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Great Basin Scientific completes clinical trial and submits FDA 510(k) application for Bordetella direct test

Published 02 February 2017

Great Basin Scientific, (GBSN), a molecular diagnostics company, announced the completion of the clinical trial and 510(k) submission to the Food and Drug Administration (FDA) of its Bordetella direct test.

The Company’s sample-to-result test detects Bordetella pertussis directly from the patient specimen, identifying the bacterium behind the highly-contagious respiratory disease commonly known as whooping cough. The Company is also seeking a CE mark for this test.

“This submission of our Bordetella Direct Test to the FDA is exciting progress toward our goal of delivering an ever-growing menu of tests and panels that add value to the microbiology lab, which increases the attractiveness of our system to labs and hospitals and grows our potential revenue per customer,” said Ryan Ashton, co-founder and chief executive officer of Great Basin Scientific.

“Furthermore, with the completion of the clinical trials and FDA submissions of our Bordetella Direct Test and Stool Bacterial Pathogens Panel, we expect a material reduction in research and development expenses starting in the current quarter.”

The Centers for Disease Control and Prevention (CDC), estimates that globally there are approximately 16 million cases of pertussis per year, with the disease being responsible for 195,000 deaths annually.

Reported cases of pertussis in the U.S. have spiked since 1955, likely a result of declines in vaccine use, waning vaccine-induced immunity in adolescent and adult populations, and continued circulation of B. pertussis in the population. Given the gravity of the disease as well as its capacity for contagion, hospitals, health systems and patients can benefit from the rapid detection and timely treatment of pertussis.

Great Basin’s Bordetella Direct Test utilizes PCR, with media from nasopharyngeal swab specimens pipetted directly into a fully-enclosed assay cartridge, simplifying the workflow for laboratory technicians and enabling sample-to-result testing with less than one minute of hands-on time. The Bordetella Direct Test runs on the Great Basin Analyzer.

“Pertussis is a very contagious disease and the incidence is steadily rising,” said Sandra Nielsen, senior vice president, sales, marketing and HR.

“We look forward to serving our customers with a valuable and cost-effective tool that provides faster and more accurate results over culture-based tests for life-threatening and life-changing diseases, like pertussis.”

The Bordetella Direct Test is an example of the Company’s commitment to developing simple-to-use, reliable and cost-effective molecular diagnostic solutions that produce timely results and help reduce the use of unnecessary and empirical antibiotic treatment. Great Basin also recently announced the 510(k) submission of its Stool Bacterial Pathogens Panel. Following expected FDA clearance of both the Stool Bacterial Pathogens Panel and Bordetella Direct Test, the Company will have six commercial assays on the market, with three additional assays in development.



Source: Company Press Release