Randox Biochip Blood Test detects Alzheimer’s Disease risk in 3 hours

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Randox Biochip Blood Test detects Alzheimer’s Disease risk in 3 hours

Randox are delighted to announce that at this week’s American Association for Clinical Chemistry Annual Scientific Meeting and Clinical Lab Expo, in Philadelphia, we have been presented with a NACB / AACC Distinguished Abstract Award for a new Randox Biochip Blood Test to identify Alzheimer’s Disease risk.

Or more specifically, an award for our “Development of a New Biochip Array for ApoE4 Classification from Plasma Samples using Immunoassay Based Methods!”

Out of 1024 posters presented at the diagnostics conference, which is the largest of its kind globally, the poster for our new ApoE4 test, presented by our R&D Scientist Dr. Emma Harte, was one of only 29 to receive this prestigious award.

Emma is one of a team of Randox scientists at our Teoranta site in Dungloe, Co. Donegal, Ireland who carried out this pioneering Alzheimer’s research.

The ApoE4 poster demonstrated the work involved in the development of our ApoE4 blood test, performed on our patented Randox Biochip Array Technology.  This blood test is an affordable method of identifying patients at risk of developing Alzheimer’s Disease, and provides a faster alternative to standard testing which analyses a patient’s DNA.  Standard molecular testing can be both time-consuming and expensive.

The Randox ApoE4 Biochip Array can conduct multiple diagnostic tests on a single blood sample, which has both cost and time-saving benefits, in addition to a rapid diagnosis for the patient.

The Randox Biochip analyses the Apolipoprotein E (ApoE), a gene which is recognised as one of the most significant genetic risk factors for dementia and other neurodegenerative diseases.

There are three versions of the ApoE gene: E2, E3 and E4. The E4 version increases a person’s risk of developing late-onset Alzheimer’s disease, and it may also be associated with an earlier onset of memory loss.

Each parent passes on one ApoE gene to their child.  Around 25% of the population inherit one copy of the ApoE4 gene. Inheriting two copies of the E4 variant increases a person’s disease risk by 10 times or more.

Our research into the identification of this gene was conducted in conjunction with our colleagues at the Medical University of Vienna, and verified the accuracy of the Randox Biochip Blood Test by analysing 384 samples and comparing the results to that of a standard molecular diagnostic test.  Both tests provided the same accurate results, however the Biochip test results were available in a significantly faster 3 hours.

In combination with information on medical and family history, medication, and lifestyle, an individual’s ApoE4 status, as obtained from the Randox Biochip test, can go a long way in advising personalised medicine for the patient.

“This type of testing is important in our quest to understand and diagnose Alzheimer’s and empower patients to understand risks, consider medication, and even make early lifestyle changes,” said Emma, our R&D Scientist.

“Pairing this test with medical and family history for risk of Alzheimer’s disease has the real potential to advance personalised medicine.  This fast, accurate testing will allow doctors and patients to make more informed choices earlier to potentially slow the possible progress of Alzheimer’s.”

Dr. Emma Harte PhD, one of our Randox R&D Scientists! Emma presented our ApoE4 poster at this week’s AACC Annual Meeting and Clinical Lab Expo, in Philadelphia.

New Randox project committed to helping bladder cancer patients

Scientists at global healthcare company Randox, recently unveiled as the sponsors for The Grand National 2017 under the banner of Randox Health, today announced the company has been awarded an Innovate UK research award, for their pioneering work in the development of a diagnostic test for the detection of bladder cancer in haematuria patients.

The urine-based test is being developed in collaboration with The Belfast Trust and Queen’s University Belfast, and has been described by the project’s Lead Scientist at Randox, Dr Mark Ruddock, as the “holy grail” of diagnostic tests to stratify patients with haemeaturia (blood in the urine), who are at high risk of bladder cancer;

“Currently, all haematuria patients are ‘red-flagged’ as candidates for an invasive procedure called a cystoscopy (a camera inserted into the bladder), which is both embarrassing and uncomfortable for the patient.    In comparison, the revolutionary Randox test is based on a simple urine sample so is non-invasive and much more comfortable for the patient.”

 Considering less than 20% of patients with visible haematuria, and less than 5% with invisible haematuria are found to have bladder cancer,   Dr Ruddock highlighted the urgent need for a test that can inform decisions for patients who present with haematuria;

“In the UK, over £33.5 million is spent each year managing patients with haematuria who are subsequently found not to have bladder cancer.  As such, haematuria is a significant healthcare burden, which is only set to increase because of our aging population.  Use of this new test will allow urology teams the opportunity to reduce the number of unnecessary cystoscopies carried out on patients identified as ‘low risk’, and stratify patients identified as ‘high risk’.  This will result in significant healthcare savings, and an improvement in the waiting times for haematuria patients who do require diagnostic services ie. those patients deemed ‘high-risk’.”

Randox was successful in winning funding for phase one of the project, which has enabled an economic study to be carried out by The National Institute for Health Research Diagnostic Evidence Co-Operative Leeds who will investigate the economic benefits of the new diagnostic test for The National Health Service, and its role in the current patient care pathway.  On successful completion of phase one, Randox will be eligible to apply for phase two funding.

Professor Peter Selby, Professor of Cancer Medicine at the University of Leeds, and Director of the NIHR Diagnostic Evidence Cooperative Leeds, said:

“Bladder cancer is a very important disease which can be life threatening but also in many patients it can generate great anxiety, frequent hospital visits and many investigations. The new approach being developed by Randox has the potential to save lives and improve the quality of lives of many people at risk of bladder cancer.”

“Diagnostic Classifier for risk stratification of haematuria patients” was selected by Innovate UK in the “Stratified Medicine: connecting the UK infrastructure” competition.

New Randox project committed to helping bladder cancer patients

New test developed by Randox will reduce severe side effects of chemotherapy for leukemia patients

Global healthcare company Randox, recently unveiled as the sponsors for the Grand National 2017 under the banner of Randox Health, today announced it has been awarded an Innovate UK Award, for their pioneering work in the development of a diagnostic test for Acute Myeloid Leukemia patients.

Randox’s award-winning test will enable the stratification of Acute Myeloid Leukemia (AML) patients, to determine patient response, before chemotherapeutic treatment.  Currently, aggressive chemotherapy is given at diagnosis for the 2900 patients diagnosed with Acute Myeloid Leukemia every year in the UK, yet up to 40% of patients do not respond to this treatment due to the type of their cancer cells, and the patient’s genetic make-up.

The competition was therefore designed to promote the development of new diagnostic products and services for use in stratified medicine; in this case studying groups of leukemia patients to predict which treatments their cancers are likely to respond to.

Dr Cherith Reid, Project Manager for the AML Test at Randox, commented;

“As with any illness, it is important to select the best treatment and care for AML patients based on their diagnosis. The majority of AML patients are over 60 years old, and with the rise in the elderly population, increased prevalence of the disease is predicted. Currently, patients in this age range who are deemed fit for treatment are prescribed cytarabine chemotherapy, where the patient’s reaction to this drug is uninformed and is based on a trial-and-error approach.    The information provided by our test will allow us to identify patients whose cancer is drug responsive, and treat them accordingly, possibly with lower doses of chemotherapy, reducing its severe side-effects. We want to assist clinicians in selecting the best treatment and care for patients as early as possible to improve patient outcomes.”

Phase one of the project includes an economic study to measure the health economic benefits for The National Health Service, conducted by The National Institute for Health Research Diagnostic Evidence Co-Operative London.

Professor George Hanna, NIHR DEC London Centre Director, commented;

“The stratification of patients within the NHS has been widely acknowledged as an important method for the efficient use of resources, as well as improving patient experience. New in vitro diagnostic tests that can classify patients in this way – such as the test being developed at Randox for Leukemia patients – personalise patient care to better inform treatment decisions which will hopefully lead to improved health outcomes and fewer side effects. This is particularly important for Leukemia patients who face the severe side effects of chemotherapy.  Through the collaboration of Randox Laboratories and the NIHR Diagnostic Evidence Co-operative London, we have a unique opportunity to evaluate the adoption pathway of the new Randox AML technology to translate it to the bedside where it can best benefit patient care.”

“Determining Acute Myeloid Leukemia patient response to chemotherapeutic treatment” was selected by Innovate UK in the “Stratified Medicine: connecting the UK infrastructure” competition.

Pictured: Dr Cherith Reid

Simple swab test taking the guess work out of antibiotic prescription

A simple swab test developed by Randox scientists could help curb the antibiotic resistance pandemic.

The test, which can rapidly detect and identify the cause of 22 respiratory infections in just 5 hours, can subsequently determine the appropriate antibiotic drug treatment for patients.

Following the Lancet Infectious Diseases report last week that antibiotic resistance is growing at a rapid rate, with many ‘superbugs’ completely unresponsive to antibiotics, it is more important than ever that antibiotics are only prescribed when they will effectively treat an infection.

With 70% of GPs admitting that they prescribe antibiotics when they are unsure if they are treating a viral or bacterial infection, many patients are therefore taking antibiotics when they are ineffective in treating viral infections.

Given that only bacterial infections can be treated with antibiotics, rapid diagnostic tests are urgently needed to identify bacterial and viral infections.

Professor Peter Coyle, who leads one of the UK’s Regional Virology Laboratories in Belfast diagnosing infectious diseases, warns against antibiotic misuse:

“The commonest types of respiratory infection are of viral origin and antibiotics are ineffective in their treatment. Improving the diagnosis of respiratory infections is an important goal in improving patient management and reducing antimicrobial resistance. The threat of antimicrobial resistance and the loss of effective antibiotics has become a major and growing concern in health care provision.”

The new rapid and accurate test will give both patient and GP confidence of their diagnosis of respiratory infections and will allow for quicker treatment if necessary.

Making this test available through GPs would have additional efficiency savings for the NHS, by eliminating the need for lengthy microbiology lab tests and unnecessarily prescribing drugs which are not needed.

John Lamont, Chief Scientist at Randox Laboratories, whose team developed the test, commented;

“Current diagnostic testing for respiratory infections take at least 36 hours to confirm the nature of an infection, and they cannot name and categorise infections as bacterial or viral in the way that this new respiratory test can. C-reactive protein tests, for example, that are currently in use can only indicate whether a bacterial infection is likely. We need more than just guess work to combat the antibiotic resistance pandemic.”

Randox Laboratories and Biosystems International announce completion of clinical trial and licencing for QuantiPlasmaTM antibodies for early lung cancer diagnostics

Randox Laboratories and Biosystems International today announced the beginning of clinical validation of a lung cancer early detection test.

A recent clinical trial involving over 1100 samples has been carried out in partnership with BioDiagnostica Kft across four leading lung cancer treatment centers in Hungary, and the promising results have resulted in advancing the test for further clinical validation.

Lung cancer is the most common cancer worldwide, with over 1.8 million new cases diagnosed in 2012 (13% of total cancer diagnosis)1. As most lung cancer cases are diagnosed at a late stage this test provides an opportunity for earlier diagnosis across the world.

Randox Chief Scientist, John Lamont, comments: “This large study has produced some exciting results and we are looking towards validating the test to bring it to a wider market. This blood test can play a significant part in the early detection of lung cancer and distributing it to a global market will support easier and early diagnosis of this disease.”

Laszlo Takacs, CEO and CTO of Biosystems International adds: “Our mAb libraries proved to be valuable for detecting both qualitative and quantitative variability of the proteome in cancer. With Randox we are looking forward to continuing towards market introduction of the early detection test for lung cancer”.

Biosystems International Kft, BioDiagnostica Kft and Randox have signed a licencing agreement which enables Randox to distribute the test globally.

Protect your family from early heart disease with a simple blood test

On World Heart Day 2015, Randox Laboratories unveiled a rapid, highly accurate diagnostic test to identify individuals with familial hypercholesterolemia (FH), a common disorder that is passed from parents to their children. FH is often called the ‘silent killer’ as it is characterised by dangerously high levels of cholesterol, leading to early onset cardiovascular disease. The good news is that if diagnosed, FH can be effectively treated; the even better news this National Cholesterol Month is that this new test has made diagnosis across the UK much simpler.

Thousands of families in the UK are affected by FH, as not only is heart disease the number one killer across the globe, there is a 50:50 chance that a parent with FH will pass it onto their children. The condition can lead to higher risk of a heart attack in men before the age of 50, or before the age of 60 in women.

A common disease, at least 1 in every 500 people in the UK are living with FH, although new international research suggests that 1 in every 200 people could be affected, which would mean as many as 300,000 people in the UK. Worryingly, it is substantially underdiagnosed and less than 12% of people with FH in the UK are aware that they have this potentially life-threatening condition.

The current recommended screening techniques are costly and time consuming, limiting the number of individuals who benefit from a timely diagnosis. Under NHS guidelines, when a person is found to have FH, their closest blood relatives should get tested too – including children before the age of 10. The new test allows definitive diagnosis within one day, rather than the usual weeks or even months for current tests, removing unnecessary anxiety and allowing people to take immediate action before it’s too late.

The new molecular test that has been developed by Randox Laboratories in Crumlin, Northern Ireland, in partnership with the Belfast Health and Social Care Trust, enables detection of the 40 most common genetic mutations that cause FH in the UK, with results available in just three hours. With early and appropriate treatment, such as adopting a healthy lifestyle and taking cholesterol-lowering medication, risk of heart disease can be significantly reduced so that someone with FH can live as long as a person who doesn’t have the condition.

Professor John Chapman, Past- President of the European Atherosclerosis Society, which promotes study into the causes of accelerated atherosclerosis and cardiovascular disease, has welcomed the new test for suspected cases of FH:

“FH is a serious condition for those with a family history of accelerated atherosclerosis and premature cardiovascular disease. With this information, preventative measures including diet, lifestyle and lipid lowering drugs can be successfully introduced. Indeed, early identification and prevention can significantly benefit all family members potentially with this condition. In fact, we are entering an exciting time in the treatment of those with cardiovascular disease as new and highly effective drugs for lipid management are becoming available.”

The test, which is available through Randox Health Clinics, has been adopted by medical professionals within the NHS, including Dr. Colin Graham, recently retired Consultant Clinical Scientist and former Head of the Regional Genetics Lab in the Belfast Health and Social Care Trust, who introduced the test within his Belfast Laboratory screen for suspected cases of FH:

“The launch of this new clinically available test is a key milestone in the detection and diagnosis of FH. Current FH diagnostic tests require a large volume of samples to be batched, leading to lengthy turnaround times of two to three months. With the new test, the turnaround time is dramatically reduced, enabling more rapid patient diagnosis.”

Dr. Graham also highlighted the importance of improving detection rates through the screening of wider patient populations:

“This new test has the potential to enable FH screening to become routine in the clinical setting for improved detection and earlier identification of familial cases.”

Dr. Peter FitzGerald, Managing Director of Randox Laboratories said:

“In the battle against cardiovascular disease, people with FH are on the front line. On World Heart Day it is important to raise awareness of FH as many people do not even know that they and their family members have this life-threatening condition. There is so much that can be done to support families with FH and with this readily available and much-needed test, detecting and treating entire families with FH is now possible.”

For more information please contact our Randox Comms Team:

Email: amy.mcilwaine@randox.com

Tel: 028 9445 1016

Randox invests £15 million in R&D ‘Roadmap’ to target the international personalised medicine market

  • £15 million invested in R&D 2014-15
  • Funding allows creation of bold new division – Randox Biosciences
  • Job creation – 30 new staff
  • International focus – Japan, USA, Europe; key markets

Global biotechnology firm Randox, is unveiling its latest enterprise, ‘Randox Biosciences’. The new specialist division within Randox, is dedicated to advancing scientific discovery, drug development and companion diagnostics. Randox Biosciences is the result of the merger and expansion of four existing business units; Life Sciences, Pharma Sciences, Research and Molecular.

15 new jobs have already been created at the unit based in Crumlin, with that figure expected to double by the end of the year. A core team of over 300 R&D scientists and engineers are employed at the Randox Biosciences hub, specialising in supplying products and services to universities, genetics labs and the pharmaceutical industry across the globe.

Exports and international collaborations will be key drivers of growth for the new division, as Patrick Henry, Head of Randox Biosciences explains:

“Our focus is on targeting the thriving personalised medicine market which at its heart relies on ‘precision medicine’ enabling technology and tests to tailor healthcare solutions to the right patients at the right time. Led by our dedicated research scientists, we offer advanced products, for use in academic research enabling new scientific discoveries and in pharma companies for their drug development and clinical trials.

“A particularly exciting area for Randox Biosciences is in Companion Diagnostic development. This is where new diagnostic tests are developed and approved alongside new drugs improving their efficacy and safety, whilst helping to reduce costs for healthcare networks by avoiding unnecessary or ineffective drug prescriptions.

“Precision medicine is next generation health care, with huge potential for Randox in terms of exports and collaborations. We are already creating traction in the US and Europe and have our sights set on Japan, in which we expect to have a solid presence by Autumn.”

Funding for the Randox Biosciences division is as a result of the Randox group’s commitment to innovative R&D says Randox MD, Dr Peter FitzGerald:

“Research and development is fundamental to the creation of new products and we recognise its importance. In 2014-15 we invested £15million into R&D, our most significant spend on this core function to date. This investment has allowed us to establish the Randox Biosciences division, which will act as a road map for our R&D, taking our tests and technology to new markets across the world.

“At the moment, Randox Biosciences is engaged in world-leading research into Alzheimer’s disease and cancer and is involved in more than 35 collaborations with internationally renowned academic research centres. The Randox Biosciences team is truly at the frontier of health care discovery, making our vision a reality.”

Randox welcomes government approval of R&D investment

World-leading research and development at global biotechnology company, Randox, will receive a significant boost, after the government’s approval of a major investment by the Gaeltacht development agency, Údarás na Gaeltachta. €5m in R&D development assistance will be invested over 5 years, in Randox’s state-of-the-art life science and engineering facility, Randox Teoranta located in Dungloe, County Donegal.

The funding will be used to support Randox Teoranta’s ambitious R&D into conditions impacting human health, it will also bolster the company’s impressive expansion and recruitment programme, known as #Dungloe2020. The #Dungloe2020 project will see Randox Teoranta increase its employment figures to 540 by 2020.

Today (7th July 2015) the government formally approved Údarás na Gaeltachta’s €5m funding for research and development at the Dungloe site. Welcoming the government’s green light for the grant, Dr Peter FitzGerald, MD at Randox, explains how the finance will assist pioneering scientific research:

“Randox Teoranta is a next generation life-sciences, engineering research and manufacturing centre and to further our progress, we have ring-fenced more than €10m for 3 special projects; Biochip Research, Disease State Research and Chemical-Mechanical Engineering. The €5m from Údarás na Gaeltachta will also be used to support these vital programmes, which will ultimately improve healthcare world-wide.

“These projects and the wider #Dungloe2020 programme, are visionary and transformative; by supporting our ambitions, both Údarás na Gaeltachta and the government, have rubber-stamped their commitment to transforming the high-value knowledge economy of the region.”

Randox Teoranta was established in 2008 in Dungloe and currently employs 85 people, with #Dungloe2020 recruitment focused on manufacturing, software development, engineering and life sciences.

New €25 blood test a breakthrough in the diagnosis of bowel cancer

  • New blood test will spot bowel cancer at earliest stage
  • Simple check will ID cancer missed by existing screening
  • No need for ‘unpleasant’ faecal screen 
  • Bowel cancer is Ireland’s second biggest cancer killer

Irish scientists are developing a new €25 blood test for bowel cancer, which could save thousands of lives by spotting the disease at the earliest possible opportunity. The simple check will pick up on antibodies in the blood, produced as the body reacts to the onset of bowel cancer. 

The collaboration between researchers from the Biomedical Diagnostics Institute at Dublin City University and Irish biotech firm Randox, promises that the new test will be a significant breakthrough in the diagnosis of bowel cancer and could be available for widespread use by the end of next year.

Studies show that the identification of these very specific biomarkers will allow for a test which is more sensitive and accurate than existing screening. This means it will not only save lives, through earlier, more reliable and faster diagnosis, but because it is a simple blood test, it is hoped it will encourage more people to come forward for bowel cancer screening.

Each year almost 2,500 people are diagnosed with bowel cancer, with 1,000 dying from it; making bowel cancer the second most common cause of cancer death in Ireland. To address this, a nationwide Bowel Screen initiative has been rolled out to check those between the ages of 60-69, thought to be at high risk. This screening involves testing traces of blood in stool samples. 

Drawbacks associated with this method, known as Faecal Occult Blood Test (FOBT), include low sensitivity, which means early stage disease is not detected in a rapid or reliable way. In addition, the nature of the sample required for these tests has resulted in worryingly low levels of patient uptake. The new blood test will do away with the need for FOBT and will prevent unnecessary and costly colonoscopies for people without the disease.

Professor Richard O’Kennedy, Scientific Director of BDI said: 

“Typically patients who experience the symptoms of bowel cancer may visit their doctor. This new, quick and non-invasive test will help in identifying patients with bowel cancer earlier, so they are sent for colonoscopy and thus treated more effectively. Survival rates from bowel cancer are closely associated with the stage at diagnosis. More than half of people with bowel cancer are diagnosed in the later stages, requiring more complex treatment, with a poorer chance of survival. The aim of this new test is to find the cancer at the earliest possible stage, when it is easier to treat, improving outcomes for patients.”

The new test will be implemented on Randox’s proprietary Biochip Array Technology detection platform. Randox Managing Director, Dr Peter FitzGerald said: 

“The potential here is quite revolutionary, while bowel cancer is a very serious illness – early diagnosis leads to improved survival. If bowel cancer is found early, the growth is typically small and can be removed, leaving the person healthy and needing less treatment. In addition bowel cancer places considerable burden on our healthcare system. Stage 3 bowel cancer treatment costs are estimated at more than €45k per patient, with Stage 1 treatment €18,550 – less than half, if we can catch this cancer early and treat it early, then the economic benefit will be considerable.”

Dr Sinéad Walsh, Acting Head of Research at the Irish Cancer Society, which is the largest voluntary funder of cancer research in Ireland said: 

“We are very excited by the results of this research as it will help us move another step forward in our strategy towards a future without cancer. The earlier bowel cancer can be detected the better the outcome for patients. This coupled with the ability to personalise treatments for bowel cancer patients, will contribute to better outcomes for people with bowel cancer.”

Dr. Conor Burke, Associate Director of the BDI commented, 

“This project is an excellent example of the translational research agenda of the BDI and its commitment to the realisation of commercial and societal impact through innovation in diagnostics. One of our primary goals is the creation of value for indigenous Irish diagnostics companies through our research and we look forward to working with Randox on realising the significant commercial and healthcare-related potential of this screening test.”

The collaboration is funded by Enterprise Ireland and Randox. Initial work was supported by Science Foundation Ireland and carried out at Dublin City University and the Royal College of Surgeons Ireland and Beaumont Hospital. The inputs of Dr. Gregor Kijanka, Dr. Julie-Anne O’ Reilly, Dr. Barry Byrne and Professors Elaine Kay and Dermot Kenny were vital in developing this research.

Randox TxB Cardio Assay gains CE Approval

Global diagnostics company Randox Laboratories has secured CE marking for their TxB Cardio Assay. TxB Cardio is used to measure the effectiveness of aspirin (ASA), a drug which is used therapeutically around the world for its blood thinning properties. Clinical studies have shown that up to 25-30% of all patients who regularly take low doses of the drug are resistant to its full affects, meaning that these patients are at a considerably increased risk of a future cardiovascular event.

The primary action of aspirin is to inhibit the production of thromboxane in the blood, a chemical which helps to cause blood clotting. However, methods of directly measuring the level of thromboxane in blood are unreliable, and so not widely used. TxB Cardio measures a direct urinary metabolite of thromboxane, 11dhTxB, therefore providing a reliable and stable measure of a patients response to their daily aspirin therapy.

TxB Cardio is the latest generation assay for measuring 11dhTxB, and means that it can now be tested by hospitals and clinics via their routine laboratory instruments, without the need for dedicated and expensive additional equipment. Randox also offers TxB quality controls and calibrators, delivering a complete testing package.

Speaking after the approval announcement, Randox Managing Director Dr Peter FitzGerald said,

“We are delighted to bring this, the first automated assay of its kind on to the global market. 11dhTxB has been clinically validated as an independent predictor of myocardial infarction (MI) and cardiovascular death in patients suffering from decreased aspirin sensitivity. The 25-30% of patients thought to be aspirin resistant have a 2 fold risk of MI and are 3.5 times as likely to die as a result of a cardiovascular incident, than those who respond fully to their aspirin therapy. This test therefore has the potential to have a significant impact on identifying and prescribing these patients with alternative and  more personalised treatment.”