Introduction

The present invention relates to the use of specific circulating microRNAs as biomarkers for the diagnosis of celiac disease without employing invasive methods, it also allows monitoring of the adherence to a gluten-free diet using one or more microRNAs, and reports the relative methods and analytical procedures.

Technical features

The present invention totally excludes an invasive approach (e.g. intestinal biopsy) for the diagnosis of Celiac Disease (CD), making use only of a particular combination of circulating microRNAs as reliable biomarkers of the disease. Through the selection of a specific combination of differentially expressed microRNAs in CD patients compared to healthy controls, the present invention makes possible both the diagnosis of CD and the monitoring of the adherence to the gluten-free diet by CD patients. Only two microRNAs, detectable both by sequencing techniques (RNA-Seq) and by quantitative real-time PCR (qPCR), are sufficient to diagnose the celiac condition, or the non-adherence to the gluten-free diet, in a liquid biological sample, such as for example serum or plasma. The advantage of this invention is the ability to diagnose celiac disease even when traditional analytical methods give uncertain results and the doctor requires further investigation, which generally consists of an intestinal biopsy, to confirm the disease.

Possible Applications

• Creation of diagnostic kits for the diagnosis of celiac disease (also for doubtful cases)
• Creation of diagnostic kits for monitoring the adherence to a gluten-free diet

Advantages

• Exclusion of invasive approaches, such as gastroduodenoscopy and duodenal biopsy for the diagnosis of CD.
• Rapid execution of the analytical test and reduction of diagnosis time.
• Possibility of using this invention also with other techniques: such as Droplet Digital PCR, Microarrays, Flow Cytometry, and other RNA hybridization methods.