Vortex Biosciences Gains FDA Registration for Liquid Biopsy System

Vortex Biosciences has registered a Class I medical device with the FDA and has gotten a CE Mark for its proprietary circulating tumor cell (CTC) capture system, the VTX-1 Liquid Biopsy System.

The Vortex VTX-1 Liquid Biopsy System is an automated bench-top system for collecting intact CTCs using microfluidic technology. Inside the VTX-1 chip, unlabeled CTCs in whole blood are trapped in microscale vortices while smaller red and white blood cells pass through. After selective trapping into the microfluidic chambers, CTCs can be flushed and collected into a variety of containers for downstream analysis.

The VTX-1 will initially be distributed into the research use only market and will be commercially available in early 2017 in the U.S. market, the company said. — Cynthia Jessup