CLIA certification enables us to accept and report on a variety of clinical samples - it’s a major milestone,” said André de Fusco, Cynvenio’s CEO. “And LiquidBiopsy’s global reach allows us to support partners worldwide in their fight against cancer.
Westlake Village, CA (PRWEB) July 09, 2013
Cynvenio Biosystems, Inc., a cancer diagnostics company focused on the molecular analysis of tumor biomarkers derived from whole blood, today announced certification 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 certification 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 operational excellence for its LiquidBiopsy service which includes the isolation of circulating tumor cells and their genomic analysis by next generation sequencing,” said Andreas Bakker, Ph.D., vice president of Operations 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 accepting clinical samples and its LiquidBiopsy genomic profiling service is commercially available for all patients with solid tumors.
CMS manage and conduct inspections of CLIA laboratories as mandated by the Code of Federal Regulations (CFR 42 Part 493.2). The regulation was enacted to ensure consistent, accurate, and reliable clinical test results reporting from laboratories across the country used for the diagnosis, treatment, and/or prognosis of disease in human subjects. CLIA applies to all clinical laboratories operating in the U.S. and its territories and encompasses more than 200,000 clinical testing sites.
About Cynvenio’s LiquidBiopsy
The LiquidBiopsy service (http://www.liquidbiopsy.com) uses next generation sequencing to analyze tumor cells isolated from whole blood. The clinical information 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 options may be available, and can be useful in metastatic disease when tissue 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 collection 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 international as well as US testing locations.
Upon receipt at the lab the sample is processed by CT-SEQ, a Cynvenio protocol for direct-isolation-to- next-generation-sequencing without whole genome amplification. CT-SEQ evaluates mutations across 50 oncogenes for the presence of over 2100 single point mutations with a sensitivity of 1%. The results are summarized in a genomic report that includes leading-edge, clinically relevant information on current and experimental treatments and diagnostics for each patient'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 patient monitoring and complements traditional FFPE tissue sample analysis. The turnaround time for CT-SEQ is typically 7 days from sample receipt. In addition to clinical oncologists, academic and industry researchers will find CT-SEQ useful for biomarker discovery and real-time monitoring of patients in clinical trials.
“Achieving CLIA certification 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 enthusiastic 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 diagnostics company dedicated to the early detection and targeted treatment of cancer. Cynvenio has developed and deployed the LiquidBiopsy system to enable realtime monitoring of tumor cell-associated mutations from a simple blood draw. This information may be used by physicians, academic centers, and drug developers to assist in the definition of treatment cycles for individual patients, the selection of patients for drug trials and to monitor patient 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 http://www.liquidbiopsy.com.
LiquidBiopsy® is a registered trademark of Cynvenio Biosystems, Inc.