Is Biomarker Multiplexing the future of kidney disease screening?

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Is Biomarker Multiplexing the future of kidney disease screening?

Chronic Kidney Disease (CKD) is both a cause and a consequence of cardiovascular diseases, and is an increasing burden on global health. As diabetes, obesity and hypertension incidences continue to rise and the world’s population steadily ages, CKD’s prevalence is already estimated to be between 11% and 13% globally for all five KDOQI stages, with a majority in Stage 3 (about 90% of all stages).

With early stages of CKD being asymptomatic and current diagnostic tools (proteinuria determined by albumin to creatinine ratio and decreased renal function estimated from GFR using the CKD-EPI equation) are insufficiently sensitive to detect most cases up to stage 3, it is likely that the true prevalence of CKD is still underestimated. Therefore the need to improve both early diagnostics and overall CKD outcome is all the more critical.

Accordingly, biomarker research has been intense in the field of renal disease for at least 10 years with a number of promising candidates emerging, some now well-known by specialists: Cystatin C, NGAL or KIM-1 for example.

However, further novel biomarkers, assessed in combination using a properly developed multiplex assays can allow superior insight into CKD than what their individual performance could achieve.  This also largely stems from selecting the markers that are indicative of complementary mechanisms that contribute to the development of CKD.

When assayed together from a single serum sample and after combinatorial analysis has been applied, these biomarkers can open new avenues in the management of CKD, such as proper diagnosis of the condition from Stage 1, clear differentiation between stages and monitoring of the progression pace of the disease. Early screening of patients at risk of CKD is now within reach and it is expected that its systematic use will have a profound impact on health system economics.

Another area of interest in renal research is Acute Kidney Injury (AKI) which may arise as a result of cardiac surgery and can subsequently lead to CKD. AKI detection is also of significant interest in the field of drug development, where early stage toxicity is still a large cause of new drug marketing withdrawal. Hence selecting and qualifying kidney tissue damage biomarkers, and assembling them into a multiplex panel is a key priority to those involved in early stage clinical trials.

An AKI panel has been worked out using the same principles as those used in the development of the CKD panel: high individual diagnostic value and multiple, independent cellular targets. This panel is now ready for final clinical qualification and will be one of the first of several organ-targeted safety panels aiming to become standard for drug induced toxicity screening.

It is key to the adoption of multiplex testing that proper validation guidelines be published and that careful, matrix-based validation data is made available to potential users. It is essential that multiplexed testing comes to the front line of testing in the field, so it can deliver to its full potential and start translating into public health improvement and cost savings. Technology is ready, let’s make a start!

Dr Claire Huguet

Randox Biosciences – Head of Biomarkers

 

For further information about kidney disease screening from Randox Biosciences, please contact randoxpr@randox.com

 

 

 


Randox / Bosch partnership delivers game-changing device in fight against antibiotic resistance

A partnership between Randox Laboratories, the UK’s largest manufacturer of in-vitro diagnostics, and the German technology giant Bosch is changing the way doctors will treat patients with antibiotics, with the launch of a revolutionary product – the Vivalytic.

It’s estimated that 20% of antibiotics currently prescribed are unnecessary, and fuel the growing threat of global antibiotic resistance. This threatens the ability to treat common infectious diseases, and a growing number are becoming harder, and in some cases impossible, to treat. The World Health Organisation warns that without action, we are heading towards a post-antibiotic era.

This problem is being addressed by the Vivalytic. The result of a decade of R&D, it is an intuitive point-of-care analyser that, depending on the complexity of the test, will deliver results from 30 minutes: enabling doctors to select the right course of therapy faster than before. In some cases, this will be life-saving.

The first tests available on the Vivalytic are Randox’s panels for respiratory and sexually-transmitted infections*.

Using Randox’s patented Biochip Array Technology, the Respiratory Multiplex Array simultaneously reports on 22 viral and bacterial pathogens including Bordetella pertussis and parapertussis which causes whooping cough without the need for secondary or confirmatory testing to inform clinical treatment decisions. The STI array enables the detection of 10 STIs from a single sample. Every day more than 1 million STIs are acquired, and many have mild if any symptoms at all. Identifying these infections correctly first time reduces the misuse of antibiotics and supports their targeted use.

The Managing Director of Randox Dr Peter FitzGerald commented:

“Antibiotic stewardship is a critical issue which we all have a responsibility to embrace and drive forward. This partnership is ideal, combining our expertise in molecular laboratory diagnostics with Bosch’s cutting-edge engineering. The Vivalytic is a game-changer for clinicians and patients: never before has there been this level of accessibility to this range of molecular diagnostics.”

Marc Meier, General Manager of Bosch Healthcare Solutions, a wholly owned subsidiary of Bosch Group, said:

“We are enthusiastic about having gained Randox as the first partner on our platform with two initial panels available from the start. It´s the beginning of jointly expanding the Vivalytic test portfolio for our clients.  In this partnership the core competencies of Bosch in automation, miniaturization, and networking are complemented by Randox’s expertise in developing and commercializing innovative diagnostic solutions.”

Vivalytic and the panels will be presented to industry professionals for the first time at the ECCMID 2018 Congress in Madrid, Spain, in hall 10, booth 55A between 21st – 24th April.

*CE pending and FDA planned.

For further information about the Vivalytic, please contact randoxpr@randox.com

 

 

 


Vivalytic: The all-in-one solution for Molecular Diagnostics

A game-changing partnership between Randox Laboratories and Bosch is changing the accessibility to molecular diagnostics with the launch of a revolutionary product – the innovative platform Vivalytic.

Using Randox-patented Biochip Array Technology, it is the easiest-to-use and most-comprehensive multiplex PCR platform on the market. It provides the broadest range of test options ever seen for an analyser of its size, and also supports single-plex and low-plex testing, simplifying the processes for otherwise-complex laboratory test procedures. Depending on the test application, results will be delivered from 30 minutes.

Biochip Array Technology, developed by Randox Laboratories, is the innovative multiplexing technology which is utilised within the cartridge aspect of the platform. The Biochip allows for the simultaneous detection of multiple analytes from a single sample.

The new platform will be initially released with two molecular arrays available including Respiratory Tract Infection and Sexually Transmitted Infection with other tests to follow.

The Vivalytic is the perfect fit for any laboratory with numerous benefits to enhance your laboratories testing capabilities.

 

Hygienic and space saving

No other peripherals such as laptop, keyboard, barcode scanner or filling stations are required. This makes Vivalytic a hygienic and space-saving all-in-one solution.

 

Direct and clear results

The test result is presented clearly in a summary, but also details on the raw data of each individual measurement can be displayed.

 

Protected system

The Vivalytic integrates the software with the instrument to ensure a safe and reliable run. This is the ultimate protection of the data and the valuable sample material.

 

Networked and combinable

Easy integration with popular standard IT systems makes test results instantly available. An analyser device can be networked and combined with several other devices so that multiple series of tests can be performed simultaneously. All devices are based on the same hardware and software, so that the product family can be expanded quickly and without major development effort.

 

28th European Congress of Clinical Microbiology and Infectious Diseases

Randox Laboratories will be attending the 28th European Congress of Clinical Microbiology and Infections from the 21st – 24th April 2018.

 

Our innovative diagnostic solutions have been developed with consolidation and economy in mind, providing cost savings whilst using pioneering technology.

 

Diagnostics is our passion. We are dedicated to developing solutions that not only meet your needs, but are of the highest quality, the most reliable and the most cost-effective. We look forward to meeting you in Madrid at IFEMA – Feria de Madrid to launch the Vivalytic at our stand 55A.

 

For further information, visit https://goo.gl/S2Yj2c or email info@randoxbiosciences.com

 

 

 


Study by Center for Disease Dynamics finds dramatic rise in global antibiotic consumption

A dramatic increase in global consumption of antibiotics has led public health experts to call for innovative new ways to rein in excessive use of the drugs, following a study by the Centre for Disease Dynamics, Economics and Policy, in Washington DC.

The study found a 65% rise in worldwide consumption of antibiotics from 2000 to 2015, despite efforts to encourage more prudent use of the drugs. The unrestrained use of antibiotics is the main cause of the increasing appearance of drug-resistant infections, which now kill more than half a million people worldwide. A report in 2014 predicted that the spread of drug resistance could claim millions of lives per year by 2050.

Eili Klein, an author of the study, which was published in Proceedings of the National Academy of Science, criticised the global response to the global antibiotic resistance crisis as “slow and inadequate” and called for a “radical thinking” of antibiotic consumption.

At Randox, our pioneering R&D teams have developed a revolutionary swab test for respiratory infections which will help to reduce the unnecessary prescription of antibiotics. Earlier this year, Public Health England reported that 59% of people who visited their GP with a sore throat were prescribed antibiotics, in spite of only 13% actually needing them.

The new Randox swab test indicates the cause of the infection and whether a patient needs antibiotics or not, by rapidly detecting and identifying the cause of 21 respiratory infections in just 5 hours

The test assists the clinician in prescribing the appropriate antibiotic.

John Lamont, Lead Scientist at Randox Laboratories, said;

“Current diagnostic testing for respiratory infections takes 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 our new respiratory test can.”

This test, if widely adopted, could allow medical practitioners to make the correct treatment choice on the same day as examination and before patients have already begun a precautionary course of inefficient antibiotics. It would also have additional efficiency savings for the NHS, by eliminating the need for lengthy microbiology lab tests and unnecessarily prescribing drugs which are not needed.

This new rapid and accurate test will give clinicians confidence in their diagnosis of respiratory infections and will allow for quicker treatment if necessary, which benefits patient outcomes. By reducing the prescription of unnecessary antibiotics, we can limit their use only for when they are truly needed.

The test is also available as a Randox Health Cough, Cold & Flu offering, and can be carried out by booking an appointment with Randox Health at our clinics in Crumlin, Holywood or London, or by arranging the mobile clinic to visit you at your home or place of work.

Book an appointment with one of our clinics, or arrange the mobile clinic, by phoning 0800 2545 130 or by clicking here.

For further information about the Randox Respiratory Infection Array please contact the Randox PR team by email: randoxpr@randox.com or phone 028 9442 2413

 

 

 


Celebrating Valentine’s Day with the Cardiac Prediction Array from Randox Biosciences

With Valentine’s Day being in the heart of National Heart Month, Randox Biosciences want to take this opportunity to talk about the importance of looking after your heart and the awareness of the tests out there currently on offer.

The British Health Foundation launched National Heart Month with the aim to spread awareness of heart disease and to encourage the nation to make small changes towards a healthier lifestyle.

Currently Coronary Heart Disease (CHD) is the leading cause of death in the UK, with 73,000 people dying from Coronary Heart Disease every year in the UK.1

Coronary Heart Disease is a disease in which plaque builds up inside the coronary arteries. Our arteries supply oxygen-rich blood to the heart muscles, however, over time plaque builds up and can harden. This hardened plaque, then narrows the coronary arteries reducing the flow of oxygen-rich blood to the heart, which can lead to angina or a heart attack to occur.2

CHD is more likely with increasing age, in men rather than in women before menopause and if close relatives have suffered CHD early in life. These risk factors cannot be changed, however, there are other risk factors that can be modified. These are known as elevated blood cholesterol, overweight and obesity, smoking, lack of physical activity, unhealthy diet and stress.

You can prevent and control many CHD risk factors with heart-healthy changes and medication. There is only a few risk factors that can’t be controlled such as your age, gender and family history. Nonetheless, many lifestyle changes help control several CHD risk factors at the same time, such as physical activity which may reduce stress, lower your blood pressure, help control diabetes and help control your weight.

If you believe you are at risk of coronary heart disease, you can ask for a risk assessment for heart diseases, heart attack or stroke. However, current CHD risk assessment tools based on common risk factors such as blood pressure and blood cholesterol levels have low predictive value and take no account of genetic predisposition to CHD.

In recent years, Genome Wide Association Studies (GWAS) have been carried out to identify genetics variants associated with CHD. Meta-analysis of such studies has identified 19 variants as being associated with CHD.

Individually, the presence of an “at risk” variant does not greatly increase the risk of developing CHD. However, the presence of multiple “at risk” alleles can increase the risk of developing CHD two-fold or greater an effect similar to being a current smoker. Combining genotype information with common risk factors could allow individuals to be more accurately classified therefore preventative therapies and lifestyle advice can be targeted to those who require it most.

In order to utilise the GWAS findings within a clinical setting, individuals require to be genotyped for each of the 19 CHD “at risk” SNPs. However, at present this can be a time consuming and expensive process.

Together with key opinion leaders in cardiovascular genetics, Randox has developed the Cardiac Risk Prediction Array which will allow all 19 SNPs to be genotyped simultaneously, which incorporates a test to identify patients predisposed to statin induced myopathy.

Firstly, a multiplex PCR reaction is performed, where the products amplified correspond to the genotype of the patient sample. The PCR products are then hybridised onto the Cardiac Risk Prediction biochip array and imaged using the Evidence Investigator analyser to identify which PCR products are present. Patient samples can be genotyped within 1 day.

This Heart Month, we are urging the pubic to not only help raise awareness of heart disease but also educate themselves on the signs and symptoms to increase early diagnosis. As a global diagnostic company, Randox Biosciences are committed to the ongoing development of diagnostic tests, as well as our research into numerous disease areas to improve health worldwide.

To find out more email us at info@randoxbiosciences.com

 

Sources

1 – HeartUK

2 – National Heart, Lung and Blood Institute

 

 


Randox Laboratories and Qnostics announce strategic partnership

Randox Laboratories and Qnostics have today announced that they have entered into a strategic partnership.  The partnership will provide Randox Laboratories with access to the Qnostics molecular range of products for sales and distribution purposes, complementing the established Randox Laboratories portfolio.

Access to the Randox Laboratories commercial capabilities will enhance Qnostics’ market penetration, whilst also maintaining their presence as an independent provider of molecular quality controls and custom services.

MD of Randox Laboratories, Dr Peter FitzGerald said;

“We are delighted to have agreed a strategic partnership with Qnostics, an arrangement we see as mutually beneficial.  We look forward to working together to strengthen the molecular service we provide to our global markets whilst enhancing the Qnostic brand and market penetration.”

Dr Frank Opdam, Head of Commercial of Qnostics said;

“We believe this is an ideal partnership. We look forward to working with Randox Laboratories and the growth that will result from the global access this partnership will provide to Qnostics for its expanding range of molecular quality control products.”

For further information please contact the Randox PR Team: phone 028 9442 2413 or email randoxpr@randox.com 


GPs are told to stop prescribing antibiotics for sore throats

Today, the National Institute for Health and Care Excellence has published guidelines that state doctors should not prescribe precious antibiotics for most people with sore throats and should instead recommend drugs like paracetamol.

The guidelines from NICE and Public Health England, which aim to limit the use of antibiotics, said doctors should only be prescribing the medicines for more severe cases that are most likely to have been caused by a bacterial infection.

This is despite recent research that suggests antibiotics are prescribed in 60% of sore throat cases, for which doctors are unable to tell if the infection is viral or bacterial.

The National Institute for Health and Care Excellence said most sore throats were caused by viral infections, which cannot be treated by antibiotics.

At Randox, our pioneering R&D teams have developed a revolutionary swab test for respiratory infections which indicates the cause of the infection and whether a patient needs antibiotics or not. This helps to limit the number of patients who are prescribed antibiotics unnecessarily.

The Randox test, which can rapidly detect and identify the cause of 21 respiratory infections in just 5 hours, assists the clinician in prescribing the appropriate antibiotic.

John Lamont, Lead Scientist at Randox Laboratories, said;

“Current diagnostic testing for respiratory infections takes 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 our new respiratory test can.”

This test, if widely adopted, could allow medical practitioners to make the correct treatment choice on the same day as examination and before patients have already begun a precautionary course of inefficient antibiotics.  It would also have additional efficiency savings for the NHS, by eliminating the need for lengthy microbiology lab tests and unnecessarily prescribing drugs which are not needed.

This new rapid and accurate test will give clinicians confidence in their diagnosis of respiratory infections and will allow for quicker treatment if necessary, which benefits patient outcomes.

The test is also available as a Randox Health Cough, Cold & Flu offering, and can be carried out by booking an appointment with Randox Health at our clinics in Crumlin, Holywood or London, or by arranging the mobile clinic to visit you at your home or place of work.

Find out more about the Cough, Cold & Flu Respiratory test here.

Book an appointment with one of our clinics, or arrange the mobile clinic, by phoning 0800 2545 130 or by clicking here.

For further information please contact the Randox PR team by email: randoxpr@randox.com or phone 028 9442 2413

 


Evidence Investigator | Adaptable, Efficient & Comprehensive

The Evidence Investigator is a compact, semi-automated benchtop analyser that offers efficient and comprehensive testing across a range of applications including clinical diagnostics, molecular, research, toxicology and food diagnostics.

Renowned for its versatility, robustness and effective reporting methods, the Evidence Investigator has been used in a wide range of laboratory settings for over 15 years. This highly advanced yet simple to use analyser has only one moving part, giving the user peace of mind.

The Evidence Investigator contains a host of innovative on-board data analysis features ensuring manual processes are kept to a minimum.

By utilising the same multiplex technology as the other Evidence Series analysers, the Evidence Investigator can process up to 44 results from a single sample, with a maximum throughput of up to 2376 tests per hour. Offering efficiency without compromising on accuracy, the Evidence Investigator is the perfect fit for medium throughput laboratories seeking maximum use of bench space.

Accurate and Robust

Like all the Evidence Series analysers, what sets it apart is technology. The Evidence Investigator is extremely well equipped to provide reliable results, while simultaneously robust enough to withstand frequent, heavy use.

Results are generated using a Charge Coupled Device (CCD) camera, which quantifies chemiluminescent light. This light measures the degree of binding between the patient sample and specific biochip bound ligands, generating highly accurate and reliable results.

Consolidation

The Evidence Investigator is the world’s first platform allowing consolidation of immunoassay and molecular diagnostics. This is achieved through utilising protein and DNA based biochips. By giving the user the ability to consolidate tests, the Evidence Investigator improves laboratory efficiency and reduces costs.

 Advanced Reporting

The Evidence Investigator image processing software translates light signal generated from chemiluminescent reactions into analyte concentration. This removes the need for any manual processing of data.

Previously unreported tests can also be retrieved, so they can be tested retrospectively. This saves time, labour costs and reduces any reagents wastage. All data is then analysed on-board, removing issues related to human error and result manipulation.

About the Randox Evidence Series

The Evidence Series is set to revolutionise diagnostic testing forever. Offering unrivalled capabilities across all analysers, we truly believe that the Evidence Series range of immunoassay analysers can meet your diagnostic testing capabilities.

For more information on the Evidence Investigator, or any of the Evidence Series analysers, visit https://www.randox.com/evidence-series/ or contact us evidenceseries@randox.com.

 


Molecular Diagnostics from Randox Biosciences

Our Randox Biosciences division is a trusted partner in supplying quality diagnostic solutions to the Clinical, Life Science, Pharmaceutical, Research and BioPharma industries.

Our molecular product range offers diagnostic, prognostic and predictive solutions across a variety of disease areas including sexually transmitted infections (STI), respiratory tract infection, colorectal cancer, familial hypercholesterolemia (FH) and cardiovascular disease (CVD).

Additionally, we can provide a wide range of assay formats including single nucleotide polymorphisms (SNP) genotyping, pathogen detection and mutation detection. The arrays are optimised for use with the Randox Evidence Investigator semi-automated, medium throughput bench-top biochip analyser.

One test, 10 results.

Our STI multiplex array II simultaneously detects 10 bacterial, viral and protozoan infections including primary, secondary and asymptomatic co-infections for a complete infection profile. The assay is based on a combination of multiplex, PCR and biochip array hybridisation. Innovative PCR priming technology permits high discrimination between multiple targets. A unique primer set is designed for each target which will hybridise to a complimentary oligo-nucleotide probe spotted on a biochip discrete test region (DTR).

The combination of priming and spatially organised biochip array technology enables enhanced specificity of the assay. Analysis can be completed from template DNA through PCR to data readout in less than 6 hours. The array is validated for urine and swab sample matrices with up to 53 patient samples being processed simultaneously. The array is CE marked for routine clinical use.

Our STI Multiplex Array II includes tests for the following STIs;

Neisseria Gonnorrhoea (NG)                                       Mycoplasma Genitalium (MG)

Ureaplasma Urealyticum (UU)                                    Chlamydia Trachhomatis (CT)

Tricomonas Vaginalis (TV)                                            Haemophilus Ducreyi (HD)

Mycoplasma Hominis (MH)                                          Treponema Pallidum (TP)

Herpes Simplex virus I (HSV-1)                                   Herpes Simplex Virus 2 (HSV-2)

Randox Biosciences also offer four additional Molecular arrays.

For more information on our Molecular arrays please contact us by sending an email to Info@randoxbiosciences.com

 

 


Focus on Chronic Kidney Disease diagnosis (CKD)

Chronic Kidney Disease (CKD) is a long term condition which involves the progressive loss of kidney function a late diagnosis can result in end stage renal disease requiring kidney dialysis or transplantation. Typically, CKD is result of a combination of other conditions which puts a strain on the kidneys, these conditions can include high blood pressure, diabetes and high cholesterol amongst many other ailments.1

Randox Biosciences are continually researching and developing new tests, targeting various health concerns around the world to improve diagnostics and health worldwide. Recently, our dedicated scientists have developed a new test, utilising our proprietary Biochip Array Technology (BAT) that simultaneously and quantitatively detects multiple early biomarkers associated with kidney damage allowing for earlier intervention and treatment, preventing further kidney damage.

We offer two multiplex Chronic Kidney Arrays as shown below:

Early detection provides those diagnosed with the opportunity to alter their lifestyle in order to improve their kidney and overall health, whether that is through the reduction of salt in their diet, increased physical activity and alcohol limitation.

To find out more about the Chronic Kidney Disease Arrays offered by Biosciences email info@randoxbisociences.com

1 NHS – https://www.nhs.uk/conditions/kidney-disease/

 

 


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