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AACR 2016 Research Shows Circulogene Liquid Biopsy Excels at Real-Time Monitoring of Cancer Mutations

Circulogene Theranostics

Interlab comparison demonstrates Circulogene’s blood-drop-volume liquid biopsy assay is fastest, most accurate process to date for tracking and treating cancer

3 May 2016
Weylan Kiam-Laine
Microbiologist

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Researchers using Circulogene Theranostics’ liquid biopsy test demonstrated the assay’s ability to quickly, accurately and cost effectively identify and monitor tumor mutations in a scientific abstract presented at the American Association of Cancer Research (AACR) 2016 Annual Meeting in New Orleans.

The study titled “Clinical validation of a next-generation sequencing assay specifically for blood-drop liquid biopsy” was presented by Circulogene Chief Scientific Officer Chen-Hsiung Yeh, Ph.D. The research demonstrated the company’s next-generation liquid biopsy assay is a highly sensitive and specific method for cancer gene mutation analysis able to rapidly impact treatment decision-making and identify targeted therapies for eligible patients using finger-stick volumes of blood.

“Our goal was to show the medical community that our test is robust, consistent and reproducible; the results presented today met that goal,” explained Yeh. “With just microliters of blood, we demonstrated the test’s analytical and clinical validation, including our limit of detection, using different labs, different sites and different operators.”

Chen noted the three layers of validation would be critical for the oncology and pathology community using the test. The proof-of-principle study was coauthored by University of Alabama-Birmingham Department of Pathology Professor Upender Manne, Ph.D., M.S.

“The thorough and rigorous clinical validation of this unique methodology further demonstrates the significant advances in patient management and treatment made possible by next generation liquid biopsies using droplet volumes of blood,” said Manne.

Study results specifically demonstrated:

  • Test specificity on a cohort of 17 apparently healthy individuals of 99.9% at the gene level (849/850) and in strong concordance (94%; 16/17) with another CLIA laboratory.
  • Test sensitivity (limit of detection) down to 0.5 - 1%.
  • Inter-assay and intra-assay concordance of 100%; inter-instrument concordance of 98.4%; inter-operator concordance of 100%.
  • An accuracy of 96% (48/50) when compared to results from another NGS platform in another CLIA lab.

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Circulogene TheranosticsCompany website

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Data AnalysisData analysis hardware and software is available to make data processing straight-forward yet powerful. Data software can be used for math and stats, technical graphing and image analysis. In addition, software is available for specific data analysis of electrophoresis, densitometry, ELISA and DNA sequencing.Assay AssemblyAssay Assembly is technique used in drug discovery to develop assays to test the cytotoxicity, genotoxicity, or other activities of a compound on a cell. Assay assembly requires chip assembly, a delivery system and a detection and analysis method. Beneficial features of assay kits or automated systems include high-throughput, high speed and sensitivity and low signal to noise ratio.BiomarkersBiomarkers are biological markers which can be measured and evaluated to indicate a biological state. The use of biomarkers in research and diagnosis can indicate a normal or disease state or drug response of cells / tissues. Biomarkers include genetic markers, cell surface markers such as antigens, antibodies or receptors and secreted molecules such as cytokines. An assay system is required for identification of biomarkers. :Clinical TrialsClinical Trials, an essential part of drug discovery process, assess the safety and effectiveness of a new medication or device in the pharmaceutical industry. Clinical Trials are a phased process (Phase 0, Phase I, Phase II, Phase III and Phase IV) which begins after initial preclinical testing.Next Generation SequencingNext-generation sequencing (NGS), also known as whole-genome sequencing, high-throughput sequencing and massive parallel sequencing, produces and analyses thousands to millions of nucleotide sequences at once. Sequencing systems operate via varying technologies depending on the manufacturer, including sequencing by synthesis, ligation, pyrosequencing, ion semiconductor and single-molecule real-time sequencing. For NGS, library preparation is paramount to successful sequencing. In this section, explore a range of library preparation kits, from targeted, amplicon-based or hybridization-based kits including epigenomic, transcriptomic and genomic workflows to fragmentation kits. Find the best next-generation sequencing products in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Cancer ResearchCancer research aims to understand the mechanisms of cancer development and progression to improve prevention, diagnosis, and treatment. From molecular biology to clinical trials, research spans a wide range of disciplines, including immunotherapy, targeted therapies, and drug discovery. Explore the best cancer research products in our peer-reviewed product directory; compare products, check reviews, and get pricing directly from manufacturers.MutationMutations are changes in the DNA sequence that can lead to diseases, including cancer and genetic disorders. Analyzing mutations is crucial in diagnostics, drug development, and personalized medicine. Explore mutation detection tools in our peer-reviewed product directory; compare products, check reviews, and get pricing directly from manufacturers.Assay DevelopmentThe process of proving an assay to be sensitive with respect to the target is known as assay development. The assay should be able to characterize novel compounds and measure the potency of these compounds against a validated biological target.Method ValidationMethod validation is the process used to prove that the analytical procedure used for a particular test is capable of providing suitable data.Clinical StudyProspective biomedical or behavioral research studies on human subjects, following tests in animals, that are designed to answer specific questions about novel vaccines, drugs, treatments, dietary supplements, devices or new ways of using known interventions, generating safety and efficacy data.TumorsTumor research focuses on understanding abnormal cell growth that leads to cancer. Identifying biomarkers, studying tumor microenvironments, and developing targeted therapies are critical for advancing cancer treatment. Early detection and personalized treatment options are key to improving outcomes for patients. Browse our peer-reviewed product directory to explore tools for tumor research, diagnostics, and cancer therapies; compare products, read customer reviews, and get pricing directly from manufacturers.Liquid BiopsiesLiquid biopsies are non-invasive tests used to detect cancer and other diseases by analyzing blood or other bodily fluids. This technique is gaining popularity for early detection, monitoring treatment response, and detecting minimal residual disease. Explore liquid biopsy solutions in our peer-reviewed product directory; compare products, check reviews, and get pricing directly from manufacturers.AACRThe American Association for Cancer Research (AACR) is a leading organization focused on cancer research and treatment. It provides a platform for scientists, healthcare professionals, and industry leaders to share knowledge and collaborate in the fight against cancer.

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AACR 2016 Research Shows Circulogene Liquid Biopsy Excels at Real-Time Monitoring of Cancer Mutations