Bacterial Pathogens Panel Receives CE Marking

A Stool Bacterial Pathogens Panel is designed to simultaneously detect Salmonella species, Shigella species, Shiga Toxin-producing E. coli (stx1, stx 2, O157 serotype-specific genes), and Campylobacter species (C. jejuni and C. coli), all significant bacterial pathogens.

The panel better supports customer needs with an easy-to-use workflow of less than two minutes hands-on steps, and a turnaround time of under two hours, compared to conventional tests that are labor intensive, requiring multiple individual tests with poor sensitivity and long turnaround times of up to 96 hours.

The Stool Bacterial Pathogens Panel has received Conformité Européenne (CE) Marking, the company’s fifth assay and second multiplex panel to receive CE Marking designation under the European Directive on In Vitro Diagnostic Medical Devices, which extends the availability of the Company’s panels to facilities across 32 countries in the European Union and Great Britain. The syndromic panel simultaneously detects and differentiates specific gene targets from the most prevalent bacterial causes of acute gastroenteritis.

The molecular diagnostics system offers low-plex and multiplex testing, with commercial assays available for the detection of Shiga Toxin-producing Escherichia coli (STEC), Group B Streptococcus (GBS), Toxigenic Clostridium difficile (C. diff), and a Staph ID/R Blood Culture Panel (SIDR) for identifying bloodstream infections caused by Methicillin-resistant Staphylococcus aureus (MRSA) and other Staphylococcus species. The platform employs an integrated disposable cartridge containing all necessary reagents; and a bench-top analyzer that executes the assay, interprets the results and provides an electronic display of the diagnostic call to the technician. The system is capable of multiplexing up to 64 distinct targets in a single assay, has a innovative closed system to minimize contamination with results in under two hours for all assays.

Sandra Nielsen, senior vice president of sales and marketing of Great Basin Scientific, said, “We are pleased with our progress in commercializing this panel, and are excited to be able to offer it in Great Britain and the EU. We are especially encouraged by the interest from our customers in the USA, many of whom have chosen to evaluate the product under Investigational Use Only (IUO) labeling which will facilitate the completion of their required evaluation and validation process in advance of our expected FDA clearance.”