Great Basin has submitted a 510(k) application for its first molecular diagnostic test for Clostridium difficile (C diff) to the US Food and Drug Administration (FDA).
The company’s technology includes an integrated disposable cartridge which comprises of all necessary reagents and a bench-top analyzer that executes the assay, interprets the results and provides electronic output to the clinician.
Great Basin CEO and president Ryan Ashton said they are very pleased with the trial results as it exceeded their sensitivity and specificity performance targets.
"The results of this clinical trial are informing our work as we prepare additional assays focusing on the most virulent HAIs, including fungal pathogens and methicillin-resistant Staphylococcus aureus (MRSA) for clinical trial in the first half of 2012," Ashton said.
The company also plans to submit C diff test application to European Union regulatory authorities to obatin CE mark.