FABPulous announces CE marking of novel rapid acute myocardial infarction triage test
12 March 2013, Maastricht, The Netherlands – FABPulous, a diagnostics company specialized in rapid tests in whole blood, announced today the CE marking of its first diagnostic product, the H-FABP True Rapid Test, as an aid in the diagnosis of acute myocardial infarction (AMI). The test will first be launched in The Netherlands. Subsequent introductions in additional European countries are being planned.
The H-FABP True Rapid Test is a disposable device with proprietary technology developed by FABPulous. It allows for the collection of a small volume of blood obtained from a finger prick, followed by a dilution and filtering step which is established by a simple twisting movement of the device. An embedded lateral flow test then informs the user whether or not H-FABP is elevated, signaling recent cardiac ischemic damage, indicative of an AMI. The test has been designed to allow first line care providers to rule out an AMI in patients presenting with acute chest pain, 3 to 18 hours after onset of symptoms, with a negative predictive value >97-98%, superior to current troponin, myoglobin and CK-MB tests and comparable to the new generation of high sensitivity troponin T tests. The test can be performed near the patient and requires maximum 5 minutes to complete, which is well within the time needed for a consultation.
“The H-FABP True Rapid Test perfectly addresses the need in primary care for practical diagnostic tools to allow for a more selective and targeted referral to second-line or hospital care”, said Mr. Diederik Engbersen, Chief Executive Officer of FABPulous. “Good diagnostic tests enabling general practitioners to make appropriate referral decisions will contribute significantly to cost savings in healthcare. As such the test will contribute to sustaining the high quality of care we enjoy today at affordable cost. ”