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Kenneth D Cole

Group Leader, Bioassay Methods Biosystems and Biomaterials Division

We are working on a number of projects in the area of heath care standards in our group, including cancer biomarker standards, cell line authentication, biomanufacturing, and flow cytometry.  We have developed a DNA standard for the HER2 breast cancer biomarker (NIST SRM 2373). The standard consists of genomic DNA prepared from 5 human breast cancer cell lines. The DNA samples have different amounts of amplification of the HER2 gene. Quantitative PCR (qPCR) and droplet digital (ddPCR) were used to certify the copy number of the HER2 gene along with a number of references genes. The standard was used to evaluate copy number measurements using different next generation sequencing methods. We are also working on a project to measure the HER2 protein expression in these cell lines and tumor samples using flow cytometry. We are developing genomic DNA standards for copy number measurements of the MET and EGFR genes, to be released as NIST RM 8366. We plan on using ddPCR measurements and interlaboratory testing measurements to characterize the reference material.

NIST is working with the Early Detection Research Network (part of the National Cancer Institute) to improve the quality of the measurements for the early detection of cancer. A promising new technology is the measurements of circulating tumor DNA (ctDNA) found in the blood and used to detect the genomic mutations present in tumors. Measurement of ctDNA has significant analytical challenges. We are working on standards to improve the measurements of ctDNA for cancer diagnosis and therapeutic monitoring.

Misidentified and contaminated cell lines are a serious problem in scientific research. We are working on developing multiplex methods to authenticate important cell lines used in research and production of biologicals. We are working multiplex short tandem repeat (STR) marker assays to identify mouse, rat, and Chinese hamster ovary (CHO) cell lines. We are also working on measurements to express and characterize protein therapeutics. CHO cells are commonly used to produce protein therapeutics in large amounts. In collaboration with a major bio-pharmaceutical company we are studying CHO genomic stability during production of protein therapeutics.

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

 Representative Publications

Almeida, J.A., Hill, C.R., Cole, K.D. Authentication of African green monkey cell lines using human short tandem repeat markers. BMC Biotechnology 11, 102-112 (2011)

Wang, L., Abbasi, F., Ornatsky, O., Cole, K.D., Misakian, M., Gaigalas, A.K., He, Hua-Jun, Marti, G.E., Tanner, S., Stebbings, R. Characterization of human CD4+lymphocytes from different cell preparations as candidate biological cell reference materials for quantitative multiparameter flow cytometry. Cytometry Part A 81A, 567-575 (2012).

Cole, K.D., He, H.J., and Wang L. Breast Cancer Biomarker Measurements and Standards. Proteomics Clinical Applications 7, 17-29 (2013).

Almeida, J.L, Hill, C.R., Cole, K.D. Mouse Cell Line Authentication. Cytotechnology10.1007/s106160-013 (2013).

L.Wang, M. Misakian, H-J He, Hua-Jun; P. Bajcsy, J. Davis, K. Cole, I. Turko, L. Wang, Lili, F. Abbasi Characterization of Two Human CD4+ Lymphocyte Preparations for Quantitative Flow Cytometry. Clinical Proteomics (2014) 11:43.

B.L. Lang and Cole, K.D. Unfolding Properties of Recombinant Human Serum Albumin Products Are Due to Bioprocessing Steps. Biotechnology Progress (2014) 31: 62-69 (2014) Sep 30. doi: 10.1002/btpr.1996

He, H.-J., Almeida, J., Lund, S., Hill, C.R., Choquette, S. and Cole, K.D. Development of NIST Standard Reference Material® 2373:  Genomic DNA Standards for HER2 Measurements. Biomolecular Detection and Quantification, (2016) 8, p. 1-8.

Lih, C.-J., Harrington, R.D., Harper, K. Sims, D.J., McGregor, P. Camalier, C. Si, H. Das, B. Williams, P.M., He, H.-J., Almeida, J., Lund, S. Choquette, S., and Cole K.D. Certified DNA Reference Materials to Compare HER2 Gene Amplification Measurements Using Next Generation Sequencing Methods. Journal of Molecular Diagnosis (2016) in press, available on line.


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