The Race Toward the Antibody Test Kits - Part 2
Mologic is a leading developer of lateral flow and rapid diagnostic technologies, products and services in human healthcare, agriculture and aquaculture. Mologic work with companies, researchers and clinicians to help them deliver fast, reliable and accurate diagnosis at the point-of-care.
Updates and Recent Progress
On March 7th, 2020 the Prime Minister, Boris Johnson, visited the diagnostics firm in Thurleigh in Bedfordshire, one day after Mologic were awarded £1m as part of the Government’s £46 million international COVID-19 prevention and research package, to develop a point-of-need diagnostic test for the virus, in addition to supporting the Company to initiate research for novel vaccine candidates.
Mologic are working on two different sets of test kits, a lateral flow test and the COVID-19 ELISA test. The COVID-19 ELISA diagnostic test is an antibody test but will be used on patient samples sent by hospitals or GPs for laboratory testing.
The firm says the new test will allow individuals to identify whether they have antibodies for the virus - produced by the immune system when it is being attacked
Photo by Fusion Medical Animation
Validation Process
March 25th, 2020 Mologic announced that it has initiated early validation of COVID-19 point-of-need diagnostic tests with the Liverpool School of Tropical Medicine and St George’s, University of London.
In just under 6 weeks Mologic have gone from specification to prototype and are currently validating the test kit. The astonishing speed at which Mologic have turned this around is incredible but not surprising considering this is a global fight against a dreadful virus and a world wide lockdown situation that the world hasn't seen before.
On April 17th, 2020 Mologic announced that both COVID-19 tests have been independently and successfully assessed by:
-The Liverpool School of Tropical Medicine (LSTM) and,
-St George’s University of London (SGUL)
Both tests are now being prepared for launch with CE mark.
Mologic stated that it is proactively engaging with further independent validation groups, the company has submitted its test to Public Health England (PHE) and NHS Scotland for formal validation, as well as other groups including, The World Health Organization (WHO), and The Africa CDC.
Other leading laboratories on each continent are also evaluating these different test kits to independently assess their performance, including:
-The Institut Pasteur de Dakar in Senegal,
-La Jolla Institute for Immunology in the United States,
-The Wuhan Institute of Virology in China,
-The University of Malaya in Malaysia,
-The Institute for Health Science Research Germans Trias I Pujol (IGTP) in Spain, and
-The Oswaldo Cruz Foundation (Fiocruz) in Brazil.
Test Kit Accuracy
Clinical performance of IgG ELISA among known COVID-19 cases (PCR positive >10 days of diagnosis) have given the following sensitivity and specificity results:
Sensitivity 99%
Specificity 98%
Total PCR positive cases tested 101
Total negative cases tested 314 (pre-2019)
When asked about the independent validation feedback Joe Fitchett, Medical Director at Mologic commented:
"Data from the independent validation studies indicates 97% sensitivity and 97% specificity across 708 positive and negative samples. Mologic will continue to update specifications as data accumulates"
Manufacturing and Production
On April 20th, 2020 Mologic entered into a Material Transfer Agreement with Omega Diagnostics. Omega will immediately start manufacture of Mologic’s first-generation ELISA diagnostic tests.
The Government is aiming to carry out 100,000 coronavirus tests a day in England by the end of April 2020, Health Secretary Matt Hancock said, as he announced a "five-pillar" testing plan.
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 by end of April.
Joe Fitchett commented that Mologic is now moving towards commercial-scale manufacture and that they have started the first manufactured batches. Capacity is expected to enable a UK throughput of up to 46,000 results per day, with a view to scale further subject to demand.
Speaking to Colin King, CEO of Omega Diagnostics, whether he believes production of 46,000 test kits per day is achievable by end of April he commented:
"This is entirely possible and if not certainly by early May. We are producing validation batches that once we CE mark would be available for sale and doesn’t need to be approved by the NHS. NHS approval is required for them to procure"
Mologic have also confirmed that the ELISA test kits are now ready and that they have orders in place, once the product has the CE mark, full scale production will start, ELISA will then be available for use in the global pandemic response.
Profitability
Mologic CEO Mark Davis stated in an interview with LBC that Mologic will be producing their Lateral flow tests at production costs, this is independent from the current MTA agreement with Omega Diagnostics to manufacture the ELISA test, Colin King CEO of Omega Diagnostics has confirmed that Omega Diagnostics will generate revenue and profit.
Future Updates
According to Mologic, they will be announcing several critical milestones in the coming week, including open access publication of the full data and additional results.
Conclusion
To recap:
1-Mologic are working on 2 test kits (a lateral flow test and the COVID-19 ELISA test)
2-Both COVID-19 tests have been independently assessed and are now being prepared for launch with CE mark.
3-Mologic has submitted its test to PHE and NHS for formal validation
4-Mologic has submitted its test to The WHO and The Africa CDC.
5-Inhouse - ELISA Sensitivity 99%, Specificity 98%
6-Data from the independent validation studies indicates 97% Sensitivity and 97% Specificity
7-Mologic and Omega diagnostics will start producing 46,000 kit per day imminently
8-Mologic confirmed that the ELISA test kit are ready now
9-Mologic have orders in place for their ELISA test kits
Note:
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The writer (@Belcourtoi) currently own shares in ODX.
