Our Technology
Our Technology
Genomic Laboratory Technologies
Relatively new to the Randox Group is our Randox Genomics Services department, having been hugely successful in aiding the COVID testing programme, our established sequencing laboratory has been specifically designed and set up to fulfil a unique range of testing from our specialised laboratory in Northern Ireland.
Nucleic Acid Extraction and Isolation
Thermo Scientific KingFisher Flex
Automated nucleic acid extraction instruction that provides high throughput purification of up to 96 samples per run within 40 minutes.
Sample Quality Control
ThermoFisher Scientific Qubit 3.0 & Qubit Flex
Capable of fast and specific nucleic acid quantification using fluorescence-based dye application, suitable for a lower throughput. More sensitive and accurate protocol than UV absorbance.
ThermoFisher Scientific Varioskan LUX
Capable of rapid fluorescence-based UV absorbance nucleic acid analysis, suitable for high throughput of processing samples.
Agilent 4200 TapeStation System
An automated electrophoresis solution that with a scalable throughput (1-96 samples) can provide results in 1-2 minutes per plate with excellent reproducibility for sizing, concentration and integrity assessment.
Liquid Handling
Tecans
Freedom EVO 150 base unit tecans, are automated liquid handling machines, enabling fully traceable, scalable (1-96 samples) automated library preparation including QC and library pooling.
Integra Viaflo 384
Viaflo 384 enables transfers of 24, 96 and 384 samples in a single step, thus increasing pipetting throughput and reproducibility significantly.
Integra Assist Plus
Pipette adapter: accommodates all Integra electronic multichannel pipettes- with fixed and adjustable tip spacing and the D-One single channel pipetting module.
Sequencing
Applied Biosystems SeqStudio Genetic Analyser
Low-throughput benchtop system that delivers gold-standard Sanger sequencing technology and fragment analysis, easily used across a broad range of applications.
Next Generation Sequencing
MiSeq
The MiSeq System is capable of automated paired-end reads and up to 15 Gb per run, delivering over 600 bases of sequence data per read.
NextSeq 2000
NextSeq 2000 System supports emerging and mid-throughput sequencing applications as well as a broad range of methods such as exome sequencing, target enrichment, single-cell profiling, transcriptome sequencing, and more. It offers an intuitive workflow with load-and-go ease and visual cues about run status. The NextSeq 2000 allows whole-exome sequencing of up to 48 samples in 33 hours.
NovaSeq6000
The most powerful sequencing instrument Illumina produce with the ability to provide scalable throughput for efficient whole-genome, whole exome and whole-transcriptome sequencing through sequencing by synthesis and patterned flow cell technology.
Genotyping
Illumina iScan
An innovative array scanner that supports rapid, sensitive, and accurate imaging of Illumina BeadChips for exceptional genetic analysis results. The iScan System can scan thousands of array samples per day, without sacrificing data quality or reproducibility. It supports an expansive portfolio of genetic analysis assays, from high-throughput genotyping to DNA methylation analysis.
Useful Resources
CDx & Biopharma Services
Next Generation Sequencing (NGS)
Next Generation Sequencing
Next-generation sequencing (NGS) is a sequencing technology that offers speed, scalability and ultra-high throughput. The technology can be used to determine the order of nucleotides in entire genomes or targeted regions of DNA or RNA. NGS has applications in environmental, agricultural and forensic science as well as genomic and clinical research.
NGS Capabilities
Whole Exome Sequencing (WES) is a wildly used NGS method that involves sequencing every protein coding region (approximately 21,000 genes) to identify any variants that may increase the risk of developing certain conditions or impact health/lifestyle. WES can be used across a broad range of applications including genetic disease, population genetics and cancer studies.
Advantages
- Attains widespread coverage of coding regions
- Cost effective alternative to Whole-Genome Sequencing (WGS)
- Smaller data set provides faster and easy data analysis compared to WGS approaches
Human Whole Genome Sequencing (hWGS) involves sequencing very single base in your DNA (approximately 3.2 billion) to identify any variants that may increase the risk of developing certain conditions or impact health/lifestyle. This sequencing method has many applications including identifying genetic disorders, mutations responsible for cancer progression, as well as monitoring disease outbreaks.
Advantages
- High-resolution view of the genome
- Detection of all variant types
- Low cost, fast library preparation
16s rRNA gene sequencing involves the analysis of the prokaryotic 16s ribosomal RNA gene which is found in all bacteria and archaea. This sequencing approach is extremely useful for microbiome research studies. 16s rRNA gene sequencing has a number of applications including, environmental, clinical and food
Advantages
- Identification and taxonomic classification of bacterial species
- Fast speed and cost efficient
- Discovery of novel pathogens
Shotgun sequencing reads all the genomic DNA in the sample, rather than just one specific region. This sequencing method provides a vast amount of genetic information as it can identify archaea, bacteria, fungi and viruses.
Advantages
- Less labour intensive than other sequencing methods.
- Faster process than clone-clone sequencing
- Requires less DNA
qPCR
qPCR allows for the analysis of particular variants of specific locations. It is a good choice when interrogating a small region of DNA on a limited number of samples. Real-time PCR can be used for both qualitative and quantitative analysis.
Advantages and Applications of qPCR
Next Generation Sequencing (NGS) Advantages
High sample throughput
High sensitivity
Comprehensive genomic coverage
Can sequence thousands of genes simultaneously
- Low sample input required
Fast turnaround time for high sample volumes
Related Services
CDx & Biopharma Services
Genotyping Services
Genotyping Services
The Randox Genomics Services Department currently has target genotyping solutions in multiple areas. Genotyping is the process of analysing DNA to detect SNPs of interest. These SNPs are compared to reference SNPs, available from years of genetic research, to determine differences in genetic makeup.
Genotyping Advantages and Applications
Clinical Diagnostics
Clinical Research
Food & Agriculture
Pharmacogenomics
Pharmacogenomics (PGx) is the study of how a person’s DNA effects their drug response. This is a relatively new field in science but it is expected to be the future of medicine as it focuses on personalised medicine and treating every patient individually.
Microarray Technology for PGx
At Randox we use Illumina’s Infinium Global Diversity Array with Enhanced PGx microarray to test for pharmacogenomic markers. This is the most comprehensive genotyping microarray on the market for pharmacogenomic research. The microarray features over 44,000 genome-wide PGx markers which span more than 20000 pharmacogenomic targets and gives 100% coverage of priority level A and B CPIC genes.
Related Services
CDx & Biopharma Services
Genomics Services
Genomics Services
An End-to-End Genomics Solution
Randox Genomics Services department is fitted with specialised, fully equipped, state of the art testing facilities, designed and set up to fulfil a unique range of end-to-end sequencing solutions inclusive of in-house bioinformaticians and data analysts.
Why Randox?
Randox Laboratories is a global market leader within the in vitro diagnostics industry. Utilising a multitude of platforms, our sequencing and genotyping facility is suited to a wide range of areas of genome sequencing.
Our team of genetic scientists and bioinformaticians provide customisable sequencing and genotyping services for research, development, validation and running of different genomic tests to generate high quality data in line with modern healthcare and future disease insights.
A dedicated team of genetic scientists including automation specialists, enabling adaption to testing throughputs changes from call small projects to large scale testing.
Huge capacity for storage and accessioning of multiple sample types with fast turnaround times.
Specific customised project planning and validation of services, tailored to the needs of each Randox customer.
Multiple options for variable throughput from low throughput instruments, to the largest sequencer on the market with targeted solutions in multiple areas.
- Targeted genotyping solutions in multiple areas
Our Services
Related Services
CDx & Biopharma Services
OLINK
OLINK® | Comprehensive Biomarker Discovery
Let Experts at Randox Run Your Samples
As one of the UK’s first commercial partners of Olink® Proximity Extension Assay (PEA) technology, a sensitive and high-throughput technology. In PEA, pairs of oligonucleotide-labeled antibodies are used to capture and detect target proteins, and the proximity of the antibodies leads to the formation of a DNA amplicon that can be quantified by qPCR or Next Generation Sequencing (NGS).
Randox offer scientists involved in drug development, clinical, or basic life science research, the service they need to run large-scale discovery proteomics.
Considered as a next-gen proteomics platform, Olink® technology is widely recognised and extensively cited in various research fields for protein profiling and biomarker development.
As an Olink® Certified Service Provider, Randox are experts in generating high-quality data using all Olink® proteomic platforms.
Supported Olink® Platforms
Proteomics are critical for understanding disease pathology and accelerating protein biomarker discovery.
Randox Service portfolio includes high throughput protein analysis using cutting-edge Olink® technology, a significant leap forward in next generation, disruptive proteomics with proven specificity. We are experts in generating high-quality data using all Olink® proteomic platforms.
Allow the Randox team to assist you in discovering how this versatile assay can advance your research by getting in touch.
Olink® Explore HT
Proteins (per panel): 5,400 + with proven specificity of 99.5% negligible cross-reactivity
Sample: 2 µL
Multiplex Panels: 1
Quantification: Relative with NGS automated workflow readout
Olink® Explore 384
Proteins (per panel) ~3000 high-multiplex biomarker discover with uncompromised data quality
Sample: 1 µL
Multiplex Panels: 8
Quantification: Relative
Olink® Target 96
Proteins (per panel) ~ 1100 covering 15 panels for biological processes and disease areas
Sample: 1 µL
Multiplex Panels: 15 with 92 proteins per panel
Quantification: Relative
Olink® Target 48 Cytokine
Proteins (panels): Each panel contains up to 45 immune-related proteins. These two panels can be combined and processed simultaneously.
Sample: 1 µL
Multiplex Panels: 1
Quantification: Relative
Olink® Flex
Proteins (per panel) ~200 within the complete protein library. Each panel contains between 15-21 proteins.
Sample: 1 µL
Multiplex Panels: Mix & Match with combinability of 99% compared to industry-leading standards.
Quantification: Relative or absolute
Olink® Focus
Proteins (per panel) 5400+ with proven specificity. Custom panels with up to 21 proteins for actionable clinical breakthroughs, designed to empower biomarker utility.
Sample: 1 µL
Multiplex Panels: Custom
Quantification: Relative or absolute
Features and Benefits
- Covers all major biological pathways with ~5400 + validated protein assays
- High sample throughput for large scale proteomic studies and research
- Minimal sample volume with just 60uL for the complete library
- Exceptional specificity in comparison to mass spec utilising PEA technology
- Compatible with a wide variety of sample types
Olink® Workflow
Randox Successfully Completed Olink® Concordance Testing
Randox successfully completed the Explore Concordance challenge as beta testers of the Concordance program, certifying the ability to operate the PEA with the same level of competency as the Olink® Analysis Service.
| Randox Summary Report | Acceptance Criteria | Result | |
|---|---|---|---|
| QC Warnings | 0% | Max 16% allowed | Passed the QC warning criteria |
| Detectability | 97.2% | Min 85% allowed | Passed the detectability criteria |
| Intra CV | 9% | Max 15% allowed | Passed the CV criteria |
| Median correlation coefficient (r) | 0.98 | Min 0.9 allowed | Passed the correlation criteria. |
| Coefficient of determination (R2) | 0.96 | Min 0.9 allowed | Passed the correlation criteria. |
Overall, Randox passed all QC criteria, successfully passing the Olink Concordance Test on Explore 3072.
Related Services
CDx & Biopharma Services
Randox Biosciences Resource Hub
CDx & BioPharma Services
CDx & BIOPHARMA SERVICES
Offering a collaborative CDx partnership approach.
As an established IVD company, Randox Biosciences offers tailored development and testing solutions to support faster, more effective and safer development of new drugs.
We have a wide range of in-house capabilities, ranging from the selection and patenting of novel biomarkers; manufacture of bioreagents; production of single and multiplex RUO and IVD grade tests; quality control; provision of clinical laboratory services; regulatory expertise and worldwide distribution.
Why Partner with Randox?
Pharmaceutical and biotech companies are increasingly investing in the research and development of new therapies to address the world’s growing need for earlier and more effective patient treatment.
Randox Biosciences is dedicated to the improvement of personalised diagnostic, prognostic, and predictive assays. We aim to help Pharma Biotechs and CROs move away from a “one treatment fits all” approach and help get a better understanding of the complexity and variability of diseases and increase efficacy of treatment. A key element to realizing the potential for personalized medicine is companion diagnostic (CDx) development. Randox have key expertise in all elements of CDx and diagnostic development and offer a fully flexible partnership to accommodate your needs, providing you with tailored protein & molecular assays.
Randox Biosciences can be your CDx and biomarker assay development partner from early phase trials through to drug launch, addressing all assay requirements in the process, including development of raw materials and assays, verification and validation studies, clinical trial sample analysis, regulatory submissions and co-commercialisation.
Complete CDx Partner Approach
CDx Assay Formats
Randox Biosciences is focused on advancing precision medicine through high quality, flexible assay development. We can offer the full package of Diagnostic and CDx assay development with a range of technologies and platforms for use in clinical trials.
We invite researchers to design their specific multiplex custom array, containing selected biomarkers, ensuring maximum output from a limited sample supply. Our proprietary multiplex biochip array technology can be used in early exploratory biomarker stages and can be brought through to IVD/CDx grade.
CDx Drug and Diagnostic Development Process
Development of Raw Materials
- Extensive portfolio of over 900 products for R&D applications
- Products manufactured under ISO13485 accreditation including mAbs, PAS, HRPs, sdAbs, scFvs
- Capable of custom antibody and protein development
Assay Development
- Randox offer a range of technologies and platforms for use in clinical trials
- Our Biochip technology can be used in early exploratory biomarker stages and brought through to IVD/ CDx grade.
- Comprehensive OEM capabilities for developing assays on any platform.
- Assays developed under full design control and ISO13485 accreditation
Sample Testing
- ISO17025, ISO15189 and GCP accredited laboratories located throughout the UK, Ireland and USA.
- Randox Clinical Laboratory Services (RCLS) can be used to meet bespoke sample analysis needs.
- Strong global network with 3rd party laboratories to ensure clinical trial requirements are met across the world.
Verification & Validation
- Performance of in depth multi lot verifications following CLSI guidelines to ensure full performance requirements are met
- Provide support for regulatory submissions and approvals
- Validation of assay performance and reproducibility across multiple sites
Regulatory Submission
- Experienced in-house regulatory teams provide FULL regulatory support preparing IVD/ CDx submissions and applications for approval.
- Regulatory and Development teams work closely in collaboration with the pharma partner to ensure a timely submission while keeping in line with country specific requirements
- 954 licences across the globe and over 3800 licensed products
Commercialization
- Pre and Post launch support with laboratory, clinician, patient and KOL engagement.
- Strong global laboratory and distribution networks, in house sales and marketing teams, with operations in over 145 countries.
- Capable of manufacturing customised sample collection kits under full design control
Randox Platforms
Biosciences Overview
Your Next Trusted Partner
What we do.
As an established IVD company, Randox Biosciences offers tailored development and testing solutions to support faster, more effective and safe development of new therapeutics. We aim to advance scientific discovery, drug development & diagnostics.
From initial cultivation of raw materials for assay development, through to providing companion diagnostics, molecular and protein based custom assays across a range of therapeutic areas, we assist Pharma, Biotechs and CROs move away from a “one treatment fits all” approach. Our aim is to advance the future of personalised medicine approaches to enable a better understanding of the complexity and variability of disease and increase efficacy of treatment.
Randox Biosciences are your next trusted partner to achieve precise results, for faster drug approval through successful assay design, validation, registrations and co-commercialisation globally.
Randox Biosciences are a world leading manufacturer of Bioreagents including, high -quality monoclonal and polyclonal antibody fragments and human recombinant proteins to assist diagnostic manufacturers. We also strive to assist clinical trials globally to reach their potential with the ability to provide multiplex technology, custom assay development, along with outsourcing solutions for testing.
Additionally, Randox Biosciences provides a wide range of assay formats including single nucleotide polymorphisms (SNP) genotyping, pathogen detection and mutation detection. Offering complete flexibility to achieve success in any collaborative partnership, assay development can be optimised for use on a wide range of third-party instruments and with the Randox Evidence Series – Biochip Technology platforms.
Our Expertise.
CDx & BioPharma Services
RCLS Testing
BioReagents
Biosciences Resource Hub
Randox Biosciences and Metabolic Syndrome
The Evidence Evolution is a fully automated immune-analyser with random access. The machine has the capability to process up to 2640 tests per hour with up to 44 analytes screened per biochip. With a wide range test menu Randox can offer the market the service they expect with state-of-the-art intuitive touchscreen software and advanced precision bio-drive robotics.
Metabolic syndrome is described as a combination of diabetes, high blood pressure and obesity. As result of three health conditions going on, it puts the individual at greater risk of developing coronary heart disease, stroke and many other risks. 1 As well as developing additional health conditions it can cause damage to the blood vessels, the blood pressure damages the blood vessels, the obesity causes a lot of strain on the blood vessels and the heart.2 Therefore, can result in serious long-term risks.
Metabolic disease is very common. Studies state that the serious health condition affects about 23% of adults. 3One in four adults in the UK are currently living with metabolic syndrome and often becomes more common with age2.
Usually it affects those who are overweight or considered obese, have an unbalanced diet containing high levels of sugar and fat and have high cholesterol and extremely high blood pressure2 therefore, the condition can be prevented by reducing the risks.
1 According to the NHS, metabolic syndrome occurs when a person has three or more of the following measurements:
- Abdominal obesity (Waist circumference of greater than 40 inches in men, and greater than 35 inches in women)
- Triglyceride level of 150 milligrams per deciliter of blood (mg/dL) or greater
- HDL cholesterol of less than 40 mg/dL in men or less than 50 mg/dL in women
- Systolic blood pressure (top number) of 130 millimeters of mercury (mm Hg) or greater, or diastolic blood pressure (bottom number) of 85 mm Hg or greater
- Fasting glucose of 100 mg/dL or greater
There are many ways to prevent metabolic syndrome from developing, making lifestyle changes for example, ensuring their weight is healthy by increasing physical exercise, eating a well-balanced healthy diet containing whole grains, fruit, vegetables and fish and finally, visiting the GP to monitor and manage blood glucose, blood cholesterol and blood pressure, quit smoking and managing your stress.
Randox offers the Evidence Evolution including two Metabolic Syndrome Arrays which allows multiplex testing from a single sample allowing rapid turnaround time and are suitable for both serum and plasma samples.
Metabolic Syndrome Array I
- Ferritin
- Interleukin-6 (IL-6)
- Insulin
- Leptin
- Plasminogen Activator Inhibitor-1 (PAI-1)
- Resistin
- Tumour Necrosis Factor α (TNFα)
Metabolic Syndrome Array II
- Adiponectin
- C-reactive Protein (CRP)
- Cystatin C
For more information on our Evidence Series or Metabolic Syndrome Range of Assays, contact us at EvidenceSeries@randox.com
Randox Biosciences and Familial Hypercholesterolemia (FH)
Familial Hypercholesterolemia (FH) is a genetic disorder where the child is born with extremely high cholesterol levels. FH can trace back through several generations. Cholesterol is vital for the normal function of the human body therefore, it is important to ensure the cholesterol levels don’t get too high because it can result in early onset cardiovascular disease. 1
The FH Foundation states an interesting fact that 1 in 250 people worldwide have FH and over 90% of these people have not been properly diagnosed 2. Majority of these people won’t know they have FH disease until they have a heart attack!
However, there are no clear symptoms if someone has FH until it is too late and the damage has been done. The warning signs include the following:1
- Swollen tendons/fatty lumps on the knuckles of your hands, at the back of your ankles and knees
- Cholesterol deposits around the eye-lids (looks like pale and yellowish patches)
- Gray-white cholesterol deposits around the corneas
A study in 2008 by the British Heart Foundation found that people with FH who are diagnosed and treated before they develop heart disease live as long people who don’t have FH 4. This theory emphasis the importance of getting early diagnosis to prevent long-term problems. Treatment to prevent cardiovascular disease involves taking medication prescribed by the doctor and making lifestyle changes including; modifying diet, increasing exercise, quit smoking, decrease drinking alcohol and ensure the patient gets regular sleep.
Randox offers the Familial Hypercholesterolemia (FH) Arrays I & II to help encourage early diagnosis with rapid turnaround time allowing results to be reported within days compared to NHS waiting lists which can be substantially longer. The two arrays are rapid, simple and accurate which enables the simultaneous detection of 40 FH-causing mutations (20 mutations per array) within the LDLR, ApoB and PCSK9 genes. The mutational status can be determined rapidly from a single test, with a reduced need for confirmatory testing with NGS. The genetic analysis for FH mutations allows for more accurate diagnosis compared to lipid profiling.
Randox can help using the award-winning Biochip Analyser to achieve early and appropriate treatment for those with FH resulting those to adopt a healthier lifestyle and taking cholesterol-lowering medication, risk of heart disease to live a longer and healthy life!
Familial Hypercholesterolemia (FH) Arrays I & II:
- LDLR – 38 mutations
- APOB – 1 mutation
- PCSK9 – 1 mutation
To find out more about the products that we offer email us info@randoxbiosciences.com
Reference:
https://www.healthline.com/health/familial-hypercholesterolemia#symptoms
