Cynvenio Biosystems and ATGen Announce Strategic Partnership to bring NK Vue Natural Killer Cell Test to US Market

Companies Team Up to Expand the Utility of LiquidBiopsy® Testing in Oncology

LOS ANGELES and SEOUL, SOUTH KOREA – September 28, 2015 – Cynvenio Biosystems, Inc., a diagnostics company dedicated to enabling the new era of individualized 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, today announced the companies 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 tumor 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.”

The NK Vue test is available now and can be ordered from Cynvenio online at www.cynvenio.com/nkvue or by calling 805-855-2050.

About Cynvenio Biosystems, Inc.

Cynvenio is a commercial stage clinical diagnostics company that leverages its proprietary LiquidBiopsy® multi-template technology for the molecular characterization of tumor cells from a standard blood draw. Commercial labs and research institutions are powered by Cynvenio’s LiquidBiopsy platform, which includes automated instrumentation, consumables/reagents, patient sample kits, and bioinformatics for sequencing rare cell populations. Oncology practices and individual physicians can also access the LiquidBiopsy system with zero upfront investment by ordering the ClearID™ blood test from Cynvenio’s CLIA/CAP lab or its clinical partners. ClearID and LiquidBiopsy are cornerstones in the emerging field of genomic peripheral blood monitoring. They are used to rapidly assess patients’ evolving mutations in support of precision medicine strategies. ClearID is reimbursable in the United States.

Cynvenio is headquartered in Westlake Village, California (Los Angeles). For more information, please visit http://www.cynvenio.com and www.liquidbiopsy.com.

About ATGen Global

ATGen Global is a privately held biotech company that manufactures and supplies a broad array of novel proteins, peptides, and antibodies worldwide. ATGen’s proprietary stable protein technology has enabled the company to expand into the development of in vitro diagnostics. The company is also involved in the research and development of cutting edge therapeutics. ATGen is headquarted in Seoul, South Korea with additional offices in Montreal, Canada and Valencia, CA. More information is available at http://atgenglobal.com/home.

LiquidBiopsy® is a registered trademark and ClearID™ is a trademark of Cynvenio Biosystems, Inc. NK Vue™ is a trademark of ATGen Global.