Validation of Nu.Q™ colorectal cancer screening triage test to identify FIT positive individuals at low risk of screen relevant neoplasia

Herzog, Mariëlle; Eccleston, Mark E.; Micallef, Jake; Pamart, Dorian; Cuvelier, B; Josseaux, Eléonore; Terrell, Jason; Christensen, Ib Jarle; Nielsen, Hans Jørgen

doi:10.1093/annonc/mdx262.021

Cited by 4 publications

(2 citation statements)

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“…A different approach applies the Nu.Q™ Colorectal Cancer Test, aiming to reduce the number of unnecessary colonoscopies. The test was developed on the principle of global hypomethylation present in cfDNA of a CRC origin [ 70 ] and utilizes the ELISA method to analyze the methylation status of nucleosomes present in the serum, with sensitivity at 75% and with a 70% specificity [ 71 , 72 ].…”

Section: Methylation Detection In Cell-free Dnamentioning

confidence: 99%

Current Challenges of Methylation-Based Liquid Biopsies in Cancer Diagnostics

Rendek,

Pos,

Duranova

et al. 2024

Cancers

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In current clinical practice, effective cancer testing and screening paradigms are limited to specific types of cancer, exhibiting varying efficiency, acceptance, and adherence. Cell-free DNA (cfDNA) methylation profiling holds promise in providing information about the presence of malignity regardless of its type and location while leveraging blood-based liquid biopsies as a method to obtain analytical samples. However, technical difficulties, costs and challenges resulting from biological variations, tumor heterogeneity, and exogenous factors persist. This method exploits the mechanisms behind cfDNA release but faces issues like fragmentation, low concentrations, and high background noise. This review explores cfDNA methylation’s origins, means of detection, and profiling for cancer diagnostics. The critical evaluation of currently available multi-cancer early detection methods (MCEDs) as well as tests targeting single genes, emphasizing their potential and limits to refine strategies for early cancer detection, are explained. The current methodology limitations, workflows, comparisons of clinically approved liquid biopsy-based methylation tests for cancer, their utilization in companion diagnostics as well as the biological limitations of the epigenetics approach are discussed, aiming to help healthcare providers as well as researchers to orient themselves in this increasingly complex and evolving field of diagnostics.

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Section: Methylation Detection In Cell-free Dnamentioning

confidence: 99%

Current Challenges of Methylation-Based Liquid Biopsies in Cancer Diagnostics

Rendek,

Pos,

Duranova

et al. 2024

Cancers

View full text Add to dashboard Cite

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“…Ii was noteworthy that the sensitivity for “screen relevant neoplasia” (considering patients with CRC and high-risk adenomas) was about 86% compared with the 80% obtained with positive FIT and a cutoff value of 200 ng/ml. The results of this large cohort evaluation were promising as the Nu.Q ™ Colorectal Cancer Screening Test can reduce unnecessary colonoscopies by 20%, while maintaining sensitivity for CRC close to 90% (Marielle et al, 2017).…”

Section: In Vitro Diagnostic Tests Based On Epigenetic Biomarkersmentioning

confidence: 99%

Epigenetic IVD Tests for Personalized Precision Medicine in Cancer

et al. 2019

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Epigenetic alterations play a key role in the initiation and progression of cancer. Therefore, it is possible to use epigenetic marks as biomarkers for predictive and precision medicine in cancer. Precision medicine is poised to impact clinical practice, patients, and healthcare systems. The objective of this review is to provide an overview of the epigenetic testing landscape in cancer by examining commercially available epigenetic-based in vitro diagnostic tests for colon, breast, cervical, glioblastoma, lung cancers, and for cancers of unknown origin. We compile current commercial epigenetic tests based on epigenetic biomarkers (i.e., DNA methylation, miRNAs, and histones) that can actually be implemented into clinical practice.

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