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Dear Rook Irwin Sweeney Good Law Project Limited V Secretary of State 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.
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