Cynvenio and TME Research Announce Neoadjuvant Breast Cancer Monitoring Study (NEAT)

Multi-center registry trial will use ClearID Breast Cancer liquid biopsy tests to monitor breast cancer patients in the neoadjuvant treatment setting

WESTLAKE VILLAGE – April 28, 2017 – Cynvenio Biosystems, Inc. a leader in personalized medicine technology and cancer diagnostics, today announced the launch of a new neoadjuvant breast cancer monitoring (NEAT) study in partnership with Allentown, PA-based TME Research. The multi-center registry study will include at least 10 centers and over 150 patients to be monitored over two years with Cynvenio’s ClearID Breast Cancer blood test. The study goal is to leverage the registry data to develop better recurrence monitoring tools and more effective testing algorithms for breast cancer patients.

Neoadjuvant chemotherapy in breast cancer is used to downstage locally advanced and inoperable tumors. By collecting tumor information via a liquid biopsy, patient data can be accrued at regular intervals via simple and minimally invasive blood draws. The registry data will help identify new biomarkers to assess patient response, measure resistance to chemotherapy, and identify new targets for alternative chemotherapy.

In the post-operative setting, the study aims to identify residual tumor burden and resistance clones or therapy-induced changes in the primary tumor that could potentially require additional adjuvant therapy.

“A small 2015 study from London by Garcia-Murillas using PCR to look for residual disease in the blood of patients undergoing neoadjuvant therapy showed a strong correlation with recurrence,” said Paul Y. Song, MD, Cynvenio’s Chief Medical Officer. “Our collaboration with TME will be the largest commercial trial to date using a serial multi-template (cell-free DNA and circulating tumor cells) approach to detect and measure residual disease. Building on the London academic study that focused on 14 driver mutation genes, our study will leverage next-gen sequencing using Cynvenio’s custom 27-gene breast cancer-specific panel that is commercially available.”

“The treatment of breast cancer is changing from ‘surgery first’, to ‘systemic therapy first’ and then surgery for residual disease,” commented Peter Beitsch, MD FACS, the founder of TME Research. “The standard population-based chemotherapy treatments are going to fall by the wayside and give way to targeted, personalized treatment. Our Registry will be a pathway to identify biomarkers and targets to optimize treatment and outcomes. We are very excited to undertake this partnership with Cynvenio.”

About TME Research

TME is a network of clinicians, researchers, educators and companies whose core mission is to improve the quality and access to targeted breast cancer care by fostering high quality and comprehensive educational programs and resources. TME Research is an extension of the TME mission and designs, executes and optimizes accrual in breast cancer and breast health studies with a focus on performing these studies with community leaders. TME is headquartered in Allentown, PA. For more information, visit www.tmeded.com.

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 www.cynvenio.com,  www.clearidmonitoring.com and www.liquidbiopsy.com.

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