Terms & Conditions

PRIVACY STATEMENT AND USER AGREEMENT

GlutenID Test – Background

Your “GlutenID” is your genetic risk to develop celiac-associated gluten sensitivity also called “celiac disease.” The GlutenID (GID) test is a DNA-based screening method for HLA risk genotypes which 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 5 Mason, Irvine CA 92618. Targeted Genomics coordinates genomic testing through its website www.targeted-genomics.com.

Test kits for the Gluten ID test are purchased and registered to the user through the website and marketed with the slogan “Do you know your Gluten ID?TM The test kit contains one ORAcollect OCD-100 swab for non-invasive collection of a saliva sample. The samples are sent to PacificDx, a  CAP/CLIA certified laboratory where DNA-based testing is performed by next generation sequencing (NGS) and results reported back to the client via a secure file sharing email portal.

PRIVACY STATEMENT

Our dedication to your privacy is paramount. Please read below our policies covering data handling and testing materials.

Protection of your Demographic Data

We collect only the demographic 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 REQUIRED PRIOR TO TESTING.

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

Protection of your Genomic Data

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 Gluten ID to friends, family, and/or other physicians but this service is not provided through Targeted Genomics.

The Gluten ID test uses SNP-based genotyping to analyze celiac disease associated genetic regions also known as loci: specifically, the DQA1 and DQB1 genes on chromosome 6p which comprise the genetic basis of celiac risk associated HLA-DQ2 and HLA-DQ8 haplotypes. NO OTHER AREAS OF THE GENOME ARE INTERROGATED BY THE GLUTEN ID TEST.

After completion of the testing process your data is securely stored for a minimum of two years as required by CLIA/CAP regulations for clinical molecular laboratories. After two years the data files are deleted. TARGETED GENOMICS DOES NOT SHARE OR SELL YOUR DATA TO ANY THIRD PARTY. In the event of  sale, acquisition, or merger of Targeted Genomics with another entity, the data policy will remain intact.

Protection of your Testing Material 

Testing material consists of saliva samples in the OCD-100 collection device used to collect saliva from inside the mouth. 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 de-identified and discarded by the laboratory.  NO BIO- BANKING SERVICES ARE OFFERED THROUGH TARGETED GENOMICS.

USER AGREEMENT

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.

Potential Risks 

Insufficient DNA

Due to the limited material collected with a saliva collection device the laboratory may not be able to process your sample due to insufficient 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.

False Positive or Negative Results

In validation accuracy studies, the Gluten ID 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 Gluten ID 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.

Gluten ID results should be discussed with your physician 

Gluten ID 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 Gluten ID results. The impact of each individual’s Gluten ID must be evaluated in context of complete health and wellness status as assessed by their personal physician or other qualified healthcare provider or licensed genetics counselor.

Sharing of Gluten ID results 

If Gluten ID 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 Gluten ID results with any family, friends, or third parties, and such information should be shared judiciously.

Terms of Use

By purchasing and using the Gluten ID test you agree to the following terms of use:

• • You consent for Gluten ID 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 the test covers only the HLA-DQ2, HLA-DQ8, HLA-DQ2.2, and HLA-DQ7 haplotypes. 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 Gluten ID testing.

• You acknowledge that your genomic data will be securely stored by the laboratory only as long as it is required by CAP and CLIA regulations. After two years the data will be deleted. UNDER NO CIRCUMSTANCES WILL YOUR GENOMIC DATA BE SOLD OR SHARED WITH ANY THIRD PARTY.
• You understand that Gluten ID 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 Gluten ID kit from outside the US you confirm that processing your sample in a US laboratory is not banned or restricted by your country.
• You agree to receive Gluten ID results emailed securely and directly to you, or to your physician if he/she ordered the testing.
• You take responsibility for any and all sharing of your Gluten ID 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 Gluten ID test including but not limited to copyrighted material, trademarks, and intellectual property. These rights are non-transferable 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.

Entire Agreement/Merger

This Agreement supersedes all prior negotiations, understandings, and agreements between you and Targeted Genomics with regard to the purchase of a Gluten ID 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.