NEW YORK (GenomeWeb) – Great Basin Scientific announced today that it has received CE marking for its stool-based bacterial pathogens detection panel.
The panel is designed to simultaneously detect Salmonella species, Shigella species, Shiga toxin-producing Escherichia coli, and Campylobacter species in stool samples. With the CE mark, the panel may now be sold in the EU and Great Britain.
Great Basin is currently awaiting a decision on the stool pathogens panel by US regulators, but the company said that a number of clinical sites in the US are evaluating the test under investigational use only (IUO) labeling.
"The value our customers have indicated they see from this product is driving early IUO validations, which will speed adoption and potentially lead to faster growth in revenues for this new panel," Great Basin Cofounder and CEO Ryan Ashton said in a statement. "We believe this product will become a major contributor to revenues in the second half of 2017 and into 2018, resulting in improved financial performance for the company."
Great Basin — which currently offers a variety of FDA-approved assays including a Staphylococcus blood culture panel, and tests for Shiga toxin, Group B Strep, Clostridium difficile, and Bordetella pertussis — has been struggling financially and was recently delisted from the Nasdaq. However, it has taken steps to improve its position, including undergoing a restructuring earlier this year.