Randox response to the Public Accounts Committee (PAC) report, ‘Government’s contracts with Randox Laboratories Ltd’

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Randox response to the Public Accounts Committee (PAC) report, ‘Government’s contracts with Randox Laboratories Ltd’

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27th July 2022: Randox response to the Public Accounts Committee (PAC) report, ‘Government’s contracts with Randox Laboratories Ltd’

A spokesperson for Randox said:

“The PAC report is deeply flawed and wrong in assumptions it makes and the conclusions it draws about Randox.

“As the UK’s largest diagnostic company, with four decades of experience, over 2,000 professional staff on hand at the start of the pandemic and more than £350m of prior investment in diagnostic and engineering innovation, Randox was uniquely situated to respond to the national need when COVID-19 emerged in early 2020.

“In supporting the UK’s urgent requirement for coronavirus testing Randox reacted with speed, efficiency and flexibility in delivering value. The company developed and built, in record time, the UK’s largest COVID-19 laboratories and testing services. It provided the Department of Health and Social Care with a PCR testing capacity at the time of greatest need, rising from 300 tests per day to 120,000 per day by January 2021.

“Altogether Randox processed over 25 million samples for UK’s National Testing Programme and in support of international travel for business and personal reasons. This played a crucial role in keeping vital elements of the UK economy functioning during lockdowns.

“In adapting to rapidly changing DHSC and Department of Transport requirements, Randox delivered unique value to the government, the national economy and to individuals.

“At no stage, either during its deliberations or in its preparation of this report, did the PAC make any contact whatsoever with Randox. Consequently many elements of its report relating to Randox are false, based as they are, on wrong and unchecked assumptions about the company. For that reason, they and any publications arising from them are the subject of a legal complaint.”

“The issues the report raises around internal DHSC record keeping are clearly a matter for DHSC”

For all media enquiries, please contact Ian Monk on ian@ianmonk.com or  +44 7970 026072 / + 44 203 011 1933

 

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Response to release of specified minutes, notes and correspondence relating to Government contracts awarded to Randox

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4th February 2022: Response to release of specified minutes, notes and correspondence relating to Government contracts awarded to Randox

A spokesperson for Randox said:

“It is clear from these papers that Randox contracts were awarded in full compliance with government procedures and protocols in place at a time of the emerging pandemic.

“The awarding of the contracts reflected Randox’s extensive diagnostics capabilities within the UK and 40 years of experience in that field. As Secretary of State, Sajid Javid says in his statement, the service Randox provided was integral to the rapid building, from scratch, of the largest ever testing industry in UK history.

“Randox’s laboratories expanded rapidly in order to operate at scale and were the first laboratory to report over 100,000 PCR results in a day. It is clear from these papers that the company has delivered a vital and core part of the UK’s testing capacity.

“Randox remains proud of its performance and delivery of Covid 19 testing throughout the pandemic. To date Randox has reported almost 24 million PCR results and has played a key role in both keeping people safe and sustaining vital national infrastructure.

“Unlike other laboratories Randox was able from the outset to provide whole-system capabilities to deliver the tests. Both the World Health Organisation and the UK government agreed this capability was crucial to combating the pandemic.”

For all media enquiries, please contact Ian Monk on ian@ianmonk.com or  +44 7970 026072 / + 44 203 011 1933

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Evaluation of Omicron Variant to Ensure Test Effectiveness

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7th December 2021

Evaluating Omicron and Other SARS-CoV-2 Variants to Ensure Test Effectiveness

SARS-CoV-2, like all viruses, evolves over time through mutations, as it spreads and replicates. Since the beginning of the COVID-19 pandemic, many variants of the SARS-CoV-2 virus, with different sets of mutations, have been observed worldwide. Most changes have little impact on the virus’ properties. However, some may cause increased transmissibility, severity of disease or the ability to evade the host immune response. Surveillance of genetic variations is therefore crucial to identify those variants which pose a higher risk to human health.

Variants may impact the performance of current diagnostic approaches. This is why Randox continuously review public genomic databases to assess whether any emerging mutations overlap with the assay design and monitor assay performance as part of post-market surveillance efforts to ensure the coronavirus assays continue to meet the highest quality standards.

In light of the emergence of the new variant of concern detected in South Africa, Omicron (B.1.1.529), Randox have analysed all publicly available sequences of the variant to predict any impact of defining mutations on assay designs.

As the COVID-19 assays from Randox Laboratories Ltd. are designed using a dual-target approach (ORf1ab, E gene) to reduce the impact of genetic variation in the SARS-CoV-2 genome, detection of SARS-CoV-2 is not predicted to be affected by the currently known variants.

Detection of SARS-CoV-2 using the Vivalytic rapid RT-PCR tests, targeting the E gene sequence are not affected by the identified mutations. Assay performance is not predicted to be impaired by the current known variants.

Randox Laboratories Ltd., in collaboration with leading technology manufacturer Bosch Healthcare Solutions, have developed a range of COVID-19 testing solutions, providing clear and concise results in a timely manner, directly at the point of care. Randox is a distributor for Vivalytic platform and cartridges.

For all enquiries regarding our COVID-19 assays performance , please contact marketing@randox.com

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Randox welcomes CMA moves to safeguard consumer interests around PCR testing

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3rd December 2021

Randox Statement: Randox welcomes CMA moves to safeguard consumer interests around PCR testing

Responding to today’s announcement by the Competition and Markets Authority (CMA), a spokesman for Randox said:

“We welcome the role played by the CMA, with our full co-operation, in ensuring that consumers continue to get a fair deal during the Covid emergency.

“Randox has been happy to engage fully with the CMA from the outset to ensure in the interests of its customers while the company delivers millions of Covid-19 PCR tests to facilitate vital international travel against the changing requirements of governments.

“As the industry leader, Randox has been in the ideal position to both review the services required to support the international traveller and provide a consumer-industry standard of Terms and Conditions. These have, of necessity, evolved over time.

“In working with the CMA, Randox’s aim has been to ensure absolute fairness whilst building and providing critical services in a highly volatile and demanding environment.”

Additional Information

Randox has today welcomed engagement with the CMA to optimise Covid-19 PCR testing support for international travel whilst ensuring the sustainability of critical national services.

As the industry leader Randox has been in the ideal position to both review the services required to support the international traveller, and provide a consumer-industry standard of Terms and Conditions, which have evolved over time. In working with the CMA Randox’s aim has been to ensure absolute fairness whilst building and providing critical services in a highly volatile and demanding environment.

“Both industry and the travelling public have faced significant pressures in enabling international travel,” said a spokesperson. “From an industry perspective Government required immediate and large scale investment to establish validated end-to-end testing services, supported by nationwide logistics, with fully secure reporting to both individuals and Government. Yet there were no contracts, no expected duration for services and the requirement was based on a single product – Covid-19 PCR testing. It was also evident that Government would remove the requirement for such testing as soon as practicable and would not provide any further support.”

The spokesperson went on; “At the same time as requiring significant investment and a rapid response from industry, Government retained the right to alter demand on an almost daily basis and did so frequently by moving countries between the green, amber and red lists with no notice. Government subsequently removed the country lists entirely and effectively closed the requirements for international travel PCRs by moving to lateral flow devices in October – only months after establishing services.” The decision by the Prime Minister to reintroduce PCR testing at very short notice this week, without prior notice to industry, further illustrates the challenges faced.

It had also been clear that the public were faced with highly variable pricing by a number of suppliers – some advertising low prices, but which were only available in very limited circumstances – something Grant Shapps asked the CMA to review. “From the very start Randox committed to highly competitive and transparent pricing which was available across the nation,” said the spokesperson. “Our home testing kits are available at an all inclusive price of £43 with a click and collect service at £34.99 – we know that these represent excellent value for money.”

Randox’s engagement with the CMA has provided the ability to review consumer-industry terms and conditions in the light of very hard won experience. “We do hope that other providers will consider our terms and conditions,” said the spokesperson, “and we know that the CMA will provide further guidance where required.”

The spokesperson went on; “We at Randox are very proud of what we have achieved in very demanding and volatile circumstances. We have built and sustained a reliable and cost effective service to enable international travel – meeting critical business needs and ensuring friends and families can continue to meet. We are committed to providing this service for as long as Government requires.”

 

For all media enquiries, please contact Ian Monk on ian@ianmonk.com or  +44 7970 026072 / + 44 203 011 1933

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House of Commons Debate | Randox Statement

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17th November 2021: House of Commons Debate | Randox Statement

Randox will be pleased to co-operate fully in laying before the House all the material required.

Public disclosure will demonstrate the extraordinary efficiency and value for money provided by Randox through contracts awarded in full compliance with government regulations at a time of national crisis.

Contrary to much of what has been written and broadcast, lobbying played no role in the awarding of these contracts.

The company has 40 years experience in testing and diagnostics. It is proud of its performance and delivery under the contracts awarded to it on merit by the Government. They resulted in the delivery of more than 21 million Covid tests, 15 million of them to the National Testing Programme from the start of the emergency in the Spring of 2020.

At this time, hindered by global shortages and less experience than Randox, other laboratories were simply not able to provide whole-system capabilities to deliver the tests which the World Health Organisation and the UK government agreed were crucial to combating the pandemic.

 

11th November 2021: COVID Contracts | Randox Statement

Randox  states categorically that political lobbying played no role in the award of Covid contracts to the company. The Department of Health and Social Care (DHSC) contracts to provide Covid-19 testing were awarded on merit to Randox as the largest healthcare diagnostic company from the UK. The entire process was transparent and compliant with government regulations in a time of national crisis.

Randox has almost 40 years experience in testing and diagnostics: it was one of the first companies in the world to develop a Covid-19 test and to have developed extensive laboratory, IT and logistic infrastructure to support large scale testing operations. The decision to award Covid-19 contracts was fully validated by the company’s performance and delivery under the terms of the contracts.

The company was awarded its initial Covid contract on 30 Mar 20 and, within a short period, had exceeded the initial Covid-19 testing capability of the entire NHS.

Subsequent DHSC planning required Randox to deliver 17,000 tests per day by the end of April and more beyond then. To facilitate and ultimately enable these extraordinary levels of delivery, Randox was temporarily allocated 5 extraction systems from universities in order to increase capacity. DHSC directed the Army to collect equipment, in line with their support for all Pillar 2 laboratories.

This was a pragmatic and transparent move by the DHSC to meet a critical national need to save lives and ease overwhelming pressure on the NHS.  The extraction systems were returned once the systems ordered by Randox, against the backdrop of a global shortage of such equipment, had been delivered and installed.

Randox and its staff have striven tirelessly and innovatively to support the national Covid-19 testing effort. We are proud of our collective achievement at a time of crisis in being the only Pillar 2 laboratory to have reported in excess of 100,000 Covid-19 results in one day.

 

For all media enquiries, please contact Ian Monk on ian@ianmonk.com or  +44 7970 026072 / + 44 203 011 1933

 

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COVID Contracts | Randox Statement

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11th November 2021: COVID Contracts | Randox Statement

Randox  states categorically that political lobbying played no role in the award of Covid contracts to the company. The Department of Health and Social Care (DHSC) contracts to provide Covid-19 testing were awarded on merit to Randox as the largest healthcare diagnostic company from the UK. The entire process was transparent and compliant with government regulations in a time of national crisis.

Randox has almost 40 years experience in testing and diagnostics: it was one of the first companies in the world to develop a Covid-19 test and to have developed extensive laboratory, IT and logistic infrastructure to support large scale testing operations. The decision to award Covid-19 contracts was fully validated by the company’s performance and delivery under the terms of the contracts.

The company was awarded its initial Covid contract on 30 Mar 20 and, within a short period, had exceeded the initial Covid-19 testing capability of the entire NHS.

Subsequent DHSC planning required Randox to deliver 17,000 tests per day by the end of April and more beyond then. To facilitate and ultimately enable these extraordinary levels of delivery, Randox was temporarily allocated 5 extraction systems from universities in order to increase capacity. DHSC directed the Army to collect equipment, in line with their support for all Pillar 2 laboratories.

This was a pragmatic and transparent move by the DHSC to meet a critical national need to save lives and ease overwhelming pressure on the NHS.  The extraction systems were returned once the systems ordered by Randox, against the backdrop of a global shortage of such equipment, had been delivered and installed.

Randox and its staff have striven tirelessly and innovatively to support the national Covid-19 testing effort. We are proud of our collective achievement at a time of crisis in being the only Pillar 2 laboratory to have reported in excess of 100,000 Covid-19 results in one day.

 

For all media enquiries, please contact Ian Monk on ian@ianmonk.com or  +44 7970 026072 / + 44 203 011 1933

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Statement on Randox COVID-19 dropbox service

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09 August 2021: Logistics Update on Randox COVID-19 Testing for International Travel 

A spokesperson for Randox said:

“Randox is constantly expanding and improving its COVID-19 testing capacity and associated logistics network, which is already the largest in the United Kingdom, to meet the rapidly growing demand resulting from the loosening of travel restrictions. Randox continues to increase the number of drop boxes across the United Kingdom, which already totals over 200, and is increasing the frequency of box collections which are already occurring multiple times per day. Randox is providing premium testing services in dynamic and rapidly changing circumstances and is committed to continuously improving its logistics network, to ensure that all international travellers receive their results in time.”

Press enquiries should be emailed to randox@newcenturymedia.co.uk 

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Randox Statement following ‘The One Show’ Broadcast of 28th July 2021

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Randox Statement following ‘The One Show’ Broadcast of 28th July

Randox Laboratories completely refute the general portrayal of our services as shown on ‘The One Show’, broadcast on 28th July 2021.  The cases shown are not indicative or representative of the services provided. Randox have been active within the diagnostics / testing industry for almost 40 years.

Randox Laboratories run the largest Covid-19 PCR testing laboratories in Europe and since the start of the pandemic have tested and reported over 15 million samples.  Within our operations we are fully committed to the provision of PCR testing to support international travel and fully recognise the importance of such travel, and of traveling safely.

Randox are also committed to operational efficiency and to processes of continuous improvement.  This commitment is borne out by the fact that, over an extended period, 99.9% of international travel samples received in our laboratories have been reported within 24 hours.

We understand that there are certain elements of the process that are not fully within any national testing providers’ control, particularly in the area of logistics.   As a result Randox have established a branded nationwide drop box system that returns samples direct to our laboratories 7 days a week, in which we have full confidence.  Other providers, which customers may elect to use, may have a less comprehensive service.

Testing providers’ customer support services also have to deal with enormous peaks and troughs of demand, largely as a result of changes to Government travel policy to which no forewarning is provided. The requirements placed upon the general public, regarding testing for international travel, also add significant demands for information. Randox understands the frustration that potential customers may experience, common to all testing providers, and are addressing this through improved website design, use of social media, redeployment of staff and additional recruitment to our Call Centre.

Randox have great experience in the provision of PCR testing to support international travel,  a proven record of success in reporting high volumes of samples in a timely manner, and continually seek to improve the customer experience.   Randox has every confidence in its services.

The full statement provided to BBC Watchdog

A spokesperson for Randox said: “We take our responsibilities towards our customers extremely seriously, and recognise the crucial role we play in ensuring that international travel can take place safely.  Randox are processing high volumes of COVID-19 tests to support such travel with 99.9% of private sample results, from January – June 2021, returned within 24 hours of receipt into our laboratory. Our stated aim is to provide next day results for clients who use Randox drop boxes, and within 12-24 hours of receipt of the sample at our laboratory for other courier services. We have investigated the cases which have been brought to our attention, and have been in communication with the customers.

“We are duty bound to follow government guidance in relation to travel. We are not provided with forewarning on changes to existing guidance and, therefore, we aim to be as flexible as possible and adjust our operations in a timely manner in what are often rapidly changing circumstances.  We are deploying more dedicated resources at our call centre to help address the unprecedented and growing demand for our testing services.”

Press enquiries should be emailed to randox@newcenturymedia.co.uk 

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Vivalytic’s rapid coronavirus test delivers results for positive samples in less than 30 minutes

   

18th December 2020

Cloud-based software update means a faster PCR test for SARS-CoV-2

We are happy to announce that due to improved software for the Vivalytic analysis device, the CE marked Vivalytic SARS-CoV-2 rapid coronavirus test, which uses polymerase chain reactions (PCR), now delivers its results even faster. By applying optimized evaluation strategies, the Vivalytic analysis device can detect a positive SARS-CoV-2 sample through its high viral load in less than 30 minutes, right where the sample is collected.

This modified product is part of a research and development project relating specifically to COVID-19, funded by the German Federal Ministry of Education and Research (BMBF) to the tune of 4.97 million euros. The project’s aim is to expand the options for detecting acute infections of the coronavirus, looking particularly at on-the-spot testing in which the sample is analyzed in a fully automatic PCR process, as this offers rapid yet reliable results.

  • Improved software for Vivalytic: turnaround time for positive SARS-CoV-2 samples reduced to under 30 minutes.
  • Update from the cloud: Vivalytic analysis devices are updated over the internet.

Dr. Volkmar Denner, chairman of the board of management of Robert Bosch GmbH said;

“In the fight to contain the coronavirus pandemic, speed is of the essence. With Vivalytic, we are delivering cutting-edge medical technology. Our IT and software expertise have helped to make the Bosch Corona test for positive samples even faster – all within a short period of time.”

The new update is available for the SARS-CoV-2 singleplex test and the SARS-CoV-2 pooled test. Updating the Vivalytic testing devices is simple and straightforward – all that is required is an internet connection to access the Bosch cloud platform Vivasuite. Developed in-house at Bosch, the Vivasuite cloud platform allows users to digitally manage and update all their Bosch Healthcare Solutions devices. This is also an advantage when Vivalytic devices are in use in the field. The platform meets the strictest security standards and data privacy is guaranteed at all times: for example, there is no remote access to Vivalytic devices, and no possibility of accessing patient data.

The turnaround time for samples negative for SARS-CoV-2 is still 39 minutes. PCR tests are considered the gold standard, and Bosch’s rapid coronavirus tests have a sensitivity of 98 percent and a specificity of 100 percent.

Contact marketing@randox.com for further information on the latest vivalytic software update for SARS-CoV-2 testing. 

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Response to Channel 4 Dispatches Monday 16th November

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The claims made about Randox in the Channel 4/Dispatches documentary ‘Lockdown Chaos: How the Government lost Control’ are underhand, deceptive, dishonest and defamatory and the producers have been notified of the true position.

 

Underhand, deceptive and dishonest behaviour hampers the fight against the pandemic

“This Channel 4 Dispatches “investigation” and use of an undercover reporter grossly misrepresents the facts on the ground and – more importantly – the hard work of all the staff at Randox to expand operations quickly so we can play an important supportive role in the national effort to defeat the pandemic. The journalist was employed for just 10 days in manufacturing and only spent a very limited time in accessioning.  He was not qualified to carry out an “investigation” on quality control measures used in the diagnostics sector. Furthermore, the consultant microbiologist who reviewed the findings of the journalist is a historic opponent of the Pillar 2 testing programme and as such clearly could not provide unbiassed expertise in his review.

“If Dispatches had approached us in an upfront and honest manner with legitimate questions, then we would have worked with them to deliver an accurate and factual programme. This is hatchet job journalism of the worst kind.”

 

Randox wish to state the following:

Randox strongly refute those allegations made regarding Randox’s laboratory operations within the Channel 4 documentary, ‘Lockdown Chaos: How the Government lost Control’, transmitted on 16th November.  Responses to the key allegations are below these more general comments.

Randox wish to state that it is particularly disappointing that Channel 4 and Dispatches appear focussed in portraying a national story of chaos and negativity – without reflecting what has been achieved during the Covid-19 pandemic.

From a standing start, Randox used its extensive experience to develop an innovative assay for Covid-19, built and equipped over 45,000 square feet of specialist molecular laboratories, developed and equipped  a further 50,000 square feet of logistic and technical support space, and mobilised its global supply chains to source equipment and consumables.  Extensive R&D capabilities were also refocussed to support innovation within Covid-19 operations.

Over 750 new staff have been employed.  Randox have invested over £68m of private money in building and resourcing new facilities and have taken testing capacity from 150 molecular assays per day at the end of March 2020 to 80,000 assays per day by early November.  In just over 7 months Randox have reported over 5 million molecular test results to the UK’s Covid-19 National Testing Programme.

There have been significant challenges to face and Randox have committed to the provision of safe, accurate, reliable and timely results at scale, within a culture of continuous process improvement.  As a result Randox often operates efficiently above its committed capacity to the National Testing Programme and meets, or improves upon, the required turnaround times for test results.

Randox, and our staff, do find the use of a covert reporter within our workforce to be disingenuous.  By default that reporter had very limited access, very limited understanding and, it appears, a particularly negative mindset.  Channel 4 could easily have asked for more open access and ensured much more balanced and reputable journalism.

Randox staff are exceptionally dedicated, working to both support and assist those in need of testing, and to optimise processes.  Randox would like to reinforce their thanks and appreciation to all staff who have achieved so much throughout this pandemic.

 

Key Rebuttals:

Allegation: Boxes of samples are unpacked at speed and he (the reporter) was warned there is a recurrent problem of swab samples mistakenly being thrown into the waste with cardboard packaging.

Response: This is a complete misrepresentation; all samples are unpacked for processing and safety checks are carried out on bulk boxes after they have been unpacked.  On the very rare occasion a sample gets accidently caught in the cardboard packaging (estimated 1 in 100,000) it is found and returned to accessioning. There are no recorded cases of samples going to waste.   It is also physically impossible, should there ever be missed samples, for any staff member to ‘get samples all over them’ due to the stringent safety measures of the compactor/baler.  Supervisors do continually stress and can occasionally embellish the importance of due diligence in accessioning, as was evidenced.

Allegation:  Randox accessioning processes run a risk of cross-contamination.

ResponseValid samples are separated from leaked samples, whilst still in leakproof packaging, at the point of accessioning.   Valid samples are wiped down with disinfectant once unpacked; disinfectant is clearly visible on the cloth being used to wipe the tubes, illustrating that tubes are disinfected.  Tubes are then racked in an upright position.  There is no possibility of cross contamination.

 

‘The Expert’

Randox also wish to record their disappointment in the approach undertaken by the ‘expert’ Dr Tom Lewis,  and note the previous stance he has taken on non-NHS laboratories.  Dr Lewis has never operated at the scale or efficiency Randox have achieved, reporting up to 80,000 Covid-19 samples in a single day.  He did not peer review his comments or, noting the inexperience of the undercover reporter (who spent only 4.5 hours in the accessioning area), seek any clarification on processes or procedures from Randox before making his comments.

 

Press enquiries should be emailed to randox@newcenturymedia.co.uk 

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