Claros Diagnostics Receives ISO 13485 Certification

WOBURN, Mass.--(Business Wire)--
Claros Diagnostics, a developer of novel point-of-care immunoassay systems,
reported the receipt of corporate ISO 13485 and CMDCAS certificates of
registration issued by the National Standards Authority of Ireland (NSAI). ISO
13485 is an internationally recognized standard which defines the requirements
for design, development, production, and distribution of medical devices. It
validates that Claros has processes in place to control the development and
production of safe and effective medical devices. Achieving ISO 13485:2003
certification under CMDCAS further demonstrates corporate compliance with the
Canadian QMS regulatory requirements for medical device licensing.

"This is the culmination of a great deal of cross-functional diligence with
respect to all of our employees. It is reflective of our mission and strategy as
we set the foundation for an international launch of our products," said Michael
J. Magliochetti, Ph.D., President and CEO of Claros. "We are committed to meet
and exceed the expectations of the clinicians and patients we serve and to
continuously improve the effectiveness of the quality management system under
which we operate."

About Claros Diagnostics, Inc.

Claros Diagnostics, Inc. has developed a novel medical diagnostic system (small
desktop or handheld configuration) which delivers high performance quantitative
laboratory blood test results with significant ease-of-use allowing the
transition of complex immunoassays from the centralized reference laboratory to
the point-of-care (bedside, physician`s office, etc.). The technology utilizes a
finger-stick of whole blood, has the inherent capability to multiplex on a
single disposable cartridge, and delivers results in minutes. A diagnostic panel
for prostate cancer is the initial focus, however this first market opportunity
is a bridge to the true platform nature of the technology which also encompasses
infectious disease, women`s health, cardiology, companion diagnostics, etc.,
with applications in settings throughout the world.

Claros Diagnostics, Inc.
Michael J. Magliochetti, Ph.D., 781-933-8010
michael.magliochetti@clarosdx.com

Copyright Business Wire 2009