HUDDINGE, Sweden, Oct. 01, 2003 (PRIMEZONE) -- LightUp Technologies AB announced today the approval by Underwriters Laboratories Inc. to CE Mark its ReSSQ(TM) CMV Assay according to the European Community In Vitro Diagnostics (IVD) Directive 98/79/EC (list B). ReSSQ CMV Assay is a nucleic acid test (NAT) to be used in conjunction with real-time polymerase chain reaction and is the first such diagnostic system for cytomegalovirus to be awarded the CE Mark.
The CE Mark indicates compliance to the essential requirements of the applicable European laws and Directives with respect to safety, health, environment and consumer protection, and accredits the product for sale in the countries of the European Economic Area (EEA). As of December 7, 2003, CE marking will be mandatory for in vitro diagnostic products to be sold throughout the EEA.
"The CE certification represents a significant milestone in our efforts to provide laboratories with reliable, standardised nucleic acid tests for infectious disease diagnosis and monitoring, and it is one of those company achievements that is an essential element in the continued success of our business in Europe," said Ulrica Sehlstedt, Ph.D., Chief Executive Officer. "ReSSQ CMV Assay is used for quantitative detection of human CMV in plasma or serum and is only the first product within our range to undergo this approval process. Our next diagnostic test for human use to be launched later this year, the ReSSQ EBV Assay, is already in the CE marking pipeline."
About LightUp Technologies AB
LightUp Technologies AB is a company developing new solutions for the in vitro diagnostics (IVD) industry. Our activities are focused on developing and bringing to the market cutting-edge molecular based technologies for medical diagnostic uses. First among these technologies is the LightUp Probe, which can be used to identify and quantify the presence of bacteria or viruses. The technique offers a simpler, more accurate method for real-time PCR and can be used in many medical applications, including gene mapping and disease diagnostics. LightUp Technologies was founded in 1998 and is located in Huddinge, south of Stockholm, Sweden. For more information, visit our web site at www.lightup.se
For more information, contact: LightUp Technologies AB Ulrica Sehlstedt, Ph.D. Chief Executive Officer Tel: +46 8 556 40 661 email: ulrica.sehlstedt@lightup.se