Mologic launches new lab-based COVID-19 antibody tests
- Follows successful validation by Liverpool School of Tropical Medicine and St George’s, University of London
- With manufacturing support from Omega Diagnostics, the laboratory-based test aims to deliver up to 46,000 results per day
- Health services and key worker communities in the UK and Africa will be prioritised for access
Bedfordshire, UK: Mologic Ltd, a leading developer of lateral flow and rapid diagnostic technologies, today announced that it will begin manufacturing its laboratory diagnostic test for COVID-19. Following successful independent validation by the Liverpool School of Tropical Medicine and St George’s, University of London, the test has also been submitted to Public Health England for formal validation.
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 UK government’s planned 100,000 tests per day.
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.
Since March, leading 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.
Mark Davis, CEO, Mologic: “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 UK and Africa.”
Dr Joe Fitchett, Medical Director, Mologic: “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.”
Colin King, CEO, Omega Diagnostics Group PLC: “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 UK diagnostics industry working in collaboration to bring effective solutions in the fight against this global pandemic.”
To find out more about Mologic, please visit: https://mologic.co.uk/
ENDS
Notes to Editors
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ELISA Test
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. Mologic is proud to partner with Omega Diagnostics, leveraging manufacturing capabilities of the highest calibre to meet worldwide demand for the ELISA test.
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About Mologic www.mologic.co.uk
Mologic is a leading developer of advanced lateral flow and rapid diagnostic technologies. Leveraging its core technology platforms, the Company works with global organisations, researchers and clinicians to help them deliver fast, reliable and accurate diagnosis at the point-of-care. Mologic’s founder, Professor Paul Davis, was the originator of the Clearblue pregnancy test that was launched in 1988 as the world’s first commercial application of lateral flow technology. The creativity, insight and knowledge that led to that ground-breaking invention has guided Mologic since its formation in 2003.
Mologic offers world-leading technology and scientific research expertise for contract research and development, alongside a portfolio of device and reagent products for clinical and commercial applications. The Company also helps organisations to scale-up manufacturing from initial prototyping through low to mid-scale production. Mologic’s science has broad application across markets and disease states where rapid, accurate point-of-care testing can help make a difference in patient care and patient outcomes.
Clients include the Bill & Melinda Gates Foundation where Mologic is leveraging core technology through its Centre for Advanced Rapid Diagnostics (CARD) to develop the next-generation of ultra-sensitive point-of-care diagnostics which are easy to use and low cost to manufacture - critical to the success of many global health programmes.
The Company is actively seeking strategic partners for its internal pipeline of respiratory, infectious disease and women’s health diagnostics.
Mologic is headquartered in Bedford in the United Kingdom and has a US subsidiary in the greater Boston area, MA, USA.
About Omega Diagnostics Group PLC www.omegadiagnostics.com
Omega (AIM: ODX) is a medical diagnostics company focused on CD4 and infectious diseases, food intolerance and allergy testing.
Global Health (CD4)
Omega has developed VISITECT® CD4 Advanced Disease to measure a patient's immune and clinical status, identifying those at risk of Opportunistic Infections (OI), and supporting diagnostic decision-making, particularly for patients living with advanced HIV disease.
VISITECT® CD4 Advanced Disease is a rapid, semi-quantitative lateral flow assay for the estimation of CD4 protein on the surface of CD4+ T cells in human whole blood that indicates whether the level is above or below 200 cells/µL. It can be used in decentralised settings at the point-of-care or primary healthcare level.
Food intolerance
Omega has developed products which tests for the presence of IgG antibodies against certain foods. IgG antibodies play a significant role in the shaping of the body’s normal immune system. Food Detective® is a point-of-care test that screens for the presence of IgG antibodies to 59 common foods, giving results in 40 minutes. FoodPrint® is a laboratory-based system which utilises an innovative, colorimetric microarray-based ELISA technology for the measurement of food-specific IgG antibodies in human serum or plasma for over 200 different foods. Both systems use specific food extracts to identify the corresponding level of circulating IgG antibodies to these potential antigens and can therefore detect foods to which the immune system is reacting.
Allergy testing
Omega has developed a range of allergy assays which allow the quantitative determination of Total IgE and Specific IgE in serum. These antibodies appear in human serum and plasma as a result of sensitisation to a specific allergen. Measurement of circulating IgE antibodies provides an objective assessment of sensitisation to an allergen.
Omega has a manufacturing facility and is headquartered in Alva, Clackmannanshire, Scotland and has a second manufacturing facility in Littleport, Cambridgeshire, England.
