PositiveID Corporation Achieves Firefly Dx Development Milestone With Completion of Breadboard PCR

Company Has Begun Testing Assays on Breadboard PCR to Prove Its Goal of Achieving PCR Results in Less Than 20 Minutes


DELRAY BEACH, Fla., Feb. 12, 2015 (GLOBE NEWSWIRE) -- PositiveID Corporation ("PositiveID" or "Company") (OTCQB:PSID), a developer of biological detection and diagnostics solutions, today announced that it has achieved a significant milestone in the development of its handheld Firefly Dx system with the completion of the build of its breadboard PCR (polymerase chain reaction) chip. The Company has begun testing assays to prove the design of achieving PCR results in less than 20 minutes at standard laboratory volumes, compared to existing technologies which require lab-based equipment and can take hours or days to provide results. The Company plans to announce the results of its testing as it is completed over the next several months.

PositiveID will run rapid thermal cycling with 40 PCR cycles of heating and cooling. Because the Firefly Dx system uses industry-standard 25 – 30 uL reaction volumes, the Company expects that existing FDA-cleared real-time PCR assays can be ported to the system rapidly, reducing development time and expense.  As PositiveID's engineering and biology teams complete their evaluation of the updated sample preparation and PCR design to be integrated into the final iteration of the Firefly Dx cartridge, the Company will also complete optimization of the lyophilized PCR reagents with its reagent supplier. Once validation is complete, the designs will be integrated into an injection molded disposable cartridge, which will be evaluated and optimized to run automatically on the breadboard Firefly Dx platform. 

"Completion of the breadboard PCR element of Firefly is a major accomplishment as it carries the highest risk of the development process," stated William J. Caragol, Chairman and CEO of PositiveID. "We are confident in our design, and our next objective is to prove we can deliver real-time PCR results at standard volumes in minutes, which, we believe, would be groundbreaking in the multi-billion dollar real-time PCR market."

PositiveID is developing Firefly Dx based on intellectual property and know-how gained during years of development and $30 million of contract funding from the U.S. Department of Homeland Security for the Company's M-BAND system, which uses PCR for the identification of airborne bio-threats. The Company has miniaturized its proven real-time PCR technology for the handheld Firefly Dx system, which is designed for use by first response teams to detect biological agents associated with weapons of mass destruction; agricultural screening in domestic sectors and developing countries; and point-of-need monitoring of pathogenic outbreaks.

The Firefly Dx instrument will combine sample lysis, purification, real-time PCR analysis, electronic reporting of results, and automated chain of custody with the embedded RFID chip in disposable cartridges. The system is designed to automatically process and purify nucleic acids from diverse sample types, which are then analyzed with the incorporated multiplex PCR assay for multiple user-defined targets. Results can be immediately obtained and processed in-situ via SMART phone interface (or personal computer) with a specialized, mobile HTML application and Cloud-based data sharing and storage. The ease-of-use, portability, low cost, and assay flexibility is designed to provide the user with confidence and assurance of an analytically accurate response in limited and remote environments.

About PositiveID Corporation

PositiveID Corporation is an emerging growth company and developer of biological detection systems for America's homeland defense industry as well as rapid biological testing. PositiveID is focused on the development of microfluidic systems for the automated preparation of and performance of biological assays in order to detect biological threats and analyze biological samples. For more information on PositiveID, please visit http://www.PositiveIDCorp.com.

Statements about PositiveID's future expectations, including the likelihood that the Company plans to announce the results of its testing as it is completed over the next several months; the likelihood that the Company will run rapid thermal cycling with 40 PCR cycles of heating and cooling; the likelihood that existing FDA-cleared real-time PCR assays can be ported to the system rapidly, reducing development time and expense; the likelihood that as PositiveID's engineering and biology teams complete their evaluation of the updated sample preparation and PCR design to be integrated into the final iteration of the Firefly Dx cartridge, the Company will also complete optimization of the lyophilized PCR reagents with its reagent supplier; the likelihood that once validation is complete, the designs will be integrated into an injection molded disposable cartridge, which will be evaluated and optimized to run automatically on the breadboard Firefly Dx platform; the likelihood that delivering real-time PCR results at standard volumes in minutes would be groundbreaking in the multi-billion dollar real-time PCR market; the likelihood that the Firefly Dx instrument will combine sample lysis, purification, real-time PCR analysis, electronic reporting of results, and automated chain of custody with the embedded RFID chip in disposable cartridges; constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934, and as that term is defined in the Private Litigation Reform Act of 1995. Such forward-looking statements involve risks and uncertainties and are subject to change at any time, and PositiveID's actual results could differ materially from expected results. These risks and uncertainties include, without limitation, the Company's ability to target the bio-threat detection and rapid medical testing sectors; the Company's ability to complete the development of its Firefly Dx system; as well as other risks. Additional information about these and other factors that could affect the Company's business is set forth in the Company's various filings with the Securities and Exchange Commission, including those set forth in the Company's 10-K filed on April 11, 2014, and 10-Qs filed on November 17, 2014, August 14, 2014, and May 20, 2014, under the caption "Risk Factors." The Company undertakes no obligation to update or release any revisions to these forward-looking statements to reflect events or circumstances after the date of this statement or to reflect the occurrence of unanticipated events, except as required by law.



            

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