Boulder Diagnostics Inc. announced today the European market launch of the CE marked SpiroFind in vitro diagnostic test for the detection of active Lyme Borreliosis. The SpiroFind test is offered as a diagnostic service by the company's clinical diagnostic service laboratory in Mellrichstadt, Germany.
The novel SpiroFind test can detect active Lyme Borreliosis through all stages of disease from early disease to late and persistent manifestation. The test is based on measuring the cellular immune response to a specific challenge with the Borrelia organism. The effectiveness of the SpiroFind test was confirmed in a clinical study at the Radboud University Nijmegen Medical Centre, which is submitted for peer-reviewed publication and for presentation at the ECCMID conference in Berlin, Germany in April 2013.
"We are proud to offer this important new tool for the correct diagnosis of Lyme disease," comments Dr. Wolfgang Pieken, CEO of Boulder Diagnostics Inc., and adds, "the SpiroFind test is the first method to query the trained immunity to Borrelia infection as a signal for active disease."
"At our clinical laboratory in Mellrichstadt, Germany, we now accept whole blood samples for testing by the SpiroFind method," states Dr. Anton Waldherr, laboratory physician of Boulder Diagnostics Europe GmbH.