SALT LAKE CITY -- Great Basin Corporation, a privately held life sciences company, has announced the initiation of its first clinical trial evaluating its molecular diagnostic test for Clostridium difficile, one of the most common and deadly hospital-acquired infections.
The company expects the trials to take place at four sites across the United States. This trial was initiated after pre-clinical study results exceeded the company's expectations for both sensitivity and specificity of the test. The Great Basin C. diff Assay compared favorably to both reference culture and molecular test methods for the deadly superbug. The independent pre-clinical study was conducted at two regional hospital laboratories with a sample of 232 test subjects.
"The goal of our rapid, low-cost, sample-to-result technology is to empower healthcare providers to accurately diagnose C. diff, and ultimately, other difficult-to-treat infections, resulting in faster time to treatment and better patient outcomes," said Ryan Ashton, president and CEO, Great Basin Corporation. "We are pleased with the exceptional performance of our C. diff assay in the pre-clinical study. 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."
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 Clostridiumdifficile 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 US, and 11 per 1,000 patents in Europe
-- Accounts for 39.5 million admissions in US per year (AHA 2008)
Great Basin Corporation's silicon chip-based technology is a simple, multiplex molecular diagnostic platform for the detection of nucleic acid and protein. The company's highly sensitive 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 dollars saved in hospitalization costs per patient. The company's goal is to deliver assays that can be performed in a CLIA-rated moderately complex or waived laboratory, providing even greater cost savings over 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:
-- Rapid results in under one hour, depending on the target of interest
-- On-demand testing; no batching of tests that delay results
-- Fully automated with no more than two to three hands-on steps
-- Multiplexes up to 64 distinct targets in a single assay