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

 

 

 

 

 


The Evidence Evolution – The newest member of the Evidence series

Launched in 2016, the Evidence Evolution has set new standards in the world of clinical, forensic and food testing.

With the most extensive test menu on offer, we can provide more tests than any other supplier and we are continually investing in R&D to keep up with industry developments and challenges, such as our extensive clinical test menu with a range of routine and novel tests including our CKD panel which detects the early stages of Chronic Kidney Disease.

The Evidence Evolution utilises Randox’s cutting-edge Biochip Array Technology, offering diagnostic testing from a single sample. The Evidence Evolution boasts 2640 tests per hour and when put to the test against our competitor machines, the Evidence Evolution gives a true walk away time of up to 2 hours, meaning staff can fully load the machine and get up to 44 results from each sample every minute, while they get on with important laboratory tasks.

The Evidence Evolution has been designed to meet the needs of a variety of laboratories. Delivering quality results, efficiently and economically in forensic and clinical immunoassay locations.

The Evidence Evolution is the latest development in our Evidence Series range, which was first launched in 2002. This trusted technology is powered by Biochip and is used throughout the world in a range of different sites for clinical, toxicology and food testing. The Evidence Series has a range of analysers that can meet the need of any laboratory.

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

 

 

 

 


Biochip vs ELISA: Which testing platform is right for me?

Biochip Vs ELISA

Randox Toxicology’s latest video series, ‘Biochip Vs ELISA’, highlights our routine and novel ELISA products and how they differ from Biochip Array Technology.

Showcasing the journey and ongoing brand evolution of Randox Toxicology, these videos will help you to discover which method is right for you!

Episode 1: Meet ELISA

Episode 1 “Meet ELISA” uses speed reading to showcase Randox Toxicology’s extensive and ever-expanding ELISA test menu, including our range of New Psychoactive Substances, drugs of abuse, stimulants, analgesics and sedatives. Manufactured in the United Kingdom, our continuous reinvestment in research and development has enabled us to develop a range of exclusive ELISA kits such as, Mitragynine, MT-45, and U-47700 which was involved in the death of the famous singer Prince.

 

Our cost effective ELISA kits are the highest quality on the market and results provide excellent correlation with confirmatory methods, typically <10% CV.

Episode 2: Meet Biochip

Based on ELISA principles, Episode 2 “Meet Biochip” illustrates Biochip Array Technology as a solid-state device with discrete test sites onto which antibodies specific to different drug compounds are immobilised and stabilised. Moving away from traditional single analyte assays, Biochip Array Technology boasts cutting-edge multiplex testing capabilities for rapid and accurate drug detection from a single sample.

As the primary manufacturers of Biochip Array Technology, Randox Toxicology offer the most advanced screening technology on the market. With the world’s largest test menu capable of detecting over 500 drugs, Randox Toxicology are changing the landscape of drugs of abuse testing.

Episode 3: Biochip Vs ELISA

Episode 3 “Biochip Vs ELISA” gives you the opportunity to hear from a professional! Laura Keery our Senior Research and Development Team Leader gives you a behind the scenes look at our Biochip Array Technology and ELISA products in action at our new Science Park, answering some of those must know questions.

Episode 4: Biochip Vs ELISA 360-Degrees

If you missed it at SOFT-TIAFT 2017, our Biochip Vs ELISA 360-degree video allows you to experience Biochip and ELISA in action.

Discover which method is right for you! #biochipvselisa

For more information about our revolutionary Biochip Array Technology and ELISA kits, email info@randoxtoxicology.com or visit www.randoxtoxicology.com

 

 

 

 

 


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

 

 

 


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

 

 

 


The rise of drug abuse in India – Randox Toxicology

A recent study completed by the Narcotics Control Bureau (NCB) reported an all-time high of 3.6 lakh kg narcotic drugs seized in India in 2017, this was an increase of over 300 percent in the last five years. Known as ganja, cannabis is the most widely abused drug in India, increasing from 40,113 in 1999 to 352,379 by 2017, according to The Times of India.

(Sourced: The Times of India: Drug abuse on the rise in India, Ganja most in demand)

A prevalent issue in the north of India is pharmaceutical drug abuse, both over the counter and prescription drugs. The Times of India reported that 566,450 bottles of cough syrup, 58,463 injections and more than 6,300,000 tablets were recovered across India in 2017. Among the drugs being smuggled out of India and into countries such as America and Canada is the opioid painkiller Tramadol, which is not covered under the Narcotic Drugs and Psychotropic Substances Act.

With daily drug seizures across the country, the situation in India has been described as akin to the US national opioid emergency. Therefore, it has been suggested that a harm-reduction approach be taken to educate the young and tackling substance abuse.

Using our revolutionary Biochip Array Technology, the Evidence MultiSTAT is a fully automated analyser that enables on-site simultaneous detection of up to 21 classical, prescription and synthetic drugs from a single sample. Designed to work across a variety of matrices and generate results in under 20 minutes, Randox Toxicology have changed the landscape of drug detection forever.

For further information about the Evidence MultiSTAT and our cutting-edge multiplex testing capabilities, contact info@randoxtoxicology.com to be put in touch with a sales member or visit www.randoxtoxicology.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.

 

 

 


RCLS: Flexibility and Quality at the Core of Service

Randox Clinical Laboratory Services is a dedicated group of laboratories across the United Kingdom with plans to expand across the world. All of the clinical laboratories are purpose built to deal with the bespoke needs of research and clinical projects. Currently we have laboratories situated in Antrim, Holywood, Liverpool and London.

Flexibility and quality are at the core of our service offering and our experienced team are available to support and advise at each step of a project to ensure deadlines are met and high quality data is delivered in the most cost efficient manner.

Specialising in biomarker and multiplex testing in addition to standard safety and clinical testing, RCLS provides a full laboratory service to accelerate your project to completion. Our patented and globally recognised Biochip Array Technology (BAT), provides multiplex testing solutions in an accurate and precise format. Vast expertise in in-house antibody and assay development also allows for customised assays to be incorporated into your testing.

A key focus for RCLS, utilising this technology (BAT) and the ability to customise, is esoteric/niche biomarker analysis within clinical trials. Randox has been providing custom assay design, development and manufacturing services to the diagnostic, pharmaceutical, contract research and biotech industries for many years. This also includes fully customised human and animal quality control sera. We have the facilities to design a novel multiplex biochip tailored to each customer’s requirements taking into account sample types, available sample volumes and expected ranges for various analytes of interest.

Our assay development specialists will endeavour to work with you to ensure your needs are constantly met and provide a smooth process from the time of your first enquiry through to final delivery.

If you would like more information on RCLS please contact info@rcls.com


Clinical Laboratory Survey