Cost-effectiveness analysis of multigene expression profiling assays to guide adjuvant therapy decisions in women with invasive early-stage breast cancer

Hannouf, Malek B.; Zaric, Gregory S.; Blanchette, Phillip; Paulden, Mike; McCabe, Christopher; Raphael, Jacques; Brackstone, Muriel

doi:10.1038/s41397-019-0089-x

Cited by 24 publications

(23 citation statements)

References 49 publications

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“…This platform can directly measure mRNA without requiring its conversion to cDNA or multiplexed target enrichment (MTE), by directly capturing and counting of individual targets (65). In fact, the FDA approved the nCounterbased Prosigna assay in 2013 to diagnosis breast cancer subtypes, and risk of recurrence, by using a 50-gene signature in breast tissue samples (66). The nCounter system also has been shown to be able to detect EV-derived mRNA (67).…”

Section: Circulating Tumor Cells (Ctcs)mentioning

confidence: 99%

Circulating Biomarkers for Early Stage Non-Small Cell Lung Carcinoma Detection: Supplementation to Low‐Dose Computed Tomography

Kan

Unis

et al. 2021

Front. Oncol.

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Lung cancer is currently the leading cause of cancer death in both developing and developed countries. Given that lung cancer has poor prognosis in later stages, it is essential to achieve an early diagnosis to maximize patients’ overall survival. Non-small cell lung cancer (NSCLC) is the most common form of primary lung cancer in both smokers and non-smokers. The current standard screening method, low‐dose computed tomography (LDCT), is the only radiological method that demonstrates to have mortality benefits across multiple large randomized clinical trials (RCT). However, these RCTs also found LDCT to have a significant false positive rate that results in unnecessary invasive biopsies being performed. Due to the lack of both sensitive and specific screening methods for the early detection of lung cancer, there is an urgent need for alternative minimally or non-invasive biomarkers that may provide diagnostic, and/or prognostic information. This has led to the identification of circulating biomarkers that can be readily detectable in blood and have been extensively studied as prognosis markers. Circulating microRNA (miRNA) in particular has been investigated for these purposes as an augmentation to LDCT, or as direct diagnosis of lung cancer. There is, however, a lack of consensus across the studies on which miRNAs are the most clinically useful. Besides miRNA, other potential circulating biomarkers include circulating tumor cells (CTCs), circulating tumor DNA (ctDNAs) and non-coding RNAs (ncRNAs). In this review, we provide the current outlook of several of these biomarkers for the early diagnosis of NSCLC.

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Section: Circulating Tumor Cells (Ctcs)mentioning

confidence: 99%

Circulating Biomarkers for Early Stage Non-Small Cell Lung Carcinoma Detection: Supplementation to Low‐Dose Computed Tomography

Kan

Unis

et al. 2021

Front. Oncol.

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“…The nCounter platform, which allows for multiplex detection of hundreds of transcripts, has been extensively used in translational research for transcriptomic tumor characterization. In addition, the nCounter Prosigna assay, based on a 50-gene expression signature, has been fully standardized and validated at the clinical level; and received FDA approval in 2013 to predict risk of recurrence in breast cancer 15,16,28 . However, studies investigating the performance of nCounter for mRNA analysis in liquid biopsies are scarce, particularly in the case of EVs.…”

Section: Discussionmentioning

confidence: 99%

“…In addition, it can be used with formalin-fixed paraffin embedded (FFPE) tumor tissue and allows for low quality and quantity tissue samples 13,14 . At this respect, the nCounter-based Prosigna assay, which differentiates breast cancer subtypes and predicts the risk of recurrence based on a 50-gene signature, has been validated in the clinical practice and received FDA approval in 2013 15,16 . Another assay developed using the nCounter platform is the 18-gene Tumor Inflammation Signature (TIS), which was able to predict clinical response to PD-1 blockade in an investigational clinical trial assay 17 .…”

mentioning

confidence: 99%

Analysis of extracellular vesicle mRNA derived from plasma using the nCounter platform

Bracht

Giménez‐Capitán

Huang

et al. 2021

Sci Rep

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Extracellular vesicles (EVs) are double-layered phospholipid membrane vesicles that are released by most cells and can mediate intercellular communication through their RNA cargo. In this study, we tested if the NanoString nCounter platform can be used for the analysis of EV-mRNA. We developed and optimized a methodology for EV enrichment, EV-RNA extraction and nCounter analysis. Then, we demonstrated the validity of our workflow by analyzing EV-RNA profiles from the plasma of 19 cancer patients and 10 controls and developing a gene signature to differentiate cancer versus control samples. TRI reagent outperformed automated RNA extraction and, although lower plasma input is feasible, 500 μL provided highest total counts and number of transcripts detected. A 10-cycle pre-amplification followed by DNase treatment yielded reproducible mRNA target detection. However, appropriate probe design to prevent genomic DNA binding is preferred. A gene signature, created using a bioinformatic algorithm, was able to distinguish between control and cancer EV-mRNA profiles with an area under the ROC curve of 0.99. Hence, the nCounter platform can be used to detect mRNA targets and develop gene signatures from plasma-derived EVs.

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“…In addition, the test is very expensive at approximately $4000 USD per test. [ 6 ] This limits its incorporation into some clinical workflows, particularly in developing economies or among populations lacking private insurance. [ 7 ] In addition, there remains a degree of uncertainty as to the test's accuracy in cases of highly heterogeneous tumor in which gene expression may be spatially variable.…”

Section: Introductionmentioning

confidence: 99%

Peri‐tumoural stroma collagen organization of invasive ductal carcinoma assessed by polarized light microscopy differs between OncotypeDX risk group

Jones

Thomas

Sprenger

et al. 2020

Journal of Biophotonics

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A commercially available genomic test, OncotypeDX has emerged as a useful postsurgical treatment guide for early stage breast cancer. Despite widespread clinical adoption, there remain logistical issues with its implementation. Collagenous stromal architecture has been shown to hold prognostic value that may complement OncotypeDX. Polarimetric analysis of breast cancer surgical samples allows for the quantification of collagenous stroma abundance and organization. We examine intratumoural collagen abundance and alignment along the tumor-host interface for 45 human samples of invasive ductal carcinoma categorized as low or higher risk by OncotypeDX. Furthermore, we probe the separatory power of collagen alignment patterns to classify unlabeled samples as low or higher OncotypeDX risk group using a linear discriminant (LD) model. No significant difference in mean collagen abundance was found between the two risk groups. However, collagen alignment along the tumor boundary was found to be significantly lower in higher risk samples. The LD model achieved a 71% total accuracy and 81% sensitivity to higher risk samples. Prognostic information extracted from the stromal morphology has potential to complement OncotypeDX as an easyto-implement prescreening methodology.

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Cost-effectiveness analysis of multigene expression profiling assays to guide adjuvant therapy decisions in women with invasive early-stage breast cancer

Cited by 24 publications

References 49 publications

Circulating Biomarkers for Early Stage Non-Small Cell Lung Carcinoma Detection: Supplementation to Low‐Dose Computed Tomography

Circulating Biomarkers for Early Stage Non-Small Cell Lung Carcinoma Detection: Supplementation to Low‐Dose Computed Tomography

Analysis of extracellular vesicle mRNA derived from plasma using the nCounter platform

Peri‐tumoural stroma collagen organization of invasive ductal carcinoma assessed by polarized light microscopy differs between OncotypeDX risk group

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