I had the pleasure of speaking to Xin Ye, an Experienced Senior Project Scientist and Director of product development at Sanmed Biotech, focused on developing Circulating Tumor Cell (CTC) capture and detection technologies. Xin attained a Ph.D. in Biochemistry from the University of Illinois at Urbana-Champaign. He joined Sanmed in 2017 as a senior scientist and later fulfilled the role of Head of R&D. <\/b><\/p>\n\n\n\n
The liquid biopsy market is rapidly evolving in China. Can you share some insights on driving forces that facilitate and hinder the introduction of LB into a clinical routine in the Chinese market?<\/strong> ” .. aiming to extrapolate the use of the different circulating molecules into the \u201creal world\u201d in clinics .. “<\/p><\/blockquote>\n\n\n\n Nonetheless, solid\nbiopsies are the current standard of care in clinical cancer management with\nunquestionable utilities in tumor histology, biomarker subtyping, and molecular\nprofiling for treatment planning and prognostic. The detection and\ncharacterization of circulating tumor materials in the early or advanced\nsetting present much more difficulties due to their low amounts in the\nbiofluids from the patients. The consensus among the physicians is that more\nresearch still needs to be performed in the standardization of sample\nextraction procedures, circulating-tumor material isolation, and the very\ndiverse methodologies employed, aiming to extrapolate the use of the different\ncirculating molecules into the \u201creal world\u201d in clinics.<\/p>\n\n\n\n It is undeniable that\nliquid biopsies show great promise based on the data from many studies.\nHowever, its clinical utility is still to be fully established and requires\nperforming large-scale multicentre clinical studies. On top of that, the\nregulatory authorities, not only in China, still hesitate to approve liquid\nbiopsy products due to the lack of clear methodological standards and\nbiological evidence that also hamper the implementation of LB into clinical\nroutine practice.<\/p>\n\n\n\n ” CTCs contain genetic abnormalities similar to those in primary tumors using the combination of immunohistochemistry and fluorescence in-situ hybridization<\/em> (FISH) “<\/p><\/blockquote>\n\n\n\n In recent years,\nresearchers have attempted to isolate tumor cells migrated from the primary\ntumor or metastases into the blood or other body fluids. Such circulating tumor\ncells (CTC) could be released at any stage of the tumorigenesis, even from a\nlocalized tumor. Capture or isolation of CTCs from peripheral blood use a\nvariety of techniques include immunomagnetic capture of EpCAM-positive cells,\nfiltration or density gradient separation based on cell physical properties.\nHowever, usually very few CTCs, which were traditionally identified as\nCytokaritin-positive and CD45-negative by immunofluorescence staining, are\nrecovered from these techniques.<\/p>\n\n\n\n Previous studies have\nreported that CTCs in the bloodstream contain genetic abnormalities similar to\nthose in primary tumors using the combination of immunohistochemistry and fluorescence\nin-situ hybridization<\/em> (FISH). Based on Katz, et al results of\nadenocarcinomas and squamous cell carcinomas using CGH arrays, four chromosomal\nloci were selected and verified that cells with these cytogenetic abnormalities\nwere detected in lung cancer patient specimens by FISH. In our recent studies,\nusing a label-free method to enumerate circulating genetically abnormal cells\n(CACs) by four-color FISH, early-stage NSCLC patients had significantly higher\nnumbers of CACs than did benign and healthy controls. The presence of CACs\nabove a certain threshold could be used as a bio-indicator for lung cancer risk\nstratifications, especially for populations with indeterminate pulmonary\nnodules.<\/p>\n\n\n\n ” The use of a FISH assay with no epithelial capture component to detect CAC is unique and attractive as it is not relying on specific antigenic expressions “<\/p><\/blockquote>\n\n\n\n You\u2019ve recently published a paper on the diagnosis of Non-Small Cell Lung Cancer via Liquid Biopsy; there you\u2019ve presented a unique approach leveraging Fluorescence-in-situ hybridization for the characterization of CACs. What are the highlights of this methodology and how can it be integrated into the clinical routine of LC patients?<\/strong><\/p>\n\n\n\n The use of a FISH assay with no epithelial capture component to\ndetect CAC is unique and attractive as it is not relying on specific antigenic\nexpressions, which are highly heterogeneous in tumor cells, and may reveal more\nCACs that could be limited by an antigenic assay for epithelial\ndifferentiation. The FISH assay could characterize losses and gains of certain\nchromosomal regions regardless of the lineage of these cells and could\nsimultaneously detect multiple DNA probes at the single-cell level. Integrating\nthe FISH assay with BioView\u2019s high-throughput automated fluorescent scanning\nsolution, enable us to interrogate multicolor fluorescent signals for different\ngenes on a per-cell basis and precisely quantify CACs population surrounded by\nup to several hundred million lymphocytes and neutrophils per ml of peripheral\nblood.<\/p>\n\n\n\n Beyond the liquid biopsy biomarker, we crossed the \u201cone analyte\u201d\nbarrier focusing on the multi-omics solution by using Sanmed\u2019s proprietary CT\nartificial intelligence analysis to generate pulmonary nodule malignancy\nprediction. Using machine learning-based modeling and large patient data from\nthe multicenter clinical studies, the FISH assay, in conjunction with the AI\ninterpretation of the lung nodule plays a synergistic role and could achieve\nearly lung cancer detection close to 90% accuracy. We believe that our\nmethodologies could be seamlessly integrated with the early lung cancer\nscreening and routine diagnostic workflow and become an important tool to shift\nthe current clinical landscape.<\/p>\n\n\n\n
The analysis of tumor cells or tumor-related matters (e.g. cell-free DNA and exosome) obtained from blood or other body fluids offers a broad range of opportunities in the field of oncology. The ideas of noninvasively portraying the entire disease at the cellular and molecular level and providing real-time comprehensive tumor information on cancer evolution, therapeutic strategies, and resistance mechanisms are attractive to both researchers and physicians. The potential clinical application areas include early detection of cancer, recurrence risk assessment, drug efficacy monitoring also propel many institutes and industrial companies to invest in liquid biopsy technologies. <\/p>\n\n\n\nInterviewed by Alex Malamud, Director of Marketing at BioView<\/strong><\/em>
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