PRIVACY STATEMENT AND USER AGREEMENT
GlutenID Test – Background
The GlutenID (GID) test is a DNA-based screening method for HLA risk genotypes which can determine presence or absence of the DQ2 and DQ8 alleles associated with celiac disease (CD). GID results should be evaluated in the context of an individual’s clinical and other laboratory findings including standard of care serology and pathology review of small bowel biopsy tissue. The GID test is designed and distributed by Targeted Genomics LLC, a privately held test developer and broker with principal place of business at 711 Navarro Street, Suite 235, San Antonio TX 78205. Targeted Genomics coordinates genomic testing through its website www.targetedgenomics.com.
Test kits for the GlutenID test are purchased and registered to the user through the website and marketed with the slogan “Do you know your GlutenID?TM The test kit contains swabs in dry transport tubes for non-invasive collection of cheek cells. The swab samples are sent to a CAP/CLIA certified laboratory where DNA-based testing is performed by next generation sequencing (NGS) and results reported back to the client via the email address supplied during kit registration.
Our dedication to your privacy is paramount. Please read below our policies covering data handling and testing materials.
We collect only the data necessary for account registration, kit purchase, positive identification of your sample by the laboratory, and email address for results reporting. NO SENSITIVE INFORMATION ABOUT YOU OR YOUR HEALTH IS REQUESTED OR REQUIRED PRIOR TO TESTING.
The GlutenID 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 GLUTEN ID TEST.
Your gluten ID test results are reported to you alone unless the test was ordered for you by your personal physician. You may independently choose to disclose your GlutenID to friends, family, and/or other physicians but this service is not provided through Targeted Genomics.
Testing material consists of two swabs in dry transport tubes used to collect cells from inside the mouth also known as buccal cells. Once the laboratory has extracted adequate DNA for GlutenID testing from the swabs, they are discarded. Upon completion of GlutenID testing, excess DNA is also destroyed by the laboratory. NO BIO- BANKING SERVICES ARE OFFERED THROUGH TARGETED GENOMICS.
By purchasing a kit and submitting swab samples in the GlutenID kit you are agreeing to and accepting the terms of service in this User Agreement.
The GlutenID test is non-invasive without associated physical risks. However, due to the limited material collected with cheek swabs the laboratory may not be able to process your sample due to inadequate DNA. If an initial sample kit cannot be processed, Targeted Genomics will provide another sample kit at no charge. If a second sample kit fails, testing is discontinued and a full refund provided. In a minor percentage of samples, the laboratory processing results are non-interpretable “ERRORS” and as this is a known consequence of genetic testing, no refunds will be provided in these cases. In validation accuracy studies, the GlutenID test methodology was shown to have > 90% sensitivity and specificity for predicting celiac disease genetic risk alleles. However, in some non- European populations, there is the risk of false positive/negative results due to the presence of rare HLA-haplotypes not covered by the assay. If clinically indicated, all GlutenID results should be followed up and interpreted in the context of serology testing including IgA anti-TG antibodies and IgA antiendomysial antibodies. If the test user is found to be IgA deficient, IgG anti-tTG antibody testing may be substituted.
GlutenID results should be discussed with your physician
GlutenID is an educational and informative method for identifying individuals at risk for developing dietary gluten intolerance thus recommendations for dietary gluten are included in the results reporting. However, these results are not to be considered as medical advice. No health and wellness behaviors should be changed based solely on GlutenID results. The impact of each individual’s GlutenID must be evaluated in context of complete health and wellness status as assessed by their personal physician or other qualified healthcare provider.
Sharing of GlutenID results
If GlutenID 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 GlutenID results with any family, friends, or third parties, and such information should be shared judiciously.
• You consent for GlutenID 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 swabs and residual DNA) will be discarded at the completion of GlutenID testing.
• You understand that GlutenID results are not intended to independently diagnose, prevent, or treat disease and you are responsible for how these results are incorporated into a wellness or treatment plan.
• 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 confirm that you have (or will) register your (and any dependents) kits before sending the sample(s) to the laboratory. UNREGISTERED KITS WILL NOT BE PROCESSED.
• If you purchased the GlutenID kit from another state or outside the US, you confirm that processing your sample in a US laboratory is not banned or restricted by your country or state.
• You agree to receive GlutenID results emailed directly to you, or to your physician if he/she ordered the testing.
• You take responsibility for any and all sharing of your GlutenID with others including but not limited to healthcare providers, friends, family members, social media, and co-workers.
• You acknowledge that Targeted Genomics owns all legal rights, title and interest in the GlutenID test including but not limited to copyrighted material, trademarks, and intellectual property. These rights are nontransferable to test users and copyrighted material may not be reproduced in any medium.
• YOU ACKNOWLEDGE THAT TARGETED GENOMICS SHALL NOT BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL, OR EXEMPLARY DAMAGES RESULTING FROM USE OF THE GLUTEN ID TEST. YOU ALSO AGREE TO INDEMNIFY, DEFEND, AND HOLD HARMLESS TARGETED GENOMICS FOR ANY LIABILITY ARISING FROM THE GLUTEN ID TEST RESULTS.
This Agreement supersedes all prior negotiations, understandings, and agreements between you and Targeted Genomics with regard to the purchase of a GlutenID test kit, and constitutes the entire understanding and 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 and assigns.