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The £1.25 COVID-19 antibody test
Weeks before the World Health Organisation declared COVID-19 a global pandemic, British diagnostic technologies experts Mologic were already working on an antibody test that they hoped would form part of the global solution for tackling the virus.
Developing a low cost Rapid Diagnostic Test (RDT) that could detect COVID-19 antibodies in ten minutes, Mologic began looking for a fast way to mass produce it for global markets.
When we heard of the opportunity to support the 70-strong Bedford-based company in its work to bring this test to market quickly, we knew it was a project that could really make a difference.
A leading developer
Mologic’s co-founder and Chief Scientific Officer, Paul Davis, was the originator of the Clearblue pregnancy test - the first commercial product to use lateral flow technology (the same technology used in the COVID-19 RDT) – when it launched in 1988.
“As a leading developer of this technology, and with the backing of the Gates Foundation, Mologic was in a strong position to bring a reliable test to market quickly, in Africa and other markets, where health care systems could easily be overwhelmed by outbreaks,” said Deloitte Consulting partner Colin Terry.
At a time when coming together to make an impact was more important than ever, we were keen to offer support where we could as part of our commitment to support the COVID-19 response.
It was clear that by combining Mologic’s scientific and responsive manufacturing expertise with our skills in operations transformation, manufacturing and supply chain, we could collaborate to get the RDT from development to market quickly.
“Just as important as Mologic’s impressive credentials was its proposal to develop a test at a very low cost” Colin continued.
This would enable the test to be used in less-developed countries, especially in parts of Africa, where Mologic has a longstanding partnership with the Institut Pasteur de Dakar on outbreak-prone epidemics such as Ebola, measles, dengue and yellow fever.
“We quickly got started on a programme of support, working side by side with Mologic, taking shared ownership of the challenge.”
Working side by side
Through an intensive four-week sprint and four further weeks of project support, we brought expertise in supply chain, procurement and corporate finance to address the various challenges.
The most pressing issues were how to secure the raw materials, manufacturing capacity and distribution network to get the test to those who needed it.
People from across our firm worked together, helping to connect Mologic with potential delivery partners – life sciences companies, investors, manufacturers and non-governmental organisations that would all be vital to a successful supply chain.
An agile model to tackle challenges
"Operating in a highly-changeable environment presented a number of challenges,” said Colin.
“The lockdown meant that manufacturing capacity and access to reagents and raw materials was scarce. And as the epicentre of the pandemic shifted, the markets that could most benefit from the test shifted with it.”
Bringing in different types of expertise at different times, we created a robust expansion plan for the test and helped Mologic build a business case to secure funding.
As a result the company was able to develop a sourcing and manufacturing plan to produce a COVID-19 triple antibody test, at a price ceiling of £1.25.
Central to this achievement was the support we gave to help Mologic submit its request for CE mark (which indicates that it meets health, safety, and environmental protection standards for products sold within the European Economic Area) a month earlier than anticipated.
Similarly, the investment we helped the company secure meant it could increase production of its test, partnering with organisations to create a robust supply chain. Production was launched at scale in July 2020 when the first shipment of 100,000 tests was sent to Senegal.
Enabling testing in the developing world
Building on this success, Mologic has established an independent manufacturing facility, Global Access Diagnostics, which is developing the tests for no commercial return and on track to manufacture up to 40 million devices per year, with a target price of £1.
Work to register the test for global distribution has been undertaken with the Liverpool School of Tropical Medicine (LSTM) and St George’s, University of London and the Institut Pasteur de Dakar. And the regulatory dossier for the test (which includes all the technical data gathered about it) is now being considered by the World Health Organisation for emergency use.
“The greatest benefit of this product will be felt in the developing world where it will enable nations with less access to health systems to test their citizens,” said Colin “and we’re proud to have been able to play our part.”
“The rapid and responsive engagement of Deloitte helped us boost our operational team at a time of great need. We look forward to working with the Life Sciences team again.”