Zilinskas: U.S. biodefense needs improvement – Homeland Preparedness News

The United States is increasingly turning to biodefense as threats against the homeland continue to grow, but the Middlebury Institute of International Studies at Monterey’s Dr. Raymond Zilinskas recently warned that the larger problem remains that no one knows the … Read More »

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Senate Homeland Security Committee hears testimony on biodefense preparedness – Homeland Preparedness News

U.S. Sen. Ron Johnson (R-WI) chaired a Senate Homeland Security and Governmental Affairs Committee hearing on Thursday to address the federal perspective on the state of U.S. biodefense preparedness. “Today, we look forward to learning the perspective of federal agencies … Read More »

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PositiveID Reports 2015 Revenue of $2.9 Million, Up 211% Year over Year – NASDAQ.com

DELRAY BEACH, Fla., April 12, 2016 (GLOBE NEWSWIRE) — PositiveID Corporation (“PositiveID” or “Company”) (OTCQB:PSID), a life sciences company focused on detection and diagnostics, announced its financial results for the year ended December 31, 2015.

Revenue and total assets increased significantly in 2015, while the Company continued to invest in research and development as it works to complete the build and testing of its Firefly Dx handheld, real-time polymerase chain reaction (“PCR”) pathogen detection system.

“Following our acquisitions of E-N-G Mobile Systems (“ENG”) and Thermomedics in late 2015, our business is stronger and better positioned than ever to compete in the detection and diagnostics industry due to the addition of complementary revenue streams and synergistic distribution networks and customers,” stated William J. Caragol
, Chairman and CEO of PositiveID. “With our continued growth and horizontal integration of our business, we are reaffirming our 2016 revenue guidance of $5-6 million.”

For the year ended December 31, 2015, revenues were $2.9 million, compared to $0.9 million for year ended December 31, 2014, an increase of 211%. Total assets for the year ended December 31, 2015 were $4.7 million, compared to $1.0 million for the year ended December 31, 2014, an increase of 360%. Revenues for 2015 included $2.5 million from a license fee paid by a large commercial partner, which had been previously deferred, and the revenue from a partial month of operations of ENG and Thermomedics. Revenue for 2014 included the proceeds from two U.S. government contracts. 

The Company recorded an operating loss of $4.4 million for the year ended December 31, 2015, compared to an operating loss of $4.3 million for the year ended December 31, 2014, primarily as a result of Firefly Dx research and development expenditures, and increased selling, general and administrative expenses. The Company’s Form 10-K can be found in the Investor Relations section of its website at www.psidcorp.com

In 2015, the Company completed the Firefly Dx breadboard prototype and proved the Firefly Dx prototype design functions as intended through the complete sample purification and PCR detection process. The Firefly Dx prototype system successfully detected multiple pathogens, including influenza, MRSA, MSSA, E.coli, C. diff and others, in less than 30 minutes on the Firefly Dx prototype system, which is targeting the real-time PCR industry, estimated to be a $5.6 billion market by 2020. The Company is currently seeking a government or commercial partner to help fund the remaining development and build of the smaller, field-able prototype for testing by third parties in preparation for commercialization.

On December 24, 2015, PositiveID acquired ENG, a leader in mobile labs, homeland security and communications vehicles with a 25-year operating history. The acquisition of ENG will bring additional revenue and cash flow to PositiveID as well as a highly synergistic technology platform and customer base. The largest and fastest growing aspect of ENG’s business over the last decade has been its mobile labs segment, which includes chemical, biological, nuclear, radiological and explosives testing in the field. In addition to the other lines of ENG’s business, PositiveID believes it will be able to continue to grow the mobile labs segment with the addition of its leading molecular diagnostics capabilities for testing samples in the field.

In early December, PositiveID assumed control of Thermomedics, Inc., which markets the Caregiver® non-contact thermometer, a clinical grade, FDA-cleared, infrared thermometer. Infrared thermometry is experiencing the fastest growth in the global market for temperature monitoring devices, which is forecast to reach $1 billion by 2020, driven in part by concerns over the spread of highly infectious diseases like Ebola, according to Global Industry Analysts, Inc. Caregiver’s established distribution and customer channels, including the federal government, combined with the additional qualitative synergies of an experienced management team with proven regulatory, sales, distribution and manufacturing expertise, is expected to be of great value when PositiveID reaches commercialization of Firefly Dx.

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Bio-threat protections inadequate

Despite the Obama administration’s repeated warnings about the menace of a widespread contagion within the United States, both lawmakers and independent experts are continuing to give low marks to government initiatives designed to detect, track, and protect against those threats.

In recent years, both the Ebola outbreak in West Africa and the spread of the Zika virus in Latin America have brought the nature of threat into sharp relief.

In the 2015 Worldwide Threat Assessment, Director of National Intelligence James Clapper admitted that the world’s response to Ebola was too slow.

“Gaps in disease surveillance and reporting, limited health care resources, and other factors contributed to the outpacing of the international community’s response in West Africa,” Clapper wrote.

In the most recent Worldwide Threat Assessment, released in February,  Clapper issued an ominous warning in regard to the Zika virus, which he said “is projected to cause up to 4 million cases in 2016; it will probably spread to virtually every country in the hemisphere.”

Earlier this month, that assessment was amplified by researchers from the National Center for Atmospheric Research and the University Corporation for Atmospheric Research.  In a study published in the Public Library of Science’s journal PLOS Currents: Outbreaks, they warned that at least 50 U.S. cities are at risk for a Zika Virus outbreak this summer.

 As the effects of climate change spread worldwide, experts warn more that contagions are on their way. And yet, the two Department of Homeland Security (DHS) programs meant to protect Americans against these biological threats aren’t up to the task, according to the Government Accountability Office (GAO).

One of these programs, the National Biosurveillance Integration Center, or NBIC, was created in 2007 to be a hub of information and coordination for federal agencies tracking diseases and biological threats. But the mission is suffering, a September 2015 GAO report said, because many federal agencies, such as the Centers for Disease Control and Prevention (CDC), are not sharing   information with NBIC.  Among the reasons, CDC officials said: legal restrictions that compel them to redact data from reports, a labor-intensive process.  The report said other federal agencies’ officials did not understand the purpose or value of giving resources to NBIC.

“[NBIC doesn’t] have the access to information and data, they don’t have the trust of partners,” said Chris Currie, director of the GAO’s Emergency Management and National Preparedness Team, in an interview.  “What they do provide is good but it isn’t really that useful for the partners.”


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Jay Ambrose: Brussels and the threat of bio-terrorism

The government needs to get going, especially noting the words of Ridge, the co-chairman of this report, as quoted in a discussion of its content:

“Our world is threatened more so than ever today by terrorist groups like ISIS, who can create undetectable immediate threats. Our government is delusional to think we can get by without a strong biodefense policy.”

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NHRC Partners with DTRA to Protect Warfighters from Emerging Infectious Diseases

SAN DIEGO (NNS) – Scientists from the Naval Health Research Center (NHRC) and the Defense Threat Reduction Agency (DTRA) held a two-day meeting to discuss progress and goals for a joint biosurveillance project, March 7-8.

NHRC has collaborated with DTRA and the Joint Science and Technology Office on the Field Forward Diagnostics program since 2013 to develop novel point of need (PON) diagnostics to identify pathogens that cause acute febrile illnesses and threaten global and public health. 

“The goal of the program is to enhance readiness by enabling our warfighters to use handheld diagnostic devices in the field to detect pathogens that can cause incapacitating or deadly diseases,” said Capt. Rita Simmons, NHRC commanding officer. “Once a pathogen has been identified, immediate guidance could be provided to troops and their leaders to help them deal appropriately with the health threat. This project has the potential to significantly impact medical and mission readiness.”

The joint NHRC and DTRA team will evaluate the handheld devices for ease of use and test a system for broadcasting data from the devices to remotely located subject-matter experts for real-time decision making on events occurring in far-forward areas. The project would bring the expertise of medical and public health professionals to troops in the field.

According to Dr. Christopher Myers, department head for biosurveillance at NHRC, emerging infectious diseases that our military could encounter around the globe, particularly those found in tropical settings such as dengue, Burkholderia melioidosis, and malaria, are often difficult to distinguish by their clinical characteristics alone.

“Confirmation from a laboratory is needed for a definitive diagnosis, but if you’re in the field, forward deployed, a lab can be hard to come by,” said Myers. 

As part of the collaborative effort, NHRC will monitor all sites involved in the study to ensure that protocols are being followed and data properly collected. NHRC will also provide logistical support by shipping supplies and instruments, and coordinating maintenance and repairs as needed, to the different study sites around the globe.

As the DoD’s premier deployment health research center, NHRC’s cutting-edge research and development is used to optimize the operational health and readiness of the nation’s armed forces. In proximity to more than 95,000 active duty service members, world-class universities, and industry partners, NHRC sets the standard in joint ventures, innovation, and translational research.

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Q&A with co-director of the Blue Ribbon Study Panel on Biodefense – Homeland Preparedness News

Homeland Preparedness News recently interviewed Dr. Asha George, co-director of the Blue Ribbon Study Panel on Biodefense, a bipartisan organization recommending changes to U.S. policy and law to strengthen national biodefense. HPN: The Blue Ribbon Study Panel on Biodefense is … Read More »

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PositiveID Achieves Major Firefly Dx Development Milestone – NASDAQ.com

Newest milestone and lab results demonstrate Firefly Dx design is capable of full biological testing process, from sample preparation to PCR and detection
DELRAY BEACH, Fla., March 15, 2016 (GLOBE NEWSWIRE) — PositiveID Corporation (“PositiveID” or “Company”) (OTCQB:PSID), a life sciences company focused on detection and diagnostics, announced today that it has achieved another development milestone for its Firefly Dx breadboard prototype pathogen detection system (“prototype system”). The Company has now demonstrated that the entire Firefly Dx prototype design functions as intended through the complete sample purification and detection process without the use of any third-party hardware, which is a critical component for future development and commercialization activities.

The Company successfully processed multiple samples on the Firefly Dx sample preparation breadboard and the purified sample DNA was put through the polymerase chain reaction (“PCR”) process and real-time detection on the Firefly Dx PCR breadboard. The testing was completed without the use of any commercial instruments. The next step in the development of Firefly Dx is to combine these processes and breadboards into single units and demonstrate the capability to run a test from putting the raw sample in the cartridge through sample preparation, PCR and real-time detection as a single system. 

“This latest development milestone further demonstrates the full capabilities of our patented Firefly Dx technology and our cartridges,” stated William J. Caragol, Chairman and CEO of PositiveID. “We are now running on all of our own equipment, which gives us additional confidence that we will be able to successfully finalize the development of Firefly Dx. We are currently seeking a government contract or other partner to help us fund the remaining development and the build of the smaller, field-able prototype for testing by third parties to prepare for commercialization.”

The Firefly Dx prototype system incorporates sample preparation on disposable, injection molded cartridges that remove contaminants and purify samples for processing and detection with real-time PCR. The inclusion of real-time optics on the Firefly Dx prototype system enables the measurement of fluorescence with every cycle of the PCR process, which is used to understand the amount of pathogen present.

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