Diagnosing UTI Complications in Mothers and Newborns
Diagnosing UTI Complications in Mothers and Newborns
Diagnosing UTI Complications in Mothers and Newborns
Urinary tract infections (UTIs) are one of the most common bacterial infections that occur in humans. Over 50% of women become infected with a UTI at least once in their lives, with up to 10% of women suffering from yearly infections5. Recurrence rates are high in UTIs, almost 50% of women who contract a UTI experience reinfection or relapse within one year of the initial infection5. Men are four times less likely to contract a UTI due to a longer urethra seen in men when compared with women.
Infections occur in the urinary organs and structures which can be categorized by the site of infection: cystitis (bladder), pyelonephritis (kidney) and bacteriuria (urine)5. So-called, uncomplicated UTIs are sited only in the bladder, however, UTIs are highly likely to cause secondary infections, commonly in the kidneys. Pyelonephritis has been shown to result in renal scarring and in some cases, subsequent renal failure2. There are various species of bacteria responsible for UTIs, which have different mechanisms of infection and virulence. However, most species have surface adhesins which function like hooks, attaching the bacteria to the urothelial mucosal surface, and colonizing the bladder. From here, the bacteria can ascend the ureters, reaching the kidney and causing secondary infections2.
Under normal conditions, the innate immune system actions an inflammatory response to the infection site. However, some species of bacteria that cause UTI can inhibit or delay the immune response resulting in secondary infections in the ureters and kidneys where the risk of severe renal defects is considerable, and the bacteria have direct access to the bloodstream2.
Common symptoms of UTI include:
- Frequent urination
- Painful urination
- Incomplete voiding of the bladder
- Pelvic, back, and/or abdominal pain
- Haematuria
- Lethargy
- Nausea and/or vomiting
- Fever
Antibiotic therapies are effective and aim to facilitate the immune response and inhibit the spread of the infection to the kidneys and upper urinary tract. Although these treatments are usually effective, antimicrobial resistance (AMR) has become a global crisis encompassing all medical disciplines3. This resistance to antibiotics can occur through several mechanisms such as dysregulation of protein expression, structural modifications, and mutations to name a few11.
Bacteria are capable of some level of intrinsic resistance, or insensitivity, to antibiotics through the production of various enzymes designed to degrade the drug or inhibit its mechanism11. Mutations found in the genome of bacterial species are often responsible for the resistance they display. These mutations commonly alter the bacterial binding sites used by antibiotics, therefore inhibiting their action. Some bacteria produce enzymes, which alter the chemical structure of the antibiotic, again, inhibiting them from binding to the antibiotic. Other examples include horizontal gene transfer and biofilm formation10.
One study reported in 2019, that AMR was the twelfth leading cause of death when compared with a susceptible infection counterfactual9. The same study went on to show that AMR had the highest mortality rate in low to middle-income countries providing evidence that AMR is an even bigger problem in the most impoverished parts of the world. New techniques such as CRISPR-Cas9 and antibiotic re-sensitization methods are at the forefront of the fight against AMR, however, the scale of the problem warrants taking all possible action to elevate the risk posed by AMR8.
UTI During Pregnancy
UTIs are a common occurrence in pregnancy with one hospital reporting over 15% of pregnant women being diagnosed with some form of UTI4. Diagnosis can usually be confirmed by a bacterial growth of over 105 counts/ml in urine4, 12, 13. Many hormonal and anatomical changes occur in a woman’s body during pregnancy that create favorable conditions for UTI. Firstly, the glomerular filtration rate is altered, causing an increase in glucose concentration and pH of the urine3. The urethral dilation, smooth muscle relaxation, enlarged mechanical compression of the uterus, and increased plasma volume result in lower urinary concentration and increased bladder size leading to urinary tract reflux and urine stagnation. These conditions are favorable for the proliferation of bacterial infections1.
Diagnosis of UTIs in pregnant women can be complicated. For example, the increased frequency of urination experienced could also be caused by additional pressure placed on the woman’s bladder by the baby, or the abdominal pain indicative of a UTI could be interpreted as Braxton Hicks contractions and vice versa3. There are several established risk factors associated with UTI in pregnancy including advanced maternal age, diabetes, sickle cell anemia, history of UTI, urinary tract abnormalities, and various immunodeficiencies3. Other reports claim that UTI in pregnancy is more common in women with hypothyroidism and women who are carrying their first child4.
Bacterial Species Responsible for UTI
There are a multitude of bacterial species responsible for UTIs, the most common is Escherichia coli (E. coli), followed by group B streptococcus (GBS), enterococcus, and Klebsiella pneumonia. Escherichia coli infections are categorized as either enteric or extraintestinal (ExPEC). Of the latter, there are two main culprits: neonatal meningitis E. coli (NMEC) and uropathogenic E. coli (UPEC)2. These infections can exist in the gut and spread, colonizing other parts of the host such as the blood or central nervous system, causing other potentially severe infections. Of these strains, UPEC is responsible for around 80% of both symptomatic and asymptomatic UTIs. UPEC strains have been associated with acute renal damage and are thought to encourage bacterial growth and persistence by inhibiting or delaying the innate immune response2.
Maternal and Perinatal UTI Complications
UTI complications in mothers and children have long been debated. However, there is sufficient evidence to support several prognostic claims. Preterm delivery is a major complication associated with UTI and has been well studied. Preterm neonates face a high risk of fatality with up to 1 million babies dying every year due to premature labor6. Those that survive are at risk of developing one or more of the following health defects1:
- Lung problems
- Diabetes
- Heart Disease
- Hearing loss
- Visual impairment
- Learning disabilities
- Behavioral problems
- Cerebral palsy
The risk of preterm birth in women who suffered from a single UTI was increased when compared to women who had no infection during their pregnancy but recurrent UTIs did not increase the risk3. Risk of low birth weight has been shown to increase by 50% in women who suffered symptomatic UTIs compared to those who remained uninfected throughout their pregnancy; this risk can be mitigated through antibiotic therapy. The same treatments did not show any significant ameliorative effects on preterm birth4. Women who contract a UTI during pregnancy are also at a higher risk of various conditions such as preeclampsia, postpartum endometritis, sepsis1, hypertensive disorders, anemia and amnionitis4.
Asymptomatic UTIs, also known as asymptomatic bacteriuria (ASB), are not known to cause as drastic primary effects on pregnancy as seen with symptomatic infections. Despite this, ASB can spread and colonize in the kidneys. At this point, pyelonephritis is likely to occur, increasing the risk of severe renal scarring4 and advanced risk of preterm birth3. In these cases, it is common to treat the patient with antibiotics to reduce the risk of a secondary, symptomatic infection. While these treatments are effective at limiting the progression of the infection, overuse of antibiotics is a primary factor contributing to antimicrobial resistance4.
Screening and Treating UTI Complications
Women who are not pregnant and show no risk factors can be tested for UTI through a simple urine dipstick. The presence of leukocyte and absence of nitrite can be considered a positive UTI diagnosis. However, where complications are likely, a urine culture is required. Cultures can be carried out on blood or MacConkey agar and require preservation of the sample in boric acid, or in a refrigerator, for 24 hours prior to testing. This culture can then be isolated and used to identify the strain of bacteria causing the infection7.
Species identification is imperative in maternal UTIs. Different species have different levels of sensitivity to the various antibiotics available. E. coli, for example, shows 93% sensitivity to Nitrofurantoin but is only 86% sensitive to Fosfomycin. Selection of the correct treatment can ameliorate symptoms rapidly and reduce the possible complications for both mother and baby4. Many species of bacteria known to be responsible for UTIs have displayed resistance to antibiotics. Group B streptococcus has been shown to be 42% resistant to clindamycin4. The selection of antibiotics available to clinicians treating maternal UTI are already limited as many antibiotics have been associated with increased risk of miscarriage and birth defects independent of UTI1.
With the patient in mind, Randox provides clinicians with both laboratory and near patient testing solutions. Bringing to the market, to help eliminate distress and improve testing turnaround times, the Randox Urinary Tract Infection Array. It has the ability to detect 30 bacterial, fungal, and associated antibiotic resistance markers from a single urine sample in under four hours. This multiplex diagnostic tool can help detect specific bacterial and fungal strains known to cause UTI allowing laboratories to confidently diagnose patients in a timely manner, aiding with targeted treatments and helping to reduce risk of complications.
The Ongoing UTI Battle
Maternal UTI is a very common problem resulting in many fatalities and morbidities worldwide. It is crucial to identify and characterize these infections to limit the negative effects seen to both mothers and their children. Quick and efficient screening is paramount in the battle against bacteria to allow the prescription of targeted treatment. While antibiotics are often an effective weapon against UTIs, care should be taken when prescribing these treatments to pregnant women due to the potential adverse effects that have been reported. Furthermore, unnecessary treatments using antibiotics should be avoided at all costs due to the increasingly serious issue of antimicrobial resistance.
References
1.Eslami V, Belin S, Sany T, Ghavami V, Peyman N. The relationship of health literacy with preventative behaviours of urinary tract infection in pregnant women. Journal of Health Literacy. 2022;6(4):22-31. doi:https://doi.org/10.22038/jhl.2021.59768.1183
2.Bien J, Sokolova O, Bozko P. Role of Uropathogenic Escherichia coli Virulence Factors in Development of Urinary Tract Infection and Kidney Damage. International Journal of Nephrology. Published online 2012:1-15. doi:https://doi.org/10.1155/2012/681473
3.Werter DE, Kazemier BM, van Leeuwen E, et al. Diagnostic work-up of urinary tract infections in pregnancy: study protocol of a prospective cohort study. BMJ Open. 2022;12(9):e063813. doi:https://doi.org/10.1136/bmjopen-2022-063813
4.Balachandran L, Jacob L, Al Awadhi R, et al. Urinary Tract Infection in Pregnancy and Its Effects on Maternal and Perinatal Outcome: A Retrospective Study. Cureus. 2022;14(1). doi:https://doi.org/10.7759/cureus.21500
5.Bono MJ, Reygaert WC. Urinary Tract Infection. Nih.gov. Published 2018. https://www.ncbi.nlm.nih.gov/books/NBK470195/
6.World Health Organization. Preterm birth. Who.int. Published February 19, 2018. Accessed February 8, 2023. https://www.who.int/news-room/fact-sheets/detail/preterm-birth
7.Sinawe H, Casadesus D. Urine Culture. PubMed. Published 2021. https://www.ncbi.nlm.nih.gov/books/NBK557569/
8.Schrader SM, Botella H, Vaubourgeix J. Reframing antimicrobial resistance as a continuous spectrum of manifestations. Current Opinion in Microbiology. 2023;72:102259. doi:https://doi.org/10.1016/j.mib.2022.102259
9.Murray CJ, Ikuta KS, Sharara F, et al. Global Burden of Bacterial Antimicrobial Resistance in 2019: A Systematic Analysis. The Lancet. 2022;399(10325):629-655. doi:https://doi.org/10.1016/S0140-6736(21)02724-0
10.Ali J, Rafiq QA, Ratcliffe E. Antimicrobial resistance mechanisms and potential synthetic treatments. Future Science OA. 2018;4(4):FSO290. doi:https://doi.org/10.4155/fsoa-2017-0109
11.Nelson DW, Moore JE, Rao JR. Antimicrobial resistance (AMR): significance to food quality and safety. Food Quality and Safety. 2019;3(1):15-22. doi:https://doi.org/10.1093/fqsafe/fyz003
12.Myers AL. Curbside Consultation in Pediatric Infectious Disease : 49 Clinical Questions. Slack; 2012:4.
13.Oie S, Kamiya A, Hironaga K, Koshiro A. Microbial contamination of enteral feeding solution and its prevention. American Journal of Infection Control. 1993;21(1):34-38. doi:https://doi.org/10.1016/0196-6553(93)90205-i
7. Sinawe H, Casadesus D. Urine Culture. PubMed. Published 2021. https://www.ncbi.nlm.nih.gov/books/NBK557569/
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Randox collaborate with Verv Technologies to Improve Health for All
Randox Laboratories, the largest diagnostics company from the UK, are proud to announce a $3.8m CAD seed round with Verv Technologies.
Randox Laboratories are the lead investor for Verv Technologies, who are focused on creating the first of its kind consumer-oriented, affordable, high-quality blood chemistry analyser with disposable tests for home use, that will help individuals measure a wide range of analytes (i.e., cholesterol, vitamin levels, hormones). With over 40 years of diagnostic experience, Randox Laboratories are focused on investment into technologies to improve health for all.
Dr. Peter Fitzgerald, Managing Director of Randox Laboratories shared, “Randox has a global lens on the development of new technologies. We have a shared vision and belief in Verv’s unique, highly differentiated microfluidics approach to creating scalable, high-quality, low-cost blood testing technology for healthcare consumers. We anticipate a great journey ahead, in partnership with Verv.
Jeff Sutton, Founder and President of Verv Technologies describes, “We are thrilled to have Randox as a major investor in Verv to help propel us to commercial readiness and the opportunity to work with the original Founder and Managing Director of Randox, Dr. Peter Fitzgerald, who will join Verv’s Board of Directors. We aim to create great value for health-conscious consumers.”
Randox and Verve share a commitment to transform testing on a global scale for the benefit of healthcare consumers.
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New test for accurate differentiation of stroke types launched at Goodwood FOS Future Lab
A ground-breaking new test which improves the accuracy of stroke diagnosis has been developed by Randox scientists.
The rapid and highly sensitive blood test, which is due to be unveiled at this year’s Goodwood Festival of Speed, can uniquely differentiate between ischaemic strokes (a blood clot) and haemorrhagic strokes (a bleed) and subsequently enable clinicians to rapidly administer the most effective treatment, which is a vital factor in limiting permanent damage.
What’s even more remarkable is that the pioneering diagnostic, appearing as part of the festival’s Future Lab exhibition, takes less than 30 minutes to complete – making sure patients get the right diagnosis as fast as possible.
Dr Peter FitzGerald, Managing Director of Randox Laboratories, whose team developed the test, commented;
“There is great tragedy in the fact that the majority of stroke damage can be minimised if intervention is delivered on time, yet too often the window closes before a diagnosis is made. For doctors, nothing is more frustrating.
“Excellent work has been undertaken to assist the public in recognising the signs of a stroke so people can get to hospital as quickly as possible. Our stroke test is the vital next step – assisting clinicians in making a rapid diagnosis and differentiation between haemorrhagic and ischaemic stroke, so their patients get the right treatment at the right time.”
Traditionally the first step in a stroke diagnosis is a CT scan, which, despite its ability to successfully diagnose haemorrhagic stroke, is significantly less capable of identifying ischaemic stroke.
Yet ischaemic stroke is the most common type of stroke and affects almost nine in ten patients. Its diagnosis and differentiation from haemorrhagic stroke is vital in enabling thrombolytic treatment to break down blood clots, which, given its nature, could be fatal if administered to a patient suffering from a haemorrhagic stroke. Worryingly though, in some areas of the UK, as little as 15% of eligible stroke patients receive this therapy in time.1
This is caused by a number of factors, including difficulty in determining stroke onset time, exceeding the appropriate time window for thrombolysis administration (4.5 hours from stroke onset), and importantly, not being able to differentiate ischaemic stroke from a number of other ‘stroke mimics’ including severe migraine, brain tumours, drug overdose and seizures.
The Randox Stroke Biochip successfully identifies ischaemic stroke in a rapid test which measures eight markers from a single blood sample simultaneously, in just 30 minutes.
John Lamont, R&D Director for Randox Laboratories, explained;
“While patients undergo a CT scan to confirm either the presence or lack of a haemorrhagic stroke, a blood test on the Randox Biochip can be run on our innovative point-of-care analyser, the MultiSTAT, to identify the same for an ischaemic stroke.
“For the almost 90% of stroke patients who are ruled out for haemorrhagic stroke2, the Randox Biochip will then accelerate decision making for clinicians with regards to thrombolytic therapy.
“Any treatment is most effective if started as soon as possible after the stroke occurs, and so every minute that passes without a diagnosis is likely to leave a permanent mark on a stroke patient’s future health and lifestyle. The vitally important diagnostic information from the Randox Stroke Biochip facilitates accurate stroke classification, directs the appropriate patient care pathway, and enables rapid thrombolytic therapy, ensuring a better patient outcome for ischaemic stroke sufferers, for whom time is of the essence.”
Whilst the Randox Stroke Biochip is currently being used as complementary testing in parallel with CT scanning, Mr Lamont is confident of a more prominent role for the test in the future patient pathway;
He commented;
“The Biochip has the potential to really revolutionise the stroke diagnosis pathway as we currently know it. The accessibility of this type of blood testing could potentially extend its use beyond the A&E department, to ambulances and even the home, in the form of a hand-held testing device.”
For further information about our pioneering new stroke test, or about the Goodwood Festival of Speed Future Lab, please contact Amy McIlwaine in the Randox PR team by emailing amy.mcilwaine@randox.com
References
1 Royal College of Physicians Sentinel Stroke National Audit Programme (SSNAP). Clinical audit Jan – Mar 2016 report prepared by Royal College of Physicians, Clinical Effectiveness and Evaluation Unit on behalf of the Intercollegiate Stroke Working Party.
2 Intercollegiate Stroke Working Party. National clinical guideline for stroke, 5th edition. London: Royal College of Physicians 2016.
£700,000 UK government investment in Randox R&D
A £700,000 UK Research and Innovation investment into manufacturing processes at Randox means patients could benefit from quicker, cheaper and more consistent diagnosis of diseases.
The announcement comes exactly one year after the government launched its modern Industrial Strategy – the long-term plan to boost productivity by backing businesses to create high-quality, well-paid jobs in every corner of the United Kingdom.
The Industrial Strategy Challenge Fund (ISCF) award, administered by UK Research and Innovation (UKRI), will allow Randox Laboratories to further develop its state-of-the-art ‘freeze-drying’ technology which enables the components of vital diagnostic kits to be manufactured, stored and transported more effectively, producing better and speedier diagnoses.
For the first time it also allows this complicated manufacturing process to be carried out in the UK rather than having to be outsourced to countries such as the United States, bringing more jobs and economic growth. These new genomic analysis tools also have the potential to make a major impact in the global fight against antimicrobial resistance by identifying and quickly sharing information about resistant microbial strains.
More in-depth analysis of biomarkers in blood and other bodily fluid levels will allow better, quicker diagnosis of cancers and a range of other diseases, ranging from respiratory infections to sepsis, such as blood poisoning.
The Secretary of State for Northern Ireland said:
“I am delighted to announce a £700,000k UK Government investment in Randox, a multinational life sciences company in County Antrim. This funding will bring significant benefits to Randox’s vital medical diagnostics and help create well-paid manufacturing jobs in Northern Ireland.
“A year-on from the launch of our Modern Industrial Strategy, this investment highlights the great progress we are making to boost productivity by backing leading businesses and creating high-quality jobs in every corner of the United Kingdom.”
John Penrose, Minister of State for Northern Ireland, who visited Randox today to mark the new investment, said:
“Everyone always says the UK needs more high-tec, high-value added manufacturing and the high-skilled, high-waged jobs it brings. But Randox are actually doing it right here in Northern Ireland. This is properly world leading, cutting-edge industry and I’m delighted that today’s money is helping bring the vision to life.”
Dr Peter FitzGerald, Managing Director of Randox Laboratories, commented:
“Innovative diagnostic technologies are not only capable of diagnosing disease and ill-health at the earliest possible stage, but they also have a real potential to advance personalised medicine. Our commitment to developing new and exciting breakthroughs in science, technology, engineering and manufacturing is therefore matched only, by our passion to transform the life of the patient. Randox is leading the way in moving from a one-size-fits-all approach towards decisions, practices, and products tailored to the needs of the individual and the Industrial Strategy Challenge Fund award brings us one step closer to realising that aim.”
Funded through UK Research and Innovation, the award forms part of the ISCF Early Diagnosis and Precision Medicine programme, focusing on the use of diagnostic information and genetic analysis to drive more personalised healthcare. Innovate UK, now part of UK Research and Innovation, has supported Randox extensively since 2010, helping grow and scale an innovative diagnostics company who are now distributing their products all over the world.
The announcement comes after the government’s announcement of the Life Sciences Sector Deal that will support healthcare innovation and back businesses to create high-paid, high-quality jobs as part of the government’s modern Industrial Strategy. The deal signals a vote in confidence in UK industry, with global biopharmaceutical company UCB investing around £1 billion in research and development.
For further information please contact Randox PR by emailing randoxpr@randox.com
£50m Randox Centres of Excellence launched in Northern Ireland
A record £50 million investment which will deliver cutting-edge technologies to diagnose conditions like cancer, heart conditions and infectious diseases has been announced by Northern Ireland diagnostics company Randox Laboratories and Invest Northern Ireland.
This major project involves the establishment of three Centres of Excellence, enabling Randox R&D scientists to work collaboratively with colleagues from Queen’s University Belfast and Ulster University. The centres are being officially launched today at the Randox Science Park. The ceremony will include a keynote address from Sir John Bell, who chaired the UK Government’s Life Sciences Industrial Strategy Board.
Advanced diagnostics have been identified as key to delivering sustainable improvement to healthcare systems struggling to cope with increasing levels of chronic and preventable conditions. Having been focused in this field for over 36 years, Randox has a successful track record of developing new and innovative tests – examples include assessing those at risk of Alzheimer’s disease and genetic cardiac conditions, to promote and enable preventive treatment, and a new clinically-approved test to diagnose prediabetes.
Managing Director of Randox Laboratories, Dr Peter FitzGerald, who today launched the three Centres of Excellence, said;
“When almost a quarter of the deaths of people under 75 in the UK are considered preventable, we need to ask ourselves what can be done to improve healthcare outcomes. There is an undeniable case for radical change in the way healthcare is delivered, and sophisticated diagnostics will be at the fore of this revolution.
“Enabling earlier and more accurate diagnosis, to identify those at the earliest stages of illness, ideally before the onset of any symptoms, is a game-changer. Through early intervention we can restrict the development of chronic conditions and improve people’s lives. Our view of the future is one where people are empowered through earlier diagnosis to stay healthier for longer, and where healthcare systems are freed to deliver quality services to patients. Our announcement today demonstrates our continuing commitment in this field.
“We are grateful for the support offered by Invest NI and look forward to addressing these pressing healthcare needs.”
The Centres of Excellence will focus respectively on clinical diagnostics, engineering for biosciences and quality control. The project, which will strengthen collaborative partnerships between Randox, Queen’s University Belfast and Ulster University, will accelerate the development of new technologies and drive healthcare improvements regionally, nationally and across the globe.
Of the £23m of support offered by Invest NI, £5m will go toward research projects at Ulster University and Queen’s University Belfast.
Welcoming the investment, Alastair Hamilton, Chief Executive of Invest NI said;
“Randox has a long history of investing heavily in innovation and R&D which has enabled it to create a globally competitive export driven business, capable of developing world leading research. This major investment will enable Randox to perform cutting-edge R&D which has the potential to revolutionise the global healthcare industry. This is excellent news for Northern Ireland’s life and health sciences sector. Northern Ireland is enjoying a growing international reputation as a region of expertise and knowledge in key areas such as Diagnostics, Precision Medicine and Advanced Manufacturing. The three new Centres of Excellence will help build on this and enhance Northern Ireland’s credibility, provide supply chain opportunities, and encourage knowledge transfer with our universities.”
Sir John Bell, commenting on the potential for the UK Life Sciences sector said;
“The life sciences industry represents one of the dominant economic sectors in the UK, and one with considerable potential for growth. However, whilst we have many natural strengths we cannot afford to be complacent. We must strive to optimise our science base, to encourage collaboration across academia, industry and the NHS, and grow our industrial capabilities. To do so we need to use our extensive data sets to best effect, and have in place a strong skills strategy. Success requires vision and drive. To that end I would like to congratulate Dr FitzGerald and Randox in the establishment of these three R&D collaborative Centres of Excellence – these are assets of national standing and will have a meaningful impact in enabling earlier and more accurate diagnosis, driving improvements in patient care, regionally, nationally and globally. They are leaders in this field, committed to innovation, and I wish them every success.”
Professor Jim McLaughlin, Director of Ulster University’s Nanotechnology and Integrated Bioengineering Centre, added;
“This very welcome investment enables pioneering Randox-inspired engineering capacity at Ulster University and reflects our research commitment to the life sciences industry. From nanotechnology to the development of systems that will enable large scale laboratory capability to be produced in the palm of your hand, the partnership brings shared industry and academic research excellence from the lab into the marketplace. Life sciences is a vital economic sector locally and this collaboration will advance diagnostics and ultimately enhance patient health outcomes.”
Dr David Jess, Senior Lecturer at Queen’s University Belfast School of Mathematics and Physics, added;
“The Randox Centres of Excellence will allow Queen’s University Belfast to continue to deliver cutting-edge and world leading research. We look forward to collaborating further with industry to develop pioneering research, focused on the needs of society.”
Invest NI’s R&D support is part funded by ERDF under the EU Investment for Growth and Jobs Programme 2014 – 2020.
For further information please contact the Randox PR Team: phone 028 9442 2413 or email randoxpr@randox.com
Heart attack test H-FABP 12 times faster than current methods
As the supplier of a pioneering diagnostic able to assist with differentiating between coronary pain and non-cardiac chest pain, Randox Laboratories has this week welcomed news about the importance of introducing new innovations which can significantly improve patient outcomes.
Prioritising people presenting with a heart attack over those with non-cardiac chest pain is one of the biggest challenges A&E doctors face – there are around 200,000 heart attacks each year in the UK, but around 1 million people come to A&E with chest pains. According to a team from King’s College London, as reported by the BBC, a faster, more accurate diagnosis of whether chest pain is caused by a heart attack would save the health service millions of pounds each year by sending well patients home and freeing up beds. Yet current testing methods do not efficiently differentiate between high-risk patients and the estimated 80% of patients who are not having a heart attack.
Randox’s revolutionary test for Heart-Type Fatty Acid-Binding Protein (H-FABP) however, when combined with current testing, is able to rule out a heart attack for patients who present at A&E with chest pain which is caused by other conditions such as respiratory issues, meaning they may not need emergency admission.
When measured at the time a patient presents to A&E with chest pain, H-FABP enables doctors to triage patients suffering with a heart attack more efficiently than before.
Dr. Gary Smyth, Medical Director at Randox Laboratories, hopes that more efficient testing will become widely available so that doctors can identify and prioritise patients at risk;
“Despite the best efforts of our NHS colleagues, EDs across the UK are under tremendous pressure. In many cases people are presenting with chest pain but aren’t suffering from a heart attack, and given that current cardiac tests are not as sensitive as clinicians would like, these patients are being admitted unnecessarily, taking up beds and valuable resources.
“It is imperative that newer, faster tests are adopted because fundamentally this means saving lives.”
H-FABP is released into the bloodstream within 30 minutes of a heart attack, whereas people who are currently admitted to hospital with chest pains may have to wait several hours for test results. Even the latest heart attack test to be adopted by the NHS, troponin, can take up to six hours to provide confirmation.
H-FABP, conversely, is released from the heart during the early stages of a heart attack and because it is so small, it can be detected when the heart cells are being damaged, rather than at the stage when troponin would usually be detected – when cell death has already occurred. The test can also be used to identify people who are at high risk of heart attack in the near future.
Dr. Peter FitzGerald, Founder and Managing Director of Randox Laboratories, commented;
“Research shows that patients who were troponin negative and therefore sent home from hospital, but who were positive for H-FABP, were at high risk of death – as high as a 20% chance of death that same year.
“If the H-FABP test was added to existing tests upon arrival at hospital, doctors could quickly and accurately rule out the 80% of chest pain patients who are not having a heart attack, allowing resources to be focused on those who are actually at high risk.”
For further information on H-FABP, please visit http://www.randox.com/h-fabp/, or contact the Randox PR team by phoning (0) 28 9442 2413 or emailing randoxpr@randox.com
Randox and partners announce opening of £7m Advanced Biomedical Devices laboratory
Randox Laboratories is pleased to announce the opening of a state-of-the-art Advanced Biomedical Engineering Laboratory today, the result of an innovative partnership with some of Northern Ireland’s leading business and education stakeholders.
The strategic collaboration with Invest Northern Ireland, Ulster University and Heartsine Technologies to develop the £7 million laboratory aims to transform the future of healthcare. The lab, which is based at Ulster University, will offer expertise and state of the art equipment to assist companies to develop prototypes for the biomedical, engineering, electronic device and aerospace sectors.
Welcoming the new lab, Dr Peter FitzGerald from Randox Laboratories said: “As one of the UK’s leading life sciences companies, we are delighted to be a partner in this innovative collaboration and to promote Northern Ireland as a global life sciences hub. We believe the greatest improvements to patients’ lives are possible through the continuous development of new technologies.
“This unique laboratory will facilitate that, as it will allow the rapid development of test prototype devices and also assist us to expand our unique range of high-calibre analyser systems.”
Tracey Meharg, Invest NI’s Executive Director of Business Solutions said: “The new Bio Devices Lab is a welcome and exciting development for Northern Ireland’s Health & Life Sciences sector. The facility will open up opportunities for stronger innovation by hosting a suite of equipment which will allow companies to quickly develop prototypes and medical devices for testing.
“It is a great example of how partnerships between government, industry and academia can enhance Northern Ireland as a knowledge economy and boost the credibility and visibility of Northern Ireland as a global leader in connected health.”
Prof Jim McLaughlin from Ulster University said: “Developing technology platforms to help translate our world class science and discovery to a device format as promptly as possible is essential for the very best design and performance.
“In healthcare technology, Ulster University leads the way in the development of new patient monitoring systems, stimulation devices, wearable solutions and diagnostic sensing.
“The lab will enable our researchers to develop the strong leadership and innovation skills so critical to future industry growth, working in collaboration with our industry partners.”
The total investment is £7.4m. Invest NI has offered assistance of £3.7m through a Grant for R&D, with Ulster University contributing £2.9m and £716,000 invested through industry collaborations with Randox Laboratories and Heartsine Technologies. Invest NI’s R&D support is part funded by ERDF under the EU Investment for Growth and Jobs Programme 2014-2020.
Celebrating the opening of the Advanced Biomedical Engineering Laboratory are (from left) Professor Brian Meenan, Ulster University; Tracy Meharg, Invest NI; Professor Jim McLaughlin, Ulster University; and Stuart McGregor, Randox Laboratories
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
Cutting-edge research and testing centre opens at Randox Science Park
Following the success of the first ever Randox Health Grand National, global health diagnostics company Randox has today announced the official opening of its new central laboratory, Randox Clinical Laboratory Services (RCLS), at the recently acquired Randox Science Park in Antrim, Northern Ireland.
Situated at this new state of the art biohub, the RCLS accredited lab now houses Randox’s latest blood screening equipment – the pioneering Evolution machine. This new technology enables the labs to conduct a full range of niche and standard research testing, as well as current health testing for the company’s Randox Health division, which offers the world’s most comprehensive full body health analysis.
Research areas at the newly accredited laboratory include but are not exclusive to cancer, fertility, heart, inflammation, stroke and kidney health, both in-house and collaboratively with external organisations. Current and past collaborations include an Acute Kidney Injury Study with the Royal Victoria Hospital, a Bladder Cancer Study in partnership with Queen’s University Belfast and The Belfast Trust, a Stroke and Brain Injury study with Cambridge University, and key partnerships with a number of major pharmaceutical companies.
A staggering 222 clinical diagnostic tests are currently run routinely with the lab, with more tests pending accreditation in the coming months.
Ann-Marie Jennings, Laboratory Manager for Randox Clinical Laboratory Services, explained that the new facilities will allow RCLS to increase their output and enter new markets;
“Randox Clinical Laboratory Services has been operational for a number of years in our headquarters in Crumlin, near the Belfast International Airport. Now that we have moved to our new, purpose-built labs in the Randox Science Park, we have the ability to increase the output of both our health testing and our research testing. This involves expanding our team of experienced scientists, working towards further accreditations and furthermore setting up independent labs in Dubai, LA, Holywood and Liverpool in addition to our current labs in Antrim and London.”
Thanks to the new Randox Science Park facilities, the company will now be able to provide an increasingly wide range of testing services to Biotechnology and In Vitro Diagnostic companies, and will deliver to pharmaceutical companies the testing services required to support their drug development projects, in addition to the testing provided to research organisations,
With the ability to conduct an unrivalled range of health testing – haematology, biochemistry and immunoassay – all under one roof, the laboratory offers unparalleled support services to the dynamic and growing healthcare industry. With a greater understanding of human complexity, pharmaceutical companies are now focusing on developing safer drugs tailored to specific patient groups or sub-groups and the expansion plans in motion at RCLS will help these organisations bring new drugs to market faster.
Ann-Marie continued;
“On our patented Randox Biochip Array Technology we can customize bespoke testing platforms based on the requirements of each drug development project, which can be a challenging process. From initial product development to clinical trial stages there can be a number of barriers and time constraints before drugs are successfully released to the public. We’re confident that our newly enhanced capabilities will benefit patients suffering from conditions in most need of research by offering pharmaceutical companies at the forefront of pioneering research, with the latest technological developments.”
For more information about RCLS please contact Randox PR on 028 9442 2413 or email RandoxPR@randox.com
Randox Biosciences and Dana-Farber Cancer Institute Celebrate Success of Transatlantic Partnership
Today, Randox Biosciences and Dana Farber Cancer Institute highlighted the milestones achieved during their joint partnership. The collaborative partnership was the focus of the Boston-Ireland Precision Medicine Seminar with partners the City of Boston and the Massachusetts Life Science Center (MLSC).
The City of Boston Office of Economic Development and the Massachusetts Life Science Center are collaborating with Randox Biosciences on an innovative event to discuss the Boston-Ireland linkage in the field of Precision Medicine. The event will build business and science relationships between leading life science organizations. The program will highlight Boston as a global life science hub and illustrate why global leaders like Randox are seeking to build business partnerships in the area.
“Dana-Farber is a world-renowned name in the field of oncology and it is great to be working on this exciting new technology which is being developed in the lab of Dr. Novina.” Marshall Dunlop of Randox Laboratories said.
In the last year, the clinical diagnostics and life sciences provider Randox Laboratories has established a collaborative agreement with Dr. Carl Novina at the Dana-Farber Cancer Institute and Harvard Medical School. The goal of this collaboration is to develop therapeutic antibodies that will be incorporated into a platform technology that can reprogram patients’ immune systems to attack cancers.
“I am excited to work with Randox and use these important antibody technologies to help develop a novel cancer therapy that could potentially make a real difference for cancer patients.” said Dr. Carl Novina, Dana Farber Cancer Institute.
The Randox BioSciences and Dana Farber relationship highlights the close ties between Boston, Massachusetts and Ireland and provides another example of the strengths of Boston and Ireland in the life sciences sector. The life sciences industry continues to thrive all across Boston, from Longwood Medical Area – a world-famous medical campus with over 43,000 scientists, researchers, and staff including over 19,000 students – to the South Boston Waterfront District, the city’s newest cluster of high tech research, development, and manufacturing firms.
The City of Boston Chief of Economic Development John Barros said, “Mayor Martin J. Walsh is proud of Boston’s historic links with Ireland and the diverse economic bridges these links have created today. Within the life sciences alone, our researchers and businesses work together in new ways every day to shape how we treat, cure, and innovate together. By partnering with Randox and other leaders in the field, we continue to tackle global challenges together. Here at the City of Boston, we are committed to maintaining open doors as a global and welcoming city. These international partnerships will continue to play an active role in fostering opportunities for collaboration and growth.”
“Collaboration is the key ingredient that makes Massachusetts the best place in the world to innovate,” said Travis McCready, President & CEO of the MLSC. “It is great to see Randox collaborating with the leading scientists at the Dana-Farber Cancer Institute, toward the development of improved, targeted treatments for cancer patients.”
For more information about the Precision Medicine Seminar in Boston please contact Randox PR on 028 9445 1016 or email RandoxPR@randox.com
