The integrated cartridge system comprises necessary reagents to perform the assay and predict the presence of infection in the sample.
The key benefits of the platform include, on-demand testing, no batching of tests, multiplexes up to 64 distinct targets in a single assay and quicker results.
Great Basin CEO and president Ryan Ashton said, "The FDA’s clearance of our C. diff assay will give health care providers access to a molecular test that improves workflow while providing answers at a cost that makes sense to the hospital."
The company has begun marketing the C. diff assay in the EU through local distributors.
The company is releasing the assay as a European CE-IVD product under the European Directive 98/79/EC on In Vitro Diagnostic Medical Devices.