GBSN has FDA APPROVAL. Could run like MME* this week.
Great Basin Scientific, Inc. (GBSN), a molecular diagnostics company, has received U.S. Food & Drug Administration (FDA) clearance for its Bordetella Direct Test, following a 510(k) submission on February 1, 2017. The Company received notification of clearance from the FDA on Friday, March 31, approximately 57 days from submission. The Bordetella Direct Test expands Great Basin’s menu of FDA cleared assays to five.
“More than a year ago, we created a clinical affairs team tasked with streamlining our clinical trial processes and strengthening our methods for presenting submissions to the FDA, with the objective of more rapidly and efficiently expanding our product menu,” said Robert D. Jenison, chief technology officer, Great Basin. “Pertussis is a very contagious disease and the incidence is steadily rising, so the swift response and clearance from the FDA is gratifying and substantiates that our investment in this aspect of our business has been well placed.”
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.
“We are pleased with the speed in which this test was cleared, and are further encouraged by the higher-than-expected demand from our customer base requesting immediate evaluations of Bordetella Direct,” said Ryan Ashton, co-founder and chief executive officer of Great Basin. “Children’s hospitals, in particular, are seeing a growing call for pertussis testing, while at the same time experiencing a reduction in reimbursements. Our on-demand test is fast, easy-to-use, and cost effective, making it a compelling option to meet growing demands.”
In addition to its Bordetella Direct test, Great Basin has commercial assays available for the detection of STEC, Group B Streptococcus (GBS), Toxigenic Clostridium difficile (C. diff), and a Staph Blood Culture Panel for identifying bloodstream infections caused by MRSA and other Staphylococcus species.
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