Great Basin Scientific Inc (NASDAQ:GBSN) reported the successful close of the clinical study of its second multiplex panel, the ‘Stool Bacterial Pathogens Panel.’ It is the first of 2 studies, the firm has closed in 2016 and shows the firm’s commitment to expand entire product menu line of sample-to-result assays to identify infectious disease.
Great Basin will seek 510(k) nod from the U.S. FDA and also CE marking, and if approved, the firm believes that the second multiplex panel will offer considerable assistance to laboratories and hospitals in identifying common bacterial agents, that are supposed to be triggering acute gastroenteritis in patients.
The company offers both multiplex and low-plex testing on a single system. It’s Stool Bacterial Pathogens Panel will instantaneously spot Shigella species, Salmonella species, Shiga Toxin-resulting E. coli species and Camphylobacter species.
Ryan Ashton, the CEO and co-founder of Great Basin Scientific, said that they are thrilled about the successful as well as timely completion of the clinical study for Stool Bacterial Pathogens Panel. If this gets FDA nod, it will prove to be the second multiplex panel that the company can offer the market. This study completion is indicative of company’s continued commitment and strategy to advancing and delivering molecular diagnostics offerings to support hospitals of all sizes fight the spread and misdiagnosis of infectious disease and enhance their antimicrobial stewardship.
Great Basin Scientific’s latest panel enables for simultaneous detection of major bacterial pathogens and the firm believes improved customer needs, against conventional assessments that are labor intensive. This will need numerous individual assessments with long turnaround times and poor sensitivity. The multiplex assay permits for simultaneous detection of vital bacterial pathogens, provides an easy-to-use workflow and a closure time of under 2 hours.
Great Basin Scientific started clinical studies for the Stool Bacterial Pathogens Panel in 2016. It currently has 4 commercially available tests, Shiga Toxin Direct Test, assessments for Group B Streptococcus, toxigenic Clostridium difficile and the ‘Staph ID/R Blood Culture’ panel. The firm also has 4 tests in advancement phase.