Today, 54gene announced the launch of its Clinical Program Services (CPS) division. The CPS division is focused on partnering with global pharmaceutical and biotechnology companies, and multilateral health organizations to discover, develop, and commercialize new therapeutic and diagnostic products.

54gene, named after the 54 countries in Africa, was started in 2019 by founder and CEO, Abasi Ene-Obong, PhD. It is a U.S.- and Nigerian-based health technology company, whose mission is to advance precision medicine capabilities in Africa through research, advanced molecular diagnostics, and clinical programs.

The research division is led by Kemi Williams, vp, clinical and regulatory affairs. Williams brings years of clinical experience as she was formerly head of clinical affairs for Siemens Healthineers U.S. molecular diagnostics business, and previously worked at Roche, Abbott, and Medtronic.

“The inclusion of Africans in clinical programs is critical to the production of medicines and health products that are more efficacious and safe for people of African descent,” explained Jessica Rich, 54gene chief commercial officer.

“It is vital that we continue to collaborate with African researchers and institutions to generate data that meets the scientific rigor found in worldwide studies and to increase African inclusion in global studies. It is essential that more research takes place on the continent and we are ready to be part of that change.”

Collaborative COVID-19 response

The launch coincides with the appointment of 54gene as the Nigerian country partner for the International Registry of Healthcare Workers Exposed to COVID-19 (UNITY Global) Study. In collaboration with Certara, a global leader in biosimulation, 54gene will provide clinical trial management oversight and support for all aspects of the study conducted in Nigeria.

The news comes just one month after the company announced its collaboration with Illumina, to open a new genomics facility in Lagos, Nigeria, equipped with a suite of Illumina’s sequencing and high-density microarray technology platforms.

“Alongside key partners like Certara and other important stakeholders across the continent, the UNITY Global Study is a great opportunity for some of the best clinical teams across Sub-Saharan Africa to come together and ensure outcomes of any COVID-19 studies are relevant to Africans. The insights generated from this program could potentially unlock breakthrough clinical discoveries that can improve health outcomes for millions of people globally,” added Rich.

The UNITY Global study is an international registry of healthcare workers to collect information on risk factors for developing COVID-19 and the use of preventative therapies. The study first launched in Pakistan on August 3 and aims to enroll 10,000 healthcare workers in additional companies including Nigeria, South Africa, Kenya, Uganda, Senegal, Zambia, and Zimbabwe.

The registry will examine the link between the use of preventive treatments and the occurrence of SARS-CoV-2 infection in healthcare workers providing care to patients with COVID-19. To mitigate their risk of SARS-CoV-2 infection, data such as medications taken by healthcare workers, level of exposure to infected patients, the use of personal protective equipment (PPE), and antibody tests will be collected on a weekly basis from enrollees across a 12-week period.

“Healthcare workers have a high incidence of severe COVID-19 as they are repeatedly exposed to individuals infected with SARS-CoV-2,” stated Roman Casciano, general manager of Certara’s evidence and access group. “With limited evidence on the effectiveness of the preventative measures and treatments currently being used, collaborating with key partners such as 54gene is invaluable for expanding the current body of research.”

“Through our country partners’ support and findings from the registry, we hope to provide meaningful data to inform decision making that will help protect healthcare workers worldwide battling COVID-19 on the frontlines.”

54gene’s collaborations and initiatives continue to demonstrate the company’s commitment to global health and position to help bridge the gap of African inclusion in global studies.

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