In addition to
certification, company officials launch ClearCell System for Cancer Research
Markets
Clearbridge BioMedics has achieved ISO13485 certification for the
development of cell-based in-vitro diagnostic devices and today launched its
revolutionary ClearCell System, for the cancer research market. This is one of
the world's first commercially-available systems that can successfully isolate
circulating tumour cells (CTC) from blood, using biomechanical properties.
The ClearCell System, which consists of the proprietary CTChip, can
retrieve intact and viable CTCs in their native states, without the use of
antibodies or magnetic beads. This will enable cancer researchers to better
understand the relationship between such cells and mechanisms of cancer.
"Through our ClearCell System, we are now entering the diverse and
growing cancer research market. This in turn will have an impact on improving
new therapies for cancer patients. We are targeting cancer research
organizations and hospitals, which regularly need to isolate and analyse CTCs.
We believe that ClearCell will be of particular interest to the
research community, since it can retrieve viable and intact cells. Moving
forward, we are working towards the development of the ClearCell System for
in-vitro diagnostic applications," said Johnson Chen, Co-Founder
Clearbridge BioMedics.
ISO 13485 is a comprehensive management system for the design and
manufacture of medical devices. This certification has become the model
standard for the medical devices industry and Clearbridge BioMedics is one of
the few companies, within the CTC sector, to have met this Quality Management System.
By complying with this regulatory requirement, Clearbridge BioMedics
demonstrates its commitment to rigorous product development standards.
The ClearCell System consists of the disposable, single-use CTChip, and
the ClearCell unit. CTCs isolated on the CTChip can be stained directly on-chip
for identification or retrieved for further analysis. ClearCell has a number of
advantages making it relevant for the research sector. These include:
-
A first-in-class research use solution for the isolation, enumeration,
staining and retrieval of CTCs.
-
Label-free isolation, allowing the heterogeneous CTC population to be
captured in their viable and native states. This is ideal for research, as it
allows for further downstream genetic analysis, such as single nucleotide
polymorphisms and next generation sequencing.
-
Only a small volume of blood, approximately 2ml, is required for the
system to effectively isolate CTCs
-
Real-time imaging, allowing researchers to monitor and observe the cell
isolation process.
CTCs are cells that have detached from a primary tumour and are
circulating in the bloodstream. These cells have been linked to metastasis and
eventual morbidity. They are extremely rare, with only a few CTCs mixed with
billions of blood cells per millilitre of blood.
The fact that the ClearCell System can retrieve such cells demonstrates
the sensitivity and accuracy of the device. In addition to being relevant to
the research community, capturing and monitoring CTCs enables healthcare
professionals to conduct cancer diagnosis, determine treatment options, measure
treatment efficacy and post-cancer monitoring.
In addition to marketing the ClearCell System directly to the research
community, Clearbridge BioMedics has partnered with Abnova, as a distributor of
Clearbridge BioMedics' proprietary ClearCell unit and CTChip
Business & Investment Opportunities
YourVietnamExpert is a division of Saigon Business Corporation Pte Ltd, Incorporated in Singapore since 1994. As Your Business Companion, we propose a range of services in Strategy, Investment and Management, focusing Healthcare and Life Science with expertise in ASEAN. We also propose Higher Education, as a bridge between educational structures and industries, by supporting international programmes. Many thanks for visiting www.yourvietnamexpert.com and/or contacting us at contact@yourvietnamexpert.com
No comments:
Post a Comment