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Vela Diagnostics Receives CE-IVD Mark for Cell-Free DNA Kit

NEW YORK (GenomeWeb) – Vela Diagnostics said today that its Sentosa SX Cell-free DNA Kit is now CE marked for in vitro diagnostics use.

The kit is designed to run on the Sentosa SX101 instrument, and enables extraction of circulating cfDNA from human plasma, for use in next-gen sequencing and real-time PCR workflows.

According to Vela, its technology has a high recovery efficiency for DNA fragments of about 170bp, and allows the recovery of low-frequency variants. Automated sample extraction takes approximately 3.5 hours with 20 minutes of operator hands-on time.

Vela doesn't currently offer PCR or NGS assays that are specifically validated for cell-free DNA, but the company said that various workflows that have been validated for IVD use in FFPE samples are now pending a cfDNA claim extension.