Great Basin Submits 510(k) Application to the FDA for Staph ID/R Blood Culture

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Company’s first multiplex panel detects blood sepsis caused by MRSA and other staph species

SALT LAKE CITY--Great Basin Scientific, Inc. (GBSN) , a molecular diagnostics company, announced today that the Company has submitted its Staph ID/R Blood Culture Panel to the U.S. Food & Drug Administration (FDA) for 510(k) clearance. The submission of the Staph ID/R panel, the Company’s first multiplex panel, comes after the successful completion of a clinical trial that met all of Great Basin’s clinical objectives. Great Basin offers the first and only molecular diagnostic platform capable of low-plex tests, as well as multiplex and direct-from-specimen panels.

“We are excited to submit our first multiplex panel to the FDA, and look forward to the value this test will add to the Great Basin platform, further setting us apart from other solutions in the molecular diagnostics space with superior scalability and cost efficiency.”

The Great Basin Staph ID/R Blood Culture Panel is a sample-to-result, automated, molecular multiplex panel that detects Staph aureus and two other staph species along with the mecA gene, a major drug resistance marker that confers resistance to methicillin and creates the superbug MRSA. In addition to Staph aureus, the panel also detects Staphylococcus lugdunensis and Staphylococcus epidermidis. The remaining staph species are detected as a group and identified as “Staphylococcus present.” When compared to traditional blood culture methods, results of this panel are expected to allow for a faster diagnosis and therefore a more timely appropriate therapy, which is associated with improved patient outcomes, lower treatment costs, and shorter length of hospital stay for affected patents.

“The successful trial completion and submission to the FDA of our Staph ID/R panel marks a significant milestone for Great Basin, and a critical advancement for our customers and hundreds of thousands of patients in the U.S. who are affected by staph bloodstream infections – including the deadly superbug MRSA – every year,” said Ryan Ashton, co-founder and Chief Executive Officer. “We are excited to submit our first multiplex panel to the FDA, and look forward to the value this test will add to the Great Basin platform, further setting us apart from other solutions in the molecular diagnostics space with superior scalability and cost efficiency.”

Ryan continued: “I am proud of the determination of the Great Basin team, which continues to execute at the highest level, delivering on the promise to provide current and future customers with a robust menu of easy-to-use and cost effective tests and panels. This panel will be higher value than our low-plex tests and increases our potential revenue per customer by offering higher revenue per test than either our C. diff test, or our GBS test.”

Once approved and commercially available, hospital and lab technicians can run the new multiplex panel on the same analyzer used to perform Great Basin’s commercially available low-plex tests for Clostridium difficile (C. diff) and Group B Streptococcus (GBS). Great Basin expects to offer the panel at a significantly lower cost than other blood panels on the market today, making fast, easy diagnosis of staph-caused blood sepsis affordable for the small to medium hospitals the Company targets. The Company’s unique scale to run a broad assay menu further enhances the economics for its customers, while also allowing Great Basin to grow their business with new and existing customers.

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 statement regarding the Staph ID/R Blood Culture Panel and its effects upon the Company. 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, including the Staph ID/R Blood Culture Panel mentioned herein; (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 year ended December 31, 2014. 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.

 

 

Contacts

ICR
Media:
Kate Ottavio Kent, 203-682-8276
Kate.Ottavio-Kent@icrinc.com
or
Investor Relations:
Bob Yedid, 646-277-1250
bob.yedid@icrinc.com

 

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Companies

Symbol Name Price Change % Volume
GBSN Great Basin Scientific Inc. 0.01 -0.00 -9.63 6,140,887

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