A new test for detecting methicillin-resistant Staphylococcus aureus (MRSA) has been launched by Vancouver's I.D. Biomedical Corporation. The company's Velogene Rapid MRSA Identification Assay diagnostic test has already received approval from the US Food and Drug Administration, and approval from Health Canada was expected by the end of August. Marketing to hospitals across North America and Europe began this summer. The test costs $10 - about the same as current hospital tests - and the company hopes to sell about 5 million annually.
Company president Dr. Tony Holler says the test, which takes about 2 hours to complete, is the first truly rapid test to identify MRSA; normally it takes up to 2 days to get test results. About 4.6 million tests for MRSA are carried out annually in US hospital laboratories. "For hospitals, it's a huge problem," says Holler, who estimates that the market is growing by about 10% a year. If hospitals "can save 1 day through early diagnosis and treatment, that saves $1000 plus. The speed means that you are treating patients with the right antibiotic quicker, which leads to shorter hospital stays."
The test identifies the gene responsible for methicillin antibiotic resistance approximately 90 minutes after a primary culture is obtained. The company says the test is both fast and accurate. In clinical trials at 4 US hospitals, the test demonstrated 100% accuracy when compared with polymerase chain reaction, the current gold standard in gene-identification technology.
I.D. Biomedical is now preparing for clinical trials for a second diagnostic test to detect vancomycin-resistant enterococci bacteria.