Development, characterization, and inter-laboratory validation of methylated human cell free DNA candidate reference materials.

Zhiyong He¹, Yves Konigshofer², Russell Garlick², Jayanthi Ramprakash², Madhumita Ramesh³, Eric Hall³, Adam Corner³, Michelle Clarissa⁴, Jocelyn H Wright⁴, Victoria K Cannon⁴, Ming Yu⁴, William M Grady^4,5,6, Cecilia C S Yeung^4,7, Zachary Heimer⁸, Zhili Wang⁸, ShiPing Zou⁹, Shidong Jia¹⁰, Fang Liu¹⁰, Giancarlo Bonora¹⁰, Karol Bomsztyk¹¹, Daniel Mar¹¹, Kenneth D Cole¹², Hua-Jun He¹³

¹National Institute of Standards and Technology, 100 Bureau Drive, MS 8312, Gaithersburg, MD, 20899, USA. Zhiyong.he@nist.gov.

²LGC Clinical Diagnostics Inc., Gaithersburg, MD, 20878, USA.

³Bio-Rad Laboratories, 1000 Alfred Nobel Dr., Hercules, CA, 94547, USA.

⁴Translational Science and Therapeutics Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.

⁵Clinical Research Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.

⁶Department of Medicine, University of Washington, Seattle, WA, USA.

⁷Department of Pathology, University of Washington, Seattle, WA, USA.

⁸JBS Biosciences, 3805 Old Easton Rd, Doylestown, PA, 10892, USA.

⁹Pillar Biosciences, 9 Strathmore Rd, Natick, MA, 01760, USA.

¹⁰Predicine, 3555 Arden Rd., Hayward, CA, 94545, USA.

¹¹UW Medicine South Lake Union, University of Washington, Seattle, WA, 98109, USA.

¹²National Institute of Standards and Technology, 100 Bureau Drive, MS 8312, Gaithersburg, MD, 20899, USA.

¹³National Institute of Standards and Technology, 100 Bureau Drive, MS 8312, Gaithersburg, MD, 20899, USA. hua-jun.he@nist.gov.

PubMed PMC DOI PDF

Abstract

BACKGROUND: Aberrant DNA methylation biomarkers have demonstrated potential for early cancer detection, multicancer detection, and determining the tissue of origin. Due to their stability, frequency, and accessibility in bodily fluids, circulating cell-free DNA (cfDNA) methylation is a promising biomarker in liquid biopsy. A reliable and quantifiable analysis of cfDNA methylation status is critica…

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