What is the innovation?

OSAXYL: A Point-of-Care (PoC) biosensor for the determination of hypolactasia in urine samples.

What problem does the innovation solve?

Hypolactasia is a gastrointestinal disorder related to low levels or reduced activity of intestinal lactase, the enzyme responsible for the hydrolysis of lactose during its digestion. Undigested lactose after intake of dairy products is then accumulated in the intestine causing flatulence, abdominal pain and diarrhea in the individuals suffering from this malfunction. Hypolactasia impacts on the quality of life, and represents a personal and social burden on those undiagnosed patients. Despite it affects over half of the world population, its diagnosis remains challenging because associated symptoms are not specific and available methods for its diagnosis are unspecific and rely on trained staff and complex equipment. Hence, there is a clear need for a more accessible, inexpensive and user-friendly diagnostic tool for hypolactasia diagnostic tests, improving the accuracy of diagnosis and resulting treatment for the benefit of patients and health care providers.

How does the innovation solve the problem?

OSAXYL is a portable, quick, easy to use, non- invasive (no biopsy or blood extraction is needed) and accurate Point of Carte (PoC) hypolactasia diagnostic tool. This novel POC biosensor is used in combination with LacTest® (a synthetic lactose analogue diagnostic drug: Gaxilose) commercialized by a Spanish pharma. Gaxilose is a suitable substrate of intestinal lactase hydrolysing it into galactose and D-xylose, which is absorbed in the intestine, and therefore can be analyzed in urine. Low levels of lactase will translate into low levels of D-xylose in urine. OSAXYL allows an easy quantification of D-xylose in urine samples offering a cost-efficient and non-invasive tool for a faster and accurate diagnosis. OSAXYL is based on a disposable biosensing strip able to transform the D-Xylose metabolite into an electroactive compound which redox processes can be measured by electrochemistry and an electronic reader, able to translate the electrochemical signal into an understandable value

Is there any other existing cutting edge solution? If so, how does yours differ?

The reference method for diagnosis is the direct determination of lactase activity following an intestinal biopsy, but it results very invasive. Currently the most commonly applied methods are clinical tests such as glycemia or a hydrogen breath test that require the intake of a high dose of lactose and the use of sophisticated equipments and trained staff. In this context, the diagnosis drug LacTEST® is a noninvasive method based on the oral administration of Gaxilose instead of the high dose of lactose required in the previously mentioned methods. However, the detection of D-Xylose in urine is based on a spectrophotometric method which also requires trained staff and specialized equipments. Therefore, there is an existing need for a more accessible, cost-effective, fast and user-friendly diagnostic tool to enable hypolactasia diagnostic tests to become Point of Care (PoC) testing systems, leveraging their impact on patients and health providers.

Tell us about your team?

BIOLAN HEALTH is made up of a multi-disciplinary team of 8 highly-qualified professionals: Dr. Larraitz Añorga (female). CEO and Scientific Manager. Broad experience on leading innovation actions, R&D strategies and researchers teams focused on the development of innovative biosensor solutions. Dr. Arrate Jaureguibeitia (female). Innovation Manager. Responsible for driving innovation with broad experience in leading R&D strategies and actions focus on the development of technological solutions. Dr. Graciela Martínez (female). Head of Electrochemistry Department. High background in the development of electrochemical biosensors for agrifood and biomedical sectors based on screen-printed electrodes, application of nanomaterials to biosensors and development of lateral flow devices. Dr Xabier Arias (male).Innovation Associate. Head of Lateral Flow Department. High background in immunoassays, ELISA, protein over-expression, purification and conjugation

How big is the market for this innovation?

Current data suggest that the incidence and prevalence of gastrointestinal disorders are increasing. In particular, hypolactasia, the incomplete hydrolysis of lactose due to lactase deficiency, which may occur as a primary disorder or secondary to other intestinal diseases (such as coeliac disease, gastroenteritis and Crohn’s disease), is one gastrointestinal disorder that affects over half of the world population (estimations indicate up to 70% of the world adult population). The prevalence of hypolactasia varies considerably between different ethnic groups, the estimation is of 90 million hypolactasic individuals in Europe. Based on these data and taken into account the information obtained from the digestive clinicians about the numbers of the tests currently prescribed, the European and worldwide potential market is expected to grow 20% due to competitive advantage of the proposed diagnostic test. A total addressable market valued of about 1 million analyses is estimated for five s

What EU-funded research project was this innovation developed in?

Project LACTOPOC.