Departments of Pathology and Chemical and Biological Engineering, University of New Mexico, Albuquerque, New Mexico.
J Mol Diagn. 2020 Feb;22(2):147-158. doi: 10.1016/j.jmoldx.2019.09.007. Epub 2019 Nov 18.
Next-generation sequencing (NGS) diagnostics continue to expand rapidly in clinical medicine. An ever-expanding menu of molecular biomarkers is deemed important for diagnostic, prognostic, and therapeutic assessment in patients. The increasing role of NGS in the clinic is driven mainly by the falling costs of sequencing. However, the data-intensive nature of NGS makes bioinformatic analysis a major challenge to many clinical laboratories. Critically needed NGS bioinformatics personnel are hard to recruit and retain in small- to mid-size clinical laboratories. Also, NGS software often lacks the scalability necessary for expanded clinical laboratory testing volumes. Commercial software solutions aim to bridge the bioinformatics barrier via turnkey informatics solutions tailored specifically for the clinical workplace. Yet, there has been no systematic assessment of these software solutions thus far. This article presents an end-to-end vendor evaluation experience of commercial NGS bioinformatics solutions. Six different commercial vendor solutions were assessed systematically. Key metrics of NGS software evaluation to aid in the robust assessment of software solutions are described. Comprehensive feedback, provided by the TriCore Reference Laboratories molecular pathology team, enabled the final vendor selection. Many key lessons were learned during the software evaluation process, which are described herein. This article aims to provide a detailed road map for small- to mid-size clinical laboratories interested in evaluating commercial bioinformatics solutions available in the marketplace.
下一代测序(NGS)诊断在临床医学中继续快速扩展。越来越多的分子生物标志物被认为对患者的诊断、预后和治疗评估很重要。NGS 在临床中的作用不断增强主要是由于测序成本的降低。然而,NGS 的数据密集性质对许多临床实验室的生物信息学分析构成了重大挑战。在中小规模的临床实验室中,急需的 NGS 生物信息学人员很难招聘和留住。此外,NGS 软件通常缺乏扩展临床实验室测试量所需的可扩展性。商业软件解决方案旨在通过针对临床工作场所量身定制的交钥匙信息学解决方案来克服生物信息学障碍。然而,到目前为止,还没有对这些软件解决方案进行系统评估。本文介绍了商业 NGS 生物信息学解决方案的端到端供应商评估经验。系统评估了六种不同的商业供应商解决方案。描述了有助于稳健评估软件解决方案的 NGS 软件评估关键指标。TriCore 参考实验室分子病理学团队提供了全面的反馈,从而最终选择了供应商。在软件评估过程中吸取了许多重要经验教训,本文对此进行了描述。本文旨在为有兴趣评估市场上可用的商业生物信息学解决方案的中小规模临床实验室提供详细的路线图。