Claros Diagnostics receives EU approval for point-of-care PSA test
12 July 2010
US company Claros Diagnostics has been granted EU approval for
its rapid quantitative point-of-care diagnostic platform, which can now
be used for prostate specific antigen (PSA) testing throughout the
European Union. The approved system consists of a small portable
analyzer and credit card-sized disposable.
“This approval represents a significant milestone of our overall
strategy to create a suite of products for the point-of-care market”
Claros is preparing for the European launch of its urology
product and continuing the process to attain regulatory clearance in
other markets, including the US.
“This approval represents a significant milestone of our overall
strategy to create a suite of products for the point-of-care
market,” said Michael J. Magliochetti, Ph.D., President and CEO of
Claros.
“We will continue to expand the menu within urology and leverage
the differentiation of our platform technology across other
verticals as a vehicle to transition virtually any complex
immunoassay from the reference laboratory to the point-of-care. This
CE Mark approval will facilitate the commercial rollout of the
system in all of the major world markets that we will pursue.”
This approval follows the announcement late last year of the
receipt of corporate ISO 13485 and CMDCAS certificates of
registration by Claros subsequent to its establishment of a new
manufacturing facility in 2009 for its microfluidic disposable test
cassettes to support clinical trials and market launch.
The Claros point-of-care system for PSA provides physicians and
patients with accurate, laboratory-quality rapid results during
their clinical visit. Healthcare providers experience more efficient
clinical workflows and direct reimbursement, while stakeholders
enjoy lower total cost of operation and enhanced customer
experience.