How to Make Safe & Effective OTC Consumer Health Products

Chief Legal & Regulatory Officer,
23andMe
@23andMe

Empowering Consumers
Through OTC Products

Confidential Information - Do Not Distribute Copyright © 2019 23andMe, Inc. All rights reservedConfidential Information - Do Not Distribute Copyright © 2019 23andMe, Inc. All rights reserved
Our mission is to help
people access,
understand and benefit
from the human genome
44

Growth over 13 Years
warning letter
GHR
authorization
~10M+ kits
sold
2008 2010 2012 2014 2016 2018
BRCA
authorization
PGt
authorization
Carrier Status
authorization
5
1M
10M
MUTYH
authorization
5

How It Works
6
Order/Buy Spit Send Discover
23andme.com | Amazon.com
CVS | Target | Walgreens
Walmart | Sam’s Club | Best Buy
Just a few milliliters of
saliva is needed
Results are returned within 6-8
weeks to secure online account
Saliva samples are
processed in labs that meet
local regulations
6

7Copyright © 2019 23andMe, Inc.
First and only DTC service with reports
authorized by the FDA
40+
Carrier
Status*
30+
Traits
8
Wellness
35+
Ancestry
10+
Health
Predispositions*
*The 23andMe PGS test includes health predisposition and carrier status reports. Health predisposition reports include both reports that meet FDA requirements for genetic health risks and the 23andMe Type 2 Diabetes health predisposition report which is based on 23andMe research and
has not been reviewed by FDA. The test uses qualitative genotyping to detect select clinically relevant variants in the genomic DNA of adults from saliva for the purpose of reporting and interpreting genetic health risks and reporting carrier status. It is not intended to diagnose any disease. Your
ethnicity may affect the relevance of each report and how your genetic health risk results are interpreted. Each genetic health risk report describes if a person has variants associated with a higher risk of developing a disease, but does not describe a person’s overall risk of developing the
disease. The test is not intended to tell you anything about your current state of health, or to be used to make medical decisions, including whether or not you should take a medication, how much of a medication you should take, or determine any treatment. Our carrier status reports can be
used to determine carrier status, but cannot determine if you have two copies of any genetic variant. These carrier reports are not intended to tell you anything about your risk for developing a disease in the future, the health of your fetus, or your newborn child’s risk of developing a particular
disease later in life. For certain conditions, we provide a single report that includes information on both carrier status and genetic health risk. For important information and limitations regarding other genetic health risk reports and carrier status reports, visit https://www.23andme.com/test-info

Sample Genetic Health Risk Report

Sample Wellness Report

Sample Trait Report

Sample Ancestry Report

Changing the Conversation about Race

23andMe Research
13

14Copyright © 2017 23andMe, Inc. All rights
reserved.
130+ peer-reviewed papers
23andme.com/publications
Diverse set of therapeutic programs
in oncology, skin, respiratory, and
cardiovascular disease
UNDERSTAND TREAT
Research Goals

reserved.
Copyright © 2017 23andMe, Inc. All rights
reserved.
From https://www.cdc.gov/about/report/chronic-disease-
prevention.html
PREVENT
Research Goals

10Mkits sold
90%don’t know they
have it
80%of customers
consent to
participate in
research
have it
2Bsurvey questions
answered
Largest Recontactable Platform for Research

Data Collection Via Online Surveys

130 + Peer-Reviewed Papers Published Since 2010
Full publication list available: https://www.23andme.com/publications/
18
Psychiatric disorders
Skin cancer
Addiction
Appendicitis
Parkinson’s disease
Cannabis use
Sexual preference
18

Discoveries from Fun...

To Serious...
450,000 23andMe Consented Customers
participated

Engaging Consumers in the Research Cycle
Make
discoveries
Share discoveries
with the consumer
Consented,
engaged
consumers

Data Powers Reports
22

From Question to Analysis
23
Q. Does drinking a caffeinated beverage (tea, coffee, soda, or
an energy drink) usually make you jittery, restless, or full of
nervous energy?
23

Further Analysis
24
“Heavy caffeine drinkers:” cases report drinking several caffeinated
drinks per day
24

23andMe Report

Polygenic Risk Report Development
26

● Most current genetic tests focus on a small number of rare variants of
large effect.
● For common diseases, rare variants of large effect only account for a
small proportion of the inherited likelihood of developing a condition.
○ Breast cancer (all panel genes account for ~25% of inherited risk)
● Much of the remaining inherited likelihood is explained by common
variants.
● The variants are detected with a machine learning algorithm and the
combined effect of the variants detected results in a polygenic score.
Polygenic Score

Type 2 Diabetes Polygenic Score
28

1 in 3Americans have
prediabetes1
have it
90%with prediabetes
don’t know they
have it
have it
$327Bestimated in
healthcare costs
annually2
Why Build a Type 2 Diabetes Report?
1. Centers for Disease Control and Prevention (CDC), Prediabetes: Your Chance to Prevent Type 2 Diabetes, https://www.cdc.gov/diabetes/basics/prediabetes.html.
2. American Diabetes Association. Economic Costs of Diabetes in the U.S. in 2017. Diabetes Care 2018 Mar. <http://www.diabetes.org/advocacy/news-events/cost-of-
diabetes.html>.

Early Diagnosis and Prevention
● When high blood sugar is identified early, it's possible to delay and even
prevent the progression of prediabetes to diabetes.1
● If you are overweight and prediabetic, losing 5-7% of your body weight can
reduce your likelihood of developing type 2 diabetes by up to half.1
● Type 2 diabetes is one of the most-requested reports from our customers.
● Roughly one million of our current customers may learn of an increased
likelihood
● We want to raise awareness about the importance of healthy lifestyle in type 2
diabetes prevention and how to reduce your likelihood of developing the
condition.
1. The Centers for Disease Control and Prevention. “Prediabetes: Your Chance to Prevent Type 2 Diabetes.” <https://www.cdc.gov/diabetes/basics/prediabetes.html>.

2.5M
GWAS of
consented
participants
have it
1,200+
genetic variants
influencing T2D
identified
Report Powered by 23andMe Data

23andMe GWAS Results Capture Same Variants of
External GWAS Dataset (Scott et al. 2017)

Type 2 Diabetes Polygenic Score Performance
Overall Polygenic Score Performance
>6x increase in diabetes prevalence from
bottom of Polygenic Score to top.
Group T2D Odds Ratio (top
5% versus average)
European 3.15
Latino 2.82
East Asian 2.22
South Asian 2.13
African American 1.91
Performance Across Ethnicities
Polygenic Score ventiles

Effect Sizes are Concordant between Studies and
23andMe GWAS Has More Power
23andMe
GWAS
Scott et al.
2017 GWAS
Number of
Cases
77,000 27,000
Number of
Controls
1,400,000 130,000

23andMe Type 2 Diabetes Report

Do Results Impact Behavior?
36

reserved.
The Saturated Fat and Weight Report
Result 2 (Genotype at rs5082: GG)Result 1 (Genotype at rs5082: AA/AG)
If we give customers this information, will they change their dietary behaviors?

reserved.
Genetic results can trigger behavior change
49% Yes
51% No
At six months, any self-reported dietary
change since viewing the report
n = 8192
Report had an impact on decision to
make dietary changes
33% No
67% Yes
A survey taken six months post-result viewing showed sustained behavior change

reserved.
Genetic results can trigger behavior change
Are you still maintaining this change
to foods high in unsaturated fats?
Are you still maintaining this change
to foods high in saturated fats?
3% No 9% No
97% Yes 91% Yes

reserved.
A prevention hypothesis
Data Prediction Action Prevention
Risk models
(genetic +
non-genetic)
Interventional
studies
Long-term
follow up

How to Make Safe & Effective OTC Consumer Health Products

How to Make Safe & Effective OTC Consumer Health Products

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