CarpeVITA Genomics Terms of Service
Please Read Carefully. If warranted, obtain professional counseling to fully understand the benefits of genomic testing and the terms and conditions of the CarpeVITA Genomics GenoTest services. This Agreement contains the terms and conditions related to the genomic testing and analysis services provided by CarpeVITA Genomics, Inc. (CV Genomics):
CV Genomics will make every effort to provide the best, personalized service and keep our clients informed throughout the process. If you have questions or if any information provided is not clear, please contact us at firstname.lastname@example.org. We are happy to assist you.
- Background – Genotyping of DNA, Interpretation and Analysis
The CV Genomics GenoTest process is designed to:
(a) inform an individual through his/her healthcare provider of the characteristics investigated, including but not limited to: degree of susceptibility to the certain conditions, health issues, illnesses or diseases, and any genetic indicators of the likely response to certain lifestyle or therapeutic interventions; (b) provide information based on the scientific evidence available of his/her susceptibility to certain conditions, but DOES NOT PROVIDE CERTAINTY of developing or not developing a condition, health issues, illness or disease in the future; (c) make predictive analysis a useful and effective tool to provide information related to the possible preventive lifestyle, monitoring, or therapeutic interventions that an individual can take as guided by a healthcare professional.
The CarpeVITA GenoTest and its interpretation must be presented to the individual and explained by a healthcare professional.
Within this document, the terms have the following meanings:
CV Genomics – A Delaware corporation with offices at 240 N. James Street, Suite 103, Newport, DE 19804.
Laboratory – in the US, RUCDR – Rutgers University Center for DNA Research in New Brunswick, NJ and in Europe, Asia and Australia – Genomix4Life Ltd. An international licensed genetic testing laboratory and affiliate of the University of Salerno; in Rome, Italy. All CV Genomcis laboratory partners are certified by leading certifying and governing bodies.
GenoTest – The genomic tests services and their interpretation.
Result – Combination of the report of DNA indicators produced by the Laboratory and its interpretation, made on the basis of scientific literature and policies adopted by specialists, aimed to inform the Applicant about genetic characteristics and their predispositions based on published scientific evidence.
Applicant – The capable adult person who wishes to take a GenoTest, has signed the Informed Consent, subscribed to the Terms of Service offered by CV Genomics and agrees to the conditions there of.
GenoTest Requisition Order – A completed order form provided by CV Genomics containing all information required to process the order for testing services and payment thereof.
Healthcare Professional – A licensed healthcare professional or specialist of relevant training and licensure, who, along with the Applicant, receives test results, explains the test results and provides evidence-based prevention and related information to the Applicant.
Kit – The set of materials for collecting DNA, including: the instructions needed to perform the test.
Sample – The biological material collected within the kit provided by CV Genomics and sent to the laboratory in order to conduct the GenoTest.
Service – Preparation, delivery and process useful and necessary for the execution of the GenoTest and the communication of test results to the Applicant through his/her Healthcare Professional.
Payment – The price, payment and billing information described on the GenoTest order.
Description of Service:
The GenoTest services offered by CV Genomics provides an analysis of genetic data derived from the sequencing of single nucleotide polymorphisms, or “SNPs” of an individual including an indication of certain genetic risks. This indication is derived from scientific studies on samples of people with ethnic characteristics equivalent to those of the Applicant.
The CV Genomics service then provides information on the individual’s genetic risk, which is calculated by comparing the output of the DNA scan with the appropriate referenced scientific literature.
The test result is subject to continuous advancement and improvement of the scientific evidence available. The accuracy of the estimates of risk depends mainly on the data used in the risk model, which can be refined or changed over time as a result of new studies and new publications. CV Genomics and its partners and affiliates have carried out a careful selection of scientific knowledge used in the service, however, this body of scientific knowledge cannot be approved by any regulatory body, including the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA).
The GenoTest DNA scan service is to be used for informational purposes only and is not, in and of itself, medical advice or diagnosis. It is not a substitute for the medical advice, genetic counseling, diagnosis or treatment from a licensed Healthcare Professional. The Applicant must seek the advice of a healthcare professional before interpreting the test results or embarking upon any activity in relation to the test results.
Purpose of the GenoTest Service:
The GenoTest can be used as a tool to inform an individual if he or she is a carrier of certain genetic variants that are associated with a higher or lower risk of developing a number of common conditions compared to the average of a referenced population. The GenoTest and the test results and report, when reviewed and explained by a Healthcare Professional, can afford that individual to take advantage of current scientific knowledge to make such lifestyle choices and take such remedial actions as guided by the Healthcare Professional to address those risks.
Scope of the GenoTest Services:
The Services provided by CV Genomics include the following: (a) delivery of the kit to the Applicant for the Test, (b) transfer of the sample to the Laboratory, (c) auditing the completeness of the sample and kit, (d) delivery of the result in a digital format to the Applicant’s Healthcare Professional (a hard copy of the report can be provided at an additional charge) and (e) supervision, guidance and support of the Healthcare Professional and the Applicant in the interpretation of results and (f) optional health coaching and consulting for the Applicant.
Payment by Credit Card or check for each GenoTest is required prior to administration of the test.
Refunds or Credits:
On occasion, continued collection and scan of biological material is not sufficient to complete the GenoTest, or the amount or purity of the DNA sample is insufficient to complete the test. In these cases, CV Genomics will promptly contact the Applicant’s or their Healthcare Professional, who can choose whether to request to receive an additional kit for sample collection at no additional cost.
If the GenoTest scan has repeatedly failed or is not possible due to errors in the collection or extraction procedures or decoding or processing problems in the Laboratory, the Applicant will be entitled to a credit or refund of the amount paid. Subsequent retests or orders from the same collection point will be accepted only on a case-by-case basis at the discretion of CV Genomics.
CV Genomics assumes no responsibility for any delays due to technical difficulties or logistics and reserves the right not to proceed with the GenoTest genetic scan if the kit instructions were not properly followed or completed or if samples are insufficient to complete the testing. CV Genomics reserves the right not to proceed with any GenoTest if in its sole discretion the test may not produce the required results or the information provided is insufficient to proceed. In this case the full amount paid by the Applicant will be refunded.
Responsibility and Liability of CV Genomics:
The genetic scan operation is complex, uses special materials and collects and analyzes a large amount of data. Although CV Genomics, its partners and affiliates use state of the art technology for genotyping and standards of the highest quality, there can be no assurance that the measures of genetic scan will be successful or will provide accurate or complete results. CV Genomics is responsible for assuring that the technologies and internal procedures, including those used in any contracted laboratory, and the protection of genetic data is appropriate, adequate, and meets national and international regulatory standards.
CV Genomics agrees not to disclose to anyone, except to the Applicant’s Healthcare Professional and to the Applicant, the information derived from the GenoTest and its analysis.
CV Genomics agrees to inform the Applicant for up to twelve (12) months of any relevant information on the results of the GenoTest. CV Genomics relies on information provided by the Applicant and his/her Healthcare Professional and does not assume responsibility for the authenticity of the samples. The risk of loss in transport of samples lies with the carriers used for such transport.
CV Genomics assumes no responsibility for any psychological consequences from the Applicant’s test results or any developments, characteristics investigated or revealed by the test, or the assessment or analysis thereof, or for any information provided to the Applicant based on the test results. CV Genomics does not assume liability for information provided to the Applicant by a Healthcare Professional.
CV Genomics does not assume liability for any computer issues or problems related to the download of information provided by CV Genomics or its partners or affiliates. It is the sole responsibility of the Applicant and the Healthcare Professional to protect information downloaded or accessed by adequate measures to protect privacy. Applicants should maintain the secrecy of passwords used to access or download information.
Responsibilities of the Applicant:
Applicant is solely responsible that all information provided to CV Genomics is proper, true and correct. Any changes to the information provided to CV Genomics that occurs after communication has been made must be communicated without delay by the Applicant to CV Genomics. In this case, however, CV Genomics reserves the right not to perform the test if changes are not made promptly or if the changes in the sole discretion of CV Genomics may in some way invalidate the test.
By requesting the service, the Applicant represents and warrants that: (a) the test has been recommended by a Healthcare Professional and that such purchase of the GenoTest Service does not violate any agreement, regulation or law; (b) the Applicant authorizes the laboratory chosen by CV Genomics to process the sample collected; and(c) the Applicant agrees to follow the procedure described in the document.
Minors or those who are mentally incapacitated are not authorized to purchase the service, unless the requisition order is signed on their behalf by a parent, guardian or healthcare proxy. The Applicant is responsible for access control, preservation and security of all data provided by CV Genomics. Applicant will receive test results and related information in digital format and the browser, e-mail, and other computer settings may affect the safety and privacy of such data. It is the responsibility of the Applicant to maintain the adequacy and privacy of their computer, data storage, and communication resources and vehicles and the suitability of these for use in the receipt, storage and use of the GenoTest results.
- Right of Return or Withdrawal
The Applicant may terminate this Agreement and cancel the GenoTest Requisition Order and obtain a refund of the amount already paid by sending a registered letter with return receipt within five (5) days after the date of submission of the GenoTest Requisition provided that the DNA laboratory processing services have not yet commenced.
The Applicant has the right to request that information is to be deleted from the records of CV Genomics, both before (in the case of cancellation) and after the commencement of the testing service by the Lab. If the Applicant requests withdrawal and cancellation of the GenoTest Requisition Order or that Applicant’s information is to be deleted after the DNA laboratory processing has commenced but has not been completed, CV Genomics will delete all Applicant information, cease processing and analysis of the GenoTest and refund fifty percent (50%) of the amount paid by the Applicant. In the event that the GenoTest services has been completed by the Lab, no refund is available, but the Applicant may elect not to receive test results.
- Privacy and Applicant Rights Regarding Changes and Deletion of Data
The objectives of the GenoTest and the science on which they are based require certain information and can be further advanced based on some optional data. This information is requested in the documents included in the Kit. The absence of required information may invalidate the GenoTest. The absence of optional data has no impact on the quality of the result of the GenoTest.
The information collected is held confidentially, subject to strict protection of privacy and is known only by CV Genomics and the Applicant’s Healthcare Professional. The Applicant has the right to modify the information or request that information be deleted. In response to this request, CV Genomics will have the obligation to correct or delete such data from all applicable systems and to verify to Applicant that such action has been taken.
- Changes to this Agreement
CV Genomics reserves the right to modify at any time the terms of this Agreement. Any change will be made known to customers, who may decide to accept the changes or to cancel the contract as defined above in the Article on “Right of Return or Withdrawal”.