23andMe Holding Co. (Nasdaq: ME) (23andMe), a leading genetic
health and biopharmaceutical company, today launched
23andMe+ Total Health, its new,
comprehensive prevention-based health membership that provides
clinical grade exome sequencing, biannual blood testing, and
unprecedented access to genetics-based clinical care. Members of
Total Health will also receive all the reports and features offered
in the Company’s existing 23andMe+ Premium Membership.
Total Health delivers on 23andMe’s mission to help people
access, understand and benefit from the human genome. This
membership is for individuals who want to augment their current
healthcare experience with even more direct access to comprehensive
genetic testing, blood biomarker testing, risk assessment in
critical health areas, and personalized health plans driven by
clinicians trained in genetics.
Through the combination of critical health data, including
comprehensive and personalized genetic information, blood
biomarkers and personal and family medical history, clinicians with
unique knowledge and training in genetics can provide risk
assessments and help build a highly personalized and actionable
preventive health plan.
“We’re bringing the power of genetics into your personal
healthcare journey, along with blood biomarkers, personal and
family health history and lifestyle to help you understand the full
picture of your disease risks,” said 23andMe’s Vice President of
Genomic Health Noura Abul-Husn, M.D. Ph.D. “We’re also helping you
understand what to do with this information through clinician
consultations and ongoing access to medical professionals. We
believe this type of comprehensive approach to prevention will lead
to longer, healthier lives.”
Total Health membership servicesExome
sequencingThrough advanced exome sequencing, members will
receive clinician-ordered genetic testing that looks deeper into
high impact genes associated with 55+ health conditions that, if
detected early, may have effective preventive measures and clinical
interventions. This includes all genes considered medically
actionable by the American College of Medical Genetics (ACMG) and
under-diagnosed hereditary conditions related to cancer,
cardiovascular, metabolic, kidney, neurological and other health
conditions.
Biannual blood testingWhile genetics offers
insight into the future, blood testing gives insight into the now.
Total Health members will get comprehensive blood tests for 55+
biomarkers, going beyond your routine labs. This includes measuring
things like blood sugar levels, kidney, liver and thyroid function,
along with cholesterol and advanced lipoprotein levels, which offer
ongoing insight for prevention and early detection. Members will
receive biannual testing, allowing them to track results and
measure progress all within their 23andMe account through the Lab
Results & Vitals feature. Blood testing is initiated by a
clinician and members will complete their testing through a local
lab offered by a third-party provider.
Access to clinicians trained in geneticsTotal
Health members will have access to clinicians with unique knowledge
and training in genetics-based care, including an annual virtual
consultation and ongoing direct messaging with healthcare
professionals. Clinicians will review all blood biomarkers, genetic
data and personal and family medical history to provide members
with personalized risk assessments and help build a preventive
health action plan tailored to each individual. Members are able to
engage in an annual virtual clinician consultation, as well as have
ongoing messaging conversations with clinicians about their
reports, progress they are making, or to ask questions.
23andMe+ PremiumTM
MembershipAs part of Total Health, members will
gain access to all the premium reports and features delivered
through 23andMe+ Premium. This includes:
- Our Health + Ancestry Service which includes FDA-authorized
reports*
- Polygenic reports (powered by 23andMe research), which look at
your genetic likelihood for more common conditions like high LDL
cholesterol, asthma and anxiety
- Pharmacogenetic reports, which help you understand how your
genetics may impact how you process certain medications**
- Enhanced ancestry features
Expanding CoverageHistorically, 23andMe has
offered reports using genotyping technology, a powerful, efficient
and accurate way to examine DNA variants at certain pre-identified
positions in the genome. The specific positions analyzed are known
to more commonly vary between individuals and span the entire
genome.
However, exome sequencing is an advanced, comprehensive genetic
testing technology that involves reading every DNA letter in its
correct order within a given piece of the genome. This provides
individuals with a more complete picture, surfacing the majority of
genetic variants known to be associated with disease risk.
For example, we use genotyping for our BRCA1/BRCA2 (Selected
Variants) Genetic Health Risk report*, which looks at 44 variants
within the BRCA1 and BRCA2 genes associated with breast, ovarian,
and prostate cancer. With exome sequencing, Total Health will
include reports that look at all the thousands of variants within
the coding region of the BRCA1 and BRCA2 genes. We’ll also report
on thousands of variants in many other genes associated with
increased cancer risks.
Our exome sequencing will go beyond cancer to also include
clinical interpretations of high impact genes associated with other
hereditary health conditions that, if detected early, may have
effective prevention measures and clinical interventions.
23andMe+ Total Health offers members a fuller picture of their
risk for disease, helping individuals navigate to a healthier
future.
Availability and EligibilityTotal Health will
be available for those 18 and older in the United States (excluding
Hawaii, New Jersey, New York, Oklahoma and Rhode Island). The
23andMe+ Total Health membership will cost $99 per month, billed in
a one-time annual payment of $1,188. It will be offered to existing
23andMe customers as an upgrade in the spring of 2024.
Important PGS Test Information*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 reports which are based
on 23andMe research and have not been reviewed by the 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.
Warnings & Limitations: The 23andMe PGS
Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) is
indicated for reporting of 44 variants in the BRCA1 and BRCA2
genes. The report describes if a person's genetic result is
associated with an increased risk of developing breast cancer and
ovarian cancer and may be associated with an increased risk for
prostate cancer, pancreatic cancer, and potentially other cancers.
The variants included in this report do not represent the majority
of the BRCA1/BRCA2 variants in people of most ethnicities. This
report does not include variants in other genes linked to
hereditary cancers and the absence of variants included in this
report does not rule out the presence of other genetic variants
that may impact cancer risk. This report is for over-the-counter
use by adults over the age of 18, and provides genetic information
to inform discussions with a healthcare professional. The PGS test
is not a substitute for visits to a healthcare professional for
recommended screenings or appropriate follow-up. Results should be
confirmed by an independent genetic test prescribed by your own
healthcare provider before taking any medical action. For important
information and limitations regarding each genetic health risk and
carrier status report, visit 23andme.com/test-info.
**23andMe PGS Pharmacogenetics reports: The 23andMe test uses
qualitative genotyping to detect 3 variants in the CYP2C19 gene, 2
variants in the DPYD gene and 1 variant in the SLCO1B1 gene in the
genomic DNA of adults from saliva for the purpose of reporting and
interpreting information about the processing of certain
therapeutics to inform discussions with a healthcare professional.
It does not describe if a person will or will not respond to a
particular therapeutic. Our CYP2C19 Pharmacogenetics report
provides certain information about variants associated with
metabolism of some therapeutics and provides interpretive drug
information regarding the potential effect of citalopram and
clopidogrel therapy. Our SLCO1B1 Pharmacogenetics report provides
certain information about variants associated with the processing
of some therapeutics and provides interpretive drug information
regarding the potential effect of simvastatin therapy. Our DPYD
Pharmacogenetics report does not describe the association between
detected variants and any specific therapeutic. Results for DPYD
and certain CYP2C19 results should be confirmed by an independent
genetic test prescribed by your own healthcare provider before
taking any medical action. Warning: Test
information should not be used to start, stop, or change any course
of treatment and does not test for all possible variants that may
affect metabolism or protein function. The PGS test is not a
substitute for visits to a healthcare professional. Making changes
to your current regimen can lead to harmful side effects or reduced
intended benefits of your medication, therefore consult with your
healthcare professional before taking any medical action. For
important information and limitations regarding Pharmacogenetic
reports, visit 23andme.com/test-info.
Forward-Looking StatementsThis press release
contains forward-looking statements within the meaning of Section
27A of the Securities Act of 1933, as amended, and Section 21E of
the Securities Exchange Act of 1934, as amended, including, without
limitation, statements regarding the future performance of
23andMe’s businesses in consumer genetics and therapeutics and the
growth and potential of its proprietary research platform. All
statements, other than statements of historical fact, included or
incorporated in this press release, including statements regarding
23andMe’s products, strategy, financial position, funding for
continued operations, cash reserves, projected costs, plans,
potential future collaborations, therapeutics development, database
growth, product development and launches, the successful
commercialization and market acceptance of new products and
objectives of management, are forward-looking statements. The words
"believes," "anticipates," "estimates," "plans," "expects,"
"intends," "may," "could," "should," "potential," "likely,"
"projects," “predicts,” "continue," "will," “schedule,” and "would"
or, in each case, their negative or other variations or comparable
terminology, are intended to identify forward-looking statements,
although not all forward-looking statements contain these
identifying words. These forward-looking statements are predictions
based on 23andMe’s current expectations and projections about
future events and various assumptions. 23andMe cannot guarantee
that it will actually achieve the plans, intentions, or
expectations disclosed in its forward-looking statements and you
should not place undue reliance on 23andMe’s forward-looking
statements. These forward-looking statements involve a number of
risks, uncertainties (many of which are beyond the control of
23andMe), or other assumptions that may cause actual results or
performance to differ materially from those expressed or implied by
these forward-looking statements. The forward-looking statements
contained herein are also subject generally to other risks and
uncertainties that are described from time to time in the Company’s
filings with the Securities and Exchange Commission, including
under Item 1A, “Risk Factors” in the Company’s most recent Annual
Report on Form 10-K, as filed with the Securities and Exchange
Commission, and as revised and updated by our Quarterly Reports on
Form 10-Q and Current Reports on Form 8-K. The statements made
herein are made as of the date of this press release and, except as
may be required by law, 23andMe undertakes no obligation to update
them, whether as a result of new information, developments, or
otherwise.
ContactsInvestor Relations
Contact: investors@23andMe.comMedia
Contact: press@23andMe.com
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