NEW YORK (GenomeWeb) — Great Basin Scientific said this week that it has initiated a clinical trial for its sample-to-result Staph ID/R (identification/resistance) molecular diagnostic test.
Compared to competitive molecular assays for blood-borne staph infections, the Great Basin Staph ID/R assay will offer speciation of several clinically critical Staphylococcus species, the company said. Such information will allow clinicians to accurately and promptly distinguish environmental contaminants, which comprise 20 to 30 percent of total positive blood cultures, from truly infectious pathogens, it added.
Further, the assay will require less than two minutes of hands-on time and will provide a result in less than two hours, Great Basin said.
All of the company's tests run on its Portrait Analyzer platform, which combines nucleic acid amplification and array-based detection using a semiconductor chip. This is the second clinical trial the company has initiated since July, with the other being for a Group B Streptococcus assay for perinatal infections. The company submitted a 510(k) application to the US Food and Drug Administration for marketing clearance for that test last month. In 2012 Great Basin launched an FDA-cleared toxigenic Clostridium difficile assay.
The Salt Lake City-based company also this week announced two new tests in its development pipeline: a fungal panel and an assay for Shiga toxin-producing Escherichia coli infections. Great Basin said it expects to begin clinical trials for these tests in 2015.
Great Basin went public earlier this year. Its shares trade on the Nasdaq Capital Market under the ticker symbol GBSN.