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  • Jefferson Adams

    FDA Approves New Test for Celiac Disease

    Jefferson Adams
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    Reviewed and edited by a celiac disease expert.

      Diagnosing autoimmune conditions can sometimes be difficult, so any progress toward faster, cheaper, or more reliable testing methods could play a significant role in improving diagnosis and reducing time to treatment.


    Image: CC BY 2.0--erica.hicks
    Caption: Image: CC BY 2.0--erica.hicks

    Celiac.com 07/18/2019 - Autoimmune conditions cause the body to attack its own healthy cells. There are nearly one-hundred known autoimmune conditions, including lupus, celiac disease, and rheumatoid arthritis.

    Diagnosing autoimmune conditions can sometimes be difficult, so any progress toward faster, cheaper, or more reliable testing methods could play a significant role in improving diagnosis and reducing time to treatment. Approval by the FDA is key to making such tests available commercially.



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    A New York startup company, Aesku.NY, has received FDA approval for tests to detect two of those autoimmune diseases, with tests for other diseases expected to follow. 

    The approved tests for celiac disease, and the connective tissue disorder, lupus, would still require patients who screen positive to receive further testing for a specific diagnosis.

    However, the tests are designed to be cost effective, and efficient, potentially increasing the availability of a reliable screening method for diseases that are best caught and treated early.

    "In many autoimmune diseases, if you don't have a good test, it takes many years to pinpoint a diagnosis," says company founder Dr. Vijay Kumar. "Again, coming back to celiac disease, it used to be 3-5 years before a diagnosis is made," he added, "[t]hink about how many physicians, clinicians, laboratories, the patient might have gone through."

    Aesku.NY tests are produced domestically, in Buffalo New York.

    Stay tuned for more news on developments in celiac disease diagnostics, and related topics.

    Listen to WBFO's Mike Desmond

    Edited by Jefferson Adams

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    I think there wasn't much more info available on the test than what the article gave at the time since the FDA approval was brand new. There is no name given for the test in the article but I image you could run it down by contacting the company who developed it. That information is contained in the article. But yes, a follow-up article on this test would be nice.

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  • About Me

    Jefferson Adams is Celiac.com's senior writer and Digital Content Director. He earned his B.A. and M.F.A. at Arizona State University, and has authored more than 2,500 articles on celiac disease. His coursework includes studies in science, scientific methodology, biology, anatomy, medicine, logic, and advanced research. He previously served as SF Health News Examiner for Examiner.com, and devised health and medical content for Sharecare.com. Jefferson has spoken about celiac disease to the media, including an appearance on the KQED radio show Forum, and is the editor of the book "Cereal Killers" by Scott Adams and Ron Hoggan, Ed.D.


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