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Anatomic Pathology

Genomics MultiOmyx™ Flow Cytometry

CDx & IVD Cytogenetics FISH Data

2 • NeoGenomics Laboratories

Covering the continuum with standard-of-care, innovative, customized, and clinical research options

• 320+ IHC antibodies• 160+ molecular tests• 17 liquid biopsy tests

• 93 FISH probe sets + 252 individual probes• 3000+ single genes

Menu OverviewNeoGenomics provides one of the largest clinical menus in the world. We add dozens of new tests and testing enhancements each year. If you don’t see a test you need, we can develop it. Highlights are:

NeoGenomics has served the oncology and pathology communities for over 13 years. In December 2015, NeoGenomics Laboratories acquired Clarient Diagnostics. With the combined medical and technical expertise of both companies, NeoGenomics has a unique depth of service in hematologic and solid tumor cancer diagnostics. We remain vigilant of patient care and customer service as we continually strive to build a better lab, not just a bigger one.

What makes NeoGenomics Pharma Services different from other laboratories? Our service promises, including:• We start when you’re ready• We guarantee you a one-business-day response on project inquiries• We will deliver your project data at the highest level

Molecular FDA• Oncomine Dx Target Test (Tafinlar®+Mekinist®/

dabrafenib+trametinib, Xalkori®/crizotinib, Iressa®/gefitinib)

• cobas® 4800 BRAF V600 (Zelboraf®/vemurafenib)• cobas EGFR Mutation Test v2 (Tagrisso®/osumertinib,

Tarceva®/erlotinib)• therascreen EGFR RGQ PCR (Gilotrif®/afatinib,

Iressa®/gefitinib) – offered as LDT• therascreen KRAS RGQ PCR (Erbitux®/cetuximab,

Vectibix®/panitumumab)• THxID™ BRAF (Tafinlar®/dabrafenib, Mekinist®/

trametinib)

FISH FDA• PathVysion HER-2 (Herceptin®/trastuzumab)• UroVysion® Bladder Cancer Kit• Vysis CLL (Venclexta®/venetoclax)• Vysis ALK (Xalkori®/crizotinib)

IHC FDA• ALK, D5F3 (Xalkori®/crizotinib)• ER PharmDx• Her2/neu Pathway (4B5) PD-L1 SP263 (Imfinzi™/

durvalumab)• HercepTest (Herceptin®/trastuzumab)• INFORM HER2 Dual ISH (Herceptin®/trastuzumab)• PD-L1 22C3 PharmDx (Keytruda®/pembrolizumab)• PD-L1 28-8 PharmDX (Opdivo®/nivolumab)• PD-L1 SP142 (Tecentriq®/atezolizumab)• PD-L1 SP263 (Imfinzi™/durvalumab)

CDx and IVD DevelopmentIf you don’t see a test for your project on our menu, we can help develop an IVD or CDx for your clinical trial. The CDx process works best when development of the test begins before the drug enters clinical trials. Early collaborations between pharmaceutical companies, test manufacturers, and laboratory services can result in faster access to promising new treatments.

NeoGenomics also runs a wide variety of clinically validated FDA-approved and FDA-cleared assays that include:

NeoGenomics Laboratories • 3

FISH

Acute Lymphocytic Leukemia (ALL)• Adult ALL Panel• Pediatric ALL Panel

Acute Myeloid Leukemia (AML)• AML Standard Panel• AML Favorable-Risk Panel• AML Non-Favorable Risk Panel

BCR/ABL1/ASS1

CLL Panel

Eosinophilia Panel

Lymphoma• High-Grade/Large B-Cell Lymphoma

Panel• Low-Grade/Small B-Cell Lymphoma

Panel• NHL Panel• TCL1

Myelodysplastic Syndrome (MDS)• MDS Extended Panel • MDS Standard Panel

Multiple Myeloma• MM/MGUS Panel• MM IgH Complex Reflex Panel• Plasma Cell Myeloma Prognostic Profile• Plasma Cell Myeloma Risk Stratification

Profile

MPN Panel

PML/RARA and RARA Break-Apart

X/Y for Engraftment

Comprehensive Menu of Individual Hematologic FISH Probes

HemeFISH™

1p/19q Deletion (Glioma)

Bladder Cancer FISH

BRAF Translocation (Brain & Others)

EGFR Amplification (Solid Tumors)

HER2• HER2 Breast• HER2 Breast Equivocal• HER2 Non-Breast

Lung Cancer - NSCLC• ALK• RET • ROS1

MET (Solid Tumors)

MYCN Amplification (Solid Tumors)

NeoSITE® B.E. (Barrett’s Esophagus)

NeoSITE Cervical

NeoSITE Melanoma

PDGFRA Amplification (Brain)

PTEN (Prostate & Others)

RET (Solid Tumors)

Sarcoma• DDIT3 (CHOP)• EWSR1 • MDM2• SS18 (SYT)

TOP2A (Breast)

X/Y for Molar Pregnancy

FISH for Solid Tumors

Comprehensive Leukemia/Lymphoma Analysis

CD4/CD8 Ratio for BAL

DNA Ploidy/Cell Cycle Analysis

Follow-Up and Add-On Panels

Plasma Cell Panel

PNH High Sensitivity Evaluation

T&B Tissue Panel

T-Cell Therapy Panel

V-Beta T-Cell Clonality

ZAP-70 Lymphoid Panel

Flow Cytometry

*All probes available individually

4 • NeoGenomics Laboratories

CD25

CD30

CD31

CD33

CD34

CD35

CD38

CD42b

CD43

CD44

CD45 (LCA)

CD45RB

CD45RO

CD56

CD57

CD61

CD68

CD71

CD79a

CD99

CD117 cKIT

CD123

CD138

CD163

CDK4

CDX2

CDX2/CK7 Double Stain

CEA (Mono)

CEA (Poly)

Chromogranin A

CK 5/6

CK 7

CK 10/13

CK 14

CK 17

CK 18

CK 19

CK 20

CK AE1/AE3

CK HMW (CK903/34BE12)

CK HMW +p63

CK HMW/LMW Double Stain

CK OSCAR

cMET

CMV

cMyc

HistologyDigital Image Analysis

CMV

EBER

HER2 Dual ISH

HPV RNA ISH

Kappa/Lambda

In Situ Hybridization (ISH)

AcP

AFB

Alcian Blue

Calcium Stain

Chloroacetate Esterase

Colloidal Iron

Congo Red

Copper Stain

Elastic Stain

Fite Stain

Fontana Masson

Giemsa

GMS

Gram Stain

Hall Bile Stain

Iron

MPO Cytochemical Stain

Mucicarmine

Naphthol Acetate Esterase ± sodium fluoride inhibition

Naphthol Butyrate Esterase

PAS

PAS for Fungus

PAS with Digestion

Reticulin

TRAP Cytochemical

Trichrome

Warthin Starry

Wright Giemsa

Special Stains

ALK (D5F3)

ALK-1 (heme)

Amyloid A

Amyloid P

Annexin A1

AR

Ariginase 1

ATRX

B72.3

BCA-225

BCL1/Cyclin D1

BCL2

BCL6

BerEP4

Beta Catenin

BG8

BOB1

BRAF V600E

BRCA1

Breast Triple Stain (CK5 + p63 + CK 8/18)

CA125

CA19.9

Calcitonin

Caldesmon

Calponin

Calretinin

CAM 5.2 (CK LMW)

Carbonic Anhydrase IX (CA IX)

Cat Scratch

Cathepsin D

CD1a

CD2

CD3

CD4

CD5

CD7

CD8

CD10

CD11c

CD14

CD15

CD19

CD20

CD21

CD22

CD23

AACT

AAT

ACTH

Adenovirus

AFP

Immunohistochemistry (IHC) Antibodies

NeoGenomics Laboratories • 5

Hepatitis B Core Antigen

Hepatitis B Surface Antigen

HepPar1

HER2 Breast

HER2 Non-Breast

HGAL

HHV8

HLA-DR

HMB45

HPL

HPV

HSV I

HSV I/II

HSV II

IDH1

IgA

IgD

IgG

IgG4

IgM

Inhibin

iNOS

Insulin

Kappa

Ki67

Ki67/Caspase 3 (Double Stain)

Lambda

Laminin

Langerin

LEF1

LH

LMO2

Lysozyme

MAL

Collagen IV

COX2

cREL

CXCR4

D240

DBA.44

Desmin

DOG1

DPC4

EBV (LMP1)

E-Cadherin

Eg5

EGFR

EGFR (E746-A750del specific)

EGFR (L858R mutant specific)

elf4E

EMA

ER

ERCC1

ERG

Factor VIII RA

Factor XIIIa

Fascin

Fli-1

FOXP1

FOXP3

FSH

Galectin 3

Gastrin

GATA3

GCDFP15

GCET1

GFAP

GH

Glucagon

GLUT1

Glycophorin A

Glypican-3

Granzyme B

GST Pi

H. Pylori

HBME1

HCG Beta

Hemoglobin A

Mammaglobin

MDM2

Melan A (Mart1)

Mesothelin

MGMT

MITF

MLH1

MOC31

MPO

MSA

MSH2

MSH6

MUC1

MUC2

MUC4

MUC5

MUC6

MUM1

MyoD1

Myogenin

Myoglobin

Napsin A

NeuN

NF (Neurofilament)

NKX2.2

NKX3.1

NSE

OCT2

OCT4

Olig2

p16

p21

p27

p40

IHC Antibodies (Continued)

p53

p57

p63

p120 Catenin

P501S

P504S

pAKT

Pan Melanoma (S100 + Melan A + Tyrosinase)

Pancreatic Polypeptide (PP)

Pan-Cytokeratin Plus (AE1/AE3 + CK8/18)

Pan-Keratin (AE1/AE3/PCK26)

Pan-Melanoma/Ki67

Parafibromin

Parvovirus

PAX2

PAX5

PAX8

PD1

PD-L1 28-8 FDA (OPDIVO®)

PD-L1 SP142 FDA (TECENTRIQ®)

PD-L1 SP263 (IMFINZI™)

PD-L1, 22C3 FDA (KEYTRUDA®)

Perforin

pERK

PgR

pHistone H3 (PHH3)

PLAP

PMS2

Pneumocystis Carinii (Jiroveci)

Prealbumin (TTR)

Prolactin

Prostate Triple Stain

PSA

PSAP/HPAP

PSMA

PTEN

PTH

PU.1

RCC1

Retinoblastoma Protein (RB)

ROS1

RRM1

S100

S100p

SALL4

SATB2

Serotonin

SF1

SMA

SMMHC

Smoothelin

Somatostatin

Somatostatin Receptor, Type 2

SOX2

SOX10

SOX11

Spirochete

STAT6

Surfactant

Survivin

SV40

Synaptophysin

Tau

TCL1

TCR BetaF1

TdT

TFE3

TGF Alpha

Thrombomodulin (TM)

Thyroglobulin (TGB)

TIA1

TLE1

TOPO1

Toxoplasma

TRAcP

Tryptase

TS

TSH

TTF1

Tuberculosis

Tyrosinase

Uroplakin II

Uroplakin III

Varicella Zoster Virus (VZV)

VEGF

Villin

Vimentin

WT1

ZAP70

6 • NeoGenomics Laboratories

NeoTYPE Cancer Profiles• Discovery (315 genes)• Precision (48 genes)• Tumor-Specific (18 options)

*Custom assays available

ALK/RET/ROS1 Fusion Profile

ALK/NTRK/RET/ROS1 Fusion Profile

Microsatellite Instability

NeoARRAY™ SNP/Cytogenetic Profile

NGS Comprehensive Sarcoma Fusion Profile

NGS Ewing Sarcoma Fusion Profile

NGS Non-Ewing Sarcoma Fusion Profile

NGS Rhabdomyosarcoma Fusion Profile

NGS Pediatric Sarcoma Fusion Profile

NGS Pediatric Sarcoma Fusion Profile

NGS Thyroid Fusion Profile

RAS/RAF Panel

Solid Tumor Cancer Panels & Profiles

Molecular Testing

AML Profile

BTK Inhibitor Acquired Resistance Panel

MDS/CMML Profile

Myeloid Disorders Profile

FLT3

IDH1/IDH2

inv(16), CBFB-MYH11 Translocation

KIT (c-KIT)

KRAS

NPM1

NRAS

PML-RARA Translocation, t(15;17)

RUNX1-RUNX1T1 (AML1-ETO) Translocation, t(8;21)

NeoLAB™ Liquid Biopsies Hematologic Cancers

EGFR T790M

Prostate

Solid Tumor Monitor (48 genes)

NeoLAB Liquid Biopsies Solid Tumor

BRCA1/2

Cancer Susceptibility for Peds

Comprehensive Panel (73 genes)

DNA Repair Panel

EGFR T790M Germline Mutation

HOXB13 Genotyping (Prostate)

Inherited Bone Marrow Failure Panel (58 genes)

Lynch Syndrome (5 genes)

Hereditary Cancer Predisposition

NeoTYPE® Cancer Profiles• Myeloid Disorders (54 genes)• Disease-Specific (7 options)

BTK Inhibitor Acquired Resistance Panel

BTK Inhibitor Primary Susceptibility Panel

Chimerism/DNA Fingerprinting

MPN Extended Reflex Panel

MPN Standard Reflex Panel

NeoARRAY™ SNP/Cytogenetic Profile

Microsatellite Instability (MSI)

Mismatch Repair IHC (MMR)

PD-L1 IHC

Tumor Mutation Burden

Hematologic Cancer Panels & Profiles

Immuno-Oncology

NeoGenomics Laboratories • 7

HPV DNA Tissue Testing

NanoString Pan Cancer Immune Profiling Panel (770 genes)

Universal Fusion/Expression Profile (1385 genes)

Specialty Tests

• Expertise, Flexibility, Scalability• Rapid Project Start-Up• Dedicated Project Scientists

• Extensive Menu• Custom Assay Design• Platform Agnostic

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. We promote joint publications with our client physicians. NeoGenomics welcomes your inquiries for collaborations. Please contact us for more information.

Our Differentiators

New tests are added frequently. See our website for the most current and complete listing.

31 ColumbiaAliso Viejo, CA 92656 United StatesPhone: 800.720.4363 Fax: 949.425.5865

A-One Business CenterBâtiment A5, 2nd FloorZ.A. La Pièce/Route de l’Etraz 11180 Rolle, SwitzerlandPhone: +41 (0)21 721 06 00Fax: +41 (0)21 826 00 73

12701 Commonwealth Dr., Suite 9Fort Myers, FL 33913United StatesPhone: 866.776.5907 Fax: 239.690.4237

2575 West Bellfort St., Suite 2001Houston, TX 77054United StatesPhone: 800.720.4363 / 713.528.4363Fax: 713.668.3565

© 2017 NeoGenomics Laboratories, Inc. All Rights Reserved. All other trademarks are the property of their respective owners. Rev. 112217

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