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Multicancer Early Detection Screening Tools: Not Economically Efficient, Not Ethically Equitable, Marginally Medically Effective.
Camb Q Healthc Ethics
December 2024
Center for Bioethics and Social Justice, College of Human Medicine, Michigan State University, East Lansing, MI, USA.
A screening test for more than 50 cancers at earlier stages would strike many as a godsend. Such a test would promise, prima facie, to save 160,000 lives annually from a premature death from cancer, reduce the intensity of medical treatment, and reduce social costs. In brief, this is what is promised by the Galleri test.
View Article and Find Full Text PDFThe Unholy Grail of cancer screening: or is it just about the Benjamins?
Clin Chem Lab Med
September 2024
Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, Sinai Health System, Toronto, Canada.
The biotechnology company Grail developed a non-invasive blood test (Galleri test) which is claimed to detect 50 types of cancer at early and potentially curable stages. The initially promising results from prospective studies, and the anticipated financial success of Grail led the sequencing giant Illumina to purchase Grail for $8 billion (2021). Following this event, Grail collaborated with the UK National Health System to further clarify the test's capability, in a 3-year prospective trial, along with the standard of care.
View Article and Find Full Text PDFUnderstanding the Landscape of Multi-Cancer Detection Tests: The Current Data and Clinical Considerations.
Life (Basel)
July 2024
Department of Medicine, Brigham and Women's Hospital, Boston, MA 02115, USA.
Multi-cancer detection (MCD) tests are blood-based assays that screen for multiple cancers concurrently and offer a promising approach to improve early cancer detection and screening uptake. To date, there have been two prospective interventional studies evaluating MCD tests as a screening tool in human subjects. No MCD tests are currently approved by the FDA, but there is one commercially available MCD test.
View Article and Find Full Text PDFEvaluation of cell-free DNA approaches for multi-cancer early detection.
Cancer Cell
December 2022
Francis Crick Institute, London, NW1 1AT, UK; UCL Cancer Institute, CRUK Lung Cancer Centre of Excellence, London, WC1E 6DD, UK.
In the Circulating Cell-free Genome Atlas (NCT02889978) substudy 1, we evaluate several approaches for a circulating cell-free DNA (cfDNA)-based multi-cancer early detection (MCED) test by defining clinical limit of detection (LOD) based on circulating tumor allele fraction (cTAF), enabling performance comparisons. Among 10 machine-learning classifiers trained on the same samples and independently validated, when evaluated at 98% specificity, those using whole-genome (WG) methylation, single nucleotide variants with paired white blood cell background removal, and combined scores from classifiers evaluated in this study show the highest cancer signal detection sensitivities. Compared with clinical stage and tumor type, cTAF is a more significant predictor of classifier performance and may more closely reflect tumor biology.
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