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Hua-Jun He ()

Research Interests

1). Standards & reference materials for cancer biomarker clinical analysis. Currently, we are working on the development of cell line based genomic DNA reference materials for gene copy number variations biomarker HER2/EGFR/MET, and spike-in based mimic cell- free DNA reference materials for cancer detection of rare allele mutation in non-invasive circulating tumor DNA (ctDNA) from patient's blood. Human artificial chromosomes (HACs) carrying a functional kinetochore were considered as a promising system for gene delivery and expression with a potential to overcome many problems caused by the use of viral-based gene transfer systems. We are interested in engineering a tailored reference material platform based on HAC and genome editing tools such as CRISPR/Cas9 for the production of defined gene copies and gene mutation, or defined fold protein overexpression reference materials.

2). Metrology for cancer biomarker and biosystems. A variety of genetic alterations, including deletions, amplifications, rearrangements and point mutations, exist in human cancer. Recently, we are working on developing digital PCR and next-generation sequencing (NGS) based robust and sensitive assays for rare allele genetic alterations. We are also interested in developing Flow-FISH for simultaneously quantitation of gene amplification and protein overexpression.







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

NIST Spectroscopic Measurement Standards

Paul C. DeRose, Kenneth D. Cole, Aaron Urbas, Steven J. Choquette, Evelyn Solis, Erica V. Stein, John E. Schiel, Brian Lang, Hua-Jun He
Ultraviolet (UV) absorbance measurements provide a rapid and reliable method to determine protein concentrations. The National Institute of Standards and
Created July 17, 2018, Updated December 8, 2022