Previously, I wrote regarding the Innova Medical Group Inc (Innova) and the government contracts awarded to Innova for its SARS-CoV-2 antigen rapid qualitative test kits, commonly referred to as lateral flow tests (LFTs), which contracts at the time of writing stood in excess of £3.3 billion. A lot of money for a start-up founded on 20 March 2020 and with LFTs of somewhat dubious sensitivity and specificity data. On 14 October 2021, however, UCL published a report and found recalibrating an apparent relative sensitivity of 50% (in other words, using a different formula), on average would approximate absolute sensitivity of over 80% in testing for individuals shedding SARS-CoV-2 antigens.
To say British companies have struggled bringing their own LFTs to market , in the UK at least, is an understatement. Following my article on Innova, I made enquiries of British manufacturers of LFTs by direct, open contact through a series of identical questions. A number replied with useful information to present an overall state of British manufacturing and the regard or indifference given to them by the government. Bear in mind, the award of a contract by the UK government does not mean orders have been or must be placed by the government.
The Brit Awards
- SureScreen Diagnostics Limited (03235601). The most successful of the British to date. Although the government claims SureScreen’s LFTs are British-made, key materials required to make them are sourced from the EU, US, and Far East depending on the material. That may be so with many of the British manufacturers. SureScreen’s R&D team is based in the UK. The SureScreen LFT shows sensitivity at 95% and specificity at 99.9%. It is CE marked for professional use only and is not for sale to the general public. Contract award worth £503 million; delivery 15.01.21 to 15.01.23.
- Abingdon Health Limited (06475379). Contract award worth £75 million; delivery 02.06.20 to 14.02.21 to provide antibody tests rather than antigen tests.  A judicial review regarding the award by the Good Law Project has meant the DHSC refusing to release the £6.7 million it owes to Abingdon, pending a hearing of the matter in December 2021.
- Mologic Limited (04784437). Mologic received a £1 million grant from the government. Porton Down recorded a 60% failure rate in Mologic’s LFTs, whereas other labs in the UK and in Germany gathered very different results and found they only had a 1-2% failure rate. The Mologic LFT is accredited for professional use only and cannot be used by the UK public. Mologic is suing the government over validation of its LFTs in the UK. Mologic LFTs are sold in the US and EU. Limited UK purchase orders to date.
- Avacta Group PLC (04748597). Developed and manufactured in the UK. The Avacta LFT has been shown by independent clinical evaluation to be 100% sensitive for patient samples with a PCR Ct value below 27 (high viral load), 98.0% sensitive across a much wider range of viral loads and with 99% specificity. Avacta carried out analytical tests with the spike proteins isolated from both the B117 and D614G variants and confirmed that its LFT detected both variants as well as the original strain. Avacta recently appointed Calibre Scientific, a global distributor of diagnostic and life science products, as the first distributor for Avacta LFTs in the UK and EU and is progressing multiple commercial opportunities with distributors and end users in the UK, EU, Asia, and elsewhere. No contract awarded. No UK purchase orders to date.
- Omega Diagnostics Limited (SC107178). Omega signed a material transfer agreement with Mologic, providing access to raw materials and know-how to manufacture their LFTs. The Omega LFT is MHRA approved for professional use only and is waiting on CE marking for self-test approval. The latest update on 6 September 2021 notified investors that all supporting data and documentation relating to the submission for CE marking for self-test use had been filed with the European Notified Body. Omega expects MHRA approval for sale in the UK to follow soon after CE marking for self-test use is confirmed. The Omega LFT provides for the detection of the nucleocapsid protein of the SARS-CoV-2 virus in respiratory swabs and has sensitivity of 98.4% on samples with a cycle threshold (Ct) of < 20 (85% overall sensitivity on samples with Ct values ranging from 9.8 to 43) and specificity of 97.8%. Contract award worth between £50 million and £374 million; delivery 12.02.21 to 11.02.23. No UK purchase orders to date.
- Global Access Diagnostics Limited (12558218). GAD is a high volume manufacturing social enterprise spun out from Mologic in April 2020 with funding from the Bill & Melinda Gates Foundation, FIND DX, the Soros Economic Development Fund, and UK government. GAD’s principal focus is upon the development and manufacture of reliable, relevant, and affordable diagnostic tests for the public health systems of around 30 countries across Africa, Asia, and Latin America. GAD is Mologic’s manufacturing partner across its full LFT R&D pipeline. The GAD LFT has been found, in the largest independent study run by FIND DX, to have an overall sensitivity of 91% and specificity of 100%, with a limit of detection of 2.5 x 10₂. At CT scores <20, sensitivity rises to 100%. GAD is one of 3 UK companies working with the government to scale up manufacturing capacity in UK for LFTs. Contract award worth between £50 million and £1.15 billion; delivery 15.02.21 to 15.02.23. No UK purchase orders to date.
- Excalibur Healthcare Services Limited (12414592). The first UK company to receive MHRA certification for its LFT. Excalibur exports its LFTs to other countries. The new Excalibur Rapid SARS-CoV-2 antigen test kit is one of the most accurate and reliable tests of its kind. The test has 100% sensitivity for high viral loads (equivalent to positive PCR values below Ct=28) and 100% specificity for SARS-CoV-2 with very few false positives observed in tens of thousands of samples tested. The Excalibur LFT is CE marked and MHRA registered for professional use only and is in use in Germany, Italy, Austria, Belgium, and the UK by customers including governments, hospitals, care homes, businesses and educational establishments. No contract awarded.
It is true to say the preliminary report from the Joint PHE Porton Down & University of Oxford SARS-CoV-2 test development and validation cell: rapid evaluation of LFTs for mass community testing dated the 8 November 2020 (Report) identified the Innova LFT as that in the most advanced stages of validation and nearing completion of the four-phase evaluation. The Innova LFT showed performance characteristics of having a low failure rate, a high specificity of 99.6%, and a high viral antigen detection. The Report acknowledged that many of the other LFTs tested had not performed to levels established by the test and validation cell and confirmed by the LFT Oversight Group to proceed to community field service evaluations.
The summaries in the Report clearly had the Innova LFT out in front and undoubtedly corroborated the DHSC’s subsequent justification, in the early days of the procurement at least, for using Innova as its sole supplier without a call for competition according to regulation 32(2)(c) of The Public Contract Regulations 2015 (the Regulations)  (the extreme urgency test) and later according to regulation 32(2)(b)(ii)  of the Regulations (the absence of competition test). As the months have gone bye, however, and British manufacturers have received approval for the supply of their own LFTs, such justifications can no longer be relied upon.
It is quite obvious the SARS-CoV-2 virus is going to be around for some time yet. The LFT market is volatile and demand already outstrips supply with global manufacturing capacity limited to c. 120 million LFTs per day. Delivery dates for British made LFTs will run a few more years based upon current contract awards, ignoring any extensions. Time will tell if the government chooses LFTs made in Britain.