Great Basin Corp, a privately held life sciences company developing sample-to-result molecular diagnostic solutions, has submitted a 510(k) application to the US Food and Drug Administration (FDA) for its first molecular diagnostic test for Clostridium difficile (C. diff).
C. diff is one of the most common and deadly hospital-acquired infections (HAIs), impacting approximately 700,000 people in the US 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.
Great Basin’s 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.
Source: Great Basin Corp
