Revna Biosciences receives historic FDA approval

CEO of FDA, Dr. Delese Darko & Co-Founder and CEO of Revna Biosciences, Dr. Derrick Akpalu

…In addition to extensive approvals by the Authority for a set of complex tests in Ghana

Ghana-based precision medicine company Revna Biosciences (RevnaBio) has received historic approval from the Food and Drugs Authority of Ghana (FDA) to use the NeuMoDx™ 96 diagnostics platform supplied by the global biotech company QIAGEN. The registration comes in addition to FDA permissions for RevnaBio to conduct its first set of complex tests for the Ghanaian/West African region.

The FDA approval secures RevnaBio as the first biomedical company to register/deploy the NeuMoDx platform in Sub-Saharan Africa, hitherto mainly available in Europe, the Middle East, and North America. 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 said:

“We are pleased by the FDA’s approval of our usage of the NeuMoDx 96 system. We are grateful for the trust, partnership, and privilege of bringing this ground-breaking molecular system to the doorsteps of patients in the region. 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.”

On the approval of the first set of diagnostic tests on NeuMoDx by the FDA, Dr Akpalu added:

“We’re also thankful to the FDA for the test approvals, which position RevnaBio to deliver high-quality diagnostic tests with the shortest turnaround times. We also look forward to introducing additional tests and novel technologies as we push to address the region’s lack of diagnostics penetration. Finally, we reiterate our commitment to localising advanced molecular diagnostics to impact lives. This is a first step towards executing translational and clinical research in multiple disease cohorts as we drive to discover novel therapies and diagnostics.”

Board Member of Revna Biosciences, Dr Sylvia J. Anie CSci FRSM FRSC, also commented on the feat, saying:

“We continue to champion precision medicine, a landmark outcome for us. We hope to move from the traditional one-size-fits-all medicine to a more preventative, personalised, 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.”

The 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. However, as is our mandate, we will 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.”

Simona Grandits, Senior Director, Head of Sales, and Marketing EMEA at QIAGEN, said the company is firmly committed to working with RevnaBio to deliver its mission to advance precision medicine in Africa. She 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, revolutionising healthcare and improving patient outcomes.”

RevnaBio has invested in QIAGEN-led training sessions for its biomedical engineers and laboratory scientists to ensure the NeuMoDx 96 advanced technology is effectively localised. They attended workshops on the QIAGEN system’s hardware and software application in Ankara, Turkey and Hilden, Germany.

In other news, RevnaBio is conducting commercial lab testing at its Adjiringanor facility, with an upcoming collection point at Korle Bu in Accra.

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