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Medical Disclaimer | Pharmacogenetic Testing USA
Policy page

Medical, Genetic and Pharmacogenetic Testing Disclaimer

This medical disclaimer explains the clinical, scientific, medication, sample, privacy and reporting limitations that apply when you use PharmacogeneticTesting.us, order a test, submit a sample, contact support or review a report.

Read this page together with our Testing Consent, Privacy Policy, Terms of Service, product instructions and laboratory documents.

Contact Support Doctor Discussion Guide
Last updated: June 23, 2026 United States
Medication limits A result does not prescribe a medication or dose by itself.
Evidence limits Not every gene-drug association has equal evidence or actionability.
Laboratory limits Certification and analytical quality do not guarantee clinical usefulness.
Privacy limits HIPAA and genetic-discrimination protections have defined scopes.
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Not for emergencies, overdose or urgent medication decisions

PharmacogeneticTesting.us, its forms, email addresses and customer-support channels are not emergency medical services. For a severe medication reaction, overdose, poisoning, difficulty breathing, loss of consciousness, rapidly worsening symptoms or another emergency, call 911 or contact an appropriate emergency or poison service immediately. Do not wait for a test result or support response.

Disclaimer guide

Find the section relevant to your test

Pharmacogenetic, genetic-risk, epigenetic, metabolism and microbiome reports answer different questions. These sections keep their purposes and limitations separate.

01

General scope

Intended use, medical relationship, FDA status, CLIA and product differences.

View sections → 02

PGx interpretation

Gene-drug evidence, metabolizer status, interactions and phenotype limitations.

View sections → 03

Medications and genes

Psychiatry, pain, cardiology, oncology and individual-gene limitations.

View sections → 04

Wellness and microbiome

Methylation, longevity, risk, caffeine, alcohol and gut-report limitations.

View sections → 05

Samples and privacy

Consent, minors, sample identity, HIPAA, GINA and employer-use limits.

View sections → 06

Service and policies

Turnaround, insurance, locations, comparisons, marketing and state rules.

View sections →
About the service

General scope and intended use

These provisions explain what this disclaimer covers and what the website, kits, laboratory reports and support services are—and are not—intended to provide.

01

Scope of this disclaimer

This disclaimer applies to:

  • PharmacogeneticTesting.us and its website content;
  • pharmacogenetic testing products;
  • medication-response and individual gene pages;
  • genetic predisposition, methylation, longevity and metabolism tests;
  • microbiome and stool-testing content and services;
  • at-home kits, sample collection, laboratory analysis and reports;
  • sample reports, comparison pages, articles and professional resources;
  • emails, forms and customer-support communications; and
  • third-party laboratory, courier, software and payment services.

“PharmacogeneticTesting.us,” “Company,” “we,” “us” and “our” refer to the operator identified in the Terms of Service.

02

Informational and decision-support purpose

Unless expressly stated in product-specific documentation, testing and website content are intended to provide information that may support education, discussion, screening or wellness planning.

They do not independently:

  • diagnose a medical or psychiatric condition;
  • prescribe, select or approve a medication;
  • establish the correct dose;
  • guarantee safety, effectiveness or absence of side effects;
  • replace physical examination or diagnostic testing; or
  • replace individualized care from a qualified professional.
03

No healthcare-professional relationship

Using the website, ordering a kit, submitting a sample, contacting support or receiving a report does not by itself create a physician-patient, pharmacist-patient, genetic-counselor or other regulated healthcare relationship.

Support staff cannot diagnose, prescribe, adjust medication or provide emergency care. Clinically important results should be reviewed with a prescriber or pharmacist.

05

FDA status must be stated accurately

A gene-drug association, drug-label biomarker or inclusion in an FDA table does not automatically mean that the FDA recommends testing before every prescription.

Do not describe a product as FDA approved, cleared, authorized or a companion diagnostic unless that status applies to the specific test, intended use and current authorization.

06

CLIA certification and laboratory quality

CLIA establishes federal quality standards for laboratories reporting patient-specific test results. CLIA certification does not by itself establish that every clinical claim, interpretation or treatment recommendation is FDA reviewed or clinically useful.

Review the current Lab Quality page for the laboratory, certificate, method and scope applicable to the selected product.

07

Professional review remains necessary

A report is most useful when reviewed with a professional who knows your diagnoses, symptoms, medication history, doses, allergies, organ function, pregnancy status and treatment goals.

Use the doctor discussion guide and PGx checklist to prepare.

08

Provider resources do not individualize care

Content for healthcare providers and pharmacists is educational and does not establish the standard of care for an individual patient.

The treating professional remains responsible for verifying the report, reviewing current evidence and making a clinically appropriate decision.

Pharmacogenetic reports

Medication-response and report limitations

Pharmacogenetic testing examines selected inherited variants that may influence medication metabolism or response. Genetics is one component of medication management.

09

Only tested genes and variants are reported

A result applies only to the genes, alleles, copy-number changes and variants included in the selected assay.

A normal or typical result does not rule out an untested variant, rare allele, structural change or non-genetic cause of an unusual medication response.

10

Not every gene-drug pair is actionable

Evidence strength and clinical actionability vary. Some findings have established prescribing guidance, while others are emerging, limited, population-specific or informational only.

A report category, colour or ranking does not automatically mean that a medication must be selected, avoided or dose-adjusted.

11

CPIC guidance explains how to use existing results

CPIC guidelines are generally designed to help clinicians use an available genotype when prescribing. They do not necessarily recommend whether a patient should be tested.

Guideline availability does not remove the need to consider diagnosis, alternatives, monitoring, drug labelling and professional judgment.

12

Metabolizer status is a predicted phenotype

Labels such as poor, intermediate, normal, rapid or ultrarapid metabolizer are predictions based on tested variants and current translation rules.

They do not directly measure current enzyme activity or guarantee a particular blood concentration, effectiveness or side effect.

13

Phenoconversion can change actual drug processing

Another medication, smoking, diet, inflammation, illness or other factors may inhibit or induce an enzyme and cause actual medication processing to differ from the genetically predicted phenotype.

14

Drug-drug and drug-gene interactions

A genetic report may not account for every prescription, non-prescription medicine, supplement, substance or interaction. A prescriber or pharmacist should review the complete and current medication list.

15

Non-genetic clinical factors

Medication response can be affected by age, body size, diagnosis, adherence, formulation, dose, timing, pregnancy, liver and kidney function, diet and other conditions.

A pharmacogenetic report does not measure or replace evaluation of these factors.

16

Population and ancestry limitations

Allele frequencies and evidence may differ across populations. A panel developed primarily from one ancestry group may have reduced coverage or uncertainty for another.

Ancestry should not be used as a substitute for testing, but assay coverage should be considered when interpreting a negative or uncertain result.

17

Pharmacogenetics and pharmacogenomics

These terms are sometimes used differently or interchangeably. Product scope—not the label alone—determines which genes, medications and interpretations are included.

18

Results do not prove medication allergy

Pharmacogenetic testing and drug-allergy testing answer different questions. A PGx report generally does not diagnose or rule out an immune-mediated drug allergy.

19

Interpretation can change over time

Your inherited DNA is generally stable, but evidence, allele definitions, translation rules, medication labels, guidelines and report software can change.

A previous report may require updated interpretation when a new medication is considered.

20

No guarantee of successful treatment

PGx testing may add useful information, but it does not guarantee that trial and error will be eliminated, adverse effects will be prevented, a medication will work, or a particular dose will be safe.

21

Review the complete report—not only the headline category

Interpret the gene, diplotype, predicted phenotype, medication, evidence level, limitations, assay coverage and clinical notes together.

Use the PGx results guide, genes overview and sample reports before relying on a report format.

Medication and gene-specific limits

Clinical-use limitations by medication area and gene

Gene results can have different meanings for different drugs. A recommendation from one gene-drug pair must not be transferred to another without appropriate evidence.

23

ADHD medication limitations

A PGx test for ADHD medications does not diagnose ADHD or determine whether medication is appropriate.

Response to stimulants and non-stimulants depends on clinical and environmental factors that may not be captured by the tested variants.

24

Pain medication and opioid limitations

A pain medication PGx report does not measure pain, diagnose its cause, guarantee relief or determine misuse risk.

Never increase, decrease, combine, stop or replace an opioid or another pain medicine solely because of a genetic report.

25

Cardiology and blood-thinner limitations

A result does not diagnose cardiovascular disease or replace blood pressure, laboratory monitoring, imaging, INR testing or urgent assessment.

Do not stop an anticoagulant, antiplatelet, statin or heart medication without the prescriber. See cardiology medications and blood thinners.

26

Clopidogrel and CYP2C19

CYP2C19 results may influence clopidogrel prescribing in certain clinical settings, but the implications depend on indication, procedure, alternatives, bleeding risk and current guidance.

Do not stop or replace clopidogrel without the treating clinician. Review clopidogrel testing and CYP2C19.

27

Warfarin, CYP2C9 and VKORC1

Genetic information may contribute to warfarin dose estimation, but it does not replace INR monitoring, bleeding assessment, diet review, interactions or dose adjustment.

Review CYP2C9 and VKORC1.

28

Statins and SLCO1B1

An SLCO1B1 result may inform risk assessment or statin selection in supported settings, but it does not diagnose muscle injury or guarantee that symptoms are statin-related.

Review statin testing and SLCO1B1.

29

Proton-pump inhibitors and CYP2C19

CYP2C19 can affect selected proton-pump inhibitors, but the clinical recommendation depends on the specific drug, indication, treatment duration and patient factors.

Review the PPI pharmacogenetic guide.

30

CYP2D6 technical limitations

CYP2D6 analysis can be complex because copy-number changes, hybrid alleles and rare variants may affect interpretation.

Confirm the assay’s structural-variant and allele coverage before a high-stakes decision. Review CYP2D6 testing.

31

HLA-B testing limitations

Selected HLA-B variants may be associated with serious medication hypersensitivity, but the relevant allele, ancestry, medication and current label or guideline must be considered together.

HLA testing does not rule out every allergic or adverse reaction. Review HLA-B testing.

32

TPMT and NUDT15 limitations

TPMT and NUDT15 results may support thiopurine dosing decisions, but they do not replace blood-count monitoring, liver testing or assessment of infection and toxicity.

Review TPMT and NUDT15.

33

DPYD and UGT1A1 oncology limitations

DPYD and UGT1A1 findings can be clinically important for selected cancer medicines, but oncology decisions require an oncology team, current guidance, regimen-specific information and close monitoring.

A consumer report must not be used to start, withhold or alter cancer treatment. Review oncology support, DPYD and UGT1A1.

34

CYP3A5 and CYP2B6 limitations

CYP3A5 and CYP2B6 associations are drug-specific. A phenotype or allele result should not be applied to medications outside the supported evidence and report scope.

Review CYP3A5 and CYP2B6.

35

G6PD and IFNL3 limitations

G6PD-related results and IFNL3 findings have distinct clinical contexts. They are not general medication-response scores and must be interpreted for the relevant condition, ancestry, assay and treatment.

Review G6PD and IFNL3.

36

Pediatric testing limitations

A child’s medication response can differ from an adult’s because of development, dose, formulation, organ maturation and condition-specific evidence.

Testing a minor requires appropriate authorization and clinical oversight. Review pediatric pharmacogenetic testing.

37

Seniors and polypharmacy

PGx may be one part of medication review for older adults, but it does not replace reconciliation, deprescribing assessment, organ-function review, adherence evaluation or interaction checking.

Review PGx for seniors and polypharmacy guidance.

Other testing services

Wellness, risk, metabolism and microbiome limitations

These reports are not substitutes for medication-response testing, diagnosis, medical screening programs or individualized prevention advice.

38

DNA methylation test limitations

A product in the epigenetic health category measures selected methylation-related markers using the chosen method and reference data.

It does not measure every epigenetic change, diagnose disease, prove biological damage or establish that a lifestyle factor caused the result.

39

Longevity and healthy-aging limitations

A product in the healthy aging category provides selected DNA-based wellness insights.

A longevity result does not predict an exact lifespan, guarantee healthy aging, diagnose disease or prove that a supplement or lifestyle program will extend life.

40

Genetic predisposition screening limitations

A product in the genetic risk screening category reports selected variants associated with certain conditions or traits.

Increased genetic risk is not a diagnosis, and a negative result does not mean that a condition cannot develop. Environment, family history, age and other genes also matter.

41

KnowYourSelf and broad DNA-package limitations

A broad foundational report may combine pharmacogenetics, predisposition, inherited conditions, wellness or traits. Each section may have a different evidence level and purpose.

Confirm that the gene, medication or condition relevant to your question is included in the selected foundational DNA test.

42

Caffeine metabolism limitations

A caffeine report may describe selected genetic factors associated with caffeine metabolism or response.

It does not establish a universally safe amount or replace advice relating to pregnancy, heart conditions, anxiety, sleep, medication interactions or another health risk.

43

Alcohol metabolism limitations

An alcohol metabolism report may describe selected variants associated with alcohol processing or sensitivity.

It does not establish a safe amount to drink, predict impairment, prevent alcohol-related harm or provide permission to consume alcohol. It must not be used to encourage alcohol use.

44

Metabolism reports are not prescriptions

A product in the metabolism test category provides focused information about the markers listed for that product.

It does not measure total metabolism, nutritional status, liver function or every factor affecting response to food, caffeine, alcohol or supplements.

45

Microbiome testing is separate from inherited DNA testing

A microbiome test analyzes microorganisms or microbial markers in a stool or other sample. It does not analyze inherited human DNA in the same way as pharmacogenetic testing.

Review the dedicated microbiome testing limitations.

46

A microbiome report is a snapshot

Results may be affected by diet, medications, antibiotics, supplements, illness, sample timing, collection, storage, shipping, laboratory method and reference database.

Results can change over time and may differ between providers.

47

Microbiome reports do not diagnose digestive disease

A consumer microbiome result does not independently diagnose IBS, SIBO, infection, inflammatory bowel disease, food intolerance, cancer or the cause of bloating.

See the educational pages for IBS, bloating and gut health.

48

Probiotic and diet recommendations

Microbiome associations do not prove that a probiotic, supplement or diet will be safe or effective for an individual.

Do not make a restrictive diet or treatment change solely from a consumer report. Review probiotic information and diet guidance.

49

Microbiome testing for children

Testing a child requires appropriate authorization and additional caution when interpreting development, diet and age-related reference data.

Review microbiome testing for kids.

50

Oral microbiome limitations

An oral microbiome report is not a dental examination and does not diagnose cavities, gum disease, oral cancer or systemic disease.

51

Do not use wellness or microbiome reports as stand-alone care plans

Do not start or stop supplements, restrictive diets, screening programs or medical treatment solely because of a methylation, longevity, predisposition, metabolism or microbiome report.

Discuss clinically important findings with an appropriate healthcare professional.

Samples, consent and privacy

Collection, identity and genetic-data limitations

Genetic testing involves sensitive biological samples and information. Review the consent and data-handling terms before ordering.

52

Sample collection and identity

Follow the instructions supplied with the selected product. Collection may fail or produce an unreliable result because of insufficient material, contamination, incorrect labelling, sample mix-up, degradation, storage or shipping conditions.

Review How It Works and the product instructions.

53

Laboratory and analytical error

No laboratory method is error-free. A result may be false-positive, false-negative, incomplete, inconclusive, unavailable or affected by technical, clerical or human error.

Recollection or confirmatory testing may be requested.

54

Informed consent

The person tested—or a legally authorized representative—must understand the test’s purpose, limitations, possible findings, data uses and available choices.

Review the current Testing Consent before collection.

55

Minors and people unable to consent

Testing a minor or person unable to provide valid consent may require authorization from a parent, guardian or legally authorized representative and may require clinician involvement.

Consider whether the result is medically appropriate and needed at the present time.

56

Unexpected and familial findings

Genetic testing may reveal unexpected information about inherited risk, ancestry, biological relationships or information relevant to relatives.

The Company does not guarantee that every incidental or secondary finding will be detected, interpreted or reported.

57

HIPAA does not automatically apply to every service

HIPAA applies to covered health plans, clearinghouses and certain healthcare providers, plus their business associates—not automatically to every direct-to-consumer testing company.

Review the service’s actual status and Privacy Policy rather than assuming that all information is protected by HIPAA.

58

Genetic information requires strong safeguards

Review the genetic testing privacy guide for information about collection, storage, security, disclosure, retention, access and deletion.

No electronic system can be represented as completely risk-free.

59

GINA has a defined scope

Federal genetic-discrimination law provides protections in health insurance and employment, but it does not answer every question involving life, disability or long-term-care insurance, military service or other circumstances.

State protections may differ. This website does not provide legal advice.

60

Employer programs require special care

Employers should not request or use individual genetic results except where clearly permitted by applicable law. Participation, consent, confidentiality, access and aggregate reporting require careful review.

The employer page is general information and not legal advice.

61

Third-party disclosure

Before sharing a result with an employer, insurer, school, family member, application, research program or online service, consider the recipient’s privacy practices and the consequences of disclosure.

62

Research and secondary use

Research, product-development, quality-improvement or secondary use of samples or data must be governed by the applicable consent, privacy policy and law.

Purchasing a test should not be treated as permission for every future use unless the relevant consent clearly provides for it.

63

Do not send unnecessary sensitive information

Do not send complete medical records, government identifiers, unrelated family information or other sensitive material through ordinary email or website forms unless specifically requested through an appropriate secure process.

Service and policies

Ordering, coverage, marketing and website limitations

These provisions explain operational and legal limits involving turnaround estimates, reimbursement, comparisons, locations, support and nationwide availability.

64

Turnaround estimates

Laboratory turnaround generally begins after the correct laboratory receives an acceptable sample and complete information—not at checkout or kit delivery.

Product estimates may differ. Review How It Works and the selected product page.

65

Shipping, loss and delay

Delivery and processing estimates are not guarantees unless expressly stated. Courier delays, weather, incorrect addresses, sample quality, recollection, laboratory workload, holidays and events beyond reasonable control may cause delay.

Review Shipping and Returns.

66

Sample reports and examples

A sample report or microbiome sample report illustrates possible structure and content. An individual report may contain different sections, findings and limitations.

67

Insurance and reimbursement

Website statements about insurance, reimbursement, HSA or FSA eligibility are general information and not a guarantee of coverage or payment.

Eligibility depends on the insurer, plan, medical necessity, provider order, documentation, network and current policy. Review Insurance.

68

Pricing and cost information

Prices, promotions, shipping charges and professional-review costs may change. Confirm the final price and included services before checkout.

Review Pricing, PGx test cost and microbiome test cost.

69

State and location pages

A state or city page may describe online availability or local relevance. It does not guarantee a physical clinic, local laboratory, prescriber, pharmacist, appointment, insurance coverage or identical ordering rules.

Review the locations directory, PGx testing near me and microbiome testing near me.

70

Online ordering availability

Availability can depend on the service, shipping destination, laboratory, provider-order model and state requirements.

Nationwide website access does not mean that every product can be ordered or fulfilled identically in every state. Review online PGx testing and online microbiome testing.

71

Comparisons and alternatives

Content in the comparison section is for general consumer information. Third-party methods, prices, features, claims and policies may change.

References to GeneSight, OneOme, Genomind, Viome, Tiny Health or another company do not imply affiliation or endorsement unless expressly disclosed.

72

Research and reference pages

Scientific references support only the propositions for which they are relevant. Publication of a study does not prove that every commercial panel, report category or marketing claim is valid.

Review Research and References.

73

Advertising and performance claims

Statements about reducing trial and error, avoiding side effects, selecting the best medication, improving outcomes, healthy aging, longevity or predictive value must be supported for the exact product and intended use.

This disclaimer does not correct a misleading claim or overall impression elsewhere.

74

Third-party laboratories and providers

Independent laboratories, couriers, payment processors, software providers, clinicians and other contractors may provide parts of the service.

They may have separate methods, terms, privacy practices, licensure, retention procedures and service interruptions.

75

Customer-support limitations

Support may assist with product scope, orders, collection instructions, shipping and report access. It cannot diagnose, prescribe, recommend an individualized medication change or interpret an urgent reaction.

Visit the general FAQ, PGx FAQ, microbiome FAQ or Contact page.

76

Accessibility

Contact support when an accessible format or assistance is needed. Availability may depend on the document, laboratory and reasonable accommodation process.

Review the Accessibility Statement.

77

Relationship with other policies

This disclaimer should be read with:

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

78

Updates to this disclaimer

We may update this page to reflect changes in products, evidence, guidelines, laboratories, privacy practices, legal requirements or business operations.

The revised version becomes effective when published unless a later date is stated.

79

Contact us

Questions about a product, kit, order, sample or report can be submitted through the Contact page.

Support provides administrative and general product assistance only. It does not replace medical care, medication review or emergency services.

Need clarification?

Questions about a test, sample or report?

Support can help with product scope, ordering, collection, shipping and report access. For diagnosis, medication changes, side effects or treatment decisions, contact your doctor, pharmacist or another qualified healthcare professional.

Contact Support Prepare for a Clinical Discussion