MEWIGEN operates a laboratory specialised in molecular genetic analyses mainly in human genetics. This includes especially Sanger or Next Generation Sequencing (NGS) of human genes including analysis of data and interpretation of results. Genetic testing on humans for medical purposes is carried out on orders of physicians exclusively.

By submitting a sample and the corresponding submission form to MEWIGEN, the customer agrees to these terms and conditions. MEWIGEN is free to change these terms and conditions at any time. The terms and conditions are binding in the version in place at the time the customer submitted an order. Individual changes or additions to these terms and conditions must be agreed on in writing before the execution of an order.

 

Terms

Customer: The person or institution placing an order. In case of genetic analysis for diagnostic purposes it may be the responsible physician arranging the genetic analysis according to Section 3 No. 5 of the German Genetic Diagnosis Act (GenDG)

Patient: Person whose biological material is intended for genetic testing

Sample: Biological material (specimen) intended to be used for genetic analysis (Section 3 No.10 GenDG)

Analysis: Genetic test of the patient’s specimen submitted by the customer

 

Ordering and conclusion of the contract

An order can only be accepted by MEWIGEN if the following requirements are fulfilled:

1. The patient identifier/name and birth date on the sample package is in full agreement with the information on the sample submission form.
2. The sample is packed appropriately for the type of material and the consignment is intact upon arrival at MEWIGEN.
3. The quality, quantity and concentration of the sample is in accordance to the requirements for the corresponding analysis.
4. The submission form is filled completely or at a minimum the following information is presented otherwise: unique patient identifier, the test requested, kind of the material send for analysis, a confirmation for the patient’s consent to the test and the contact/billing information of the ordering health care professional as well as his/her signature and affiliation. These documents need to fulfill the requirements under the German Genetic Diagnostic Act (GenDG).

An order is accepted by MEWIGEN if the request is either confirmed in writing or MEWIGEN starts to execute the respective analyses. This applies also for additional analyses on specimen already present at MEWIGEN, when the customer sends such a request by mail or e-mail.

MEWIGEN reserves the right to refuse individual requests. In particular, if the analyses cannot be performed due to technical or capacity reasons. The customer will be informed as soon as possible.

The ordering health care professional is responsible for providing a genetic consultation to the patient before ordering and for communication of the findings.

The customer is responsible for the organization and payment of sample shipment and MEWIGEN shall not be held responsible for damage or loss of a sample during transportation or possible delays.

In general patients may have the right of objection at any time for a genetic test without giving a reason. In case of such a withdrawal MEWIGEN should be informed immediately. The incurred expenses until information about the withdrawal is received will be invoiced. Money paid already for the analysis cannot be reclaimed.

 

Prices and Payment

The customer will be invoiced by e-mail or regular mail for the ordered analysis soon after execution and reporting. Upfront fees may be agreed. Prices depend on type and extent of intended analysis and may be given on a specific request. MEWIGEN has the right to change prices. The current price at the time of placing the order is valid. VAT is generally not included in the price, will be stated separately on the invoice and covered by the customer.

The customer agrees to pay the invoice in Euro (€) within 30 days upon receipt of the invoice by bank wire transfer. MEWIGEN reserves the right to charge overdue fees of 0,05% per calendar day, if the payment is delayed. Furthermore, MEWIGEN may stop analysing samples and issuing results if the payment is overdue. Invoice number and date should be indicated as reason for payment.

 

Sample analysis and issuing of the results

MEWIGEN will analyse the received samples in respect to the genetic test indicated on the submission form. The analysis may be stopped in case the material is of poor quality and not suitable for the intended use. The customer will be informed and MEWIGEN is entitled to ask for additional material and to charge an appropriate amount of the costs already incurred.

The processing time depends on the genetic test ordered. It is usually between 2 and 6 weeks for most of the analyses and is not binding, unless MEWIGEN has agreed in writing. MEWIGEN is dedicated to fulfill all orderings in a timely manner, but cannot be held responsible for a delay in issuing the result due to unanticipated, time-consuming issues outside of its control or force majeure. If MEWIGEN still fails to execute the order in an appropriate grace period the customer may withdraw from the contract.

The results of the analyses will be issued in a clear and concise written report directed to the customer. The customer shall present the report to the patient or third parties (depending on the patient’s consent) without changes and only in its entirety. The interpretation of the obtained results always reflects the current scientific state of knowledge and may change over time. Incidental findings are reported according to the ACMG recommendations for reporting of secondary findings [PMID: 27854360].

MEWIGEN cannot be held responsible for differences in the results, if later a second sample of the patient is send for confirmation.

 

Confidentiality

MEWIGEN only collects the patient data necessary for the analyses and interpretation of the results. MEWIGEN will not disclose personal information and details of the analysis to third parties.

The remaining material is destroyed upon completion of the analyses. According to the German Genetic Diagnostic Act (GenDG) documentations of the test results will be destroyed after 10 years.

MEWIGEN is entitled to use regular mail, e-mail, fax and telephone for the communication with the customer, unless the customer requests a certain form of communication in writing. MEWIGEN is released from claims arising from the risks due to use of these communication forms.

 

Liability

The law of the Federal Republic of Germany applies exclusively. Court of jurisdiction shall be Dresden/Germany.

The warranty is limited to the error-free execution of the specific assay, the application of careful scientific assessment and compliance with recognized guidelines. Notification of obvious errors in the report shall be made in writing two months after issuing of the result. MEWIGEN will fix the results and where appropriate perform additional investigations. If in case of a repeated analysis, the correctness of the previous analysis is confirmed, the customer has to pay the additional expenses.

MEWIGEN is not liable to lost money or other damages to the customer, unless it was caused by MEWIGEN with intent or gross negligence.

MEWIGEN is not responsible for legal, material, social, psychological or moral consequences that may appear relating to the genetic test. Furthermore, MEWIGEN shall have no liability for the deductions, inferences and generalizations drawn from the reported results by the health professional, the patient or third parties.

 

Final Provisions

Different agreements, omissions or additions to these terms and conditions must be in writing.

Invalidity of a provision does not affect validity of the remaining provisions. The invalid provision shall be replaced by a provision coming closest to the intent of the invalid one.