Mologic has entered into a material transfer agreement with Omega Diagnostics Ltd. (Omega) and Omega will immediately start manufacture of Mologic’s first-generation ELISA diagnostic tests. The laboratory-based ELISA diagnostic test is expected to produce up to 46,000 results per day, potentially contributing a significant portion of the U.K. government’s planned 100,000 tests per day.
Mologic CEO Mark Davis said, “The launch of Mologic’s laboratory-based test for COVID-19 is an exciting development in our efforts to support the global pandemic response. With the capability to process tens of thousands of tests results every day, these kits will relieve immediate testing pressures in the U.K. and Africa.”
Mologic will make the technology and materials for its tests available for use in Africa through a partnership with the Institut Pasteur de Dakar in Senegal, in order to support efforts to contain the pandemic on the continent. The availability of fast, reliable diagnostics for COVID-19 has been identified as a critical opportunity to facilitate contact tracing and flatten the curve of the global pandemic.
Mologic Medical Director Dr. Joe Fitchett said, “Alongside the Liverpool School of Tropical Medicine and St. George’s, University of London, we launched a radically open, responsive, and rapid validation model to accelerate the submission of our COVID-19 diagnostics to Public Health England and for regulatory approval. Our laboratory and point-of-need tests will allow individuals to detect whether they have antibodies to COVID-19 and bring us one step closer to improving access to high quality diagnostics.”
Since March, laboratories across the world have partnered with Mologic to evaluate a variety of diagnostic prototypes and independently assess performance. Results have now been submitted to Public Health England for review. While the assessment and optimisation has been expedited, it is vital that any prototype device for COVID-19 is subject to rigorous validation before it is made available for use in the global pandemic response.
Omega Diagnostics Group PLC CEO Colin King said, “I am pleased that Omega has been able to support Mologic with the development and scale up of their ELISA test. This is another example of the U.K. diagnostics industry working in collaboration to bring effective solutions in the fight against this global pandemic.”
ELISA (Enzyme Linked Immuno-Sorbent Assay) tests are one of the most tested and proven laboratory technologies used by the global diagnostic industry, and remain the principle reference point from which rapid diagnostics are coordinated, especially serological tests, including for COVID-19.