NetScientific PLC Vortex Gains CE Mark and FDA Class 1 Registration (2980O)
03 Novembro 2016 - 2:34PM
UK Regulatory
TIDMNSCI
RNS Number : 2980O
NetScientific PLC
03 November 2016
("NetScientific" or the "Company" or the "Group")
Portfolio Company Vortex Biosciences Gains CE Mark and registers
Class 1 Medical Device with FDA
London, UK - November 3 - NetScientific plc (AIM:NSCI), the
transatlantic healthcare IP commercialisation group, announces that
its portfolio company, Vortex Biosciences, has been awarded a CE
Mark for its proprietary Circulating Tumour Cell (CTC) capture
system, the VTX-1 Liquid Biopsy System, and has registered a Class
I medical device with the U.S. Food and Drug Administration
(FDA).
Commenting on the news, NetScientific's Chief Executive Officer
and Chairman of Vortex, Francois R. Martelet, said: "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."
Vortex Bioscience's press release follows:
Vortex Biosciences Establishes CE Mark and Receives FDA Class 1
Registration for Circulating Tumor Cell Capture System
CE Mark and FDA Class 1 Registration of VTX-1 Liquid Biopsy
System Represents Significant Milestone Towards Commercializing a
Next Generation Circulating Tumor Cell Capture System
MENLO PARK, CA, November 3, 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
- Ends -
For more information, please contact:
NetScientific Tel: +44 (0)20 3514
François R. Martelet, 1800
M.D., CEO
Ian Postlethwaite, CFO
Stifel Nicolaus Europe Limited Tel: +44 (0) 20 7710
(NOMAD and broker) 7600
Jonathan Senior / David
Arch / Ben Maddison
Consilium Strategic Communications Tel: +44 (0)20 3709
Mary-Jane Elliott / Jessica 5700
Hodgson / Chris Welsh / netscientific@consilium-comms.com
Laura Thornton
About NetScientific Plc
NetScientific is a transatlantic healthcare IP commercialisation
group focused on improving the health and well-being of people with
chronic diseases. For more information, please visit the website at
www.netscientific.net.
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
www.vortexbiosciences.com.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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