Re: Clinical Validation of a Targeted Methylation-based Multi-cancer Early Detection Test Using an Independent Validation Set.
Accepted version
Peer-reviewed
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Authors
Rossi, Sabrina H
Stewart, Grant D
Abstract
The Galleri¬TM test consists of a single blood test evaluating methylation, rather than mutations, in cell free DNA (cfDNA) to enable pan-cancer screening. DNA sequencing is coupled with a machine learning classifier to report the presence of a cancer (cancer signal detection) and predict cancer signal origin (CSO) for >50 malignancies. Klein et al performed a prospective case-control study to validate the assay and evaluate diagnostic performance. The study included cancer patients (N=2823) and controls (N=1254; confirmed absence of cancer at one year follow-up) aged >20 years, recruited across North America. Results are summarised in Table 1.
Description
Keywords
Biomarkers, Tumor, DNA Methylation, Early Detection of Cancer, Humans, Neoplasms
Journal Title
Eur Urol
Conference Name
Journal ISSN
0302-2838
1873-7560
1873-7560
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Publisher
Elsevier BV