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
Great Basin Scientific, Inc. (GBSN) granted 510(k) clearance 3/31/17 by the FDA for Great Basin Bordetella Direct Test.
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:
https://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 Panel. https://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
SALT LAKE CITY, March 22, 2017 (GLOBE NEWSWIRE) -- Great Basin Scientific, Inc. (OTCQB:
GBSN), a molecular diagnostic company, today reported operating results for the fourth quarter and full year ended December 31, 2016.
"The fourth quarter of 2016 was a period of significant progress and change for Great Basin," said Ryan Ashton, co-founder and chief executive officer of Great Basin. "During the third quarter, research and development spending and gross margin inefficiency peaked as we invested in significant menu expansion, which included concurrently running two clinical trials and preparing for the commercial launch of two products that the U.S. Food and Drug Administration (FDA) cleared in early 2016. With those efforts either behind us or winding down, we turned our focus to improving operational efficiencies and implementing cost management programs in preparation for 2017. These efforts resulted in a reduction in sequential quarterly operating expenses and our strongest gross margins of the fiscal year. Furthermore, we expect that the changes we made in the fourth quarter—along with the January completion of the clinical trial for our Bordetella Direct Test and the restructuring and reduction plan we announced in early February—will result in further improvements to our operating expenses, burn rate and gross margins in the first half of 2017."
"Beyond the sequential improvements in gross margins and reduced operating expenses, 2016, overall, was a year of noteworthy progress for the Company. For the first time, we launched two new products and successfully completed two clinical trials in a single year. The doubling of our menu to four assays will promote our objective of continually expanding our customer footprint and increasing our revenue per customer."
Read more: http://www.nasdaq.com/press-release/great-basin-scientific-reports-fourth-quarter-and-full-year-2016-results-20170322-00266#ixzz4dDMOoLMH