By Ben Butkus
Great Basin has commenced a clinical trial to evaluate its first molecular diagnostic test, an assay for Clostridium difficile using the company's cartridge-based sample-to-answer molecular testing platform
The company also said that it has achieved encouraging results in a preclinical study of the C. difficile assay, and that if clinical trial results are equally positive the company plans to submit the test for US Food and Drug Administration approval by the end of the summer.
Salt Lake City, Utah-based Great Basin emerged from stealth mode in February, unveiling an early version of its molecular diagnostics platform that it had developed using approximately $20 million in equity financing and other private funding raised since October 2008 (PCR Insider, 2/17/11).
In February, President and CEO Ryan Ashton told PCR Insider that the company had hoped to begin clinical trials for its first two tests — one for detecting C. difficile in stool and one for detecting Staphylococcus aureus in blood culture — in the early summer.
This week the company announced that it had met its goal for the C. difficile assay by initiating trials at four undisclosed sites in the US. Great Basin said that it initiated trials after a preclinical study conducted at two regional hospital laboratories on 232 test subjects produced positive results.
A spokesperson for Great Basin told PCR Insider this week that the company could not share details on the preclinical study; however, in a statement the company said that the trial exceeded its expectations for both sensitivity and specificity and compared favorably to both reference culture and molecular test methods.
"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," Ashton said in a statement. "We are pleased with the exceptional performance of our C. diff assay in the preclinical 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."
Besides developing a test for S. aureus in blood culture, Great Basin is also working on tests for S. aureus and methicillin-resistant S. aureus in nasal swabs; and for fungal pathogens in blood culture.
Great Basin's yet-to-be-named molecular diagnostics platform features an integrated disposable cartridge containing all necessary reagents and a bench-top analyzer that runs the assay, interprets results, and provides electronic data to a clinician.
Key technological aspects of the platform include a thin-film biosensor technology licensed from Yale University; a helicase-dependent amplification technology licensed from New England Biolabs spin-off BioHelix; and Great Basin's own technology enhancements and analysis software.
Great Basin said that it believes that it has several key advantages over existing molecular testing platforms, including a testing turnaround time of less than an hour, depending on the target; on-demand testing, which eliminates the need for test batching; full push-button automation with no more than two to three hands-on steps; and multiplexing of up to 64 distinct targets in a single assay.
The company has said that its system is similar to Cepheid's GeneXpert platform, but that the use of isothermal amplification technology and inexpensive silicon chip technology allows the instrument platform to be manufactured for less than $5,000. Further, the platform's endpoint chip-based detection scheme enables a level of multiplexing that can't be achieved with real-time PCR-based systems, according to the company.
Great Basin said that its goal is to develop assays that can be performed in a CLIA-rated moderately complex or waived laboratory.
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