Discover End-to-End Applications for the Clinically Driven, Real

USE EXPLORATION

Discover End-to-End Applications

for the Clinically Driven,

Real-Word Oncology Data

in Cohort Builder

from NeoGenomics

Cohort Builder is changing the way that development and commercial teams answer strategic

questions and build more impactful biomarker programs from pre-clinical to post-launch

surveillance. In this document, we will explore real-world use cases for generating insight across

the drug development lifecycle with the ultimate goal of accelerating precision medicine.

INFORMATICS

INFORMATICS USE EXPLORATION

Discover End-to-End Applications for the Clinically Driven, Real-World Oncology Data in Cohort Builder from NeoGenomics

TECHNOLOGICAL ADVANCES have put information at our fingertips in

all facets of life. Services such as Google, Siri, and Alexa ensure no question

goes unanswered for more than a few seconds. We believe this should also

be the case for Oncology lab data. Whether you’re a clinical lead, a commercial

marketing manager, or a data analyst, you are regularly faced with questions

about the current landscape of oncology biomarker testing. Having a clear

understanding of testing algorithms and their implications to the patient journey

and treatment paradigms is critical.

The need to make more informed, strategic, evidenced-based decisions across

the entire precision medicine development lifecycle drove us to develop

Cohort Builder, an online subscription-based application that gives our client

partners access to real-world, de-identified testing data from the largest

oncology lab in the US.

Cohort Builder leverages the largest volume oncology testing

lab and provides access to NeoNucleus,

™

a real-world database

developed to drive better, faster precision medicine outcomes.

Following are examples of real-world

applications for Cohort Builder that will

enable you to explore its capabilities

and see its value at different stages of

the drug development lifecycle.

FIG.1

WITH A FEW CLICKS,

USERS CAN FILTER THE

›

1.9M

DE-IDENTIFIED PATIENT

RESULTS BY TUMOR TYPE,

MUTATION STATUS BY

GENE, AND VARIANT

CLASSIFICATION.

Preclinical

SCENARIO #1

An R&D team from a fortune 500

pharmaceutical company seeks to under-

stand the prevalence of KRAS G12C

and STK11 co-mutations in non-small cell

lung cancer (NSCLC) to inform Phase 1

trial design.

COHORT BUILDER SOLUTION

With a few clicks, users within the

R&D team can filter the >1.9 million

de-identified patient results within

NeoNucleus by tumor type, mutation

status by gene and variant classification.

The team can easily perform an annual

analysis of results from the >15,000

lung cancer patients tested for KRAS

mutations through NeoGenomics to

understand the percentage of patients

that also harbor STK11 mutations. They

can then examine pathogenic variants

versus variants of unknown significance

as well as differences by gender, age

and geographic distribution. The team

can also look at other tumor types

to understand the prevalence of these

co-mutations outside of lung cancer.

REAL-WORLD VALUE

This data provides the evidence required

to optimize the design of trial cohorts and

enrollment targets.

FIG.1 Cohort Builder’s drag and

drop function allows users to create

cohorts by diagnosis, test or panel

performed, and mutation result, as

patient counts update in real time.

FIG.2 Data visualizations within the

Cohort Builder explore page allow

for real time analysis of variables

of interest.

FIG.2

INFORMATICS USE EXPLORATION

Discover End-to-End Applications for the Clinically Driven, Real-World Oncology Data in Cohort Builder from NeoGenomics

Preclinical

SCENARIO #2

The computational pathology team within

the pharmaceutical company is beginning

development work on an artificial

intelligence (AI) algorithm to predict KRAS

mutations from H&Es of NSCLC patients.

In order to train its algorithm to recognize

the relevant cellular features from an H&E,

the team needs to source hundreds of

images with known KRAS mutation status

(both positive and negative).

COHORT BUILDER SOLUTION

In addition to mining test result data from

NeoNucleus,™ Cohort Builder pulls in

counts from our repository of >1 million

whole slide images to determine in real

time how many H&Es are available for

NSCLC patients with and without KRAS

mutations. The computational pathology

team can then request access to these

images through a NeoPixel contract.

REAL-WORLD VALUE

As a leading provider of whole slide images

in the US, access to this image count

directory accelerates access to the required

images and associated metadata for

digital pathology AI initiatives.

FIG.3 As cohorts are created,

Cohort Builder provides a real

time count of the number of

H&Es available for that cohort.

IN ADDITION TO MINING

TEST RESULT DATA FROM

NEONUCLEUS,™ COHORT

BUILDER ALLOWS USERS

TO BROWSE COUNTS

FROM A REPOSITORY OF

›

WHOLE SLIDE IMAGES.

FIG.4

Cohort Builder visualizations

include geographical distribution of

providers with patients in the cohort

of interest.

FIG.5 Cohort Builder provides a

list of the highest volume ordering

facilities that have patients in the

cohort of interest.

FIG.4

FIG.5

Phase 1

‒

3: clinical trials

SCENARIO

Following initial trial design, the Clinical

Trial Lead is tasked with identifying

trial sites with the highest likelihood of

enrollment based on patient volumes.

COHORT BUILDER SOLUTION

Through Cohort Builder, users can drill

down into the total patients counts for

specific criteria—in this case, NSCLC

cancer patients harboring both KRAS

G12C and STK11 mutations—to the

facility and provider level. By visualizing

“hotspots” of patients that meet the

clinical-trial criteria and providing counts

by ordering facility and provider, pharma

sponsors can identify potential clinical

trial sites and principal investigators

who are already treating these patients

in-house.

REAL-WORLD VALUE

Pharmaceutical organizations can bring

the trial to patients versus spending

time and resources bringing the right

patients to the trial.

INFORMATICS USE EXPLORATION

Discover End-to-End Applications for the Clinically Driven, Real-World Oncology Data in Cohort Builder from NeoGenomics

FIG.6 Cohort Builder data

visualization includes a break

down of ordering facility type.

FIG.7 Further breaking down facility

by subtype provides a look at the

specialty of institutions from which

orders for the test of interest are

being sent to NeoGenomics.

FIG.8 Diagnosis code break down

helps to further stratify patients in

the cohort of interest.

Pre-launch

SCENARIO

As the therapy advances to late-stage

clinical trials, the commercial team works

to understand the landscape into which

the therapy will launch so they can prepare

impactful sales and marketing strategies.

COHORT BUILDER SOLUTION

Cohort Builder helps commercial teams

develop a deep understanding of the

current biomarker-testing landscape and

any hurdles that will need to be removed

prior to launch by answering pressing

pre-launch questions, such as:

• How many patients are currently tested

(and equally as important, not tested)

for KRAS G12C and STK11?

• What are current testing algorithms –

panel vs. single gene?

• What is the real-world positivity rate of

KRAS G12C mutations with and without

STK11 co-mutation?

• What types of providers are testing

(and not testing) for KRAS G12C and

STK11 today?

• What is the total available market and

what can we anchor our forecast on?

Given that >80% of ordering facilities that

send testing to NeoGenomics are based

in the community setting, NeoNucleus

data is more representative of real-world

trends that are happening outside of

academic medical settings. Access to this

real-time, real-world de-identified lab data

provides a more accurate assessment of

the current landscape and enables more

appropriate allocations of budget and

resources in program planning.

REAL-WORLD VALUE

Cohort Builder can serve as a springboard

for linking lab data to other external

data sets such as medical/Rx claims and

EMR data through tokenization, which

enables a better understanding of the

patient journey and treatment patterns in

the tested population.

MORE THAN

80%

OF ORDERING

FACILITIES THAT SEND

TESTING TO

NEOGENOMICS ARE

BASED IN THE

COMMUNITY SETTING.

FIG.8

FIG.6

FIG.7

FIG.9

Cohort Builder provides a list

of the highest volume ordering

providers that have patients in the

cohort of interest.

Commercial launch

SCENARIO

The biomarker-driven targeted therapy

becomes FDA approved and commercially

available, and brand teams are tasked

with driving both biomarker and therapy

awareness at the provider level.

COHORT BUILDER SOLUTION

Through real-time access to NeoNucleus,

brand teams and commercial marketing

managers can identify providers that have

therapy-eligible patients, allowing for a

tailored, targeted and relevant treatment

message. This can help them optimize

field team resources and ensure that

provider-level communication is beneficial

and actionable.

REAL-WORLD VALUE

Cohort Builder accelerates connections

between the field team and the provider

to ensure informed decisions are made

within the treatment window and without

the delay associated with many test signal

or trigger alert programs.

FIG.9

Post-launch surveillance

SCENARIO

The pharma company recognized a gap in

testing and deployed a number of

biomarker education programs at the time

of commercial launch. It is interested in

tracking the impact of these initiatives on

testing behavior.

COHORT BUILDER SOLUTION

Cohort Builder allows users to compare

historical data with real-time data to track

testing trends over time. The brand team

or supporting data analytics team can look

at KRAS testing rates prior to the targeted

therapy launch and track changes

prospectively on a weekly, monthly or

annual basis to understand whether their

biomarker programs have moved the

needle. They are also able to look at this

at a facility level to identify the need

to expand or contract their programs in

certain regions.

REAL-WORLD VALUE

In addition to answering targeted questions

around a single biomarker, Cohort Builder

helps track overall changes in the lung

cancer landscape, keeping pharma teams

at the forefront of evolving testing and

treating dynamics in their spaces.

* Contact a Data Strategy Consultant to discuss

the various levels of service available for

Cohort Builder for commercial applications.

9490 NeoGenomics Way

Fort Myers, FL 33912

Phone: 866.776.5907 | Fax: 239.690.4237

www.neogenomics.com

COHORT BUILDER USE EXPLORATION

Discover End-to-End Applications for the Clinically Driven, Real-World Oncology Data in Cohort Builder from NeoGenomics

Let Cohort Builder work for you

Wherever your precision medicine programs are in the development lifecycle,

Cohort Builder will provide meaningful insights for better, faster outcomes.

Request a demo today to learn more about how you can harness the power of

having real-world lab data at your fingertips.

To connect with a Data Strategy

Consultant on the various subscription

levels available for Cohort Builder,

email: informatics@neogenomics.com

INFORMATICS RESOURCES:

Learn more about Cohort Builder

and download the fact sheet at

cohort-builder.com

Explore insights from NeoNucleus in

our latest Lite Paper: Using Real-World

Data Insights to Improve Biomarker Testing

in Lung Cancer at neogenomics.com/

lung-cancer-testing-litepaper

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