New Test for Celiac Disease: Faster, Cheaper
"Lab-on-a-Chip" Blood-Analysis Technology Shows Promise
Imagine having an accurate, quick, cost-effective diagnosis and monitoring solution for celiac disease and gluten-sensitivity available. All of you that have endured the current costly and invasive methods of testing for Celiac Disease — like an upper-GI / duodenal endoscopy and biopsy (been there, done that, hated it) — will certainly appreciate how much better testing could be if a simple drop of blood could be analyzed to determine if you have Celiac Disease or are being exposed to, and are reacting adversely to, gluten. The thought of being able to simply place a drop of blood on a sensor, either at a doctor's office or perhaps even at home, sure sounds like a fantastic alternative to me!A promising new technique for analysis and detection of Celiac Disease got my attention when I just read about it. If things progress as expected, we could see a test within the next couple years that is no worse than pricking your finger and placing a drop of blood on a sensor (sort of like what people monitoring their blood sugar for diabetes do regularly). Words alone can hardly express how much better this sounds than endoscopes and biopsies!
The new "CD-MEDICS" (Celiac Disease Management Monitoring and Diagnosis using Biosensors and an Integrated Chip System) project being undertaken by a consortium of 20 partners with substantial funding from the European Commission has created a system using a combination of technologies from microfluidics, nanotechnology and genetic testing to produce what is in effect a "lab on a chip" technology that will offer a quick, low-cost and highly accurate test for Celiac disease.
Imagine having INSTANT ACCURATE RESULTS Available!
This new CD-MEDICS approach offers the incredible advantage of instant diagnosis. A disposable lab-on-a-chip (the whole "chip" looking about like a credit-card in size), upon which a drop of blood has been applied, is placed into a biomedical interface instrument and analysis of the blood sample is carried out in a matter of minutes. Results can then be immediately output to the hospital information system and added to the patient's electronic health record — can you imagine?Let's contrast this with the current incredibly slow, potentially invasive, costly, and often incorrect or overlooked diagnosis of Celiac Disease... as the article I read states:
The condition [Celiac Disease] is thought to affect one in a hundred genetically predisposed individuals, but many sufferers may be unaware of the causes of their health problems: the average delay from onset of symptoms to diagnosis is almost 12 years. And, if they seek medical attention, there is a high risk of misdiagnosis: for every case of Celiac disease that is correctly identified it is thought that there are seven more that are undiagnosed or misdiagnosed [i.e., ONLY ONE IN EIGHT cases are diagnosed properly now!].
You may be wondering how this new approach can replace other tests and be accurate. Well, it combines DNA testing along with testing for gluten-antibodies in your blood:
'For the first time, we have two microsystems of completely different functionalities -- one for DNA typing and the other for the detection of antibodies -- and we have designed these microsystems to have a common interface with the instrument so that only one instrument with one slot is required for both microsystems,' Prof O'Sullivan says. 'For diagnosing Celiac patients two tests are necessary as DNA testing -- specifically for variants of the HLA gene associated with the disease -- or testing for gluten antibodies alone can return false positives. Testing for both means the results are much more accurate.'
Perhaps even more interesting is how this approach can be used to test for gluten-free diet compliance and exposure to gluten:
Follow up tests to monitor the patient's response to treatment can be carried out in the same way using only the microsystem to detect gluten antibodies.
How much will it cost? When will it be available?
Current DNA testing is expensive, and invasive testing is ridiculously cost-prohibitive. That is where this new testing method really shows promise. How about $25! Yes, only twenty-five bucks — if we (here in the USA) can ultimately get the test for the 20-Euro price equivalent that is projected for European markets. Of course we are the only major developed country without any universal national healthcare program, so it will not surprise me if that $25 turns into $100++ here! But, I guess we will have to wait and find out.Perhaps I can make a new business of purchasing a testing device (expected to cost around $8,000 USD) and a bunch of these "labs-on-a-chip" and specialize in just giving people Celiac Disease testing and gluten-free-diet compliance monitoring? It sure would be nice if something like that was available to drive down cost and make this available to a wide range of people. I'd be a my own first customer; I am curious to see how my diet-compliance is, especially in case I am accidentally being exposed to gluten somewhere I do not know about.
This system and process is currently being tested in Slovenia and is expected to be widely available in the next 2 or 3 years if all goes well. For validation, testing of a few hundred patients is underway and involves comparing the results of Celiac tests using this new system with those from analyzed tissue biopsy samples (i.e., results from traditional invasive approach). If you want to read the entire article that I did, see this link.
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