Salt Lake City, UT, United States
Salt Lake City, UT, United States

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Patent
Great Basin | Date: 2013-10-03

Methods and materials are disclosed relating to an improved method for amplifying a signal in a diagnostic assay for a nucleic acid, comprising the steps of providing an amplification polymer bound to a nucleic acid analyte, wherein the amplification polymer comprises a plurality of amine groups; binding amine groups on the amplification polymer with a detectable label complex; and reacting under high salt conditions an acetylating compound with amine groups not bound with a detectable label complex.


Composition and methods for amplifying and detecting solution-state polynucleotide targets in a single device are described. In one aspect, a method for a coupled isothermal amplification and detection process utilizes a coated solid support, including a solid substrate, a cationic layer, and a plurality of target-specific probes attached to the coated solid support. Polynucleotide targets in the sample are amplified by an isothermal amplification process involving in situ hybridization onto the coated solid support. The entire process can be carried out with a high degree of specificity under low salt conditions in less than one hour. Further aspects of the present invention include methods for coupled hybridization/detection of polynucleotide targets, coated silicon biosensors optimized for use with the coupled detection systems to provide visual detection of polynucleotide targets under visible light conditions, and kits for practicing in the above described methods.


Patent
Great Basin | Date: 2015-11-23

Methods and materials are disclosed relating to an improved method for amplifying a signal in a diagnostic assay for a nucleic acid, comprising the steps of providing an amplification polymer bound to a nucleic acid analyte, wherein the amplification polymer comprises a plurality of amine groups; binding amine groups on the amplification polymer with a detectable label complex; and reacting under high salt conditions an acetylating compound with amine groups not bound with a detectable label complex.


An in vitro diagnostics analyzer and assay cartridge for carrying out biochemical assays is disclosed. The analyzer includes a tilted clamp assembly for holding an assay cartridge, upper and lower motor assemblies for manipulating the assay cartridge, and an optical reader. The cartridge includes an injection port for receiving a biological sample, a central channel through which the sample passes, one or more processing chambers, one or more reagent containers, a detection chamber, and optionally a waste chamber. The analyzer and cartridge may be used for detection of a variety of analytes, including pathogens for medical diagnostics.


Patent
Great Basin | Date: 2015-06-26

Methods, materials, and kits for distinguishing a population of cells or organisms truly present in a clinical specimen from contaminating cells or organisms is disclosed. The methods and kits use a suppressor to avoid false positive detection of contaminants in nucleic acid amplification reactions.


Patent
Great Basin | Date: 2013-06-03

Methods for rapidly detecting clinically relevant mutations in the infectious genome of an agent are disclosed. The methods include use of a novel target and temperature dependent RNase H mediated cleavage of blocked DNA primers to initiate isothermal helicase-dependent amplification of a target sequence such as a sequence in the rpoB gene.


Compositions and methods for amplifying and detecting solution-state polynucleotide targets in a single device are described. In one aspect, a method for a coupled isothermal amplification and detection process utilizes a coated solid support, including a solid substrate, a cationic layer, and a plurality of target-specific probes attached to the coated solid support. Polynucleotide targets in the sample are amplified by an isothermal amplification process involving in situ hybridization onto the coated solid support. The entire process can be carried out with a high degree of specificity under low salt conditions in less than one hour. Further aspects of the present invention include methods for coupled hybridization/detection of polynucleotide targets, coated silicon biosensors optimized for use with the coupled detection systems to provide visual detection of polynucleotide targets under visible light conditions, and kits for practicing the above described methods.


SALT LAKE CITY, Feb. 15, 2017 (GLOBE NEWSWIRE) -- Great Basin Scientific, Inc. (OTCQB:GBSN), a molecular diagnostics company, today announced the Journal of Clinical Microbiology published results of a multicenter study that demonstrated the effectiveness of its Staph ID/R Blood Culture Panel in rapidly identifying several species of Staphylococci and in accurately detecting the mecA gene directly from a positive blood culture. The results of the study, which was conducted across three clinical sites, demonstrated the performance and efficacy of the Staph ID/R Blood Culture Panel compared to conventional methods, and concluded that the Company’s panel provided decreased time to results at a lower price, helping physicians diagnose and deliver a timely, accurate and cost-effective course of treatment. “Bloodstream infection-related sepsis, including those caused by MRSA and other pathogenic Staphylococcus species, is not only a leading cause of morbidity and mortality in the U.S., but is also associated with over $17 billion in rising healthcare costs annually. Traditional blood culture methods provide physicians with a diagnosis 48 to 72 hours after a positive sample is identified, delaying appropriate treatment and putting the patient at further risk,” said Rob Jenison, chief technology officer and senior vice president of R&D at Great Basin Scientific. “Great Basin’s Staph ID/R Blood Culture Panel is proven to provide highly accurate and actionable results in under two hours. Our panel potentially eliminates 32 to 88 hours of inappropriate antibiotic therapy, thereby potentially reducing length of patient stay and improving patient care - creating time and cost efficiencies for hospitals and labs of all sizes.” Led by Dr. Gerald A. Denys from the Department of Pathology & Laboratory Medicine at Indiana University, the study found that Great Basin’s Staph ID/R Blood Culture Panel correctly identified positive results for Staphylococcus species 99.4 percent of the time and negative results were correctly identified 99.9 percent of the time. Also, the mecA gene, a major drug resistance marker conferring resistance to methicillin and other beta-lactams and creating the superbug MRSA, was detected accurately from positive samples 99.7 percent of the time and negative results were properly identified 99.2 percent of the time. The results of this study also revealed that the Great Basin molecular assay was more effective than conventional biochemical and cefoxitin disk methods performed at an independent laboratory, with performance estimates at 95 percent confidence intervals (CI) across all three sites. The Company believes the Staph ID/R Blood Culture Panel is one of the most comprehensive Staphylococcus molecular tests currently on the market, in that it identifies Staphylococcus aureus, Staphylococcus lugdunensis and other Staphylococcus species to the genus level and detects the mecA gene in all Staphylococcal species from positive blood cultures. “We’re so pleased by the positive findings of this study and are excited by the response from the market for our blood culture panel,” said Sandra Nielsen, senior vice president, sales, marketing and HR at Great Basin.  “The results of this study illustrate our panel’s accuracy, cost-effectiveness and ability to deliver definitive and highly actionable information which we believe contribute to the increased adoption of our panel by a significant percentage of our installed customer base, as well as new and larger hospitals and labs.” The Company announced the commercial launch of the Staph ID/R Blood Culture Panel in U.S. and Europe in September 2016, and the test also has CE mark designation under the European Directive of In Vitro Diagnostic Medical Devices. Great Basin’s molecular diagnostics system offers low-plex (one to three analytes), mid-plex (four to six analytes) and multiplex (syndromic) testing, with commercial assays available for the detection of Shiga Toxin-producing Escherichia coli (STEC), Group B Streptococcus (GBS), Toxigenic Clostridium difficile (C. diff), and Staph ID/R Blood Culture Panel. Continuing the Company’s efforts to expand its menu of sample-to-result assays to diagnose infectious disease, Great Basin has five additional tests on their product roadmap, including a Stool Bacterial Pathogens Panel and a Bordetella Direct Test, both of which recently completed clinical trials and have been submitted to the U.S. Food & Drug Administration (FDA) for 510(k) clearance; and a Nasal S. aureus Pre-surgical Screen, Candida Blood Infections Panel, and CT/NG Test, which are currently in development. 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 events, trends and business prospects, which may affect our future operating results and financial position, including but not limited to statements regarding the anticipated current customer uptake of the Staph ID/R Blood Culture Panel, the effectiveness and role of the Staph ID/R Blood Culture Panel in patient care decisions, anticipated FDA approval of current pending assays, commercialization of future approved assays, 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: 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, 2015 and Quarterly Report on Form 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.


SALT LAKE CITY, March 02, 2017 (GLOBE NEWSWIRE) -- Great Basin Scientific, Inc. (OTCQB:GBSN), a molecular diagnostics company, announced today that Dr. Suzette Chance, senior director of regulatory and clinical affairs, has won a 2017 Women Worth Watching® in STEM Award by Profiles in Diversity Journal. The publication is dedicated to promoting and advancing diversity and inclusion in the corporate, government, nonprofit, STEM, and higher education sectors. Dr. Chance was one of 45 women nationwide to receive the award, which is an expansion of the publication’s annual Women Worth Watching leadership awards program. “In the short time since Suzette joined Great Basin, she has shepherded the clinical trials and FDA submissions for our last three assays – one of which is now commercially available, with two others awaiting FDA clearance – a feat that is nothing short of remarkable,” said Rob Jenison, senior vice president, R&D and chief technology officer of Great Basin Scientific. “Her professionalism, commitment to quality and prior success in running clinical trials has had a tangible impact on the Company’s success in accelerating the build-out of our product menu. We are so pleased to have Suzette on our team and congratulate her on this well-earned recognition.” Dr. Chance joined Great Basin in February 2016 with over 20 years of experience in in vitro diagnostics, working with clinical and regulatory affairs and product innovation and design. Prior to joining Great Basin, she served senior leadership roles with Immucor GTI Diagnostics, Gen-Probe/Hologic, and Genetic Testing Institute. Dr. Chance started her career as a scientist and biochemist with DuPont Medical Products in Glasgow, where she created and established a new bio-analytical laboratory for the DuPont facility. She earned her B.S. degree in biochemistry at the University of Minnesota, her Ph.D. in biochemistry at Johns Hopkins University, School of Hygiene and Public Health, and completed a post-doctoral fellowship at Johns Hopkins University, Department of Cell Biology and Anatomy. Dr. Chance has been involved in the development of three patents and has co-authored 13 published papers. Speaking about diversity in STEM fields, Dr. Chance said, “Diversity across STEM industries is paramount in driving innovation and advancement. While women remain underrepresented in STEM industries, particularly in leadership roles, recognitions like this shed light on the many successful women who are making a difference, and hopefully inspire a younger generation of women to pursue their own rewarding careers in these important fields. I’m pleased to be part of an organization like Great Basin that values diversity, and am honored to be included in the first group of women recognized by Profiles in Diversity Journal for contributing to the advancement of STEM.” Dr. Chance will be profiled in a special STEM Women Worth Watching edition issued in April 2017. To view the publication’s press release and a full list of this year’s award winners, click here. 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 events, trends, and business prospects, which may affect our future operating results and financial position, including but not limited to statements regarding the Company’s anticipated FDA approval of current pending assays, commercialization of future approved assays, 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, 2015 and Quarterly Report on Form 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.


News Article | February 14, 2017
Site: globenewswire.com

SALT LAKE CITY, Feb. 14, 2017 (GLOBE NEWSWIRE) -- Great Basin Scientific, Inc. (OTCQB:GBSN), a molecular diagnostics company, announced today that it has filed a registration statement on Form S-1 with the Securities and Exchange Commission (SEC) relating to a proposed equity offering. The Company anticipates that it will conduct the offering with the assistance of a placement agent on a “best efforts” basis. The Company expects to use the net proceeds from the offering for research and development, sales and marketing, manufacturing analyzers for customers, automation of manufacturing facility and increasing manufacturing capacity, and general working capital purposes. Roth Capital Partners will act as sole placement agent for the offering. The offering of the equity securities may only be made by means of a prospectus filed with the SEC. A copy of the preliminary prospectus relating to the offering is available, for free, on the SEC’s website at http://sec.gov. A copy may also be obtained from the Company. The registration statement relating to these securities has been filed with the SEC, but has not yet become effective. No offer to buy the securities can be accepted and no part of the purchase price can be received until the registration statement has become effective, and any such offer may be withdrawn or revoked, without obligation or commitment of any kind, at any time prior to notice of its acceptance given after the effective date. This press release shall not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any offer or sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction. 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. Forward-Looking Statements This press release includes forward-looking statements regarding the Company’s proposed registered offering, including but not limited to, statements regarding the offering of the Company’s equity securities, the planned use of net proceeds, the Company’s anticipated capital needs and expenditures during the year ended December 31, 2017 and other similar statements. 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 Company’s ability to complete an offering of our equity securities when expected, if at all, the Company’s anticipated capital needs not varying significantly from those currently projected through 2017, the Company’s anticipated business and customer growth occurring as anticipated 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 fiscal year ended December 31, 2015 and Quarterly Report on Form 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.

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