Cynvenio Announces ClearID, a Breakthrough Test for Monitoring Breast Cancer Patients and Early Detection of Recurrence

ClearID Breast Cancer program enables early detection of recurrence by sequencing DNA of tumor cells from the bloodstream, using a standard blood draw; empowers patients to take action and defend their health

Los Angeles, CA – October 3, 2013 – Cynvenio, a cancer diagnostics company focused on transforming cancer treatment and management through the molecular analysis of tumor biomarkers in blood, today launched a new weapon in the fight against breast cancer, the ClearID Breast Cancer monitoring program. ClearID Breast Cancer is a high-tech monitoring program that enables the early detection of breast cancer recurrence – a valuable tool that empowers patients to defend their health by actively monitoring for recurrence.

“We know that breast cancer survivors are concerned about recurrence, and studies show that as many as 1 in 5 survivors will see their cancer return within 10 years of treatment,” said André de Fusco, chief executive officer and director, Cynvenio. “Based on recent advances in sequencing technology, the ClearID Breast Cancer monitoring program is designed to replace ‘watchful waiting’ with new blood-based genomic information to regularly check for breast cancer recurrence, and if necessary, help form individualized treatment plans. Incorporating ClearID Breast Cancer into routine recurrence monitoring is a simple and effective way to provide patients with the peace of mind that their cancer has not returned.”

Using a standard blood sample that is analyzed in Cynvenio’s CLIA-approved laboratory, ClearID Breast Cancer first detects the presence or absence of CT-cells1 (cancer cells circulating in the blood) that may still be invisible through standard mammography. If these cells are elevated, ClearID Breast Cancer assesses 50 common cancer-associated genes (oncogenes), covering more than 4,500 genetic mutations using next-generation sequencing technology. Patients and their physicians receive a comprehensive, actionable genomic report detailing the types of mutations present, a summary of the available targeted therapeutic options, and open clinical trials that may be suitable for the patient based on the identified mutations.

“ClearID Breast Cancer is a valuable clinical tool to help physicians and patients detect cancer cells in the blood, describe their biology and actively monitor for lack of efficacy (advanced disease) or early recurrence (high-risk). One of the most important features of this test is the opportunity to offer patients a less invasive option for genomic analysis over a traditional tissue biopsy,” commented Massimo Cristofanilli, M.D., director, Jefferson Breast Care Center at the Kimmel Cancer Center and Thomas Jefferson University and Hospitals. “We understand that the mutations in DNA of each patient’s cancer contribute to the most distinct features of their cancer, and may change during the natural history of the disease making it difficult to provide real-time and highly individualized monitoring and treatment. In patients with aggressive disease and high-risk of recurrence, we believe this sensitive technology may also detect a patient’s recurrence very early, and contribute to advancing the care of these patients at the microscopic level with a chance for a cure. In summary, we believe that by knowing and monitoring the mutations driving the disease, physicians are well-positioned to build an informed, individualized treatment plan that can improve patient outcomes.”

ClearID Breast Cancer may be the right approach for breast cancer survivors and those who are considered high risk for breast cancer due to family history or other factors. The ClearID Breast Cancer monitoring program includes four blood tests (recommended quarterly over the course of a year), and if necessary, a full sequencing analysis with a comprehensive genomic report. For more information and to order ClearID Breast Cancer, please visit http://www.cynvenio.com.

Cynvenio and its cancer detection technology have been recognized for their breakthrough innovations which are applicable to all phases of the cancer care cycle. In September 2013 the National Cancer Institute awarded Cynvenio a contract valued at $1 million through its Small Business Innovation Research program, which provides funding for developing and commercializing novel technologies and products to prevent, diagnose and treat cancer. The company received the contract under the topic, “Developing Predictive BioMarkers in Metastatic Breast Cancer Using LiquidBiopsy”, and will apply the funds to support ClearID clinical trials at a major cancer center in the United States.

About ClearID Breast Cancer

ClearID Breast Cancer is an innovative new weapon in the fight against breast cancer recurrence. It is a high-tech cancer monitoring program that enables the early detection of breast cancer recurrence – a valuable tool that empowers patients to defend their health. When present, tumor cells circulate in the bloodstream. The ClearID Breast Cancer monitoring program proactively tests for these cells using a standard blood draw. The blood test, ClearID SCORE, is a threshold test that measures the level of potential tumor cells in the blood. Results from the ClearID SCORE test that show less than 15 cells/mL indicate that the cells are similar to those of healthy individuals. If the level of these cells is elevated, or greater than 15 cells/mL, the cells are further analyzed for cancer-associated genetic mutations through the ClearID SEQ test. Patients and their physicians will receive a comprehensive, actionable genomic report detailing the types of mutations present, the available targeted therapeutic options, and open clinical trials that may be suitable for the patient based on the identified mutations. The ClearID Breast Cancer monitoring program includes four blood tests (recommended quarterly over the course of a year), and if necessary, a full sequencing analysis and comprehensive genomic report. For more information and to order ClearID Breast Cancer, please visit http://www.cynvenio.com.

About Cynvenio

Cynvenio is a cancer diagnostics company focused on transforming cancer treatment and management through the molecular analysis of tumor biomarkers in the bloodstream. This expertise has resulted in two distinct product offerings: ClearID Breast Cancer monitoring program and LiquidBiopsy®. ClearID Breast Cancer, designed for use by patients and their physicians, is a cancer detection and monitoring program that assesses 50 oncogenes for more than 4,500 genetic mutations using next-generation sequencing. This test and real-time molecular analysis provide actionable information that can inform treatment considerations and help improve treatment outcomes. LiquidBiopsy is designed for industry and academic researchers to identify the presence of tumor-cell genetic mutations in whole blood. Founded in 2008, Cynvenio is headquartered in Westlake Village, Calif. (Los Angeles). For more information visit http://www.cynvenio.com.

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1. CT-cells (Cynvenio Target-cells) are epithelial cells that are nucleated cytokeratin positive and CD45 negative.