The CE Mark and FDA Class 1 registration both represent significant milestones towards making the powerful VTX-1 commercially available in early 2017
Menlo Park, CA (PRWEB) November 03, 2016
Vortex Biosciences, provider of circulating tumor cell (CTC) capture systems, today announced it has registered a Class I medical device with the U.S. Food and Drug Administration (FDA) and established a CE Mark for its proprietary CTC capture system, the VTX-1 Liquid Biopsy System. 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.
“We are committed to introducing a next generation CTC capture system that allows CTCs to realize their tremendous potential for investigating and diagnosing cancer,” said Gene Walther, Chief Executive Officer of Vortex Biosciences. “The CE Mark and FDA Class 1 registration both represent significant milestones towards making the powerful VTX-1 commercially available in early 2017.”
Representative of cancer status in the patient, CTCs, shed by tumors, can potentially allow for better characterization 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 utilizing 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. This offers significant advantages for downstream analysis:
- Isolated CTCs remain representative of the patient’s cancer status and unbiased by molecular characteristics.
- CTCs collected at higher purity increase the accuracy and sensitivity of downstream assays.
- CTCs are unaltered and undamaged by labels or reagents and easily collected, making them ideal for live cell assays and cell culture experiments
About Vortex Biosciences
Vortex Biosciences is a cancer research and diagnostics company that integrates cancer biology, microfluidic engineering and informatics to develop tools for isolating and characterizing circulating tumor cells. The Vortex technology will enable the harvesting of intact circulating tumor cells from whole blood samples for use in downstream research and clinical applications such as patient stratification in clinical trials, monitoring disease progression and drug treatment effectiveness. With a mission to enable noninvasive diagnosis of cancer and real-time monitoring throughout a patient’s treatment, Vortex is at the forefront of accelerating cancer research and improving patient outcomes. Vortex is a core subsidiary of NetScientific plc, a transatlantic healthcare technology group with an investment strategy focused on sourcing, funding and commercializing technologies that significantly improve the health and well-being of people with chronic diseases. For more information, visit http://www.vortexbiosciences.com.