Jan 21, 2015 PositiveID Corp. (OTCQB:PSID) is preparing the launch of its latest innovation in bio-detection, and it could not come at a better time. In the midst of several epidemic outbreaks, PositiveID (“PSID”) is introducing Firefly Dx, a hand-held polymerase chain reaction (PCR) pathogen detection system capable of processing biological samples (e.g., blood, urine, mouth/nose swabs) on-site, alerting users within minutes of the presence of contagions. The Firefly Dx technology could prove vital for agencies entrusted with addressing public health needs on national and global levels.
Biological Threats At Hand
Without a proper detection, an invasive disease outbreak, whether natural or man-made, often cannot be effectively contained and treated without significant loss of life. Although there are biological and chemical-based technologies available to detect a wide range of pathogenic threats, unfortunately these technologies can still be costly, labor intensive, and are often limited to laboratory settings, thus falling short of truly effective and timely point-of-need monitoring and detection.
Recently in California, 45 cases of measles were confirmed after park-goers were exposed to the virus while visiting Disneyland. Seven more cases were later identified in other states and Mexico that trace back to the Disneyland outbreak. Measles is a highly contagious disease and a leading cause of death in young children worldwide despite its readily available vaccine.
This year’s predominant seasonal flu (“H3N2”) is an especially nasty strain. The Centers for Disease Control and Prevention (“CDC”) reports that 43 states are having widespread flu activity, up from 36 states last week. There have been 21 pediatric deaths from H3N2 this season. While states are only required to report pediatric deaths, the CDC estimates between 3,000-49,000 people die each year as a result of the flu. This year the H3N2 virus mutated, greatly diminishing the vaccine’s effectiveness.
Further, Ebola virus and avian flu are two deadly infectious diseases on the cusp of pandemic status. In 2014 alone, the World Health Organization (“WHO”) noted over 20,000 cases of Ebola worldwide, mostly in Africa. This is the largest Ebola outbreak recorded in history. Ebola has a 21-day incubation period and between 25%-90% of those infected will die.
Avian flu (“H5N1”) made headlines in November, 2014 after an Egyptian woman died, bringing its death toll to almost 400 worldwide. Human cases of H5N1 are rare in comparison to many endemic diseases; however, researchers are watching this strain closely. There is a grave concern that a variant strain may form that combines avian and human influenza. Epidemiologists fear this strain would be both highly contagious and lethal to humans. The results would be devastating, similar to the Spanish Flu that killed between 20-40 million people globally in 1918.
Firefly Dx’s Capabilities
Firefly Dx is a point-of-need, hand-held system designed to deliver molecular diagnostic results using real-time PCR chemistry. Firefly can identify an expansive range of biological agents, from cancer cells and microorganisms to viruses and bacteria with the use of DNA sequencing. Currently, when the CDC is made aware of a possible biological threat, a team of highly trained officers in the Epidemic Intelligence Service (“EIS”) are dispatched to investigate the cause, spread, and containment of the disease. In these situations EIS must expose themselves to the biological threat and then obtain samples to send back to a laboratory for processing. Results can take many hours or days to obtain depending on the remoteness of the location. Firefly Dx could be pivotal in streamlining the diagnostic process and possibly prevent further exposure to disease because the device is battery-operated and can be transported directly into a hot zone by local personnel, without the need for bulky lab equipment.. Firefly Dx then processes the samples and delivers its findings in less than 20 minutes. Incubation periods for certain diseases and quarantines for individuals who have possibly been exposed to disease would no longer be an issue, having infection confirmed or denied on the spot. Being automated, Firefly Dx can be operated with minimal instruction and training. The design is both affordable and disposable making it accessible and beneficial to many markets. Firefly Dx’s potential is not confined to human epidemiology. Firefly is also capable of detecting agricultural disease in plants and animals, which could be beneficial to farmers and ranchers worldwide.
PositiveID projects the completion of the Firefly Dx prototype to be available for field testing in late 2015 to early 2016. Recently PositiveID has been awarded many esteemed contracts. The U.S. Defense Threat Reduction Agency (“DTRA”) in conjunction with Leidos has partnered with PSID to conduct research and development in combating weapons of mass destruction. Further, NASA signed a Space Act Agreement in May 2014, to assess Firefly’s compatibility in extreme environments such as space. In October, 2014 PSID partnered with ENSCO, Inc. under contract with the U.S. Department of the Interior on behalf of the Department of Homeland Security to engineer faster and less expensive bio-threat detection systems. In November 2014, PSID earned a U.S. Special Operations Command (“USSOCOM”) Cooperative Research and Development Agreement to further develop Firefly’s capabilities in Special Operations Force applications.
The bio-detection market has grown exponentially in recent years. The global PCR market is projected to reach approximately $27.4 billion by 2015, according to Research and Markets’ “Polymerase Chain Reaction (PCR) – Products/Tools – A Global Market Watch, 2009-2015” report. PSID Chairman and CEO, William Caragol wrote to stockholders, “We are continuing to pursue several U.S. Government agency contracts for the continued development of Firefly Dx. We anticipate completing the second phase prototype of Firefly Dx in the first half of 2015, which will enable us to demonstrate the technology and run data for potential partners, an important step in the development of the final prototype.”
By identifying threats at the point of need and delivering results within minutes, Firefly Dx has the potential to revolutionize the way the world combats biological threats.
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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 at high-value locations, as well as analyze samples in a medical environment. For more information on PositiveID, please visit http://www.PositiveIDCorp.com.
Statements about PositiveID’s future expectations made in its interview with SmallCapVoice.com, including, without limitation, statements made about the Company’s $4 million financing; statements made about the capabilities and expected development timeline of its Firefly Dx; 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; 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.