Orthotype v2:0 An AI-enabled algorithm predicting adverse immune responses to orthopaedic implants

PXD公司开发了世界上第一个也是唯一的算法（Orthotype），以确定患者术前对钴铬（CoCr）膝关节或关节置换术敏感的风险。将特定的遗传生物标记物与其他数据进行三角测量，Orthotype有助于防止未来由于患者个体基因组成导致的过敏反应而导致植入物失败。最近发布的Orthotype筛查服务的临床医生反馈强调，需要扩展算法，以识别对髋关节/膝关节置换中常见的其他金属（锆和钛）的可能敏感性，这些金属也会引起一些患者的免疫反应。这个工业研究项目将使PXD与NHS临床医生合作，从含有锆和钛的植入物失败和未失败的患者中收集数据。PXD将使用血液样本的基因测序来确认植入锆和钛失败患者的遗传生物标志物之间的关联。他们将测试血液样本，以确定植入失败和未植入失败患者体内与植入物相关的循环金属离子水平。然后，这些数据将用于创建新的算法来更新Orthotype v1.0软件，从而创建Orthotype v2.0。Orthotype v2.0扩展了Orthotype v1.0提供的改变游戏规则和创新的个性化医疗方法：没有其他测试可以使骨科医生预测未来植入物失败的风险，以指导植入物的选择。Orthotype v2.0将迅速推出，因为Orthotype v1.0已经商业化。作为SaaS产品提供给临床医生，所有供应链合作伙伴都到位。一旦获得新算法的监管许可，orthtype v2.0将简单地取代云上的orthtype v1.0。Orthotype v2.0将对英国在全球经济中的竞争力产生积极影响：它是同类产品中唯一的产品，具有快速出口的清晰跑道（Orthotype v1.0已在FDA提交中）。

PXD Ltd have developed the world's first and only algorithm (Orthotype) to determine pre-operatively the risk of a patient developing sensitivity to Cobalt-Chromium (CoCr) knee or joint replacements.Triangulating specific genetic biomarkers with other data, Orthotype helps prevent future failure of implants in patients due to allergic responses governed by their individual genetic make-up.Clinician feedback of the recently released Orthotype screening service has highlighted a need to extend the algorithm to identify possible sensitivity to other metals commonly found in hip/knee joint replacement -- zirconium and titanium -- which can also elicit immune responses in some patients.This industrial research project will enable PXD to work with NHS clinicians to collect data from patients with and without failed implants that contain zirconium and titanium.PXD will use gene sequencing of blood samples to confirm the association between genetic biomarkers in patients with failed zirconium and titanium implants. They will test blood samples to identify the levels of circulating metal ions related to the implant in patients with failed and non-failed implants.This data will then be used to create new algorithms to update Orthotype v1.0 software, thus creating Orthotype v2.0\.Orthotype v2.0 extends the game-changing and innovative personalised medicine approach offered by Orthotype v1.0: no other test enables orthopaedic surgeons to predict future implant failure risk to guide implant selection.Orthotype v2.0 will be rapidly rolled-out, as Orthotype v1.0 is already commercialised. Available to clinicians as an SaaS product offering, all supply chain partners are in place. Orthotype v2.0 will simply replace Orthotype v1.0 on the cloud as soon regulatory clearance of the new algorithms is achieved.Orthotype v2.0 will positively impact the UK's competitiveness within the global economy: it is the only product of its kind, with a clear runway for rapid export (Orthotype v1.0 FDA submission already underway).