Category: Diagnostic / Testing
- Published: 18 May 2016
- Written by Editor
Great Basin Initiates Clinical Trial For Bordatella Direct Test
First of five clinical trial starts the Company expects in 2016
SALT LAKE CITY--- Great Basin Scientific, Inc. (GBSN), a molecular diagnostics company, today announced it has initiated a clinical trial for its sample-to-result Bordatella Direct Test, which will detect, directly from patient specimen, Bordatella pertussis, a bacterium causing a highly contagious respiratory disease commonly known as whooping cough. This is the first of five clinical trials the Company plans to initiate in 2016.
“As we’ve committed to our customers and stockholders, 2016 is going to be a time of continued R&D progress and customer growth for Great Basin,” said Ryan Ashton, co-founder and Chief Executive Officer of Great Basin Scientific. “The on-time start of the clinical trial for our Bordatella Direct Test is indicative of our commitment to delivering on our menu targets and represents Great Basin’s dedication to meeting strategic objectives.”
Great Basin intends to submit its 510(K) Clearance application for the Bordatella Direct Test to the U.S. Food & Drug Administration (FDA) in the fourth quarter of this year, on-track with guidance previously issued by the Company.
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.
Forward-Looking Statements
This press release includes forward-looking statements regarding the Company’s continuing business efforts related to its products, including but not limited to planned tests to be brought to clinical trial in 2016. Forward-looking statements involve risk and uncertainties, which could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risk and uncertainties include, but are not limited to: (i) our limited operating history and history of losses; (ii) our ability to develop and commercialize new products and the timing of commercialization; (iii) our ability to obtain capital when needed; and (iv) 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 fiscal year ended December 31, 2015. 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.
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