Cynvenio Biosystems, Inc., a diagnostics company dedicated to enabling the new era of individualized medicine for all cancer patients and ATGen Global, a Korea-based biotech company, announced the launch of 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, which means these women test negative for estrogen receptor, progesterone receptor, and Her-2 receptor gene expression. Despite a relatively favourable 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 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. 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 tumour cells. In this study, patients who show low NK levels will receive further analysis with the ClearID test to molecularly characterize circulating tumour 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 tumour cells can be found,” said 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 analyse them to identify specific targeted therapies in hopes of improving outcomes.”

While the role of circulating tumour 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,” said André de Fusco, Cynvenio’s CEO. “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/CAP certified lab in Westlake Village and will be expanded to include academic medical centres in Chicago, New York, Pittsburgh in the first half of 2016.