NEW YORK (GenomeWeb News) – Great Basin today announced it has filed for 510(k) clearance of its molecular diagnostic test for Clostridium difficile.
In addition to its application to the US Food and Drug Administration, the Salt Lake City firm said also that it plans to submit an application to the European Union by the end of the year to obtain CE marking for the test, and upon regulatory approvals in the US and Europe, the company will launch its assay and instrument immediately.
The company's goal, it added, is to develop assays that can be used in a CLIA-rated waived or moderately complex laboratory at lower costs than other molecular diagnostic solutions.
Other firms that have gained FDA clearance for a C. difficile molecular test, include Meridian Bioscience, Cepheid, and Gen-Probe through its Prodesse acquisition in 2009.
Great Basin's technology consists of an integrated disposable cartridge that contains all the necessary reagents and an inexpensive benchtop analyzer that performs the assay, interprets the results, and provides electronic output to the clinician. Advantages of its technology include test results in as little as one hour, simple sample-to-result steps, the ability to do on-demand testing without having to wait for batching of tests, and multiplexing of up to 64 targets on one assay, the company said.
In a statement, Ryan Ashton, president and CEO of Great Basin, said that the clinical trial for the C. difficile submission is "informing our work" as the company prepares other assays that focus on the most virulent hospital-acquired infections, such as fungal pathogens and methicillin-resistant Staphylococcus aureus, for clinical trial in the first half of 2012.