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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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Type

Article

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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

Volume Title

Publisher

Elsevier BV