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Cynvenio Bio Gains CLIA Certification for NGS Lab

NEW YORK (GenomeWeb News) – Cancer diagnostics company Cynvenio Biosystems announced today its sequencing laboratory has received CLIA certification.

As a result, the lab, located in Westlake Village, Calif., can accept clinical samples from most of the US. In April the company received licensure to accept clinical samples from California, one of the states that require other regulatory approval in addition to CLIA certification before a lab offering an LDT can accept patient samples from the state.

Cynvenio offers LiquidBiopsy, a next-generation sequencing-based service for the analysis of tumor cells isolated from whole blood. LiquidBiospy provides information about the specific molecular pathways driving tumor growth, which can be used to tailor individualized treatments for patients earlier in the disease cycle.

BioArray News recently reported that after receiving CLIA certification, Cynvenio plans to clinically validate its circulating tumor cell sequencing service and some targeted PCR assays for isolated CTCs. The assays are already offered by the company to the research community.

"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," Cynvenio CEO André de Fusco said in a statement today. "We are enthusiastic about LiquidBiopsy’s global reach and our ability to support partners worldwide in their fight against cancer."