* FDA EVIDENCE LEVELS: 1. Companion diagnostic; 2. Cancer mutations with evidence of clinical significance; 3. Cancer mutations with potential clinical significance (Per FDA: Level 3 “mutations may be informational or used to direct patients towards clinical trials for which they may be eligible.”)2

OmniSeq AdvanceSM AssayA SINGLE TEST TO INFORM CANCER TREATMENT

Your single-source laboratory solution

ACTIONABLE RESULTS SHOWN BY OMNISEQ TESTING DATA1

● 52% of patients tested to date have had targeted

and/or immuno evidence Level 1/Level 2 results,*1,2

notably higher than rate of targeted therapy tests.

● Actionability reaches 99% by combining indicated

and contraindicated biomarker results for targeted

therapy and immunotherapy.

● Overexpression of immune markers, measured by

RNA-seq gene expression, highlight rational targets

for immuno-oncology clinical trials.

● Where applicable, summary interpretation will

include response rates where patients have multiple

Level 1 or Level 2 indications*1,2 to guide treatment

decisions.

OmniSeq Advance Retrospective Results by Status, All Histologies*1,2

Targeted Only Level 3 Evidence

Targeted AND Immuno Level 1 & 2 Evidence

Immuno OnlyLevel 1 & 2 Evidence

Immuno Only Level 3 Evidence

No Actionable Markers

Targeted AND Immuno

Level 3 Evidence

Targeted Only Level 1 & 2 Evidence

1%

33%

12%

22%

18%8%

6%

Number of samples, n=1,212

A single test with 99% actionability.1 Combine both targeted therapy and immune-oncology biomarkers in a single test.

Genomic Profiling● Evaluates 144 genes● Measures SNVs, CNVs, Fusions● 2% QNS rate

Immune Profiling● Evaluate entire cancer-immunity cycle● TMB, TILs, MSI, PD-L1 and RNA-Seq

OmniSeq AdvanceSM

● One Test● One Sample● One Report

* FDA EVIDENCE LEVELS: 1. Companion diagnostic; 2. Cancer mutations with evidence of clinical significance; 3. Cancer mutations with potential clinical significance (Per FDA: Level 3 “mutations may be informational or used to direct patients towards clinical trials for which they may be eligible.”)2

COMPONENTS OF OMNISEQ ADVANCESM

● PD-L1 IHC according to histology

● CD8 IHC to characterize tumor-infiltrating lymphocytes (TILs)

● MSI by NGS, no normal tissue required

● Tumor mutational burden (TMB) – 409 genes

● RNA-sequencing of over 50 critical immune markers to characterize the tumor micro-environment (TME)

● Somatic genomic profiling of 144 genes

● Personalized summary of findings written by a pathologist

OMNISEQ ADVANCE FOR NON-SMALL CELL LUNG CANCER (NSCLC)

Due to the high prevalence of PD-L1 staining above 1% TPS, and the number of targeted therapies available across multiple genetic alterations, 82% of NSCLC patients were found to have Level 1 or 2 biomarkers.*1,2

The NCCN NSCLC Guidelines® recommendcomprehensive genomic

profiling to assess the full

spectrum of treatment

options.3

Number of samples, n=597

OMNISEQ ADVANCE RETROSPECTIVE RESULTS BY STATUS FOR NSCLC*1,2

100%

Level 1 or 2 Targeted Therapy Markers*1,2

Percentages based on 302 samples

Immuno OnlyLevel 1 & 2 Evidence

Targeted AND ImmunoLevel 3 Evidence

Targeted Only Level 3 EvidenceImmuno Only Level 3 Evidence

No Actionable Markers: 0%

Targeted AND Immuno Level 1 & 2 Evidence

Targeted Only Level 1 & 2 Evidence

ALK or EGFR positive Level 1 & 2 Evidence

34%

12%

9%

3%

27%

12%

3%

ERBB2

65%

21%

KRAS

EGFR

ALK

3%

MET4%

BRAF1%

RET2%

3%

ROS11%

INTERROGATES THE CANCER-IMMUNITY CYCLE

Tumor Antigen Production● Tumor Mutational Burden (TMB)● Microsatellite Instability (MSI)

T-Cell Receptor Signaling● RNA-Sequencing (RNA-Seq)● PD-L1 Immunohistochemistry (IHC)

Tumor Infiltrating Lymphocytes● RNA-Sequencing (RNA-Seq)● CD8 Immunohistochemistry (IHC)

Priming and activation

(APCs & T cells)

Trafficking of T cells to tumors (CTLs)

Cancer antigen presentation

(dendritic cells/APCs)

Release of cancer cell antigens

(cancer cell death)

Killing of cancer cells (Immune and cancer cells)

Infiltration of T cells into tumors (CTLs, endothelial cells)

Recognition of cancer cells by T cells (CTLs, cancer cells)

Source: Adapted from Immunity, Volume 39, Chen, Daniel S et al., Oncology Meets Immunology: The Cancer-Immunity Cycle, 1-10. Copyright 2013, with permission from Elsevier. http:/dx.doi.org/10.1016/j.immuni.2013.07.012

BIOMARKERS THAT INDICATE AN INFLAMED TUMOR MICROENVIRONMENT MAY MORE ACCURATELY PREDICT RESPONSE TO IMMUNOTHERAPY4

48%

27%

10%

12%

3%

No Highly Expressed Markers (Immune Desert)

High Expression of Other Immune Markers, but not TMB or PD-L1 High

TMB High

PD-L1 High (IHC)

TMB High & PD-L1 High IHC

IMMUNOTHERAPY ACTIONABILITY PERCENTAGE BY BIOMARKER

~50% of patients with negative results by standard markers had high expression of secondary immune markers. These overexpressed markers are direct targets for therapies commercially available or in clinical trials.

Initial Immune Report Card Reference Population by Status

Source: Initial OmniSeq® Assay Reference Population, 2016

Number of samples, n=167

1 MarkerOverexpressed

2 MarkersOverexpressed

3+ MarkersOverexpressed

● GITR● CD40● ADORA2A● CCR2● CTLA4● PD-1● VISTA● CD38● FOXP3● TIM3● IDO1● TGFβ1● OX40● TNF

Actionable Targets48%

The OmniSeq Advance assay was developed by OmniSeq® and is performed by OmniSeq as a send-out from Integrated Oncology, part of LabCorp Specialty Testing Group, its US distributor.

OmniSeq AdvanceSM is a service mark of OmniSeq, Inc.NCCN Guidelines® is a trademark owned by the National Comprehensive Cancer Network, Inc.

©2019 Laboratory Corporation of America® Holdings. All rights reserved. | onc-999-v3-0519 | L18846-0519-3

REFERENCES1. Based on OmniSeq Internal data. 2. FDA Fact Sheet, CDRH’s Approach to Tumor Profiling Next

Generation Sequencing Tests, U.S. Food and Drug Administration. FDA website, https://www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/UCM584603.pdf. Accessed 5/10/18.

3. National Comprehensive Cancer Network. Non-Small Cell Lung Cancer Version 4.2018. http://www.nccn.org. Published April 26, 2018. Accessed May 21, 2018.

4. Ott, PA et al., T-Cell-Inflamed Gene-Expression Profile, Programmed Death Ligand Expression, and Tumor Mutational Burden Predict Efficacy in Patients Treated With Pembrolizumab Across 20 Cancers: KEYNOTE-028. J Clin Oncol 2018: DOI:10.1200/JCO.2018.78.2276.

www.integratedoncology.com

SPECIMEN REQUIREMENTS

Tissue Submission Guidelines

All blocks and slides must at a minimum be labeled with the pathology case number and part. Reports and other provided materials must be labeled with the pathology case number and at least two patient identifiers, such as name, medical record number, or date of birth. Please include the pathology report.

Recommended Specimen Submission

**DO NOT SUBMIT Decalcified Specimens or Cytology Smears**The preferred specimen is at least one formalin-fixed, paraffin-embedded (FFPE) block. If a block cannot be provided, see slide requirements below. Specimens with very small amounts of tumor and/or less than requested number of slides will be accepted with the caveat that complete testing may not be possible.

Slide Requirements

Preferred: FFPE blockAlternate: send 20 unbaked, positively charged, unstained slides cut at 5 μm plus one H&E.

Transportation Requirements

FFPE blocks: Stored at room temperature and shipped with no special precautions, except when daily outside temperatures exceed 35°C, and then ship with cool packs to avoid paraffin meltdown.

FIND OUT MORELearn more about Integrated

Oncology’s comprehensive

menu of testing services.

Contact your local Integrated

Oncology territory manager,

call client services at

800.447.5816, or visit

www.integratedoncology.com.

LAB LOCATIONSArizonaIntegrated Oncology5005 South 40th StreetPhoenix, AZ 85040800.710.1800 • Fax 800.481.4151

Connecticut/New YorkIntegrated Oncology3 Forest ParkwayShelton, CT 06484800.447.5816 • Fax 212.258.2143

North CarolinaLabCorp Center for Molecular Biology and Pathology1912 Alexander DriveResearch Triangle Park, NC 27709800.345.4363 • Fax 919.361.7798

TennesseeIntegrated Oncology201 Summit View Drive, Suite 100Brentwood, TN 37027800.874.8532 • Fax 615.370.8074

Integrated Oncology – a LabCorp Specialty Testing Group

More than 541,000 tests performed on 387,000+ patients annually

1,600 contractual relationships with plans, payors, and other health care organizations across the US, some of which are on an exclusive basis

More than 700 connectivity solutions that integrate >250 EMR, LIS, and PMS systems

Menu of more than 550 genetic, pathology, IHC, and FISH tests, including both somatic and hereditary testing 

Staff of more than 75 pathologists, PhDs, and genetic counselors dedicated to oncology and familial cancer testing

More than 95 oncology- and pathology-specific publications and presentations since 2013