Information Update and Sample Repetition Policy

Version VB-PAR-2026-01 · Effective from September 14, 2026 · Replaces the previous version ·

GENELINK, S.L. (trading as «Vivabioma»), NIF B98649494, calle Arquitecto Mora 5, 2nd floor, door 4, 46010 Valencia, Spain · info@vivabioma.com · Telephone: +34 960 090 596.

This Policy forms part of the contract together with the Legal Terms and the Informed Consent and is available on the Website before the contract is entered into. It explains the technology we use to analyse your sample, how that technology evolves, how your reports are updated and what happens if a sample does not meet the minimum quality criteria.

1. Purpose and scope

1.1 Vivabioma aims to enable you to access information about your gut microbiome from anywhere and share it with a healthcare professional of your choice. To do so, we maintain a platform that stores, interprets and updates that information.

1.2 This Policy applies to the Starter, Advanced and Ultra products insofar as they are available in your country.

1.3 The conditions governing purchase, payment, upgrades and withdrawal are set out in the Legal Terms. The scope, limitations and processing of your data are set out in the Informed Consent. In the event of any discrepancy, those documents prevail in the matters they govern.

2. Analysis technology

2.1 The analysis is performed using shotgun metagenomic sequencing on a stool sample. This technique sequences the genetic material present in the sample without first selecting a specific gene, allowing the composition and diversity of the microbial community to be estimated and potential metabolic functions to be described.

2.2 In addition to bacteria, the analysis may detect sequences attributable to viruses, fungi and other microorganisms. Sensitivity for these groups is lower and highly variable, depends on their relative abundance and on the reference databases available, and under no circumstances constitutes a diagnostic microbiological, virological or parasitological examination. Failure to detect a microorganism does not rule out its presence.

2.3 The achievable resolution depends on the sequencing depth obtained, the proportion of microbial material in the sample, the reference databases and the classification methods used. Identification of all microorganisms present or uniform coverage is not guaranteed.

2.4 As microbiome science evolves, we may incorporate new bioinformatics tools and updated databases. These improvements apply to analyses and interpretations performed after they are implemented and do not, by themselves, create a right to repeat an analysis already issued free of charge.

3. Updating databases and interpretations

3.1 The taxonomic classification, functional assignments and indices shown in your reports depend on the databases and models in force at the time of analysis. Both are reviewed periodically.

3.2 We may update the interpretive content of your reports without requiring a new sample, within the features included in your product. Each report is identified by a version and date indicating the interpretation applicable at that time.

3.3 An update may modify, qualify or remove a previous result: a microorganism may be reclassified, a function may be reassigned and an index may be recalibrated. This is inherent to the nature of the analysis and does not constitute an error in the previous report.

3.4 We do not undertake to contact you individually whenever an interpretive change occurs. We will do so when a quality control identifies a material error affecting one of your results, in which case we may correct it, temporarily withdraw it and provide you with the corrected version.

3.5 No result, whether initial or updated, replaces assessment by a healthcare professional or confirmation through the appropriate clinical test at an authorised centre or laboratory.

4. Upgrades and reinterpretations

4.1 Where available, you may upgrade one tier at a time—from Starter to Advanced or from Advanced to Ultra—through a separate purchase. The upgrade may consist of reinterpreting data already retained, without a new sample or new sequencing.

4.2 The possibility of upgrading depends on the quality of the original data, the retained format, the age of the sample, technical compatibility and territorial availability. This will be confirmed before you complete the purchase.

4.3 If you request deletion of your technical data, upgrades will no longer be possible without a new sample. We will warn you before carrying out the deletion.

4.4 Comparing two analyses performed at different times requires a new sample and does not eliminate technical or temporal variability: a change between reports does not, by itself, demonstrate that an intervention has caused an improvement or deterioration.

4.5 If you would like information about analysis versions or the availability of an upgrade, write to us at info@vivabioma.com and we will tell you the current options, including their price and conditions, before you confirm anything.

5. Minimum sample quality criteria

5.1 To issue reliable results, the sample must meet the minimum quality criteria in force. These are currently:

•      Microbial DNA concentration obtained equal to or greater than 8 ng/µL.

•      Sequencing quality: sequence quality parameters, including the proportion of bases with a Q30 score or higher, must meet the thresholds defined in our quality management system and applied uniformly to all samples.

•      Proportion of human DNA below 10% of the total sample.

5.2 The third criterion exists because a stool sample always contains human cells. When their proportion is high, the microbial material available is insufficient for reliable analysis. Human sequences are filtered during processing as described in the Informed Consent.

5.3 These criteria reflect the state of the art and our quality management system and may be updated. The criteria in force at the time of analysis will apply and will appear in the published version of this Policy.

6. What happens if a sample does not meet the quality criteria

6.1 In the vast majority of cases, a single sample is sufficient. Occasionally, the amount or quality of microbial DNA obtained does not meet the minimum criteria. This is usually due to incorrect collection, unsuitable storage or transport, or biological factors such as recent antibiotic use, an acute infection or certain digestive conditions that affect the stability of the genetic material.

6.2 If the first analysis does not produce valid results, we will contact you by email and send you, free of charge, a new kit so that the sample collection, extraction and analysis can be repeated.

6.3 If the second sample also fails to meet the criteria, we will offer you a choice between a third sample collection, also free of charge, or termination of the contract with the refund provided for in section 8.

6.4 After that, any additional analysis you wish to carry out will be charged at the current price, which we will communicate to you before you confirm it.

6.5 Repeating the sample collection does not guarantee a satisfactory result. There are exceptional cases in which stabilisation of the microbial genetic material in the kit is not viable for reasons beyond the laboratory's control.

6.6 If a valid sample does not produce a usable result after repetition, and this is not attributable to you, we will offer, as appropriate, a new run, a price reduction or termination with reimbursement of the non-conforming part. A free repeat does not replace the legal remedies for lack of conformity.

7. When repetition is not free of charge

7.1 Repetition will not be free of charge when the invalidity of the sample results from a failure attributable to you to comply with the instructions on collection, storage, quantity, labelling, deadlines or shipping.

7.2 Attribution must be supported by an objectively verifiable element: an expired or unregistered kit, an incorrect label or return route, late shipping, material that is clearly tampered with or contaminated, or insufficient quantity attributable to collection. In the absence of such an element, the incident will be treated as not attributable to you and the repetition will be free of charge in accordance with section 6.

7.3 Before charging any amount, we will inform you of the price of the materials, logistics and, where applicable, the new processing, and we will not charge it without your confirmation.

7.4 If the collection material is accidentally damaged during sampling—through a fall, breakage, contamination or loss of a component—the replacement arrangements set out in the Legal Terms apply: a free kit is not sent, but a voucher is provided covering the material and its shipping, without requiring you to pay again for the analysis service.

7.5 If the authorised carrier loses the sample after you have provided evidence of its correct handover, the repetition is free of charge.

8. Response periods and refunds

8.1 You have three months from the date of our email to tell us whether you wish to repeat the sample or terminate the contract. If we do not receive a response, we will send you a reminder before that period expires.

8.2 Once the three months have elapsed without a response, we will close the incident and will not reserve materials or laboratory capacity for that order. This does not prevent you from contacting us later and does not affect any rights granted to you as a consumer by applicable law: if you write to us later, we will assess your request in accordance with this Policy and the applicable law.

8.3 Where the inability to issue results is not attributable to you and you choose to terminate the contract instead of repeating the sample, we will refund the amount paid for the analysis service.

8.4 The refund will be made using the same payment method used for the purchase, unless otherwise agreed, within 14 calendar days after you inform us of your decision.

8.5 The foregoing is without prejudice to the right of withdrawal and the statutory guarantee of conformity, which are governed by the Legal Terms and are not limited by this Policy.

9. Cases in which results cannot be issued

9.1 In addition to sample quality, it may be impossible to issue results if the sample is received damaged or late, if the kit has expired, if it has not been registered on the platform, if its link to an account cannot be verified, or if proof of representation is missing when the holder is a minor or a person subject to support measures.

9.2 In such cases, we will inform you of the cause and the available options. Where the cause is not attributable to you, sections 6 to 8 apply.

10. Unsent samples and expired kits

10.1 You must activate the kit and send the sample within 12 months of purchase and, in all cases, before the expiry date printed on the material. Once the first of those limits has passed, we cannot guarantee the viability of collection or the validity of the analysis, and this Policy does not entitle you to a free repetition.

10.2 If your kit has expired unused, write to us and we will tell you the current conditions for purchasing replacement materials.

11. How we inform you

11.1 Communications concerning sample incidents, repetitions and updates are sent by email to the address associated with your account and, where appropriate, through notices on the platform. You are responsible for keeping it up to date and accessible.

11.2 We retain records of those communications within our quality management system.

12. Validity and amendments

12.1 This Policy has a version code and date. Each order is governed by the version in force at the time of purchase, unless a later version is more favourable to you.

12.2 We may update it for technical, scientific, legal or supplier-related reasons. You may request the version history at info@vivabioma.com.

12.3 For any questions about this Policy: info@vivabioma.com.