Osmetech Inc. asked the Food & Drug Administration for emergency approval to use its Respiratory Pathogen Test Panel to screen for the Swine Flu.
The London-based molecular diagnostics maker, which has operations in Maynard, is the latest company to enter the H1N1 virus diagnostics race.
Inverness Medical Innovations Inc. first told the Centers for Disease Control that it stood ready to supply point-of-care tests for the virus.
Then Kansas City-based Evogen Inc. said it planned to ask the FDA to approve its molecular PCR diagnostic test in the next two to three months.
But it looks like Osmetech, which said it expects to launch its test as a “research use only” product next quarter, has taken the lead in submitting its test for FDA approval. The company is also developing an extension to the test to discern the differences between the human and swine subtypes of the H1N1 virus.
The test was adapted from Qiagen’s QIAplex respiratory viral test for use on Osmetech’s eSensor XT-8 molecular diagnostics system, under a licensing agreement it inked with the Dutch firm last year.
