GHANA—Revna Biosciences, a Ghanaian precision medicine company, has received the thumbs up from Ghana Food and Drug Authority (FDA) to use the NeuMoDx™ 96 making it the first company to register & deploy the system in Sub-Saharan Africa.
NeuMoDx™ 96 is supplied by global biotechnology company QIAGEN and has recently only been available in Europe, the Middle East, and North America.
The registration comes in addition to Ghana FDA permissions for RevnaBio to conduct its first set of complex tests for the Ghanaian/West African region.
The three-step NeuMoDx 96 Molecular System extracts and isolates the target nucleic acids and conducts a real-time polymerase chain reaction.
In addition to its self-developed tests, RevnaBio will also use QIAGEN tests for blood-borne viruses and assays covering sexual and reproductive health.
Co-Founder and CEO of Revna Biosciences, Dr. Derrick Akpalu, was thankful for the positive outcome of the biomedical company’s regulatory submission to the FDA.
He reiterated RevnaBio’s intention to work with QIAGEN to ensure the practical usage of the NeuMoDx 96 system to further its goals to champion precision medicine for all.
Dr. Akpalu also said, “As we transition to impact lives with the NeuMoDx, we look forward to the furtherance of our relationships with our international and local partners. Thank you to the FDA and QIAGEN for this impactful opportunity.”
Board Member of Revna Biosciences, Dr. Sylvia J. Anie CSci FRSM FRSC, also commented that they would continue to champion precision medicine, a landmark outcome for us.
Dr. Anie also added that RevnaBio hoped to move from the traditional one-size-fits-all medicine to a more preventative, personalized, data-driven disease management model that achieves improved patient outcomes and cost efficiencies.
“The regulatory approval we have received is a boost towards achieving this. We will continue to move forward collaboratively and in partnership with key stakeholders on this journey,” said Dr. Anie.
The Ghana FDA is the government agency with the mandate to regulate health products and health-related technologies, including diagnostics, cosmetics and household chemical substances, food, tobacco, and tobacco products, and conduct clinical trials in Ghana.
Speaking on the approval process, the Chief Executive Officer of the FDA, Dr. Delese Darko, said,
“Based on the evaluation of information RevnaBio presented and our successful on-site audit inspection, we concluded that the NeuMoDx™ medical device system and tests are safe for use.”
Dr. Darko however noted that it was the mandate of the FDA to continue to work with RevnaBio in our regulatory capacity to ensure the appropriate usage of the systems.
“We wish them well on their journey to advance precision medicine through international-standard diagnostics and therapies,” Dr. Darko expressed.
Simona Grandits, Senior Director, Head of Sales, and Marketing EMEA at QIAGEN, said the company was firmly committed to working with RevnaBio to deliver its mission to advance precision medicine in Africa.
Grandits said, “We proudly support Revna Biosciences as they advance molecular diagnostics and therapeutics discovery in Africa and beyond. At the heart of QIAGEN is a vision for making life improvements possible. Together, we champion precision medicine for all, revolutionizing healthcare and improving patient outcomes.”
Leading the way in localizing advanced diagnostics in Africa
The localization of advanced molecular diagnostics to impact lives is very important for RevnaBio and the new technology now positions it to deliver high-quality diagnostic tests with the shortest turnaround times.
As the first in the region, the NeuMoDx will assist RevnaBio in executing translational and clinical research in multiple disease cohorts and drive to discover novel therapies and diagnostics.
The biotech company reiterates its commitment to introducing additional tests and novel technologies to address the region’s lack of diagnostics penetration.
Primarily, RevnaBio is an integrated biomedical company advancing molecular diagnostics and therapeutics discovery in Africa and beyond.
RevnaBio also invested in QIAGEN-led training sessions for its biomedical engineers and laboratory scientists to ensure the NeuMoDx 96 advanced technology was effectively localized.
They attended workshops on the QIAGEN system’s hardware and software application in Ankara, Turkey, and Hilden, Germany.
RevnaBio commits to working with strategic international partners, including biotech leaders QIAGEN, Diatech, and more, to provide state-of-the-art biomedical services comprising oncology, medical research, and applied life sciences while tackling microbial genomics and infectious diseases.
RevnaBio has attained all local permits and licenses, including the Health Facilities Regulatory Authority (HeFRA) permit, with permits from Ghana’s Food & Drugs Authority (FDA), and is an active American Association for Laboratory Accreditation (A2LA) member.
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