An automated optical device that uses direct visualisation of single molecules for routine screening of cancer biomarkers.

SMi正在开发一种新技术，通过直接观察导致不同疾病的单个分子来分析患者样本。使用这种方法，SMi将患者样本应用于其消耗性诊断芯片的表面，并将这些芯片放入专用的台式超分辨率显微镜中，该显微镜可以在不到1秒的时间内扫描每个患者的大量样本（96或384）。这种分辨率在诊断方面是前所未有的，并产生了质量极高的准确数据，其中包括疾病颗粒的确切数量。这使临床医生能够快速诊断患者并监测疾病进展。SMi将诊断试剂的显微图案打印到诊断芯片上，从而可以同时检测多种疾病。这种方法对于癌症是理想的，因为当癌症颗粒（称为生物标志物）的模式同时被筛选时，可以给出改进的诊断。2018年，一项针对1005名患者的临床研究确定了100种可用于准确诊断的生物标志物，但由于当前测试程序的复杂性、所需的高水平培训/专业知识、运行测试所需的时间以及高昂的成本，这些生物标志物的常规使用受到了阻碍。SMi的新技术是利用这些生物标志物的理想选择，因为它可以直接可视化并计算每种不同生物标志物的确切数量。在这个研究项目中，SMi将把检测这些生物标记物的试剂打印到其可消费的诊断芯片上。当一个病人的样本被添加到芯片中，SMi将使用复杂的数学公式来分析结果的模式来预测诊断。使用已经取得成功的生物标记物，可以对最初的结果进行重新评估，并让SMi证明其技术可以产生类似的结果。重要的是，通过与药物发现弹射器（Alderley Park的一个国家研究实验室）合作，SMi可以在自己的预生产设备上测试样品，并将这些样品与在临床环境中常用的其他设备上测试的相同样品进行比较。这些实验的积极结果将验证一组有价值的癌症生物标志物，改变它们在常规癌症筛查中的应用，并允许实时监测治疗效果。由于SMi的技术可以可视化任何单个分子，因此在本研究中对该方法的成功验证将为支持采用这一突破性技术诊断许多其他疾病（包括传染性和非传染性疾病）提供进一步的证据。

SMi is developing a new technology that analyses patient samples by directly visualising the single molecules that are responsible for different diseases. Using this approach SMi applies a patient sample to the surface of its consumable diagnostic chips and places these chips inside a specialised, benchtop, super-resolution microscope that can scan a large number of samples (96 or 384) in less than 1 second per patient. This resolution is unprecedented in diagnosis and yields an extremely high quality of accurate data that includes the exact number of disease particles. This enables clinicians to rapidly diagnose patients and to monitor disease progression.SMi prints a microscopic pattern of diagnostic reagents onto the diagnostic chips which allows multiple diseases to be tested simultaneously. Such an approach is ideal for cancer as an improved diagnosis is given when a pattern of cancer particles (termed biomarkers) are screened at the same time. In 2018, a clinical study of 1005 patients identified 100 biomarkers that could be used for accurate diagnosis, but their routine use is hindered by the complexity of current test procedures, the high level of training/expertise required, the time needed to run tests, and their prohibitive costs. SMi's new technology is ideal for utilising these biomarkers as it can directly visualise and count the exact number of each different one.In this research project, SMi will micro-print reagents that detect these biomarkers onto its consumable diagnostic chips. When a patient sample is added to the chip, SMi will use complex mathematical formulae to analyse the pattern of results to predict the diagnosis. The use of biomarkers that have already shown success allows the original results to be reappraised and for SMi to prove that its technology produces a similar outcome. Importantly, by partnering with the Medicines Discovery Catapult (a national research laboratory at Alderley Park) SMi can test samples on its own pre-production devices and compare these to the same samples tested on other devices that are commonly used in a clinical setting.A positive outcome from these experiments would validate a valuable set of cancer biomarkers, transform their use for routine cancer screening, and allow real-time monitoring of treatment efficacy. As SMi's technology can visualise any single molecule, a successful validation of the approach in this study would provide further evidence to support adoption of this ground-breaking technology for diagnosis of numerous other diseases, both infectious and non-infectious.