Quantech Cleared to Market Quantitative CK-MB Cardiac Test

Quantech Ltd. (St. Paul, MN) has received FDA clearance to market a quantitative CK-MB cardiac test. The test measures levels of CK-MB, one of three proteins in the body that are widely considered to be definitive diagnostic markers to assess whether or not individuals with chest pain are experiencing acute myocardial infarctions (heart attacks). The other proteins are myoglobin, for which Quantech has already received FDA clearance, and troponin I, a test for which Quantech has completed development and will submit to the FDA. All three proteins will be combined by Quantech into a cardiac test panel that will be available on its Patient Treatment Information Platform for the hospital emergency department.

"With our second clearance from the FDA, Quantech is demonstrating that its diagnostic technology, integrated with wireless information technology, will provide a completely new platform for patient treatment information delivery in the emergency department," said Robert Case, chief executive officer of Quantech. "This will enable us to achieve our primary goal of significant emergency department (ED) productivity improvement and higher patient satisfaction," he added.

Quantech is developing its ED Patient Treatment Information Platform incorporating a rapid diagnostic system that uses the company's Surface Plasmon Resonance (SPR) technology. The instrument will allow the ED staff to perform diagnostic tests for multiple patients, simultaneously and directly from tubes of whole blood. The platform will also allow the wireless delivery of test results directly to the appropriate ED nurse and physician at bedside within 10 to 20 minutes, without further ED staff intervention. Quantech's instrument is expected to include an initial menu of tests grouped in patient diagnosis-related panels including cardiac enzymes (heart attack), pregnancy, red and white blood cell counts, blood coagulation and kidney function. Additional tests for liver functions, electrolytes, drugs of abuse, therapeutic drugs and other STAT tests are also expected to be available on the system.

Edited by Ursula Jones