Great Basin Corp. has announced it has received FDA 510(k) clearance for its molecular diagnostic test for Clostridium difficile, according to a news release (pdf).
According to the company's website, the test will diagnose C. diff by the presence of the tcdB gene in the PaLOC region of C. diffi. Swabs from a loose stool will be placed into transfer solution. An aliquot of the solution will be added to the cartridge and the test initiated.
"Workflow matters, especially when diagnosing a difficult-to-treat and time-critical infection like C. diff," said Ryan Ashton, CEO and president of Great Basin, in the release. "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."
Great Basin is based in Salt Lake City.
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