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Search Publications by: Hua-Jun He (Fed)

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Displaying 1 - 25 of 46

Standards and Metrology for Viral Vectors as Molecular Tools: Outcomes from a CCQM Workshop

May 24, 2024
Author(s)
Janathan Campbell, Neil Almond, Y Bae, Ravneet Bhuller, Andrea Briones, S-Y CHO, Megan Cleveland, Thomas Cleveland, Francis Galaway, Hua-Jun He, U Herbrand, Jim Huggett, Sarah Kempster, Ibolya Kepiro, Afifa Khan, Edward Kwee, Wilson Li, Sheng Lin-Gibson, Luise Luckau, Caterina Minelli, M Ryadnov, I Searing, Lili Wang, Alexandra Whale, Julian Braybrook
Viral vectors are agents enabling gene transfer and genome editing and have widespread utility across the healthcare and biotechnology sectors. In January 2023, the International Bureau for Weights and Measures' Consultative Committee for Amount of

Digital PCR for the Characterization of Reference Materials

February 14, 2024
Author(s)
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) can measure the absolute concentration of a specific nucleic acid sequence in a background of non

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

July 11, 2021
Author(s)
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 increasingly commercialized, there are concomitant demands for their characterization to ensure

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

May 21, 2019
Author(s)
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 (epidermal growth factor receptor) and MET (proto-oncogene, receptor tyrosine kinase), important targets

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

May 2, 2019
Author(s)
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 background of wild-type DNA at four different variant allele fractions (VAF): 2%, 0.5%, 0.125%, and 0 %

NIST Spectroscopic Measurement Standards

May 1, 2018
Author(s)
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 Technology (NIST) has developed Standard Reference Material (SRM) 2082as a pathlength standard for UV

Certified DNA Reference Materials to Compare HER2 Gene Amplification Measurements Using Next- Generation Sequencing Methods

September 1, 2016
Author(s)
Chih-Jian Lih, Robin D. Harrington, Kneshay Harper, David J. Sims, Paul McGregor, Corinne Camalier, Han Si, Biswajit Das, P. M. Williams, Hua-Jun He, Jamie L. Almeida, Steven Lund, Steven J. Choquette, Kenneth D. Cole
The National Institute of Standards and Technology (NIST) Standard Reference Materials 2373 is a set of genomic DNA samples prepared from five breast cancer cell lines with certified values for the ratio of the HER2 gene copy number to the copy numbers of

Quantifying CD4 receptor protein in two human CD4+ lymphocyte preparations for quantitative flow cytometry

December 11, 2014
Author(s)
Meiyao M. Wang, Martin Misakian, Hua-Jun He, Peter Bajcsy, Jeffrey M. Davis, Kenneth D. Cole, Illarion Turko, Lili Wang, Fatima Abbasi
For quantitative flow cytometry, a biological cell reference material with a known biomarker expression level is needed to transform a linear arbitrary fluorescence intensity scale obtained with fluorescent microspheres to an antibody bound per cell (ABC)

Breast Cancer Biomarker Measurements and Standards

January 24, 2013
Author(s)
Kenneth D. Cole, Lili Wang, Hua-Jun He
Cancer is a heterogeneous disease characterized by changes in the levels and activities of important cellular proteins, including oncogenes and tumor suppressors. Genetic mutations cause changes in protein activity and protein expression levels that result