Holiday ho-ho-ho: GBSN Submits 510(k) Application
Post# of 129
Posted On: 12/19/2016 11:06:46 AM
Holiday ho-ho-ho: GBSN Submits 510(k) Application to FDA for Stool Bacterial Pathogens Panel
http://www.marketwatch.com/story/great-basin-...2016-12-19
Upon anticipated FDA clearance, Company's syndromic panel will provide cost effective identification for common gastrointestinal pathogens
SALT LAKE CITY, Dec 19, 2016 (GLOBE NEWSWIRE via COMTEX) --
Great Basin Scientific, Inc. (otcqb:GBSN), a molecular diagnostics company, announced today the 510(k) submission for the Stool Bacterial Pathogens Panel to the U.S. Food and Drug Administration (FDA). Upon anticipated clearance, this syndromic panel for the identification of bacterial causes of acute gastroenteritis will be the Company's second multiplex panel in its growing menu of sample-to-result assays to diagnose infectious disease. The Company is also seeking CE marking for the panel.
"As the demand in healthcare grows for more targeted and cost effective diagnostic panels, we're excited about the potential of our Stool Bacterial Pathogens Panel to fill a critical market niche," said Ryan Ashton, co-founder and Chief Executive Officer of Great Basin Scientific. "By taking a syndromic approach to our panel - testing based on specific set of symptoms - our objective is to offer a simple-to-use, competitively priced panel that is easy for labs and physicians to adopt that will combat misdiagnosis and the spread of infectious disease while improving the antimicrobial stewardship objectives of these facilities."
The Company's Stool Bacterial Pathogens Panel is designed to simultaneously detect Salmonella species, Shigella species, Shiga Toxin-producing E. coli (stx1, stx 2, O157 serotype-specific genes), and Campylobacter species (C. jejuni and C. coli), key bacterial pathogens the Company believes better supports customer needs with an easy-to-use workflow of less than two minutes hands-on steps, and a turnaround time of under two hours, compared to conventional tests that are labor intensive, requiring multiple individual tests with poor sensitivity and long turnaround times (96 hours). Great Basin Scientific provides both low-plex and multiplex testing on a single system.
The FDA has 90 days to respond to the Company's 510(k) submission. "Great Basin has received clearance for its previously-submitted products at, on average, 176 days from submission. With that timeframe as our benchmark, we are preparing for commercial launch of the Stool Bacterial Pathogens Panel late in the first half or early second half of 2017," Ashton said.
Great Basin Scientific's system provides both low-plex and multiplex testing, and currently has four commercially available tests; the Staph ID/R Blood Culture Panel, Shiga Toxin Direct Test, tests for Group B Streptococcus (GBS), and toxigenic Clostridium difficile (C. diff). The Company also has four tests in development: Nasal S. aureus Pre-surgical Screen, Candida Blood Infections Panel, CT/NG Test, and the Bordetella Direct test, which is currently in clinical trial.
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 statements regarding the Company's ability to obtain 510(k) clearance from the FDA for the Stool Bacterial Pathogens Panel and CE marking, the potential future marketing of the Stool Bacterial Pathogens Panel if FDA clearance is obtained, the potential benefits of the Stool Bacterial Pathogens Panel for the Company's potential customers, planned tests to be brought to clinical trial in 2016, expansion of the Company's menu, the Company's development goals and other similar statements.
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 and Quarterly Report on From 10-Q for the quarter ended September 30, 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.
Media Contact: Nirav Suchak ICR 646.277.1257 nirav.suchak@icrinc.com
Investor Relations Contact: Betsy Hartman
Great Basin Scientific 385.215.3372 ir@gbscience.com
Copyright (C) 2016 GlobeNewswire, Inc. All rights reserved.
http://www.marketwatch.com/story/great-basin-...2016-12-19
Upon anticipated FDA clearance, Company's syndromic panel will provide cost effective identification for common gastrointestinal pathogens
SALT LAKE CITY, Dec 19, 2016 (GLOBE NEWSWIRE via COMTEX) --
Great Basin Scientific, Inc. (otcqb:GBSN), a molecular diagnostics company, announced today the 510(k) submission for the Stool Bacterial Pathogens Panel to the U.S. Food and Drug Administration (FDA). Upon anticipated clearance, this syndromic panel for the identification of bacterial causes of acute gastroenteritis will be the Company's second multiplex panel in its growing menu of sample-to-result assays to diagnose infectious disease. The Company is also seeking CE marking for the panel.
"As the demand in healthcare grows for more targeted and cost effective diagnostic panels, we're excited about the potential of our Stool Bacterial Pathogens Panel to fill a critical market niche," said Ryan Ashton, co-founder and Chief Executive Officer of Great Basin Scientific. "By taking a syndromic approach to our panel - testing based on specific set of symptoms - our objective is to offer a simple-to-use, competitively priced panel that is easy for labs and physicians to adopt that will combat misdiagnosis and the spread of infectious disease while improving the antimicrobial stewardship objectives of these facilities."
The Company's Stool Bacterial Pathogens Panel is designed to simultaneously detect Salmonella species, Shigella species, Shiga Toxin-producing E. coli (stx1, stx 2, O157 serotype-specific genes), and Campylobacter species (C. jejuni and C. coli), key bacterial pathogens the Company believes better supports customer needs with an easy-to-use workflow of less than two minutes hands-on steps, and a turnaround time of under two hours, compared to conventional tests that are labor intensive, requiring multiple individual tests with poor sensitivity and long turnaround times (96 hours). Great Basin Scientific provides both low-plex and multiplex testing on a single system.
The FDA has 90 days to respond to the Company's 510(k) submission. "Great Basin has received clearance for its previously-submitted products at, on average, 176 days from submission. With that timeframe as our benchmark, we are preparing for commercial launch of the Stool Bacterial Pathogens Panel late in the first half or early second half of 2017," Ashton said.
Great Basin Scientific's system provides both low-plex and multiplex testing, and currently has four commercially available tests; the Staph ID/R Blood Culture Panel, Shiga Toxin Direct Test, tests for Group B Streptococcus (GBS), and toxigenic Clostridium difficile (C. diff). The Company also has four tests in development: Nasal S. aureus Pre-surgical Screen, Candida Blood Infections Panel, CT/NG Test, and the Bordetella Direct test, which is currently in clinical trial.
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 statements regarding the Company's ability to obtain 510(k) clearance from the FDA for the Stool Bacterial Pathogens Panel and CE marking, the potential future marketing of the Stool Bacterial Pathogens Panel if FDA clearance is obtained, the potential benefits of the Stool Bacterial Pathogens Panel for the Company's potential customers, planned tests to be brought to clinical trial in 2016, expansion of the Company's menu, the Company's development goals and other similar statements.
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 and Quarterly Report on From 10-Q for the quarter ended September 30, 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.
Media Contact: Nirav Suchak ICR 646.277.1257 nirav.suchak@icrinc.com
Investor Relations Contact: Betsy Hartman
Great Basin Scientific 385.215.3372 ir@gbscience.com
Copyright (C) 2016 GlobeNewswire, Inc. All rights reserved.
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