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Vortex Bio gains FDA registration for Class 1 medical device

Thursday, November 3, 2016 13:30
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Vortex Biosciences, a provider of circulating tumor cell (CTC) capture systems, Thursday announced it has registered a Class I medical device with the US Food and Drug Administration and established a CE Mark for its proprietary CTC capture system, the VTX-1 Liquid Biopsy System.

Vortex is a portfolio company of the UK’s NetScientific plc (AIM:NSCI, LON:NSCI), the transatlantic healthcare IP commercialisation group.

“Both the CE Mark and FDA Class 1 registration are significant milestones achieved towards making VTX-1 commercially available in early 2017 and bringing us closer to the sale of the system in the clinical market in the US,” said Chief Executive Officer and Chairman of Vortex, Francois R. Martelet.

The CE Mark allows Vortex to install systems in the European Economic Area (EEA). VTX-1 will initially be distributed into the Research Use Only (RUO) market. The FDA Class 1 registration is a first step towards the sale of the system in the clinical market.

A CE mark indicates the VTX-1 has met all applicable directives of the European Commission (EC) and subsequently the laws and regulations of the European Union (EU) member states and therefore can be commercialized within the 30-nation EEA and Switzerland. The establishment of this CE mark involved thorough evaluation and testing of the VTX-1 to assure it performs safely and as designed.  The FDA Class 1 registration ensures we are operating within FDA guidelines for the use of the system.

Representative of cancer status in the patient, CTCs, shed by tumors, can potentially allow for better characterisation of the disease, resulting in more informed treatment decisions. Cancer cells are traditionally obtained through tissue biopsies. Biopsies are costly, painful, often not possible, and cannot be performed on all possible tumor sites.

CTCs offer tremendous potential, but are relatively scarce, with concentrations as low as 1-10 CTCs/mL of whole blood, against a background of millions of white blood cells and billions of red blood cells. Capturing CTCs out of whole blood is a critical step in utilising CTCs for cancer diagnosis, better cancer treatment decisions and disease monitoring.

The Vortex VTX-1 Liquid Biopsy System is a fully automated benchtop 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 Vortex CTC isolation process is label-free and contact-free, keeping CTCs intact and viable. Samples processed by the VTX-1 minimize white blood cell contamination, resulting in a highly pure CTC sample with minimal white blood cell contamination.

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