New Research Involving Circulogene’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)–#ASCO16–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

“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
  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
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
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
or call 855-614-7083.


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