Skip to main content
Premium Trial:

Request an Annual Quote

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.

The Scan

Renewed Gain-of-Function Worries

The New York Times writes that the pandemic is renewing concerns about gain-of-function research.

Who's Getting the Patents?

A trio of researchers has analyzed gender trends in biomedical patents issued between 1976 and 2010 in the US, New Scientist reports.

Other Uses

CBS Sunday Morning looks at how mRNA vaccine technology could be applied beyond SARS-CoV-2.

PLOS Papers Present Analysis of Cervicovaginal Microbiome, Glycosylation in Model Archaea, More

In PLOS this week: functional potential of the cervicovaginal microbiome, glycosylation patterns in model archaea, and more.