April 15, 2015 – April marks National Irritable Bowel Syndrome Awareness Month. Coincidentally, last week, BÜHLMANN, a Swiss medical laboratory company received EC’s regulatory approval to distribute its home test for irritable bowel disease. The test kit, IBDoc, will allow for testing at home and provide immediate results which can then be shared digitally with a medical provider. BÜHLMANN reports that trial participants’ feedback has been “phenomenal.” IBDoc requires a smartphone and an internet connection.
Enthusiasm at the Swiss company is apparent. Chris Moore, CPO, states “never before has such a sophisticated biologic test system been brought to patient’s homes,” and predicts that IBDoc will have the same impact on irritable bowel disease, as monitoring blood sugar levels at home had on diabetes over a generation ago.
The test name, IBDoc, is an acronym for Irritable Bowel Doctor and measures calprotectin, a biomarker for gastrointestinal inflammation, which is used as indicator for severity of gastrointestinal conditions such as Crohn’s disease and ulcerative colitis. Patients with chronic irritable bowel conditions measure their calprotectin levels normally every three months. BÜHLMANN claims that IBDoc is “superior to classically used blood biomarkers, such as C-reactive protein, erythrocyte sedimentation and others.”
- * Smart phone required
- * Non-invasive
- * No laboratory needed
- * Stool testing simplified
- * Results in minutes
- * Patient empowerment
- * Results shared by internet
As of now, Christian Reinhard, IBDoc’s product manager, is focusing on European distribution, but plans on future trials to meet FDA approval. When contacted about US distribution, Reinhard responds, “As for all FDA approvals, this can be a long process, especially for a new product category like this — smartphone based diagnostic tests — but we hope that we can launch in the US in the next two years.” Although this time frame may be average in the medical industry, it likely feels like eternity for those who make up the more than 20 percent of the estimated US population who have to live with irritable bowel disease.