Cynvenio Biosystems Announces New PD-L1 Test for Tumor Cells in Blood

New Blood Test Expands Utility of Company's Multi-Template LiquidBiopsy Analysis

LOS ANGELES – October 1, 2015 – Cynvenio Biosystems, Inc., a diagnostics company dedicated to enabling the new era of individualized medicine for cancer patients, announced that it has developed, validated, and fully implemented a PD-L1 (Programmed Death-Ligand 1) assay for circulating tumor cells (CTCs) obtained via its LiquidBiopsy® technology for several tumor subtypes.

PD-L1 has been identified as the primary immunosuppressive driver and an important facilitator for tumor growth and metastasis. PD-L1 has been detected in up to 50 percent of all human cancers, making it a major focus of therapeutic research. Unlike most circulating tumor cell technologies which enumerate CTCs, Cynvenio’s multi-template approach allows for simultaneous isolation of cell-free DNA and CTCs that can be both evaluated for PD-L1 expression using immunofluorescent staining, as well as further interrogated for additional DNA and protein biomarkers.

Several recent clinical trials have reported an association between the degree of PD-L1 expression in the primary tumor with a response to anti-PD-1/PD-L1 targeted therapies, and others have been less conclusive. While most trials were performed in the metastatic setting, they nevertheless examined PD-L1 expression in primary tumor specimens, not metastatic samples. Cynvenio’s LiquidBiopsy closes this gap by allowing real-time sampling of metastatic patients for PD-L1.

“Given that all current immunotherapy trials originate in the metastatic setting, and that PD-L1 expression represents an adaptive change whose expression can fluctuate and vary over time, analysis of archival primary tumor tissue may not be the best indicator of immunologic phenotype and this may explain the variation in usefulness of PD-L1 expression as a therapeutic biomarker,” said Paul Song, M.D., Chief Medical Officer of Cynvenio. “We have already found significant heterogeneity between the primary tumor sample and isolated CTCs in numerous tumor types, and we believe that our LiquidBiopsy technology may better determine which patients in the metastatic setting will respond, thus allowing for truly optimized treatment.”

“It is estimated that up to 60 percent of all cancer therapy will be immunotherapy-based by 2025,” commented André de Fusco, Cynvenio’s CEO. “By enabling clinicians to determine which patients might better respond to treatment, we aim to improve healthcare economics while securing better clinical results for patients and the pharmaceutical industry.”

Clinicians or scientists interested in obtaining access to the assay can visit: www.cynvenio.com or www.liquidbiopsy.com.

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.

LiquidBiopsy® is a registered trademark and ClearID™ is a trademark of Cynvenio Biosystems, Inc.