Cynvenio Research Highlights Need for Longitudinal Monitoring of Triple Negative Breast Cancer Patients

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Preliminary results from Company’s 211 patient TNBC clinical research study will be presented at the 2017 ASCO Annual Meeting, June 2-June 6, 2017 in Chicago, Illinois.

The preliminary data shows the importance of a multi-template approach to provide greater visibility on a patient’s tumor landscape and the ultimate value of longitudinal monitoring to track persistent mutations.

Cynvenio Biosystems, Inc. a leader in personalized medicine technology for cancer diagnostics, announced the company will present preliminary data to support the utility of longitudinal monitoring of triple negative breast cancer patients using Cynvenio’s ClearID liquid biopsy tests. These data were collected during the first year of Cynvenio’s clinical research study, “A Pilot Surveillance Study to Monitor Natural Killer Cells and Circulating Tumor Cells in Women with Previously Treated Non-metastatic Triple Negative Breast Cancer and Women with Previously Treated Non-metastatic Breast Cancer With a confirmed BRCA Mutation” (clinicaltrials.gov identifier NCT02639832).

This ongoing study, which launched in December 2015, examines the utility of serial liquid biopsies using a multi-template approach that identifies and analyzes cell-free DNA (cfDNA), circulating tumor cells (CTCs), and germline DNA (gDNA). Enrolled in the study are 211 women with a confirmed diagnosis of Triple Negative Breast Cancer (TNBC), who were within three years of completion of therapy when they entered the study and had no evidence of residual/recurrent cancer. On average, each participant has had four serial samples collected to date which have been analyzed using Cynvenio’s ClearID® Breast Cancer custom 27-oncogene panel.

The data collected shows the majority of participants have had evidence of genomic mutations in at least one sample, but did not show these changes in consecutive blood draws and have not experienced documented recurrence. In contrast, a small percentage of the group did show changes in both cfDNA and CTC’s on consecutive blood draws and have developed documented evidence of recurrence.

Despite a relatively favorable response rate to chemotherapy, TNBC-classified patients are more likely to develop distant recurrence and die from breast cancer within five years of diagnosis compared with other patients, and one-third of all triple-negative patients will eventually develop metastatic disease.

"Currently the medical community has limited methods to identify recurrence in cancer patients consisting mainly of CT, MRI or PET scans," said Peter Beitsch, MD FACS, Founder of TME Research Network. "These tests are expensive, require a significant time commitment for the patient, and are not without side effects. We need a better way to monitor breast cancer patients which is less invasive, convenient, and detects cancer at the earliest time point possible with the smallest volume of recurrent cancer, which is easier to treat. The ClearID test appears to be that method. I look forward to longer follow up of this cohort with serial monitoring."

“We are encouraged by the findings to date,” commented Paul Y. Song, MD, Chief Medical Officer of Cynvenio. “The preliminary data shows the importance of a multi-template approach to provide greater visibility on a patient’s tumor landscape and the ultimate value of longitudinal monitoring to track persistent mutations. Our aim is to help find cancerous cells well before they embed themselves in organs or bone, and then analyze them to identify specific targeted therapies in hopes of improving outcomes.”

The data will be presented in a poster “Use of serial multi-template liquid biopsies in triple negative breast cancer monitoring” by Dr. Paul Y. Song et. al. at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting, June 2-June 6, 2017 in Chicago, Illinois.

About Cynvenio Biosystems, Inc.

Cynvenio’s liquid biopsy testing technology is leading the way to more affordable and clinically actionable precision medicine strategies for cancer patients.  Among the company’s breakthroughs is its line of ClearID® tests for greatly improved cancer detection and monitoring via a patient-friendly blood draw, and a suite of proprietary, distributable LiquidBiopsy® platforms and consumables for deployment in hospitals and third party diagnostic labs. Cynvenio is based in Westlake Village, California. For more information, please visit http://www.cynvenio.com http://www.clearidmonitoring.com and http://www.liquidbiopsy.com.

LiquidBiopsy® and ClearID® are registered trademarks of Cynvenio Biosystems, Inc.

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Heidi Brown
@cynvenio
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