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

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.