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

在西方世界，反流性疾病影响着20%到40%的成年人，诊断过程要么高度主观，要么高度侵入性。详细的侵入性诊断过程很昂贵，而且只有在二级护理中才能使用。因此，我们在开发一种快速诊断设备方面发现了一个重要的商机，该设备可以在任何情况下使用来检测是否存在反流性疾病。该项目的主要目的和目标是在真实环境中评估由Technostics Ltd开发的名为Peptest的原型诊断设备。这种非侵入性设备使用抗体技术，首次将分子诊断技术广泛应用于胃肠病/耳鼻咽喉科。这项评估将确定最合适的采样方法，以获得可靠的结果，并将产生大量有关该设备使用的临床数据，这将有助于加快其商业开发。市场研究表明，在英国和国际上，初级和二级护理领域的临床医生对这种设备的需求将会很大。这种设备的成功商业开发的潜在好处不仅仅局限于Technostics总部所在的赫尔。虽然这种设备的成功商业化将使技术人员能够创造就业机会并投资于内部的进一步研发，但它也将进一步刺激技术人员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，使用这种设备可能每年节省NHS预算3亿GB。这对患有反流病的患者也有很大的好处。侵入性诊断测试的需要将大大减少，通过对疾病根本原因进行更有针对性的治疗，总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.