U.S. Department of Homeland Security Validates Performance of PositiveID Corporation's Multiplex BioThreat Assay Through an In-House Blind Study
DHS' Science and Technologies Division Confirms Performance of the PSIDMBA
New Website Available at www.psidmba.com
DELRAY BEACH, Fla., Aug. 11, 2011 (GLOBE NEWSWIRE) -- PositiveID Corporation ("PositiveID" or "Company") (Nasdaq:PSID), a developer of medical technologies for diabetes management, clinical diagnostics and bio-threat detection, announced today that the Department of Homeland Security ("DHS") Science and Technologies division has validated the performance of the Company's recently launched Multiplex BioThreat Assay ("MBA"), the PSIDMBA, through an in-house blind study. This validation was performed under the direction of and funded by DHS S&T. The PSIDMBA, available at
www.psidmba.com, is the first commercially available MBA for the detection of up to six bio-threat organisms on the Centers for Disease Control & Prevention ("CDC") Category A and B lists. The PSIDMBA was developed and perfected over a five-year period by MicroFluidic Systems ("MFS"), the Company's wholly owned subsidiary.
The PSIDMBA tests for the following six organisms with 16 organism specific signatures: Bacillus anthracis (Anthrax); Yersinia pestis (Plague); Francisella tularensis (Tularemia); Burkholderia pseudomallei (Melioidosis); Burkholderia mallei (Glanders); and Variola major* (Small Pox). The PSIDMBA is also fully customizable to meet specific customer needs, and is the first in a series of environmental and food pathogen assays expected to be available.
Intended for investigative and research use, the PSIDMBA offers rapid, accurate and efficient multiple organism identification in a cost-effective manner. Currently available methods require up to 16 times more sample, are more costly per signature and are not amenable to high-throughput analyses. The PSIDMBA assay is designed to provide test results for up to six organisms in the time of a single polymerase chain reaction (i.e. 30 to 90 minutes), versus the several hours or more required to test multiple samples with conventional methods. A blind assay validation study was successfully completed through DHS with more than 150 competing natural occurring strains, near-neighbors, and environmental samples. Samples were tested in triplicate with 100% agreement being achieved for all positives and negatives at a limit of detection which is equivalent or better than similar assays performed
in a singleplex format. Further, the PSIDMBA was evaluated in real condition environments in a major east coast U.S. city for a period of one year without any false positive results. The ease of use and data interpretation makes the PSIDMBA suitable for a broad range of settings such as environmental monitoring, clinical, agricultural and veterinary settings.
The PSIDMBA kit provides added specificity and selectivity by using a total of 16 genomic and plasmid specific signatures to confirm the presence or absence of a strain specific organism. The proprietary multicolor combinatorial approach allows a user to rapidly screen a biological sample for the presence of five bacteria and one virus in only three simultaneous reactions, whereas a traditional singleplex method would require at least 16 reactions to accomplish the identical task. An additional benefit of the multiplex kit is a significant reduction in cost per test when compared to running the samples in a singleplex format.
Mr. Lyle Probst, Senior Director of Programs at MFS, and co-developer of the assay said, "Having worked in the field of biodefense and assay development for the last 10 years, I believe the PSIDMBA achieves better performance and higher cost savings than any other assay currently on the market. In order to assess the assay's ability to detect unknown samples, our team challenged it in triplicate against a series of blind samples provided by DHS. Our results indicate that the multiplex assay was strain specific and produced no false positives or negatives when challenged with in house gDNA collections and DHS provided panels. Also, these results were achieved with a limit of detection that is state-of-the-art and equivalent or better than those achieved with in singleplex fashion."
For more information the PSIDMBA, please call 1-866-402-2447 or visit http://www.psidmba.com, where a free white paper on the PSIDMBA is available.
*Variola major is an optional component of the PSIDMBA.
About PositiveID Corporation
PositiveID Corporation develops unique medical devices and biological detection systems, focused primarily on diabetes management, rapid medical testing and airborne bio-threat detection. Its wholly-owned subsidiary, MFSI, is focused on the development of microfluidic systems for automated preparation of and performance of biological assays. For more information on PositiveID, please visit www.PositiveIDCorp.com.
The PositiveID Corporation logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=7717
Statements about PositiveID's future expectations, including the likelihood that the PSIDMBA is the first commercially available MBA for the detection of up to six bio-threat organisms on the CDC Category A and B lists; the likelihood that the PSIDMBA is the first in a series of environmental and food pathogen assays expected to be available; the ability of the PSIDMBA to offer rapid, accurate and efficient multiple organism identification in a cost-effective manner; the ability of the PSIDMBA to provide test results for up to six organisms in the time of a single polymerase chain reaction (i.e. 30 to 90 minutes), versus the several hours or more required to test multiple samples with conventional methods; the likelihood that the ease of use and data interpretation makes the PSIDMBA suitable for a broad range of settings such as
environmental monitoring, clinical, agricultural and veterinary settings; the likelihood that the PSIDMBA achieves better performance and higher cost savings than any other assay currently on the market; and all other statements in this press release other than historical facts are "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 PositiveID's ability to successfully commercialize the MBA, as well
as certain 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 March 25, 2011, and 10-Q filed on May 13, 2011, 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.
CONTACT: Allison Tomek
Source: PositiveID Corporation
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