Assay for Bordetella pertussis, or whooping cough, shipping to U.S. customers; Company also announces CE Marking
Salt Lake City, May 16, 2017 – Great Basin Scientific, Inc. (OTCQB: GBSN), a molecular diagnostics company, today announced the U.S. commercial launch of its Bordetella Direct Test and its receipt of CE Marking designation under the European Directive on In Vitro Diagnostic Medical Devices. The Company received notification of 510(k) clearance from the U.S. Food & Drug Administration (FDA) for the assay on March 31, 2017, approximately 57 days from submission. The Bordetella Direct Test expands Great Basin’s menu of commercially-available assays in the U.S. to five, and is the sixth assay to receive CE Marking under the European Directive on In Vitro Diagnostic Medical Devices.
“The processes we put in place that resulted in a swift FDA clearance also supported our ability to quickly commercialize the Bordetella Direct Test, much to the relief of many of our customers” said Ryan Ashton, co-founder and chief executive officer of Great Basin. “Immediately after announcing FDA clearance, several hospitals contacted us requesting immediate access to the assay in order to respond to the testing demands from local pertussis outbreaks. We’re pleased to be able to respond quickly to support these hospitals and their patients with our easy-to-use, cost-effective, STAT solution for identifying this highly contagious and deadly disease. Bordetella Direct represents a continuation of our strategy to bring to market high value tests that we expect will improve gross margins as they become a significant part of our revenues, as we anticipate them to be.”
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, timely detection through PCR testing is essential in preventing the spread of disease and reducing the risk of widespread outbreaks. Great Basin’s Bordetella Direct Test allows random access (no need to batch) testing for B. pertussis without any sample preparation steps and at a considerably lower cost than large respiratory panels, providing results in under two hours.
“Currently, the most common route for Bordetella testing is to send specimens to a state or reference lab which, in the case of a reference lab, can be prohibitively expensive and cause several days – even weeks – delay in obtaining a result, during which time the patient may not be receiving appropriate treatment,” said Sandra Nielsen, senior vice president of sales and marketing for Great Basin. “While some labs have adopted molecular diagnostic testing for in-house Bordetella testing, their commercial options are a choice of expensive panels that test for a wide variety of unrelated respiratory issues or more cost-effective, but labor-intensive stand-alone tests. We believe that our solution offers the best of all worlds – an easy-to-use, cost-effective test that provides an answer in less than two hours. We’re pleased to be able to offer this assay to our customers, who have been awaiting its approval, so quickly after FDA clearance.”
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.
About Great Basin Scientific
Great Basin Scientific is a molecular diagnostics company that commercializes breakthrough chip-based technologies. The Company is dedicated to the development of simple, yet powerful, sample-to-result technology and products that provide fast, multiple-pathogen diagnoses of infectious diseases. The Company’s vision is to make molecular diagnostic testing so simple and cost-effective that every patient will be tested for every serious infection, reducing misdiagnoses and significantly limiting the spread of infectious disease. More information can be found on the Company’s website at www.gbscience.com.
This press release includes forward-looking statements regarding events, trends and business prospects, which may affect our future operating results and financial position, including but not limited to statements regarding anticipated current customer uptake of the Bordetella Direct Test, the effectiveness and role of the Bordetella Direct Test in patient care decisions, the expected contribution of the Bordetella Direct Test to revenues, and the Company’s general development plans of sample-to-result technology and products. Forward-looking statements involve risks and uncertainties, which could cause actual results to differ materially, and reported results, should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: the assumptions of management in the revenue projections not occurring as anticipated, delay or denial in obtaining FDA approval of pending assays, uncertainty in the Company’s ability to commercialize new assays, changes in customer needs, competition in the industry being greater than anticipated, our limited operating history and history of losses; our ability to develop and commercialize new products and the timing of commercialization; our ability to obtain sufficient capital to continue as a going concern and implement our business plan; and other risks set forth in the Company’s filings with the Securities and Exchange Commission, including the risks set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2016. These forward-looking statements speak only as of the date hereof, and Great Basin Scientific specifically disclaims any obligation to update these forward-looking statements, except as required by law.View Post View/Download PDF