Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.The FDA has granted approval for Great Basin's first molecular diagnostic test for Clostridium difficile (C. diff).
Subscribe to our email newsletter
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.