Claros Diagnostics, a developer of point-of-care in vitro diagnostic systems, has received the CE mark approval for its rapid quantitative point-of-care diagnostic platform, 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.
Claros has been preparing its urology product for the European launch and continuing the process to attain regulatory clearance in other markets, including the US.
The approval follows the receipt of corporate ISO 13485 and CMDCAS registration certificates 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.
Michael Magliochetti, president and CEO of Claros, said: “This approval represents a significant milestone of our overall strategy to create a suite of products for the point-of-care market.
“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.”