Dr Peter FitzGerald: “Nothing will ever be the same again.”

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Dr Peter FitzGerald: “Nothing will ever be the same again.”

Dr Peter FitzGerald: Nothing will ever be the same again.

An Interview with Ulster Business Editor John Mulgrew in The Belfast Telegraph, in which Dr FitzGerald speaks to John about developing and helping roll out millions of tests for Covid-19, a forever changed society, the high likelihood of a similar pandemic returning and when a vaccine for the virus could be found.

Dr Peter FitzGerald’s expertise and opinion has probably never been taken as seriously as it has in the last few months.

“Nothing will be the same again,” he tells Ulster Business. And, of course, he’s right.

His firm Randox – based in Antrim – has been on the front line of testing for Covid-19 right across the UK and beyond. And as a result, he’s hired hundreds of new staff and built a £30m testing lab to deal with additional deluge of work resulting from a global pandemic unlike anyone here has ever seen.

“I think there is a reasonable chance there will be more pandemics, with globalisation and increased population,” he told Ulster Business. “I have no idea how much it will come back again in second wave.

“We know we have the capacity as a company to respond, and respond well. I suspect the country is going to be better prepared… it’s hard to predict.”

The medical testing giant’s first involvement with the current coronavirus strain began back in January, before it became an increasingly concerning dinner conversation in homes across Northern Ireland.

“In late January, research called and were looking at doing a test,” Peter said. “We downloaded the genetic sequence of the virus and spent the next two weeks developing a test. We can do it very quickly, as we already had coronaviruses on chip.

“It was sent to Public Health England, which took a while to prove it. We then got a contract to test for the NHS… we were doing what we thought was for the national good.”

The initial deal didn’t include all of the UK, but Randox is now also testing Northern Ireland.

“We do the testing and we have different analysers that do the testing as well, which we sell to labs across the world.”

The virus has led to a new complete lab being built (in which Peter is pictured in) to deal with the additional testing. “We decided to accelerate the manufacturing in our Randox Science Park in Antrim,” he says.

As a result, it has hired around 200 staff in the space of six to eight weeks to deal with the surge.

“Because we had closely related strains of the virus, it was wasn’t so difficult to modify our tests to allow for slightly different variations… once we got the contract we soon realised that we didn’t have enough lab space to deal with the ramp up.

“We then decided to be 33,000 sq ft of new lab space, and it was needed in three weeks. We got that done – work was 24 hours a day, and seven days a week. It’s now operating well. That has been very important in the process.”

Randox had a workforce of around 1,450 worldwide before the coronavirus crisis began, but has since taken on around 280 additional staff for a range of roles, partly in ramping up demand for the additional testing.

“A lot were being taken on a temporary basis but many will be permanent. We are not sure of the final numbers, but well over 100.” Those roles include scientists, manufacturers, and engineers.

“Nothing will be the same again,” Peter says. “What it has done is heightened the importance of testing. People sometimes don’t know what we do here at Randox… but people now realise.

“In the end, it’s a good thing. We are advocates of testing. It identities disease before symptoms occur and can save lives in many occasions. It saves lives and saves costs. It fits in with what we have been trying to do for years… as far as we are concerned, it’s the silver lining.

“We have customers worldwide and other products kept going. We moved around 100 scientists into Covid-related things and then they have gone back to normal jobs as we bring in new people.

“Some of our R&D projects have changed, new systems and new analysers allow for efficient and accurate testing.”

Peter says that just a small element of the business has seen a decrease amid the crisis, while other areas around Covid-19 have grown. “Only a small element of core business decreased. But our Covid and other genetic products have increased… overall sales will be up and by end of year normal business up as well.”

As a result of the latest expansion and growth across the business, generally speaking, Peter says the workforce looks set to climb to 1,650, with around 500-600 based at its main headquarters, just outside Antrim.

Peter’s also keen to reiterate the importance of Northern Ireland and its people to Randox. “This is our home base. It’s where we do our primary R&D and manufacturing. We also have a facility in Donegal.”

And, could all of this happen again soon, with a further outbreak or a similarly devastating strain or pandemic?

“(We are) more prepared and our technology is getting more accepted through bio chips. Early detection is a very important next stage. You don’t want people who have a cough or fever to think they have Covid all the time. That is where testing comes in and that differentiates.”

Peter says the next stop forward in a bid to address similar future incidents it also understanding how our immune systems work – better.
“The other major step forward in many ways is understanding the immune system better. How to better respond to infection. This will be very important.

“Some people are susceptible, and this could be genetic. (It’s about) working on certain genes in those who may have a bad attack. It will prepare humans better, the body’s defence, dealing with it as well.

“I have a deficiency in a particular gene which means I’m more susceptible to respiratory (conditions) but the spin-off of the gene means I’m less susceptible to certain cancers. This is the issue – it is so complex. One could be a strength and one moment, a weakness.”

And as for the formulation of a proven vaccine, Peter says: “I would say it would be well into next year.”

    For further information please email randoxpr@randox.com

    Photo Credit Elaine Hill

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    Westgard’s Great Global QC Survey 2017

    In a QC survey conducted this year, Sten Westgard reached out to more than 45,000 laboratory professionals to gain a comprehensive view of the world’s Quality Control practices. It was one of the largest surveys that have been conducted and shared publicly.

    Read on as we take a summarised look at our favourite bits.

    Setting control Limits

    Most labs are using their actual performance to set their mean and SD, however, a large percentage of labs still use manufacturer’s ranges, peer group ranges, and other non-individual sources for SD. These ranges can typically be set wider than they would if the ranges were based on their actual mean and SD. This can result in labs releasing incorrect patient results.

    Laboratories were asked if they used 2 SD control limits on all tests and it was found that a majority use 2 SD. The strict use of 2 SD can generate a high level of false rejections (9% for two controls and higher for three). This causes a high level of out-of-control events; the use of QC multi-rules is recommended.

    Respondent Map - Westgard QC Survey

    The types of Controls used by labs

    More than 60% of labs were found to be using manufacturer controls, the drawbacks of which are well known. The latest ISO standards strongly encourage the use of independent / third-party controls. Westgard speculates that this will become a mandatory requirement in the next version of ISO 15189.

    Frequency of QC

    The first question about frequency asked how often labs ran QC during a run. Respondents reported how often they schedule QC in their labs. Around half only run QC at the beginning of a run with labs running it throughout the day coming in close second. A small proportion of labs reported running QC at both the beginning and the end of a run.

    The final, least popular option involves spacing out QC based on test volume, the most scientific method determining how many patient samples can be run between controls without raising the risk of unacceptable results.

    The next question asked about the overall frequency of QC. Most labs are meeting the once-a-day minimum standard for CLIA regulations.

    “QC frequency remains primarily based on the rotational speed of the earth, not driven by needs of the clinician and patient.” – Sten Westgard

    QC Frequency Influences

    Regulator and accreditation requirements lead the way in influencing the frequency of QC with manufacturer recommendations, and professional judgement following close behind. Only a quarter of labs use the volume of testing to guide their QC frequency and one in six look to EP23 or IQCP for guidance.

    Managing QC

    Most labs are using on-board instrument informatics to support their QC charting, followed by LIS charting programs, and peer group software.

    Of significance is the number of labs using Excel spreadsheets as their primary QC tool as well as standalone QC programs or even manual graph paper. This could be due to varying technological capabilities where some locations may not have access to, or the funds to afford, informatics.

    A combined third of labs are out-of-control every day. In some labs this could be the result of running such a high volume of controls that false rejections are inevitable. However, rationalising in this way can lead to ‘alert fatigue’, where users begin to ignore alert flags and stop troubleshooting.

    More than a quarter of labs have an out-of-control flag every few days while another roughly one in six have just one per week. A small number of labs report having few QC flags.

    Managing QC Costs

    Finally, laboratories were asked about the steps they take to manage QC costs. 60% claimed that they take no steps to manage costs. One in six reduced QC frequency, one in eight switched to cheaper controls, while, worryingly, almost one in ten changed their QC rules or widened limits.

    Conclusion

    Westgard’s Global QC Survey suggests there exists many inefficient implementations of Quality Control, with plenty of room for improvement. The current state of QC is, like many aspects of healthcare, unsustainable. Labs must adopt better approaches or risk their continuing feasibility, or worse, their patient’s results.

    How Randox Can Help

    Westgard highlights particular issues with labs mismanaging costs, still using manufacturer controls, and setting control limits this is where Randox comes in.

    Acusera Third Party Controls offer the highest quality solution for any lab – regardless of size or budget. Designed to provide an unbiased, independent assessment of performance, our internal quality controls have not been manufactured in line with, or optimised for use with any particular reagent, method or instrument helping you to easily meet ISO 15189 recommendations. Unrivaled consolidation allows for significant cost savings.

    Acusera 24•7 Live Online allows you to automatically apply multi-rules and generate charts to help with setting accurate control limits, helping you get your quality control under control.

    Reference: Westgard, S (2017), The 2017 Great Global QC Survey Results

    To learn more about how Randox Quality Control can help you improve your QC visit the pages below or fill out the contact form and someone will be in touch.


    Randox Evidence Investigator used in major HIV/AIDS study

    The Department of Clinical Biochemistry in the Royal Free Hospital in London has recently completed a major HIV/AIDS study into the cause of lipodystrophy, with the help of the Randox Evidence Investigator.

    Lipodystrophy is a disorder in which the body’s distribution of fat undergoes serious changes.  People with lipodystrophy can suffer from the build-up, the loss, or the redistribution of body fat and HIV/AIDS patients often suffer from the disorder.

    The exact reason for its cause and progression is not completely understood, but it is thought that it can sometimes be triggered by an infection within the body.

    The Department of Clinical Biochemistry in the Royal Free Hospital, alongside the Department of Pharmacology, The Institute of Biomedical Statistics and Infectious and Tropical Diseases, all at the University of Belgrade in Serbia, therefore launched a study to determine the relationship between levels of interleukins in HIV/AIDS patients and the presence or lack of lipodystrophy.  Interleukins are produced by white blood cells to stimulate the immune response.

    The Randox Evidence Investigator, a semi-automated benchtop analyser, which is capable of processing up to 2376 tests per hour, was used to measure interleukins IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, and IL-10, in 66 HIV/AIDS patients.  The results demonstrated that lower levels of IL-4 and IL-10 influenced lipodystrophy in those people.

    Significantly lower levels of IL-4 and IL-10 were observed in patients suffering from lipodystrophy compared to those who did not suffer from lipodystrophy.  The interleukin levels were measured using the Cytokine Array I that utilises Randox’s Biochip Array Technology and enabled all of the tests to be performed simultaneously on the patient sample.

    These results show for the first time a significant correlation between IL-4 levels and lipodystrophy in HIV/AIDS patients, making the study a significant breakthrough in understanding the development of the condition and potential therapy.

    You can find more information about the study on PubMed: https://www.ncbi.nlm.nih.gov/pubmed/28189545

    For more information on our Evidence Series range of Biochip immunoanalysers please visit www.randox.com/multiplex-testing or email EvidenceSeries@randox.com


    IL-6 and IL-18 Important in Rapid Cycling Bipolar Disorder

    Rapid cycling bipolar disorder is identified as when a person experiences four or more distinct episodes of either mania or depression within a one year time period. Although not hugely common, it is estimated that 1 in every 100 people suffers with the disorder.

    Previous studies have identified a link between immune dysregulation and cytokine levels within the condition; however these were based upon case control studies which were limited by methodological difficulties. New research published in October’s edition of ‘Brain, Behavior and Immunity’ (1) sought to identify varying cytokine levels when a person is in a state of rapid cycling bipolar disorder when compared to healthy control subjects.

    Plasma samples were taken from 37 patients with rapid cycling bipolar disorder and measured for IL 6, IL 10, IL 18, IL 1b and TNFa and compared to 40 healthy aged and gender matched control patients in a 6-12 month longitudinally designed study. Adjustments were made for demographic, clinical and lifestyle factors.

    When comparing manic and depressive states, investigators reported that levels of IL 6 (p<0.05) and IL 18 (p<0.05) were significantly elevated when the patient was experiencing a manic or hypomanic state. It was also found that when compared to healthy subjects, unadjusted levels of IL 6 (p<0.05) and IL 18(p<0.05) were elevated in manic/hypomanic bipolar disorder patients.

    Researchers disclosed that levels of IL 10 and IL 1b were undetectable in the majority of samples, as well as finding high TNFa assay variability.

    These results show clinical significance as they support the role of the immune response in rapid cycling bipolar and suggest that IL 6 and IL 18 could be markers of manic episodes meaning that a person with suspected bipolar can be more quickly diagnosed.

    References:

    1. Brain, Behavior and Immunity http://www.sciencedirect.com/science/article/pii/S0889159114004772

    If you are interested in researching the effects that various cytokines have on the body, Randox Research offers numerous high quality multiplex cytokines arrays; allowing for a comprehensive panel of 35 cytokines, chemokines, cytokine receptors and growth factors, over five multi-analyte arrays to be simultaneously measured. Alternatively custom arrays can be created, allowing researchers to custom choose from over 180 immunology focused biomarkers. For more information, download our Immunology Research brochure or email: research@randox.com.


    BRAF melanoma cells secrete factors that activate stromal fibroblasts

    BRAF mutations are thought to be a leading contributor to skin cancer which has been increasing year on year in the UK and the condition is now the most common form of cancer within the British population. In 2011, 13,348 people in the UK were diagnosed with malignant melanoma skin cancer (the most deadly form of the disease which is solely responsible for 80% of all skin cancer deaths).

    Malignant melanoma is highly metastatic, reaching other organs by spreading through the lymph nodes. Previous studies have identified that the BRAF V600E gene is found to be mutated and results in constitutive activation of the mitogen-activated protein kinase pathway.

    In new research published in 2014’s edition of the British Journal of Cancer(2), genetically engineered melanoma cell lines and xenograft mouse models were used to investigate how BRAF V600E affected cytokine (IL-1β, IL-6, and IL-8) and matrix metalloproteinase-1 (MMP-1) expression in tumour cells and in human dermal fibroblasts.

    Results suggested that BRAF V600E melanoma cells secreted higher levels of the cytokines and MMP-1 than their wild-type counterparts. It was also found that the conditioned medium from the BRAF V600E melanoma cells activated the stromal fibroblasts, inducing expression of SDF-1 and its receptor CXCR4. This increase was mitigated when the conditioned medium was taken from melanoma cells treated with the BRAF V600E specific inhibitor, vemurafenib.

    These results show that BRAF V600E plays a key role in activating the stroma and supports the theory that there is a mechanistic link between BRAF V600E and MMP-1 in mediating melanoma progression and in activating adjacent fibroblasts in the tumour microenvironment.

    References:
    1. Cancer Research
    2. British Journal of Cancer

    If your research is focused on oncology, you may benefit from Randox’s Evidence Investigator and the KRAS, BRAF and PIK3CA array. Find out more with our Oncology Research brochure or e-mail research@randox.com.


    Randox launches White Paper on Quality Control in POCT

    Randox has launched the first in a series of White Papers, focusing on the importance of quality control in point-of-care testing (POCT). The White Paper is free to download and will help laboratories define an appropriate QC procedure for all POCT devices.

    Patient testing at the point-of-care has increased dramatically in recent years, as technology makes it more convenient to test patient samples at the bedside producing rapid results and allowing immediate action. However, the benefits of this are only true if the results are both accurate and reliable, making quality control vitally important in the POC setting, just as it is in the laboratory.

    A recent survey* identified that POCT is the largest source of error when compared to other sources of laboratory testing errors. Furthermore, the most common phase for errors in POCT is in the analytical stage, whereas in laboratory-based testing this is the least common source for errors. This highlights how vital it is to have a robust QC procedure in place for POCT as the potential risk of harm to a patient appears to be far greater for POC tests compared to those performed in a laboratory.

    The White Paper from Randox covers the fundamentals of developing a POCT QC strategy in line with ISO15189 requirements, looking at who is responsible for QC, what QC is appropriate for different types of POC devices and tips for choosing IQC material and an EQA scheme.

    The Paper can be downloaded from the Randox website here.

    Randox second White Paper, which studies the importance of using 100% human serum controls to avoid lot-to-lot variations in immunoassay testing, will be available in December.


    Preventing Cancer- Various Effective Diets and Tests

    People get confused about whether certain vitamins and foods prevent cancer? Cancer is not a single disease and can have many different causes that make it impossible for anyone nutrient to protect against all types of cancer. There is no guarantee that you’ll remain cancer free for your life time. But proper nutrition and a healthy lifestyle like no smoking, not abusing alcohol, limited exposure to pollutants, eliminating food additives and exercise can lower your odds of developing cancer.

    What is an anti-cancer diet?

    Healthy food is like an anti-cancer agent, which helps people in reducing cancer growing properties. Some of the anti-cancer foods that people can add in their diet are:

    • A variety of fresh, natural and less processed foods that lowers the risk of cancer production in humans.
    • Fruits such as berries and kiwifruit are a good source of vitamins and nutrients.
    • Fish and chicken (organic) lays the foundation of lowering the risk of cancer development.
    • Fruits like nuts and whole grains are also a great source of anti-cancer diet.
    • Tomatoes are antioxidant that is rich in lycopene. These have the capability to reduce the possibilities of prostate, lung and stomach cancers.
    • Avoiding fast food, fried foods and packaged foods.
    • Spinach is full of iron and other antioxidants that protect cells from the type of damage that can create cancerous mutations.
    • You can also eat fish once or twice a week.

    These are some of the anti-cancer precautions that people can add in their diet plan so as to prevent cancer developing agents.

    Various tests for anti-cancer

    There are only two main popular and effective tests for anti-cancer are

    • In-virto
    • In-vivo efficacy.

    In-vitro anti-cancer efficacy testing

    In-vitro anti-cancer is a test research that provides patients with various options and its effective capabilities include:

    Medicines and drug radiation combination and scheduling studies

    • Cell cycle analysis
    • Apoptosis measurements
    • Custom assay
    • Angiogenesis assays
    • Caco-2 assays
    • Hollow fibre screening assay
    • Enzyme and receptor binding assays
    • Gene and protein expression
    • Imaging and cellular localization
    • Drug uptake/retention studies

    In-vivo testing efficacy

    This testing efficacy is the most clinically useful agents. Following are the In-vivo anti-cancer efficacy evaluations that are available to assist clients in advancing pharmaceutical products:

    • Anti-cancer efficacy models
    • Establishment of maximum tolerated dose
    • Determination of schedule dependency
    • Spectrum of activity analyses
    • Radiation treatments
    • Early vs. late-stage disease comparisons
    • Evaluation to maximize compound effectiveness
    • Cross-resistance profiles

    Some cancers are treated primarily by a wide range of anti-cancer drugs, whereas many cancers are treated by a combination of surgery and radiotherapy.
    Meggie is a niche writer who loves to write on hot and trending topics. She is currently writing for OnlineRxMEdicines.


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