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Mologic Gains CE Mark for COVID-19 Rapid Diagnostic Test

Mologic has announced that, following successful independent validation by the Liverpool School of Tropical Medicine (LSTM) and St George’s, University of London, its professional-use rapid diagnostic test for COVID-19 has received a CE mark (meeting European Economic Area standards) and is ready for manufacture and global distribution. Rigorous independent assessment has shown the tests to have a sensitivity of up to 96% (21-28 days post-symptom onset), and specificity of 98.8% (95% CI 96.6-99.8). The test has been validated to date on 108 positive samples, 255 negative samples, and 223 cross-reacting samples in line with the WHO pre-qualification requirements. As with its laboratory antibody test, the company will continue to validate the rapid diagnostic test against a large number of well-characterized positive and negative samples. Devices are currently completing validation with the Institut Pasteur de Dakar in Senegal. In the coming days, full performance data to date will be published, alongside a full breakdown of pricing. To guarantee access to the technology in low-income areas, Mologic has established an independent manufacturing facility that is delinked from commercial return. Global Access Diagnostics is nearing completion and will manufacture up to 40 million devices per annum, with a target price of £1.

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