1. 22
by Franziska Moeckel, MBA
Consumer-Directed products, in the context
of this article, are services that may or may
not be marketed directly to consumers and
can be purchased directly by the individual
but that require a healthcare professional to
order the test or test bundle. Some recent
examples include Color Genomics – a company
that offers affordable genetic testing, including
BRCA1 and BRCA2, to help understand genetic
risk for breast and ovarian cancer; Arivale – a
business dedicated to providing individuals a
scientific path to wellness; the Health Nucleus
– a wholly owned subsidiary of Human
Longevity Inc. that is the first-of-its-kind
genomic enhanced, research based health
platform; Veritas Genetics – “the first
company in medical history to offer
individuals the opportunity to easily and
affordably unlock the secrets of their
entire genome.” While Color Genomics
focuses on making genetic testing accessible
and “allow[ing] people to catch cancer at an
earlier and more treatable stage or prevent it
altogether,” Arivale focuses on wellness “by
leveraging an individual’s unique genetic
makeup, clinical lab data and lifestyle to
optimize wellness and avoid disease.” The
Health Nucleus, also concentrating on
wellness, “uses whole genome sequence
analysis, advanced clinical imaging and
innovative machine learning – combined with
a comprehensive curation of personal health
history – to deliver the most complete picture
of individual health.” In comparison,
Veritas Genetics promises that “you can
sequence your entire genome and gain a
completely new understanding of what’s
possible when it comes to using your genetic
information together with your doctor to
improve your health and longevity.”
There are many other choices. Healthcare
providers – independent practitioners,
physician groups, and health systems alike,
are increasingly confronted with DTC and CD
products as part of their day-to-day practice,
a trend that is anticipated to only grow in the
future as the sophistication and curiosity of
empowered, educated individuals regarding
their genetic makeup (and other organisms
living within the human body) matures.
W ith more and more Direct-to-Consumer (DTC) and Consumer-Directed (CD) ‘Omics products
hitting the US market, leading providers, physician groups and healthcare systems in the field
of personalized or precision medicine have a decision to make. Should they be active participants
in the Consumer-Directed and/or Direct-to-Consumer movement; should they invest in alternative offerings;
or should they even separate themselves from such products completely? Experts in the field define Direct-to-
Consumer (genetic) testing as testing sold directly to consumers via various marketing channels, including TV,
the internet, social media platforms or other marketing venues without involving a healthcare professional or
insurance company. Companies such as 23andMe – a leading personal genetics company with the goal to help
people access, understand and benefit from the human genome, and uBiome – a citizen science project that
allows the public access to cutting edge sequencing technology to understand their microbiome, are just two
prevalent examples for DTC testing. While 23andMe markets itself as the “first and only genetic service available
directly to you that includes reports that meet FDA standards” and includes reports on carrier status, ancestry,
wellness, and personal traits, uBiome, on the other hand, allows an individual to “explore your microbiome”
by extracting bacterial DNA out of an individual’s sample.

2. 23
COGNOSCIENTI
People who have participated in one of the
DTC testing services approach their primary
care physician (or specialist) and present
their results with the expectation that the
information is either understood by their
doctor or that this information should be
part of the treatment pathway and medical
record moving forward.
Regardless of what the situation may be,
providers have a choice to make: to either
participate and partner with patients and
these companies, to build their own version
of DTC and CD offerings, or to ignore this
trend altogether. They can choose to lead
the movement, follow the leader, or watch
from the sidelines (Figure 1). Yet, there is
no black-and-white answer to this question.
When taking an active approach to this
overarching strategic issue, assessing whether
or not a product is worth the investment by
evaluating many competing elements before
making a business decision is crucial. The
framework below can assist in making these
decisions.
l Legal: Reviewing company policies and
compliance with the Food and Drug
Administration (FDA) regulations if applicable
– especially for DTC services.
l Media: Researching paid and earned media
content. Is the tone positive, neutral, or
negative?
l Marketing: Estimating the company’s
marketing engine and strength in conjunction
with the associated brand awareness and value
in your market.
l Core Competencies: Understanding the
company’s core competencies in comparison
to your own, e.g. clinical testing quality, report
information comprehension levels, customer
service, etc.
Product Overview and Fact Gathering
To understand which product(s) and service(s)
the company is offering and associated
customer group(s). This step includes:
l Test Benefits & Target Market: Summarizing
product offerings and benefits for each target
customer group – especially the individual;
assessing user interfaces based on user-
friendliness and a certain “fun” factor.
l Cost Structure: Listing test costs as part of
the service package, incl. individual and bundle
test costs, discounts, membership models,
affiliation programs, premium versus standard
services etc.
l Technical Test Specifications: Reviewing
the list of genes (or other test specifications),
laboratory environment (can be multiple
laboratories at different locations) where each
of the tests is performed (internal/external
laboratory, Clinical Laboratory Improvement
Amendments (CLIA) / College of American
Pathologists (CAP) certified / research setting),
technology used (platform(s)/machine(s)),
depth of coverage (for whole genome and
whole exome sequencing) and associated test
report details.
l Customer Service: Understanding customer
service standards and access points (phone,
email, chat) for both the individual and the
physician.
Figure 1. Precision Medicine Implementation Lifecycle
Introduction &
Education
Limited Acceptance
Low Utility
High Cost
No Reimbursement
Utility
Time
Awareness &
Undestanding
Growing Acceptance
Increasing Utility
High Cost
Limited Reimbursement
Awareness &
Adaptation
High Acceptance
Constant Utility
Reduced Cost
Wide Reimbursement
Awareness &
Abandonment
Diminished Acceptance
Decreased Utility
Constant Cost
Wide Reimbursement
Innovators Early Adaptors Majority Laggards
First Mover
Threshold
Organizational Fit
To determine organizational fit between your
entity and that of the company providing DTC
or CD services – it encompasses how the
company aligns with your mission, vision,
business objectives, and overall strategy. This
step includes:
l Company Profile: Assembling a company
profile, incl. the type of entity you are evaluating
(for-profit vs. not-for-profit, mission/vision,
core values, etc.) and how it compares to your
purpose.
l Leadership: Reviewing the leadership team,
incl. the medical and research team, board
of directors, and advisory board (balance
between scientific, clinical, and business
experts is important), as well as the number
of staff employed, etc.
l Investments: Profiling the company’s
investors (if any) and the type of investments
made, incl. the amount and type. This history
is also crucial for assessing investment
potential (if applicable).

3. A B
24
Figure 2. Direct-to-Consumer and Consumer-Directed
Product Assessment Framework
Categories Objectives Assessment Components
• Company Profile / Core Values
• Leadership Team
• Investments
• Legal/Government Regulations
• Media Coverage
• Marketing Plan
• Company Core Competencies
• Test Benefits & Target Markets
• Cost and Pricing Structure
• Technical Test Specifications
• Customer Service
• Company Fact Sheets
• Current Customers
• Data Sharing Models
• Report Templates & Integration
• Support Services
• Competition
• Research Projects
• Test Panel Composition
• Clinical Validity and Patient Benefits
• Research Application
• Physician Interaction
• Quality Controls
• Partnership Model
• Staffing Requirements
• Buy versus Make Decisions
• Electronic Health Record (EHR)
Integration
• Payment Terms
• Education & Training
• Product Modification / Enhancements
l Fact Sheets: Reviewing company fact sheets
(scientific and non-scientific).
l Customers: Researching company partners
and current customers.
l Data Sharing: Investigating data sharing
principles with the individual and physician
and in which format, incl. information shared
with individuals as part of coaching process.
l Reports: Reviewing report templates
and content, including support tools for
both the individual and physician, as well
as interpretation benchmarks.
l Support Programs: Evaluating existing health
coach or genetic counselor programs and
format thereof (face-to-face, group setting,
phone, email, video conference, etc.)
l Competition: Comparing product(s) to
other similar internal and or external products
available, incl. cost, list of genes and associated
reports, customer support services, etc.
l Research: Understanding whether or not
the data generated is used for research.
Clinical Validity and Physician Uptake
To clarify whether or not the product or
service has clinical validity (is evidence-based)
and to gauge physician acceptance. This step
includes:
l Test Panel Composition: Analyzing test
details, tests included and not included in an
assay and reasons for doing so.
l Clinical Validity: Establishing if test(s) are
based on evidence and have clinical validity
that can be supported by peer-reviewed
research studies, research data, publications,
etc., as well as assessing which patient/
consumer benefits are derived from offering
the test(s).
l Research: Determining whether or not
data is used for the company’s research
endeavors, and, if so, whether or not the
study has undergone International Review
Board (IRB) approval, incl. informed consent
forms used, research goals established, etc.
l Physician Interaction: Setting expectations
for physician interactions and requirements,
such as test ordering and report returns, as well
Organizational Fit To determine organizational
fit between your entity and
that of the company providing
DTC or CD service – it
encompasses how the company
aligns with your mission, vision,
business objectives, and overall
strategy.
Product Overview To understand which
and Fact Gathering product(s) and service(s) the
company is offering and
associated customer group(s).
Clinical Validity and To clarify whether or not the
Physician Uptake product or service has clinical
validity (evidence-based) and
to gauge physician acceptance,
and benefits to patient care.
Business Approach To define the business model
most appropriate for your
provider(s).
as addressing how the use of the test will add
or reduce time spent on clinical workflows.
l Quality Controls: Agreeing on what quality
controls must be in place at both institutions.

4. 25
COGNOSCIENTI
Business Approach
To define the business model most appropriate
for your provider(s). This step includes:
l Partnership Model: Negotiating partnership
details such as a pilot project and beta sites,
patient benefits for participation, cost and
profit sharing terms, volume discounts and
requirements, additional services provided as
part of the partnership agreement, distribution
channels (concierge medicine, employees,
insurance plan participants, all patients, etc.)
l Staffing: Understanding any additional
internal staffing requirements if any.
l Buy versus Make: Agreeing on which
laboratories will be used for which test
(internal/external) and environment (research
versus CLIA/CAP certified) and understanding
the impact on market share if any.
l Electronic Health Record (EHR) Integration:
Defining whether or not the platform used
by the company is compatible with your
Information Technology infrastructure and
whether or not one- or bi-directional data
sharing is permitted.
l Payment Terms*: Determining who pays for
test offering and through which channel – your
entity, the company (as a pilot project), the
individual, or the insurance plan*.
l Education & Training: Agreeing on which
entity is responsible for consumer education
and physician training. This includes an
evidence-based library, marketing materials,
and type of education channels (print, video, etc.)
l Product Modification / Enhancements:
Evaluating if product modifications or
enhancements are beneficial to the new
offering, e.g., your own organization’s
(add-on) services.
l Data Storage and Management: Facilitating
an agreement making determinations about
data sharing, research use of data and by which
parties, specific data access points, and the
responsible party for data storage and management.
l Intellectual Property: Understanding who
owns the rights (if not shared) to intellectual
property created as part of the business deal.
Workflow Integration
To determine how the new test or offering
will be integrated into any existing internal
processes and workflows. This step includes:
l Information Technology: Identifying any
requirements for technology integration and
interoperability, such as with an EHR, third
party billing system, laboratory reporting
platform, as well as data sharing structures,
ICD-10 medical necessity coding requirements
for reimbursement (if any) and the location
and management of these systems.
l Legal and Compliance: Following internal,
state, and federal regulations specific to your
company, as well as assessing other existing
partnership agreements and contingencies.
l Managed Care Contracting*: Understanding
any impact on existing managed care contracts
for medically indicated testing services similar
to the product being assessed.
l Marketing / Communications: Facilitating
an integrated marketing and communications
plan if needed.
l Pricing (Charge Master): Determining a price
for a product that has either been modified,
enhanced, or will be promoted and sold
directly by your entity.
l Laboratory Interface: Facilitating the
integration of internal laboratory services
into the new process, such as phlebotomy,
courier services, etc.
Franziska Moeckel, MBA. Franziska Moeckel is
the Assistant Vice President, Personalized Health
at Inova. In her role, Franziska is leading business
operations and product launch activities for molecular
diagnostic testing as part of an in-house, CLIA-certified
genomics laboratory, and is assessing and promoting
new ‘omics features for clinical practice, including
consumer-directed and direct-to-consumer products
and services.
As part of the new Inova Center for Personalized
Health team, she is providing strategic direction
and thought leadership around the integration of
precision medicine and individualized wellness.
“ Regardless of what the situation
may be, providers have a choice to
make: to either participate and
partner with patients and these
companies, to build their own version
of DTC and CD offerings,
or to ignore this trend altogether.”
These steps are suggestions and may or may
not apply to your organization as DTC and
CD products evaluated may differ and as
company goals, management structure, as
well as overall sophistication levels and
technological integration requirements vary
from entity to entity.
*Generally, Managed Care Contracts and
insurance plans currently do not cover or
reimburse for Direct-to-Consumer (DTC)
or Consumer-Directed (CD) tests due to the
lack of medical necessity. However, a forward
looking approach has been taken in this
assessment and for this framework.