NEW YORK (GenomeWeb) – Great Basin Scientific has submitted a molecular panel assay for stool pathogens to the US Food and Drug Administration for 510(k) clearance.
The panel detects Salmonella species, Shigella species, Shiga Toxin-producing E. coli (stx1, stx 2, and O157 serotype-specific genes), and Campylobacter species (C. jejuni and C. coli) from stool samples. It requires less than two minutes of hands-on time and has a turnaround time of under two hours, the company said in a statement.
"By taking a syndromic approach to our panel ... our objective is to offer a simple-to-use, competitively priced panel that is easy for labs and physicians to adopt that will combat misdiagnosis and the spread of infectious disease while improving the antimicrobial stewardship objectives of these facilities," Great Basin CEO Ryan Ashton added.
Should the panel obtain clearance as expected, Great Basin anticipates a commercial launch in the first half of 2017.
The panel would join an FDA-cleared menu from the company that now includes a staphylococcus blood culture panel, and tests for Shiga toxin, Group B Strep, and Clostridium difficile. The firm also noted that it has several other assays in development: a nasal S. aureus pre-surgical screening test, a candida blood infections panel, and an assay to detect and differentiate chlamydia and gonorrhea. A test for Bordetella pertussis is currently in clinical trials, as previously reported.
Great Basin was delisted from the Nasdaq in October after the company failed to maintain the minimum $35 million market value.