Management of breast cancer in limited-resource settings is hindered by a lack of low-cost, logistically sustainable approaches toward molecular and cellular diagnostic pathology services that are needed to guide therapy. To address these limitations, we have developed a multimodal cellphone-based platform—the EpiView-D4—that can evaluate both cellular morphology and molecular expression of clinically relevant biomarkers directly from fine-needle aspiration (FNA) of breast tissue specimens within 1 h. The EpiView-D4 is comprised of two components: (1) an immunodiagnostic chip built upon a “non-fouling” polymer brush-coating (the “D4”) which quantifies expression of protein biomarkers directly from crude cell lysates, and (2) a custom cellphone-based optical microscope (“EpiView”) designed for imaging cytology preparations and D4 assay readout. As a proof-of-concept, we used the EpiView-D4 for assessment of human epidermal growth factor receptor-2 (HER2) expression and validated the performance using cancer cell lines, animal models, and human tissue specimens. We found that FNA cytology specimens (prepared in less than 5 min with rapid staining kits) imaged by the EpiView-D4 were adequate for assessment of lesional cellularity and tumor content. We also found our device could reliably distinguish between HER2 expression levels across multiple different cell lines and animal xenografts. In a pilot study with human tissue (n = 19), we were able to accurately categorize HER2-negative and HER2-positve tumors from FNA specimens. Taken together, the EpiView-D4 offers a promising alternative to invasive—and often unavailable—pathology services and may enable the democratization of effective breast cancer management in limited-resource settings.

在资源有限的情况下，乳腺癌的管理因缺乏指导治疗所需的分子和细胞诊断病理学服务的低成本、后勤可持续的方法而受到阻碍。为了解决这些限制，我们开发了一个基于手机的多模式平台——EpiView-D4——它可以在 1 小时内直接从乳腺组织标本的细针抽吸 (FNA) 中评估细胞形态和临床相关生物标志物的分子表达。EpiView-D4 由两部分组成：(1) 建立在“无污染”聚合物刷涂层（“D4”）上的免疫诊断芯片，可直接从粗细胞裂解物中量化蛋白质生物标志物的表达，以及 (2)一种定制的基于手机的光学显微镜（“EpiView”），专为细胞学制备成像和 D4 测定读数而设计。作为概念验证，我们使用 EpiView-D4 评估人类表皮生长因子受体 2 (HER2) 的表达，并使用癌细胞系、动物模型和人体组织样本验证其性能。我们发现由 EpiView-D4 成像的 FNA 细胞学标本（使用快速染色试剂盒在 5 分钟内制备）足以评估病变细胞结构和肿瘤内容。我们还发现我们的设备可以可靠地区分多种不同细胞系和动物异种移植物的 HER2 表达水平。在人体组织的初步研究中（我们发现由 EpiView-D4 成像的 FNA 细胞学标本（使用快速染色试剂盒在 5 分钟内制备）足以评估病变细胞结构和肿瘤内容。我们还发现我们的设备可以可靠地区分多种不同细胞系和动物异种移植物的 HER2 表达水平。在人体组织的初步研究中（我们发现由 EpiView-D4 成像的 FNA 细胞学标本（使用快速染色试剂盒在 5 分钟内制备）足以评估病变细胞结构和肿瘤内容。我们还发现我们的设备可以可靠地区分多种不同细胞系和动物异种移植物的 HER2 表达水平。在人体组织的初步研究中（n  = 19），我们能够准确地对 FNA 标本中的 HER2 阴性和 HER2 阳性肿瘤进行分类。总而言之，EpiView-D4 为侵入性（通常无法获得）病理学服务提供了一种有前途的替代方案，并可能在资源有限的环境中实现有效乳腺癌管理的民主化。