Claros Diagnostics received CE Mark approval for its point-of-care prostate cancer screening test.
The Woburn, Mass.-developer of in vitro diagnostic and microfluidic systems is preparing to launch its point-of-care prostate-specific antigen testing product in the European Union.
The device is a portable urology analyzer that works with disposable, credit card-sized assays. It gives physicians laboratory-quality test results during a clinical visit, the company said.
Claros plans 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," CEO Michael Magliochetti said in prepared remarks.
The test has not yet won Food & Drug Administration approval.