Cynvenio Biosystems, Inc., a diagnostics company dedicated to enabling the new era of individualised medicine for all cancer patients, and ATGen Global, a private biotech company in Korea that manufactures and supplies a wide array of recombinant proteins and antibodies worldwide, have formed a collaborative partnership to bring ATGen’s NK Vue test to the US market.

NK Vue is a unique ELISA-based blood test that measures Natural Killer (NK) cell activity. NK cells are part of the innate immune system and represent the first line defense against infections and cancer. Abnormally low levels of NK cell activity have been associated with an increased risk of cancer and autoimmune diseases. Recent publications have described a strong relationship between NK cell activity and the degree of circulating tumor cells in patients with metastatic prostate, breast, and colorectal cancer.

While already approved to measure Natural Killer cell function in Korea and Canada by their respective regulatory agencies, NK Vue will be sold in the United States as a laboratory developed test (LDT) that has been certified by Cynvenio’s CLIA and CAP-accredited laboratory. The test will provide US physicians a means to monitor overall immune wellness in the general population, provide a complementary tool in cancer screening and cancer surveillance post-treatment, and also to provide additional insights into the condition of active autoimmune diseases such as multiple sclerosis and inflammatory bowel disease.

André de Fusco, CEO of Cynvenio said, “We are very impressed with ATGen’s technology and overall team, and are especially excited to incorporate the NK Vue test as a complement to our proprietary ClearID testing and LiquidBiopsy technology that will increase the yield of cell-free DNA and circulating tumour cells (CTCs) available via standard blood draw to support cancer care.”

Sangwoo Park, CEO of ATGen said, “We are grateful for this opportunity to partner with Cynvenio; their management, staff and CLIA laboratory are truly world class and present us with an ideal entry into the US market. Our ultimate goal is work with Cynvenio to expand access to our test in the US and globally as new clinical indications are validated.”

Numerous clinical trials are planned or underway in Korea, Canada, Denmark, China, and the United States looking at the use of NK Vue to monitor several different cancer types, including breast, prostate, lung, colorectal, ovarian, and gastric cancers. In addition, several trials are on-going to measure NK cell activity in autoimmune diseases and correlate this with response to treatment and relapse.

Dr. Paul Y. Song, chief medical officer at both Cynvenio and ATGen said, “An extensive amount of published scientific and clinical research has established the role of NK cell activity in numerous cancers and autoimmune diseases. The problem has been that, up to now, the techniques used to measure NK cell activity have not been easily reproducible or commercially available. We are confident that NK Vue will provide a consistently reliable and affordable means to measure NK cell activity, while spawning new studies that will result in clinically relevant associations with a wide range of diseases not yet explored.”