Development of a robust and validated protocol for sample collection for clinical diagnosis of reflux using Peptest.

在西方世界，20%到40%的成年人患有反流性疾病，其诊断过程要么非常主观，要么具有高度侵入性。详细的、侵入性的诊断过程是昂贵的，并且只能在二级保健中使用。因此，我们已经确定了一个重要的商业机会，围绕着一种快速诊断设备的发展，这种设备可以在任何情况下用于检测反流疾病的存在。该项目的主要目的和目标是在现实生活中评估一种名为Peptest的原型诊断设备，该设备由techntics Ltd.开发。这种非侵入性设备使用抗体技术，首次将分子诊断广泛应用于胃肠病学/耳鼻喉科。该评估将允许采用最合适的抽样方法来确定可靠的结果，并将产生大量关于该设备使用的临床数据，这将有助于加速其商业开发。市场研究表明，在英国和国际上，初级和二级医疗的临床医生对这种设备的需求很大。这种设备成功商业开发的潜在好处不仅仅局限于赫尔技术公司的总部。虽然该设备的成功商业化将使techntics能够创造就业机会，并投资于进一步的内部研发，但它也将进一步刺激techntics与英国大学合作的能力，并为这些大学的研究职位提供资金。此外，独立的经济模型表明，如果大规模部署，使用这种设备每年可能为NHS节省3亿英镑的预算。对患有反流疾病的患者也有显著的好处。侵入性诊断测试的需求将大大减少，通过对疾病的根本原因进行更有针对性的治疗，整体生活质量将得到改善。

Reflux disease affects 20% to 40% of all adults in the western world with the diagnostic process being either highly subjective or highly invasive. Detailed, invasive diagnostic processes are expensive and only available in secondary care. We have therefore identified a significant business opportunity around the development of a rapid diagnostic device which can be used in any setting to detect the presence of reflux disease.The key aims and objectives of this project are to evaluate in a real-life setting a prototype diagnostic device known as Peptest developed by Technostics Ltd. This non-invasive device uses antibody technology and brings molecular diagnostics into widespread use in gastroenterology/ENT for the first time. This evaluation will allow the most appropriate sampling methodology for a reliable result to be determined and will generate a significant amount of clinical data regarding use of the device which will help with accelerating its commercial exploitation. Market research has indicated that there will be a significant demand for this device from clinicians in both primary and secondary care in the UK and internationally. The potential benefits of successful commercial exploitation of this device are not just localised to Hull where Technostics is based. Whilst successful commercialisation of this device will allow Technostics to create jobs and invest in further R&D in house, it will also allow further stimulation of Technostics’ ability to collaborate with UK Universities and fund research posts within these. Furthermore, independent economic modelling has suggested that use of this device could potentially save the NHS budget £300 million per annum if deployedat scale. There would also be significant benefits to patients who suffer from reflux disease. Invasive diagnostic tests would be much less needed and overall quality of life would be improved through much more targeted treatment at the underlying causes of the condition.