Medical Disclaimer for Methylation and Genetic Testing

1 Scope and definitions

Please read this Medical Disclaimer before using Methylation.us, purchasing a test, submitting a sample, reviewing a report, following a website recommendation, or communicating with customer support.

This disclaimer applies to website content, product descriptions, articles, comparison pages, emails, calls, forms, support communications, sample reports, downloadable materials, test kits, laboratory processing, genetic reports, epigenetic reports, biological-age estimates, and related wellness information.

It includes products and information presented through the Methylation Testing category, including DNA Methylation Tests, Biological Age Tests, Folate and Homocysteine Tests, Nutrient Metabolism Tests, Healthy Aging Tests, and Weight and Lifestyle Tests.

“Company,” “we,” “us,” and “our” refer to the legal entity identified in the Terms of Service as the operator of Methylation.us. “Services” includes the website, test kits, laboratory testing, reports, educational content, and administrative support.

Product-specific instructions, consent forms, laboratory requirements, shipping rules, refund terms, and the Terms of Service may also apply. This Medical Disclaimer does not replace a required consent document or product-specific instruction.

2 Educational and wellness purposes only

Unless a particular service is expressly identified in writing as a regulated diagnostic service, the website, consumer tests, and reports are provided for general educational, informational, and wellness purposes.

They are not intended to:

• Diagnose, confirm, screen for, or rule out a disease or medical condition.
• Determine the cause of a symptom.
• Replace a medical history, physical examination, clinical laboratory test, imaging study, or other professional assessment.
• Recommend a particular medication, supplement, vitamin, diet, exercise plan, or treatment.
• Predict a medical outcome, biological age, rate of aging, or lifespan with certainty.
• Monitor the progression or treatment of disease.
• Treat, cure, or prevent disease.
• Replace advice from a physician, pharmacist, genetic counselor, registered dietitian, or other qualified professional.

Do not interpret the presence or absence of a reported genetic variant, methylation marker, score, or pathway observation as proof that you have, will develop, cannot develop, or have recovered from a medical condition.

3 Different products use different testing methods

The words “methylation test,” “DNA methylation test,” “genetic methylation test,” “MTHFR test,” and “biological age test” may describe different forms of analysis. They must not be treated as interchangeable.

Some products evaluate inherited genetic variants. Other products may evaluate selected epigenetic methylation markers in a submitted sample. Some reports may combine laboratory results with algorithms, databases, scientific literature, questionnaires, or general wellness interpretation.

Review the product page, sample type, method, included markers, report description, and product-specific limitations before ordering. General explanations are available through Tests, How It Works, What Is Methylation?, and What Is DNA Methylation?.

4 No diagnosis, medical screening, or exclusion of disease

Consumer methylation and wellness reports must not be used to diagnose or exclude conditions involving cardiovascular health, blood clotting, cancer, neurological health, mental health, fertility, pregnancy, metabolism, autoimmune disease, nutrient deficiency, gastrointestinal health, allergy, intolerance, or any other medical concern.

A normal-looking, favorable, or low-risk result does not prove that you are healthy. An unusual, unfavorable, or high-priority result does not establish that a disease or deficiency exists.

A result should never be used as the sole reason to delay medical evaluation, stop screening, reject a clinician’s advice, or assume that symptoms are explained by genetics or methylation.

5 No healthcare provider-patient relationship

Unless expressly stated for a separately identified professional service, Methylation.us is not acting as your physician, nurse, pharmacist, genetic counselor, psychologist, registered dietitian, clinic, hospital, or other regulated healthcare provider.

Using the website, placing an order, submitting an inquiry, speaking with support, receiving a kit, or receiving a report does not create a physician-patient, clinician-patient, therapist-client, fiduciary, or other professional healthcare relationship.

Support personnel may explain administrative matters such as ordering, shipping, sample return, report access, or the general layout of a report. They are not authorized to diagnose symptoms, prescribe treatment, determine supplement dosing, or provide individualized medical advice.

Material available through Clinicians or For Patients does not make Methylation.us the treating provider. An independent professional remains responsible for their own assessment and professional judgment.

6 Limitations of inherited genetic-variant reports

A genetic-variant report generally evaluates selected inherited DNA differences associated with particular genes, pathways, or traits. Your inherited DNA is only one part of a much larger health picture.

A genetic-variant report does not directly measure:

• Your current DNA methylation activity or current gene expression.
• Whether a gene is currently “on,” “off,” underactive, or overactive in a particular tissue.
• Your present folate, B12, vitamin D, iron, zinc, homocysteine, hormone, neurotransmitter, inflammation, or oxidative-stress levels.
• Your current liver, kidney, brain, cardiovascular, immune, or digestive function.
• Whether a medical condition is present.
• How you will personally respond to a medication, supplement, diet, or treatment.

Age, environment, diet, medication, medical history, family history, laboratory findings, lifestyle, other genes, and non-genetic factors may influence health and may outweigh or modify the effect associated with a reported variant.

An association between a variant and a pathway, trait, symptom, or condition does not prove causation.

7 Limitations of epigenetic and DNA methylation reports

When a product evaluates selected DNA methylation markers, the result reflects the submitted sample, tested locations, analytical platform, algorithms, databases, and interpretation method used by the laboratory or report provider.

Methylation patterns can differ among tissues and cell types. A result obtained from one sample type may not represent every organ, tissue, pathway, or biological process in the body.

An epigenetic methylation result does not necessarily establish:

• Your overall health or the cause of a symptom.
• Your exact rate of aging throughout the body.
• The presence, absence, severity, or prognosis of a disease.
• That a particular diet, supplement, medication, or lifestyle factor caused the result.
• That changing a result will improve health or prevent disease.

Results obtained from different laboratories, sample types, platforms, marker sets, reference populations, or algorithms may not be directly comparable.

8 Biological age, longevity, and healthy-aging limitations

A biological-age or healthy-aging result is an estimate generated from the data and method used by the relevant product. It is not your legal age, a clinical diagnosis, a guaranteed measure of health, or a prediction of how long you will live.

A biological-age estimate may vary because of sample type, sample quality, laboratory method, algorithm, reference population, technical variation, recent health or lifestyle factors, and ordinary biological variation.

A lower estimated biological age does not prove that you are free of disease. A higher estimate does not prove that you have a disease or that your health will worsen.

A longevity or healthy-aging report cannot guarantee that a person will live longer, avoid disease, reverse aging, or obtain a particular outcome by following a recommendation.

9 Folate, homocysteine, B12, vitamin D, zinc, and iron limitations

A gene-based folate, homocysteine, vitamin D, zinc, iron, or other nutrient-metabolism report evaluates inherited information associated with selected pathways. It does not directly measure current blood, tissue, or nutrient status.

A report cannot by itself confirm that you have a folate, B12, vitamin D, zinc, iron, or other deficiency. It also cannot confirm that homocysteine is high, normal, or low.

Current status may require appropriately selected clinical laboratory testing and professional interpretation. A person can have a reported variant without having an abnormal nutrient level, and can have a deficiency or abnormal laboratory value without the variant evaluated by a consumer test.

10 MTHFR and other gene-specific results

A reported MTHFR, COMT, MTR, MTRR, CBS, BHMT, PEMT, SHMT1, AHCY, MAOA, SUOX, DAO, or other variant is not a diagnosis and does not explain a person’s health by itself.

One gene or variant rarely determines a complex symptom, nutrient response, behavior, mood, detoxification capacity, histamine response, or disease outcome on its own.

Gene effects may be small, uncertain, population-dependent, modified by other genes, or not clinically actionable.

Learn about the general educational context of an MTHFR gene result, but do not use that information as a substitute for clinical evaluation or personalized medical advice.

11 Diet, healthy weight, and lifestyle report limitations

A diet, weight, or lifestyle genetics report may discuss selected inherited associations. It does not measure your complete metabolism, caloric needs, body composition, eating behavior, fitness, or current nutritional health.

It cannot guarantee weight loss, weight gain, improved fitness, better sleep, increased energy, improved performance, or another lifestyle result.

Do not begin an extreme diet, prolonged fasting program, elimination diet, excessive exercise routine, or other substantial lifestyle intervention based solely on a report.

Weight and metabolic health can be affected by many medical, psychological, social, environmental, and lifestyle factors that are not measured by a consumer genetic test.

12 Intolerance, sensitivity, and supplement-reaction topics

Website content may discuss histamine intolerance, folate intolerance, methylfolate side effects, methyl-B12 sensitivity, caffeine sensitivity, alcohol intolerance, lactose genetics, gluten sensitivity, or food sensitivity for general educational purposes.

Genetic information alone cannot diagnose an allergy, food intolerance, celiac disease, histamine-related condition, adverse drug reaction, nutrient deficiency, or supplement intolerance.

Similar symptoms may have many different causes. Appropriate assessment may require a medical history, physical examination, supervised elimination and reintroduction, allergy testing, clinical laboratory testing, or another professional evaluation.

The Intolerances library is educational and must not be used to self-diagnose or replace professional care.

13 “Undermethylation” and “overmethylation” terminology

Website content may use terms such as “low methylation,” “undermethylation,” “high methylation,” “overmethylation,” “methylation support,” or “methylation optimization” as educational shorthand.

These terms must not be interpreted as a diagnosis, a standardized whole-body clinical measurement, or proof that all methylation activity in the body is globally too low or too high.

Methylation is tissue-specific, location-specific, and biologically complex. A consumer report or symptom list cannot reduce that complexity to a single universal state.

14 Sample collection, identity, and handling limitations

The completeness and reliability of testing may be affected by:

• Incorrect, incomplete, insufficient, or contaminated collection.
• Collection from the wrong person or use of incorrect identifying information.
• Failure to follow the kit or laboratory instructions.
• Sample degradation, leakage, damage, shipping delay, or unsuitable storage conditions.
• Medication, food, drink, oral products, recent illness, or other factors relevant to the sample method.
• Use of an expired, damaged, or incorrect collection kit.

Follow the product-specific instructions and review Sample Collection Support before collecting your sample.

The Company or laboratory may reject a sample, request recollection, or produce an incomplete, inconclusive, unexpected, or unavailable result where requirements are not met.

15 Laboratory, database, and reporting limitations

All genetic and epigenetic testing has limitations. Results may be affected by:

• Extraction, amplification, genotyping, sequencing, array, or other processing limitations.
• The genes, variants, CpG sites, methylation markers, or genomic locations included or excluded.
• Analytical sensitivity, specificity, detection thresholds, and quality-control rules.
• Reference sequences, reference populations, databases, scientific literature, software, and algorithms.
• The sample type and the mixture of cells present in that sample.
• Incomplete, conflicting, or evolving scientific evidence.
• Technical, computational, clerical, labeling, or human error.

A result may be false-positive, false-negative, incomplete, inconclusive, unexpected, or unavailable. The absence of a reported variant or marker does not eliminate medical risk. The presence of a variant or marker does not prove that a condition exists or will occur.

Reports from different companies may differ because they test different markers, use different databases, apply different algorithms, or interpret evidence differently.

16 Scientific knowledge and interpretation may change

Genetics, epigenetics, methylation, nutrition, healthy aging, and biological-age research continue to develop.

A classification, association, score, recommendation, or interpretation considered reasonable when a report is issued may later change because of new research, updated databases, revised algorithms, different reference populations, improved methods, professional guidance, or regulatory developments.

Unless expressly included in the purchased service or required by law, the Company is not obligated to continuously reinterpret, update, or reissue a previously delivered report.

17 Clinically confirm medically important information

Do not use a consumer wellness report as the sole basis for a diagnosis, medical decision, screening decision, or treatment change.

A qualified healthcare professional may recommend a detailed medical and family history, physical examination, blood work, nutrient testing, homocysteine testing, clinically validated genetic testing, confirmatory analysis through another method, genetic counseling, or referral to another professional.

A healthcare professional may reasonably disagree with an interpretation, suggestion, score, or priority presented in a consumer report.

Review How to Read Your Report for general report-navigation help, not individualized medical interpretation.

18 Medication, supplements, nutrition, and exercise

Do not start, stop, replace, increase, or decrease a prescription medication, nonprescription medication, vitamin, mineral, herb, methyl donor, methylfolate, folinic acid, B12 product, iron product, zinc product, vitamin D product, probiotic, or other treatment based solely on website content or a report.

Do not make substantial changes to diet, fasting, exercise, pregnancy care, or a treatment plan without appropriate professional advice.

Supplements can cause side effects, interact with medications, affect laboratory tests, be unsuitable during pregnancy or breastfeeding, be inappropriate for children, worsen certain conditions, or be harmful in excessive amounts.

The Company does not guarantee that a supplement, diet, exercise plan, or other wellness action will be safe, suitable, or effective for you.

19 Pregnancy, fertility, and serious health decisions

Do not use a consumer methylation or wellness report as the sole basis for decisions involving:

• Pregnancy, prenatal care, fertility treatment, or contraception.
• Blood clotting, anticoagulation, or cardiovascular risk.
• Cancer screening, diagnosis, or treatment.
• Neurological, psychiatric, or mental-health care.
• Surgery, prescription medication, or emergency treatment.
• Care of a child, dependent person, or person who may lack decision-making capacity.
• Any urgent, serious, or potentially life-changing medical matter.

These matters require individualized review by an appropriately qualified healthcare professional.

20 Symptoms, health concerns, and urgent care

Website content may discuss fatigue, mood, concentration, digestion, histamine-related symptoms, sleep, energy, nutrient concerns, or other health topics for general educational purposes.

Similar symptoms can have many causes. Genetic or epigenetic information alone cannot determine why a symptom is occurring.

Do not delay, avoid, or discontinue professional medical assessment because of website content, a support communication, a normal-looking report, or the absence of a reported variant.

This website and its support channels are not monitored or designed for emergencies. Call 911 or seek immediate professional help for an emergency or rapidly worsening condition.

21 Consent, identity, and authority to submit a sample

You must not submit a biological sample, genetic information, or personal information belonging to another person unless you have lawful authority and all consent required by applicable law and laboratory policy.

By submitting or arranging submission of a sample, the responsible person represents that:

• The sample was obtained lawfully and with all required informed consent.
• The sample-provider identity and information supplied with the order are accurate.
• The person placing the order has authority to act.
• The sample provider understands the general purpose for which the sample will be used.
• The sample was not obtained secretly, deceptively, or without authorization.

The Company may refuse, suspend, or cancel testing when consent, identity, authority, sample integrity, or lawful collection is uncertain.

22 Testing minors and dependent persons

A parent, guardian, or other representative must not order testing for a minor or dependent person unless that representative has legal authority to provide consent and the test is permitted by applicable law, product eligibility rules, and laboratory policy.

The Company may request evidence of identity, guardianship, parental responsibility, or other authority. Testing may be declined when capacity, consent, authority, product suitability, or the interests of the person being tested are uncertain.

A consumer wellness test should not be used to label a child with a medical, behavioral, psychiatric, nutritional, or developmental condition.

23 Unexpected, uncertain, and family-related information

Genetic and epigenetic testing may produce information that is unexpected, uncertain, confusing, or emotionally difficult.

Genetic results may also have implications for biological relatives because family members can share inherited characteristics.

A result may raise questions about family history, inherited traits, health associations, ancestry, or biological relationships. The Company cannot predict how an individual or family will react to this information.

Consider speaking with a qualified genetic counselor or healthcare professional when a result may have significant personal, family, reproductive, or medical implications.

24 Not intended for legal, forensic, or official use

Unless a service is expressly sold and documented for a specific official purpose, consumer methylation and wellness testing is not intended for:

• Court proceedings, criminal investigations, or forensic identification.
• Immigration, custody, child-support, or inheritance matters.
• Proof of identity or biological relationship.
• Employment, insurance, disability, or government eligibility decisions.
• Official medical diagnosis or another regulated clinical purpose.

The Company does not represent that a consumer report will be accepted by a court, insurer, employer, government agency, healthcare institution, or other third party.

25 No guarantee of benefit, suitability, or outcome

The Company does not guarantee that:

• A sample will produce a complete, accurate, or conclusive result in every case.
• A report will explain symptoms or identify a clinically significant issue.
• A healthcare professional will agree with the report.
• A result will lead to diagnosis, prevention, or effective treatment.
• Following a report suggestion will improve health, energy, weight, mood, sleep, performance, biological age, or longevity.
• A customer will avoid, prevent, reverse, or delay disease or aging.
• A report will meet every personal expectation.
• A kit, sample, or result will arrive by a particular date.

Turnaround times are estimates unless expressly guaranteed in writing. Postal, courier, sample-quality, laboratory, technical, customs, and other issues may cause delays.

26 Sample reports, articles, comparisons, testimonials, and illustrations

A sample report illustrates possible structure and presentation. It may not show every section, limitation, finding, outcome, or recommendation that appears in an individual report.

Articles, gene pages, intolerance pages, solution pages, symptom pages, comparisons, and blog posts are educational content and are not individualized medical advice.

Testimonials, reviews, examples, and case studies describe individual experiences, may not be typical, are not clinical evidence, and do not guarantee a similar result.

Images, pathway diagrams, charts, labels, and illustrations may be simplified and may not represent the exact kit, laboratory process, biological mechanism, or individual result.

27 Third-party laboratories and service providers

The Company may use independent laboratories, couriers, payment processors, hosting providers, report platforms, software providers, and other contractors to provide parts of the Services.

Third parties may have their own terms, privacy practices, eligibility requirements, technical limitations, service interruptions, sample rules, and turnaround times.

A reference to a laboratory accreditation, certification, standard, validation, or quality status applies only to the laboratory, service, method, and scope for which that status is current and applicable.

Review Lab Quality and Privacy for general information, and rely on the applicable product and laboratory documents for specific claims.

28 Privacy, genetic information, and sample data

Biological samples, genetic information, epigenetic information, reports, account details, health-related communications, and order information may be sensitive.

The Privacy Policy and any applicable consent or laboratory privacy document govern collection, use, disclosure, storage, access, retention, transfer, and deletion practices.

This Medical Disclaimer does not replace the Privacy Policy or a product-specific consent document.

Do not send medical records, photographs, identification documents, or other sensitive information through an ordinary contact form unless requested through an approved process.

29 Applicable documents, updates, and contact

Your purchase and use of the Services may also be governed by:

• Terms of Service
• Privacy Policy
• Product descriptions and eligibility requirements.
• Sample-collection and return instructions.
• Consent forms and laboratory requirements.
• Shipping, cancellation, return, and refund terms.

If documents conflict, the document specifically governing the relevant product, laboratory process, consent, or transaction may control to the extent permitted by law.

We may update this Medical Disclaimer when products, scientific information, operational practices, or legal requirements change. The date at the top identifies the current version.

Nothing in this disclaimer removes a right, remedy, warranty, duty, or liability that cannot lawfully be excluded or restricted.

For administrative questions concerning an order, kit, sample return, or report access, visit Contact or Support.