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Great Basin Receives 510(k) Clearance for C. difficile MDx Test

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.