Great Basin this week announced the opening of a new manufacturing facility for its recently launched molecular diagnostics system and first test.
The new facility, located adjacent to Great Basin's administrative and R&D facility in Salt Lake City, will be dedicated to manufacturing the company’s closed-system molecular diagnostics cartridges, and more than triples the company’s current manufacturing capacity.
Great Basin's Portrait Analyzer features disposable molecular testing cartridges, detection based on thin-film biosensor technology, and dedicated analysis software, and thus far runs assays based on helicase-dependent amplification or signal amplification technology.
In May, the company received approval from the US Food and Drug Administration for its first product, an HDA-based molecular diagnostic test for Clostridium difficile (PCR Insider, 5/3/2012).
Great Basin this week said that it is in "full production" manufacturing its C. difficile test cartridges, and that the new facility will support "future manufacturing needs for the company’s aggressive product roadmap of molecular assays to aid in the diagnosis of other critical hospital-acquired infections."
Great Basin intends to begin clinical trials for its Staph ID/R assay in early 2013. This multiplex assay can identify major pathogenic strains of Staphylococcus to the species level, and can also identify the presence or absence of the methicillin-resistance determinant gene, mecA.
Once clinical trials are completed, the company anticipates FDA clearance and CE-IVD product marketing in the second quarter of 2013.