De Klerk Manie, Van Der Merwe Nicole, Erasmus Johny, Whati Lindiwe, Moremi Kelebogile E, Olivier Daniel W, Kotze Maritha J
Health Care Leadership, University of Stellenbosch Business School, Cape Town, South Africa.
Division of Chemical Pathology, Department of Pathology, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.
Ann Hum Genet. 2025 Jul;89(4):208-227. doi: 10.1111/ahg.12582. Epub 2024 Oct 29.
An ethics-guided decision-making framework was developed for applying pathology-supported genetic testing, a multifaceted pharmacodiagnostic approach that translates population risk stratification into clinical utility. We introduce this service, supported by the Open Genome Project, which aligns with the beneficence principle in personalized medicine.
Genetic testing of six noncommunicable disease pathways was conducted as part of a pilot program, benchmarked against a readiness checklist for implementation of genomic medicine in Africa. Patient referral criteria were determined using healthcare funder claims data, employing the Adjusted Clinical Groupers and Resource Utilization Band risk rating structure to identify potential nonresponders to treatment.
Three of the 135 doctors (2.2%) invited expressed immediate disinterest in the pilot, while 24 (17.8%) actively participated. Inherited, lifestyle-triggered, and therapy-related pathologies were simultaneously assessed in case reports, with special medical scheme reimbursement tariff codes applied to 25 patient referrals. The findings were used by the participating genetic counselor to select three patients for whole exome sequencing, utilizing a novel, level-up data processing algorithm for adaptive reporting.
This study demonstrated the implementation of genomics into an evolving workflow for patients with a history of frequent clinic visits. Eliminating the cost barrier provided valuable insights to guide future reimbursement policy decisions.
我们开发了一个以伦理为导向的决策框架,用于应用病理学支持的基因检测,这是一种多方面的药物诊断方法,可将人群风险分层转化为临床效用。我们介绍这项由开放基因组计划支持的服务,该服务符合个性化医疗中的行善原则。
作为一个试点项目的一部分,对六种非传染性疾病途径进行了基因检测,并以非洲实施基因组医学的准备情况清单为基准。使用医疗保健资助者的索赔数据确定患者转诊标准,采用调整后的临床分组器和资源利用带风险评级结构来识别潜在的治疗无反应者。
受邀的135名医生中有3名(2.2%)立即表示对该试点不感兴趣,而24名(17.8%)积极参与。在病例报告中同时评估了遗传性、生活方式引发的和与治疗相关的病理情况,25例患者转诊适用了特殊医疗计划报销关税代码。参与的基因咨询师利用这些结果选择了三名患者进行全外显子组测序,采用了一种新颖的、升级的数据处理算法进行适应性报告。
本研究展示了将基因组学应用于具有频繁门诊病史患者的不断发展的工作流程中。消除成本障碍为指导未来的报销政策决策提供了有价值的见解。