Rook Irwin Sweeney LLP Our ref: SS/335/10241.0086 107-111 Fleet Street Your ref: AMI:AIR;162 London EC4A 2AB 4 May 2021
By email:
Dear Rook Irwin Sweeney
Good Law Project Limited v Secretary of State for Health and Social Care v Abingdon Health Limited
As you are aware, Abingdon Health plc (“Abingdon”) has not yet decided whether to participate in the judicial review proceedings that the Good Law Project (“GLP”) have brought against the Secretary of State for Health and Social Care, in which Abingdon is named as an Interested Party.
Our client acknowledges the GLP’s right to challenge the Department of Health and Social Care’s (“DHSC’s”) processes, but is concerned about the basis on which the case is proceeding. Therefore, we would like to set out some points of clarification below, and have enclosed documents that we hope are useful. The test developed by Abingdon that is the subject of these proceedings is referred to as the “AbC-19TM Test”.
Abingdon Health and its expertise
1. Throughout the proceedings to date, the GLP has made multiple disparaging statements about Abingdon’s expertise and its ability to develop a COVID-19 antibody test.1 Such statements have led the Court to conclude that “the extent to which Abingdon Health itself had any expertise is open to serious doubt”.2 In our view, there is no doubt at all as to Abingdon’s expertise, and it was eminently qualified for the task of developing a COVID-19 antibody test. On a full analysis of the facts, a Court would be likely to conclude the same.
2. Abingdon has significant experience of developing and manufacturing immunodiagnostic tests including those to detect antibodies in lateral flow format. Immunodiagnostics is the science of using antibodies to detect substances of interest (antigens). Substances of interest may be, for example, other antibodies, proteins, peptides, bacteria, viruses, drugs, and hormones.
1 See, for example, RASFG at 18A(d); RASFG at 116(ag); GLP Skeleton for the Renewal Hearing (“GLP Skeleton”) at [72]; and Transcript for the Renewal Hearing (“Transcript”) at [7G] and [9C]. 2 Judgment of Mr Justice Waksman dated 29 March 2021(“Judgment”) at [16].
3. As a contract developer3 and manufacturer4 of lateral flow assays and devices (“LFDs”)5 the company produces LFDs under the Abingdon brand or under the brand name of its customers. Whatever the substance, similar techniques are used for each LFD. Some examples of assays developed and/or manufactured by Abingdon include, but are not limited to:
Abingdon’s ‘Seralite®’ LFD product6 – a quantitative lateral flow test which measures the levels of the two antibody components: kappa free light chains and lambda free light chains and calculates the ratio of these two parameters. This product is used to aid the diagnosis and management of the blood cancer, myeloma;
Abingdon’s PCRD product7 – a lateral flow-based system which uses antibodies to detect the output from a PCR reaction;
An LFD HIV antibody self-test – used as an aid to diagnosis and management of HIV using a whole blood finger-prick sample.
LFD tests for antibodies to Borrelia bacteria – used to diagnose Lyme disease;
LFD tests for serum amyloid A as a marker of infection in the veterinary sector;
LFD tests for pepsin as a marker for gastroesophageal reflux disease;
LFD tests for legionella bacteria;
LFD tests for plant diseases including viruses;
LFDs for fungal and bacterial contamination; and
LFD tests for hormones such as cortisol.
4. From March 2020, Abingdon approached various agencies including Public Health England (“PHE”) [see enclosed E-mail 1] and the NHS, its local MPs,8 and its trade association, the British In Vitro Diagnostics Association (“BIVDA”) [E-mail 2], to raise awareness of its LFD manufacturing and development expertise and its desire to help develop and manufacture LFDs to assist with the evolving COVID-19 pandemic.
5. The five scientific staff who lead the project that is the subject of this proceedings (Dr Chris Hand, Dene Baldwin, Nina Garett, Jonathan Flint and Dr Abbas Din) have over 100 years of immunodiagnostic and lateral flow experience between them. They were supported by twenty other R&D, production, quality assurance, quality control and regulatory specialists in-house at Abingdon.
Dr Chris Hand9
6. Dr Chris Hand, Abingdon Chairman, has worked in the immunodiagnostics industry since 1986 and has worked within the lateral flow area since the mid-1990s. Dr Hand began his career after completing a DPhil at the University of Oxford which included development of novel immunodiagnostic assays.
3 https://www.abingdonhealth.com/services/lateral-flow-development/ 4 https://www.abingdonhealth.com/services/lateral-flow-manufacturing/ 5 https://www.abingdonhealth.com/services/what-is-lateral-flow-immunoassay/ 6 https://www.abingdonhealth.com/products/seralite/ 7 https://www.abingdonhealth.com/products/pcrd/ 8 Julian Sturdy for York Outer (Conservative) [E-mail 3]; and Layla Moran for Oxford West and Abingdon (Liberal Democrat) [E-mail 4]. 9 A CV for Dr Hand is provided at Annex A.
7. Dr Hand has developed tests in a vast array of sectors including breast cancer, and drugs of abuse. He was the founder and CEO of Cozart Bioscience Ltd (Cozart plc), which was a speciality immunodiagnostics company making antibodies and test kits for a variety of applications. Alongside Dene Baldwin and colleagues at Cozart, Dr Hand developed the ground- breaking “Cozart® RapiScan” to detect multiple drugs simultaneously in saliva using LFDs. The testing system won Millennium Product Status. The Cozart® RapiScan was the world’s first on- site saliva-based lateral flow drug testing system and was successfully used by the Home Office in custody and probation settings, and internationally at the road-side, in drug clinics and industry. Cozart’s elisa-based drugs of abuse systems were used extensively by the Forensic Science Service and other forensic laboratories. Dr Hand and colleagues also developed the world’s first non-isotopic assay for LSD in collaboration with the Laboratory of the Government Chemist.
8. At US medical diagnostics company DPC (now part of Siemens Healthcare Solutions), Dr Hand developed a wide range of immunodiagnostic kits for many different analytes in RIA, EIA, chemiluminescent and point of care format. Examples of tests developed include those for drugs of abuse, therapeutic drugs, breast cancer, prostate cancer, gliadin-specific IgG and IgA antibodies (coeliac disease) and various proteins such as sex hormone binding globulin (SHBG).
Mr Dene Baldwin10
9. Dene Baldwin, formerly Technical Director of Abingdon, acts as a consultant to Abingdon and did so for this project. Mr Baldwin has spent his entire career in immunodiagnostics, beginning in the late 1970s as a Medical Laboratory Scientific Officer in the NHS, where he gained his HNC in Medical Laboratory Sciences. His expertise extends to all aspects of the research, development, production, assembly, QARA & support of immunodiagnostic reagents and kits. He has managed the development and manufacture of a vast array of immunodiagnostic products across teams in the UK and Spain and ran the scientific aspects of a collaboration with Netherlands based Philips Healthcare.
10. Mr Baldwin has developed many immunoassays in multiple formats. In addition to the Cozart® RapiScan developed with Dr Hand and described above, Mr Baldwin further developed the successor test, the Cozart DDS, which was recognised in 2010 with the Queen’s Award for Enterprise: Innovation. In 2006, Cozart collaborated with Philips Healthcare to develop a “next- generation” point-of-contact device based on magnetic biosensors (now sold as a cardiac marker test: “Minicare”). Mr Baldwin lead the technical teams at Cozart on this development.
11. Further examples of Mr Baldwin’s work include the development of kits to test for:
analytes such as thyroid hormones (T4, T3, TSH and thyroid binding globulin);
antibodies to disease and infection (including thyroid autoantibodies, insulin autoantibodies, Herpes simplex IgG, Herpes simplex IgM, Rubella IgG and Malaria);
small molecules (bromocriptine, cortisol, testosterone, progesterone, oestradiol, oestriol);
cancer markers (free beta hCG, CEA, EMCA, PSA, alpha-fetoprotein);
markers of diabetes (insulin, proinsulin, C-peptide, microalbumin);
large molecules (ferritin, IgG4, total IgG, total IgM, total IgA) human growth hormone, prolactin, kappa and lambda free light chains, C reactive protein);
drugs of abuse (18 different single and multiplexed assays for drugs such as cocaine, cannabinoids, opiates, amphetamines etc);
cardiac markers (myoglobin, troponin I, troponin T, CKMB); and
10 A CV for Mr Baldwin is provided as Annex B.
allergy (such as total IgE antibodies, and specific IgE antibodies to cats, dogs, and dust mites).
12. These assays have employed a spectrum of different formats, labels and assay configurations including lateral flow with gold or latex particles, chemiluminescence, RIA, ELISA and fluorescence.
Ms Nina Garrett11
13. Abingdon R&D Director Nina Garrett has over 20 years of experience in the development and production of lateral flow rapid tests. Ms Garrett held several senior roles at British Biocell International (now BBI Solutions) before moving to oversee Abingdon’s assay development and technical transfer teams in 2019. She has a Masters in Chemistry (MChem) from the University of Exeter and is a Fellow of the Royal Society of Chemistry.
14. Ms Garrett has developed many assays in lateral flow format using a wide range of detection molecules, including gold nanoparticles, magnetic particles, and fluorescent particles. She has developed assays with different configurations (such as singleplex, multiplex, sandwich, and serological) and these have been developed for use with visual read or with smartphone apps and/or benchtop readers. Examples of analytes for which Ms Garrett has developed assays include: infectious disease tests for conditions such as herpes and legionella; environmental safety tests; a suite of food borne pathogen tests; female and male fertility markers; allergy tests; blood and plasma markers tests for inflammation or contamination and biodefence tests.
Dr Abbas Din12 and Mr Jonathan Flint13
15. The two R&D team leaders on the AbC-19 development were Jonathan Flint and Dr Abbas Din. They both have a wealth of lateral flow development, technical transfer and production expertise in the field of lateral flow immunodiagnostics. This gives know-how across the whole development cycle through to manufacture which is important to allow development of products which can be produced at scale.
16. Dr Abbas Din, Technical Transfer Manager, is experienced in the development and scale-up to manufacture of lateral flow assays. Dr Din’s immunodiagnostics experience extends to tissue typing using ELISA; growth factors, endotoxin detection through ELISA and microfluidics; respiratory virus detection using ELISA (and also PCR); lateral flow assays developed and/or manufactured include those for HIV antibodies, measles antibodies, tetanus antibodies, pepsin; tests for a cardiac marker, kappa and lambda free light chains, tests for legionella bacteria, plant diseases, and fungal and bacterial contaminants.
17. Jonathan Flint, Product Development Manager, has 20 years’ experience in lateral flow development, scale-up and production. Following a BSc from Edinburgh University, Mr Flint was employed at the Central Science Laboratory in York initially as a Lateral Flow R&D Assistant in May 2001, then as a Lateral Flow Device Research Officer from March 2002 to January 2007. He has been employed by Abingdon and its predecessor (Forsite Diagnostics) since 2007.
18. As with Dr Din, Mr Flint’s role has involved development and/or scale-up of the lateral flow devices across a spectrum of animal, human and plant disease tests including those for HIV antibodies, measles antibodies, tetanus antibodies, pepsin, serum amyloid A (infection marker) kappa and lambda free light chains (myeloma markers), tests for legionella bacteria, plant diseases, and fungal and bacterial contaminants and tests for prostate specific antigen (PSA). His role has extended from development through to scale-up (Technical Transfer) and manufacture of lateral flow devices.
11 A CV for Ms Garrett is provided as Annex C. 12 A CV for Dr Din is provided as Annex D. 13 A CV for Mr Flint is provided as Annex E.
19. The scientists listed above have a portfolio of scientific papers, patents and patent applications. As an illustration of the depth of the skills base, knowledge and competency in the field of lateral flow testing we list below a selection of some of the patents and patent applications filed in this field by Dr Chris Hand, Dene Baldwin and Jonathan Flint. Examples of one patent for each patent family (i.e. rather than including international variants) are:
UK patent GB2339615 (filed in July 1998, authored by Dr Hand and Mr Baldwin and colleagues) disclosed the invention of a lateral flow system: “Screening device and method of screening an immunoassay test”. This invention combined lateral flow devices with a hand-held reader incorporating a CCD camera. It was the basis for the Cozart® RapiScan system described above.
UK patent application GB2391813 (filed in August 2002, authored by Dr Hand, Mr Baldwin and a colleague) describes the invention of a saliva collection and transport device for incorporation into lateral flow devices.
Application WO2005/090987 (co-authored by Mr Baldwin, with priority dating back to March 2004) describes an invention relating to production processes of lateral flow strips.
UK patent GB2433989 (filed in June 2005 by Abingdon Health subsidiary Forsite Diagnostics Ltd) describes an invention by Jonathan Flint and a colleague which teaches methods to quantify and semi-quantify the results of a lateral flow test.
Patent application GB2541221 (filed by Abingdon subsidiary Molecular Vision Ltd in August 2015, and authored by Dr Hand and colleagues) incorporates lateral flow devices with organic photodiodes (oPDs) and organic light-emitting diodes (oLEDs) to provide “Quantitative optical determination of analyte concentration in lateral flow devices”.
Patent applications GB2541420 and US 2019033223 (filed by Abingdon subsidiary Molecular Vision Ltd, with Dr Hand, Mr Baldwin and colleagues as authors) provide disclosure of further inventions in the area of LFDs coupled with oLEDs and oPDs.
Financial status of Abingdon Health in early 2020
20. In order to try make good its allegation of state aid, the GLP has sought to create a perception of a small, struggling company in financial distress, whose fortunes changed following the award of the contract(s) subject to these proceedings.
21. The idea that Abingdon was a company in financial difficulty appears to be predicated solely on unreferenced statements attributed to Abingdon’s directors that were made in June 2019.14 For the renewal hearing on 29 March 2021 (the “Renewal Hearing”), counsel for the GLP went further, submitting at paragraph 18(f) of the GLP Skeleton that Abingdon as at 1 April 2020 was “in grave financial difficulties and at risk of impeding insolvency”. The basis for the belief that Abingdon was at risk of insolvency is entirely unclear.
22. As is evident from the accounts up to 30 June 2020, the Balance Sheet filed at Companies House on 11 November 2020, and public statements, Abingdon was not in financial distress. The company had grown revenues by 90% in the previous 12 months to December 2019 and in January 2020 announced the expansion of its operational footprint by 42% following this revenue growth.15
14 Re-Amended Statement of Facts and Grounds (“RASFG”) at 14. 15 https://www.abingdonhealth.com/news/abingdon-health-confirms-expansion/; https://www.bivda.org.uk/The- IVD-Industry/Find-a-Member/Member-Press-Releases/ArticleID/231/UK-lateral-flow-rapid-test- manufacturer-confirms-expansion
23. On 14 April 2020, Abingdon also announced the completion of the acquisition of a Doncaster lateral flow manufacturing site which had been in negotiation since the start of 2020.16 At that time, Abingdon had a number of supportive existing shareholders / investors (including the Northern Powerhouse Investment Fund17) and Abingdon had received written offers of additional funding from a number of venture capital companies in February 2020 and March 2020, prior to any involvement with DHSC or the commencement of the development of the AbC-19TM Test.
24. Abingdon chose to raise further capital via an IPO on AIM in 2020. This raised £22 million (£20 million net of expenses) to further invest in the company’s manufacturing scale-up. No shareholders (including management) sold any shares at IPO and the £20 million was fully invested in the company.
25. Prior to 2020, the directors of Abingdon had intended to list the company. However, the outbreak of COVID-19 – not the contracts that are the subject of these proceedings – accelerated those plans.
The COVID-19 pandemic
26. We note the statements made by the GLP about there being established COVID-19 antibody tests already available when the Government transacted with Abingdon.18 The idea that, as at April 2020, the manufacturer of any COVID-19 antibody test was an “established operator” is subjective and lacking context. Such statements should consider the evolution of the COVID-19 pandemic, and key events in the period up to 6 April 2020 include:
3 January 2020 – Chinese officials provided information to the WHO on a cluster of cases of “viral pneumonia of unknown cause” identified in Wuhan.19 Secretary Hancock was alerted.20
5 January 2020 – the WHO shared information about the cluster with Member States, and its first (publicly available) Disease Outbreak News report.21
9 January 2020 – Chinese authorities determined that the outbreak was caused by a novel coronavirus.22
11 January 2020 – the WHO confirmed that it had received the genetic sequences for the novel coronavirus from the People’s Republic of China and expected these to soon be made publicly available. On the same date, Chinese media was reporting the first death from the novel coronavirus.23
21 January 2020 – the WHO confirmed that it was clear there was human-to-human transmission, backtracking on advice given on 12 January.24
22 January 2020 – PHE moves the risk level to the British public from ‘very low’ to ‘low’.25
29 January 2020 – the first cases in the UK are confirmed.26
16 https://www.abingdonhealth.com/news/acquisition-concepta-yorkshire-lateral-flow-manufacturing-site- outsource-concepta-manufacturing-requirements/ 17 https://www.npif.co.uk/abingdon-health/ 18 RASFG at 116(ag). 19 https://www.who.int/news/item/29-06-2020-covidtimeline 20 https://healthmedia.blog.gov.uk/2020/04/19/response-to-sunday-times-insight-article/ 21 https://www.who.int/news/item/29-06-2020-covidtimeline 22 https://www.who.int/news/item/29-06-2020-covidtimeline 23 https://www.who.int/news/item/29-06-2020-covidtimeline 24 https://www.who.int/news/item/29-06-2020-covidtimeline; and https://www.who.int/csr/don/12-january-2020- novel-coronavirus-china/en/ 25 https://www.gov.uk/government/news/dhsc-and-phe-statement-on-coronavirus 26 https://bfpg.co.uk/2020/04/covid-19-timeline/
3 February 2020 – the UK government announced it was making £20 million available to fund vaccines for coronavirus and other infectious diseases.27
11 February 2020 – the WHO announced that the disease caused by the novel coronavirus would be named COVID-19.28
17 February 2020 – a paper is published online suggesting that serology should be considered for COVID-19 epidemiology (i.e., detection of antibodies could show previous infection).29
19 February 2020 – weekly WHO Member State Briefings on COVID-19 began, in order to share the latest knowledge and insights on COVID-19.30
27 February 2020 – first experimental antibody test for COVID-19, developed in Singapore by a team at Duke-NUS Medical School, confirms that a patient was infected with COVID- 19.31
6 March 2020 – the WHO published the Global Research Roadmap, outlining research priorities in the natural history of the virus, epidemiology, diagnostics, clinical management, ethical considerations and social sciences, as well as longer-term goals for therapeutics and vaccines.32
11 March 2020 – the WHO made the assessment that COVID-19 could be characterised as a pandemic.33
13 March 2020 – the Director-General of the WHO says that Europe had become the epicentre of the pandemic.34
16 March 2020 – at the sixteenth SAGE meeting, antibody testing is flagged as vital. PHE was tasked with developing a proposal to ‘ramp up’ antibody serology and diagnostic testing capacity.35
19 March 2020 – Prime Minister Johnson confirmed that negotiations were ongoing over the purchase of “gamechanger” antibody tests.36 Chief Medical Officer for England Professor Chris Witty stated “On the antibody tests we should be clear that although we're confident there will be antibody tests, we're not absolutely confident yet about whether the ones that are currently on the market are the right ones and that needs to be tested out.”37
24 March 2020 – Secretary Hancock confirms that the UK government had purchased 3.5 million antibody tests from multiple companies, which were intended to be used by health
27 https://www.gov.uk/government/news/20m-announced-to-fund-vaccines-for-coronavirus-and-other- infectious-diseases 28 https://www.who.int/news/item/29-06-2020-covidtimeline 29 https://www.tandfonline.com/doi/full/10.1080/22221751.2020.1729071 30 https://www.who.int/news/item/29-06-2020-covidtimeline 31 https://www.sciencemag.org/news/2020/02/singapore-claims-first-use-antibody-test-track-coronavirus- infections 32 https://www.who.int/news/item/29-06-2020-covidtimeline 33 https://www.who.int/news/item/29-06-2020-covidtimeline 34 https://www.who.int/news/item/29-06-2020-covidtimeline 35 https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/888 784/S0384_Sixteenth_SAGE_meeting_on_Wuhan_Coronavirus__Covid-19__.pdf 36 https://www.gov.uk/government/speeches/pm-statement-on-coronavirus-19-march-2020 37 https://news.sky.com/story/coronavirus-uk-plans-to-buy-antibody-tests-which-may-be-gamechanger-in- fighting-covid-19-spread-11960554
professionals to determine if they had been infected.38 The price for 2 million of these tests was reportedly £16 million.39
6 April 2020 – Professor John Newton, director of public health improvement for PHE, confirmed that the 3.5 million antibody tests purchased were unreliable.40 41
27. That short, condensed timetable is particularly relevant when considering the standard for evaluating an antibody test, as explained by Professor Bell on 5 April 2020:
“To validate these tests you need to obtain a range of tools. You need a gold standard test so you know the correct answer and you need sera from patients who have recovered from the virus infection they had approximately 28 days before. You also need blood from people who donated before the epidemic so you know whether you falsely see positive tests when there is no Covid-19 in the sample. For example, there are a number of other coronaviruses circulating that might stimulate antibodies that cross react to Covid-19 proteins. It has taken some time to gather these tools for validation but the UK is now uniquely positioned to evaluate and find the optimal test for this disease. We clearly want to avoid telling people they are immune when they are not, and we want all people who are immune to know accurately so they can get back to work” (emphasis added).42
28. Exhibit 27 to the First Witness Statement of Jolyon Tony Dennis Maugham QC (“Exhibit 27”), provided as support for the argument that there was “a mature and well-developed market for antibody testing devices” shows that, as at 6 April, only one test was approved for diagnostic use in the US, and two tests were approved for diagnostic use in ‘other countries’. It is difficult to understand how a market that is, at best, 3 months old43 could be considered ‘mature and well- developed’.
29. The GLP has also failed to deal in its submissions with the fact that Abingdon was tasked with developing a COVID-19 antibody test for home use. The GLP has not provided any evidence to show that any of tests in Exhibit 27 would have been suitable for home use. In fact, contrary to the statement made at 3(ca) of the RASFG that “tests suitable for the Defendant’s purposes were available on the open market for c.£3/test”, no such test was available at the time any of the contracts were entered into – and indeed, the MHRA still has yet to approve any COVID-19 antibody test for home use.44 It should be noted that MHRA have now provided derogation for home use for certain tests (including the AbC-19TM Test) for home use as part of a project being run by the UK Biobank.45
30. When considering the suitability of other allegedly available tests, the GLP should also consider the type of antibodies that such proposed alternatives detect. The AbC-19 lateral flow assay is
38 https://www.theguardian.com/world/2020/mar/24/matt-hancock-35m-coronavirus-test-kits-are-on-the-way- to-the-nhs 39 https://www.independent.co.uk/news/uk/home-news/uk-coronavirus-tests-symptoms-covid-19-testing-kit- a9470071.html; https://www.bmj.com/content/369/bmj.m2284 40 https://www.independent.co.uk/news/uk/home-news/coronavirus-test-antibody-kit-uk-china-nhs-matt- hancock-a9449816.html 41 Abingdon’s understanding of the tests is that they were total antibody tests, measuring a number of different types of antibodies, and they did not perform well because they were not specific to COVID-19. 42 https://www.research.ox.ac.uk/Article/2020-04-05-trouble-in-testing-land 43 An estimate of 3 months is taken from the date of 9 January 2020, when the determination was made that the outbreak was due to a novel coronavirus. However, it could be argued that a shorter period would be reasonable, given the time required to develop and properly evaluate any antibody test. We note that, based on Exhibit 27, the earliest diagnostic test approval (for professional use in China) was on 20 March 2020. 44 Abingdon did not receive any explanation from the MHRA as to why the AbC-19TM Test was not approved for home use. Given that no tests have been approved, Abingdon would query whether the MHRA has concerns about the use of home tests in general that prevented authorisation, rather than concerns specific to the AbC- 19TM Test. 45 https://www.ukbiobank.ac.uk/explore-your-participation/contribute-further/coronavirus-self-test-antibody- study-phase-2
designed to detect IgG antibodies to the full spike protein of SARS-CoV-2 (the virus which causes COVID-19) to indicate a measure of immune response. Antibodies of this type bind to the ‘spike’ of the external coat of the virus, and interfere with the ability to enter cells. Antibodies of this type are known as neutralising antibodies, and this is what the AbC-19TM Test targeted. Other antibody tests target a protein from the inside of the virus known as nucleocapsid protein (“NP”).46
31. In addition to different antibody targets, different antibody classes exist (such as IgG, IgM and IgA). IgM is an early immune response, and IgA is generally an antibody of mucosal membranes. The AbC-19TM Test targets IgG antibodies, which are those that develop as the immune system deals with and neutralises an infection. The AbC-19 IgG assay will therefore show an immune response after infection or after successful vaccination (the COVID-19 vaccines are designed to produce IgG antibodies to the spike protein of SARS-CoV-2). Tests which target NP – as many of the early and current LFDs do – will not detect antibodies to the spike IgG and so do not indicate immunity.
32. In short, as at today’s date, the AbC-19TM Test is one of a small number of antibody tests authorised for use in the UK, none of which have been authorised for home use. Of these, the AbC-19TM Test was shown to have the highest accuracy of those tested in a recent study (see below).
Evaluation of the AbC-19TM Test
33. The GLP focuses heavily on the idea that the AbC-19TM Test was effectively useless. This ignores the fact that it has received a CE marking and was registered with the MHRA for professional use. The GLP has also sought to infer that such approval should not even be considered because of the element of self-certification; that is the process which Abingdon was required to follow according to the EU in vitro Diagnostic Medical Devices Directive (98/79/EC), and the process that would apply to any of the comparator tests the GLP may seek to rely on.
34. Abingdon’s development and LFD manufacturing processes, including CE marking, are performed according to its Quality Management System which is certified by the British Standards Institute (BSI) to the ISO13485:2016 standard for: “The design, development and manufacture of lateral flow devices and ELISA kits, reagents and device readers for in vitro diagnostic medical use in the diagnosis and management of disease status”.47 Abingdon is also certified by BSI to the ISO9001:2015 standard for “Design, development and manufacture of test kits, instruments and reagents for use in plant, food, veterinary and healthcare industries including contract services”.
35. For clarity, the CE marking for professional use adhered to MHRA’s target product profile which required 200 confirmed positive and 200 confirmed negative samples. Abingdon’s CE marking data included (along with other data on, for example, product performance, product stability, manufacturing reproducibility, lack cross-reactivity to antibodies to other viruses, quality control procedures and standard operating procedures), analysis of 350 negative samples and 203 positive samples performed during an independent assessment at Ulster University, plus an additional 100 pre-pandemic negative samples analysed at Abingdon’s laboratories in York. This gave a specificity of 99.6% (95% confidence interval 98.4 to 99.95%) and sensitivity of 98.03% (95% confidence interval 95.0 to 99.5). The Ulster University data set has since been expanded to include 304 positive and 350 negative samples with a sensitivity of 97.7% and specificity of 100%.48
46 An additional point regarding NP is that it is more conserved across the coronavirus family than spike protein. This produces the potential of cross-reactivity with other coronaviruses and false positive results. 47 https://www.abingdonhealth.com/app/uploads/2021/01/AH-ISO13485-EXP-20211209.pdf 48 https://www.medrxiv.org/content/10.1101/2020.09.29.20201509v1; https://www.medrxiv.org/content/10.1101/2020.09.29.20201509v2.full.pdf+html
36. As part of the agreement to supply the Government (the “Supply Agreement”, discussed in more detail below), PHE were required to perform an evaluation of the AbC-19TM Test prior to the placing of any purchase orders by DHSC.49
37. Abingdon was not involved in this evaluation, and once it was provided with a draft of the report in September 2020, it raised significant concerns on the methodology used by PHE. In essence, the PHE study was comparing ‘apples with pears’, by using a comparator test that was measuring something different to the AbC-19TM Test. The bulk of the samples tested were of ‘unknown status’. Abingdon’s concerns were largely ignored and the study was published in the BMJ. Following publication, Abingdon did however set out these concerns on its website.50
38. In addition, in February 2021, PHE released the results of a study performed by scientists at PHE, and the Universities of Bristol, Warwick and Cambridge which examined the performance of four lateral flow rapid antibody tests using the same cohort of samples.51 The study showed, on samples of known status, an accuracy for the AbC-19TM Test of 97.3%, which was the highest accuracy out of the four tests evaluated. The study was titled “Accuracy of four lateral flow immunoassays for anti SARS- CoV-2 antibodies: a head-to-head comparative study” but did not actually quote figures for accuracy. However, the paper helpfully provided detailed data allowing calculation of accuracy which was reported online by UKRTC:
“The AbC-19TM rapid antibody test displayed high accuracy (a combination of sensitivity and specificity) on samples from patients who had a self-declared positive PCR and presumed negative samples collected pre-pandemic. The provision of full data sets in the pre-print is useful and allows us to consider other parameters such as accuracy*. When looking at these positive PCR and pre- pandemic negatives, all devices tested had accuracy of >92% with AbC-19TM showing the highest accuracy at 97.3%. Accuracy is an important value which is derived from the number of false positive and false negative results in the population being tested combined with prevalence. No test is 100% accurate – tests with high sensitivity will have a tendency for lower specificity and tests geared towards high specificity may show lower sensitivity. (When calculating accuracy for all devices we used the positive prevalence of the sample set (11.8%) and accuracy will change depending on prevalence)”.52
39. A full summary by UKRTC is listed online: https://www.abc19.com/further-performance-data-abc- 19-rapid-antibody-test/
The formation of the Consortium
40. The above demonstrates that Abingdon had extensive expertise relevant to the development sought by the Government, and that the AbC-19TM Test it did ultimately develop is one of the most accurate tests available. Any criticism about the selection of Abingdon based on experience or finances is therefore clearly unwarranted. However, we understand that GLP also has concerns about the selection of Abingdon based on suspected prior contact with certain individuals within (or advising) the UK government. We therefore believe it would be helpful to set out how the consortium that developed the AbC-19TM Test came to be formed.
41. Abingdon was contacted by Professor Geoff Dusheiko on Sunday 22 March 2020 enquiring about LFDs [E-mail 5]. Professor Dusheiko, of Kings College Hospital and University College London Medical School, was advising Professor Sharon Peacock of PHE in relation to rapid tests for the COVID-19 pandemic. Professor Peacock was Director of the National Infection Service in 2019, a department of PHE and in 2020 was Director of Science at PHE.
49 This evaluation occurred during and after the announcement by Secretary Hancock on the restructuring of PHE to form the National Institute for Health Protection. 50 https://www.abingdonhealth.com/news/preliminary-report-independent-evaluation-abc19/ 51 https://www.medrxiv.org/content/10.1101/2021.01.30.21250777v1.full.pdf 52 https://www.medrxiv.org/content/10.1101/2021.01.30.21250777v1
42. Professor Dusheiko asked “Given your expertise in the field, would it be feasible to discuss the possible development of a lateral flow point care of test for SARS-CoV-2?” [E-mail 5]. In addition, he commented: “The country would like to assist and procure, even perhaps taking some risks with assays in development” [E-mail 5].
43. Following a conversation between Dr Hand and Professor Dusheiko on 22 March 2020, Dr Hand, summarised the conversation by email including the following:
“I believe all UK manufacturers of scale, including ourselves, should be brought together under one framework to make the test according to the same specifications. This would ensure co-ordination of supply chains (including UK Government guarantees for purchase orders) and also surety of supply if, for example, one site is closed due to a COVID-19 outbreak. We, along with our competitors I’m sure, are receiving numerous enquiries from overseas and if we’re not careful UK manufacturing will be not have the spare capacity to cope with the required number of tests for UK-use.” [E-mail 6].
44. Professor Dusheiko responded by email on 22 March 2020 noting:
“Thank you for the follow up; these are all cogent points, including the fact that the demand for appropriate tests is growing. I know that Sharon Peacock is cognisant of this fact, and the need to secure tests for the UK.
I have forwarded your first reply and will forward this email reply to Sharon right away who I am sure, together with colleagues, will want to make supply chain decisions soon” [E-mail 6].
45. Professor Dusheiko asked Dr Hand to provide information through the appropriate channels and write directly to NHS/DHSC to make them aware of Abingdon’s capabilities. Abingdon did so through contact with: [email protected] and [email protected] [E- mail 7; E-mail 8].
46. Abingdon was contacted by Professor Sir John Bell on 1 April 2020 when he phoned the main office line, initially speaking to the Operations Director, Michael Hunter [E-mail 6]. On the same date, Chris Yates, Abingdon CEO, was asked to join a conference call with Secretary Hancock and others from industry [Email 19]. Prior to 1 April 2020 and to the best of their recollection, none of the directors of Abingdon have had any previous contact with Professor Bell, Lord Bethell (Parliamentary Under Secretary of State at the DHSC) or Secretary Hancock.53
47. Dr Hand returned Professor Bell’s call and answered questions on how Abingdon could support in developing an antibody test, and confirmed that Abingdon would help if it could. On 2 April 2020, Professor Bell by email introduced Abingdon Health to a number of individuals at the University of Oxford as follows:
“The government wants to proceed with the development of a UK lateral flow test. Abingdon Health are a respected supplier in the UK who make these tests and have had experience in infectious diseases such as HIV. They have agreed to lead but need our help. They will need access to recombinant antigen. Your call but I think you had decided on Spike. They will also need sera for verification of the test. Derrick can you help? We need to move fast. Can you link up and discuss today please? Jb” [E-mail 9]
53 Further, no Directors of Abingdon are, or have ever been, members, of the Conservative Party or have ever provided donations to the Conservative Party. Steven Barclay, the then Brexit Minister, had visited Abingdon Health in 2018 on his visit to Yorkshire and met with management, where, as an export-led company we expressed our concerns on the impact of Brexit on our business, notably around staff recruitment, tariffs and movement of goods and materials.
48. This was also followed by discussions with Tamsin Berry, the then director of life sciences at DHSC. The number of tests sought by DHSC varied throughout the discussions with Ms Berry and others, and at one point, the number requested was 40 million. The figures the DHSC was talking about were not typical commercial volumes; they were figures on the scale needed for tackling a global pandemic. Abingdon was clear on its size and the challenges faced not only by it, but by the UK diagnostic industry in meeting the potential requirements of millions of tests per week.54 It was discussed that the potential requirements to manufacture the assay at the volumes indicated by DHSC could not be met by any single UK lateral flow company.
49. Following contact from Professor Bell, and discussions with Ms Berry and Lord Bethell, Abingdon agreed to form a consortium of companies in early April 2020 to support the scale-up of any developed test [E-mail 10]. It therefore contacted BBI Solutions, Omega Diagnostics and CIGA Healthcare to form the UK Rapid Test Consortium (“UKRTC”). To the best of Abingdon’s knowledge, the only other UK company that could manufacture lateral flow devices in the UK at scale was Mologic. Mologic was not contacted for this project, as Abingdon was aware that it was already working with the Government.55
50. Oxford University was originally named as a member of the UKRTC but did not sign up to the consortium agreement and played no part in the development of the lateral flow device [E-mail 11]. All the development work was performed at Abingdon, and Abingdon kept the UKRTC consortium informed of progress on weekly calls.
51. Various professors at Oxford provided initial insight into COVID-19 diagnostics and also provided a small amount of antigen reagent (a component of a lateral flow test), and access to samples for testing of preliminary prototypes of the device [E-mail 12]. The advice and use of the particular antigen was information already in the public domain which Abingdon had been discussing with researchers at the University of Birmingham before contact from Professor Bell or the establishment of UKRTC [Paper 1]. The involvement of the University of Oxford ceased in May 2020 as understandably the reagent volumes required for development and manufacture were far in excess of what could be provided by the University. In any event, by this time Abingdon had sourced a third-party German supplier of this reagent. For the avoidance of doubt, the University of Oxford did not provide any know-how to Abingdon and there is no royalty due to the University of Oxford arising from the development of the AbC-19TM Test.
52. Professor Bell had no involvement in the development of the assay. From the commencement of the project, the UKRTC consortium had a cadence of weekly calls; CEO calls, CTO calls and COO calls to update on progress. To our knowledge, neither Lord Bethell nor Professor Bell attended any of these calls. We understand that both Lord Bethell and Professor Bell were kept informed as to progress on a weekly call with the chair of the UKRTC consortium, Dr Jonathan Allis.
The contracts that are the subject of the proceedings
53. As well as understanding how the contracts that were subject to these proceedings came to be, it is important that the GLP has a clear understanding of the nature of each contract. We take each of the three core parts below (research, the purchase of components, and the sale of the tests) in order to provide necessary details that we hope we remove some of the misunderstandings that have emerged in the proceedings.
Research Contract
54 Secretary Hancock appears to have acknowledged this point, given comments he has made about the size of the UK diagnostic industry (see, for example, the Ministerial Foreword on the challenges of scaling up of COVID-19 testing ability, available at https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/878121/c oronavirus-covid-19-testing-strategy.pdf). 55 https://www.gov.uk/government/news/pm-announces-new-funding-in-fight-against-spread-of-coronavirus.
54. The contract entered into between the Secretary of State for Health and Social Care and Abingdon Health on 11 April 2020 (the “Research Contract”) has been mischaracterised by the GLP as a “straightforward £2.5 million subsidy”,56 and comprises unlawful state aid. In respect of the Research Contract, Abingdon has received £2.5 million (plus VAT). Contrary to previously inaccurate leaked information, Abingdon has paid the VAT to HMRC.
55. The development by Abingdon of a COVID-19 neutralising antibody test was funded by a fee for service paid by the DHSC. The profit margin on the Research Contract was in fact at a rate lower than Abingdon would typically receive on a commercial R&D agreement. It should also be noted that as part of the Research Contract, Abingdon developed the assay within three months. This is far quicker than a typical R&D process and was achieved by allocating a high level of resources including R&D teams who worked from 8am to 10pm (or longer) across shifts including weekends.
56. Abingdon Health put on hold a number of other commercial contracts to focus a significant proportion of its organisation (e.g. R&D, Operations, Regulatory) on fast-tracking the development and scale-up of the AbC-19 assay and building of the supply chain. This plan was set out in a proposal to DHSC emailed to Tamsin Berry on the 2 April 2020 [E-mail 13; Presentation 1]. This included a proposal for the UK Government to procure significant volumes of components. In Abingdon’s experience, it is normal for its customer to supply specific components (such as reagents) to Abingdon.
57. The initial research proposal was for Abingdon to be provided with a grant, but this was changed to a fee for service contract which allowed DHSC to have ownership of the foreground intellectual property generated, and access to the background intellectual property owned by Abingdon, therefore giving DHSC the potential to license the test to other manufacturers if required. In addition, as a way for DHSC to recoup its costs of the research contract, Abingdon agreed to pay the DHSC royalties on any UKRTC consortium sales of the antibody test to third parties in a separate commercial agreement signed on 14 August 2020.
58. It is clear that on an analysis of the full facts, the Court will not conclude that the Research Contract was a ‘straightforward subsidy’, and that there was no award of unlawful state aid.
Component Contract
59. The Advance Purchase Agreement entered into between the Secretary of State for Health and Social Care and Abingdon Health on 2 June 2020 (the “Component Contract”) has been mischaracterised by the GLP as “an interest free loan to [Abingdon]”,57 which comprised unlawful state aid.
60. Developing an antibody test was step one of the process, but if the components couldn’t be secured for the developed product, then the development process would be a waste of time. Global demand for components for antibody testing was (and remains) high with many companies chasing the same materials. Therefore, as part of its performance of the Research Contract, Abingdon put in place a robust supply chain to acquire components on behalf of the Government to enable manufacture of 10 million devices.
61. On 6 April 2020, Abingdon was offered the support of Lord Agnew, Cabinet Office Procurement Minister: “If you need kit that you can’t get through normal channels we have over 1,000 procurement officials who can be pivoted to support you in tracking down, ordering and paying for items (with DHSC’s agreement” [E-mail 14]. The potential for a volume of tests in excess of the 10 million originally discussed was further confirmed in an email on 7 April 2020 [E-mail 15]. It had been indicated to Abingdon by a DHSC official on 21 April 2020 that HM Treasury had “given the green light to procure 40 million tests’ worth of materials.” [E-mail 16]. In addition, on 2 May 2020, an official from DHSC stated:
56 Transcript at [10C]. 57 RASFG at 119(b).
“I want to make sure any agreement covers the potential for 40m kits worth of materials. I realise this has never been your ask, which has always focussed on the first 10m. However, the Department’s view has always been better to cover the full amount if we can. Of course, if you are comfortable that you will not want us to assist in funding materials beyond the first 10m then it would be helpful to know that now (and may speed this process up). But don’t say you won’t need it if in all likelihood 2-3 months down the line you will – I want to avoid opening another difficult set of conversations with cabinet office”. [E-mail 17]
62. The Component Contract was signed on 2 June 2020, and this allowed Abingdon to procure, on behalf of the Government, the components needed to produce AbC-19TM Tests. The total value of the components expected to be purchased under the Component Contract was £8.56 million (net of VAT). In the event, fewer components were procured such that expenditure is expected to be c£6.7 million (net of VAT).
63. In this context, Abingdon effectively acted as a purchasing agent for the Government. Abingdon managed the procurement of these components and paid for them on the basis that it would be reimbursed by DHSC. It is important to note that these components belong to DHSC until they enter the manufacturing process, at which point title transfers. In addition, whilst purchasing on behalf of the Government, it was Abingdon that took the financial risk and paid suppliers in the first instance in almost all cases. Abingdon was to be reimbursed separately under the terms of the contract.
64. To date, Abingdon has paid suppliers £4,047,803 (plus VAT) for components, which it has invoiced to DHSC and for which it has received payment from DHSC. It has paid suppliers for £2,116,339 (plus VAT) of components, which it has invoiced to DHSC, but in respect of which it has not received payment from DHSC. Abingdon owes a further c. £600,000 (plus VAT) to companies from which it procured components on behalf of the Government and for which it would expect reimbursement under the terms of the contract. Abingdon was able to cancel orders it had made on behalf of the Government that were for approximately £2 million.
65. Until the components are used in the production process, DHSC can distribute these components as they see fit. To be clear, Abingdon does not have a loan agreement or working capital facility with the DHSC. It should also be noted that Abingdon has been warehousing and insuring the components owned by DHSC at considerable cost without recompense by DHSC. We would also note that, when Abingdon has acted as a contract manufacturer of diagnostics tests in the past, it has not been uncommon for its customers to provide some of the components necessary for manufacture of the relevant tests.
66. The GLP has focused particularly on clause 6 of the Component Agreement, whereby DHSC could have requested components to be returned if Abingdon had not met the relevant standards for use (namely CE-marking) by 31 July 2020. Abingdon confirms that the CE-marking for professional use of the AbC-19TM Test, and registration with MHRA declaring conformity with the essential requirements of the EU in vitro Diagnostic Medical Devices Directive (98/79/EC), was completed on 29 July 2020. Contrary to statements made by the GLP in its pleading and at the Renewal Hearing,58 Abingdon had met the contractually required standard within the required timeframe.
67. For clarity, clause 6 related to components, and their potential return, and not the order of the AbC-19TM Test by DHSC (which was the subject of the Supply Agreement, discussed below). As part of the CE marking process, the AbC-19 assay was shown to meet the target product profile as provided by MHRA as published at the time; namely testing of at least 200 confirmed positives and at least 200 confirmed negatives.
68. Further, pursuant to the Supply Agreement (discussed below), Abingdon is required to account for its use of components procured under the Component Agreement by paying/crediting the DHSC the sum of £0.856 for each of the first 10 million units of AbC-19TM Tests sold. This may
58 RASFG at 30.
be done by way of a discount on the unit price charged for the tests where DHSC is the purchaser; or by a payment or credit note reflecting purchases made by third parties.
69. It is in any event clear that on an analysis of the full facts, a Court will not conclude that the Component Contract was an ‘interest-free loan’, and there is no basis for a finding of unlawful state aid.
Supply Agreement
70. In order to support its allegations of state aid, the GLP has repeatedly claimed that Abingdon’s tests were excessively priced.59 These statements are supported by claims such as “tests suitable for the Defendant’s purposes were available on the open market for c. £3 per test”.60 These statements are unsupported, and should the GLP maintain its allegation of state aid, we would expect it to put forward full evidence demonstrating both equivalency of comparative tests, and the pricing of such tests.
71. Abingdon’s understanding from the negotiation of the Supply Agreement is that Cabinet Office officials benchmarked the price of the AbC-19TM Test against other antibody tests it had procured, namely Roche and Abbott antibody tests that had been bought previously by DHSC.
72. In any event, assertions about Abingdon’s test being £7.50 per test,61 or “effectively £20/test”62 are factually incorrect. The price per AbC-19TM Test paid by DHSC under the Supply Agreement was £5.15; or £4.30 taking account of the discounts/credits on account of use of components provided by DHSC under the Component Contract. Note that this price is not simply for bulk supply of lateral flow devices: it is a price for unitary packaged LFDs, and associated materials, each in their own outer box including two blood lancets, a transfer pipette, a filled buffer vial and instructions for use (which also links via a barcode to an instructional video).
73. Therefore, once evidence is provided to the Court on the actual price of Abingdon’s tests, the price can clearly not be considered to be excessive – either in and of itself, or in comparison to a benchmark product. Consequently, any claim of unlawful state aid is bound to fail.
74. We note that in its Reply, the GLP relies heavily on a Daily Mail article dated 5 February 2021 with the extremely inflammatory headline “Ministers ignored legal advice to give failing company a huge Covid test contract leaving taxpayers with £87MILLION bill when tests didn’t work”.
75. Abingdon received a purchase order for 1 million tests in September 2020 from DHSC and these AbC-19TM Tests were made by Abingdon with significant support from other members of the UKRTC consortium. As above, the net price paid was £4.30 per test after applying the discount in respect of the components owned by the Government. Contrary to the claim made by the GLP that these tests were “non-compliant”,63 these tests had received authorisation for professional use. As noted above, the AbC-19TM Tests are not currently authorised for “home use”; but nor, to Abingdon’s knowledge, is any other anti-body test. As also noted above, the AbC-19 TM Test has been found to be the most accurate of four tests evaluated in a study by scientists at PHE and the Universities of Bristol, Warwick and Cambridge, with an accuracy of 97.3%. The assertion that the tests do not work is plainly incorrect.
76. For the 1 million AbC-19TM Tests supplied, Abingdon invoiced DHSC £4.294 million (plus VAT). To date, this invoice has not been paid by the DHSC, but Abingdon has paid VAT to HMRC as due, and will pay additional VAT when it becomes due.
77. With reference to a ‘cancellation’ of further or outstanding orders, Abingdon were never in possession of any subsequent purchase orders for the balance of 9 million tests and there were
59 See, for example, GLP Skeleton at [38]; RASFG at 121A(d). 60 RASFG at 119(ca). 61 RASFG at 119(c). 62 GLP Skeleton at [38]. 63 Reply at 3(x).
therefore no outstanding orders to cancel [E-mail 18]. Abingdon detailed this in a regulatory news service announcement dated 27 January 2021.64 It is unclear how there can be a cancellation of ‘outstanding orders’ by DHSC that never existed.
We hope that the above is helpful information in understanding the various contracts, the role of Abingdon and its experience in these areas. In light of the above, we also invite your client to reconsider the merits of its claim (in particular, its allegations on unlawful state aid).
Yours faithfully,
Bristows LLP
Encs. cc. Government Legal Department
64 https://www.londonstockexchange.com/news-article/ABDX/media-clarification/14843058