WESTLAKE VILLAGE, CA -‐ July 9, 2013 -‐-Cynvenio Biosystems, Inc., a cancer diagnostics company focused on the molecular analysis of tumor biomarkers derived from whole blood, today announced certfication from the U.S. Department of Health and Human Services' Centers for Medicare and Medicaid Services (CMS) under the Clinical Laboratory Improvement Amendments (CLIA) of 1988 for its genomic sequencing laboratory in Westlake Village, California. This certificaton follows receipt of a California State license and allows the company to accept clinical samples from most U.S. states.
“Cynvenio has achieved an enviable level of operatonal excellence for its LiquidBiopsy service which includes the isolaton of circulatng tumor cells and their genomic analysis by next generaton sequencing,” said Andreas Bakker, Ph.D., Vice President of Operatons at Cynvenio Biosystems, Inc.
Cynvenio Biosystems achieved California State licensing in April 2013, enabling the company to begin processing clinical samples. The company is currently acceptng clinical samples and its LiquidBiopsy genomic profiling service is commercially available for all patents with solid tumors.
CMS inspect and certfy CLIA laboratories as mandated by the Code of Federal Regulatons (CFR 42 Part 493.2). The regulaton was enacted to ensure consistent, accurate, and reliable clinical test results reportng from laboratories across the country used for the diagnosis, treatment, andtor prognosis of disease in human subjects. CLIA applies to all clinical laboratories operatng in the U.S. and its territories and encompasses more than 200,000 clinical testng sites.
About Cynvenio’s LiquidBiopsy
The LiquidBiopsy service uses next generaton sequencing to analyze tumor cells isolated from whole blood. The clinical informaton produced by LiquidBiopsy sequencing provides an understanding of the specific molecular pathways that are driving tumor growth. This analysis can help develop individualized treatment strategies earlier in the disease cycle when more optons may be available, and can be useful in metastatc disease when tssue samples may no longer be reliable or easily obtainable.
The LiquidBiopsy process starts with Cynvenio’s self-‐contained 7.5mL blood sample kit which includes collecton materials and pre-‐paid FedEx packaging for return delivery to the processing lab. Significantly, the kit can travel unrefrigerated for up to five days which enables Cynvenio to support internatonal as well as US testng locatons.
Upon receipt at the lab the sample is processed by CT-‐SEQ, a Cynvenio protocol for direct-‐isolaton-‐to-‐ next-‐generaton-‐sequencing without whole genome amplificaton. CT-‐SEQ evaluates mutatons across 50 oncogenes for the presence of over 2100 single point mutatons with a sensitvity of 1%. The results are summarized in a genomic report that includes leading-‐edge, clinically relevant informaton on current and experimental treatments and diagnostcs for each patent's tumor type, based on their specific molecular profile. This report can be a useful decision-‐support tool for physicians, and since LiquidBiopsy requires only a normal blood draw, it is suitable for longitudinal patent monitoring and complements traditonal FFPE tssue sample analysis. The turnaround tme for CT-‐SEQ is typically 7 days from sample receipt. In additon to clinical oncologists, academic and industry researchers will find CT-‐ SEQ useful for biomarker discovery and real-‐tme monitoring of patents in clinical trials.
“Achieving CLIA certficaton enables us to accept and report on a variety of clinical samples and is a major milestone in our company’s development,” commented André de Fusco, Cynvenio’s CEO. “We are enthusiastc about LiquidBiopsy’s global reach and our ability to support partners worldwide in their fight against cancer.”
About Cynvenio Biosystems, Inc.
Cynvenio Biosystems, Inc. is a molecular diagnostcs company dedicated to the early detecton and targeted treatment of cancer. Cynvenio has developed and deployed the LiquidBiopsy system to enable realtme monitoring of tumor cell-‐associated mutatons from a simple blood draw. This informaton may be used by physicians, academic centers, and drug developers to assist in the definiton of treatment cycles for individual patents, the selecton of patents for drug trials and to monitor patent response at any stage of disease.
Cynvenio’s CLIA service lab is based in Westlake Village, California. To find out more about the company please visit www.liquidbiopsy.com