USER AGREEMENT AND PRIVACY STATEMENT

USER AGREEMENT AND PRIVACY STATEMENT

CeliacDx Report – Background
The CeliacDx report is a comprehensive report for Celiac disease, comprising a board certified pathologist’s review of: i) small bowel biopsy results; ii) tTg antibody testing; and iii) genetic testing. The goal of this report is to provide healthcare providers and patients with an understandable, written report with one of the following classifications based on the three tests:

Classification	Antibodies	Biopsy	Genetics
Celiac Disease	Positive	Positive	Positive
Potential Celiac Disease	Positive	Negative	Positive
Seronegative Celiac Disease	Negative	Positive	Positive
Negative for Celiac Disease	Negative	Negative	Positive/Negative

If test results provided to CeliacDx are inadequate for making a positive/negative classification for Celiac Disease, recommendations for followup testing will be included in the pathology consultation report. It is the patient/physician’s responsibility to obtain any recommended followup testing. Upon request, An updated report incorporating the additional test results information may be issued.

The CeliacDx consultation report contains critical information for a user’s doctor or health care provider. The CeliacDx genetic test and report are only available in certain states detailed on the company’s website.

Privacy Statement and Genetic Test Results
CeliacDx only collects the data necessary for account registration, genetic test kit purchase, positive identification of your sample by the laboratory, and email address for results reporting. Additional questions in the CeliacDx questionnaire provide valuable information regarding lifestyle and prior small bowel biopsy and/or tTg antibody testing. This information is used in compiling the final report. CeliacDx uses a HIPAA-compliant server, private-encrypted email service, and the company has cybersecurity protocols in place.

The CeliacDx genetic test uses SNP-based genotyping to analyze celiac disease associated genetic loci: the DQA1 and DQB1 genes on chromosome 6p which comprise the genetic basis of celiac associated DQ2 and DQ8 haplotypes. NO OTHER AREAS OF THE GENOME ARE INTERROGATED BY THE CELIACDX GENETIC TEST. If your test is patient-ordered, your results will be emailed to you. If your test is provider-ordered, your report will be emailed to your physician or other healthcare provider. You may independently choose to disclose your genetic results to friends, family, and/or other physicians but this service is not provided through CeliacDx

Credit card data for kit purchase through the CeliacDx website is managed and protected by Stripe. Documentation of the Stripe privacy policy is can be found at https://stripe.com/us/privacy.

Testing Material
Testing material in the genetic test consists of two saliva collection tubes intended to collect DNA samples for analysis. Once the laboratory has extracted adequate DNA for genetic testing from the tubes, they are discarded. Upon completion of genetic testing, excess DNA is also destroyed by the laboratory. NO BIO-BANKING SERVICES ARE OFFERED THROUGH CELIACDX TO THIRD PARTIES. Your genetic information is not being banked or sold.

User Agreement
By purchasing a kit and submitting saliva samples in the CeliacDx genetic test kit you are agreeing to and accepting the terms of service in this User Agreement. The scope of the services rendered by CelaicDx is strictly limited to the sale of a genetic test kit and rendering of a report. No continuing medical services are contemplated under this agreement beyond these two services.

Potential Risks
The CeliacDx genetic test and report is used for making a Celiac classification. These results are not considered medical advice or treatment for changes in the user’s life. No health or wellness behavior should be changed before the user consults with his or her attending physician or other healthcare provider about the results in the CeliacDx report. The impact of each individual’s CeliacDx report must be evaluated within the health and wellness as assessed by each user’s attending physician or other qualified healthcare provider. This doctor-patient relationship is not provided by CeliacDx.

Sharing of CeliacDx Results
If CeliacDx testing is ordered by your physician or you choose to share the results with a healthcare provider, this information can become part of your medical record. You assume responsibility for the sharing of any CeliacDx results with any family, friends, or third parties, and such information should be shared judiciously.

Terms of Use
By purchasing and using the CeliacDx Genetic Test you agree to the following terms of use:
You consent for genomic testing as a DNA-based evaluation of your susceptibility for developing intolerance to gluten consumption through testing of the HLA-DQA1 and DQB1 genes. You understand that other genomic regions and HLA haplotypes are not included in the test.

• You acknowledge that all materials (including saliva collection devices and residual DNA) will be discarded at the completion of genetic testing.
• You understand that genetic results combined with the CeliacDx Report are not intended to independently prevent or treat Celiac disease and you are responsible for how these results are incorporated into a wellness or treatment plan in accord with your personal physician or other qualified healthcare provider.
• You are 18 years of age or older and authorized to purchase testing for yourself or your dependent(s) under the age of 18.
• You guarantee that the samples provided are your own, or have been properly designated for your dependents under the age of 18.
• You acknowledge that all information provided to CeliacDx is accurate, including name, age, biopsy and/or antibody testing results, insurance information, email address, phone number, mailing address, and card payment data.
• You possess the software and hardware necessary to access the CeliacDx website, receive emails from CeliacDx, and open reports sent by CeliacDx.
• You reside in the USA and in one of the States listed on the CeliacDx website, where CeliacDx is allowed to sell genetic test kits and issue its report.
• You agree to receive CeliacDx results emailed directly to you, or to your physician if he/she ordered the testing. You assume the responsibility of monitoring your email account for communications from CeliacDx, including checking any spam or junk folder used by your email provider.
• You take responsibility for any and all sharing of your CeliacDx report with others including but not limited to: healthcare providers, friends, family members, social media, and co-workers.
• You acknowledge that CeliacDx owns all legal rights, title and interest in the genetic test and accompanying diagnostic report including but not limited to copyrighted material, trademarks, and intellectual property. These rights are non-transferable to test users or any other third parties, and copyrighted material may not be reproduced in any medium.
• You acknowledge that while CeliacDx has a HIPAA-compliant server, a secure email, and cybersecurity protocols in place, electronic communications can never be fully guaranteed in delivery and safety. You relieve CeliacDx of any liability connected with technology failure or interference by bad actors.
• YOU ACKNOWLEDGE THAT CELIACDX SHALL NOT BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL, SPECIAL CONSEQUENTIAL, OR EXEMPLARY DAMAGES RESULTING FROM THE USE OF THE CELIACDX GENETIC TEST, REPORT, OR THE COMPANY WEBSITE. YOU ALSO AGREE TO INDEMNIFY DEFEND, AND HOLD HARMLESS CELIACDX FOR ANY LIABILITY ARISING FROM USE OF THE CELIACDX GENETIC TEST, REPORT, AND USE OF THE COMPANY’S WEBSITE.

Changes in User Agreement
CeliacDx reserves the right to update this User Agreement, and user assumes the responsibility of reading this User Agreement before each purchase.

Governing Law 
This Agreement is governed by and shall be construed in accordance with the laws of the State of Texas.

Venue, Mediation, Arbitration
The Parties agree that in the case of a dispute under this Agreement, they will submit the case first to a good faith mediation within 90 days of the onset of the dispute. The mediator shall be located in Bexar County, Texas or elsewhere as agreed to by the Parties. Absent a successful mediation, the Parties hereby waive their right to a trial by jury and agree that any controversies arising out of the terms of this Agreement or its interpretation shall be resolved in accordance with the Federal Arbitration Act and the rules of the American Arbitration Association. The arbitration shall occur in Bexar County, Texas or elsewhere as agreed to by the parties. The arbitrator’s judgment may be entered in and enforced by any Bexar County Court or District Court at Law. User must assert a dispute within one year after the cause of the dispute occurs, or it shall be forever barred.

Entire Agreement/Merger
This Agreement supersedes all prior negotiations, understandings, and agreements between you and CeliacDx with regard to the purchase of a genetic test kit, and constitutes the entire understanding and agreement.

Waiver
Waiver by one party hereto or breach of any provision of this Agreement by the other shall not operate or be construed as a continuing waiver or a waiver of any other provision of the Agreement.

Review of Agreement
By executing this Agreement, you agree and represent that you have had an adequate opportunity and sufficient time to review the terms of this Agreement and seek legal or medical counsel prior to execution.

Successors and Assigns.
This Agreement shall be binding upon and inure to the benefit of the parties hereto, and their respective successors, assigns heirs, executors, and other legal representatives.

Severability
If any provision of this Agreement, or any portion thereof, is held to be invalid and unenforceable, then the remainder of this Agreement shall nevertheless remain in full force and effect.