Bordetella Direct Test Receives FDA Clearance

It is estimated that there are approximately 16 million cases of pertussis per year globally, with the disease being responsible for 195,000 deaths annually and reported cases of pertussis, known vernacularly as whooping cough, in the USA have spiked since 1955.

This increase in cases is likely a result of declines in vaccine use, waning vaccine-induced immunity in adolescent and adult populations, and continued circulation of Bordetella 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.

A molecular diagnostics company, Great Basin Scientific, Inc has received US Food & Drug Administration clearance for its Bordetella Direct Test, following a 510(k) submission. Great Basin’s System employs an integrated disposable cartridge containing all necessary reagents, and a bench-top analyzer that executes the assay, interprets the results and provides electronic output to the clinician. The true sample-to-result is obtained with less than one minute of hands-on time.

The Bordetella Direct Test expands Great Basin’s menu of FDA cleared assays to five. 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.

Ryan Ashton, co-founder and chief executive officer of Great Basin Scientific, said, “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. 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.”