Cynvenio, Los Angeles, introduces the high-tech ClearID Breast Cancer monitoring program, which enables the early detection of breast cancer recurrence.

“We know that breast cancer survivors are concerned about recurrence, and studies show that between one and five survivors will see their cancer return within 10 years of treatment,” says André de Fusco, CEO and director. “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.”

He says that incorporating this progam 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 the company’s CLIA-approved lab, 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.

Massimo Cristofanilli MD “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),” says Massimo Cristofanilli, MD, director, Jefferson Breast Care Center, Kimmel Cancer Center and Thomas Jefferson University and Hospitals, both in Philadelphia.

“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. 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. 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 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.

The National Cancer Institute recently 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.

[Source: Cynvenio]

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