that?"
Founded last year, Revna's approach involves diagnostics, clinical research, and biobanking, which are all interconnected.
For example, addressing the diagnostic need has a knock-on benefit of generating local public health data and patient characterization, which in turn can encourage clinical trials. The team is also building a biobank across indications to support further development.
"While helping today's patients, we get insights for companion diagnostics or even therapeutics, and can say for the next iteration, these are the tweaks that are required for our population," Akpalu said.
The firm spent its first year building a dedicated 10,000-square-foot facility. It has seven BSL 2 and two BSL 3 lab spaces, including three molecular diagnostics labs, lab spaces for microbiology, virology, bacteriology, and multiomics, and dedicated areas for sequencing and biobanking.
Revna also focused in the first year on going through the ISO certification process, successfully completing the on-site inspections by the American Association of Laboratory Accreditation.
With this, "we can play at the international level and be sure that the [standard operating procedures] and the facility are being run similarly to any other elsewhere," Akpalu said.
Over the past year, Revna has registered two molecular diagnostic test systems with the Ghana Food and Drug Authority — the Diatech EasyPGx and Qiagen NeuMoDx 96 — and has begun performing patient testing. The firm has also already undertaken clinical studies while in stealth mode, and it plans to start sharing data from these next year.
In terms of financing, Revna aims to be self-sustaining as quickly as possible. Akpalu said the firm was founded with an extensive angel round comprising financing from friends and family. The company intends to self-fund clinical studies through its commercial activities. Although it is looking into grant funding mechanisms, the firm has eschewed typical venture capital, he said, because the pressure that can bring is not necessarily conducive with the slower pace of the local political and economic ecosystem.
Akpalu says the mantra, "Where clinical goes, commercial goes," seems likely to apply in Africa, so that by showing there is a patient population that could use molecular testing, "the life sciences companies will find a way to get their products here."
Revna is also poised to attract more therapeutics, as well. "We're providing molecular profiling to say the evidence is here," Akpalu said, and highlighting the fact that the population that could benefit from a product exists in Africa may lead developers to "find a way through market access or compassionate use to get these products here."
Developers might also be encouraged by the fact that, overall, the local population is very treatment naïve.
"You have patients who are far gone in their diseases, oftentimes with no medical intervention before access to any of these newer medication or treatment options," Akpalu said.
And while this is valuable for investment in the growing healthcare market in Africa, clinical trial data collected there can potentially be used in US Food and Drug Administration submissions, as well, which can support FDA directives on diversity in clinical trials.
Partners and progress
Revna has so far partnered with Diatech Pharmacogenetics and Qiagen in its molecular diagnostic test service and has begun marketing its offering to local hospitals and university research programs.
Specifically, the team presents the panels for molecular profiling that it offers and explains why they are important to matching patients to treatments. For example, Akpalu said a mutation in a gene encoding dihydropyrimidine dehydrogenase (DPYD) can indicate increased likelihood of chemotherapy-related toxicity. With a personalized approach, these patients can get lower doses rather than anti-emetics.
So far, Revna has partnered with investigators at Accra's Korle-Bu Teaching Hospital, 37 Military Teaching Hospital, Sweden Ghana Medical Center, and Cape Coast Teaching Hospital, and it is in discussions with others, he said.
Revna obtained Ghana Food and Drug Authority registration for the NeuMoDx system in June, making it the first company in sub-Saharan Africa to deploy the system. In addition to lab-developed tests, Revna plans to use Qiagen blood-borne viruses, sexual, and reproductive health assays.
And data from Revna's ongoing Ghana FDA-mandated cancer clinical research covering solid and blood cancers using the Diatech EasyPGx system has also begun supporting registration of that product.
Diatech CEO Oliva Alberti said in a statement that the collaboration makes "personalized therapy more accessible in West Africa," adding, "We're doing our part towards a future where every patient can access advanced molecular diagnostic testing."
While Revna scoped out other molecular diagnostic systems, the fit with Qiagen felt particularly right, Akpalu said. The Revna team felt that Qiagen viewed them as part of an overall developmental plan, rather than a traditional commercial entity.
"They have everything you probably need — and they have a plan for public health and diagnostic penetration in the region," he said. "The more we listened to the plan and solutions they had, and the more we got exposed to the new toys, so to speak, the more excited we got," he added.
As part of both collaborations, Revna has invested in training its scientists and biomedical engineers to use the systems. For example, the firm sent its scientists to Qiagen to be trained on the NeuMoDx, and then, with the support of a Qiagen engineer, the system was shipped flat to Revna and built from scratch at its facility. Because of this, Revna now has resident engineers who understand the instrument and can perform maintenance, if needed, shortening any downtime.
In terms of reagents and consumables, Akpalu said Ghana is a five to seven hour flight from anywhere in Europe, so these will be straightforward to obtain.
Simona Grandits, Qiagen's senior director and head of sales and marketing in the Europe, the Middle East and Africa region, said that the strategic partnership with Revna is centered on deepening genomic research in West Africa.
"By providing cutting-edge technologies and services, as well as essential training, we aim to address the region's lack of skilled labor in this field," Grandits said. Qiagen also strives to bridge the affordability, accessibility, and skills gap for West Africans more generally, "ensuring they can benefit from precision medicine," she said.
Overall, the current state of molecular diagnostics in Africa lags behind the rest of the globe, Grandits said. "Qiagen strongly believes that no one, including Africans, should be left behind in accessing quality healthcare," she added. As such, Qiagen's overall strategy in Africa involves "addressing skill gaps, increasing genomics and bioinformatics capacity, promoting equitable participation for African researchers, and making diagnostics more affordable for the region's most vulnerable populations."
To achieve these goals, partnering directly with organizations like Revna Biosciences is essential. "By working closely with commercial partners and in-country Qiagen teams, we build networks to facilitate technology and knowledge transfer at scale, maximizing impact and becoming a trusted partner for both public and private sector stakeholders in the area of public health and infectious diseases," Grandits said.
In the short term, Grandits said that Africa's growing knowledgebase in precision medicine can empower the region and lead to an increase in clinical trials on the continent.
"The continued absence of substantial government investment in this area will likely lead to an influx of private players, transforming the genomics landscape in the region," Grandits said, adding that Africa's young and rapidly growing population can contribute to technological and economic integration.
"As more people are lifted out of poverty in the long term, the total accessible market size for molecular diagnostics and precision medicine is expected to expand, leading to more competitive pricing for services," Grandits added.
While testing in Africa currently focuses on infectious diseases, precision medicine is gaining ground, Grandits said, with access and quality of diagnostic services playing a large role in influencing patient management pathways.
And although genomics use in research and diagnostics is not yet mainstream in Africa, Grandits pointed to centers of excellence led by pan-African organizations such as the African BioGenome Project and the Africa CDC as evidence of change in this area.
Ghana's national health insurance scheme is currently expanding its coverage, Akpalu said, and he believes that diagnostic testing data can be used to focus these efforts on priority areas.
The Revna team remains motivated by a moral imperative in the face of rapidly evolving technology. "If we don't do this now, the disparity between the continent and the rest of the world is going to be too much," he said.
But as grand and global as the goals are, Akpalu said, the team also keeps the community at the center of its work. "We keep saying to ourselves, what we're doing could benefit my uncle who lives next door, for example," he said.
Going forward, Revna hopes to attract more collaborations while continuing to earn the trust of the patient population, physicians, and lab partners.
"Then hopefully we can move the agenda, which is ultimately to get more diagnostic penetration here to help the current patient population as much as we can while preparing for better solutions for tomorrow's patients," Akpalu said.