Knight Diagnostic Laboratories, Oregon Health & Science University, Portland, OR 97239, USA.
Knight Diagnostic Laboratories, Oregon Health & Science University, Portland, OR 97239, USA; Cancer Early Detection Advanced Research Center, Knight Cancer Institute, Oregon Health & Science University, Portland, OR 97201, USA.
Am J Hum Genet. 2023 Aug 3;110(8):1249-1265. doi: 10.1016/j.ajhg.2023.06.014. Epub 2023 Jul 27.
The Healthy Oregon Project (HOP) is a statewide effort that aims to build a large research repository and influence the health of Oregonians through providing no-cost genetic screening to participants for a next-generation sequencing 32-gene panel comprising genes related to inherited cancers and familial hypercholesterolemia. This type of unbiased population screening can detect at-risk individuals who may otherwise be missed by conventional medical approaches. However, challenges exist for this type of high-throughput testing in an academic setting, including developing a low-cost high-efficiency test and scaling up the clinical laboratory for processing large numbers of samples. Modifications to our academic clinical laboratory including efficient test design, robotics, and a streamlined analysis approach increased our ability to test more than 1,000 samples per month for HOP using only one dedicated HOP laboratory technologist. Additionally, enrollment using a HIPAA-compliant smartphone app and sample collection using mouthwash increased efficiency and reduced cost. Here, we present our experience three years into HOP and discuss the lessons learned, including our successes, challenges, opportunities, and future directions, as well as the genetic screening results for the first 13,670 participants tested. Overall, we have identified 730 pathogenic/likely pathogenic variants in 710 participants in 24 of the 32 genes on the panel. The carrier rate for pathogenic/likely pathogenic variants in the inherited cancer genes on the panel for an unselected population was 5.0% and for familial hypercholesterolemia was 0.3%. Our laboratory experience described here may provide a useful model for population screening projects in other states.
健康俄勒冈计划(HOP)是一项全州范围内的努力,旨在通过为参与者提供下一代测序 32 基因panel 的免费遗传筛查,建立一个大型研究存储库并影响俄勒冈州人的健康,该 panel 包含与遗传性癌症和家族性高胆固醇血症相关的基因。这种无偏见的人群筛查可以发现可能被传统医学方法遗漏的高危个体。然而,在学术环境中进行这种高通量测试存在挑战,包括开发低成本高效率的测试和扩大临床实验室以处理大量样本。对我们的学术临床实验室进行修改,包括高效的测试设计、机器人技术和简化的分析方法,提高了我们使用一名专门的 HOP 实验室技术员每月测试超过 1000 个样本的能力。此外,使用符合 HIPAA 的智能手机应用程序进行登记和使用漱口水进行样本采集提高了效率并降低了成本。在这里,我们介绍了 HOP 进行三年的经验,并讨论了所学到的经验教训,包括我们的成功、挑战、机遇和未来方向,以及前 13670 名测试参与者的遗传筛查结果。总体而言,我们在 24 个 panel 基因中的 710 名参与者中发现了 730 个致病性/可能致病性变体。该 panel 中遗传性癌症基因的致病性/可能致病性变体的携带者率为 5.0%,家族性高胆固醇血症为 0.3%。这里描述的我们的实验室经验可能为其他州的人群筛查项目提供有用的模型。