Version 2026-09, effective 01.09.2026

Dear patient, dear legal representative,

This document informs you about the genomic analysis offered by Arcensus, a trademark of Rolfs Consulting und Verwaltungs (RCV) GmbH, Leibnizstrasse 58, 10629 Berlin, Germany (“Arcensus”, “we”). Please read it carefully. Your consent is required before your sample can be analysed. If anything is unclear, contact us at [email protected] or ask your treating physician before you sign.

1. Definitions

Term	Meaning
GDPR	The EU General Data Protection Regulation (Regulation (EU) 2016/679), which governs the processing of personal data in the European Union.
Genome	The entire genetic material (DNA) in your cells.
Whole genome sequencing (WGS) / whole exome sequencing (WES)	Methods that read the complete genome (WGS) or the protein-coding part of the genome plus selected non-coding regions (WES).
Genomic data	Any data derived from the analysis of your DNA.
Health data	Data relating to your state of health, including symptoms, diagnoses, medication and family history.
Personal data	Any information relating to an identified or identifiable person.
Pseudonymisation	Replacing your name and contact details with a code so that data can no longer be attributed to you without additional information held separately (Art. 4(5) GDPR). Third parties involved in sequencing or research receive only the code, never your name, address, e-mail or telephone number.
Secondary findings	Results that are unrelated to the reason for testing but concern conditions for which preventive or therapeutic measures exist.
Carrier status	Having one disease-causing variant for a recessive condition or a variant in a gene on the X chromosome, which usually does not cause disease in the carrier but is relevant for family planning and for relatives.
Pharmacogenomic (PGx) findings	Genetic variants that influence how your body responds to certain medicines.

2. What you agree to

By giving this consent you confirm that you have been informed about the procedures used by Arcensus, the possible benefits, limitations and risks of genomic analysis, and that Arcensus will have access to your genomic and health data to perform the analysis. If you consent as a legal representative, you confirm that you hold the legal authority to consent on behalf of the person tested and that all information in this document applies to that person.

3. Procedure

Step 1 – Order and registration. The analysis is ordered by your treating physician or, where permitted by the law of your country, by you via the Portal. You or your physician register the case in the Portal and provide your clinical symptoms, medication (for pharmacogenomic reports) and family history as completely as possible. Complete information improves the interpretation of your genomic data.

Step 2 – Sample. A blood sample, buccal swab, saliva sample or dried blood spot is collected by your healthcare provider or with the collection kit provided. Instructions and the shipping address of the laboratory are provided with the kit and in the Portal. Isolated DNA is accepted only from qualified laboratories.

Step 3 – Sequencing. Your sample is labelled with a code (pseudonym) and processed in an accredited partner laboratory in Germany (currently CeGaT GmbH, Tübingen; accredited under ISO 15189 and CAP), which isolates the DNA and performs the sequencing. Depending on the product ordered, either the whole genome or the whole exome is sequenced. The laboratory transfers the sequencing data to Arcensus and destroys the remaining sample material and its copy of the data within 30 working days after processing.

Step 4 – Interpretation and report. Arcensus’s bioinformaticians and medical geneticists analyse the regions of your genome relevant to the product ordered and to your clinical question, combine them with the clinical information provided and issue a diagnostic report. The report is made available in the encrypted Portal to your ordering physician and, where applicable, to you.

Step 5 – Re-analysis. If the product ordered includes re-analyses, your stored genomic data are re-evaluated against the current scientific knowledge at the intervals specified for the product and an updated report is issued. No new sample is required. Outside the scope of the product ordered, there is no obligation to re-contact you.

4. Your sample

You confirm that the sample was taken from you or from the person for whom you are the legal representative, and that you do not act on behalf of a third party such as an insurer or employer. Sample material and DNA are used solely for the analysis ordered and, if you consent to it in section 12, for research. Remaining sample material is destroyed at the partner laboratory within 30 working days after processing. Genomic data are stored by Arcensus for the duration of your account and for the statutory retention period for medical records (at least 10 years), unless you request earlier deletion (section 10).

5. Results and report

You understand that the result may be positive (a disease-causing variant is found), negative (no such variant is found) or inconclusive (a variant of uncertain significance). Unexpected results may cause emotional distress. The interpretation of genetic variants may change as scientific knowledge evolves.

Variants are classified according to the guidelines of the American College of Medical Genetics and Genomics (ACMG) into five classes. The report includes pathogenic (class 5) and likely pathogenic (class 4) variants related to your clinical question. Variants of uncertain significance (class 3) are reported where relevant to your phenotype.

In addition to primary findings, the following can be reported only if you tick the corresponding optional item in section 12:

• Secondary findings (item B1): pathogenic or likely pathogenic variants in the genes of the current ACMG secondary-findings list – conditions such as hereditary cancer syndromes, cardiomyopathies or familial hypercholesterolaemia, for which prevention or treatment exists. The current gene list is available at www.arcensus-diagnostics.com/secondary-findings.
• Carrier status (item B8): variants that make you a carrier of a recessive or X-linked condition without necessarily being affected yourself.
• Pharmacogenomic findings (item B9): gene–drug interactions reported according to the CPIC and DPWG guidelines valid at the time of reporting. These results inform your physician; they are not instructions to change medication.

The report describes the condition identified, its typical clinical features, available treatments and, where relevant, ongoing clinical trials. It is addressed to a medical professional and to you.

6. Purpose and limitations

The analysis is performed in accredited laboratories and interpreted by medical experts in accordance with current scientific evidence. A report is a snapshot of the knowledge available at the time of reporting. A negative result does not exclude a genetic cause. Not all types of genetic variation are detected by every method; the variant categories covered by each product are described on the product page. Reference data are most extensive for populations of European ancestry, so the interpretation may be less complete for other ancestries.

Recommendations in the report are for information and do not replace consultation with, and treatment by, your treating physician. Genetic counselling before and after the test is recommended and, in some countries, required by law.

7. Risks

Unexpected information. Results may reveal conditions you did not expect, including conditions with implications for relatives or for family planning.

Analytical error. Despite strict quality assurance, a very small proportion of data may be incorrect or uninterpretable. Clinically relevant findings are confirmed according to laboratory procedure.

Change of interpretation. Future research may alter the interpretation of your data.

Sharing of genetic data. Genetic information shared with third parties (including insurers or employers) may be used against your interests. We recommend sharing results only with your treating physicians. Arcensus is not responsible for consequences of information you share yourself.

Data security. Like any online service, your account can be compromised if your password is disclosed. Arcensus applies the security measures described in the Privacy Policy. Suspected security incidents can be reported to [email protected].

Re-identification. Genomic data are unique to you. Although third parties receive only pseudonymised data, a theoretical risk of re-identification remains. Do not publish your genomic data in public databases together with identifying information.

8. Data we collect

During registration and analysis we process: first and last name, date of birth, sex, nationality and – optionally – ancestry/ethnic background (used only for variant frequency interpretation), clinical symptoms, medication, family history, sample identifiers, e-mail address, telephone number, postal address, sequencing data and the report. Your name and contact details are stored separately from your genomic data; only a unique code links them.

Where the analysis is ordered by your physician or a laboratory, that organisation is the controller of your data and Arcensus processes your data on its behalf under a data processing agreement (Art. 28 GDPR). Where you order directly, Arcensus is the controller. Where you consent to research or commercial secondary use (section 12), Arcensus is the controller for that processing. Details are set out in the Privacy Policy.

9. Data protection

Genetic and health data are processed on the basis of your explicit consent (Art. 9(2)(a) GDPR) and, for physician-ordered testing, for the purpose of medical diagnosis (Art. 9(2)(h) GDPR). Samples and genomic data are processed exclusively in Germany. Pseudonymised data are transferred to countries outside the European Economic Area only under the safeguards described in the Privacy Policy (adequacy decision or standard contractual clauses) and, for research or commercial use, only within the scope of your consent in section 12. Arcensus may use sub-processors (sequencing laboratory, hosting, bioinformatics) under written agreements; the current list is available on request.

Arcensus implements technical and organisational measures pursuant to Art. 32 GDPR, including pseudonymisation, encryption at rest and in transit, role-based access with multi-factor authentication and regular security testing. Personal data breaches are notified to the competent authority and, where required, to you without undue delay.

Contact for all data protection matters: Data Protection Officer, Rolfs Consulting und Verwaltungs (RCV) GmbH, Leibnizstrasse 58, 10629 Berlin, Germany; e-mail [email protected].

10. Your rights and withdrawal

You may at any time, without giving reasons and with effect for the future:

1. withdraw your consent to the analysis – if the sample has not yet been analysed, the analysis is stopped (payment obligations for services already rendered remain unaffected);
2. request destruction of your sample and deletion of your genomic and health data, subject to statutory retention obligations;
3. withdraw any optional consent given in section 12 (secondary findings, carrier status, pharmacogenomics, research, commercial use) – data already included in completed studies cannot be withdrawn;
4. request access to, rectification of, restriction of, or a copy of your personal data, including your raw genomic data (data portability);
5. lodge a complaint with a supervisory authority, in particular the Berliner Beauftragte für Datenschutz und Informationsfreiheit, Alt-Moabit 59–61, 10555 Berlin, Germany, or the authority at your place of residence.

Requests: [email protected] or by post to the address in section 9. Withdrawal of consent does not affect the lawfulness of processing carried out before the withdrawal. Providing a sample does not give you any rights in research results, products or services developed by Arcensus or its partners.

Minors: if you consent as legal representative of a minor, testing is performed only where medically indicated and ordered by a physician. The minor may access his or her own data upon reaching the age of majority.

11. Questions

[email protected] · Support: [email protected] · Data protection: [email protected]

12. Declaration of consent

Each optional item below is voluntary and independent. Ticking an optional item is not a condition for performing the analysis. Each consent can be withdrawn at any time with effect for the future.

Optional

Item	Declaration
☐ B1	I wish to be informed about secondary findings in the genes of the current ACMG secondary-findings list (excluding carrier status and pharmacogenomic findings).
☐ B8	I wish to be informed about my carrier status for recessive and X-linked conditions.
☐ B9	I wish to receive pharmacogenomic findings (gene–drug interactions according to CPIC/DPWG guidelines) for the information of my treating physician.
☐ B2	I consent to the use of my pseudonymised sample, genomic and health data by Arcensus for scientific research on the causes, early detection and treatment of genetic diseases, including statistical analyses and publications, and to sharing pseudonymised data for this purpose with academic and non-profit research institutions that maintain data protection standards equivalent to the GDPR. The specific research questions cannot be predicted today.
☐ B3	I consent to the use of my pseudonymised genomic and health data by Arcensus for commercial purposes, including the licensing of de-identified datasets to pharmaceutical, biotechnology and diagnostics companies for the development of medicines, diagnostics and health services. I understand that Arcensus and its partners may derive commercial benefit from such use and that I will not receive any payment.

Mandatory

Item

Declaration

☐ A

I confirm that I have read and understood this information, that my questions have been answered, and that I have had the opportunity to obtain genetic counselling. I consent to the genomic analysis (WGS/WES or interpretation of existing data) of my sample or the sample of the person I represent by Arcensus, a trademark of Rolfs Consulting und Verwaltungs (RCV) GmbH, in accordance with the product ordered, to the processing of my genetic and health data for this purpose, and to the delivery of the report via the Portal to the ordering physician and/or to me.