The BioCard Home Celiac Test is poised to become a landmark screening method for celiac disease in the United States. It’s already used around the world and, with the help of some of the best researchers out there, the FDA is currently reviewing the test for widespread use across the United States.
To help update all of our loyal readers on the status of the test kit’s approval, we’ve called upon Dr. Daniel Leffler, MD, MS, Director of Clinical Research at The Celiac Center at Beth Israel Deaconess Medical Center. He’s leading the charge on a study to investigate whether the test is as reliable as other screening methods to diagnose celiac disease.
Question 1: How are you testing people using the finger-prick test? Are they coming into the clinic and being tested by a nurse? Are they doing it on their own with supervision?
Answer from Dr. Leffler: “We are actually having people use the test on their own at their home or wherever they feel most comfortable taking it. We are really interested to see if this technology would be a useful way of reaching the undiagnosed population who wouldn’t otherwise come in to be tested or take part in a study.”
Question 2: Who are you testing?
Answer from Dr. Leffler: We are handing out the tests to people with celiac disease and asking them to give the test to their family members who are at-risk for having the condition but have not been recently tested and are on a regular diet. They are left to their own device to take the test.
Question 3: What sort of follow-up guidance do participants receive?
Answer from Dr. Leffler: We provide participants with detailed instructions on what to do after taking the test in terms of follow-up. They have the option of following-up with us at Beth Israel Deaconess or they can follow-up with their own primary care physician. We also let them know that even if they test negative, that having a family member with celiac disease puts them in a high-risk group for the condition and that if they have symptoms, they should consider further screening methods.
Question 4: What are the goals of the study?
Answer from Dr. Leffler: The main goal of the study is to show that this finger prick test kit is a technology that people are willing and capable of using on their own without oversight. Also, we’re looking to find and diagnose a new population of celiac disease amongst family members of those with the condition. It’s so hard for people to get tested even when they want to get tested that this provides a method for people to take control of it on their own.
Question 5: How are you getting people to participate and can others join in?
Answer from Dr. Leffler: So far we’ve worked on a local level in Boston in our clinic and with support groups, however anyone in the United States can participate. If anyone is interested in participating they can contact the Celiac Center at Beth Israel Deaconess Medical Center at:firstname.lastname@example.org