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Great Basin Scientific Inc. (GBSN)

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GBSN http://www.gbscience.com/ 


GREAT BASIN SCIENTIFIC, INC.2441 SOUTH 3850 WEST, SALT LAKE CITY, UT 84210
PHONE: 801-990-1055TOLLFREE: 888-360-4022; CUSTOMER SUPPORT: 888-333-9793

 


***News Out: 6/27/2017 Great Basin Provides Business Update***


http://gbscience.com/great-basin-provides-business-update/


New Business Pipeline exceeds $5.0 million in potential new revenue; Nearly $2.0 million in potential pipeline revenue is from Stool Bacterial PathogensPanel, currently awaiting FDA clearance


Salt Lake City, June 26, 2017 – Great Basin Scientific, Inc. (OTCQB: GBSN), a molecular diagnostics company, today provided a general business update on the Company, focusing on its efforts to drive growth in second half 2017 and into 2018 through an expanded menu of diagnostic panels and tests.  Highlights include:

  • New business pipeline exceeds $5.0 million, an increase of 123% over the fourth quarter of 2016;
    Pipeline includes $1.96 million in expected annual revenue from the Company’s Stool Bacterial Pathogens Panel (SBPP), currently awaiting expected 510(k) clearance from the U.S. Food and Drug Administration (FDA);
    Average expected annual revenue of sites in evaluation increases 279% to $47,866 compared with $12,620 in the second quarter of 2016; and
    New customer sites now comprise 34% of new business pipeline.

“We are pleased to see such exciting results from the large investments we made in 2016 to diversify and expand our product menu. Already, we believe the potential revenues of our new business pipeline exceed our revenues for all of fiscal year 2016,” said Ryan Ashton, co-founder and chief executive officer of Great Basin Scientific. “Especially encouraging has been the response to our most important product, the Stool Bacterial Pathogens Panel, currently awaiting FDA clearance. We will not commence sales and marketing outreach on that panel until we receive FDA clearance, but inbound demand has been promising, and, based on the pre-clearance demand, we expect to see our new business pipeline growth accelerate once we receive FDA clearance for this important assay.”

Ashton continued, “In addition to menu expansion and new business progress, we also continue to execute our cash management program, which was initiated in late 2016. This program is intended to re-align Company resources from a heavy focus on product development to an increased focus on customer acquisition and revenue growth. We expect our cash burn rate to continue to decline during 2017, and reiterate our target for total operating expenses at or below $4.0 million for the third quarter of 2017, proving our dedication to executing on the fundamentals that will both serve our target market and our stockholders.”

New Business Pipeline and Product Mix

As of June 22, 2017, the Company had approximately $5.0 million of potential new revenues in the new business pipeline. These potential revenue estimates, as well as those below are based on the evaluating site’s own estimate of their expected testing volumes multiplied by the product price offered to the prospective customer[1].

The Company’s highest-value multiplex panels – Staph ID/R Blood Culture Panel (SIDR) and Stool Bacterial Pathogens Panel (SBPP) SBPP – comprise 34% of new customer site evaluations in the new business pipeline. Staph ID/R has a list price 50% above that of the Company’s low-plex tests, with the same general cost-of-goods as the low-plex assays. SBPP, which is awaiting 510(k) clearance from the FDA, comprises 25% of the new customer evaluations in the pipeline. SBPP, when commercially available, will have a list price 2-3 times higher than the Company’s low-plex tests. Based on customer feedback, the Company anticipates significant pipeline growth for SBPP once it receives FDA clearance and the Company is free to market the panel. The new business pipeline follows:

To the extent these evaluations and scheduled evaluations are converted into customers, we expect such conversions to occur between the fourth quarter of 2017 and the first quarter of 2018. The Company’s historical “win rate” (those evaluations that elect to become customers) has been 82%.

New Customers from Larger Hospitals and Labs Mark Largest Evaluation Growth

A substantial increase in the number of larger hospitals and labs in the new business pipeline, along with greater interest in the Company’s newest and higher-priced panels, is resulting in significant growth in the Company’s expected average annual revenue per customer. Expected annual revenue from new customers evaluating the Company’s products increased approximately 279% from the second quarter of 2016 and 186% from the third quarter of 2016. This significant increase occurred prior to launch of the Company’s first mid-plex panel, its Staph ID/R Blood Culture Panel for blood sepsis caused by staphylococcus species. The Company believes its expanded product mix of low-, mid- and multi-plex assays is the primary driver of the increase in expected average revenue per customer, and believes this trend will accelerate with the addition of SBPP to its commercial offerings, as well as the anticipated development of other, higher-priced assays in the future. The chart below shows the average expected annual revenue of new customer evaluation starts by quarter:

Stool Bacterial Pathogens Panel (SBPP)

The Company expects its SBPP assay to be its primary growth driver in 2018, having already seen large demand for this assay pre-FDA clearance. The Company believes this response has been driven by three factors:

  • SBPP addresses, by far, the largest market of any of the Company’s products—that for the approximately 48 million food-borne illnesses that occur annually in the United States;
    The assay fulfills an unmet need by providing a powerful, focused set of answers that allow clinicians to quickly and accurately diagnose and treat their patients suffering from food-borne gastrointestinal distress; and
    The Company’s low-cost structure allows it to offer its hospital and lab customers a powerful value proposition. The test will be priced below expected reimbursement rates, which means SBPP can be run profitably by customers.

According to the Centers for Disease Control (CDC), there are 48 million food-borne (bacterial) illnesses annually in the United States. SBPP powerfully addresses this large market where current solutions are either too slow (culture) or too expensive relative to reimbursement rates (mega-plex panels). The Company believes its low-cost, easy-to-use solution will drive placements for its system, accelerating revenue growth and, because of SBPP’s higher selling price and exceptional gross margins, resulting in profitability.

In late December 2016, the Company submitted its 510(k) application for SBPP to the FDA. Previous 510(k) clearances for the Company’s assays have been approximately 180 days from submission to clearance, with the Company’s first FDA-cleared mid-plex panel, Staph ID/R, requiring 205 days.

Mid-Plex Panels and Reimbursement as a Competitive Driver

In late April 2017, Medicare contractor Palmetto GBA issued a draft of Local Coverage Determinations (LCDs)[2] proposing reimbursement coverage for a variety of diagnostic panels, including Foodborne Gastrointestinal Panels Identified by Multiplex Nucleic Acid Amplification Tests (NAATs), recommending the use of smaller, more targeted panels over larger and broader panels. Their reasoning for non-coverage included the fact that the pathogen targets in larger (more than five pathogens) panels don’t represent a common syndrome, and that many targets can be very rare. “A panel that includes pathogens that are very rare, or a panel in which all pathogens do not cause overlapping clinical syndromes, or when some pathogens are found only in specific patient populations (immuno-compromised patients) is not reasonable and necessary,” Palmetto wrote. This recommendation supports Great Basin’s mid-plex panel approach of smaller panels that represent a common syndrome, for which there is broad applicability and, per Palmetto’s recommendation, offers a lower rate of reimbursement denial.

“In ongoing discussions with customers and prospects, they report a strong preference for smaller panels targeting the most common pathogens, noting high-cost molecular diagnostic mega-panels are meeting reimbursement resistance from payors and clinical resistance from clinicians who prefer a more targeted, therapy-focused set of answers for their patients. This preference maps to the updated reimbursement recommendations being issued from payors like Palmetto, reinforcing our mid-plex panel strategy,” said Sandra Nielsen, senior vice president of sales and marketing for Great Basin Scientific. “We are excited about the opportunity to serve the needs of clinicians with SBPP and our in-development Stool Parasite Panel, two right-sized, cost effective panels that we believe will offer a significant competitive advantage over either culture or our competitors’ high-cost molecular diagnostic mega-panels.”

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.


***6/1/2017 NEWS UPDATE***


Data to be Presented June 1-5, 2017 at American Society of Microbiology's "Microbe 2017" Conference Demonstrates Great Basin Scientific, Inc.’s Stool Bacterial Pathogens Panel Efficacy 

https://globenewswire.com/news-release/2017/06/01/1005228/0/en/Data-to-be-Presented-at-ASM-Microbe-2017-Demonstrates-the-Efficacy-of-Great-Basin-s-Stool-Bacterial-Pathogens-Panel.html
                 Four posters describing the Company’s platform are to be presented, including a third-party (Laboratory Alliance of Central New York) clinical study poster of the Stool Bacterial Pathogens Panel 

SALT LAKE CITY, June 01, 2017 -- Great Basin Scientific, Inc. (GBSN), a molecular diagnostics company, announced today that it will present 3 posters describing the reliability and effectiveness of its diagnostic platform to attendees of American Society of Microbiology's (ASM) Conference "Microbe 2017" in New Orleans on June 1-5, 2017. Additionally, Dr. Paul Granato from the Laboratory Alliance of Central New York will present a poster summarizing the results of a multi-site independent clinical study evaluating the Great Basin Scientific, Inc. Stool Bacterial Pathogens Panel, which is awaiting 510(k) clearance from the US Food and Drug Administration (FDA). In the independent study by the Laboratory Alliance of Central New York, the Company’s Stool Bacterial Pathogens Panel is shown to process results in approximately 2 hours with superior detection rates of over 97%, compared to 51% for conventional culture and EIA methods.



***5/24/2017 NEWS UPDATE*** 

Great Basin Scientific Issued Second U.S. Patent for PCR Amplification Suppressor


https://globenewswire.com/news-release/2017/05/24/995607/0/en/Great-Basin-Scientific-Issued-Second-U-S-Patent-for-PCR-Amplification-Suppressor.html


SALT LAKE CITY, May 24, 2017 (GLOBE NEWSWIRE) -- Great Basin Scientific, Inc.(OTCQB:GBSN), a molecular diagnostics company, today announced that the United States Patent and Trademark Office (USPTO) issued U.S. Patent 9,657,353 for the Company’s amplification suppressor. This patent is the second U.S. patent relating to Great Basin’s amplification suppressor technology, expanding the Company’s protection to assays, kits, and products. The protection afforded by this patent allows the Company to explore licensing of the technology to applications such as medical research, food safety, veterinary, and more.

 

***4/12/2017 NEWS UPDATE***


Announced today (4/12/2017) that it has received CE Marking for its Stool Bacterial PathogensPanelhttp://www.otcmarkets.com/stock/GBSND/news?id=155739


 
***4/3/2017 NEWS UPDATE*** 
 
FDA 510(k) Premarket Notification - Effective 3/31/2017 - Great Basin Scientific, Inc. - Bordetella Pertussis DNA Assay System:  https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K170284


FYI (Why this particular diagnostic product is so important and useful for healthcare professionals): Pertussis, a respiratory illness commonly known as whooping cough, is a very contagious disease caused by a type of bacteria called Bordetella pertussis. These bacteria attach to the cilia (tiny, hair-like extensions) that line part of the upper respiratory system. The bacteria release toxins (poisons), which damage the cilia and cause airways to swell. Pertussis is a very contagious disease only found in humans. It is spread from person to person. People with pertussis usually spread the disease to another person by coughing or sneezing or when spending a lot of time near one another where you share breathing space. Many babies who get pertussis are infected by older siblings, parents, or caregivers who might not even know they have the disease.

GBSN's most recent 510(k) clearances and applications: 


Great Basin Scientific, Inc. (GBSN) granted 510(k) clearance 3/31/17 by the FDA for Great Basin Bordetella Direct Testhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K170284


Great Basin Scientific, Inc. submits 510(k) application to FDA 12/19/16 for diagnostic Stool Bacterial Pathogens Panelhttps://gbscience.com/great-basin-scientific-submits-510k-application-fda-stool-bacterial-pathogens-panel/



Great Basin Scientific Reports Fourth Quarter and Full Year 2016 Results
 
(GlobeNewswire,  March 22, 2017, 07:03:00 AM EDT)

*Company reduces operating costs, improves gross margin and cash burn rate quarter-over-quarter *
 
 
Fourth quarter revenue increased 39% year-over-year; 2016 revenues increased 42%
14% reduction in net cash used in operating activities from the third quarter to the fourth quarter of 2016
34% reduction in fourth quarter G&A expenses leads to 4% reduction in total operating expenses compared to third quarter
Quarterly gross margin improved 42 basis points over third quarter to best level of the year
Percentage of customers using more than one assay increased 17% quarter-over-quarter and 81% year-over-year


Read more: http://www.nasdaq.com/press-release/great-basin-scientific-reports-fourth-quarter-and-full-year-2016-results-20170322-00266#ixzz4dDMOoLMH


PATENTS



US8936921: METHODS OF ISOTHERMAL APPLICATION USING BLOCKED PRIMERS 
US8637250 : SYSTEMS & METHODS OF POINT-OF-CARE AMPLIFICATION & DETECTION OF POLYNUCLEOTIDES
US20130331298: ANALYZER & DISPOSAL CARTRIDGE FOR MOLECULAR INVITRO DIAGNOSTICS


SEC FILINGS : http://www.nasdaq.com/symbol/gbsn/sec-filings

FACEBOOK PAGE : https://www.facebook.com/gbscience
CEO: RYAN ASHTON

About Great Basin Scientific, Inc: Great Basin Scientific, Inc. (ticker symbol: GBSN) 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. Great Basin's molecular diagnostics system is uniquely capable of answering both the ‘What is it?’ question --answered by a low-cost, low-plex assay-- and the ‘What is causing it?’ question, identified by a multi-plex panel. Great Basin has FDA Clearance on tests for Clostridium difficile and Group B streptococcus. Low-plex tests in development include SA Nasal and Staph ID/R and multi-plex panels being developed include Fungal Pathogens, Shiga-toxin-producing E. coli (STEC) and Food-borne Pathogens (GI Panel). Great Basin Scientific’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. Fast, accurate results. More answers. One easy-to-use and cost-effective system. Only Great Basin delivers a powerful product pipeline of tests and panels that allows every lab to adopt molecular diagnostics that will assist clinicians in better diagnosing and managing patients outcomes. The company sells its diagnostic tests through a direct sales force in the United States, as well as through distributors in the European Union and New Zealand. Great Basin Scientific, Inc. is headquartered in Salt Lake City, UT. For more information on the company or its products, please feel free to contact us at our Corporate Headquarters.

 

 
 
Amended Statement of Ownership (sc 13g/a)
Date: January 24, 2017 @ 4:29 PM
Source: EDGAR (US Regulatory)
Stock: Great Basin Scientific, Inc. (QB) (GBSN)

http://ih.advfn.com/p.php?pid=nmona&article=73684421&symbol=GBSN
NASDAQ : $GBSN


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GBSN News: Current Report Filing (8-k) 04/10/2017 09:02:48 AM
GBSN News: USMJ Experiencing High Volume On Verge Of PPS Breakout With Stock Rated Very Bullish And Major Short Position Getting Squeezed 04/06/2017 11:49:40 AM
GBSN News: Annual Report (10-k) 03/22/2017 07:18:09 AM
GBSN News: Current Report Filing (8-k) 03/22/2017 07:01:46 AM
GBSN News: Current Report Filing (8-k) 03/10/2017 07:17:42 AM
PostSubject
#37031  Sticky Note NEWS The_BORG 06/26/17 06:51:44 PM
#36943  Sticky Note Great-Basin-Scientific-Issued-Second-U.S.-Patent-for-PCR-Amplification-Suppresso EnergySaver 05/29/17 01:07:57 PM
#37102   It didn't really have a pop this time goodword88 07/23/17 06:37:03 PM
#37101   Hit .122 Friday. Single pennies coming on. Weeeeeee. TKane 07/23/17 12:14:42 PM
#37100   Yea, I took my little loss on this Drugdoctor 07/22/17 11:42:34 AM
#37099   So did ya but it below .25? BRoberts1982 07/22/17 11:17:46 AM
#37098   ((WOWSERS)) GBSN .16 ALL TIME LOW BRoberts1982 07/22/17 11:16:14 AM
#37097   There is no bottom to a a stock BRoberts1982 07/22/17 10:53:56 AM
#37094   It may-touch-back-down-to-.122 before it reaches=quilibrium-with-selling-and-starts-to rise again OR Euripides90 07/21/17 11:27:01 AM
#37093   R/S, 1 for 25000 shares could b on Id StockUser 07/21/17 11:25:28 AM
#37092   #1 (UNO) CEO, Ryan Ashton! Id StockUser 07/21/17 11:22:53 AM
#37091   Are we WINNING yet? BRoberts1982 07/21/17 09:22:52 AM
#37090   GBSN is a very heavily shorted stock, i SerialThriller 07/21/17 03:02:40 AM
#37089   Years & Years of DILUTION is still pending IMO Id StockUser 07/20/17 12:10:06 PM
#37088   Careful! DILUTION! Millions & Millions of shares will Id StockUser 07/20/17 12:05:11 PM
#37087   back in at .25 with some play money. Atlanta1 07/20/17 09:51:58 AM
#37086   And there you have the markets answer...... BRoberts1982 07/19/17 11:15:59 AM
#37085   Setting up for a huge pop! Matt74 07/18/17 10:41:22 AM
#37083   Why are the latest FDA approvals any different BRoberts1982 07/18/17 09:37:40 AM
#37082   So why in your estimation can they not Beauneedsbiscuits 07/17/17 03:36:24 PM
#37081   I am still bullish dudes...if it may concern Luc Hill 07/17/17 11:20:44 AM
#37080   There are no bulls left, just people that BRoberts1982 07/17/17 09:28:52 AM
#37079   After 3 years, only 1 bull left... LMFAO! dandan2x72 07/17/17 01:42:30 AM
#37077   This company LOSES MULTI MILLIONS each and EVERY Quarter. BRoberts1982 07/16/17 01:48:27 PM
#37076   Wondering if the latest run was a pump robtewms 07/16/17 11:18:45 AM
#37075   I already learned dude...you lost a lot of Luc Hill 07/14/17 07:23:30 PM
#37074   U'll learn soon if u don't understand. Sure, Id StockUser 07/14/17 04:39:18 PM
#37073   #1 (UNO) CEO, Ryan Ashton! The king of dilution!!! Id StockUser 07/14/17 04:36:18 PM
#37072   Thanks for all the week hands who gave Luc Hill 07/14/17 01:30:57 PM
#37071   Thanks for the information dude...but I don t Luc Hill 07/14/17 01:25:38 PM
#37070   Yeha if you don't buy now at above G3TCRUNK3R 07/14/17 01:16:44 PM
#37069   Nice resistance...strong stock...big future...last moments to buy on Luc Hill 07/14/17 12:52:02 PM
#37068   back in at avg .27 Atlanta1 07/14/17 10:22:48 AM
#37067   You are so very green, is it BRoberts1982 07/14/17 10:13:36 AM
#37066   OK dude! BRoberts1982 07/14/17 10:11:02 AM
#37065   Tomorrow we continue the ride up dudes... Luc Hill 07/13/17 05:35:30 PM
#37064   After an early run-up=crashing again,seemed chance-to-dump more than Euripides90 07/13/17 03:54:00 PM
#37063   potential for nearly $2.0 million in annual Atlanta1 07/13/17 09:34:59 AM
#37062   This is only the beginning dudes..2 dollar... Luc Hill 07/13/17 09:33:54 AM
#37061   Why this was not showing in the website? Vis567 07/13/17 08:13:30 AM
#37060   News: https://www.benzinga.com/pressreleases/17/07/g9772323/great-basin-s davidsson10 07/13/17 07:04:44 AM
#37059   Gbsn - I played before the split and charliewho 07/12/17 11:15:57 PM
#37058   $GBSN looking for 100% and more here beach_trades 07/12/17 10:55:42 PM
#37057   I think more on a big pump that Luc Hill 07/12/17 12:22:14 PM
#37056   IMO Huge dumping is expected any moment now! Id StockUser 07/12/17 12:20:49 PM
#37055   TIM!!! you hit this for 15400?? swiftearl 07/11/17 12:00:40 PM
#37054   Haven't been paying much attention lately..is os at trd4profit 07/09/17 09:22:48 PM
#37053   Great stock...bought huge last friday...uprise next week...believe me...huge... Luc Hill 07/08/17 06:01:22 PM
#37052   IMO TOP + TOP SQUARE CLASS TYPE CEO, Id StockUser 07/07/17 05:45:06 PM
#37051   Ryan Ashton!!!! #1 (UNO) CEO!!!! Id StockUser 07/07/17 05:42:23 PM
#37050   Next R/S could be in Aug/Sept but SP Id StockUser 07/07/17 01:54:39 PM
#37049   A little Green, Thank you. dandan2x72 07/06/17 04:01:11 PM
PostSubject