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Revna Biosciences becomes West Africa’s first ISO-certified clinical diagnostics and biobank healthtech.

by Staff Reporter
April 25, 2024
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Revna Biosciences becomes West Africa’s first ISO-certified clinical diagnostics and biobank healthtech.
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Revna Biosciences, the Accra-based biotechnology startup, has announced that it has secured dual International Organization for Standardization accreditations (ISO 15189:2022 for clinical diagnostics and ISO 20387:2018 for biobanking) for its facility. This makes it the first facility in Ghana and West Africa to secure the dual certification. 

Why are the ISOs important to the company’s success? 

ISO 15189:2022 is a global standard that specifies requirements for quality and competence in medical laboratories. Achieving this certification indicates that a medical laboratory meets internationally recognized standards for accuracy, reliability, and quality in its testing procedures.

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The ISO 20387:2018 specifies requirements for the competence, impartiality, and consistent operation of biobanks ensuring quality management in the collection, processing, storage, and distribution of biological materials for research and diagnostic purposes.

Dr. Derrick Edem Akpalu, CEO and Co-founder of Revna Biosciences, stated, “Our dual ISO accreditations reflect our commitment to excellence and quality, from sample collection to data analysis. This not only reassures patients but also benefits researchers and industry partners. These accreditations enhance our clinical research services, paving the way for global therapeutics and diagnostics development. By adhering to these ISO standards, we ensure the reliability of our archived biosamples and data, thereby enriching clinicogenomic insights and propelling the advancement of personalized medicine in the region. “

What problem is Revna Biosciences solving?

The company aims to address the critical gap in access to advanced molecular diagnostics and precision medicine in Africa. Africa is known to be the most genetically diverse continent, and several populations from other continents have genetic roots in Africa. However, only about 3% of global genomic data used in studies come from individuals of African heritage. As a result, the lack of diverse genomic data limits understanding of genetic variations and their implications for diseases prevalent in African populations. This hinders the development of precision medicine tailored to the genetic makeup of African individuals, potentially leading to suboptimal diagnosis, treatment, and prevention strategies for diseases such as cancer, malaria, tuberculosis, and others. Ultimately, the disparity in genomic data undermines efforts to address health disparities and improve healthcare outcomes for people of African descent worldwide.

Revna Biosciences provides advanced molecular diagnostics tests locally, supports clinical trials, and offers biobanking. With a 10,000-square-foot facility, the company boasts seven Biosafety level 2 and two Biosafety level 3 labs. These include three molecular diagnostics labs, lab spaces for microbiology, virology, bacteriology, multiomics, and sequencing and biobanking areas.

The company collaborates with stakeholders across the health value chain. For instance, in 2023, the company received approval from Ghana’s Food and Drugs Authority to deploy the NeuMoDx™ 96 molecular diagnostics platform supplied by the global biotech company QIAGEN. 

Source: Revna Bioscience

Tags: BiobankDiagnosticsentrepreneurshipGhana Innovation Journalhealth
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