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Leading a new era of precision oncology
PRECISION ONCOLOGYFOR TARGETED THERAPIES
CONTRACT RESEARCHSERVICES
MOLECULAR PATHOLOGY DIAGNOSTIC SERVICES
RESEARCH & DEVELOPMENTPROGRAMMES
Oncologica provides precision oncology testing to address the growing demand for molecular profiling of cancer patients for targeted therapies and functions as a Contract Research Organisation to support biomarker and drug development programmes worldwide.
In addition, Oncologica runs its own in-house R&D programmes focusing on the development of novel diagnostic and therapeutic intervention strategies targeting the cell cycle machinery.
Oncologica is a new molecular profiling laboratory set up to address the growing demand for personalised medicine. Our scientists and clinicians utilise state-of-the-art molecular diagnostic platforms in the analysis of patients’ tumour samples to maximise treatment benefit and reduce healthcare costs.
“The linking of specific cancer genetic alterations to the new generation of molecular targeted therapies is driving a new era of personalised medicine.”
PRECISION ONCOLOGYFOR TARGETED THERAPIES Comprehensive analysis of major cancer driver genes
in one single workflow dramatically reducing the cost of molecular profiling and accelerating reporting times
Reduced number of tests that cancer patients require
NGS semiconductor platform uses low DNA/RNA input (10ng) from FFPE samples enabling detection of actionable variants in fine needle biopsies and core needle aspirates
Generates a comprehensive picture of actionable mutations providing the clinician with a detailed molecular blueprint for optimal therapy choices and improved patient outcomes
Prevent the unwarranted prescribing of expensive targeted therapies to patients unlikely to benefit from such treatments
PRECISION ONCOLOGYFOR TARGETED THERAPIES
ALK, AR, BRAF, CCND1, CDK4, CDK6, EGFR, ERBB2, FGFR1, FGFR2 FGFR3, FGFR4, KIT, KRAS, MET, MYC, MYCN, PDGFRA, PIK3CA.
COPY NUMBER VARIANTS
ALK, RET, ROS1, NTRK1, NTRK2, NTRK3, FGFR1, FGFR2, FGFR3, MET, BRAF, RAF1, ERG, ETV1, ETV4, ETV5, ABL1, AKT3, AXL, CDK4, EGFR, ERBB2, PDGFRA, PPARG.
FUSION DRIVERS
BRCA Test Ion Ampliseq BRCA1 and BRCA2 panel for breast and ovarian cancer
Utilises 167 amplicons to analyse the coding regions of tumour suppressor genes BRCA1 and BRCA2. Assessment of therapeutic response to targeted therapies (rucaparib and veliparib) and chemotherapy (carboplatin, cisplatin and oxaliplatin).
22 Gene Test Ion Ampliseq Lung and Colon cancer panel
22 gene panel for coverage of over 500 mutations implicated in colorectal (CRC) and non small cell lung cancer (NSCLC)KRAS, EGFR, BRAF, PIK3CA, AKT1, ERBB2, PTEN, NRAS, STK11, MAP2K1, ALK, DDR2, CTNNB1, MET, TP53, SMAD4, FBXW7, FGFR3, NOTCH1, ERBB4, FGFR1, FGFR2.Panel includes FDA and NICE approved predictors of response to erlotinib (Tarceva), gefitinib (Iressa), cetuximab (Erbitux).
Custom panels Custom designed DNA and RNA panels also available on request
Contact us at [email protected]
Oncofocus was developed as part of the US NCI-MATCH (Molecular Analysis for Therapy Choice) program for precision oncology involving 2400 NCI-affiliated hospitals, >700,000 patients samples, 120 phase 3 and 215 early phase trials.
The Oncofocus test utilises state of the art semiconductor technology to rapidly sequence DNA/RNA extracted from routine FFPE surgical biopsy material. The assay is designed to detect thousands of genetic alterations including SNPs, indels, CNVs and fusions across 52 of the major cancer driver genes linked to solid tumours. The data generated by the Oncofocus test is analysed using Oncologica’s bioinformatics platforms linked to the world’s largest curated compendium of cancer genetic information, enabling genetic alterations/variants to be linked to over 280 targeted therapies. Targeted therapies include all classes: -FDA approved therapies, -national comprehensive cancer network (NCCN) guideline referenced therapies and -therapies entered into US, EU and Japanese phase I, II and III clinical trials.
ONCOLOGICA TEST MENU FOR PERSONALISED ONCOLOGY
Oncofocus Test Comprehensive NGS targeted panel for precision therapy
52to
Genes relevantto solid tumors
gene alterations
aligneddetection of thousands of
variants
targeted therapies andmany more
undergoing clinical trials
over 270
AKT1, ALK, AR, ARAF, BRAF, CDK4, CTNNB1, DDR2, EGFR, ERBB2, ERBB3, ERBB4, ESR1, FGFR2, FGFR3, GNA11, GNAQ, HRAS, IDH1, IDH2, JAK1, JAK2, JAK3, KIT, KRAS, MAP2K1, MAP2K2, MET, MTOR, NRAS, PDGFRA, PIK3CA, RAF1, RET, ROS1, SMO, TERT.
HOTSPOT GENES:
PRECISION ONCOLOGYFOR TARGETED THERAPIES
TARGETED NGS FOR ALL SOLID TUMOUR TYPES
FGFR2 AMPLIFICATION
AXL FUSION
MET FUSION
TSC2 MUTATION
SMO MUTATION
AXL FUSION
Bladder
Breast
Colorectal
Endometrial
Oesophagus
Gastric
Mesothelioma Osteosarcoma
Ovarian Pancreatic
GIST
Glioblastoma
Head and Neck
Kidney
Liver
Testicular
Thyroid
Prostate
Skin
Small Cell Lung Cancer
Soft Tissue SarcomaNon Small Cell Lung Cancer
EGFR FUSION
AKL FUSION
PDGFRA MUTATION
CDK4 MUTATION
HRAS MUTATION
CRIZOTINIB + DASATINIB
IPILIMUMAB
VEMURAFENIB
IMATINIB MESYLATE
VORINOSTAT
CABOZANTINIB
CLR-457
JNJ-42756493
CETUXIMAB
DABRAFENIB
ERLOTINIB
NERATINIB
ABL1 ABERRATION
PTCH1 MUTATION
RET MUTATION
BRAF MUTATIONERBB2 AMPLIFICATION
EGFR MUTATION
AFATINIB
DABRAFENIB + TRAMETINIB
MGCD-265
JNJ-42756493
CERITINIB
RIBOCICLIB
NTRK3 MUTATION
CDK4 MUTATION
EGFR AMPLIFICATIONFGFR2 FUSION
PROSTATE
TUMOUR TYPE GENETIC VARIANTS
35 genes and hundreds of variants tested in this tumour type
TARGETED THERAPIES
Over 90 potential treatments in this tumour type
NTRK2 FUSION
MAP2K1 MUTATION
ALK FUSION
TARGETED TREATMENTSThe fully integrated Oncofocus Assay and linked Oncofocus Reporter Database provide unparalleled information regarding an individual’s tumour that can be exploited to optimise treatment selection using the new generation of molecular targeted agents.
IHC protein expression profiling
FISH/CISH/DDISH molecular probes
Companion Diagnostics
State-of-the-art molecular tissue analytics for cancer diagnosis, patient stratification and personalised medicine. These services are available globally to healthcare providers, biopharma and biotech industries.
MOLECULAR PATHOLOGY DIAGNOSTIC SERVICES
ONCOLOGY FISH - Amplification
HER2/CEP17MET/CEP7FGFR1/CEP8FGFR2/CEP10EGFR/CEP7ERCC1/19p13TOP2A/CEP17AR (Xq12)/CEPXCDNK2A (p16, 9p21)/9q12)FGFR3/4p11PTEN (10q23)/CEP10
LYMPHOMA FISH (Breakapart probes)
MYC t(8:14)BCL2 t(14:18)BCL6 t(3q27)CCND1 t(11:14)MALT1 t(11:18)IGH t(14q32)
LYMPHOMA FISH (Fusion probes)
MYC/IGH/CEP8 Dual-Fusion Triple Colour
MELANOMAMELANOMA FISHRREB1/CCND1/MYB/CEP6 Abbott Molecular/Vysis
CISH
KAPPALAMBDAEBERCMVHPV Low RiskHPV High Risk
BLADDER CANCER
UroVysion FISHCEP3/CEP7/CEP17/CDKN2A (p16/9p21) Abbott Molecular/Vysis
ONCOLOGY FISH (Translocation)
RET (10q11) BreakapartROS1 (6q22) BreakapartBRAF (7q34) BreakapartALK Breakapart
MOLECULAR PATHOLOGYDIAGNOSTIC SERVICES
FISH/CISH/DDISH
OVER 30 tests available
Molecular probes for gene amplification and rearrangements including breakapart translocations
34βE12 (CK HMW)3β-HSD
0-9
ACTHAE1/AE3 (PAN CK)AFPALK-1 (lung)ALK-1 (lymphoma)Alpha-1-anti-chymotrypsinAlpha-1-anti-trypsinAmyloid AAndrogen ReceptorAnnexinAP-G2ABCG2AIMP-3 (EEF1E1)Annexin A5AprataxinAromatase (CYP19, P-23)
A
bAPPbcl-2bcl-2 (E17)bcl-6BerEP4Beta cateninBLIMP-1BOB-1BRCA1BRD-1
B
CA19.9CA125CA-IXCalcitoninCalponinCalretininCAM 5.2CD1aCD2CD2APCD3CD4CD5CD7CD8CD10CD11cCD13CD14CD15CD16CD19CD20CD21CD22CD23CD25CD27CD28CD30CD31CD33CD34CD35CD38CD40CD43CD44v6
CD45 (LCA)CD45RACD43CD44v6CD45 (LCA)CD45RACD45ROCD52CD54CD56 (N-CAM)CD57 (HNK-1, LEU7)CD61CD68 (KP1)CD68 (PGM1)CD71CD79aCD99CD105CD117 (C-KIT)CD123CD138CD163CD235a (GLYCOPHORIN A)CDK4CDK6CDX2CEAChromogranin ACK5CK7CK8CK14CK17CK18CK19CK20C-METCMV
Collagen IVCOX-2CXCL-12CXCL-13Cyclin ACyclin D1Cyclin D2Cadherin 6CD9CD147CK 5/6CXCL12CXCR4
C
C
D2-40DBA44Desmin DOG-1DRG-1
D
E2F3E-CadherinEBV (LMP)EGFR (HER1)EMAERER BETAERCC-1ESA (EPCAM)E2F3ELAV-1EN2
E
Factor VIII (vWF)Factor XIIIaFascinFibrinogenFoxP1FoxP3FSH
F
GalectinGastrinGCDFP-15GCET-1gemininGFAPGlucagonGlut-1Glypican 3Granzyme BGrowth HormoneGlutamine synthetaseGSTP-1
G
H.PyloriHBcAgHBME-1HBsAgh-caldesmonHCGHemaglobinHER2 (cerb-B2)HIF-1aHMAHMB45HMFG2HPVHSA (HepPar1)HSVIHSVIIHemoglobin gammaHER2 (Conc)HIG-2HOXA10H3S10phHSVIIHemoglobin gammaHER2 (Conc)HIG-2HOXA10H3S10ph
H
IHC for protein expression profiling Immunohistochemistry test menu
OVER 200 tests available
Napsin ANestinNeurofilament (NFP)Neutrophil elastaseNSE
N
Oct-2OCT-3 / 4Osteopontin
O
p16P24p27p40p53 (D01)p53 (D07)p57p63Pancreatic PolypeptideParvovirusPAX-2PAX-5PAX-8PD1PDGFRaPerforinPGP9.5PKC thetaPLAPPLK1PMS2PRProlactinPSAPSAPPSMAPTENPTHPARP-1Phospho AKTPhospho MTORPhospho RbpIGF-1RPIK3IP-1PNMA2
P
S100Sarcomeric ActinSerotonin (5TH)SMASMMSomatostatinSOX11SurfactantSynaptophysinSerpina3Sox-5
S
TAL 1B5 (HLA-DR)TCR-Beta (Beta F1)TdtThrombomodulin (CD141)ThyroglobulinTIA-1ToxoplasmaTP (Treponema pallidum)TRAPTSHTTF-1TDP-1TOPO-1TYRO3
T
Uroplakin-III
U
VEGFVEGFR3VimentinVS38cVZVVEGF-CVEGF-D
V
WT1
W
ZAP70
Z
Racemase (AMACR. P504S)Racemase/p63 cocktailRCCRET40f (Glycophorin C)RAD51
R
ICOSIDH1IgAIgDIgGIgG4IgMInhibinInsulinIRTA-1I-CAM 1IGF-1RIL-6RIL-7IL-8
I
J chain
J
KappaKappa (plasma cells)Kappa (renal)KPL1KSHV (HHV8)
K
L1 (CD171, L1-CAM)LambdaLambda (plasma cells)Lambda (renal)LamininLangerinLHLP34LysozymeLIFLM02
L
M30 cytodeathMast cell tryptaseMCM2Melan AMesothelinMGMTMIB-1 (Ki67)mLH1MNF116mSH2mSH6MUC-1MUC-2MUC-5ACMUM-1MyeloperoxidaseMYO D1MyogeninMyoglobinMCP-1MMP-7MMP-9MMP-10MMP-14MRE11aMSR-1MUC-1MUC-2MUC-5ACMUM-1MyeloperoxidaseMYO D1MyogeninMyoglobinMCP-1MMP-7MMP-9MMP-10MMP-14MRE11aMSR-1
M
MOLECULAR PATHOLOGYDIAGNOSTIC SERVICES
Veterinary pathology servicesMolecular biomarker analysis using IHC, ISH and sequencingfor primary and differential diagnosis applications.
Quantitative image analysisGeneration and validation of image processing algorithms for automated quantification of protein biomarkers and molecular probes.
Digital scanningFully integrated high throughput high resolution digital scanning of test slides for digital pathology solutions.
We use high throughput automated platforms allowing fast turnaround reporting times.
Anatomic pathologySpecimen embedding Section cutting Special stains TMA production
H&E Preparation of cell line blocks for positive/negative controls for IHC and ISH
MOLECULAR PATHOLOGYDIAGNOSTIC SERVICES
Pathology analytics for theranostic programmes
Analysis of protein biomarkers for companion diagnostics
Proof of concept and proof of mechanism studies
Biomarker clinical trials
Extensive knowledge base in anatomical and molecular oncopathology, companion diagnostics and translational medicine to provide high quality and cost effective contract research services for development of cancer biomarkers and molecular targeted therapies.
CONTRACT RESEARCHSERVICES
We offer contract research services for pharmaceutical, biotech, academic institutions and healthcare providers.
Development of novel companion diagnostics and new therapeutic intervention approaches
New testing strategies for patient stratification, companion diagnostics and personalised medicine
Biomarker discovery, verification and validation Proof of concept and proof of mechanism studies
Establishing cancer detection systems for primary diagnosis, treatment response and post-treatment
tumour surveillance
Analysis of pre- and post-treatment biopsies for assessment of therapeutic response
Preparation of cell line blocks for antibody characterisation and controls for test kits
Pre-clinical studies, including tissue culture model systems, tumour progression model systems,
xenografts, transgenics, tumourigenicity assays
Integration of pathology analytics with drug development programmes Identification of new drug targets and target validation
Our portfolio of services include:
CONTRACT RESEARCHSERVICES
Clinical Biomarker Trials
Expert tumour pathological assessment by diagnostic pathologists, including tumour
verification, evaluation of tumour area, proliferative fraction, vascular invasion, stromal response, % tumour
necrosis, scoring of inflammatory infiltrates and assessment of tissue fixation
Analysis of protein biomarkers including cell proliferation, apoptosis, signal transduction, invasion,
metastasis, cell metabolism and new candidate biomarkers
Molecular tissue analytics including IHC, FISH/CISH, Next generation sequencing, Analysis of tumour DNA
content, Assessment of tumour growth kinetics
Preparation of high density tissue microarrays for high throughput tissue analytics
Evaluation of H&E and IHC staining
Comparative pathology analyses
Clinical validation of biomarkers on FDA approved panels of normal and diseased human tissues
Human/animal tissue evaluation for microdissection studies
Development and validation of image processing algorithms
CONTRACT RESEARCHSERVICES
Oncologica capitalises on its extensive knowledge base and expertise in anatomical and molecular oncopathology, companion diagnostics and translational medicine to
provide high quality and cost effective contract research services to support theranostic programmes at all stages of the development pipeline.
With a tailored approach to our clients, we provide molecular pathology analytics to support biomarker and drug development from discovery through preclinical studies to
clinical trials.
Companion diagnostics
Cell cycle directed therapies
In house R&D programmes focusing on development of novel diagnostic and therapeutic intervention strategies targeting the cell cycle machinery
RESEARCH & DEVELOPMENTPROGRAMMES Theranostic strategies are often directed against complex and redundant growth signalling
networks from surface ligands and receptors through transducers to downstream effector molecules.
However the redundancy of these networks can result in low efficacy of molecularly targeted drugs and constraints on the performance of cancer biomarkers directed at these pathways.
An alternative approach is to target the cell cycle machinery, which acts as a convergence point for information transduced through upstream signalling networks and therefore
represents an exceptionally attractive diagnostic and therapeutic target.
Cell cycle machinery
RESEARCH & DEVELOPMENTPROGRAMMES
ReferencesJ Pathol. 2014 Aug;233(4):344-56.EMBO J. 2010 Oct 6;29(19):3381-94.
Clin Cancer Res. 2009 Apr 1;15(7):2417-25.J Pathol. 2012 Jan;226(2):352-64.
Am J Pathol. 2010 Oct;177(4):2034-45
Signalling cascades
Transcription factors
Growth factor receptors
G1
S
G2
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Suite 15 -16, The Science Village, Chesterford Research Park, Chesterford, Cambridge, CB10 1XL
www.oncologica.com
TELEPHONE
+44 1223 785327
Professor Gareth Williams and Dr Marco Loddo are Co-founders and Directors of Oncologica and have in-depth knowledge and expertise in diagnostic oncopathology, translational biology, biomarker discovery and drug development.
Kitty Williams is the Senior Commercial Manager and is responsible for providing advice and implementation on commercial and corporate matters
Philippa Jones is the Senior Operations Manager and directs the tissue based diagnostic services of the company.
Katherine Marquis is the Senior Biomedical Scientist who directs the precision oncology services for targeted therapies
Keeda-Marie Snelson is the Lead Clinical Scientist with extensive expertise in the analysis of cancer genetic variants of clinical prognostic and predictive significance.
Rebecca Cadman is the Business Development Manager and is responsible for exploring new market opportunities and providing comprehensive support for existing clients.
MANAGEMENT TEAM
Read more about our team by visitng www.oncologica.com/team
Suite 15-16, The Science Village, Chesterford Research Park, Chesterford, Cambridge, CB10 1XL
www.oncologica.com
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