Programme Terms
These Supplementary Terms of Service (“Programme Terms”) govern your participation in the Danon Disease Patient Finding Programme as a participant receiving services from GeneLinx GmbH i.L. (“GeneLinx”, “we”, “us”).
For your data protection rights, professional standards, and governing law, please also refer to GeneLinx’s general Terms of Service. Where these Programme Terms conflict with the general Terms of Service, these Programme Terms take precedence.
By booking an appointment with GeneLinx as part of this programme, you agree to these Programme Terms.
1. About This Programme
The Danon Disease Patient Finding Programme is a clinical screening programme sponsored by Rocket Pharmaceuticals and operated by Sano Genetics LTD (“Sano Genetics”). GeneLinx has been engaged as an independent clinical provider to deliver genetic counselling sessions and to act as the ordering provider for LAMP2 genetic testing.
GeneLinx is responsible only for the clinical sessions described in these Programme Terms. Sano Genetics is separately responsible for your programme participation, the testing logistics, and results delivery. Your participation in the programme is subject to Sano Genetics’ own terms and consents, which Sano Genetics obtains from you separately.
2. GeneLinx's Role and Scope of Services
GeneLinx’s services under this programme are limited to:
– Conducting a mandatory pre-test session (45 minutes) online, covering the purpose of LAMP2 genetic testing, your testing pathway, possible results and their implications, test limitations, and family implications
– Collecting additional family and medical history from you to prepare for your session
– Obtaining your informed consent for LAMP2 genetic testing and countersigning as the ordering clinician
– Notifying Sano Genetics that you have consented to proceed with testing
– Conducting a mandatory post-test session (15-20 minutes) online to disclose and discuss your test result(s)
– Releasing your test result(s) to you via the Sano Genetics platform at the end of the post-test session
– Uploading a clinical note to the Sano Genetics platform summarising each session
GeneLinx does not provide any services beyond those listed above as part of this programme and is not responsible for the programme itself, the study you may be invited to join, or any activities conducted by Sano Genetics or Rocket Pharmaceuticals.
3. Testing Arrangements
The test ordered under this programme is a clinical-grade LAMP2 gene analysis. The specific test, laboratory, and sample handling arrangements are predetermined by Sano Genetics and Rocket Pharmaceuticals. GeneLinx’s clinicians have no discretion to order a different test, use a different laboratory, or change sample transfer arrangements.
Sano Genetics manages all testing logistics including sample collection, laboratory analysis, and delivery of results. Your sample and associated data will be processed by Sano Genetics’ contracted laboratory in the United States. GeneLinx has no direct relationship with the laboratory and no control over laboratory selection, sample handling, or the data transfer to the US. You will be informed of these arrangements during your pre-test session and asked to confirm your understanding before the test is ordered.
4. Your Sessions
Pre-test session (45 minutes)
Your pre-test session takes place online. Before the session, your GeneLinx clinician will review your clinical information and the medical and family history form you complete at booking.
The session covers the purpose and nature of LAMP2 testing, your specific testing pathway, possible results and their implications, and family implications. If you are on a two-stage pathway, you will also be informed that a second test may be automatically performed on the same sample if the first result is negative or uncertain, and that results may take longer in this case.
If you wish to proceed with testing, you will be asked to sign GeneLinx’s testing consent form. Your clinician countersigns as the ordering clinician. If you decide not to proceed, no test will be ordered and the session ends at this point.
Post-test session (15-20 minutes)
Your post-test session takes place online and is mandatory. Your result(s) will not be released to you without a post-test session. Sano Genetics will notify you when your results are ready and will send you a booking link to schedule this session.
Your clinician will discuss your result(s) with you. If a second reflex test was performed, both results will be covered in the same session. At the end of the session, your result(s) and clinical note are released to you via the Sano Genetics platform.
Clinical notes
Within 2 business days of each session, a clinical note summarising the discussion will be uploaded to the Sano Genetics platform and released to you. Your test result(s) are released to you via the Sano Genetics platform at the end of the post-test session; the clinical note follows within 2 business days.
5. Out-of-Scope Clinical Findings
This programme covers LAMP2 testing only. If during your session your clinician identifies something relevant to your health that falls outside the scope of this programme, they may inform you under their professional duty of care and advise you to raise it with your own doctor or request a genetics referral. Out-of-scope information will not be uploaded to the Sano Genetics platform. Your clinical note will include a brief generic line confirming that additional information was discussed and that you have been advised to follow up with your own provider.
6. Payment
Your sessions under this programme are funded by Sano Genetics. You will not be charged.
As you are not paying for GeneLinx’s services directly, the statutory right of withdrawal applicable to paid consumer contracts does not apply. You may withdraw from the programme at any time by contacting Sano Genetics directly.
7. Cancellation and Rescheduling
You may cancel or reschedule your appointment up to 24 hours before the scheduled time using the link in your booking confirmation email or by contacting appointments@gene-linx.com.
You will not be charged for cancellations or rescheduling. If you cancel within 24 hours or do not attend, a fee may be charged to Sano Genetics as the referring partner. If you do not attend your pre-test session, your clinician will attempt to contact you by phone twice. After 15 minutes the session will be marked as a no-show. For the post-test session, your clinician will wait 5 minutes, attempt to contact you by phone, and close the session if there is no response.
8. Limitation of Liability
GeneLinx’s liability is limited to the clinical services it directly provides: the pre-test session, the informed consent process, the test ordering notification to Sano Genetics, and the post-test results disclosure session.
For the avoidance of doubt, GeneLinx’s services are strictly limited to the provision of genetic counselling sessions and the administrative ordering of tests via the Sano Genetics platform. GeneLinx exercises no control over, and accepts no liability or responsibility for:
– the platform functionality, data security, or logistics managed by Sano Genetics;
– the laboratory analysis, accuracy, sample handling, or data processing performed by Sano Genetics’ contracted laboratory; or
– any international data transfers executed between Sano Genetics and its laboratory partner.
9. Data Protection
GeneLinx processes the following personal data as an independent data controller in connection with this programme:
– Booking information and appointment records
– Family and medical history collected at booking and during sessions
– Clinical notes from your pre-test and post-test sessions
– Your testing consent form — retained in GeneLinx’s clinical file only and not shared with Sano Genetics
GeneLinx accesses the following data from the Sano Genetics platform to conduct your sessions:
– Your pre-screener questionnaire and eligibility information
– Your LAMP2 test result(s)
GeneLinx uploads the following to the Sano Genetics platform:
– Pre-test clinical note (within 2 business days of your pre-test session)
– Post-test clinical note and result release (at the end of your post-test session)
GeneLinx retains clinical records for the statutory retention period applicable to medical records. For your data protection rights in relation to data held by GeneLinx, contact contact@gene-linx.com. For data held by Sano Genetics, contact dataprivacyofficer@sanogenetics.com.
10. Subcontractors
GeneLinx delivers these services through contracted genetic counsellors and geneticists. These clinicians act under GeneLinx’s instructions within the scope of this programme and have no independent discretion to modify the testing pathway, select a different laboratory, or alter sample handling arrangements.
11. Governing Law
These Programme Terms are governed by the laws of the Federal Republic of Germany. The legal venue for any disputes is Berlin, Germany.
GeneLinx’s general Terms of Service at gene-linx.com/terms-service apply where not superseded by these Programme Terms.
Version: 1.0 || 26/07/2026
