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Hua-Jun He (Fed)


Research Interests

  1. Standards & reference materials development for cancer biomarker measurements. Currently, we are working on the development of circulating cell-free tumor DNA (ctDNA), cell-free DNA (cfDNA) methylation, cfRNA, extracellular vesicles and other cancer biomarker reference materials for liquid biopsy. In addition, we are working on the development of next generation cell-based reference materials: a) broadly consented and characterized human tumor and matched normal cell lines for multi-omics cancer biomarker detection and benchmark testing; and b) chimeric antigen receptor-T (CAR-T) cell, CAR-NK (natural killer) and CAR engineered in other type of human cell lines for standardization of cell therapy.
  2. Metrology for cancer biomarker and biosystems. We are working on the development of digital PCR and next-generation sequencing (NGS) based robust and sensitive assays for rare allele genetic and epigenetics alterations. Other interests include adopting and validating emerging technologies for fast, sensitive, specific, and accurate cancer biomarker measurements, such as electric field induced release and measurements (EFIRM), lateral flow assays and other portable devices for liquid biopsy.

Research Opportunities

NIST-NRC Postdoctoral Research Associateship Program: 2-year fellowship at NIST, US citizens only, competitive salary plus benefits, travel stipend and relocation expenses. Application deadlines are Feb. 1 and Aug. 1. Requires a 10-page research proposal plus additional materials. Contact me if interested in writing a research proposal on cancer biomarker measurements.

Current opportunities available:

  1. Precision Measurements of Cancer Biomarkers for Liquid Biopsies
  2. Metrology for Epigenetics

Interlaboratory Testing Program


Digital PCR for the Characterization of Reference Materials

Megan Cleveland, Hua-Jun He, Mojca Milavec, Young-Kyung Bae, Peter Vallone, Jim Huggett
Well characterized reference materials are essential to ensuring the harmonization and accuracy of nucleic acid-based tests (such as qPCR); digital PCR (dPCR)

Reference standards for accurate validation and optimization of assays that determine integrated Lentiviral vector copy number in transduced cells

Barbara S. Paugh, Lajos Baranyi, Andre Roy, Hua-Jun He, Lindsay Harris, Kenneth D. Cole, Caroline Raimund, Patricia S. Langan, Moria Artlip, Srikanta Jana, Rimas J. Orentas, Sheng Lin-Gibson, Winfried Krueger, Boro Dropuli?
Lentiviral vectors (LV) have emerged as a robust technology for therapeutic gene delivery into human cells as advanced medicinal products. As these products are

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 July 17, 2018, Updated April 4, 2023