1.1 These General Terms and Conditions (“Terms”) govern the use of the website www.arcensus-diagnostics.com (“Website”), the online platform portal.arcensus-diagnostics.com (“Portal”) and the ordering of genomic testing and interpretation services (“Services”) from Rolfs Consulting und Verwaltungs (RCV) GmbH, Leibnizstrasse 58, 10629 Berlin, Germany, registered with the Commercial Register of the Local Court (Amtsgericht) Charlottenburg, Berlin under HRB 224347 B, VAT ID DE337852332, represented by its Managing Director Prof. Dr. med. Arndt Rolfs (“RCV”, “we”). RCV operates the Services under the trademark “Arcensus”.
1.2 “User” means any person accessing the Website or Portal. “Customer” means the person or entity ordering Services. “Healthcare Professional” means a physician, clinical laboratory or other healthcare provider ordering Services for a patient. “Patient” means the individual whose sample and data are analysed. “Distributor” means a partner that has concluded a separate Distributor Agreement with RCV.
1.3 For Distributors and Healthcare Professionals that have concluded a separate written agreement with RCV (Distributor Agreement, General Terms and Conditions for Laboratory Services, Data Processing Agreement), that agreement prevails over these Terms in case of conflict.
1.4 By using the Website or Portal or by ordering Services, the User accepts these Terms in the version valid at the time of the order. Diverging terms of the Customer do not apply unless RCV has agreed to them in writing.
2.1 The User shall use the Website and Portal in compliance with applicable law and these Terms and shall refrain from any use that could damage, disable, overburden or impair the Website, the Portal, the servers on which they are hosted, or the rights of RCV, its suppliers or other Users.
2.2 Where access requires a user name and password, the User shall keep these credentials confidential, shall not make them available to third parties and shall notify RCV without undue delay at [email protected] of any loss, theft or suspected unauthorised use. The User is responsible for all activity under the User’s account until such notification.
2.3 The User shall, in particular, not (a) provide false registration data; (b) upload or transmit content that is unlawful, defamatory, discriminatory or infringes third-party rights; (c) upload malware or attempt to gain unauthorised access to systems or data of RCV, other Users or third parties; (d) use the Website or Portal for unsolicited advertising or for collecting personal data of third parties; (e) impersonate another person or use another person’s credentials.
2.4 Hyperlinks to the Website may be set to the home page only. Framing, inline linking and any presentation that suggests an endorsement by or affiliation with Arcensus are prohibited without RCV’s prior written consent.
2.5 RCV may suspend or restrict access to the Website or Portal for maintenance, security reasons or in the event of a breach of these Terms.
3.1 The Services consist of whole genome sequencing (WGS), whole exome sequencing (WES) or the interpretation of existing sequencing data (Data2Report), the medical interpretation of the resulting data and the issuance of a diagnostic report, including re-analyses to the extent specified for the product ordered. Sequencing is performed in an accredited partner laboratory in Germany; medical interpretation and reporting are performed by Arcensus.
3.2 The presentation of products on the Website or Portal does not constitute a binding offer. An order placed via the Portal or by written order form constitutes a binding offer by the Customer. The contract is concluded when RCV confirms the order by e-mail (order confirmation) or begins performing the Services, whichever occurs first. RCV stores the contract text and sends the order data and these Terms to the Customer by e-mail.
3.3 Services on Patients are performed only on the basis of a signed Informed Consent of the Patient (or the Patient’s legal representative) in the version valid at the time of the order. Where the law of the country in which the Patient resides so requires (for Germany: Genetic Diagnostics Act, GenDG), the Services are ordered by, and the report is addressed to, a licensed physician. Genetic testing of minors and of persons unable to consent is performed only where medically indicated and requested by a physician.
3.4 The contractual language is English. Reports are issued in English unless otherwise agreed.
4.1 Prices are those stated in the Portal, the price schedule of the applicable partner agreement or the order confirmation. Prices for consumers include statutory VAT; prices for business customers are net of VAT. Shipping costs for collection kits are stated separately where applicable.
4.2 Payment is due upon order confirmation unless otherwise agreed. Accepted payment methods are stated in the Portal at the time of order. RCV may make performance conditional on receipt of payment.
4.3 Collection kits remain the property of RCV until paid in full.
5.1 A consumer (§ 13 German Civil Code, BGB) who orders Services at a distance has the statutory right to withdraw from the contract within fourteen days without giving reasons. The withdrawal period begins on the day the contract is concluded (or, for a collection kit, on the day the kit is received). Withdrawal is declared by an unambiguous statement (e.g. e-mail to [email protected] or letter to the address in clause 1.1). The model withdrawal form provided by RCV may be used.
5.2 If the consumer has expressly requested that RCV begin performing the Services before the end of the withdrawal period and the Services have been fully performed, the right of withdrawal expires. If the consumer withdraws after performance has begun, the consumer owes a proportionate amount for the Services rendered up to the withdrawal (§ 357a BGB). Once the sample has been sequenced, the Services are deemed fully performed with respect to the sequencing component.
5.3 Collection kits that have been opened or used cannot be returned for hygiene and health-protection reasons (§ 312g para. 2 no. 3 BGB).
6.1 Arcensus performs the Services in accordance with the state of the art in medical genetics at the time of analysis and in accredited laboratories (ISO 15189, CAP). Reports classify variants according to the ACMG/AMP guidelines in force at the time of reporting.
6.2 The Customer acknowledges the following inherent limitations: (a) scientific knowledge of the genetic basis of disease is incomplete and evolving; a variant classification may change over time; (b) reference data and association studies are unevenly distributed across populations and are most extensive for populations of European ancestry, so that the interpretation may be less complete for other ancestries; (c) no sequencing technology detects all variant types; the variant categories covered by each product are stated on the product page; (d) a negative result does not exclude a genetic cause.
6.3 Reports and any recommendations therein are for the information of the ordering physician and the Patient. They do not replace medical consultation, genetic counselling, treatment decisions or the prescription of medicines by a treating physician.
6.4 Turnaround times stated on the Website are target times from receipt of a sample that meets the acceptance criteria and are not binding delivery dates unless expressly agreed. Samples that do not meet the acceptance criteria (quantity, quality, labelling, consent) may be rejected; the Customer will be informed and may submit a new sample.
6.5 Re-analyses are performed to the extent included in the product ordered and are delivered as an updated version of the primary report. RCV is not obliged to re-contact Customers or Patients outside the agreed re-analysis scope.
7.1 Statutory warranty rights apply. Descriptions, illustrations and technical data on the Website are for information only; the order confirmation is decisive for the scope of Services.
7.2 RCV does not guarantee uninterrupted availability of the Website or Portal. Data transmission over the Internet cannot be guaranteed to be error-free at all times.
8.1 RCV is liable without limitation for damage caused intentionally or by gross negligence, for injury to life, body or health, under the Product Liability Act and to the extent RCV has assumed a guarantee.
8.2 In cases of slight negligence, RCV is liable only for the breach of an essential contractual obligation (an obligation whose fulfilment is a prerequisite for the proper performance of the contract and on whose fulfilment the Customer regularly relies), and such liability is limited to the foreseeable damage typical for this type of contract.
8.3 Any further liability of RCV is excluded. The limitations of this clause also apply to the personal liability of RCV’s employees, representatives and vicarious agents.
8.4 RCV is not liable for consequences arising from the User sharing credentials, reports or genetic information with third parties, or from the User’s failure to follow the instructions for sample collection and shipping.
9.1 RCV processes personal data in accordance with the General Data Protection Regulation (GDPR), the German Federal Data Protection Act (BDSG), the GenDG and the Privacy Policy published on the Website. For Patient data processed on behalf of Healthcare Professionals or Distributors, RCV acts as processor under the Data Processing Agreement pursuant to Art. 28 GDPR.
9.2 Genetic and health data are processed only on the basis of the Patient’s Informed Consent (Art. 9(2)(a) GDPR) or, where applicable, for the purpose of medical diagnosis under the responsibility of a physician (Art. 9(2)(h) GDPR). Secondary use of pseudonymised data for research or commercial purposes takes place only where the Patient has separately consented to it.
9.3 Data-subject requests may be addressed to [email protected] or to the postal address in clause 1.1.
The Website and Portal use technically necessary cookies. Analytical and marketing cookies are set only with the User’s consent given via the consent manager, which can be revoked at any time via “Cookie settings” in the footer. Details are set out in the Privacy Policy.
11.1 All content of the Website and Portal (texts, graphics, images, videos, software, report templates, databases, source code and design) is protected by copyright and other intellectual property rights and is owned by RCV or its licensors. Reproduction, distribution, modification or public communication without RCV’s prior written consent is prohibited.
11.2 “Arcensus”, “myLifeGenome”, “myLifeExome”, “Data2Report”, “ArcFlow” are trademarks or trade names of RCV or its partners. Use of these signs requires RCV’s prior written consent.
11.3 The Customer and the Patient receive the diagnostic report for their own use, including sharing with treating physicians. Genomic raw data are made available to the Patient or ordering physician on request in accordance with the Informed Consent.
12.1 These Terms apply for as long as the User maintains an account or uses the Services. The User may terminate the account at any time by e-mail to [email protected]. RCV will confirm the request to the e-mail address linked to the account and then delete the account; the consequences for stored data and samples are described in the Privacy Policy and the Informed Consent.
12.2 RCV may terminate the agreement and close an account with immediate effect if (a) the User materially breaches these Terms; (b) RCV is legally required to do so; (c) the partner through which the Services were offered has terminated its agreement with RCV; or (d) RCV ceases to offer the Services in the User’s country. Ordered and paid Services will be completed or refunded pro rata.
12.3 Suspected fraudulent, abusive or unlawful activity may be reported to the competent authorities.
13.1 Communications between RCV and the User are made by e-mail to the addresses provided at registration and via the Portal. RCV’s contact address for these Terms is [email protected]; postal address as in clause 1.1.
13.2 Reports and genetic data are made available via the encrypted Portal. RCV does not send reports by unencrypted e-mail unless the Customer expressly requests this and accepts the associated risk.
RCV may amend these Terms for valid reasons (in particular changes in law, jurisprudence, technology or the scope of Services). Registered Users will be notified of material changes by e-mail at least thirty (30) days before the effective date. If the User does not object within thirty days of notification, the amended Terms are deemed accepted; RCV will point out this consequence in the notification. If the User objects, either party may terminate the account with effect from the effective date of the change. Changes do not affect Services already ordered.
15.1 These Terms and all contracts concluded under them are governed by the laws of the Federal Republic of Germany, excluding the UN Convention on Contracts for the International Sale of Goods. For consumers, mandatory consumer-protection provisions of the country of habitual residence remain unaffected.
15.2 The place of performance is Berlin, Germany.
15.3 If the Customer is a merchant, a legal entity under public law or a special fund under public law, or has no general place of jurisdiction in Germany, the courts of Berlin have exclusive jurisdiction. RCV may also sue at the Customer’s general place of jurisdiction.
15.4 The European Commission’s online dispute resolution platform has been discontinued. Rolfs Consulting und Verwaltungs (RCV) GmbH is neither obliged nor willing to participate in dispute resolution proceedings before a consumer arbitration board (§ 36 VSBG).
16.1 Should individual provisions of these Terms be or become invalid, the validity of the remaining provisions is not affected. The invalid provision shall be replaced by the statutory provision.
16.2 Questions regarding these Terms: [email protected].