Abnova Corporation announced the completion of Abnova Diagnostics GMP facility in Dongguan aiming for the precision medicine market in China. Precision medicine uses diagnostic testing to diagnose and predict individuals’ susceptibility to a particular disease and select optimal therapies based on the context of their genetic content, thereby maximizing treatment response while minimizing side effect and resistance. Abnova develops and leverages
circulating rare cell, circulating exosome, and
circulating cell-free RNA as the next generation diagnostics to catapult its precision medicine platform for in vitro diagnostics (IVD) clinical trials, and product and service commercialization in China. Abnova’s platform enables the full spectrum of early to metastatic to recurrent disease and treatment diagnosis, prediction, guidance and monitoring. The diagnostic precision medicine currently accounts for $10 billion USD market worldwide with 20% projected annual growth rate in China¹.
While most companies focus on a technological niche, Abnova has vertically integrated the development and manufacturing of proprietary bioreagents, high-throughput automations (CytoQuest™ CR, CytoQuest™ Dx, CytoBot™), and high-content software for isolation and analysis of circulating rare cells. The diverse scope of commercial applications includes circulating epithelial cells (CECs), circulating tumor cells (CTCs), circulating cancer stem cells (CSCs), and circulating fetal cells (CFCs). Abnova’s patented and exclusive access to antibodies and gene markers pertaining to CTCs and CSCs provides a highly competitive stance in the precision medicine market. Most importantly, actionable biomarker-driven applications are needed to accurately diagnose and predict metastasis and relapse, select appropriate drug and/or surgical treatments and monitor their response and resistance².
For early disease detection, circulating exosome and circulating cell-free RNA provide better detection sensitivity. Exosomes are 50-150nm small membrane vesicles secreted by most cell types and travelled in the blood stream for intercellular communications. They contain protein and RNA enveloped in a membrane bi-layer like circulating cells. Exosomes are amenable to isolation and analysis similar to circulating rare cells of 10-50um but required more scaled-down nano-engineering. Nonetheless, the principle of Abnova’s antibody and microfluidic technologies apply equally and effectively to the isolation of exosomes. Exosome technology is new and the related biomarkers are not as known as those identified for circulating rare cells, but its potential for non-invasive diagnosis has just been demonstrated for early detection of pancreatic cancer³. Future applications of exosomes await with great anticipation and excitement.
Cell-free RNA analysis is an ideal, non-invasive diagnostic method for early detection of disease, particularly cancer. Blood sample is taken directly from the individual’s peripheral vein for RNA analysis. Since no cells or encapsulated vesicles are involved, isolation process is obviated. However, specialized RNA extraction combined with sophisticated bioinformatics is needed to identify and apply RNA signature profiling of early disease in the clinical setting. The signal amplification which can be obtained from cell-free RNA detection is greater than that of cell-free DNA. As a result, cell-free RNA is more applicable for early cancer detection. For cancer metastasis and relapse, circulating tumor cells and circulating cancer stem cells are more specific for diagnosis and prediction. Abnova is currently investigating the RNA profiles for early gastrointestinal cancer detection. Similar analytical approach can be applied to other cancers.
1. Precision Medicine, A Disruptive Innovation of Health Care. GosReports 2015.
2. Becker TM et al. New Frontier in Circulating Tumor Cells Analysis: A Reference Guide for Biomolecular Profiling Toward Translational Clinical Use. In J Cancer 134: 2523-2533, 2013.
3. Melo SA et al. Glypican-1 Identifies Cancer Exosomes and Detects Early Pancreatic Cancer. Nature 178(523): 177-200, 2015.
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About Abnova
Abnova has established a comprehensive portfolio of fully integrated solutions to address the needs of the in vitro diagnostic (IVD) industry. Abnova provides its partners and customers access to the technologies, products and services relating to circulating rare cell, circulating exosome, and circulating cell-free RNA for early to metastatic to recurrent disease and treatment diagnosis, prediction, guidance and monitoring. Abnova facility is ISO13485 and GMP certified for proprietary bioreagent and high-throughput automation development and manufacturing for clinical trials and IVD commercialization. (
www.abnova.com)
