23andMe Granted New FDA Clearance to Provide Interpretive Drug Information for a Commonly Prescribed Cholesterol Medication
October 27 2022 - 6:45AM
23andMe Holding Co. (Nasdaq: ME) (“23andMe”), a leading human
genetics and biopharmaceutical company with a mission to help
people access, understand, and benefit from the human genome, today
reported that the U.S. Food and Drug Administration (FDA) granted
510(k) clearance for its pharmacogenetics (PGt) report for SLCO1B1
to include interpretive drug information for simvastatin, a common
drug used to treat high cholesterol and triglyceride levels. The
510(k) clearance modifies the labeling of the previously authorized
23andMe SLCO1B1 Drug Transport report, removing the need for
confirmatory testing and allowing the company to provide
interpretive drug information based on genetic factors for
simvastatin.
“This is an important win for consumers, as they will have
access to critical information on how they may respond to a
commonly prescribed medication, based on their genetics,” said
Noura Abul-Husn, M.D. Ph.D., Vice President of Genomic Health at
23andMe. “A complete health picture requires a number of inputs,
including genetics, which too often are left off the table in
healthcare. With this clearance we are continuing to champion
access to actionable health information so that everyone can
benefit from a personalized health care experience, and avoid
negative side effects of medications where possible.”
Simvastatin is a medication in the statin family of drugs,
commonly prescribed to lower cholesterol to help reduce the risk of
heart attack and stroke. In 2020, simvastatin was the second-most
commonly prescribed statin, and the thirteenth-most commonly
prescribed medication overall, in the U.S.* A variation of a
particular gene, SLCO1B1, influences the body’s response to
simvastatin. In certain ethnicities, up to 38% of people have a
SLCO1B1 genotype that increases the possibility of experiencing
side effects related to taking simvastatin, particularly
statin-associated musculoskeletal symptoms (SAMS) risk**.
23andMe underwent rigorous analytical validation in order to
meet FDA requirements to remove the need for confirmatory testing
of the 23andMe pharmacogenetics report for SLCO1B1. This included
method comparison studies with expanded sample collection
activities in order to further mitigate the risk for false positive
and false negative results. Accuracy testing achieved 99%
concordance with Sanger sequencing.
As with its previously authorized pharmacogenetics reports, both
23andMe and the FDA also want to ensure that consumers understand
these reports and use them properly, which includes adhering to
their current medications and consulting with their healthcare
providers. Based on 23andMe's previous consumer comprehension
studies, over 95 percent of users understood that they should not
use the report to make any changes to treatment without consulting
their doctor.
About 23andMe23andMe is a genetics-led consumer
healthcare and therapeutics company empowering a healthier future.
For more information, please visit investors.23andme.com.
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, 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.
*Source: https://clincalc.com/DrugStats/ **Source: Sychev DA et
al. (2016). “The frequency of SLCO1B1*5 polymorphism genotypes
among Russian and Sakha (Yakutia) patients with
hypercholesterolemia.” Pharmgenomics Pers Med. 9:59-63.
Contacts: Investor Relations Contact:
investors@23andMe.comMedia Contact: press@23andMe.com
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