Randox Food Diagnostics test committed to fighting antibiotic resistance is awarded AOAC Performance Tested Certification
Randox Food Diagnostics test committed to fighting antibiotic resistance is awarded AOAC Performance Tested Certification
After several years of dedicated R&D, Randox Food Diagnostics are pleased to announce that the industry’s leading body, the AOAC, has granted its Performance TestedSM certification to the company’s Antimicrobial Array I Ultra Kit (License Number 051705).
AOAC standards are used globally to facilitate public health and safety and promote trade, and the rigorous three year certification process was completed in conjunction with the US Food and Drug Administration Center for Veterinary Medicine validation protocol. In addition to internal validation studies and reporting to the AOAC Research Institute, an external independent expert laboratory was required to evaluate the methodology.
Achieving the AOAC Performance TestedSM certification sends a strong statement to the industry about RFD’s commitment to support food producers by providing the highest quality diagnostic tests.
The widespread use of antibacterial agents in veterinary practice, as bacteriostatic agents as well as to promote growth, has increased the concern about the levels of contamination of food products that can be consumed by the public. To protect both the consumer and the industry, regulatory authorities have specified maximum residue limits.
The Antimicrobial Array I Ultra Kit tests for 13 antibacterial agents: for consumer protection, the presence of these compounds in the food supply is highly regulated or banned. This Biochip based kit uses a multi-analytical approach, and therefore maximises detection capability which will improve food safety.
Head of Randox Food Diagnostics, David Ferguson, said:
“This is a major achievement for our team and we are delighted to receive this certification from AOAC. One of our central goals is to be a catalyst for improving food safety, which is why we invested so much into tackling the widely-reported dangers of antibacterial residue in food.
“There’s a growing awareness among consumers and producers about the critical issue of food safety. The Antimicrobial Array I Ultra Kit will meet the increasing demand for highly accurate diagnostic tests.”
The test kit is exclusively available on Randox’s proprietary Biochip Array Technology.
For more information please contact enquiries@randoxfood.com
About AOAC-RI
The AOAC Research Institute (AOAC-RI) was incorporated in 1991 as a wholly owned subsidiary of AOAC INTERNATIONAL. The AOAC-RI serves as an independent, third-party, nongovernment administrator of AOAC conformity assessment programs including the AOAC Performance Tested MethodsSM (PTM) and Official Methods of AnalysisSM (OMA) programs for alternative and sole source methods.
For more information, visit www.aoac.org.
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
The RX series – Precision. Reliability. Accuracy
Precision
The RX series analysers ensure that the on-board testing process is precise through many stages and therefore lead to accurate results in the laboratory. Our automated analysers go through an extensive washing system for cuvettes and includes acid, alkali and pure water wash steps. Liquid level sensor, crash, bubble and clot detection ensure that after the washing process is complete, whatever residue remaining has been completely removed from the cuvettes so that they are ready to be used again.
Reliability
Randox understand the demands of the clinical chemistry laboratory and recognise the importance of maintaining a consistent workflow of high quality results. We pride ourselves in excellence of service. Through our global network, our team of trained engineers provide local service and support. There are 3 levels of service maintenance provisions to ensure a package to suit all laboratories; bronze, silver and gold packages.
Randox also offers technical support 24 hours a day, 7 days a week via a free electronic service called Powerline; this service provides customers with instant access to instructions for use (IFU), and instrument specific application (ISA) documents for a comprehensive list of instruments. Each RX series analyser requires minimal maintenance, as little as 5 minutes daily, and between 1 and 2 yearly preventative maintenance checks depending on the workflow of the analyser.
Accuracy
70% of medical decisions are based on laboratory results, therefore it is imperative that accurate results are produced in the laboratory. These test results lead to key decisions for the treatment of patients, therefore it is essential for an accurate diagnosis of all patient samples. A misdiagnosis can be life threatening, or lead to incorrect treatment plans delaying the recovery of the patient, which in turn can lead to high compensation costs for Hospitals and Laboratories for the affected patients.
The RX series analysers ensure accurate test results with a stringent validation process of all Randox Reagents. The QC functionality provides automatic flagging of inaccurate results and testing errors therefore helping laboratories identify and resolve issues quickly, minimising the possibility of misdiagnosis.
Precision, reliability and accuracy are hugely important within a laboratory. The RX series analysers offer these in abundance. Randox can provide consolidation of testing with validated reagents and cost effective Quality Controls, ensuring that your laboratories testing results are precise, reliable and accurate.
If you are interested in finding out more and would like to speak with a Randox representative, please contact us by emailing therxseries@randox.com
Celebrate Christmas with Randox Quality Control
T’was the week before Christmas and all through the lab not a thing could be heard not even a sound. The analyser lay silent asleep in the corner, the lab staff at home dreaming of a few days’ rest, only a few more days to go before the big day!
The big man in red, what will he bring those who already have everything? Peace, happiness and health for their loved ones throughout the festive break, that would be the wish for everyone to make. And what better way to ensure they stay healthy, well it all begins in the laboratory…
An important consideration to remember when choosing your lab Quality Control (QC) is that approximately 70% of clinical decisions are based on laboratory test results. It is therefore essential that the results gained from laboratory testing are accurate and reliable in order to provide the appropriate treatment and avoid or prevent potential misdiagnosis.
Patient results are of the utmost importance for a laboratory and therefore running the best Quality Control material should be at the top of their agenda. QC material should have a number of features that allow a lab to judge the overall quality of their output. These features include the controls ability to be commutable (which means how well it reacts as a replicate of a patient sample), is it a true third party control that has been manufactured to provide an independent and unbiased assessment of performance, does your control come with clinically relevant levels and does it have a long shelf life as well as a good open vial or reconstituted stability? These are the questions lab staff will be asking themselves when deciding on what QC is the right QC.
So stay off Santa’s naughty list by providing accurate and reliable patient test results, do this by employing Randox QC in your laboratory. Our controls have been designed to deliver significant cost savings without sacrificing on quality. With consolidated controls (combining up to 100 analytes in a single vial) your lab can reduce QC costs and preparation time, the inclusion of analytes present at clinical decision levels will eradicate the need for additional controls and because of our long shelf life (2 years for liquid controls, 4 years for lyophilised) and excellent stability claims your laboratory can be sure that expensive lot changes will be a thing of the past! Our controls can be described as true third party and this, combined with the commutable nature of the controls, leads to us being able to claim that we have the best Quality Control material around.
So this Christmas when deciding what QC to choose – make sure you look no further than Randox Quality Control. Our QC family is known as Acusera and our product offering includes QC and calibrator material, Interlaboratory Data Management Program (Acusera 24.7), the world’s largest international EQA/PT scheme better known as RIQAS and the newest addition to the family, Linearity or Calibration Verification material.
We have packages for every lab regardless of size and budget and we guarantee you will become ho-ho-hooked on Randox QC.
Wishing you all season’s greetings and a prosperous New Year from everyone at Randox QC.
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 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
New Acusera PTH Control for Randox Quality Control
Randox Quality Control are pleased to announce a further expansion to our comprehensive laboratory quality control portfolio, the Acusera PTH Control.
Parathyroid Hormone (PTH) is a hormone released by the parathyroid glands. It is often referred to as the parathormone and is often requested to help determine the cause of a low or high calcium concentration, helping to distinguish between parathyroid related and non-parathyroid related causes.
For health professionals
The new PTH Control has been designed with convenience in mind, providing laboratories with a true third party solution for the measurement of PTH. Our assayed liquid control has been developed with an extended open vial stability of 30 days and 2 year shelf life, reducing waste and ensuring consistency for this notoriously unstable assay.
Is your laboratory currently running PTH? Are you seeing shifts in QC results when you change reagent batch? If so, visit the new Acusera PTH Control product page for more information or register your interest.
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.
