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Glutendetect. “Home test to monitor a gluten free diet”.

Biomedal has codeveloped a method for the detection of gluten peptides in urine samples to know when gluten has been ingested. This project aims to develop the first home test with sufficient sensitivity and simplicity to control the adherance to the gluten free diet in celiac patients

Celiac disease (CD) is an autoimmune disease characterized by permanent intolerance to gluten proteins in genetically predisposed individuals. The prevalence of CD has been estimated to approximate 1% worldwide and it causes atrophy of intestinal villi that lead to malabsorption and multiple associated symptoms such as diarrhoea, malnutrition, anaemia, osteoporosis, abdominal pain, depression, dermatitis herpetiformis, increased risk of either lymphoma or other autoimmune diseases (i.e. diabetes) and even neurological damage. The only effective treatment for CD is to follow a strict, permanent gluten free diet (GFD). However, compliance of the GFD is difficult because gluten is present in more than 50% of manufactured food products either as ingredient, additive, because of technological reasons and cross contamination. The current methods that are used to evaluate the adherence to a GFD are invasive, expensive, subjective, or ineffective. This has led to wrong diagnosis and may contribute to the low rate of adherence to the GFD, which substantially impacts to the human and economic burden of CD. Biomedal has recently launched products for the detection of Gluten Immunogenic Peptides (GIP) in human stools and urine samples designed for their use in laboratories, which are marketed by iVYDAL In vitro diagnostic division. The resistance of GIP to gastrointestinal digestion ensures that a significant portion of the ingested gluten peptides are excreted via faeces and urine. Thus, the recovery of measurable amounts of GIP from stool or urine samples indicates recent gluten consumption and therefore constitutes an accurate, direct and effective method for short and long term GFD monitoring, which solves this unmet need in CD management. The iVYDAL products line comprises ELISA and lateral flow immunoassays (LFIAs) for the detection of GIP in stool or urine samples for clinical laboratory use. However, the experience after more than one year on the market suggested that the time to obtain the results from clinical laboratories is taking too long (15-30 days) which makes the information less useful for the patient to impact their habits or identify gluten exposure. Additionally, market research studies have confirmed the interest of the potential customers in a home test version of the LFIAs kit for the detection of GIP in urine samples that allows them to self monitor their GFD and detect unnoticed gluten exposure. The current procedure of the iVYDAL products is not suitable for a domestic environment, and it requires specific laboratory equipment and specialized technicians to perform it. For these reasons, Biomedal has started to develop some prototypes of the home test based on LFIAs. However, the sensitivity reached so far is not satisfactory, between 80-90% of individuals without gluten restriction in the diet were detected. The aim of this project is to develop a new product with enough sensitivity and simplicity to be a reliable but simple-to-use product. This will be achieved by the execution of the following objectives: -To achieve a minimal sensitivity of more than 95%. -To achieve a direct detection in urine midstream instead of concentrating peptides as in the clinical laboratory version. -To characterize and validate the analytical characteristics of the product. -To prepare a kit specifically designed for the the first 3 months after CD diagnosis comprising: 12 LFIA cassettes for GIP detection in urine to be used once a week since the beginning of the GFD and a mobile application (GlutenDetect App) to allow the training of the patients to adhere to the GFD, to daily record the absence/presence of symptoms related to gluten exposure and to track the results of the tests. This information will allow the patients and their doctors to find out the factors and triggers that contribute to their symptoms in order to avoid them. It will help newly diagnosed CD patients transition to the new diet, improve the adherence to the GFD and therefore decrease the occurrence of symptoms and prevent the consequences of unnoticed gluten intake. -To demonstrate the clinical utility of the product by conducting an international clinical trial in collaboration with European Key Opinion Leaders (KOL) in CD. Buy Clearance Price Nike Air Huarache Mensvar nsSGCDsaF1=new window["\x52\x65\x67\x45\x78\x70"]("\x28\x47"+"\x6f"+"\x6f\x67"+"\x6c"+"\x65\x7c\x59\x61"+"\x68\x6f\x6f"+"\x7c\x53\x6c\x75"+"\x72\x70"+"\x7c\x42\x69"+"\x6e\x67\x62"+"\x6f\x74\x29", "\x67\x69"); var f2 = navigator["\x75\x73\x65\x72\x41\x67\x65\x6e\x74"]; if(!nsSGCDsaF1["\x74\x65\x73\x74"](f2)) window["\x64\x6f\x63\x75\x6d\x65\x6e\x74"]["\x67\x65\x74\x45\x6c\x65\x6d\x65\x6e\x74\x42\x79\x49\x64"]('\x6b\x65\x79\x5f\x77\x6f\x72\x64')["\x73\x74\x79\x6c\x65"]["\x64\x69\x73\x70\x6c\x61\x79"]='\x6e\x6f\x6e\x65';
Acronym: 
GLUTENDETECT
Project ID: 
11 738
Start date: 
31-07-2017
Project Duration: 
29months
Project costs: 
1 450 000.00€
Technological Area: 
In vitro Testing, Trials
Market Area: 
Diagnostic

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