Discussing Companion Diagnostics with Dr Miguel Quesada-González

Discussing Companion Diagnostics with Dr Miguel Quesada-González

You may have heard of Companion Diagnostics. This type of diagnostic provides information that is essential for the safe and effective use of a corresponding drug or biological product. It can help to stratify groups of patients which will respond safely to a clinical drug trial, and those who may suffer undesirable side effects.

But why are Companion Diagnostics useful?

Randox Biosciences Pharma Relationship Manager Dr Miguel Quesada-González, PhD has the answer.

“As part of my new role, I’ll be supporting drug development and clinical trials. So as a scientist by background (the nature of the beast) I’ve been reading into and researching this incredibly interesting area of science.

“Since Day 1, Companion Diagnostics (CDx) especially caught my eye.

“When it comes to new drug development, either for Pharma or Biotech, there are many benefits of running a CDx. Based on well-acknowledged scientific papers that I have read, and my own personal perception of the current situation, I’d like to summarise and simplify in just 2 bullet points, what I personally believe to be the most important benefits of running a CDx.

“(a)  Delivering the right treatment to the right patient at the right time.

“We should never forget that our priority is the health and integrity of patients. It’s been proven that patients who have similar diagnoses very often respond differently to the same treatment. This variability presents a risk in both the efficacy of the treatment and the safety of the patient.

“The development of a drug is already a risky, long and costly process, so wouldn’t you like to avoid the initial high risk by having a good defined target initially?

“(b)  Saving time.

“Money is valuable but time even more so. Time is precious and priceless. Once it’s gone, there’s nothing we can do about it!

“The smaller and more targeted the clinical trials are, the less time and resources you’ll be spending. Normally, the CDx is not initiated until a drug has reached the later stages of development, but, actually, if you put the CDx in place at early development stages (preclinical) it presents many advantages because it enables the selected biomarker to be validated and determined before large amounts of resources have been put in place.

“The faster a potential treatment is developed and approved, the more people you can save, cure or simply improve their quality of life.”

For further information on Companion Diagnostics from Randox Biosciences please email us at info@randoxbiosciences.com

Dr Miguel Quesada-González, PhD, Randox Biosciences Pharma Relationship Manager

 

 

 

 

 


Your outsourcing solution enhanced by Randox Biochip Array Technology

Randox Clinical Laboratory Services (RCLS) strives to provide a clinical laboratory service to meet the time sensitive, bespoke requirements of research and clinical projects globally.

RCLS utilises the expertise and knowledge Randox has built up over 35 years producing high quality IVD products. Many years of development and the expertise of highly qualified scientists from Randox has been invested to create the Biochip Array Technology (BAT) – a multi-analyte testing platform facilitating the simultaneous quantitative or qualitative detection of a wide range of analytes from a single sample.

Biochip Array Technology provides a unique platform for assessment of biological samples in a rapid, accurate and easy to use format and users can have the utmost confidence in this proven technology.

A chemically activated 9x9mm ceramic biochip acts as a solid phase reaction vessel. Biochips are pre-fabricated with discrete test regions (DTRs); a different antibody/oligonucleotide is immobilised at each spatially distinct DTR. Up to 49 individual DTRs can be arrayed on to a single biochip with one biochip per sample used to generate multiple results simultaneously.

This eliminates the need to run costly, time consuming and sample intensive single analyte assays. The biochip detection is based on a chemiluminescent signal emitting light, without heat, as a result of a chemical reaction. The light emitted is simultaneously detected and quantified using a CCD camera.

Overall, by utilising Randox Clinical Laboratory Services you can save your laboratory time and money. Due to our multiplex panels we offer a cost-effective, labour-saving and time-reducing solutions for your sample testing. As a result we provide your laboratory with the best solution to outsource your sample.

If you would like to find out more information about RCLS you can visit dev.randox.com/rcls

Or for any additional questions on what it has to offer you can email the RCLS team at info@rcls.com

 

 

 

 


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

 

 

 


Sir AP McCoy and father of late “King of Heswall” team up for Randox Health Week

Almost a year to the day of the tragic death of the “King of Heswall” Tim Cogley, his father will be joined by some of the UK’s best-known sports stars at an event in Liverpool to raise awareness of how lives can be saved through improving access to earlier routine health screening.

On April 9th 2017 Tim, who was only 34-years old, suffered a fatal heart attack due to a genetic condition which could have been managed had it been diagnosed earlier. It spurred his father, Frank Cogley, to set up a charity to raise awareness of the importance of health checks for young people.

He’ll be joined at the free Randox Health Week event in Exchange Station on 11th April by legendary jockey Sir AP McCoy, champion boxer Paul Smith and Olympic sailor Matt McGovern. The public will be invited to join the discussions as well.

Frank said: “It’s been recently reported that at least 12 under-35s die from undiagnosed heart conditions every week in the UK. The current lack of routine screening of 18-40-year olds leaves a gaping chasm in our healthcare provision. With our highly motivated partners, through events like this, we hope to redress this through lifestyle changes and preventative medical programmes. The ‘Tim Cogley Cardiac Screening Foundation’ is committed to delivering positive, action-focused and life-changing programmes. I can’t imagine a legacy more in tune with the generous, kind and supportive person that was Tim!”

This is the second year that Randox Health Week has been held in the city. The areas of mental health and active cities will be explored on days one and two – the 9th and 10th respectively. On each of the mornings, local athletes Franny Norton and Derry Mathews will be putting pupils to the test with a range of sporting activities at LJMU’s Byrom Street campus.

By working with the city’s leading universities – Liverpool John Moores and Liverpool Hope – cutting-edge innovations in healthcare and emerging trends are being shared with a global audience. One such ground-breaking development is a test for prediabetes which is key to tackling the worldwide threat of preventable cases of Type-2 diabetes. It’s something that legendary jockey Sir Anthony McCoy, also taking part in Wednesday’s talk, has first-hand experience of:

“When I got my first test results back that said I had prediabetes, it floored me. I had never imagined that I, someone who had been a professional athlete all of my life, could develop it. It just goes to show that we’re all vulnerable. I only wish it had been around when it could have helped my mum who lived with Type-2 diabetes for many years. As daunting as it was getting the diagnosis, it’s been empowering to very simply make lifestyle changes to reverse it. This needs to be accessible to everyone – it needs to be on the national diabetes screening programme.”

Dr Peter FitzGerald, Managing Director of Randox Health, commented: “The themes we’re focusing on this week are some of the most important global concerns facing us today – mental health, physical activity and showing people the benefits to being proactive about their health, rather than facing the consequences of preventable sickness. You need look no further than Frank Cogley who is working tirelessly to turn his son’s tragic death into a force for good to see how important this is. With the support from AP McCoy and Paul Smith, we hope this event will inspire many people in the city and beyond.”

Tickets are free and can be reserved at www.eventbrite.co.uk/e/randox-health-week-2018-tickets-43648350391

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

 

 

 

 


Biochip Carrier Applications in the Randox Evidence Series

Biochip Array Technology is the fundamental component which drives the Randox Evidence Series immunoanalysers. The simultaneous detection of multiple analytes from a single sample allows for a complete patient profile, providing exceptional time, resource and cost savings.

The Evidence Series analysers all carry the Biochip in different applications. In order to gain a better understanding of how it is utilised, the illustrations below demonstrate how adaptable and flexible the technology is across the Evidence Series.

Evidence Evolution

  • One strip contains 10 biochips
  • Analyser can hold 20 strips
  • Can produce a throughput of up to 2640 tests per hour

Evidence

  • Each cassette contains 10 carriers
  • Each carrier has 9 wells
  • Analyser can hold 4 cassettes at once
  • Can produce a throughput of up to 3960 tests per hour

 Evidence Investigator

  • Analyser holds 1 cartridge
  • 1 cartridge contains 9 wells
  • Thermoshaker capable of carrying 6 cartridges
  • Can produce a throughput of up to 2376 tests per hour

 Evidence MultiSTAT

  • Analyser holds 1 cartridge
  • Cartridge comes pre-loaded with reagents and QC
  • Can produce a throughput of up to 132 tests per hour

 

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 any of the Evidence Series analysers, visit https://dev.randox.com/evidence-series/ or contact us evidenceseries@randox.com.

 

 

 


Welcome to the Evidence Series

Introduction

For over 30 years, we have been researching and manufacturing market-leading diagnostics products globally. With a mission statement of ‘dedicated to improving health worldwide’ the patient needs are a central focus of everything we do. It is this experience and commitment to improving healthcare that has allowed us to continually improve our product offering and make advancements globally to reach as many people as possible and provide greater diagnostic facilities.

From this experience and commitment to research, we believe we have developed a technology that has changed diagnostic testing forever.

Biochip Array Technology

In 2002, we invented a world first, which changed the landscape of diagnostic testing forever. Biochip Array Technology is a precision multiplex testing platform allowing for the simultaneous quantitative or qualitative detection of a wide range of analytes from a single sample.

Biochip Array Technology uniquely offers immunoassay diagnostic testing for simultaneous multi-analyte biomarker detection. After addition of a single patient sample to the biochip, analytes present in the sample bind to the specific biochip bound ligands. The degree of binding is determined using a chemiluminescent light source and quantified using a Charge Coupled Device (CCD) camera and imaging system.

An individual biochip has up to 49 Discrete Test Regions with each detecting a different biomarker. That means up to 44 tests can be carried out simultaneously, with the additional DTRs being reserved for visual quality control and visual reference; a feature unique to Biochip Array Technology.

The Evidence Series

Having developed this patented technology following £250 million investment in research and development, we needed a platform that allowed Biochip Array Technology capabilities to be showcased. Step forward the Evidence Series. The series includes the Evidence, the Evidence Evolution, the Evidence Investigator and the Evidence MultiSTAT. Each analyser has been designed and built with boundary pushing engineering, to ensure financial, labour and time savings for the end user.

Have a read below of the brief overview of each analyser in the Evidence Series

Evidence Evolution

The world’s first fully automated random-access biochip testing platform, the Evidence Evolution is the world’s most advanced immunoanalyser. With the capability to process up to 2,640 tests per hour, the Evidence Evolution offers complete system integration, as well as the most comprehensive test menu on the market.

Evidence

As the world’s first Biochip Array Technology system, the Evidence immunoanalyser has revolutionised laboratory screening worldwide. With the capability to process 3,960 tests per hour and a sample capacity of 360, the Evidence is ideal for use in a high throughput laboratory.

Evidence Investigator

The Evidence Investigator is a compact, semi-automated benchtop immunoanalyser that offers efficient and comprehensive testing across a range of applications including clinical diagnostics, molecular, toxicology and food diagnostics. The Evidence Investigator boasts a throughput of up to 2,376 tests per hour, offering efficiency without compromising on accuracy.

Evidence MultiSTAT

The Evidence MultiSTAT is a fully automated immunoanalyser that enables on-site simultaneous detection of up to 44 analytes from a single sample of oral fluid, urine or blood. With a three-step process and results generated in less than 20 minutes, the Evidence MultiSTAT is an ideal solution for those with no knowledge of laboratory procedures and offers a throughput of up to 132 tests per hour.

 

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 any of the Evidence Series analysers, please visit http://dev.randox.com/evidence-series/ or contact us evidenceseries@randox.com.


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