Great Basin seeks FDA 510(k) approval for C. difficile molecular diagnostic test

Great Basin Corporation, a privately held life sciences company developing sample-to-result molecular diagnostic solutions, today announced it has submitted a 510(k) application to the U.S. Food and Drug Administration (FDA) for its first molecular diagnostic test for Clostridium difficile (C. diff).

“We are very pleased with the exceptional trial results as it exceeded our sensitivity and specificity performance targets. We believe the accuracy and workflow of the test will make it especially competitive in the marketplace”

C. diff is one of the most common and deadly hospital-acquired infections (HAIs), impacting approximately 700,000 people in the U.S. annually, according to the Centers of Disease Control and Prevention. The company also plans to submit an application to European Union regulatory authorities before the end of 2011 to obtain CE Marking for the C. diff test.

"We are very pleased with the exceptional trial results as it exceeded our sensitivity and specificity performance targets. We believe the accuracy and workflow of the test will make it especially competitive in the marketplace," said Ryan Ashton, CEO and president, Great Basin Corporation. "Once we secure approvals in the U.S. and Europe, we plan to launch our low-cost, sample-to-result assay and instrument without delay."

Great Basin's highly sensitive, easy-to-use, integrated cartridge system allows for more accurate and information-rich detection of infectious diseases, allowing providers to diagnose and define a clear treatment path sooner for improved patient outcomes, shorter hospital stays and significant cost savings. The company's goal is to deliver assays that can be performed in a CLIA-rated waived or moderately complex laboratory at a lower cost than other molecular diagnostic solutions.

"The results of this clinical trial are informing our work as we prepare additional assays—focusing on the most virulent HAIs, including fungal pathogens and methicillin-resistant Staphylococcus aureus (MRSA)—for clinical trial in the first half of 2012," continues Ashton.

Great Basin's technology entails an integrated disposable cartridge containing all necessary reagents and an inexpensive bench-top analyzer that executes the assay, interprets the results and provides electronic output to the clinician. The platform has several key advantages over other molecular solutions:

• Results in under one hour, depending on the target of interest
• True sample-to-result with no more than two to three hands-on steps
• On-demand testing; no batching of tests that delay results
• Multiplexes up to 64 distinct targets in a single assay