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Genedrive Hepatitis C Test Garners WHO Prequalification, Firm Plans £8M Raise

NEW YORK – Molecular diagnostics firm Genedrive announced Monday its hepatitis C in vitro diagnostic kit received World Health Organization Prequalification.

The HCV ID test will be included in the WHO's list of prequalified diagnostics and becomes eligible to be included in United Nations agencies' procurement processes. The prequalification process includes an independent performance evaluation and site visits to manufacturers. 

Genedrive's PCR-based point of care test provides results within 90 minutes from a plasma sample and is performed on the Genedrive molecular diagnostics platform. The WHO prequalification will help the company tackle "the real problem of undiagnosed HCV infection in low- and middle-income countries," CEO David Budd said.

Genedrive also announced Tuesday it will issue 8.75 million new ordinary shares at 80 pence ($1 dollar) per share to raise £7 million ($8.7 million). The company proposed raising another £1 million by issuing 1.25 million additional ordinary shares to enable smaller shareholders to participate in the funding.

The UK-based company said the funds will be used to support the development of Genedrive's SARS-CoV-2 tests, scale up the Genedrive-96-SARS-CoV-2 test and build up inventory, support product development and commercialization, and for general corporate purposes.