Great Basin Scientific, a molecular diagnostics company, announced today that it has initiated a clinical trial for its Stool Bacterial Pathogens Panel, a multi-plex molecular assay detecting common bacterial agents, including foodborne pathogens, present in individuals suspected of acute gastroenteritis.
The Stool Bacterial Pathogens Panel is the Company’s second multiplex panel.
The Stool Bacterial Pathogens Panel will target nucleic acids of Salmonella species, Shigella species, Shiga toxin-producing E. coli (stx1 and stx2 genes), the E. coli O157 serotype (reported if stx1 and/or stx2 are positive), and Campylobacter species (combined C. jejuni and C. coli).
This is the second start of five clinical trials Great Basin has planned in 2016. The Company began the clinical trial on its Bordetella Direct Test in May of this year. Both assays are on-track with the guidance for trial starts in 2016 that the Company provided in its business update call in April of this year.
"Our second on-time clinical trial start this year highlights the commitment, organization and talent in our R&D group," said Ryan Ashton, co-founder and Chief Executive Officer of Great Basin Scientific.
"We are proud of their accomplishments so far in 2016 and have confidence in their ability to bring our aggressive product development plans to fruition.
"Great Basin is particularly excited to begin this trial on another sample-to-result multi-plex panel, which will provide a great value to our customers, and provides significant opportunity to increase our revenue per customer and further demonstrates the unique and powerful versatility of our platform to the market."
Great Basin’s menu of FDA-cleared sample-to-result assays includes low-plex molecular tests for toxigenic Clostridium difficile (C.diff), Group B Streptococcus (GBS), Shiga toxin-producing E. coli (STEC) detection, and a multi-plex Staph ID/R Blood Culture Panel that identifies Staphylococcus aureus and Staphylococcus species and detects the mecA gene directly from positive blood cultures in about two hours. All assays run on the Great Basin Analyzer.
Great Basin Scientific is a molecular diagnostics company that commercializes breakthrough chip-based technologies.
The Company is dedicated to the development of simple, yet powerful, sample-to-result technology and products that provide fast, multiple-pathogen diagnoses of infectious diseases.