Great Basin has started first clinical trial to evaluate its molecular diagnostic test for hospital-acquired infections (HAIs) caused by Clostridium difficile (C. diff).
The trial was initiated after pre-clinical study results exceeded the company’s expectations for both sensitivity and specificity of the test.
The C diff assay compared favorably to both reference culture and molecular test methods for the deadly superbug.
Great Basin’s silicon chip-based technology is sample-to-result, molecular diagnostic platform for the detection of nucleic acid and protein.
The technology also entails an integrated disposable cartridge containing all necessary reagents and an inexpensive analyzer that executes the assay, interprets the results and provides electronic output to the clinician.
Great Basin president and CEO Ryan Ashton said the goal of sample-to-result technology is to empower healthcare providers to diagnose C diff, and other difficult-to-treat infections, resulting in faster time to treatment and better patient outcomes.
"If the full clinical trial results are as positive, we anticipate submitting a 510(k) application to the FDA by late Summer 2011 and preparing additional HAI assays for clinical trials later this year," Ashton said.