Cost-Effective Molecular Diagnostic Identifies Clostridium difficile

The test for Clostridium difficile uses 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 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.

Great Basin Corporation (Salt lake City, Utah, USA) 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 C. difficile. 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. difficile test.

The platform has several key advantages over other molecular solutions including results obtained in under one hour; true sample-to-result with no more than two to three hands-on steps; on-demand testing; no batching of tests that delay results, and multiplexes up to 64 distinct targets in a single assay

C. difficile causes severe and sometimes deadly diarrhea, and is one of the most difficult to treat infections, with the BI strains being especially virulent. Patients are often prone to disease recurrence leading to additional hospitalization. At the same time, a false positive test or misdiagnosis for C. difficile can also lead to unnecessary and ineffective treatments.

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Great Basin Corporation