Kenneth Cole


Kenneth 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.

Listen to the interview with Kenneth (published July 2017) https://mendelspod.com/podcasts/need-better-standards-your-clinical-assa...



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