Intelligent Medical Devices Inc. won emergency clearance from the Food & Drug Administration for a test that can detect the presence of Swine Flu in about 90 minutes.
The Cambridge, Mass.-based molecular diagnostics firm won emergency use authorization from the FDA for its IMDx 2009 Influenza A H1N1 Real-Time RT-PCR Assay. The EUA for the test, which can be performed on several instrument platforms, is not a formal clearance or approval from the federal watchdogs and is good only for the duration of the Swine Flu emergency set to expire April 26.
IMDx is working on so-called “intelligent” diagnostic kits for rapid tests of infectious diseases. The devices make copies of genetic material from a small number of cells or fluid samples, simultaneously testing them for chemical markers specific to different diseases. The devices also rely on mathematical algorithms to predict test failure and to simulate outside factors such as genetic mutations or contamination that could affect results. CEO Alice Jacobs and two other Boston-area researchers received a U.S. patent in June 2005 for a prototype of the devices now being readied for production.
Last June the company drummed up $3 million from a pair of unidentified investors in a convertible debt offering.