Non-invasive ‘Liquid Biopsy’ Technology May Provide Early Warning System for Metastasis and Lead to Improved Targeted Outcomes
LOS ANGELES, March 3, 2016 – Cynvenio Biosystems, Inc., a diagnostics company dedicated to enabling the new era of individualized medicine for all cancer patients, today will honor Triple Negative Breast Cancer Day by launching a clinical trial for women with triple negative breast cancer (TNBC) using the company’s non-invasive liquid biopsy technology to monitor participants and identify early signs of metastasis. An event for breast cancer advocates, including women with the disease and those enrolling in the trial, will take place this morning in Beverly Hills at the Pink Lotus Breast Center - the first site to participate in the nationwide study.
Of the estimated one million cases of breast cancer diagnosed annually worldwide, some 170,000 or more will have the TNBC subtype, which means these women test negative for estrogen receptor, progesterone receptor, and Her-2 receptor gene expression. 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 TNBC patients will eventually develop metastatic disease. Younger women, African Americans, and Latinas are at highest risk.
“Currently there is no effective way to monitor women who have completed standard therapy for TNBC and who remain at high risk of recurrence and metastases.” said Paul Y. Song, MD, Chief Medical Officer of Cynvenio. “Our LiquidBiopsy®-based solution, which uses a simple blood draw and includes monitoring a woman’s immune system for signs of cancer recurrence, may help find cancerous cells well before they embed themselves into organs or bone. These cells can then be analyzed to identify specific targeted therapies in hopes of improving outcomes.”
“We strive to provide the highest quality breast care medically and technologically possible, so we are excited to be the first center in the country to participate in this cutting-edge research,” said Kristi Funk, MD, Founder of the Pink Lotus Breast Center. “The ‘watch and wait’ plan is not reassuring to our patients; therefore, our goal is to provide women a better method for monitoring their health, and hopefully, cancer-free existence.”
André de Fusco, Cynvenio’s Chief Executive Officer added: “This trial is an important milestone for our company and for the field of breast cancer research. It represents the culmination of four years of intense bioengineering development and we are thrilled to support Drs. Funk and Song in their quest to change the patient monitoring paradigm. Most importantly we hope our work will lead to tangible improvements in the standard of care for triple negative breast cancer survivors. ”
About the Trial
The new study will use Cynvenio’s ClearID™ genomic test, powered by its LiquidBiopsy® technology, in combination with the NK Vue™ blood test from ATGen Global, which is distributed by Cynvenio in the U.S. The NK Vue test monitors the immune system – specifically the presence of natural killer (NK) cells – and can be used as a tool for assessing changes in patients with conditions where innate NK cell activity has been shown to be reduced, such as in some types of cancer. There has been a strong correlation between low NK cell activity and increased presence of circulating tumor cells. In this study, patients who show low NK levels will receive further analysis with the ClearID test to molecularly characterize circulating tumor cell and cell-free DNA present in their blood for genetic alterations that may support specific treatment regimens. More information about the trial is available at https://clinicaltrials.gov/show/NCT02639832.
About Cynvenio Biosystems, Inc.
Cynvenio is a commercial stage clinical diagnostics company that leverages its proprietary LiquidBiopsy® multi-template technology for the molecular characterization of tumor cells from a standard blood draw. Commercial labs and research institutions are powered by Cynvenio’s LiquidBiopsy platform, which includes automated instrumentation, consumables/reagents, patient sample kits, and bioinformatics for sequencing rare cell populations. Oncology practices and individual physicians can also access the LiquidBiopsy system with zero upfront investment by ordering the ClearID™ blood test from Cynvenio’s CLIA/CAP lab or its clinical partners. ClearID and LiquidBiopsy are cornerstones in the emerging field of genomic peripheral blood monitoring. They are used to rapidly assess patients’ evolving mutations in support of precision medicine strategies. ClearID is reimbursable in the United States.
LiquidBiopsy® is a registered trademark and ClearID™ is a trademark of Cynvenio Biosystems, Inc.
NK Vue™ is a registered trademark of ATGen Ltd. (Seoul, Korea)