MDI is developing a pipeline of Detect-Ready® molecular detection kits for a number of indications. The first product—the Detect-Ready MRSA Panel, an rt-PCR-based diagnostic test for detecting MRSA, MSSA and methicillin-resistant non-S. aureus carriers using nasal samples—is currently available in the European Union and in Australia, with additional launches expected soon. Plans for a U.S. 510(k) validation trial are well advanced, with clinical sites on board and needed approvals in place. U.S. regulatory clearance is expected in 2011.
MDI is also developing kits for the detection of bloodstream MRSA infection and bloodstream VR (vancomycin resistant) infection. In addition, MDI’s Detect-Ready tests are being developed to detect the presence of other microbial agents, including C. difficile, a bacteria strain that can cause severe colitis and diarrhea; sexually transmitted diseases; and a number of foodborne pathogens.