Cynvenio Biosystems Inc, Westlake Village, Calif, and AtGen Global, Seoul, Republic of Korea, have launched a pilot study to evaluate a new method for early detection of cancer in women who have completed treatment for triple-negative breast cancer (TNBC) and show no radiographic signs of metastases.

Of the estimated 1 million cases of breast cancer diagnosed annually worldwide, some 170,000 or more will have the TNBC subtype, producing negative test results for estrogen receptor, progesterone receptor, and HER2 receptor gene expression. Despite a relatively favorable response rate to chemotherapy, TNBC-classified patients are more likely than other patients to develop distant recurrence and die from breast cancer within 5 years of diagnosis, and one-third of all triple-negative patients will eventually develop metastatic disease.

The new study will use Cynvenio’s ClearID test based on its LiquidBiopsy technology in combination with the NK Vue blood test from AtGen. LiquidBiopsy is a multitemplate technology that enables the molecular characterization of tumor cells from a standard blood draw. 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.

A strong correlation exists 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 characterize circulating tumor cell and cell-free DNA present in their blood for genetic alterations that may support specific treatment regimens.

“It is highly likely that some women will harbor subclinical metastatic disease that cannot yet be radiographically detected and for which no specific biomarker has been identified, but in whom circulating tumor cells can be found,” says Paul Y. Song, MD, chief medical officer of Cynvenio and AtGen. “Using a combination of Cynvenio’s ClearID technology and AtGen’s NK Vue test, we believe we may help find these 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.”

André de Fusco, Cynvenio.

André de Fusco, Cynvenio.

While the role of circulating tumor cells in blood has been understood for some time and is a growing area of interest, existing methods to monitor them are laborious, inconsistent, and costly. “Our method is simple, reliable, and inexpensive, and is not limited like some blood tests to only cell-free DNA,” says André de Fusco, CEO of Cynvenio. “Further, our technology provides information about cell surface markers and proteins in addition to genomic insights. Our ultimate goal is to bring a practical and effective diagnostic test that offers actionable advice to a population of at-risk women for whom there is currently no concrete way to monitor cancer-free existence.”

The trial will begin enrollment immediately at Cynvenio’s CLIA- and CAP-certified lab in Westlake Village, Calif, and will be expanded to include academic medical centers in Chicago, New York, and Pittsburgh during the first half of 2016.

For more information, visit Cynvenio.