At-Home Celiac Test Coming Soon to U.S. Market

By Vanessa Maltin
NFCA Director of Programming & Communications

One of the most common complaints I hear from patients is “my doctor won’t test me for celiac disease.”

These are patients who have clear symptoms of celiac disease and should be screened, but can’t get a doctor to acknowledge that celiac is one of the most common conditions in the United States and affects more than 3 million people!

The good news is that within the next year, patients could be able to accurately and easily screen themselves for celiac disease from the comfort of their own home. And, it won’t cost a fortune…only about $50.

For the first time, Health Canada has approved the Biocard Celiac Test Kit, an at-home test that measures (anti-tTG) IgA antibodies from a fingertip blood sample. The U.S. FDA is currently evaluating the test and is expected to grant approval in the United States sometime in 2009.

The test comes from 2G Pharma and was developed by two women who are best friends and worked for years in the corporate pharmaceutical world. Their closest friend was diagnosed with celiac disease after more than 10 years of severe suffering from celiac and almost bleeding to death from intestinal damage. The ladies used all of their skills to find and bring to market a test that would prevent anyone from suffering the same pain their friend had while trying to get a celiac diagnosis.The Biocard Celiac test has been approved in Europe since 2005.

So, how does the test work? The Biocard Celiac Test measures the presence of antibodies in the blood. Certain antibodies in a person’s blood indicate whether or not the body is having an immune system response to the presence of some foreign substance. For people with celiac disease, the foreign substance is gluten!

The test is simple and quick to administer! And, the company even created a video with step-by-step instructions so that you will be sure to take it correctly. Watch the video! Just be sure that you are consuming a diet containing gluten in order to obtain accurate results.

To take the test, start by setting up all of the different parts of the kit. Gently massage your index finger to drive blood to it. Then wipe your finger with an alcohol swab and let it dry. Prick your clean fingertip with the lancet that is included in the test kit. It is a very small needle, so it is practically painless. Gently press the blood out of your fingertip into the vile and mix it with the included buffer solution. Turn the vile upside down and mix the blood and buffer together. Then squeeze three drops of the blood/buffer liquid into the sample holder. Wait 10 minutes to read results.

The Biocard Celiac Test is positive if you have two red lines on the test card. One red line appears in the control field, which indicates that you have done the test correctly. The second red line will only appear if you are having an immune system response to the gluten protein. If the test comes out positive for celiac disease, the makers of the test recommend consulting with a doctor to confirm the diagnosis with an intestinal biopsy.

How reliable is the test? According to the creators at 2G Pharma Inc., the test is as accurate as a tissue transglutaminase (tTG) laboratory test that your doctor would request and uses the same technology to detect specific IgA antibodies that react with tissue transglutaminase (tTG), a well known indicator of celiac disease. The test has been approved by Health Canada and meets all of the European medical device requirements for a home test.

Additionally, a study published in the British Medical Journal found that the simple rapid antibody test allowed nurses working in primary care medical offices to detect celiac disease in patients who were not picked up during routine clinical care. The study evaluated 2,690 children around six years old and 120 nurses. The study found 31 newly diagnosed celiac patients. The rapid test accurately detected celiac disease in 30 of the 31 patients.

The Biocard Celiac Test is a landmark development for the entire celiac community. It is the first time that patients will have immediate access to find out if they have the autoimmune disorder. It makes celiac disease as easy to diagnose as strep throat! It will also allow for simple mass screening, especially amongst family members of those already diagnosed.

So, be sure to check back soon—I’ll have all of the details for when the test becomes available in the United States and how you can get it! Also, be sure to keep visiting the Beyond Celiac website to find out how 2G Pharma will be working with the NFCA on several programs in the United States next year!

Posted 10/24/2008