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Cynvenio Biosystems Receives CLIA Certification for its Genomic Sequencing Laboratory
Date:7/9/2013

cal 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 LiquidB
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