Meet Celiac Disease Foundation Proud Sponsor empowerDX – an online shop for FDA-approved health testing that offers the at-home Celiac Disease Risk Gene Test. Celiac disease is a genetic autoimmune condition where the body’s immune system attacks the small intestine when gluten is consumed. Currently, 60-70% of people with celiac disease are considered to be misdiagnosed – or undiagnosed, and more than 99% of people who develop celiac disease carry one of the genetic variants identified in the empowerDX at-home Celiac Disease Risk Gene Test. Using a simple, painless mouth swab, this test can help you better understand the risk to you and your loved ones of developing celiac disease in your lifetime. If you have symptoms of celiac disease and a positive gene test result, it is important to work with your health care provider to determine an appropriate diagnosis and treatment.

1. Tell us about empowerDX and the Celiac Risk Gene Test.

empowerDX , a subsidiary of Eurofins Scientific, has access to some of the most advanced laboratories in the world. We offer unique at-home testing that often has barriers to access, helping people better understand their health. Our Celiac Risk Gene Test is a simple, at-home mouth swab that provides a risk assessment for celiac disease in your lifetime and is available for ages 2 and up in all 50 states

2. What does the test measure? 
The Celiac Risk Gene Test looks at 3 HLA gene markers: HLA-DQ2 + HLA-DQ8 + DQA1*05. HLA stands for human leukocyte antigen; they are encoded by highly complex genes that tell parts of your immune system how to function properly. This testing is difficult to access and is not part of standard DNA testing. Our test identifies the genetic predisposition to HLA factors that are necessary for the development of celiac disease. 

3. How is the DNA analyzed? 
DNA is isolated from the saliva on the mouth swabs. Molecular testing (PCR-RSSO) determines the presence or absence of certain HLA markers associated with greater risk for celiac disease. This approach is more complex and provides higher resolution than other methods like RT-PCR. 

4. Do you have to consume gluten on a regular basis to get an accurate result? 
No – these genetic markers will not change based on gluten intake. 

5. Is this celiac HLA gene test the same as the celiac tTg-IgA antibody test that at the doctor’s office? 
No, these are different tests. Our HLA celiac risk gene test assesses whether you have a genetic risk of having, or developing, celiac disease in your lifetime. The tTg-IgA antibody test for celiac disease is a screening blood test with limitations that are important to understand. Antibody testing requires that you eat gluten for the test to be accurate, and gluten antibodies can often only be detected at later stages of the celiac disease progression. Ideally, you’d catch the disease earlier, when the villi that line your small intestine are healthier and better able to heal. In later stages the villi are severely damaged, so a positive antibody test at these later stages can lead to a slower, more difficult healing process. 

6. How long does it take to receive the results? 
You will receive results within 10 business days of the lab receiving your sample.

7.  How will a doctor know that the empowerDX test results are accurate? 
Our laboratory is: 

  • Clinical Laboratory Improvement Amendments (CLIA) certified by the Centers for Medicare & Medicaid Services (CMS);
  • Accredited by the American Society of Histocompatibility & Immunogenetics (ASHI); and
  • Staffed with D. professionals and experienced technical personnel that are certified by the American College of Histocompatibility & Immunogenetics (ACHI).

Additionally, we worked with Eurofins DPT Laboratory to develop a best-in-class celiac HLA gene test because of their extensive experience in organ transplant testing, which is considered some of the most complex lab testing in the world.

8. What makes the empowerDX Celiac Risk Gene Test unique compared to other tests available on the market today? 

Our Celiac Risk Gene Test is easy to collect in the comfort of your own home, and we worked with a top lab in the USA to bring this celiac HLA gene test to market. Our test is for anyone ages 2 and up, and it’s available in all 50 states. The turnaround time for your lab results is among the fastest in the industry.

9. How can consumers buy the test? 

Anyone can order the test on here