NovoGluten Clinical Gluten
Convenient, consistent and credible in gluten challenges throughout your program.
Novoviah is launching NovoGluten to simplify gluten food challenges.
Our aim is to provide greater confidence to patients, clinicians and researchers that the effects they observe following gluten food challenge in patients with celiac disease or other gluten-mediated disease are due to a calibrated reactivation of gluten-specific immunity rather than irritable bowel syndrome or other non-immune effects.
Symptoms, immune and intestinal effects of gluten in celiac disease may be confounded by quantitative and qualitative aspects of the gluten food challenge.
Large, well characterised single-source stocks of Vital Wheat Gluten provide a resource that is essential for high-fidelity gluten challenge. NovoGlutenTM is extensively tested well beyond standard protein, water, R5-ELISA, and microbiology assessments. The NovoGlutenTM stock is also assessed in ongoing stability studies in various storage conditions and packaging.
Novoviah works with clients to:
- Customize single-serve packaging to ensure appropriate dosing for single-bolus or extended challenges.
- Support and advise on gluten food challenge design, protocols and readouts.
- Advise how immune and symptom readouts such as serum cytokines or whole blood cytokine release tests such as the Novoleukin-C system can be incorporated
- Work with CRO’s to ensure suitable labelling and documentation to comply with IRB/HREC approvals, and import/export documentation
To support users, Novoviah is assembling a NovoGlutenTM - gluten challenge database with details of readouts to inform study design, statistical powering and analysis.
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Novoviah is dedicated to pioneering sensitive clinical tests for antigen-specific T cells, supporting clinical trials for drug developers and researchers. Established in 2020, Novoviah specialised in developing a cutting-edge testing platform for clinical trials and aspires to expand its usage into healthcare settings in the future. With a focus on enhancing pharmaceutical programs, Novoviah is committed to developing customised and highly precise blood tests for a variety of medical conditions associated with antigen-specific T cells.