NEW YORK (GenomeWeb News) – Great Basin today announced it has received 510(k) clearance from the US Food and Drug Administration for its first molecular diagnostic test for Clostridium difficile.
The test is based on a technology that uses an integrated disposable cartridge containing all necessary reagents and runs on a benchtop analyzer. The goal, the Salt Lake City-based firm said, is to deliver assays that can be performed in a CLIA-rated waived or moderately complex laboratory at a lower cost than other molecular diagnostics.
Other firms that offer FDA-cleared molecular tests for C. difficile include Meridian Bioscience, Cepheid, and Gen-Probe through its Prodesse acquisition.
"Workflow matters, especially when diagnosing a difficult-to-treat and time-critical infection like C. diff," Great Basin President and CEO Ryan Ashton said in a statement. "The FDA's clearance of our C. diff assay will give healthcare providers access to a molecular test that improves workflow while providing answers at a cost that makes sense to the hospital."
He added that this year the company intends to augments its menu offering and to initiate clinical trials for a broad panel sepsis assay and a fungal pathogen assay.
Great Basin filed its FDA submission for the C. difficile in November.
The company said it also is launching its C. difficile test as a CE-IVD product in Europe and has begun marketing it in the European Union through local distributors.