The FDA today approved for marketing the first DNA probe-based assay that can be used in a physician's office.
MicroProbe Corp.'s Affirm VP microbial identification system isconfigured to test for the two organisms that commonly arelinked to vaginal infections: the protozoan Trichomonasvaginalis and the bacterium Gardnerella vaginalis.
The company said this is the first DNA probe assay that can beused to identify multiple organisms. simultaneously from asingle patient sample. Moreover, its format makes it easy touse.
"Anybody can be trained to use it in 10 minutes," said JohnBishop, the Bothell, Wash., company's chief executive officer.
The test format, which contains negative and positive controls,as well as DNA probes specific to the two pathogens, relies on a30-minute color reaction to report results. This represents afinancial savings to the physician. The test will be available at acost of approximately $16 per test panel, compared withstandard pathogen identification methods, which can cost about$25 per culture, said Bishop.
There is also a savings of time: standard diagnostic methodstake two to three days to yield results. And "there are majorsavings" in terms of the total cost of health care, Bishop said.
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