New Research Involving Circulogene Theranostics’s Liquid Biopsy Further Validates Test’s Cancer Mutation Detection Capabilities

Studies show droplet volume liquid biopsy detects new tumor mass earlier than current imaging methods and detects more mutations than tissue biopsy

BIRMINGHAM, Ala.--(BUSINESS WIRE)--Newly published research involving the Circulogene droplet-volume liquid biopsy test has demonstrated for the first time that circulating cell-free tumor DNA (ctDNA) sequencing can detect the presence of a new tumor mass earlier than current, standard-of-care imaging methods. Additionally, research presented at the American Society of Clinical Oncology (ASCO) 2016 Annual Meeting demonstrated that Circulogene’s propriety DNA enrichment methodology could detect more cancer mutations than DNA extracted from solid tumor

“In this ground-breaking research, we were able to examine the correlation between tissue and blood biopsies in both pre- and post-chemotherapy in ovarian cancer patients”

“These studies further demonstrate the potential and viability of non-invasive, droplet-volume liquid biopsies for accurate, affordable and personalized cancer tracking and treatment decision making using just microliters of blood,” said Circulogene Chief Scientific Officer Chen-Hsiung Yeh, Ph.D.

Chen coauthored the study with Hope Health Center Medical Director and oncologist Nader Javadi, M.D., “Blood-Drop Liquid Biopsy for Monitoring Mutation Load and Therapeutic Responses” published in the June 2016 issue of the Cancer Therapy & Oncology International Journal. The case report focused on plasma ctDNA as a versatile biomarker, enabling accurate monitoring of tumor burden and treatment response. Study observations included:

1. Mutation load measured by blood-drop ctDNA sequencing correlated well with PET/CT, CA biomarkers and clinical outcome in response to therapy
2. Blood-drop ctDNA testing could detect new tumor mass earlier than PET/CT
3. Blood-drop liquid biopsy possessed longitudinal and real-time monitoring capability
4. Blood-drop liquid biopsy testing could be a surrogate for accurate, affordable and accessible personalized testing

The authors concluded that mutation detection of ctDNA in drops of blood is a powerful monitoring tool able to provide accurate and earlier assessment of tumor behavior, burden and patient responses following treatment, representing significant benefits over conventional protein biomarkers and imaging technology.

In the ASCO 2016 poster presentation “Circulating cell-free DNA: The future of personalized medicine in ovarian cancer management,” authors reported that plasma ctDNA detected more mutations than DNA extracted from solid tumor.

“In this ground-breaking research, we were able to examine the correlation between tissue and blood biopsies in both pre- and post-chemotherapy in ovarian cancer patients,” said lead author Rebecca C. Arend, M.D., Assistant Professor, University of Alabama – Birmingham. “Our research also revealed that tumor heterogeneity was potentially better captured by circulating ctDNA than from a small tumor biopsy, and more mutation changes are picked up in the plasma following therapy compared to tumor biopsy.”

The abstract authors commented that precision medicine programs should consider utilizing ctDNA to optimize detection of the molecular diversity of ovarian cancer when performing genetic profiling.

Circulogene continues to collaborate with other biotechnology research institutions on additional research projects. Circulogene is the first and only biotechnology company able to enrich circulating cell-free DNA from blood drops 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 855-614-7083.

About Circulogene

Headquartered in Birmingham, Ala., Circulogene 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 855-614-7083.