BIRMINGHAM, Ala.--(BUSINESS WIRE)--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 today 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
The study’s results will be published in the 2016 Proceedings of the AACR.
Circulogene continues to collaborate with other biotechnology research institutions on additional research projects, including: concordance studies comparing the Circulogene’s blood biopsy with traditional tissue biopsy; comparing the company’s liquid with a competitive assay and comparing Circulogene liquid biopsy test results with clinical outcomes.
Circulogene is the first and only biotechnology company able to enrich circulating cell-free DNA from a single blood drop for patient-specific monitoring of cancer, achieving maximal output from minimal input. The company currently provides testing for breast, colorectal, lung, gastric, gastrointestinal stromal (GIST), hematological, melanoma, ovarian, pancreatic and thyroid cancers.
Circulogene is Clinical Laboratory Improvement Amendments (CLIA) certified and is continuing research initiatives to independently demonstrate greatly increased sensitivity and specificity compared to current methods. For more information, visit our website, connect with us on LinkedIn, email us at info@circulogene.com or call 205-278-1600.
About Circulogene Theranostics
Headquartered in Birmingham, Ala., Circulogene Theranostics is an innovative molecular diagnostics company founded and operated by a team of experienced industry executives and skilled molecular diagnostics scientists. Applying its proprietary laboratory developed test for cfDNA liquid biopsies, Circulogene has developed the first droplet-volume, next-generation sequencing (NGS) method to provide full genomic load analysis, enabling more accurate data to help clinicians and their patients. For more information, visit www.circulogene.com or call 205-278-1600.
