Medical Disclaimer for At-Home Microbiome Testing

1Scope of this Medical Disclaimer

This Medical Disclaimer applies to website pages, articles, guides, comparison pages, educational materials, product descriptions, checkout information, at-home collection kits, laboratory processing, microbiome analysis, reports, sample reports, follow-up testing, and customer-support communications.

It applies to the Microbiome Tests, Gut Health tests, Follow-Up and Monitoring tests, Oral Health tests, and Vaginal Health tests.

“Company,” “we,” “us,” and “our” refer to the legal entity identified in the Terms of Use as the operator of MicrobiomeTest.us. “Services” includes the website, test kits, sample processing, reports, educational materials, and administrative support.

2Educational and wellness purposes only

Unless a product is expressly identified in writing as a regulated diagnostic service, MicrobiomeTest.us products, reports, and website content are provided for general educational and wellness purposes only.

They are not intended to:

• Diagnose, confirm, screen for, or rule out a disease, infection, or medical condition.
• Determine the cause of symptoms.
• Replace a medical history, physical examination, dental examination, pelvic examination, or clinical laboratory test.
• Recommend a specific medication, antibiotic, antifungal, probiotic, supplement, diet, dental product, vaginal product, or treatment.
• Predict a medical outcome with certainty.
• Monitor the progression or treatment of disease.
• Establish fertility, pregnancy, or reproductive-health status.

A result that appears favorable does not prove that you are healthy. An unusual result does not establish that you have a disease.

3Conditions these tests do not diagnose

A consumer microbiome report must not be interpreted as diagnosing or excluding:

• Irritable bowel syndrome, inflammatory bowel disease, small intestinal bacterial overgrowth, celiac disease, food allergy, food intolerance, or nutrient deficiency.
• Gastrointestinal infection, parasites, bleeding, ulcers, or cancer.
• Tooth decay, gum disease, periodontal disease, oral infection, or oral cancer.
• Bacterial vaginosis, yeast infection, sexually transmitted infection, urinary tract infection, pelvic inflammatory disease, or reproductive disorder.
• Infertility, pregnancy complications, or other gynecological conditions.

Appropriate medical, dental, or laboratory testing may be required to evaluate these conditions.

4No healthcare provider-patient relationship

Using this website, placing an order, submitting a sample, contacting support, or receiving a report does not create a physician-patient, dentist-patient, dietitian-client, therapist-client, fiduciary, or other professional healthcare relationship.

Customer-support personnel may assist with ordering, kit delivery, collection instructions, sample return, account access, and report availability. They are not authorized to diagnose symptoms, prescribe treatment, interpret a result as a clinical diagnosis, or provide individualized medical advice.

Information available through For Practitioners does not make MicrobiomeTest.us the treating healthcare provider.

5What a microbiome test may show

Depending on the product and laboratory method, a report may describe selected microorganisms, microbial groups, diversity measures, relative abundance information, or general wellness observations associated with the submitted sample.

Review our microbiome test results guide and sample report for general information about report presentation.

A microbiome report does not directly measure:

• Your complete state of health or the cause of a symptom.
• The health of every part of the digestive, oral, or reproductive system.
• The absolute number, viability, or biological activity of every microorganism.
• All interactions among microorganisms and your body.
• How you will respond to a medicine, probiotic, supplement, diet, or treatment.
• Whether a condition will develop in the future.

6Gut microbiome and stool-sample limitations

A gut microbiome test analyzes material recovered from the submitted stool sample. It does not provide a complete examination of every part of the gastrointestinal tract.

Stool findings may differ from organisms found in the stomach, small intestine, intestinal lining, or other body sites. A stool microbiome test is not the same as a clinical stool culture, parasite examination, gastrointestinal pathogen panel, colonoscopy, endoscopy, blood test, or other diagnostic investigation.

Do not use a gut result by itself to explain persistent pain, bleeding, diarrhea, constipation, vomiting, unexplained weight changes, fever, or other symptoms.

7Oral microbiome test limitations

An oral microbiome result reflects the submitted oral sample and the conditions at the time and location of collection.

Results may be affected by oral hygiene, eating and drinking, smoking or vaping, dental products, mouthwash, dental work, medication, illness, sample technique, and other factors.

An oral microbiome test does not replace a dental examination, dental X-rays, periodontal measurements, oral cancer screening, examination of an oral lesion, or clinical infection testing.

8Vaginal microbiome test limitations

A vaginal microbiome report reflects the submitted sample at a particular time. Results may be influenced by menstrual timing, sexual activity, pregnancy, menopause, medication, antibiotics, antifungal products, hygiene practices, hormonal products, illness, and other factors.

The report is not a substitute for a pelvic examination, pregnancy care, sexually transmitted infection testing, vaginal culture, urinalysis, cervical screening, or other clinical testing.

Do not use a vaginal microbiome report to self-diagnose or independently treat bacterial vaginosis, yeast infection, a sexually transmitted infection, pelvic inflammatory disease, infertility, or a pregnancy-related concern.

9Follow-up and repeat-testing limitations

A follow-up microbiome test provides another sample-based result. It does not prove that a treatment, supplement, probiotic, diet, or lifestyle intervention was effective or ineffective.

Differences between reports may reflect:

• Natural microbiome variation.
• Different collection conditions.
• Diet, routine, medication, antibiotic, menstrual, or hormonal changes.
• Sample handling and shipping.
• Analytical variation.
• Changes to laboratory methods, databases, software, or reporting rules.

Follow the instructions supplied with each kit and, where reasonably possible, collect repeat samples under similar conditions.

10Sample collection and handling limitations

The reliability and completeness of a result may be affected by:

• Incorrect or incomplete collection.
• Insufficient sample quantity.
• Contamination or mislabeling.
• Damage, leakage, improper sealing, storage temperature, or shipping delay.
• Use of an expired or damaged kit.
• Failure to follow product-specific instructions.
• Collection from the wrong person or body site.

Follow the instructions included with your kit. General guidance is available on How to Collect a Sample and How It Works.

A laboratory may reject a sample, request recollection, or produce an incomplete, inconclusive, or unavailable result.

11Laboratory and analytical limitations

All microbiome testing methods have limitations. Results may be affected by:

• Extraction, amplification, sequencing, and laboratory controls.
• Detection thresholds and the organisms or markers included in the analysis.
• The analytical platform, bioinformatics software, and classification rules.
• Reference databases and reference populations.
• The quality of available scientific evidence.
• Technical, computational, clerical, or human error.

Not every microorganism can necessarily be detected, identified, or reported. Closely related organisms may be difficult to distinguish.

When a report uses relative abundance, a higher percentage does not necessarily mean that the absolute amount of that microorganism increased.

Learn more through Microbiome Testing Limitations, Science, and Microbiome Sequencing Technology.

12The microbiome changes over time

The human microbiome is dynamic. It may change in response to diet, hydration, antibiotics, other medication, probiotics, prebiotics, supplements, illness, travel, environment, sleep, stress, exercise, hygiene practices, hormones, age, and other personal factors.

A report is a snapshot of the submitted sample rather than a permanent description of your microbiome. A later sample may produce a different result even when you have not intentionally changed your routine.

13Scientific knowledge and interpretation may change

Microbiome research continues to develop. Associations among microorganisms, diversity measures, symptoms, and health outcomes may be incomplete, uncertain, population-dependent, or later revised.

An association does not prove that a microorganism caused a symptom or condition. It also does not prove that increasing or decreasing that microorganism will improve health.

Interpretations may change because of new research, updated databases, improved classification methods, different platforms, professional guidance, or regulatory developments.

14Clinically confirm important findings

Do not use a consumer microbiome report as the sole basis for a diagnosis or medical decision.

A qualified healthcare professional may recommend a medical history, physical or dental examination, clinical laboratory testing, imaging, specialist referral, or another form of assessment.

A healthcare professional may reasonably disagree with an interpretation, wellness observation, or discussion point in a consumer report.

15Medication, supplements, probiotics, and diet

Do not start, stop, increase, decrease, or replace prescription medication, nonprescription medication, antibiotics, antifungals, probiotics, prebiotics, supplements, medical foods, dental products, vaginal products, or a medically prescribed diet solely because of website content or a report.

Do not begin a highly restrictive diet, prolonged fast, elimination program, or major nutritional change without appropriate professional advice.

Medications and supplements can cause side effects, interact with one another, affect laboratory testing, or be unsuitable during pregnancy, breastfeeding, childhood, or certain medical conditions.

16Pregnancy, children, and higher-risk individuals

Speak with a qualified healthcare professional before relying on microbiome-related wellness information if you:

• Are pregnant, trying to become pregnant, or breastfeeding.
• Are ordering for a child or dependent person.
• Have a weakened immune system or serious chronic condition.
• Recently underwent surgery or hospitalization.
• Are receiving cancer treatment or immune-suppressing medication.
• Have persistent, severe, or unexplained symptoms.

Testing a minor or dependent person requires lawful authority and any consent required by law, product eligibility rules, and laboratory policy.

17Consent and authority to submit a sample

You must not submit a biological sample or personal information belonging to another person unless you have lawful authority and all required consent.

By submitting a sample, the responsible person represents that:

• The sample was obtained lawfully.
• Required consent has been obtained.
• The sample provider's information is accurate.
• The person placing the order has authority to do so.
• The sample provider understands the general purpose of the test.
• The collection did not involve deception or unauthorized use.

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

18Reports, articles, sample reports, and testimonials

A sample report illustrates possible structure and presentation. It does not guarantee that an individual report will contain the same findings, categories, formatting, or detail.

Website articles and learning resources are general educational materials, 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 similar results.

19Third-party laboratories and service providers

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

Third parties may have their own technical procedures, service limitations, privacy practices, processing schedules, and terms.

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

20No guarantee of outcome or benefit

We do not guarantee that:

• A sample will produce a complete or conclusive result.
• Every microorganism present will be detected or reported.
• A report will explain symptoms or identify a clinically significant problem.
• A healthcare professional will agree with an interpretation.
• A report will lead to a diagnosis or effective treatment.
• A diet, supplement, probiotic, or lifestyle change will improve health.
• Follow-up results will show a particular change.
• A kit, sample, or report will arrive by a particular date.

Any stated processing or turnaround period is an estimate unless expressly guaranteed in writing.

21Privacy and microbiome data

Microbiome samples, order information, account information, and reports may involve sensitive personal data.

Our Privacy and Data page explains applicable practices concerning data collection, use, disclosure, storage, access, retention, and deletion.

This Medical Disclaimer does not replace the Privacy Policy, consent documents, or laboratory-specific privacy terms.

22Applicable documents and changes

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

• Terms of Use
• Privacy and Data information
• Product descriptions and collection instructions.
• Consent forms.
• Shipping, cancellation, and refund terms.
• Laboratory-specific requirements.

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

Nothing in this Medical Disclaimer excludes a right, warranty, duty, remedy, or liability that cannot lawfully be excluded or limited.