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• W4308061187 abstract "CancerVolume 128, Issue 22 p. 3905-3905 CancerScopeFree Access Liquid biopsy prototype assay for breast cancer First published: 02 November 2022 https://doi.org/10.1002/cncr.34524AboutSectionsPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat Researchers have developed a liquid biopsy prototype assay for breast cancer designed to offer clinicians a diagnostic tool that is highly accurate, technically simple, convenient to use, and has a fast turnaround time. The prototype is still in development and considered the first step toward what the researchers say is a long-term goal of developing an assay for routine use as a clinical management tool. Called the automated Liquid Biopsy for Breast Cancer Methylation (LBx-BCM), the prototype is a joint venture between Johns Hopkins University, Baltimore, Maryland, and diagnostics company Cepheid, Sunnyvale, California. The researchers developed the assay based on prior work in which a cMethDNA liquid biopsy laboratory assay was developed that showed a high degree of specificity and sensitivity in identifying cumulative methylation levels of 10 genes altered in breast cancer.1, 2 Although the test detected up to 90% of patients with metastatic breast cancer, its widespread use is limited by the length of time it takes to complete (a minimum of one week) and high degree of technical competency required. The LBx-BCM is based on principles of cMethDNA and is run on the platform GeneXpert (by Cepheid), a commercially available automated polymerase chain reaction-based molecular testing platform that uses self-contained cartridges for DNA extraction. Details of the development of the LBx-BCM and its technical validation were recently reported by the researchers in a study published in Cancer Research Communications.3 In the study, the assay demonstrated a high degree of sensitivity and specificity in quantitatively detecting nine methylated markers of metastatic breast cancer and performed with a high level of accuracy. These findings were validated by interassay reproducibility and interuser reproducibility studies, both of which showed high levels of concordance. Unique to LBx-BCM, and a primary reason for its development, was the short time required to perform the assay: about 4.5 hours. In addition, the assay was technically simple and convenient to use. “Our goal was to develop an assay that would be sophisticated yet simple to perform worldwide and [that] could be used at the point of care to provide same-day feedback to clinicians and patients,” said senior author of the study Saraswati Sukumar, PhD, professor of oncology and pathology at Johns Hopkins University School of Medicine, in a press release.4 The researchers cited the small sample size of their study as a main limitation and underscored the need for large, prospective studies that include a balanced representation of all histological subtypes of breast cancer to evaluate LBx-BCM, as well as more ethnic diversity. Commenting on the study, Victor Velculescu, MD, PhD, professor of oncology and co-director of Cancer Genetics and Epigenetics at Johns Hopkins University, says he is encouraged by the researchers’ efforts to advance automation for the detection of a common cancer like breast cancer, as he sees automation as part of a solution to reduce costs and attain high performance for liquid biopsy applications. “In the future, this work will need to be extended to demonstrate performance in early disease stages and during therapy, and costs inherent to larger scale methylation assays may be more challenging to overcome,” he says. “These considerations are particularly important to ensure that cancer detection and monitoring tests become widely accessible and available to all, helping to reduce health disparities among patients with cancer.” References 1 Fackler MJ, Lopez Bujanda Z, Umbricht C, et al. Novel methylated biomarkers and a robust assay to detect circulating tumor DNA in metastatic breast cancer. Cancer Res. 2014; 74: 2160– 2170. https://doi.org/10.1158/0008-5472.CAN-13-3392 2 Visvanathan K, Fackler MS, Zhang Z, et al. Monitoring of serum DNA methylation as an early independent marker of response and survival in metastatic breast cancer: TBCRC 005 prospective biomarker study. J Clin Oncol. 2017; 35: 751– 758. https://doi.org/10.1200/JCO.2015.66.2080 3 Fackler MJ, Tulac S, Venkatesan N, et al. Development of an automated liquid biopsy assay for methylated markers in advanced breast cancer. Cancer Res Commun. 2022; 2: 391– 401. https://doi.org/10.1158/2767-9764.crc-22-0133 4 Mone A, Mehl V. Liquid biopsy quickly detects DNA markers in advanced breast cancer. The Hub. Johns Hopkins University. June 24, 2022. Accessed October 5, 2022. https://hub.jhu.edu/2022/06/24/biopsy-quickly-detectsadvanced-breast-cancer/ Volume128, Issue22November 15, 2022Pages 3905-3905 This article also appears in:CancerScope Articles ReferencesRelatedInformation" @default.
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