ID Biochemical seeks to market infection test:
This article was originally published in Clinica
Executive Summary
ID Biochemical has filed for US FDA 510(k) clearance to market its rapid gene test for methicillin-resistant Staphylococcus aureus (MRSA), the cause of potentially fatal infection which is prevalent in hospitals. Data from clinical trials at four US hospitals showed that the Velogene Rapid MRSA test correctly identified 99.3% of samples when compared with conventional susceptibility tests and 100% when compared with results from the "gold standard" gene identification technology, PCR. Based on the Vancouver, British Columbia company's Cycling Probe Technology, the new test detects the MecA gene responsible for methicillin resistance.