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Diagnostic, Prognostic, Therapeutic, and Predisposition Tests in Precision Medicine Molecular Oncology & Pathology Next-Gen Sequencing qPCR Sanger Sequencing Liquid Biopsy Hereditary Cancer Somatic Cancer

Molecular Oncology & Pathology Brochure · NeoTYPE Pancreas Tumor Profile Other Tumors BRAF HRAS KRAS NeoTYPE Thyroid Profile NGS ALK, NTRK, RET, ROS1 Fusion Profile NGS ALK, RET,

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Diagnostic, Prognostic, Therapeutic, and Predisposition

Tests in Precision Medicine

MolecularOncology & Pathology

Next-Gen Sequencing

qPCR Sanger Sequencing

Liquid Biopsy

Hereditary Cancer

Somatic Cancer

2 • NeoGenomics Laboratories

NeoGenomics is a full-service cancer diagnostic laboratory committed to helping the cancer community incorporate informative, effective, and innovative tests into the care of their patients. With over 155 molecular assays in-house, we provide one of the largest oncology-focused molecular test menus available along with top-quality consultation and laboratory services in cytogenetics, FISH, flow cytometry, and IHC. NeoGenomics has developed a unique expertise in analysis and reporting of cancer biomarkers.

By having one of the fastest development cycles in the industry, we are also responsive to opportunities to improve service and patient care. We rapidly bring our clients state-of-the-art tests for newly reported, significant genetic indicators for disease diagnosis and classification, assessing prognosis, and selecting therapy. Our oncology and pathology clients always have the flexibility to customize their orders to their patient’s specific needs.

Molecular testing has become the primary tool for precision medicine.

Molecular Testing Capabilities

Somatic Germline Liquid Biopsy Early Detection/ Prediction

• One of the most comprehensive oncology-focused menus of single-gene and multi-parameter tumor profiles available

• Full range of molecular diagnostic technologies including next-gen sequencing, quantitative PCR, gold-standard Sanger sequencing, fragment analysis, and SNP microarray

• Extensive cell-free DNA/RNA liquid biopsy testing capabilities useful for diagnostic screening, monitoring and detecting minimal residual disease

• Testing enhancements to improve detection of low-level abnormalities in select assays through plasma analysis and high-sensitivity sequencing

• All complementary testing methods including morphology, cytogenetics, FISH, flow cytometry, and IHC are available in-house, which maximizes yield from small specimens and minimizes TAT

• Growing hereditary cancer testing menu using leading-edge platforms

• Pharma Services supporting academic institutions, pharmaceutical companies, and the biotechnology industry

Highlights of Our Molecular Program Include:

Solid Tumor Tests

NeoGenomics Laboratories • 3

ATRX

BRAF

EGFR

EGFRvIII Analysis

IDH1/IDH2

MGMT Promoter Methylation

NeoTYPE Brain Tumor Profile

PIK3CA

PTEN

TERT Promoter

Brain

Microsatellite Instability Analysis (MSI)

NeoARRAY® SNP/Cytogenetic Profile

NeoLAB™ Solid Tumor Monitor – Liquid Biopsy

NeoTYPE Discovery Profile for Solid Tumors

NeoTYPE Precision Profile for Solid Tumors

Tumor Mutation Burden

Universal Expression/Fusion Profile

All Tumors

BRAF

KIT

KRAS

NeoTYPE Liposarcoma Fusion Profile

NeoTYPE Soft Tissue Tumor Profile

NGS Comprehensive Sarcoma Fusion Profile

NGS Ewing Sarcoma Fusion Profile

NGS Non-Ewing Sarcoma Fusion Profile

NGS Pediatric Sarcoma Fusion Profile

NGS Rhabdomyosarcoma Fusion Profile

NRAS

PDGFRA

PIK3CA

PTEN

Soft Tissue

HPV DNA Tissue Testing

NeoTYPE Head & Neck Tumor Profile

NeoTYPE Liver/Biliary Tumor Profile

NeoTYPE Other Solid Tumor Profile

NeoTYPE Pancreas Tumor Profile

Other Tumors

BRAF

HRAS

KRAS

NeoTYPE Thyroid Profile

NGS ALK, NTRK, RET, ROS1 Fusion Profile

NGS ALK, RET, ROS1 Fusion Profile

NGS Thyroid Fusion Profile

NRAS

PIK3CA

TERT Promoter

Thyroid

Androgen Receptor Mutation Analysis

HSD3B1 Genotyping

NeoLAB Prostate - Liquid Biopsy

Prostate

BRAF

EGFR

KIT

KRAS

KRAS Exon 4

Microsatellite Instability Analysis (MSI)

MLH1 Promoter Methylation

NeoTYPE Colorectal Tumor Profile

NeoTYPE GI Predictive Profile

NOTCH1

NRAS

NRAS Exon 4

PDGFRA

PIK3CA

PTEN

RAS/RAF Panel

Colorectal

BRAF

KIT

KRAS

NeoTYPE Esophageal Tumor Profile

NeoTYPE GI Predictive Profile

NRAS

PDGFRA

PIK3CA

PTEN

Esophageal

BRAF

EGFR

KIT

KRAS

NeoTYPE Gastric Tumor Profile

NeoTYPE GI Predictive Profile

NRAS

PDGFRA

PIK3CA

PTEN

Gastric

ALK

BRAF

EGFR

KIT

KRAS

MET

MET Exon 14 Deletion Analysis

NeoLAB EGFR T790M - Liquid Biopsy

NeoTYPE Lung Tumor Profile

NGS ALK, NTRK, RET, ROS1 Fusion Profile

NGS ALK, RET, ROS1 Fusion Profile

Oncomine™ Dx Target Test

PDGFRA

PIK3CA

PTEN

Lung

BRAF

KIT

NeoARRAY SNP/Cytogenetic Profile

NeoTYPE Melanoma Profile

NRAS

TERT Promoter

Melanoma

BRAF

KIT

NeoTYPE GIST Profile

PDGFRA

GIST

BRAF

KRAS

NeoTYPE Ovarian Tumor Profile

NRAS

PIK3CA

PTEN

TP53

Ovarian

RAF

KRAS

NeoTYPE Cervical Tumor Profile

NOTCH1

NRAS

PIK3CA

Cervical

BRAF

EGFR

KIT

NeoTYPE Breast Tumor Profile

PIK3CA

PTEN

Breast

Hematologic DiseasesLeukemias

4 • NeoGenomics Laboratories

ASXL1

CEBPA

DNMT3A

ETV6-RUNX1 t(12;21)

FLT3

IDH1

IDH2

Inv(16) CBFB-MYH11

KIT

KRAS

NeoLAB AML Profile - Liquid Biopsy

NeoLAB FLT3 Mutation Analysis - Liquid Biopsy

NeoLAB IDH2 Mutation Analysis - Liquid Biopsy

NeoLAB Inv(16), CBFB-MYH11 Translocation - Liquid Biopsy

NeoLAB KIT (c-KIT) Mutation Analysis - Liquid Biopsy

NeoLAB KRAS Mutation Analysis - Liquid Biopsy

NeoLAB NPM1 Mutation Analysis - Liquid Biopsy

NeoLAB NRAS Mutation Analysis - Liquid Biopsy

NeoLAB PML-RARA Translocation, t(16;17) - Liquid Biopsy

NeoTYPE AML Favorable Risk Profile

NeoTYPE AML Prognostic Profile

NPM1

NPM1 MRD Analysis

NRAS

PML-RARA t(15;17)

RUNX1

RUNX1-RUNX1T1 t(8;21)

TP53

AML

ABL1 Kinase Domain Mutation

B-Cell Gene Rearrangement

BCR-ABL1 t(9;22)

ETV6-RUNX1 t(12;21)

IgH Clonality/MRD by NGS

T-Cell Beta Gene Rearrangement

T-Cell Gamma Gene Rearrangement

TPMT Genotyping

ALL

BTK Inhibitor Acquired Resistance Panel

BTK

IgVH

NeoLAB BTK Inhibitor Acquired Resistance Panel - Liquid Biopsy

NeoTYPE CLL Prognostic Profile

NOTCH1

PLC-Gamma-2

SF3B1

CLL

KRAS

NeoLAB KRAS Mutation Analysis - Liquid Biopsy

NeoTYPE JMML Profile

NRAS

PTPN11

JMML

Hairy Cell: BRAF

LGLL: STAT3, T-Cell

Other Leukemias

PML-RARA t(15;17)

APL

B-Cell Gene Rearrangement

BCL1 t(11;14)

BCL2 t(14;18)

BTK Inhibitor Acquired Resistance Panel

BTK Inhibitor Primary Susceptibility Panel

EZH2

IgH Clonality/MRD by NGS

MYD88

NeoTYPE AITL/Peripheral T-Cell Lymphoma Profile

NeoTYPE Lymphoma Profile

RHOA Mutation Analysis

T-Cell Beta Gene Rearrangement

T-Cell Gamma Gene Rearrangement

TET2

Lymphomas

BCR-ABL1 t(9;22)

BCR-ABL p230

CALR

JAK2 Exon 12-14

JAK2 V617F

KRAS

MPL

MPN Extended Reflex Panel

MPN Standard Reflex Panel

NeoLAB KRAS Mutation Analysis - Liquid Biopsy

NeoTYPE MPN Profile

Myeloproliferative Neoplasms

ABL1

BCR-ABL1 t(9;22)

CSF3R for aCML

CML

B-Cell Gene Rearrangement

Plasma Cell Myeloma

Chimerism/DNA Fingerprinting

Transplant

ASXL1

ETV6

EZH2

KRAS

NeoARRAY SNP/Cytogenetic Profile

NeoLAB KRAS Mutation Analysis - Liquid Biopsy

NeoLAB NRAS Mutation Analysis - Liquid Biopsy

NeoLAB MDS/CMML Profile - Liquid Biopsy

NeoTYPE MDS/CMML Profile

NRAS

PPM1D

RUNX1

SF3B1

TET2

TP53

Myelodysplastic Syndromes

Hereditary Cancer Tests NeoLAB Liquid Biopsy Tests

NeoGenomics Laboratories • 5

BRCA1 Mutation & Del/Dup Analysis

BRCA1/2 Mutation & Del/Dup Analysis

BRCA2 Mutation & Del/Dup Analysis

EGFR T790M Germline Mutation Analysis

Hereditary Cancer Comprehensive Panel

Hereditary Cancer Susceptibility for Pediatrics

Hereditary DNA Repair Panel for Prostate Cancer

HOXB13 Genotyping

Inherited Bone Marrow Failure Panel

Lynch Syndrome

NeoLAB AML Profile - Liquid Biopsy

NeoLAB BTK Inhibitor Acquired Resistance Panel - Liquid Biopsy

NeoLAB EGFR T790M - Liquid Biopsy

NeoLAB FLT3 Mutation Analysis - Liquid Biopsy

NeoLAB IDH1 Mutation Analysis - Liquid Biopsy

NeoLAB IDH2 Mutation Analysis - Liquid Biopsy

NeoLAB inv(16), CBFB-MYH11 Translocation - Liquid Biopsy

NeoLAB KIT (c-KIT) Mutation Analysis - Liquid Biopsy

NeoLAB KRAS Mutation Analysis - Liquid Biopsy

NeoLAB MDS/CMML Profile - Liquid Biopsy

NeoLAB Myeloid Disorders Profile - Liquid Biopsy

NeoLAB NPM1 Mutation Analysis - Liquid Biopsy

NeoLAB NRAS Mutation Analysis - Liquid Biopsy

NeoLAB PML-RARA Translocation, t(15;17) - Liquid Biopsy

NeoLAB Prostate - Liquid Biopsy

NeoLAB RUNX1-RUNX1T1 (AML-ETO) - Liquid Biopsy

NeoLAB Solid Tumor Monitor - Liquid Biopsy

6 • NeoGenomics Laboratories

Test MenuSingle Gene Tests

ABL1 Kinase Domain

ALK

Androgen Receptor

ASXL1

ATRX

B-Cell Gene Rearrangement

BCL1 Translocation, t(11;14)

BCL2 Translocation, t(14;18)

BCR-ABL1 Non-Standard p230

BCR-ABL1 Standard p210, p190

BRAF

BRCA1 Mutation & Del/Dup Analysis

BRCA2 Mutation & Del/Dup Analysis

BTK

CALR

CARD11

CBL

CD79B

CEBPA

Chimerism/DNA Fingerprinting

CSF3R

CXCR4

DNMT3A

EGFR

EGFR T790M Germline Mutation Analysis

EGFRvIII Analysis

EPCAM Mutation & Del/Dup Analysis

ETV6

ETV6-RUNX1 Translocation, t(12;21)

EZH2

FLT3

GNAS

HOXB13 Genotyping

HPV DNA Tissue Testing

HRAS

HSD3B1 Genotyping

IDH1 & IDH2

IgH Clonality/MRD by NGS

IgVH

Inv(16), CBFB-MYH11 Translocation

JAK2 Exon 12-14

JAK2 V617F

KIT

KRAS

KRAS Exon 4

MET (c-MET)

MET Exon 14 Deletion Analysis

MGMT Promoter Methylation

Microsatellite Instability

MLH1 Mutation & Del/Dup Analysis

MLH1 Promoter Methylation

MPL

MYD88

MSH2 Mutation & Del/Dup Analysis

MSH6 Mutation & Del/Dup Analysis

NeoLAB EGFR T790M - Liquid Biopsy

NeoLAB FLT3 Mutation Analysis - Liquid Biopsy

NeoLAB IDH1 Mutation Analysis - Liquid Biopsy

NeoLAB IDH2 Mutation Analysis - Liquid Biopsy

NeoLAB inv(16), CBFB-MYH11 Translocation - Liquid Biopsy

NeoLAB KIT (c-KIT) Mutation Analysis - Liquid Biopsy

NeoLAB KRAS Mutation Analysis - Liquid Biopsy

NeoLAB NPM1 Mutation Analysis - Liquid Biopsy

NeoLAB NRAS Mutation Analysis - Liquid Biopsy

NeoLAB PML-RARA Translocation, t(15;17) - Liquid Biopsy

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

NOTCH1

NPM1

NRAS

NRAS Exon 4

PDGFRA

PIK3CA

PML-RARA Translocation, t(15;17)

PMS2 Mutation & Del/Dup Analysis

PTEN

PTPN11

PLC-Gamma-2

PMS2 Mutation & Del/Dup Analysis

RHOA

RUNX1

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

SETBP1

SF3B1

SRSF2

STAT3

T-Cell Gamma Gene Rearrangement

T-Cell Beta Gene Rearrangement

TERT Promoter

TET2

TP53

TPMT Genotyping

U2AF1

UGT1A1 Genotyping

VHL

WT1

ZRSR2

NeoGenomics Laboratories • 7

Panels and ProfilesAML Reflex Panel

BRCA1/2 Mutation & Del/Dup Analysis

BTK Inhibitor Acquired Resistance Panel

BTK Inhibitor Primary Susceptibility Panel

Hereditary Cancer Comprehensive Panel

Hereditary Cancer Susceptibility for Pediatrics

Hereditary DNA Repair Panel for Prostate Cancer

Inherited Bone Marrow Failure Panel

Lynch Syndrome

MPN Extended Reflex Panel

MPN Standard Reflex Panel

NeoARRAY SNP/Cytogenetic Profile

NeoLAB AML Profile - Liquid Biopsy

NeoLAB BTK Inhibitor Acquired Resistance Panel - Liquid Biopsy

NeoLAB MDS/CMML Profile - Liquid Biopsy

NeoLAB Myeloid Disorders Profile - Liquid Biopsy

NeoLAB Prostate - Liquid to Biopsy

NeoLAB Solid Tumor Monitor - Liquid Biopsy

NeoTYPE AITL/Peripheral T-Cell Lymphoma Profile

NeoTYPE AML Favorable-Risk Profile

NeoTYPE AML Prognostic Profile

NeoTYPE Brain Tumor Profile

NeoTYPE Breast Tumor Profile

NeoTYPE Cervical Tumor Profile

NeoTYPE CLL Prognostic Profile

NeoTYPE Colorectal Tumor Profile

NeoTYPE Discovery Profile for Solid Tumors

NeoTYPE Endometrial Tumor Profile

NeoTYPE Esophageal Tumor Profile

NeoTYPE Gastric Tumor Profile

NeoTYPE GI Predictive Profile

NeoTYPE GIST Profile

NeoTYPE Head & Neck Tumor Profile

NeoTYPE JMML Profile

NeoTYPE Liposarcoma Fusion Profile

NeoTYPE Liver/Biliary Tumor Profile

NeoTYPE Lung Tumor Profile

NeoTYPE Lymphoma Profile

NeoTYPE MDS/CMML Profile

NeoTYPE Melanoma Profile

NeoTYPE MPN Profile

NeoTYPE Myeloid Disorders Profile

NeoTYPE Other Solid Tumor Profile

NeoTYPE Ovarian Tumor Profile

NeoTYPE Pancreas Tumor Profile

NeoTYPE Precision Profile for Solid Tumors

NeoTYPE Soft Tissue Tumor Profile

NeoTYPE Thyroid Profile

NGS ALK, NTRK, RET, ROS1 Fusion Profile

NGS ALK, RET, ROS1 Fusion Profile

NGS Comprehensive Sarcoma Fusion Profile

NGS Ewing Sarcoma Fusion Profile

NGS Non-Ewing Sarcoma Fusion Profile

NGS Pediatric Sarcoma Fusion Profile

NGS Rhabdomyosarcoma Fusion Profile

NGS Thyroid Fusion Profile

RAS/RAF Panel

Tumor Mutation Burden

Universal Fusion/Expression Profile

Specimen and Ordering InformationSpecimen RequirementsNeoGenomics’ molecular testing is routinely performed on blood, bone marrow aspirate, fixed cytogenetic pellets, fresh tissue, and formalin-fixed paraffin-embedded tissue of all types. Acceptable specimen types vary by test, so please see our website for requirements for the test of interest. Please inquire if you have an alternative specimen type as we can often accommodate these.

OrderingTests in panels or profiles may be ordered separately or in custom combinations. The most commonly-ordered tests are shown, but for many diseases, more testing that encompasses emerging research and clinical trial opportunities is available. For an extended list of tests correlated with each tumor, please search by disease state on the NeoGenomics website.

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.

12701 Commonwealth Dr., Suite 9Fort Myers, FL 33913 Phone: 866.776.5907/ Fax: 239.690.4237 neogenomics.com© 2018 NeoGenomics Laboratories, Inc. All Rights Reserved. All other trademarks are the property of their respective owners.Rev. 041718