FDA clears Great Basin’s first C. diff molecular diagnostic test

May 2 2012

Great Basin Corporation, a privately-held life sciences company developing sample-to-result molecular diagnostic solutions, today announced that the U.S. Food and Drug Administration (FDA) has granted approval 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 U.S. annually, according to the Centers of Disease Control and Prevention. With the number of outbreaks for the difficult-to-treat infection on the rise since 2003, the new diagnostic test from Great Basin will empower health care providers to quickly diagnose patients with C. diff, resulting in faster time to treatment and better patient outcomes.

"Workflow matters, especially when diagnosing a difficult-to-treat and time-critical infection like C. diff," said Ryan Ashton, CEO and president, Great Basin Corporation. "The FDA's clearance of our C. diff assay will give health care providers access to a molecular test that improves workflow while providing answers at a cost that makes sense to the hospital. Great Basin is focused on developing cost-effective tests that markedly change the way clinicians diagnose the most virulent HAIs, with enhanced ease-of-use and by providing more answers per assay. This year we intend to augment our menu offering and have plans to initiate clinical trials for both a broad-panel sepsis and a fungal pathogens assay."

Great Basin's 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.

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:

• 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
• Results in under an hour, depending on the target of interest

C. diff causes severe and sometimes deadly diarrhea, and is one of the most difficult-to-treat infections, with the BI strains of C. diff 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. diff can also lead to unnecessary and ineffective treatments.

The number of C. diff outbreaks has risen markedly since 2003, according to the Association for Professionals in Infection Control and Epidemiology. Accurate and rapid diagnosis of Clostridium difficile infection (or CDI) is essential to aid in therapy selection and improve patient outcome, prevent disease spread and lessen negative impacts on healthcare systems:

• CDI accounts for increased length of stay of 5.6 days
• Incremental cost of CDI infection is estimated at $7,179
• CDI affects 13 per 1,000 admitted patients in the US, and 11 per 1,000 patients in Europe

The company is also releasing this assay as a European CE-IVD product under the European Directive 98/79/EC on In Vitro Diagnostic Medical Devices, and has begun marketing the C. diff assay in the EU through local distributors.