Great Basin Scientific Inc (NASDAQ:GBSN) filed the 510(k) application for the Stool Bacterial Pathogens Panel to the Food and Drug Administration. Upon expected approval, this syndromic panel for the classifying of bacterial causes of acute gastroenteritis is the firm’s second multiplex panel in increasing list of sample-to-result assays to identify infectious disease. The firm is even looking for CE marking for the piece.
The expert view
Ryan Ashton, the CEO of Great Basin Scientific, said that as the demand in healthcare enhances for more cost effective and targeted diagnostic panels, they are thrilled about the prospect of their Stool Bacterial Pathogens Panel to fit in a critical market niche. By following a syndromic approach to their panel – testing depending on specific set of symptoms, their goal is to provide a simple-to-implement, fairly priced panel that is convenient for physicians and labs to adopt that will restrict spread of harmful diseases and fight misdiagnosis while enhancing the antimicrobial stewardship goals of these facilities.
The firm’s Stool Bacterial Pathogens Panel is planned to simultaneously detect Shigella species, Shiga Toxin-producing E. coli, Salmonella species and Campylobacter species, major bacterial pathogens Great Basin Scientific considers better supports client needs with an easy-to-implement workflow of less than 2 minutes steps, and a turnaround time of less than two hours, against traditional assessments that are labor intensive, necessitating numerous individual tests with long turnaround times and poor sensitivity. Great Basin Scientific offers both multiplex and low-plex testing on a single platform.
The FDA has 90 days to retort to the firm’s 510(k) filing. Great Basin has obtained approval for its previously-submitted offerings at, on average, less than six months from filing. Keeping that timeframe as yardstick, they are planning for commercial release of the Stool Bacterial Pathogens Panel in next year. The company’s system has four commercially accessible tests.
In the last trading session, the stock price of Great Basin jumped over 9% to close the day at $0.0128.
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