Multi Cancer Early Detection by Using Circulating Tumor DNA-The Galleri Test. Reply to Klein et al. The Promise of Multicancer Early Detection. Comment on "Pons-Belda et al. Can Circulating Tumor DNA Support a Successful Screening Test for Early Cancer Detection? The Grail Paradigm. Diagnostics 2021, 11, 2171"

Oscar D Pons-Belda; Amaia Fernandez-Uriarte; Eleftherios P Diamandis

doi:10.3390/diagnostics12051244

Multi Cancer Early Detection by Using Circulating Tumor DNA-The Galleri Test. Reply to Klein et al. The Promise of Multicancer Early Detection. Comment on "Pons-Belda et al. Can Circulating Tumor DNA Support a Successful Screening Test for Early Cancer Detection? The Grail Paradigm. Diagnostics 2021, 11, 2171"

Diagnostics (Basel). 2022 May 17;12(5):1244. doi: 10.3390/diagnostics12051244.

Authors

Oscar D Pons-Belda¹, Amaia Fernandez-Uriarte¹, Eleftherios P Diamandis^{1

2

3}

Affiliations

¹ Department of Pathology and Laboratory Medicine, Mount Sinai Hospital, Toronto, ON M5G 1X5, Canada.
² Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, ON M5S 1A8, Canada.
³ Department of Clinical Biochemistry, University Health Network, Toronto, ON M5G 2N2, Canada.

Abstract

We recently published some concerns with new technologies which are based on circulating tumor DNA (ctDNA) for early cancer detection. Most of our published criticism, including a commentary in this journal, has focused on tests developed by the biotechnology company GRAIL (their commercial product is also known as The Galleri Test). Scientists from GRAIL provided explanations and rebuttals to our criticism. They also posed some questions. Here, we reiterate our position and provide rebuttals, explanations and answers to these questions. We believe that constructive scientific debates, like this one, can profoundly contribute to advancements in scientific fields such as early cancer detection.

Keywords: GRAIL; Galleri test; cancer screening; circulating tumor DNA; methylation assay; multi-cancer early detection.

Grants and funding

This research received no external funding.