Advancing scientific discovery, drug development and diagnostics

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Introduction

Biochip Array Technology (Multiplex Testing)Key Features & Benefits Biochip Array Technology WorkflowMultiplex PlatformsMultiplex Arrays - Proteins & ToxicologyCustom Assay DevelopmentA-Z Custom Biochip Test MenuToxicology Test MenuMultiplex Molecular Arrays

Companion Diagnostics

Antibodies & Human Recombinant ProteinsProduct Portfolio Key Features & Benefits Custom Development Services

Clinical ChemistryReagentsRX series of clinical chemistry analysersRX Test Menu

Quality Management SolutionsAcusera Internal Quality ControlsAcusera 24•7Customised Quality Control SeraAvailable analytes for customised QC

External Quality AssessmentRIQASAvailable Programmes

Publications

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CONTENTS

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Spanning four key divisions; Life Sciences, Pharma Sciences, Research and Molecular; Randox Biosciences offers complete tailored solutions for clinical and research use.

From initial cultivation of raw materials for assay development, through to providing companion diagnostics, custom and molecular based assays across a range of therapy areas; Randox Biosciences is a trusted partner supplying quality diagnostic solutions to the clinical, life science, pharmaceutical, research and biopharma industries.

Introduction

Therapeutic AreasRandox Biosciences extensive product range covers over 400 separate biomarker assays for routine and esoteric testing across a broad range of therapeutic areas including:

• Cardiovascular & Cerebrovascular• Metabolic & Nutrition• Immunology• Oncology• Endocrinology• Rheumatology• Nephrology• Neuroscience• Pulmonary & Respiratory• Infection• Ophthalmology

Randox Laboratories is an international clinical diagnostic solutions company with over 30 years’ experience in the industry. Randox is a global market leader, providing revolutionary products for laboratories worldwide and is dedicated to improving health.

Randox Biosciences is part of Randox Laboratories and is dedicated to advancing scientific discovery, drug development and diagnostics.

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Biochip Array Technology

Exquisite precision in multiplex testing

Many years of development and the expertise of highly qualified scientists have gone into the creation of 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 (DTR’s); a different antibody/oligonucleotide is immobilised at each spatially distinct DTR. Up to 49 individual DTR’s 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 singleplex Elisas.

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.

Applications:

• Academic Research• Drug Development (CRO’s and Pharma)• Molecular Research and Diagnostics• Forensic and Clinical Toxicology

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Key Features & Benefits

Biochip Array Technology workflow

Highly accurate testing

• Fully validated arrays offering reproducible testing with CV’s <10%

• Multiplex analysis minimises analytical variation between tests

Consolidated testing

• One platform/system for immunoassays and nucleic acid testing

• Custom biochip arrays eliminates requirement for multiple Elisas

Cost consolidation

• Multiplex testing reduces the amount of time spent on individual tests and associated lab costs

Reduced sample volume

• Multiple biomarker results from as little as 7µl conserves valuable sample

Wide test menu

• Expanding menu of routine and novel biomarkers plus custom array development

Multiple sample matrices

• Multiple matrices can be used with BAT including serum, plasma, whole blood, urine, oral fluid, extracted DNA and alternative matrices

Extensive quality control features

• Internal controls on each biochip ensure optimum assay performance

• Multi-analyte QC sera standardised to WHO/NIBSC reference material where available

Result traceability

• Bar-coded biochips and scanner for patient samples ensures complete traceability of results

Retrospective Reporting• Retrieve previously unreported results without additional

testing, saving time

Biochip Array technology operates via the Evidence series of analysers designed to deliver efficient high-quality testing and significant time and cost savings.

The following workflow represents that of the semi-automated Evidence Investigator analyser, however Biochip Array Technology also operates on fully automated instruments such as the Evidence which is CE marked and FDA 510K cleared.

Addition of assay reagents and sample to

the biochips

Place in thermoshaker and

incubate

Wash biochips Biochip carrier loaded into Evidence

Investigator

Automatic biochip imaging and

result processing

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Multiplex Platforms

Biochip Array Technology

Investigator

The bench-top semi-automated Evidence Investigator is the world’s first platform with the unique ability to consolidate immunoassay and nucleic acid testing. In addition, the Investigator boasts the most comprehensive test menu on the market with a full custom panel service available.

Evidence

The Evidence analyser is the world’s first protein Biochip Array Technology system and has transformed laboratory screening worldwide. This fully automated platform, which is CE marked and FDA 510K cleared, is suited to the larger laboratory. The Evidence offers a throughput of >1500 tests per hour.

Evolution

The Evidence Evolution is the world’s first fully automated random access biochip testing platform with the ability to process up to 2,640 tests per hour and comes equipped with intuitive software, highly innovative robotics and sample processing technology.

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Multiplex Arrays

Adhesion Molecules (serum & plasma)

E SelectinL SelectinP SelectinVascular Cell Adhesion Molecule 1(VCAM 1)Intercellular Adhesion Molecule 1 (ICAM 1)

Cardiac Array (serum & plasma)

Creatine Kinase MB (CK MB)Heart type Fatty Acid Binding Protein (H-FABP)Myoglobin (MYO)Troponin I (cTnl)

Cerebral Array I (serum, plasma & CSF)

Brain-Derived Neurotrophic Factor (BDNF)Glial Fibrillary Acidic Protein (GFAP)Heart Type Fatty Acid Binding Protein (H-FABP)Interleukin-6 (IL-6)

Cerebral Array II (serum, plasma & CSF)

C-Reactive Protein (CRP)D-dimerNeuron Specific Enolase (NSE)Soluble Tumour Necrosis Factor Receptor I (sTNFRI)Neutrophil Gelatinase-Associated Lipocalin (NGAL)

Cytokine Array I (serum & plasma)

Epidermal Growth Factor (EGF)Interleukin 1 alpha (IL 1α)Interleukin 1 beta (IL 1β)Interleukin 2 (IL 2)Interleukin 4 (IL 4)Interleukin 6 (IL 6)Interleukin 8 (IL 8)Interleukin 10 (IL 10)

PROTEINS

TOXICOLOGY

Interferon gamma (IFN γ)Monocyte Chemotactic Protein 1 (MCP 1)Tumour Necrosis Factor alpha (TNF α)Vascular Endothelial Growth Factor (VEGF)

Cytokine Array II (serum & plasma)

EotaxinInsulin Like Growth Factor l (IGF-1)Interleukin 12p40 Subunit (IL12-p40)Interferon-γ Inducible Protein 10 (IP-10)Platelet Dervied Growth Factor BB (PDGF-BB)Regulated on Activation, Normal T Expressed and Secreted (RANTES)

Cytokine Array III (serum & plasma)

Interleukin 5 (IL 5)Interleukin 15 (IL 15)Granulocyte Macrophage Colony Simulating Factor (GM-CSF)Macrophage Inflammatory Protein - 1 alpha (MIP-1α)

Cytokine Array IV (serum & plasma)

Matrix Metalloproteinase 9 (MMP 9)Soluble IL 2 Receptor Alpha (sIL 2Rα)Soluble IL 6 Receptor (sIL 6R)Soluble Tumour Necrosis Factor Receptor I (sTNFRI)Soluble Tumour Necrosis Factor Receptor II (sTNFRII)

Cytokine Array V (serum & plasma)

Interleukin 3 (IL 3)Interleukin 7 (IL 7)Interleukin 13 (IL 13)Interleukin 12p70 (IL-12 p70)Interleukin 23 (IL 23)

Endocrine (serum & plasma)

CortisolDehydroepiandrosterone Sulphate (DHEA’s)Leptin17α Hydroxyprogesterone

Metabolic Syndrome Array I (serum & plasma)

FerritinInsulinInterleukin-6 (IL-6)LeptinPlasminogen Activator Inhibitor-I (PAI-I)ResistinTumour Necrosis Factor-α (TNF-α)

Metabolic Syndrome Array II (serum & plasma)

Adiponectin

C-Reactive Protein (CRP)Cystatin C

Thyroid Free Array (serum & plasma)

Free Thyroxine (FT4)Free Tri-iodothyronine (FT3)Thyroid Stimulating Hormone (TSH)

Thyroid Total Array (serum & plasma)

Thyroid Stimulating Hormone (TSH)Total Thyroxine (TT4)Total Tri-iodothyronine (TT3)

Tumour PSA Array (serum & plasma)

Carcinoembryonic Antigen (CEA)Free Prostate Specific Antigen (fPSA)Total Prostate Specific Antigen (tPSA)

Drugs of Abuse I Plus (urine, whole blood and oral fluid)

AmphetamineBarbituratesBenzodiazepine IBenzodiazepine IIBuprenorphineCannabinoidsCocaine metabolite (Benzoylecgonine)MethamphetamineMethadone3,4 Methylenedioxymethamphetamine (MDMA)OpiatesPhencyclidineTricyclic Antidepressants (TCA’s generic)Creatinine (Dilution for urine)

Drugs of Abuse II (urine and whole blood)

BuprenorphineFentanylGeneric OpioidsKetamineLysergic Acid Diethylamide (LSD)3,4 Methylenedioxymethamphetamine (MDMA)MethaqualoneOxycodone IOxycodone IIPropoxypheneCreatinine (Dilution for urine)

Drugs of Abuse III (urine and blood)

Choral Hydrate MetaboliteEthyl GlucuronideFentanyl

FlunitrazepamKetamine MetaboliteMeperidineMeprobamateZaleplonZolpidemZopicloneCreatinine (Dilution for urine)

Drugs of Abuse IV (urine and blood)

AcetaminophenDextromethorphanEthyl GlucuronideEscitalopramFluoxetineHaloperidolIbuprofenMethylphenidate/Ritalinic AcidSalicylateSertraline

TramadolTrazodoneTricyclic Antidepressants (TCAs Generic)Creatinine (Dilution for urine)

Drugs of Abuse Array V (urine & blood)

Bath Salts l (Methcathinone and Mephedrone)Bath Salts ll (MDPV)BenzylpiperazinesMescalinePhenylpiperazines lPhenylpiperazines llSalvinorinSynthetic Cannabinoids lSynthetic Cannabinoids llSynthetic Cannabinoids lllSynthetic Cannabinoids lVCreatinine (Dilution for urine)

Other biological matrices are feasible following end user assay optimisation/validation.

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Custom Assay Development

Custom multiplex solutions that advance your clinical research

Custom Assay Development For over 30 years, Randox Biosciences has been providing custom assay design, development and manufacturing services to the diagnostic, pharmaceutical, contract research and biotech industries. This also includes fully customised human and animal quality control sera and calibrators.

Randox Biosciences expertise, highly specialised scientists and world-class ISO accreditated manufacturing facilities enables us to provide a service and product tailored to a specific research and development or clinical trial requirement.

Custom Build ProcessClients can select either individual or multiple analytes from the current A-Z Menu. We offer an impressive menu of over 320 clinical and research biomarkers including 70 toxicology drug assays.

Randox Biosciences dedicated custom unit can then design a novel singleplex or multiplex biochip tailored to each customer’s requirements taking into account sample types, available sample volumes and expected ranges for various analytes of interest.

Should your needs exceed those provided by one of our standard arrays, or if you are researching a particular set of analytes, we would encourage you to approach a Randox Biosciences representative with your specific requirements or email info@randoxbiosciences.com.

Randox Biosciences 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.

Submission of custom array requirements

(completion of Biochip Questionnaire Form)

Randox custom R&D unit carry out

feasibility assessment

If feasible, a quote will be forwarded to

the customer

Confirmation of order and biochip

manufacturing commences

STEP 1 STEP 2 STEP 3 STEP 4

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Chemokine (C-C motif) Ligand 28 CCL28 MECChemokine (C-X-C motif) Ligand 1 CXCL1 GRO1Chemokine (C-X-C motif) Ligand 4 CXCL4 PF-4Chemokine (C-X-C motif) Ligand 5 CXCL5 ENA-78Chemokine (C-X-C motif) Ligand 7 CXCL7 NAP-2Chemokine (C-X-C motif) Ligand 9 CXCL9 MIGChemokine (C-X-C motif) Ligand 11 CXCL11 I-TACChemokine (C-X-C motif) Ligand 12 CXCL12 SDF-1Chemokine (C-X-C motif) Ligand 13 CXCL13 BCA-1Chemokine (C-X-C motif) Ligand 16 CXCL16 SRPSOXChemokine (C-X-C motif) Ligand 17 CXCL17 VCC-1Chemokine 3 Ligand 1 CX3CL1 FractalkineCleaved Poly ADP Ribose Polymerase Cleaved-

PARPCluster of Differentiation 4 CD4Cluster of Differentiation 14 CD14 Cluster of Differentiation 28 CD28Cluster of Differentiation 30 CD30Cluster of Differentiation 36 (soluble) sCD36Cluster of Differentiation 56 CD56Cluster of Differentiation 66e CD66e CEACAM5Cluster of Differentiation 127 CD127Cluster of Differentiation 163 CD163Clusterin CLUSCollagen Type 2 CIIMCollagen Type 3 C3M COL3A1Collagen Type 4 C4 COL4Complement 3 C3Complement 3a C3aCortisol *** CORT HydrocortisoneC-Peptide *** CPEPC-Reactive Protein *** CRPCreatine Kinase *** CKMBCRPM CRPM SH3BP2Cyfra 21-1 Cyfra 21-1Cystatin C *** CST3Cytokeratin 18 M-65 CK18D-Dimer DDDefensin NP1Defensin 2 beta BD-2 SAP1Dehydroepiandrosterone *** DHEASDickkopf Related Protein 1 DKK-1Elafin SKALPEndothelin-1 EDN1Eotaxin CCL11Epidermal Growth Factor EGF Epidermal Growth Factor Receptor EGFREpigen EPGNEpiregulinE-selectin ESELEstradiol *** E2Factor VII F7Fatty Acid Binding Protein 1 FABP1Fatty Acid Binding Protein-Liver L-FABPFatty-Acid Binding Protein FABPFerritin *** FTNFerritin Light Chain FTLFibrinogen Fib

17-Hydroxyprogesterone *** PROG70 Kilodalton Heat Shock Proteins HSP70A Disintegrin and Metalloproteinase Domain 12

ADAM12

A Disintegrin And Metalloproteinase with Thrombospondin Motifs 1

ADAMTS-1

A Proliferation-Inducing Ligand APRILActivin AAdiponectin *** GBP-28Adrenocorticotropic Hormone ACTHAdrenomedullin ADMAgouti AgRPAlbumin ALBAlpha Synuclein SNCAAlpha-1 Antitrypsin a-1-ATAlpha-1 Microglobulin a-1MAlpha-2 Macroglobulin a-2MAmphiregulinAmyloid A SAAAngiopoietin I ANG1Angiopoietin II ANG2Angiotensin IIAnti-Müllerian hormone AMH MIF, MIS, MIHApelinApolipoprotein A1 APOA1Artemin ARTNAtrial Natriuretic Peptide ANPBasal Cell Adhesion Molecule BCAMB-cell Activating Factor BAFF BLyS/TNFSF13BB-cell Attracting chemokine 1 BCA-1 CXCL13/BLCB-cell Lymphoma Extra Large BCL-XLBcl-2 Associated X Protein BaxBone Morphogenetic Protein 6 BMP-6Bone Morphogenetic Protein 7 BMP-7Brachyury TBrain Natriuretic Peptide BNPBrain-Derived Neurotrophic Factor BDNFCalcitonin CTCarbonic anhydrase III CaIII Cardiac Troponin I *** cTnI Cartilage Oligomeric Matrix Protein COMPCaspase 1 CASP 1Caspase 6 CASP 6Caspase 9 CASP 9Cathepsin C CTSCChemerin RARRES2Chemokine (C-C motif) Ligand 1 CCL1 I-309Chemokine (C-C motif) Ligand 13 CCL13 MCP4Chemokine (C-C motif) Ligand 14 CCL14 HCC-1Chemokine (C-C motif) Ligand 15 CCL15 MIP-5Chemokine (C-C motif) Ligand 17 CCL17 TARCChemokine (C-C motif) Ligand 18 CCL18 PARCChemokine (C-C motif) Ligand 19 CCL19 MIP-3bChemokine (C-C motif) Ligand 20 CCL20 MIP-3aChemokine (C-C motif) Ligand 21 CCL21 Exodus-2Chemokine (C-C motif) Ligand 22 CCL22 MDCChemokine (C-C motif) Ligand 26 CCL26 Eotaxin-3Chemokine (C-C motif) Ligand 27 CCL27 CTACK

A-Z Custom Biochip Test MenuAnalyte Abbrev. AKA Analyte Abbrev. AKA

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Fibroblast Growth Factor 4 FGF-4Fibroblast Growth Factor 7 FGF-7Fibroblast Growth Factor 19 FGF-19Fibroblast Growth Factor 21 FGF-21Fibroblast Growth Factor 23 FGF-23Fibronectin FNFMS-Related Tyrosine Kinase 1 FLT-1 VEGFR1FMS-Related Tyrosine Kinase 3 FLT-3 Ligand CD135Folate Receptor Alpha FOLR1Follicle-Stimulating Hormone *** FSHFollistatin FSTGalectin 3 G3Glial Fibrillary Acidic Protein GFAPGlutathione S-Transferase A1 GSTA1Glycogen Phosphorylase Isoenzyme BB GPBBGranulocyte Colony Stimulating Factor G-CSF CSF3Granulocyte-Macrophage Colony-Stimulating Factor

GMCSF

Granzyme B GZMBGrowth Differentiation Factor 11 GDF-11Growth Differentiation Factor 15 GDF-15Growth Differentiation Factor 8/Myostatin GDF-8Heme Oxygenase-1 HO-1Hemopexin HPXHeparin-Binding Epidermal Growth Factor HB-EGFHeparin-Binding Protein HBP Azurocidin/

CAP37Hepatocyte Growth Factor HGFHepcidin HEPCIDINHeregulin NRG-1High-mobility group protein B1 HMGB1Histone Deacetylase 6 HDAC 6Human beta Defensin 2 BD-2Human epididymis protein 4 HE4Human Growth Hormone HGHHypoxia-Inducible factor 1, alpha subunit HIF-1aImmunoglobulin E IgEInsulin INSInsulin Growth Factor IGF1Insulin Growth Factor 2 IGF2Insulin-Like Growth Factor 1 IGF-1 Insulin-Like Growth Factor 1 Receptor IGF1RInsulin-Like Growth Factor 2 Receptor IGF2RInsulin-Like Growth Factor Binding Protein 2

IGFBP2

Insulin-Like Growth Factor Binding Protein 3

IGFBP3

Intercellular Adhesion Molecule 1 ICAM-1Interferon alpha IFNaInterferon gamma IFNgInterferon gamma-induced protein 10 IP-10Interleukin 1 alpha IL-1aInterleukin 1 beta IL-1bInterleukin 1 Receptor 4 IL-1R4 ST2Interleukin 1 Receptor alpha IL-1RaInterleukin 2 IL-2Interleukin 3 IL-3Interleukin 4 IL-4

A-Z Custom Biochip Test Menu

Interleukin 5 IL-5Interleukin 6 IL-6 Interleukin 7 IL-7Interleukin 8 IL-8Interleukin 9 IL-9Interleukin 10 IL-10 Interleukin 11 IL-11Interleukin 12 IL-12Interleukin 12p40 IL-12p40 Interleukin 12p70 IL-12p70Interleukin 13 IL-13Interleukin 15 IL-15 Interleukin 16 IL-16Interleukin 17A IL-17AInterleukin 17F IL-17FInterleukin 18 IL-18Interleukin 22 IL-22Interleukin 23 IL-23Interleukin 26 IL-26Interleukin 28a IL-28AInterleukin 33 IL-33Interleukin 36g Il-36gKidney Injury Molecule 1 KIM-1Kirsten Rat Sarcoma Viral Oncogene K-RASLeptin LEPTLeukemia Inhibitory Factor LIFLeukotriene B4 LTB4LIGHT TNFSF14 CD258Lipopolysaccharide Binding Protein LBPLipoprotein-associated Phospholipase A2 Lp-PLA2Liver Fatty Acid Binding Protein FABP1 LFABPL-selectin LSELLuteinizing Hormone LHLymphotactin XCL1Macrophage Colony Stimulating Factor M-CSF CSF-1Macrophage Inflammatory Protein 1 Alpha

MIP-1a CCL3

Macrophage Inflammatory Protein 1 beta MIP-1b CCL4Macrophage Migration Inhibitory Factor MIFMatrix Metallopeptidase 9 MMP-9 Matrix Metalloproteinase 1 MMP-1Matrix Metalloproteinase 2 MMP-2Matrix Metalloproteinase 3 MMP-3Matrix Metalloproteinase 7 MMP-7Matrix Metalloproteinase 8 MMP-8Matrix Metalloproteinase 13 MMP-13MHC Class 1 Chain Related Protein A MICAMidkine MKMonocyte Chemotactic Protein 1 MCP-1 CCL2Monocyte Chemotactic Protein 2 MCP-2Monocyte Chemotactic Protein 3 MCP-3 CCL7Monokine induced by gamma interferon MIGMucin-1 MUC-1Myeloperoxidase MPOMyoglobin MYOMyosin Light-Chain Kinase MLCKNerve Growth Factor beta NGF b

Analyte Abbrev. AKA Analyte Abbrev. AKA

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A-Z Custom Biochip Test Menu

Neuregulin 1 NRG-1Neuron-Specific Enolase NSE Neutrophil Elastase ELA2Neutrophil Gelatinase-Associated Lipocalin

NGAL

Nitrotyrosine NTN-Terminal pro B-type Natriuretic Peptide NT-proBNPNuclear Factor 2 NRF2Oligoadenylate Synthetase 1 OAS1Orexin A OAOsteoactivinOsteocalcin PGLAP SPP1Osteopontin OPNOsteoprotegerin TNFSF11BOxidised Low-Density-Lipoproteins ox-LDL TSG-14Pentraxin-Related Protein PTX 3Pepsinogin 1 PG1Periostin POSTNPersephinPhosphatidylinositol-Glycan Biosynthesis class F

PIGF

pi Glutathione S-Transferase pi-GSTPlacental Growth Factor PGF PIGFPlasminogen Activator Inhibitor-1 PAI-1 Serpin E1Platelet Derived Growth Factor PDGFPlatelet Derived Growth Factor - AA PDGF-AAPlatelet Derived Growth Factor Receptor beta

PDGFRB

Platelet-Derived Endothelial Cell Growth Factor

PD-ECGF

Platelet-Derived growth factor BB PDGF-BB Pro Insulin INSProlactin PRLProprotein Convertase Subtilisin/Kexin type 9

PCSK9

P-selectin PSELRegulated and Normal T cell Expressed and Secreted

RANTES CCL5

Renin RENResistin ADSFRetinol Binding Protein 4 RBP-4S100 Calcium Binding Protein A8 S100A8S100A8/A9S100A12 EN-RAGESclerostin SOSTSecretory IgA IgASerotonin 5-HTSerum Amyloid A SAASex Hormone-Binding Globulin sHBGSoluble CD40 Ligand sCD40LSoluble gp130 sgp130Soluble Interleukin 2 Receptor alpha sIL-2Ra Soluble Interleukin 6 Receptor alpha sIL-6RaSoluble Interleukin 15 Receptor alpha sIL-15RaSoluble Tumor Necrosis Factor Receptor 1 sTNFRISoluble Tumor Necrosis Factor Receptor 2 sTNFRII Stem Cell Factor SCFStem Cell Factor Receptor SCFR

Stromal Cell-Derived factor-1 SDF-1Surfactant Protein A SP-ASurfactant Protein D SP-D SFTPDTestosterone TESTThrombomodulin TM Thrombopoietin THPOThrombospondin-1 TSP-1Thymic stromal lymphopoietin TSLPThyroid-Stimulating Hormone TSHThyroxine T4Tissue Inhibitor of Metalloproteinase 1 TIMP-1Tissue Inhibitor of Metalloproteinase 2 TIMP-2Tissue Inhibitor of Metalloproteinase 3 TIMP-3Tissue Inhibitor of Metalloproteinase 4 TIMP-4TNF-related apoptosis-inducing ligand TRAILTransferrin TFTransforming Growth Factor Alpha TGF-aTrefoil Factor 3 TFF3Triiodothyronine T3Tumor Necrosis Factor Ligand Superfamily Member 12

TWEAK TNFSF12

Tumour Necrosis Factor alpha TNF-aTumour Necrosis Factor beta TNF-bTumour Necrosis Factor Receptor II TNFR2Type IV Collagen COL4Tyrosine Kinase with Immunoglobulin-Like and EGF-like Domains 1

Tie-1

Tyrosine Kinase with Immunoglobulin-Like and EGF-like Domains 2

Tie-2

Ubiquitin Carboxy-Terminal Hydrolase L1 UCH-L1u-Plasminogen Activator uPAUrokinase Receptor uPARUromodulin UMOD THPUteroglobin CC16Vascular Cell Adhesion Protein 1 VCAM-1Vascular Endothelial Growth Factor VEGF Vascular Endothelial Growth Factor A VEGFaVascular Endothelial Growth Factor B VEGFbVascular Endothelial Growth Factor C VEGFcVascular Endothelial Growth Factor D VEGFdVascular Endothelial Growth Factor Receptor 1

VEGFR1

Vascular Endothelial Growth Factor Receptor 2

VEGFR2

Vascular Endothelial Growth Factor Receptor 3

VEGFR3

Visfatin PBEF1X-linked Inhibitor of Apoptosis Protein XIAPYKL-40/Cartilage Glycoprotein 39 YKL-40

Analyte Abbrev. AKAAnalyte Abbrev. AKA

*** These assays have clinical implications and require QA approval before an order is accepted.

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Toxicology Test Menu

• (7-NH2) Flunitrazepam

• AB Pinaca

• Acetaminophen

• AK B48

• Amphetamine

• Barbiturates

• Bath Salts (αPvP/MDPV)

• Bath Salts 2 (Methcathinone

and Mephedrone)

• Benzodiazepine 1

• Benzodiazepine 2

• Benzylpiperazines

• Buprenorphine

• Cannabinoids

• Carbamazepine

• Chloral Hydrate Metabolite

• Cocaine Metabolite

• Benzoylecgonine

• Dextromethorphan

• Digoxin

• DOX Series

• EDDP

• Escitalopram

• Ethanol

• Ethyl Glucuronide

• Fentanyl

• Fluoxetine

• Generic Opiods

• Gentamicin

• Haloperidol

• Ibuprofen

• JWH-018 / AM-2201

• JWH-250 / RCS-8

• Ketamine

• Lithium

• LSD

• MDMA

• Meperidine

• Meprobamate

• Mescaline

• Methadone

• Methamphetamine

• Methaqualone

• Methylphenidate

• Mitragynine

• NBoMe

• Nor Buprenorphine

• Nor Fentanyl

• Opiates

• Oxycodone 1

• Oxycodone 2

• Phencyclidine

• Phenobarbital

• Phenylpiperazines 1

• Phenylpiperazines 2

• Phenytoin

• Propoxyphene

• Ritalinic Acid

• Salicylate

• Salvinorin

• Sertraline

• Theophylline

• Tramadol

• Trazodone

• Tricyclic Antidepressants

• (TCAs Generic)

• UR-144 / XLR-11

• Valproic Acid

• Zaleplon

• Zolpidem

• Zopiclone

Biomarkers are available for a diverse range of therapeutic areas which include but are not limited to:

Cardiovascular & Cerebrovascular

Neuroscience

Metabolic & Nutrition

Pulmonary & Respiratory

Endocrinology Rheumatology Nephrology

Immunology

Infection

Oncology

Ophthalmology

For additional information about our custom assay development services, please contact info@randoxbiosciences.com

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Multiplex Molecular Arrays

Precise diagnostics for targeted therapy

Randox Biosciences molecular arrays offer diagnostic, prognostic and predictive solutions across a variety of disease areas including sexually transmitted infection, respiratory tract infection, colorectal cancer, familial hypercholesterolemia (FH) and cardiovascular disease (CVD).

A wide range of assay formats are offered including SNP genotyping, pathogen detection, mutation detection and gene expression. These assays are optimised for use with the Randox Evidence Investigator semi-automated bench top biochip analyser, offering consolidation, speed and ease-of-use.

The assay is based on a combination of multiplex PCR and biochip array hybridisation. Innovative PCR priming technology permits high discrimination between multiple targets in a number of genes. A unique primer set is designed for each target which will hybridise to a complementary oligo-nucleotide probe spotted on a biochip discrete test region (DTR). This combination of priming and spatially organised biochip array technology enables enhanced specificity of the assay.

*PIK3CA Array for research use only

Rapid multiplex SNP genotyping is based on innovative primer design that can discriminate DNA sequences differing only by one base. Products amplified will correspond to target portions of DNA from tissue, buccal swabs or blood. Amplified regions are then hybridised to a biochip array with spatially tethered probes complementary to target amplicons. Each position on the biochip array corresponds to a specific SNP genotype and is capable of both multiplexing and determining the zygosity of the sample.

SNP Genotyping - Cardiovascular Risk Prediction Array

Pathogen detection, through nucleic acid (DNA/RNA) analysis offers rapid, sensitive, multiplex detection of viral, bacterial and protozoan pathogens. Following nucleic acid extraction from a broad range of sample types (sputum, urine, swabs etc.), target DNA/cDNA is amplified in a single reaction and subsequently hybridised to a biochip array containing multiple pathogen-specific probes. This rapid, highly sensitive and specific process enables identification of primary and co-infections simultaneously, often in asymptomatic patients and has the capacity for use with many pathogen panels.

Pathogen Detection - STI Multiplex Array and Respiratory Multiplex Array

Mutation Detection - KRAS BRAF PIK3CA* Array and Familial Hypercholesterolemia (FH) Arrays I & II

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Assay protocol & test menu

Multiplex Molecular Arrays

ExtractionNucleic acid is extracted from patient sample

Wash step and addition of signal reagentAfter washing, signal reagent is added to each biochip before imaging

Chemiluminescence The chemiluminescent light signal generated from each discrete test region (DTR) is simultaneously detected

Biochip carrier loaded into Evidence InvestigatorA Charged Coupled Device (CCD) camera inside the Evidence Investigator takes 2 minutes to image each biochip carrier

Result reportingImage processing software translates the light signal generated from the chemiluminescent reaction into relative light units (RLUs) and Randox QC-assigned cut-offs allow simple reporting of positive or negative results with no data interpretation or manual processing required

AmplificationSingle tube multiplex PCR reaction

Hybridisation / conjugation Batches of 3 to 54 biochips are placedin the thermoshaker

• Ready-to-use, nine biochip carrier• Randox Biochips can support multiple

assays per biochip• Minimum batch of three biochips (one

strip) which includes patient sample, positive and negative controls

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4

6 7

5

2 3

Molecular testing with the Evidence Investigator is undertaken following the protocol outlined below:

The Sexually Transmitted Infection (STI) Multiplex Array simultaneously detects 10 bacterial, viral and protozoan

infections including primary, secondary and asymptomatic co-infections for a complete infection profile.

Neisseria gonorrhoea (NG)Chlamydia trachomatis (CT)Trichomonas vaginalis (TV)Treponema pallidum (TP)

Herpes simplex Virus 1 (HSV-1)Herpes simplex Virus 2 (HSV-2)Mycoplasma genitalium (MG)Ureaplasma urealyticum (UU)

Haemophilus ducreyi (HD)Mycoplasma hominis (MH)

STI Multiplex Array

Respiratory Pathogens Array

The Respiratory Pathogens Array is the most comprehensive screening test for infections of both the upper and lower

respiratory tracts, simultaneously detecting 22 viral and bacterial pathogens from a single sputum, lavage or nasopharyngeal

sample.

Viral:Human Respiratory Syncytial Virus AHuman Respiratory Syncytial Virus bHuman Parainfluenza Virus 1/2/3/4Human Coronavirus 229E/NL63Human Coronavirus OC43/HKU1

Human MetapneumovirusHuman Rhinovirus A/BHuman Enterovirus A/B/CHuman Adenovirus A/B/C/D/EHuman Bocavirus 1/2/3Influenza A/B

Bacterial:Chlamydophila pneumoniaeMycoplasma pneumoniaeLegionella PneumophilaMoraxella CatarrhalisStreptococcus Pneumoniae

Staphylococcus AureusHaemophilus Influenza

The Familial Hypercholesterolemia (FH) Arrays I & II are rapid, simple and accurate diagnostic tests

which enable simultaneous detection of 40 FH-causing mutations (20 mutations per array) within the

LDLR, ApoB and PCSK9 genes.

Familial Hypercholesterolemia (FH) Arrays I & II

LDLR - 38 mutations APOB - 1 mutation PCSK9 - 1 mutation

15

The Cardiac Risk Prediction Array provides simultaneous genotyping of 20 SNPs identified from

a GWAS study, for enhanced CHD risk assessment which incorporates a test to identify patients

predisposed to statin-induced myopathy.

Cardiac Risk Prediction Array

The KRAS, BRAF PIK3CA Array simultaneously detects 20 point mutations within the KRAS, BRAF and PIK3CA genes.

Whilst designed for colorectal cancer, the array has implications for mutation screening in other cancer types.

KRAS, BRAF PIK3CA* Array

KRAS (codon 12, 13, 61, 146)

*PIK3CA Array for research use only

BRAF (codon 600) PIK3CA* (codon 542, 545, 1047)

16

Companion Diagnostics

Randox Biosciences - your Ideal Companion for

CDx Development

Personalised medicine is the result of our increased understanding of human complexity and variability. It is now accepted that the future of the Pharmaceutical Industry is dependent on the development of therapeutic agents that are more closely tailored to targeted patient groups or sub-groups resulting in safer drugs with enhanced therapeutic efficacy and specificity, developed in a more cost-effective manner.

A key element to realising the potential for personalised medicine is in companion diagnostic (CDx) development.

Randox Biosciences are committed to revolutionising healthcare by providing class-leading diagnostic, prognostic, and predictive assays.

Building on these unrivalled capabilities Randox is engaged in companion diagnostic programs with a number of global Biopharma companies.

Randox Companion Diagnostic Development Plan

Pharmaceutical Development Phases

Pre-ClinicalClinical

Phase 1 Phase II

• Customer requirements• Design specifications• Regulatory strategy

• Randox Life Sciences – custom Antibodies, Proteins, ScFv development

• Immunoassay development & optimisation – single analyte & multiplex

• Clinical Chemistry assays• Multiplex nucleic acid arrays

• Verify assay performance• Perform internal validations• Manufacture three GMP lots

Feasibility Develop Prototype

Analytical Validation

17

These include not only single analyte clinical chemistry based assays but multiplex pathogen detection, mutation, SNP and gene expression based arrays with applications across therapeutic areas such as oncology, immunoinflammation, CNS, infection and cardiovascular disease.

If you are interested in discussing a potential collaboration with Randox Biosciences please contact one of the team on:

T +44 (0) 28 9442 2413 E info@randoxbiosciences.com W randoxbiosciences.com

CDx services CDx Assay formats

• Off-the-shelf and fully customised clinical diagnostic and biomarker reagents

• Assay development for new biomarkers• Full Life Sciences/Biotechnology service

including monoclonal, polyclonal, antibody fragments and recombinant protein manufacture

• Quality controls and calibrators to support bespoke CDx assay requirements

• Full regulatory support at Randox for FDA 510k, FDA PMA, CE, cFDA and Health Canada regulatory submissions

• Global distribution and operations in over 145 countries ensuring no block to commercial adoption of the CDx

With over 220 FDA cleared assays Randox offers the full package of Diagnostic and CDx assay development and optimisation which includes:• Clinical chemistry assays and analysers• Immunoassay assays and analysers• Multiplex protein and nucleic acid arrays

and analysers

• Supply of kits• Conduct clinical trials• Perform external validations

• Prepare submission• Regulatory co-filing• Full regulatory support including

PMA/CE• Global registrations• Reimbursement

• Production lots in inventory• Training & education• Distribution

ClinicalValidation

RegulatorySubmission

Post Launch Support

RegulatorySubmission

Post Launch Support

Clinical

Phase III

Antibodies & Human Recombinant

Proteins

Advancing discovery, revolutionising diagnostics

Randox Biosciences is a world-leading primary manufacturer of high-quality monoclonal and polyclonal antibodies, antibody fragments and human recombinant proteins. Our team of scientists possess unrivalled expertise which enables us to provide you with a comprehensive suite of products and services dedicated to advancing biopharmaceutical research and diagnostics.

Monoclonal Antibodies

Frozen Human Plasma

• Available in three formats (Male, Female and Mixed Gender)

• Highly screened for; HIV, Hepatitis B+C, HTLV I + II,

Syphilis, CMV and Procleix WNV

Recombinant Antibody Fragments

• Single chain variable fragment (scFv’s)

• Drugs of abuse: Alcohol, Anti-depressants, Barbituates, Hallucinogens, Opiates, Stimulants

• Drug Residues: Antimicrobial Drugs, Growth Promoters, Mycotoxins

• Biochemical markers: Biochemical messengers, fatty acid binding proteins and products with applications in the following therapeutic areas; Immunology, Oncology, Cardiovascular/Cerebrovascular and Metabolic/Nutrition

18

Polyclonal Antibodies

• Drugs of abuse: Alcohol, Analgesics, Anti-depressants, Barbituates, Benzodiazepines, Hallucinogens, Opiates, Sedatives, Stimulants, Synthetic Drugs, Therapeutic drugs

• Drug Residues: Anti-inflammatory Drugs, Antimicrobial Drugs, Anti-Parasitic Drugs, Growth Promoters, Mycotoxins

• Biochemical markers: Biochemical messengers, fatty acid binding proteins and products with applications in the following therapeutic areas; Immunology, Oncology, Cardiovascular/Cerebrovascular and

Metabolic/Nutrition

Buffers & Diluents

• Complementary range available

Human Recombinant Proteins

• Chemokines• Cytokines• Proteases• Tumour markers

Product PortfolioRandox Biosciences offers an extensive portfolio of over 1,000 products for a multitude of R&D applications including more than 800 monoclonal and polyclonal antibodies and over 400 human recombinant proteins as well as antibody fragments, buffers & diluents and plasma.

19

Supply of Immunogen &

screening materials

Nodal collection & lymphocyte assessment

Supply of purified

Antibodies

Initial immunisation

of sheep

Cloning & characterisation

studies

Scale up & characterisation

of purified antibody Fusions

Monoclonal Antibodies

Polyclonal Antibodies

RecombinantAntibody Fragments

Antibody Development

Process

Key Features & Benefits • All products manufactured at our ISO 13485

accredited UK manufacturing plant

• Extensive product range of over 1,000 products

• Over 30 years experience in raw material manufacture

and assay development

• Many unique and novel products including designer

drugs, Mycotoxins and oncology markers

• As our host animals are sheep, our antibodies can have

higher sensitivity and specificity

• Excellent reproducibility between lot numbers

• Products reflect the components used in-house in the

production of Randox diagnostic products and research

programs

• Highly experienced in developing difficult targets (i.e.

small molecules)

• Full customisation service available

• A range of pack sizes available including bulk quantites

for commercial development

• Products can be used in a multitude of diagnostic and

research applications

Custom Development ServicesRandox Biosciences customisation service which encompasses antibodies and human recombinant proteins has achieved tremendous success within the biopharmaceutical and diagnostic industries. Key components of our custom service are our range of monoclonal antibodies as well as our recombinant antibody fragments (sdAb’s, scFv’s, fAb’s).

We have a specialised offering of Single Domain Antibody Fragments (sdAb’s) for research and therapeutic applications. SdAb’s provide a new mechanism for the generation of antibody therapeutics and offer numerous advantages such as better tissue penetration, ease of expression, stability and uniformity of product. SdAb’s also have benefits in traditional diagnostic settings, due to their small size, a much higher coating concentration can be achieved for assay development.

Ordering onlineFurther information available at randox-lifesciences.com - order online or e-mail us at: info@randoxbiosciences.com

20

Clinical Chemistry

Enrich your research with the highest quality range of routine and novel reagents

ReagentsExtensive test menu

We supply one of the largest reagent test menus offered by any clinical diagnostics company encompassing routine and esoteric clinical chemistry, immunoassay and safety testing.

Our impressive product portfolio covers over 100 disease markers. In addition to a wide range of routine chemistries, we provide reagents for specific proteins, lipids, therapeutic drugs, drugs of abuse, antioxidants, coagulation, diabetes, food & wine and veterinary parameters.

This portfolio is continually expanding to offer you an increased choice of high-quality cost-effective reagents.

Unique tests

We are a primary manufacturer of a comprehensive range of high performance and unique tests which can benefit you at every stage of your equally unique pre-clinical research and clinical development projects.

Dedicated and non-dedicated reagents

We provide dedicated reagents for the Randox RX Series, Dimension™, Hitachi™, AU™, Architect C™ and Aeroset™ range of chemistry analysers providing you with freedom of choice from an independent manufacturer. We also provide over 13,000 instrument specific applications enabling the use of Randox reagents on over 195 clinical chemistry analyser platforms.

Highest quality

Our reagents are of the highest quality producing accurate and precise results. This is recognised through official accreditation to both national and international standards including UKAS, ISO 13485:2003, and SFDA.

21

RX series of clinical chemistry analysers Excellence in Research and Diagnostics

The RX series has been developed by Randox to meet the growing needs of clinical chemistry testing offering an impressive range from the semi-automated RX monza through to the fully automated RX imola.

The RX series provides performance like no other. Robust hardware combined with intuitive software ensures unrivalled precision and accuracy for results you can trust. Delivering high quality routine and specialised testing through the most comprehensive dedicated test menu on the market, the RX series of clinical chemistry analysers guarantees flexibility, cost savings and consolidation. The RX series is capable of catering for a variety of laboratory settings, from low to mid-volume testing through to 1 million tests per year.

RX monza is a compact semi-automated analyser offering all the functionality of a much larger, fully automated instrument. Its offering of 192 channels, of which 79 are dedicated, together with the flexibility to perform clinical chemistry or coagulation testing creates new and exciting opportunities for routine and specialised testing.

RX monaco is the newest, fully automated addition to the RX series and offers the ultimate in convenience, performance and confidence. At optimal configuration the RX monaco performs 170 tests per hour and provides cost effective, high quality testing for low to mid volume laboratories.

RX daytona+ offers a superior performance fully automated solution for mid-volume clinical chemistry testing. This bench-top analyser which is capable of running 450 tests per hour including ISE, has the most comprehensive dedicated test menu on the market. It provides unrivalled flexibility and versatility covering both routine and specialised tests ensuring optimum efficiency.

RX imola is a compact fully automated bench-top clinical chemistry analyser with the ability to handle the workload of a medium to high throughput laboratory. With a throughput of 560 tests per hour including ISE, it is the most versatile analyser in its class combining rapid comprehensive testing with the most comprehensive dedicated test menu on the market.

22

Autoimmune

Complement Component 3 Complement Component 4 CRP CRP Full Range (0.3-160mg/l)CRP High Sensitivity IgA IgEIgGIgMRheumatoid Factor

Basic Metabolic Profile

Calcium CO2 TotalChlorideCreatinine (Enzymatic)Creatinine (Jaffe)GlucosePotassiumSodiumUrea

Bone Profile

Alkaline PhosphataseCalciumPhosphorusTotal Protein

Cardiac

CholesterolCK-MBCK-NACCRP CRP Full Range (0.3-160mg/l)CRP High Sensitivity DigoxinDirect HDL CholesterolDirect LDL CholesterolHeart-Type Fatty Acid Binding Protein (H-FABP)HomocysteineLipoprotein (a)Myoglobin sLDLTriglycerides TxB Cardio

Comprehensive Metabolic Profile

Albumin Alkaline PhosphataseALTAST (GOT)

Direct BilirubinCalcium ChlorideCO2 Total Creatinine (Enzymatic)Creatinine (Jaffe)GlucoseLactate Potassium SodiumTotal BilirubinTotal Protein Urea

Diabetes

AdiponectinCholesterolCreatinine (Enzymatic)Creatinine (Jaffe)Cystatin CDirect HDL CholesterolDirect LDL Cholesterol FructosamineGlucoseGlycerol HbA1c/Hb Microalbumin NEFA (Non-Esterified Fatty Acids)Ranbut (Hydroxybutyrate)Total Protein Triglycerides Urinary Protein

Electrolytes

Calcium Chloride (Direct / Nondirect)CO2 Total LithiumMagnesium Potassium (Direct / Nondirect)Sodium (Direct / Nondirect)

Haemolytic Anaemia

G-6-P-DHHaptoglobinLDH

Hepatic Function

Albumin AldolaseAlkaline PhosphataseAlpha-1 AntitrypsinALT

AmmoniaAST (GOT) CholinesteraseComplement Component 3 Complement Component 4 Direct Bilirubin Gamma GTGLDHGlycerolHaptoglobin IgA IgG IgM Iron (UIBC)LDHLeucine Arylamidise (LAP)Total Bilirubin Total Protein Transferrin Transthyretin (Prealbumin)

Inflammation and Infection

Acid PhosphataseAlpha-1Acid GlycoproteinASOCRPLactateRheumatoid Factor

Lipids

Apolipoprotein A-I Apolipoprotein A-II Apolipoprotein B Apolipoprotein C-II Apolipoprotein C-IIIApolipoprotein E CholesterolDirect HDL CholesterolDirect LDL CholesterolLipoprotein (a)sLDLTriglycerides

Neonatal Screening

Alpha-1 AntitrypsinCRP CRP Full Range (0.3-160mg/l)CRP High Sensitivity IgETransthyretin (Prealbumin)

Neurological Disorders (CSF)

IgA IgG IgM

Nutritional Status

AlbuminCopper FerritinIronIron (UIBC)LipaseMagnesiumPotassiumTIBCTransferrin Transthyretin (Prealbumin) Zinc

Pancreatic Function

AmylaseGlucoseLDHLipasePancreatic Amylase

Renal Function

Albumin AmmoniaBeta-2 MicroglobulinCalciumChloride Creatinine (Enzymatic)Creatinine (Jaffe)Cystatin CGlucose HbA1c/Hb IgGLDHMagnesium Microalbumin PotassiumSodiumPhosphorus (Inorganic)Urinary ProteinUrea Uric Acid

RX Test Menu

CLINICAL

23

TOXICOLOGY

Therapeutic Drugs

AcetaminophenCarbamazepineDigoxin GentamicinLithiumPhenobarbitolPhenytoinSalicylateTheophylineValproic Acid

Drugs of Abuse

AmphetaminesBarbituratesBenzodiazepinesCannabinoidsCocaine metaboliteEDDPEcstasyEthanolMethadone Opiates

PROTEINS

Specific Proteins

Alpha-1 AntitrypsinAlpha-1 Acid GlycoproteinApolipoprotein A-I Apolipoprotein A-II Apolipoprotein B Apolipoprotein C-II Apolipoprotein C-III Apolipoprotein E ASO Beta-2 MicroglobulinCeruloplasminComplement Component 3 Complement Component 4 CRP CRP Full Range (0.3-160mg/l)

CRP High Sensitivity Cystatin CFerritinFructosamineHaptoglobin HbA1c/Hb IgA IgEIgG IgM Lipoprotein (a)Microalbumin Myoglobin Rheumatoid Factor Transthyretin (Prealbumin) Transferrin VETERINARY

Albumin Alkaline phosphatase ALT (GPT) AldolaseAmmonia AmylaseAST (GOT) Bile acids Bilirubin Calcium Chloride Cholesterol Cholinesterase (Butyryl)CK-NAC CO2 Total Copper Creatinine CRPFructosamine Gamma-GT GLDH Glucose GlycerolHDL

Iron (UIBC) Lactate Lactate dehydrogenase LDLLipaseMagnesium NEFA (Non-esterified fatty acids)Phosphorus (Inorganic) PotassiumRanbut (Hydroxybutyrate)Ransel (Glutathione peroxidase)Ransod (Superoxide dismutase)SodiumTherapeutic drugsTotal ProteinTriglyceridesUreaUric AcidUrinary proteinZinc

RESEARCH

Antioxidants

AlbuminBilirubinFerritinGlutathione Reductase Ransel (Glutathione Peroxidase)Ransod (Superoxide Dismutase)TIBCTotal Antioxidant StatusTransferrinUric Acid

Biotechnology

GlutamateGlutamine

Food and Wine Testing

Acetic AcidAmmonia CalciumCopperGlucose Glucose/FructoseGlycerolIron L-Lactic AcidMalic AcidPotassiumTotal Antioxidant Status

RX Test Menu

24

Quality Management

Solutions

Validate your clinical research with Randox

Quality Control Solutions

Internal Quality Controls

An Effective Tool for Evaluating Laboratory Performance

Randox Biosciences is one of the largest manufacturers of Quality Controls in the world. This includes our own brand Acusera portfolio of controls and calibrators, and customised material for laboratories, research organisations, EQA/PT schemes and other diagnostic manufacturers.

Acusera 24•7 is an interlaboratory data management package, primarily designed to complement the Acusera range of true third party controls. An effective IQC and peer group reporting program like Acusera 24•7 will help to improve your laboratory’s analytical performance, meet regulatory requirements and most importantly, ensure accurate results.

The software has two complementary functions; the internal function of the software is designed to help laboratories manage and interpret their daily QC data while the peer group function of the software allows comparison to worldwide peer group statistics, enabling rapid and effective troubleshooting.

With over 390 parameters in our Acusera range, choice and flexibilityis guaranteed. Principle control products include:

• Clinical Chemistry• Immunoassay• Urine• Immunology / Proteins• Lipids• Cardiac• CSF

• Therapeutic Drug Monitoring• Toxicology• Urine Chemistry• Urinalysis• Coagulation• Haematology

• Blood Gas• Tumour Markers• Maternal Screening• Antioxidants• Diabetes• Speciality / Research

24•7

25

Global harmonisation Options

Choice

Flexibility

Quality

Consolidation

Tailor made

Stability

Randox can manufacture custom QC lots and ship globally ensuring identical QC sera is run across your global laboratory operations (ideal for laboratory networks supporting clinical trials)

Customised controls in different matrices, e.g. serum, urine, aqueous

3 different formats – lyophilised, liquid, liquid frozen

Batch sizes manufactured between 50-250,000 vials. Randox can provide a wide range of vial sizes from 1ml to 10ml

High quality specification, fully compliant with ISO 13485

Randox will significantly consolidate your existing controls. An average laboratory may rationalise from 7 sera to a single control product

Specify the analytes and levels you require. We can provide the levels tailored to your cut off values

Randox sera are stable for up to 4 years, enabling use of the same lot over an extended period

Customised Quality Control Sera

Randox Customised Quality Controls – bespoke solutions for your clinical research

Randox Biosciences is the leading provider of customised quality control materials. We supply bespoke QC solutions to leading CRO’s, pharma companies, reference laboratories and EQA/PT schemes all over the world.

Customising control materials can involve selecting analytes, analyte concentration, vial size or kit format ensuring a precise QC solution tailored to your clinical requirement.

Week 1

Manufacture of Customised Sample

Randox sends blind sample to you

Sample checked and approved by you

QC order placed by you

You run blind sample and return results

to Randox

Enables Randox to view how the material

recovers on your machines

If end sample does not meet specifications, you are under no obligation

to accept

Week16

Sample is despatched to you

Randox generates labels and packages kit

Randox despatches and delivers final product to you

Custom Control Timeline

26

Factor IXFactor XFactor XIFactor XIIFibrinogenPlasminogenProtein CProtein SProthrombin Time (PT)Thrombin Time (TT)

CSF

Albuminα-1-globulinα-2-globulinβ-globulinChlorideγ-globulinGlucoseIgGLactateProteinSodium Cytokine & Growth Factors

Epidermal Growth Factor (EGF) Granulocyte Macrophage Colony-Stimulating Factor (GMCSF)Intercellular Adhesion Molecule 1 (ICAM-1)Interferon-gamma (IFN-γ)Interleukin-1 alpha (IL-1 α)Interleukin-1 beta (IL-1β)Interleukin-2 (IL-2)Soluble Interleukin-2 Receptor Alpha (SIL-2Rα)Interleukin-3 (IL-3)Interleukin-5 (IL-5)Soluble Interleukin-6 Soluble Receptor(SIL-6SR)Interleukin-4 (IL-4)Interleukin-6 (IL-6)Interleukin-7 (IL-7)Interleukin-7D (IL-7D)Interleukin-8 (IL-8)Interleukin-10 (IL-10)Interleukin-12p (IL-12p)Interleukin-13 (IL-13)Interleukin-15 (IL-15)Interleukin-23 (IL-23)Macrophage Inflammatory Protein-1 Alpha (MIP-1a)Matrix Metalloproteinase 9 (MMP-9)Monocyte Chemotactic Protein-1 (MCP-1)Soluble Tumour Necrosis Factor Receptor-1 (sTNFRI)Soluble Tumour Necrosis Factor Receptor-2 (sTNFR2) Tumour Necrosis Factor - alpha (TNF - α)Tumour Necrosis Factor - beta (TNF - β)Vascular Endothelial Growth Factor (VEGF)

Antioxidant

Glutathione PeroxidaseGlutathione Reductase Superoxide DismutaseTotal Antioxidant Status

Blood Gas

CalciumChlorideGlucoseLactatepCO2pHpO2PotassiumSodiumTotal CO2

Cardiac

BNPCK (Total)CK-MBCarbonic Anhydrase III (CAIII)D-DimerDigoxinHeart-type Fatty Acid-Binding Protein (H-FABP)Glycogen Phosphorylase BB (GPBB)hs-CRPHigh Sensitivity Troponin THomocysteineMyoglobinNT-ProBNPTroponin ITroponin T

Cellular Adhesion Molecules

E-Selectin ICAM-1L-SelectinP-SelectinVCAM-1

Cerebral

BDNFGFAPIL-6NSENGALsTNFRIThrombomodulin

Coagulation

Activated Partial Thromboplastin Time (aPTT)Antithrombin III Factor IIFactor VFactor VIIFactor VIII

Diabetes

FructosamineHbA1c HbfHbsHbA2

Drugs (Therapeutic)

Acetaminophen (Paracetamol)Amikacin CarbamazepineCaffeineCyclosporineDigoxinEthosuximideGentamicinLithiumMethotrexatePhenobarbitalPhenytoinPrimidoneSalicylateTheophyllineTobramycinValproic AcidVancomycin

Drugs of Abuse

7-aminoflunitrazepam11-Nor D-9-THC-9-COOHAcetaminophenAmphetamineBath Salts 1+2BenzylpiperazinesBarbituratesBenzodiazepineBenzoylecgonine BuprenorphineCannabinoidsChloral Hydrate MetaboliteCocaine MetaboliteDextromethorphanEcstasyEDDPEthyl Glucuronide EthanolEscitalopramFentanylGeneric OpiodsHaloperidolIbuprofenKetamine LSDMescalineMeprobamateMeperidineMethadoneMethamphetamineMethaqualoneMethylphenidate

Available Analytes for customised QCThis list is not exhaustive. If the analyte you require is not present, please contact info@randoxbiosciences.com

27

MorphineMDMAOpiatesOxazepamOxycodone IOxycodone IIPhencyclidine Phenobarbital PhenylpiperazinesPropoxypheneSalicylateSalicyluric AcidSalvinorinSecobarbitalSetralineTricyclic AntidepressantsTramadolTrazodoneZoleplonZolpidemZopiclone

Endocrine

Leptin Immunoassay

17-OH – ProgesteroneACTH AFPAldosterone Amikacinβ-2-MicroglobulinCEACA 125CA 15-3CA 19-9CA 72-4CalcitoninCarbamazepineC-PeptidesCyfra 21-1CortisolC-PeptideDHEA-SulphateDigoxinEstriolEstriol (unconjugated)EthosuximideFerritinFolateFSHGastrinGentamicinGrowth HormonehCGFree β hCGIgEIGF-1Inhibin AInsulinLHNeuron Specific EnolaseOsteocalcinOestradiolParacetamolPAPP- A PhenobarbitalPhenytoinPrimidoneProcalcitoninProgesteroneProlactinPSA (Free)

PSA (Total)PTHReninSalicylateSHBGTBGT UptakeT3 (Free)T3 (Total)T4 (Free)T4 (Total)TestosteroneTestosterone (Free)TheophyllineThyroglobulinAnti-TGAnti-TPOTobramycinTSHVanomycinValproic AcidVitamin B121-25-(OH)2-Vitamin D25-OH-Vitamin D

Lipids

Apolipoprotein A-IApolipoprotein A-IIApolipoprotein BApolipoprotein C-IIApolipoprotein C-IIIApolipoprotein ECholesterol (Total)Cholesterol (HDL)Cholesterol (LDL)Lipoprotein (a)Triglycerides sLDL

Metabolic Syndrome

ResistinPlasminogen Activator Inhibitor-1

Proteins

AFPAlbuminα-1-Acid Glycoprotein (AAG)α-1-Antitrypsin (AAT)α-2-Macroglobulin Antistreptolysin OAnti-thrombin IIIβ-2-MicroglobulinCeruloplasminComplement C3Complement C4CRPCystatin CFerritinHaptoglobinIgAIgEIgGIgMKappa Light ChainKappa Light Chain (Free)Lambda Light ChainLambda Light Chain (Free)PrealbuminProtein (Total)RBP (Retinol Binding Protein)Rheumatoid FactorTransferrin

Routine Chemistry

Albumin α-1-globulin α-2-globulin β-1-globulin Acid Phosphatase (Prostatic) Acid Phosphatase (Total) AlbuminALP ALT (GPT) Amylase Amylase (Pancreatic) AST (GOT) Bicarbonate Bile Acids Bilirubin (Direct) Bilirubin (Total) Cholinesterase Calcium Calcium (Ionised) Chloride CopperCreatinine γGT γ-globulinGlucose GLDH a-HBDH D-3-Hydroxybutyrate Iron LAP LD (LDH) Lipase Lactate Magnesium Osmolality Phosphate (Inorganic) Potassium SodiumTIBC Urea Uric Acid (Urate) Zinc

Urine

AmylaseCalciumChlorideCopperCortisolCreatinineDopamineEpinephrineGlucose5-H1AAhCGMagnesiumMetanephrineMicroalbuminNorepinephrineNormetanephrineOsmolalityOxalatepHPhosphorousPotassiumTotal ProteinSodiumSpecific GravityUreaUric AcidVMA (Vanillylmandelic Acid)

28

External Quality

Assessment

RIQAS - The largest international EQA/PT scheme in the world

Randox International Quality Assessment Scheme (RIQAS) is used by more than 31,000 laboratory participants in 115 countries worldwide and offers 24 comprehensive programmes with a wide range of options and parameters.

RIQAS provides an independent means of assessing the analytical performance of a laboratory compared to other laboratories using the same methods and instruments.

Developing inter-laboratory comparability maintains and improves analytical quality so raising the standard of clinical testing.

RIQAS features and benefits• Custom manufactured from human samples to mirror performance of patient samples • Programmes accepted by National and International accreditation bodies worldwide• High level of participants increases statistical validity• Wide range of parameters covers a broad spectrum of testing• Regular reports with rapid turnaround• Time saving user-friendly, easy to read reports • Reduced parameter options for selected programmes offers flexibility• Certificates provide proof of participation in a reputable EQA/PT scheme• Multi-instrument reports permit assessment of all laboratory systems• Reference method values provided in the Clinical Chemistry programme

RIQAS Accreditation

RIQAS provides Certificates as proof of EQA participation and performance for laboratory accreditation purposes.

RIQAS is a UKAS accredited Proficiency Testing Provider, No. 0010, and is accredited to ISO/IEC 17043:2010, ‘Conformity Assessment- General Requirements for Proficiency Testing’.

Accreditation to ISO/IEC 17043:2010 highlights the superior quality and excellence of RIQAS.

29

Available Programmes

* = with target scoring + = awaiting accreditation to ISO/IEC 17043

AMMONIA/ETHANOL PROGRAMME+ RQ91642 Parameters

BLOOD GAS PROGRAMME*RQ9134 RQ9134/AFirst registered instrument Subsequent instruments10 Parameters 10 Parameters

BNP PROGRAMME+ RQ9165 RQ91651 Parameter (BNP alone) Order with RQ9136/a when BNP and Liquid Cardiac parameters are required

CARDIAC PROGRAMME*RQ9127/a RQ9127/b2 Parameters only (choose from 7) Full 7 Parameters

COAGULATION PROGRAMME* RQ9135/a RQ9135/b5 Selected Parameters only Full 17 Parameters (aPTT, PT, TT, Fibrinogen, Antithrombin III)

ESR PROGRAMME+ RQ91631 Parameter

GENERAL CLINICAL CHEMISTRY PROGRAMMES*RQ9112 RQ911310 Parameters only Full 50 Parameters

RQ9112/S17 Parameters only

GLYCATED HAEMOGLOBIN PROGRAMME (HbA1c)*RQ91292 Parameters

HAEMATOLOGY PROGRAMME*RQ911811 Parameters

HUMAN URINE PROGRAMME*RQ911525 Parameters

IMMUNOASSAY PROGRAMMES*RQ9125/a RQ9125/c4 Parameters only (choose from 55) Full 55 Parameters

RQ9125/b RQ913013 Parameters only (choose from 55) Full 55 Parameters

IMMUNOASSAY SPECIALITY 1 PROGRAMME+RQ914110 Parameters

IMMUNOASSAY SPECIALITY 2 PROGRAMME+RQ91425 Parameters

LIPID PROGRAMME*RQ9126/a RQ9126/b3 Parameters only (choose from 7) Full 7 Parameters

LIQUID CARDIAC PROGRAMME* RQ9136 RQ9136/a9 Parameters only Order with RQ9165/a when BNP and Liquid Cardiac parameters are required

MATERNAL SCREENING PROGRAMME*RQ91376 Parameters

SEROLOGY (EBV) PROGRAMME+RQ91533 Parameters

SEROLOGY (HIV-HEPATITIS) PROGRAMME+RQ915110 Parameters

SEROLOGY (SYPHILIS) PROGRAMME+RQ91541 Parameter

SEROLOGY (TORCH) PROGRAMME+RQ915212 Parameters

SPECIFIC PROTEINS PROGRAMME* RQ9114 (3ml) RQ9160 (2ml) RQ9161 (1ml)26 Parameters

THERAPEUTIC DRUGS PROGRAMME*RQ911118 Parameters

URINALYSIS PROGRAMME+RQ913814 Parameters

URINE TOXICOLOGY PROGRAMME+RQ913920 Parameters

30

Publications

A sample of publications relating to our clinical chemistry, immunoassay and molecular products across a wide range of therapeutic areas is detailed below.

For further information, please contact the Biosciences team on info@randoxbiosciences.com.

C3 (RX daytona) & MetS Arrays I and II (Evidence Investigator)

Phillips, C.M., et al. Comparison of diabetes risk score estimates and cardiometabolic risk profiles in a middle-aged Irish population. PloS ONE. 2013. 8(11): e78950.

H-FABP IT Ruff, C,T., et al. Evaluation of the diagnostic performance of heart-type fatty acid binding protein in the BWH-TIMI ED chest pain study. J. Thromb. Thrombolysis 2013, 36(4): 361-367. (H-FABP IT)

MetS Array I and II (Evidence Investigator) Phillips, C.M., et al. Defining metabolically healthy obesity: role of dietary and lifestyle factors. PloS ONE. 2013. 8(10): e76188.

Glucose, HDL, TG (RX daytona)Camarillo-Romero, E., et al. Effects of a physical activity program on markers of endothelial dysfunction, oxidative stress, and metabolic status in adolescents with metabolic syndrome. ISRN Endocrinol. 2012, 2012: 970629.

Analyser / Assay Publication

CTKI (Evidence Investigator) Manavalan, J.S., et al. Serum cytokine elevations in celiac disease: Association with disease presentation. Human Immunology. 2010. 71: 50-57.

RANSODBachmeier, E., et al.Mucositis and salivary antioxidants in patients undergoing bone marrow transplantation (BMT). Med. Oral Patol.Oral Cir. Bucal 2014 19(5): e444-450

Custom Array (Evidence Investigator) Bünger, S., et al . A novel multiplex- protein array for serum diagnostics of colon cancer: a case-control study. BMC Cancer. 2012, 12: 393

TAS (RX daytona)Kontakiotis, T., et al. Bronchoalveolar lavage fluid alteration in antioxidant and inflammatory status in lung cancer patients. Eur. J. Intern. Med. 2011, 22(5): 522-526.

C3 (RX daytona)& MetS Arrays I and II (Evidence Investigator)

Phillips, C.M., and Perry, I.J. Does inflammation determine metabolic health status in obese and nonobese adults? J. Clin. Endocrinol. Metab. 2013. 98: E1610-E1619.

Glucose, HDL, TG (RX daytona)Camarillo-Romero, E., et al. Effects of a physical activity program on markers of endothelial dysfunction, oxidative stress, and metabolic status in adolescents with metabolic syndrome. ISRN Endocrinol. 2012, 2012: 970629.

Cardiovascular & Cerebrovascular

Oncology

Endocrinology

Metabolic & Nutrition

Immunology

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CTKI (Evidence Investigator) Fabre, S., et al. Protein biochip array technology to monitor rituximab in rheumatoid arthritis. Clin. Exp. Immunol. 2009, 155(3): 395-402.

CRP & CTKI (Evidence Investigator)Fabre, S., et al. Protein biochip array technology for cytokine profiling predicts etanercept responsiveness in rheumatoid arthritis. Clin. Exp. Immunol. 2008, 153(2): 188-195.

CTKIAttar B.M., et al. Disease dependent qualitative and quantitative differences in the inflammatory response to ascites occurring in cirrhotics. World J. Hepatol. 2014, 6(2): 85-91.

Creatinine (RX daytona)Peralta, C.A. et al. Associations of urinary levels of kidney injury molecule 1 (KIM-1) and neutrophil gelatinase-associated lipocalin (NGAL) with kidney function decline in the Multi-Ethnic Study of Atherosclerosis (MESA). Am. J. Kidney Dis. 2012, 60(6): 904-911.

Custom BAT ArrayVeitinger, M., et al. A platelet protein biochip rapidly detects an Alzheimer’s disease-specific phenotype. Acta Neuropathol. 2014, 128(5): 665-677.

Zinc Farahani, H.N., et al. Study on serum zinc and selenium levels in epileptic patients. Neurosciences (Riyadh) 2013, 18(2): 138-142.

Respiratory Multiplex Array (Evidence Investigator)

Memish, Z.A., et al. Etiology of severe community-acquired pneumonia during the 2013 Hajj-part of the MERS-CoV surveillance program. Int. J. Infect. Dis. 2014. 25: 186-190

RANSEL, RANSOD, TASVasilyeva, E.M., et al.Correlation between antioxidant enzymes activity and intraerythrocyte concentration of Fe, Mg, Zn, Cu in pulmonary arterial hypertension and cor pulmonale in children with congenital lung disease and cystic fibrosis. Int. J. BioMed. 2013 3(1): 15-19.

CTKI (Evidence Investigator)Park, Y., et al. Serum cytokine levels in chronic hepatitis B patients receiving peginterferon alpha-2a therapy. Hepatobiliary Pancreas Dis. Int. 2012, 11(5): 499-506.

High Linearity CRPJitpean et al. Decreased plasma Chromogranin A361-372 (Catestatin) but not Chromogranin A17-38 (Vasostatin) in female dogs with bacterial uterine infection (pyometra), BMC Vet. Res., 2015 11:14

Cytokine Array I (Evidence Investigator)Murugeswari P. et al. Angiogenic Potential of Vitreous from Proiferative Diabetic Retinopathy and Eales' Disease Patients. PLoS one. 2014. 9 (10): e107551

TASAbu-Amero et al. Total antioxidant level is correlated with intra-ocular pressure in patients with primary angle closure glaucoma. BMC Research Notes. 2014 7:163

Rheumatology

Nephrology

Neuroscience

Pulmonary & Respiratory

Infection

Ophthalmology

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