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Comprehensive testing from one responsive laboratory
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
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