23andMe Holding Co. (Nasdaq: ME) (23andMe), a leading human
genetics and biopharmaceutical company, today announced the Company
has received a U.S. Food and Drug Administration (FDA) 510(k)
clearance to expand its existing BRCA1/BRCA2 (Selected Variants)
Genetic Health Risk Report*. The clearance allows 23andMe to report
an additional 41 variants in the BRCA1 and BRCA2 genes known to be
associated with higher risk for breast, ovarian, prostate and
pancreatic cancer. 23andMe received the first FDA authorization for
a direct-to-consumer genetic test for cancer risk in 2018 to report
3 variants in the BRCA1 and BRCA2 genes, primarily found in people
of Ashkenazi Jewish descent. Many of the 41 BRCA variants added
through this clearance are known to have a higher rate of
occurrence in populations traditionally underserved by genetic
testing, including the African American and Hispanic/Latino
communities. This marks the Company’s fourth FDA clearance for
genetic cancer risk.
In addition to the 510(k) clearance, the FDA also granted
23andMe the first-ever Predetermined Change Control Plan (PCCP),
which allows the Company to add additional validated BRCA1 and
BRCA2 variants and associated cancer risk information to its
BRCA1/BRCA2 (Selected Variants) report without additional premarket
review. The PCCP outlined the specific protocols and acceptance
criteria that 23andMe intends to use to clinically and analytically
validate eligible BRCA1/BRCA2 variants. The PCCP is pursuant to the
FDA's "Marketing Submission Recommendations for a Predetermined
Change Control Plan for Artificial Intelligence/Machine Learning
Enabled Device Software Functions” Guidance announced this
spring.
“We continue to be the first and only company with FDA clearance
to provide genetic information on cancer risk directly to
consumers, without a prescription,” said Anne Wojcicki, CEO and
Co-Founder of 23andMe. “This clearance also allows us to increase
the impact and reach of our results for traditionally underserved
populations, a critical long-term goal of the Company. We are proud
to continue pioneering a path for greater access to health
information by becoming the first company to receive PCCP clearance
from the FDA under this novel approach, which will enable us to
increase the pace at which we improve and expand our BRCA
report.”
23andMe will now report on 44 variants in the BRCA1 and BRCA2
genes associated with a significantly higher risk of breast and
ovarian cancer in females, and breast cancer in males. The variants
may also be associated with an increased risk for prostate cancer,
pancreatic cancer, and potentially other cancers. In addition to 3
BRCA variants common among people of Ashkenazi Jewish descent, the
updated 23andMe BRCA report will now include variants accounting
for about 30-40% of cancer-related BRCA variants among people of
African American, non-Ashkenazi European and Hispanic/Latino
descent; as well as variants found of people of East Asian and
South Asian.
New and existing 23andMe Health + Ancestry Service customers who
were genotyped on the Company’s most recent platform will have
access to the expanded BRCA1/BRCA2 (Selected Variants) report once
it is updated. The Company plans/expects to release this report
update by the end of fiscal year 2024. As with select other Genetic
Health Risk reports, customers must specifically opt-in if they
want to receive this information. The report also includes an
education module to ensure customers are fully informed on what
they can learn from this report and how to use the results.
The 23andMe BRCA1/BRCA2 (Selected Variants) Genetic Health Risk
Report utilizes the same informational concepts previously
demonstrated in studies submitted to the FDA for its Genetic Health
Risk reports, which were shown to have 90% or greater overall user
comprehension in a demographically diverse population study.
23andMe also underwent robust analytical validation in order to
meet FDA requirements to add variants to the BRCA1/BRCA2 (Selected
Variants) report. Each variant tested demonstrated >99%
concordance with Sanger sequencing, and each variant tested also
showed >99% reproducibility when tested under different
laboratory conditions.
With this clearance, 23andMe continues to lead consumer access
to genetic information, and remains the only company that is able
to offer carrier, genetic health risk, cancer risk and drug
metabolism and response reports, without a prescription. This
clearance is the eighth pre-market authorization granted by the FDA
to 23andMe covering its multiplexed Personal Genome Service.
BRCA variants indicated in the 510(k)
clearance: The 23andMe Personal Genome Service (PGS)
Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) is
indicated for the reporting of the following 44 variants in the
BRCA1 and BRCA2 genes.
BRCA1: c.68_69del, c.213-11T>G, c.427G>T, c.815_824dup,
c.1556del, c.1687C>T, c.1960A>T, c.1961del, c.2681_2682del,
c.2864C>A, c.3481_3491del, c.3598C>T, c.3627dup,
c.3756_3759del, c.3770_3771del, c.4035del, c.4065_4068del,
c.4327C>T, c.4357+1G>A, c.4964_4982del, c.4986+6T>G,
c.5123C>A, c.5177_5180del, c.5266dup.
BRCA2: c.658_659del, c.771_775del, c.1929del, c.2808_2811del,
c.2957_2958insG, c.3170_3174del, c.3264dup, c.3545_3546del,
c.3847_3848del, c.4471_4474del, c.5542del, c.5576_5579del,
c.5682C>G, c.5946del, c.6037A>T, c.6275_6276del,
c.7024C>T, c.7480C>T, c.7934del, c.8904del.
Warnings and Limitations:The 23andMe PGS 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, including the 23andMe PGS
Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants).
Your ethnicity may affect the relevance of each report and how your
genetic health risk results are interpreted. The test is not
intended to diagnose any disease and does not describe a person’s
overall risk of developing any type of cancer. It 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 treatments. 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.
About 23andMe23andMe is a genetics-led consumer
healthcare and therapeutics company empowering a healthier future.
For more information, please visit investors.23andme.com.
Additional InformationThis press release shall
not constitute an offer to sell or a solicitation of an offer to
buy any of the securities, nor shall there be any sale of these
securities, in any state or jurisdiction in which such an offer,
solicitation or sale would be unlawful prior to registration or
qualification under the securities laws of any such state or
jurisdiction.
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 strategy, financial position, funding for continued
operations, cash reserves, projected costs, plans, potential future
collaborations, 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.
Contacts: Investor Relations Contact:
investors@23andMe.comMedia Contact: press@23andMe.com
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