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Kenneth (Ken) D. Cole

Group Leader, Bioassay Methods Biosystems and Biomaterials Division

Research Interests and projects

  • Improving the quality and confidence of measurements of biomarkers for early detection of cancer by working with stakeholders and scientific collaborators.
  • Development of fully consented matched tumor/normal cell lines for the new generation of reference materials
  • Reference lab for the Early Detection Research Network (NCI) and collaborations with NCI laboratories
  • Foundation NIH Biomarkers Consortium Project: Development of Reference Materials for circulating tumor DNA
  • Methods for quantification of immunohistochemistry (IHC) assays including harmonization of measurements of check point inhibitor antibodies used in cancer immunotherapy
  • Development of assays for Cell Line Authentication, short tandem repeat DNA multiplex PCR assay development for African green monkey, mouse, and Chinese hamster cell lines.

Postdoctoral research fellowships for U.S. citizens are available at NIST through the National Research Council (

Reference materials

  • SRM  2373 Standard Reference Material measured by quantitative PCR, certified for ERBB2 (HER2) gene copy number
  • RM 8366 Reference Material 8366 measured using dPCR, certified for MET and EGFR gene copy numbers.
  • SRM 2082 Standard Reference Material, pathlength standard for measurements in the UV for microvolume spectrophotometers
  • Development of a reference material for a mouse allelic ladder to be used for allele call determination in mouse cell line authentication
  • Development of a reference material for methylation biomarkesr  in cancer



  • Almeida, Jamie L., Cole, Kenneth D. Mouse Cell Line Authentication. US 9,556,482 B2, United States Patent and Trademark Office, 31 January 2017.
  • Almeida, Jamie L., Cole, Kenneth D. Mouse Cell Line Authentication. US 2017/0101677 A1, United States Patent Application Publication, 13 April 2017.
  • Cole, Kenneth D., Cabezas Jr., Heriberto Electrochromatography Apparatus U.S. #5,611,904
  • Cole, Kenneth D. Concentration and Size-fractionation of Nucleic Acids and Viruses in Porous Media, U.S. #5,707,850
  • Cole, Kenneth D. Chemically Reversible Gels for Electrophoretic Separations of DNA and Proteins, U.S. #6,203,680

Consensus Standards

  • ASN-0003 Species-Level Identification of Animal Cells through Mitochondrial Cytochrome c Oxidase Subunit 1 (CO1) DNA Barcodes- member of working group
  • ASTM E2800 - 11 Standard Practice for Characterization of Bacillus Spore Suspensions for Reference Materials.  Chaired working committee
  • ASTM E2805 - 11 Standard Practice for Measurement of the Biological Activity of Ricin. Chaired working committee



  • NIST Judson C. French Award, “for development of copy number standard reference material SRM 2373 for diagnosing cancer”, 2016
  • US Department of Commerce Bronze Medal Award, “for development of a method for mouse cell line authentication”, 2015
  • NIST, Department of Commerce, Bronze Medal “for Electrophoretic DNA Separations”, 1998



Metrological Tools for the Reference Materials and Reference Instruments of the NIST Material Measurement Laboratory

Carlos R. Beauchamp, Johanna Camara, Jennifer Carney, Steven J. Choquette, Kenneth D. Cole, Paul C. DeRose, David L. Duewer, Michael S. Epstein, Margaret C. Kline, Katrice A. Lippa, Enrico Lucon, Karen W. Phinney, Maria Polakoski, Antonio M. Possolo, Katherine E. Sharpless, John R. Sieber, Blaza Toman, Michael R. Winchester, Donald A. Windover
The National Institute of Standards and Technology (NIST), formerly the National Bureau of Standards, was established by the U.S. Congress in 1901 and charged

Development and Interlaboratory Evaluation of a NIST Reference Material RM 8366 for EGFR and MET Gene Copy Number Measurements

Hua-Jun He, Biswajit Das, Megan H. Cleveland, Chen Li, Corinne Camalier, Liang-Chu Liu, Kara L. Norman, Andrew Fellowes, Christopher McEvoy, Steven P. Lund, Jamie L. Almeida, Carolyn R. Steffen, Chris Karlovich, P. M. Williams, Kenneth D. Cole
The National Institute Standard and Technology (NIST) Reference Material RM 8366 was developed to improve the quality of gene copy measurements of EGFR

Multi-Laboratory Assessment of a New Reference Material for Quality Assurance of Cell-Free Tumor DNA Measurements

Hua-Jun He, Erica V. Stein, Yves Konigshofer, Thomas Forbes, Farol L. Tomson, Russell Garlick, Emiko Yamada, Tony Godfrey, Toshiya Abe, Koji Tamura, Michael Borges, Michael Goggins, Sandra Elmore, Margaret L. Gulley, Jessica L. Larson, Lando Ringel, Brian C. Haynes, Corinne Camalier, Chris Karlovich, Biswajit Das, P. M. Williams, Aaron Garnett, Anders Stahlberg, Stefan Filges, Lynn Sorbara, Mathew R. Young, Sudhir Srivastava, Kenneth D. Cole
We conducted a multi-laboratory assessment to determine the suitability of a new commercially- available reference material with 40 cancer variants in a
Created April 2, 2019, Updated March 9, 2020