NEW YORK (GenomeWeb News) – Meridian Bioscience has submitted a 510(k) application with the US Food and Drug Administration for its illumigene C. difficile molecular diagnostic test.
The illumigene C. difficile test detects and amplifies a pathogenic DNA region of all toxin-producing strains of Clostridium difficile. The test uses a stool sample and can provide results in less than an hour, said Meridian.
The test represents the first molecular diagnostic product for the Cincinnati-based firm, which makes diagnostic tests for gastrointestinal and upper respiratory infections, serology, parasitology, and fungal diseases. It is based on Meridian's loop amplification technology, which is isothermal, requires no costly capital equipment, and can therefore run in any size laboratory, the company said.
Meridian hopes to have the test on the market later this year.