SOUTH SAN FRANCISCO, Calif., Nov. 07, 2023 (GLOBE NEWSWIRE) -- 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 services

Exome sequencing

Through 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 testing

While 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 genetics

Total 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+ Premium^TM Membership

As 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 Coverage

Historically, 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 Eligibility

Total 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 Statements

This 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.

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