The US Food and Drug Administration (FDA) has granted 510(k) approval to Great Basin's Clostridium difficile (C. diff) molecular diagnostic test.
The C. diff test utilizes the company’s technology comprising of an integrated disposable cartridge containing all necessary reagents and an analyzer that executes the assay, interprets the results and provides electronic output to the clinician.
The integrated cartridge system facilitates providers to diagnose infectious diseases and define a clear treatment path for improved patient outcomes, shorter hospital stays and cost savings.
Great Basin CEO and president Ryan Ashton said the FDA’s clearance of the company’s C. diff assay will give health care providers access to a molecular test that improves workflow.
"Great Basin is focused on developing cost-effective tests that markedly change the way clinicians diagnose the most virulent HAIs, with enhanced ease-of-use and by providing more answers per assay," Ashton added.
"This year we intend to augment our menu offering and have plans to initiate clinical trials for both a broad-panel sepsis and a fungal pathogens assay."