empowerDX Launches Easy At-Home Celiac Disease Genetic Risk Test
Eurofins Scientific company named official Celiac Disease Foundation sponsor
FRAMINGHAM, Mass.--(BUSINESS WIRE)--#autoimmune--Clinical Enterprise, Inc. d/b/a empowerDX, today announced the launch of a revolutionary at-home Celiac Risk Gene Test. The launch, combined with becoming a sponsor of the Celiac Disease Foundation, puts empowerDX in a unique position to help a large population of Americans in debilitating physical and mental pain without clear answers. The Celiac Disease Foundation leads the fight to increase the rate of diagnosis, improve treatments, and find a cure.
Celiac disease is a genetic autoimmune condition where the body’s immune system attacks the small intestine when gluten is consumed. More than 99% of people who develop celiac disease carry one of the genetic variants identified in our test. Symptoms can range from abdominal issues and joint pain to brain fog, depressed mood, and concentration issues. If left untreated, celiac disease can lead to serious health complications including heart disease, intestinal cancers, and fertility issues.
An estimated three million Americans have celiac disease. With increased risk awareness and accessible testing, more of these individuals can be properly diagnosed. Currently, 60-70% of individuals with celiac disease are misdiagnosed or undiagnosed. On average, it takes 6-10 years for a symptomatic individual to be diagnosed with celiac disease. Celiac disease can present with a spectrum of gastrointestinal and non-gastrointestinal symptoms which can make early diagnosis challenging. Knowledge of disease risk facilitates the path to proper diagnosis for physicians and healthcare providers. The empowerDX Celiac Risk Gene Test provides access to high quality HLA genetic testing, which requires specialized equipment and rare expertise, at a remarkable value.
Unlike most blood-based celiac disease genetic tests, the empowerDX assay uses a sample taken from two non-invasive mouth swabs to analyze HLA markers. Results for each marker are provided to individuals through a secure online portal ten business days after sample-receipt at the company’s CLIA-certified lab. The test is $199 and available for ages 3+.
Susceptibility to celiac disease is strongly associated with the HLA alleles DQA1*05:02 and DQB1*02:01, but these markers alone do not necessarily mean people have or will develop the disease. Individuals with the presence of genetic markers should consult with their physician on how to monitor for celiac disease and improve their overall gut health. Testing negative for all three markers means the lifetime risk of developing celiac disease is less than one percent.
The revolutionary at-home Celiac Risk Gene Test is characteristic of the ethos defining the mission of empowerDX. Celiac disease affects the lives of millions of people in the US, and this test bridges to the gap between demand and access to a test critical to lifetime risk assessment. Eurofins Donor & Product Testing, Inc. performs the molecular testing and carries extensive experience to test and interpret HLA results.
Boston-area based, empowerDX, now has a robust portfolio of more than 20 products, including the first at-home PFAS test as well as MTHFR, CoQ10, vitamin D, APOE, and one of the most sensitive at-home COVID PCR tests on the market. The start-up strives to make testing for a wide range of issues, including heart, sexual and mental health, thyroid, and vitamin-deficiencies, affordable and accessible to the consumer.
For more information on the empowerDX Celiac Risk Gene Test, please visit empowerDXlab.com.
Launched in 2019 empowerDX is the online shop for easy at-home health testing. empowerDX specializes in FDA-authorized COVID-19 testing, women’s health, men’s health, sexual health, and general wellness testing. Along with its affiliated CLIA-certified clinical laboratories in the U.S., empowerDX is positioned to lead the market for cutting edge, self-collected diagnostic and non-diagnostic testing. All clinical tests are reviewed by empowerDX’s licensed ordering physician to eliminate the need for a phlebotomist or a telemedicine-observed sample collection. Welcome to health clarity with just a few clicks. The company is based outside of Boston, in Framingham, MA and is a subsidiary of the Eurofins Group. To learn more, please visit empowerdxlab.com.
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- As of April 2022, our SARS-CoV-2 assay offers the best sensitivity of the 117 laboratories that have submitted results to FDA’s SARS-CoV-2 Reference Panel, with a limit of detection (LoD) of 180 NAAT Detectable Units/mL1. Source:https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/sars-cov-2-reference-panel-comparative-data#results