IHC, FISH AND CYTO SERVICES - IMMUNOHISTOCHEMISTRY (IHC), FLUORESCENCE IN SITU HYBRIDIZATION (FISH) AND CYTOGENETICS - NeoGenomics Laboratories
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IHC, FISH AND CYTO SERVICES IMMUNOHISTOCHEMISTRY (IHC), FLUORESCENCE IN SITU HYBRIDIZATION (FISH) AND CYTOGENETICS
OU R M I S S I O N I S T O HE LP
REDUCE CANCER DEATHS
ACROSS THE GLOBE
NEOGENOMICS PHARMA SERVICES
Because every sixth death in the world is due to cancer, our mission
at NeoGenomics is to partner with pharmaceutical companies to bring
new life-saving oncology drugs to market so we can help reduce
cancer-related deaths worldwide.
Our unique and comprehensive product and service offerings include:
• Unparalleled expertise, flexibility and scalability
• Largest oncology focused clinical research organization (CRO) in the USA
• Complete one-stop testing
• Medical and scientific consultation
>2000 #1 >1500 #1
Biomarker projects In breast Completed projects
in PD-L1
in development & cancer testing* with a backlog of
Testing
testing to date *Data from CMS claims database more than $145MM
>120 ~1,000,000 620+
MDs & PhDs across
pathology & scientific Cancer-related Oncology & pathology
disciplines tests per year tests ready for order
2
IHC, CISH, FISH, CYTO: TISSUE BASED VIEW OF TUMORS
Our vast experience in clinical grade anatomic pathology (AP) services
includes comprehensive histology services, a full IHC menu and image
analysis/digital pathology capabilities to support oncology and inflammatory
diseases. Our FISH portfolio includes single and multi-marker disease-focused
panels covering hematologic diseases and solid tumor applications. With
decades of experience developing and implementing leading-edge tests to
service the pharma, oncology, pathology and research communities, our AP
and FISH services are capable of delivering results for any project scope.
Our AP services include:
• High-quality, tailored solutions for a wide range of image analysis requirements
• Pathology + technology expertise built on decades of experience and
industry leadership
• Platform-agnostic, customizable qualitative and quantitative image analysis to
support your CDx, clinical trials or development needs—delivered with rigorous,
industry-leading quality standards
• Histology (processing, embedding and microtomy), which services many
downstream modalities including FISH, MultiOmyx/Polaris and Molecular.
• Custom IHC/chromogenic in situ hybridization (CISH) development, validation
and testing
• Expert (relevant) pathologist evaluation criteria and reportable format
development incorporating evaluation by a sub-specialized pathology team
• >400 validated IHC/CISH stains across our Clinical and Pharma divisions
• Multiple platforms for technology agnostic development of optimal stain quality
or downstream partnering with an in vitro diagnostics (IVD) partner of choice
3
AP TECHNOLOGIES
CAPABILITIES AND PLATFORMS
TECHNOLOGIES CAPABILITIES PLATFORMS
• > 2,500 IHC/ISH stains per
day (in antivirus (US) testing)
• Dako Link 48
• > 400 validated IHC assays
(in AV testing) • Dako Omnis
IHC/ISH
• Laboratory developed test • Leica BOND-III/BOND RX
(LDT), IVD, clinical trial assay • Ventana Benchmark ULTRA
(CTA) and CDx options
Ventana Benchmark ULTRA
Imaging • Bright field • Aperio ScanScope AT
• Cell morphology & cell
count
• Dot count (ISH) • Indica HALO
Image analysis • Whole specimen analysis • Visiopharm
• Pattern recognition and
tissue discrimination
• Fully customizable
We take an equipment and reagent agnostic approach in order to provide our
clients with the highest quality of service by producing the best stain quality for
each individual target.
We chose to work with NeoGenomics, due to their scientific strength, the breadth of
the methods they are able to offer and their flexibility around the customer needs.
-- Associate Director, Translational Medicine
4
PHARMA AP
CAPABILITIES AND ASSAYS
APPLICATIONS/CAPABILITIES RELEVANT PHARMA IHC ASSAYS
Histology supports AP, FISH,
PD-L1 28-8 (Opdivo®)
Molecular and Multiplex modalities
Custom development and validation of PD-L1 22C3 (Keytruda®)
novel biomarkers, fit for purpose and
designed to evolve with your program
PD-L1 SP263 (IMFINZI®)
Assay transfer, assay development,
technical/exploratory test development, PD-L1 SP142 (TECENTRIQ®)
validation, enrollment/screening and
investigational use only (IUO)->CDx
test development HER2 (HercepTest®, Pathway (4B5))
Trial testing: disease diagnosis, MMR panel (Ventana)
prognosis and confirmation; specific
biomarker screening; tumor profiling
FOXP3
From single-plex IHC/CISH assays to
supporting multiplex development CD3
Qualitative and quantitative
scoring and image analysis CD8
Tissue microarray (TMA)
CD68
screening (prevalence)
Offered US, EU and Asia Pacific, Not currently offered in Singapore but will be brought up soon.
Our IHC staining and image acquisition were recognized for both assay validation and clinical study workflows in:
Phase I Clinical studies in TAK-981 (first-in-class inhibitor of SUMOylation) drug development: Assessment of tumor
and skin samples using IHC and HALO® image analysis by Vaishali Shinde, Assoc. Dir, Mol Path (CBID) Takeda; Jun
10, 2020.
5CUSTOMIZABLE AND EXPANDABLE
IHC DEVELOPMENT/VALIDATION
PROJECT TYPE STARTING POINT DEVELOPMENT VALIDATION ELEMENTS
• Accuracy; clinical
• Development and sensitivity, clinical
Optimization specificity
• Precision (repeatability
• Assay transfer (and intra-run replicates;
Standard translation to IVD reproducibility
Customizable
LDT/CTA platform) (inter-run replicates)
• Pathologist evaluation (includes inter-operator
criteria development/ and inter-instrument)
reportable format(s) • Antigen and reagent
stability (optional)
• Down select/screen
• De novo assay antibody clones • Accuracy; clinical
development sensitivity, clinical
• Staining platform specificity
and validation
comparison/
• Usually for evaluation • Precision (repeatability
early phase • Clone not intra-run replicates;
intended use Specified • TMA screen for reproducibility
• Platform not prevalence prior to (inter-run replicates)
• Can be
Specified validation phase — (includes inter-
amended per
optional, per operator and inter-
indication for
indication instrument)
screening/
enrollment • Pan-tumor/multiple • Antigen and reagent
intended use indications for early stability (optional)
phase
6CUSTOMIZABLE AND EXPANDABLE
IHC DEVELOPMENT/VALIDATION
(CONT.)
PROJECT TYPE STARTING POINT DEVELOPMENT VALIDATION ELEMENTS
• Development and
Optimization
• Assay • Staining platform
comparison/ • Accuracy; clinical
development sensitivity, clinical
and Validation evaluation
specificity
• Usually for • Antibody
• Proprietary • Precision (repeatability
early phase characterization
clone intra-run replicates;
intended use (peptide competition)
reproducibility
• Can be • Platform not (inter-run replicates)
• TMA screen for
amended per specified (includes inter-operator
prevalence prior to
indication for validation, phase — and inter-instrument)
screening/ optional, per • Antigen and reagent
enrollment indication stability (optional)
intended use
• Pan-tumor/multiple
indications for early
phase
• Addition of
indications to
existing validated test
for exploratory/
research use
Technical Study/ • CTA for • Research /
Amendment early phase Exploratory use
• Abbreviated
validation for early
phase or pre-phase
research/exploratory
use
7PROJECT TYPE STARTING POINT DEVELOPMENT VALIDATION ELEMENTS
• Assay confirmation
(sponsor assay)
• Translate to IVD
platform (if
Assay transfer developed on Rx
• Same as above with
and validation: • Research use platform)
expanded precision
support for all only (RUO)
• Antibody testing
study phases investigational
use only (IUO) characterization • Multiple indications
– leading up
(peptide competition)
to prospective • IVD • Emphasis on potential
screening for manufacturer • Utilize all IVD cut-off during precision
enrollment with collaboration partner-specific testing
CDx pathway reagents
• Develop pathologist
criteria, reportable
format(s) and training
program
Validation expansion:
• For use in determining enrollment status, the assay is validated with an emphasis
on the cutoff point during precision testing, per indication.
- Additional specimens, per indication, may need to be screened,
depending on the prevalence of expression at the cutoff.
- Additional specimens per indication at the cutoff
• Antigen Stability: real-time and/or accelerated
• Peptide competition
• Inter- and/or intra-pathologist concordance
• Pathologist training program and certification
• Inter-lot reproducibility
• Inter-lab reproducibility
• Reagent stability: real-time and/or accelerated
• Instructions for use (IFU) drafting for submissions
8Assay Transfer:
• Sponsor developed assays may require:
- Assay Translation to an IVD version of the staining platform (i.e. Bond RX
> Bond III; Ventana Discovery > Ventana Benchmark).
- Assay Confirmation to ensure no additional adjustments are necessary
prior to initiating the validation phase.
- Confirmation of pathologist evaluation criteria and reportable format(s)
per indication and per subcellular compartment and cell type.
Technical studies for research use:
• Addition of indications for research/exploratory use—precision testing
can be optional for added indications.
• Prevalence testing: transcription mediated amplification (TMA) screening
to estimate prevalence prior to validation phase, but subsequent to assay
development approval.
• CTAs, where one or more elements of validation are not performed at
NeoGenomics, under sponsor direction; in some cases, these may also be
used for prospective patient screening.
PD-L1 IHC Stains
PD-L1 Tumor Positive IHC Stain
9PHARMA IHC/CISH MENU
PHARMA IHC MENU/EXPERTISE
ALK (D5F3) CD30 Cyclin E1
CDx (Lung Ca)
ALK-1
CD32b EGFR
(for Lymphoma cases)
AKR1C3 CD34 EGFR pharmDx
AMYLOID A CD38 EGFRvIII
AR EphA2
(Androgen Receptor) CD54
BCL2 CD86 Filaggrin
BCL-XL CD137 FGFR2pharmDx
BCMA CD138 FGFR4
Beta Catenin Chromogranin A FGF19
CD3 CD3 FOXP3rin
CLL-1
CD4 (MICL/CLEC12A) gH2AX2pharmDx
CD8 C-MET Globo H
CD11b c-MYC HER2 (4B5)
CD19 CTLA-4 Her2 (Hercep Test)
10PHARMA IHC MENU/EXPERTISE (CONT.)
HLA-DR p90RSK RANK
ICAM1 pERK (Phospho-p44/42) RANKL
Retinoblastoma
ICOS PD-L1, 22C3 pharmDXFDA Protein (RB)
ICOS-L PD-L1, 28-8 pharmDXFDA RIPK2
IDO1 PD-L1, SP263 (IVD Kit) STING
PD-L1, E1L3N
Ki67 Synaptophysin
(Phospho-p44/42)
LAG-3 PD-L222C3 pharmDXFDA SUMO 2/3noblastoma
Protein (RB)
MCL-1 pHH328-8 pharmDXFDA Survivin
MLH1 pMCM2SP263 (IVD Kit) TLR4
MSH2 PMS2 VCAM1
VEGFR2/3noblastoma
MSH6 pRSKL222C3 pharmDXFDA
Protein (RB)
NQO1 pS6 WT1
OX40 pSTAT3 p53
PTEN
Bold indicates assay is ready for general use.
11CLINICAL IHC/CISH MENU
CLINICAL IHC/CISH MENU
Adrenocorticotropin
Adenovirus Hormone AE1/AE3 Albumin
Alpha-1-
Alpha Feto Protein Alpha-1-Antitrypsin Amyloid A
Anti-Chymotrypsin
ALK-1 - Anaplastic ALK (D5F3) CDx (for
Amyloid P Cell Lymphoma Androgen Receptor
(for Heme cases)
Lung Adeno CA only)
Annexin A1 Arginase 1 ATRX B72.3 (TAG-72)
BAP1 BCA-225 BCL-1 BCL-2
BCL-6 BCL-10 BerEP4 Beta-Catenin
Blood Group
Beta-3 Tubulin Related Antigen BOB1 BRAF V600E
BRCA1 Breast Triple Stain CA19-9 CA-125
Calcitonin Caldesmon Calponin Calretinin
Carbonic Carcinoembryonic Carcinoembryonic
CAM 5.2
Anhydrase IX Antigen (Mono) Antigen (Poly)
Cat Scratch
(RED Protocol) Cathepsin D CD1a CD2
CD4 CD5 CD7 CD8
12CLINICAL IHC/CISH MENU (CONT.)
CD10 CD11c CD14 CD15
CD19 CD20 CD21 CD22
CD23 CD25 CD30 CD31
CD33 CD34 CD35 CD38
CD42B CD43 CD44 CD45 (LCA)
CD45RB CD45RO CD56 CD57
CD61 CD68 CD71 CD79a
CD99 CD103 CD123 CD138
CDX2/CK7
CD163 CDK4 Double Stain Chromogranin A
C-KIT C-MET CMV c-Myc
Collagen IV c-REL CXCL13 Cyclooxygenase-2
Cytokeratin 5/6 Cytokeratin 7 Cytokeratin 10/13 Cytokeratin 14
Cytokeratin 17 Cytokeratin 18 Cytokeratin 19 Cytokeratin 20
13CLINICAL IHC/CISH MENU (CONT.)
Cytokeratin- High Molecular
Cytokeratin- High
Molecular Weight
Weight +Cytokeratin-Low Cytokeratin OSCAR D2-40
Molecular Weight Cocktail
DBA.44 Desmin DOG-1 DPC4
EBER PROBE BY ISH
(ventana) EBV by IHC E-Cadherin Eg5
Epidermal Growth EGFR (E746-A750del EGFR (L858R
EiF-4E Factor Receptor Specific) Mutant Specific)
Epithelial Membrane Estrogen Receptor Excision Repair Cross
Antigen (6F11) ETS-Related Gene Complementing
Follicle Stimulating
Factor XIIIa Fascin Fli-1 Hormone
FOXP1 FOXP3 Galectin-3 Gastrin
Glial Fibrillary
GATA-3 GCET1 Geminin Acidic Protein
Glutathione S
Glucagon GLUT1 Glutamine Synthetase Transferase p
Gross Cystic Disease
Glycophorin A Glypican-3 Granzyme B Fluid Protein
Growth Hormone HBME-1 Helicobacter Pylori Hemoglobin A
Hepatitis B Hepatitis B Hepatocyte
Core Antigen Surface Antigen Specific Antigen HER2 Dual ISH
Her2/neu Herpes Simplex 1 and
(PATHWAY)
Herpes Simplex 2 HGAL HLA-DR
Cocktail
HMB-45 Human Chorionic Human Herpesvirus,
HMB-45 (RED Protocol) Gonadotropin Type 8
14CLINICAL IHC/CISH MENU (CONT.)
Human Placental
HPV LR 10 by CISH HPV HR 18 by CISH Lactogen ICOS
IDH1 Immunoglobulin A Immunoglobulin D Immunoglobulin G
Immunoglobulin G4 Immunoglobulin M Inhibin Alpha INI1
Kappa Light Chain Kappa Light Chain
INSM1 Insulin Immunoglobulin Immunoglobulin by ISH
Lambda Light Chain Lambda Light Chain
Ki-67 Immunoglobulin by IHC Immunoglobulin by ISH Laminin
Langerin LEF1 LMO2 Luteinizing Hormone
Lysozyme MAL Mammaglobin MDM2
Melan A
Melan A (Red protocol) Mesothelin MGMT
MITF
MITF (Red protocol) MLH1 MOC-31
MSH2 MSH6 MUC-1 MUC-2
Muscle Specific -
MUC-5AC MUC-6 MUM1 Actin
Myeloperoxidase Myo D1 Myogenin Myoglobin
Neuron Specific
Napsin A NeuN Neurofilament Enolase
NGFR (p75NTR) NKX2.2 NKX3.1 ‘OCT2
‘OCT4 ‘Olig2 P16INK4A P-21
15CLINICAL IHC/CISH MENU (CONT.)
P-27 p40 P53 p57
P63 P120 Catenin P501S P504S
Pan-Melanoma + Pan-Melanoma +
S100 Ki67 Parafibromin Parathyroid Hormone
Parvovirus Pax-2 Pax-5 Pax-8
PD-L1, 22C3 pharmDXFDA PD-L1, SP142FDA - for PD-L1, SP263FDA - for
PD1 (KEYTRUDA® CDx) urothelial carcinoma and urothelial CA (IMFINZI™)
NSCLC (TECENTRIQ™)
Placental Alkaline
Perforin pHistone-H3 Phosphorylated AKT Phosphatase
Pneumocystis Carinii Progesterone
PMS2 (Jiroveci) Prealbumin Receptor (1294)
Prostate Specific Prostate Specific
Prolactin Antigen Membrane Antigen Prostate Triple Stain
Prostatic Acid
Phosphatase PTEN PU.1 Renal Cell Carcinoma
Retinoblastoma
Protein ROS1 RRM1 S-100
S-100
(Red Protocol) S100p SALL4 SATB2
Smooth Muscle -
Serotonin SF-1 Smoothelin Actin
Smooth Mucle Myosin, Somatostatin
Heavy Chain Somatostatin Receptor, Type 2 SOX2
SOX10 SOX11 Spirochete STAT6
16CLINICAL IHC/CISH MENU (CONT.)
Tartrate-Resistant Acid
Survivin SV40 Synaptophysin Phosphatase
Terminal
TCL1 TCR bF1 Deoxynucleotidyl TFE3
Transferase
Thymidylate Thyroid Stimulating
Thrombomodulin Synthase Thyroglobulin Hormone
Thyroid Transcription
Factor-1 TIA-1 TLE-1 Topoisomerase I
Transforming Growth Tuberculosis
Toxoplasma gondii Factor Alpha Tryptase (RED Protocol)
Tyrosinase
Tyrosinase (RED Protocol) Uroplakin II Uroplakin III
Varicella Zoster Virus VEGF Villin Vimentin
WT-1 ZAP70
For Current Listing, please contact a NeoGenomics representative.
RNAScope Tumor Staining
17CLINICAL FISH MENU
ASSAYS/PANELS*
11q Aberration in NHL High-Grade B-Cell MDS FISH Panel
BCR/ABL1 t(9;22)
Lymphoma Reflex (New York)
1p/19q Deletions FISH Panel BIRC3(API2)/ MDS Standard
for Glioma (Non-New York) MALT1 t(11;18) FISH Panel
Panel
1p36 Deletion Bladder Cancer MET FISH
(NY and non-NY)
ALK for Lymphoma High-Grade/Large BRAF Rearrangement MLL (11q23)
B-Cell Lymphoma
ALK for NSCLC IgH (14q32) CBFB inv(16) MPN FISH Panel
ALL Adult FISH Panel IgH/BCL2 t(14;18) CCND1(BCL1)/ Multiple Myeloma
IgH t(11;14) IgH Complex FISH
CDKN2A (p16) Multiple Myeloma-MGUS
ALL Pediatric FISH Panel IgH/MAFB t(14;20)
Deletion FISH for ALL FISH Panel (New York)
ALL FISH Panel IgH/MAF t(14;16) CDKN2A (p16) Deletion IgH/MAF t(14;16)
(Ph-Like) for Mesothelioma
AML Favorable-Risk Panel JAK2 (9p24.1) CLL FISH Panel MYC (8q24)
AML FISH Panel MYC Amplification
(New York) FISH Panel DDIT3 (CHOP) for Angiosarcoma
AML Non-Favorable Low-Grade/Small DUSP22-IRF4 MYC/IgH/Cen
Risk FISH Panel B-Cell Lymphoma Rearrangement 8 t(8;14)
AML Standard MALT1 (18q21) MYCN (n-MYC)
EGFR Amplification
FISH Panel Amplification
Eosinophilia
BCL2 (18q21) MDM2 FISH Panel
FISH Panel
BCL6 (3q27) MDS Extended FGFR2 Rearrangement NeoSITE™
FISH Panel Melanoma
18NTRK 1, 2, 3 Plasma Cell Myeloma
FGFR3/IgH t(4;14) IgH Complex FISH Panel ROS1
FISH Panel
(non-New York)
HER2 Breast Cancer NTRK3 FISH Plasma Cell Myeloma
IgH Complex FISH Panel RUNX1T1/RUNX1
(non-New York) (ETO/AML1) t(8;21)
HER2 Gastric &
NUP98
Non-Breast Plasma Cell Myeloma
Prognostic FISH Panel SS18 (SYT)
(New York)
PDGFB Rearrangement PML/RARA
(22q13) t(15;17)
Plasma Cell Myeloma
Prognostic FISH Panel TCL1
(Non-New York)
PDGFRA Amplification PTEN
Plasma Cell Myeloma
Prognostic FISH Panel
RARA Break-Apart TOP2A
PDGFRA Rearrangement (Non-New York)
Plasma Cell Myeloma FISH Ploidy FISH for TP63 Rearrangement
RET FISH Molar Pregnancy
Panel (non-New York)
*For specific FISH assays supported at our pharma sites, please contact a NeoGenomics representative.
FISH PHARMA PROJECT TYPES AND EXPERIENCE
Batched or Real-time Testing
• LDT and IVD FISH assays
Custom Assay Development
• Probe design and manufacturing (4 – 5 weeks)
• Custom FISH assay development (2 – 4 weeks)
• Assay validation or RUO qualification (Up to 8 weeks)
Clinical Trial Experience:
• Development and multi-site deployment
• Global real time FISH testing
• Phase 3 CDx FISH trial experience
19OUR GLOBAL
HEADQUARTERS
1 & LAB LOCATIONS
2
3 4
1 ALISO VIEJO (ORANGE COUNTY), CA
Anatomic Pathology, Molecular, Multiplexed IF, Flow Cytometry
2 LA JOLLA, CA
Molecular, FISH & Cytogenetics
3 HOUSTON, TX
Anatomic Pathology, Molecular, Immunoassays
4 FT. MYERS, FL
Anatomic Pathology, FISH & Cytogenetics
20NeoGenomics is a premier cancer
diagnostics and pharma services
company that provides innovative
5 diagnostic, prognostic and predictive
testing with uncompromising quality,
exceptional service and innovative
solutions—all to help save lives by
improving patient care. 7
6
5 GENEVA, SWITZERLAND
Anatomic Pathology, Molecular*, Flow Cytometry, Immunoassays, FISH & Cytogenetics
6 SINGAPORE
Anatomic Pathology, Flow Cytometry, Molecular* FISH & Cytogenetics
7 CHINA
Anatomic Pathology*, Molecular*, Flow Cytometry*, Immunoassays*, FISH & Cytogenetics*
* Through Collaborations
21
5NEOGENOMICS.COM © 2020 NeoGenomics Laboratories, Inc. All Rights Reserved. All other trademarks are the property of their respective owners. Rev. XXXXXXX NeoGenomics Laboratories is a specialized oncology reference laboratory providing the latest technologies, testing partnership opportunities, and interactive education to the oncology and pathology communities. We offer the complete spectrum of diagnostic services in molecular testing, FISH, cytogenetics, flow cytometry, and immunohistochemistry through our nation-wide network of CAP-accredited, CLIA-certified laboratories. Committed to research as the means to improve patient care, we provide Pharma Services for pharmaceutical companies, in vitro diagnostic manufacturers, and academic scientist-clinicians. Wepromote joint publications with our client physicians. NeoGenomics welcomes your inquiries for collaborations. Please contact us for more information.
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