The US may have inadvertently increased the risk of a biological attack

The United States is far more vulnerable to bioterrorism attacks than it should be, according to a major report released October 28. Worse still, some of our own research into bioweapons — along with some serious biosecurity failures — could make us even more vulnerable to an attack using viruses and bacteria to infect large numbers of people.

As former senator Joseph Lieberman and former Secretary of Homeland Security Tom Ridge, the two co-chairs of the committee behind the report, point out in an editorial in The Philadelphia Inquirer, “safety and security lapses in our nation’s laboratories involving agents like anthrax” have led to threats and problems in the US.

They’re mostly referring to incidents where government labs accidentally exposed employees to anthrax and potentially deadly pathogens were uncovered in improperly secured locations. But these aren’t the only internal risks.

Improperly secured biological agents and the growing number of people able to work with them could pose another deadly threat.

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Panel report recommends blueprint for fixing biodefense gaps

Biological threats lack the same attention as other security concerns and need the political muscle of the vice president’s office to form a national policy and streamline funding, according to a high-level panel that aired its findings in a Senate hearing yesterday.

The Blue Ribbon Study Panel on Biodefense—headed by seasoned politicians Joseph Lieberman and Tom Ridge—published its complete findings in an 82-page report that contains 33 urgent recommendations and 100 action items.

Lieberman represented Connecticut in the Senate for 24 years, which included 6 years as chair of the Senate Homeland Security Committee. Ridge is a former Secretary of Homeland Security, who also served in the US House of Representatives and as governor of Pennsylvania.

During opening statements in the hearing before the Senate Homeland Security and Governmental Affairs Committee, Congress members discussed bioterrorism concerns, along with natural disease threats, such as Ebola in West Africa and H5N2 avian influenza, and problems at federal laboratories.

Sen. Thomas Carper, D-Del., said biological threats have the potential not only to impact human health but also to adversely affect the economy. “I urge us to give the recommendations the attention they deserve and take action.”

Leadership void needs executive-level fix
Lieberman said the bipartisan panel’s main conclusion is that the country is better defended against biological threats since the 2001 anthrax attacks, but the state of biodefense is inadequate. Experts who assisted with the panel’s work found that the country spends about $6 billion a year on biodefense, but funds aren’t unified and the country isn’t getting its money’s worth.

He reminded the committee that Islamic State of Iraq and Syria (ISIS) has endorsed bioweapons as a threat to the American homeland and that even naturally occurring outbreaks, such as the H5N2 outbreak in US poultry, can have severe economic impacts.

“No one is driving this bus,” he said of the lapse in biodefense leadership that the panel identified. “We don’t know how much is being spent and who should do it.”

The panel suggests that the office of the vice president is the only office with the political authority and influence to create its suggested biodefense council, national policy, and unified biodefense budget. Lieberman said, “We fear that if someone’s not driving the bus, implementation will be haphazard.”

Ridge told the committee that four different commissions have tackled biodefense issues since 2001, but not much has changed. “We’re looking for bipartisan champions. This is a national problem.”

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PositiveID Enters Into Agreement to Acquire Thermomedics Inc. and the Caregiver(R) Non-Contact Thermometer

DELRAY BEACH, Fla., Oct. 21, 2015 (GLOBE NEWSWIRE) — PositiveID Corporation (“PositiveID”) (OTCQB:PSID), a developer of biological detection and diagnostics solutions, announced today that it has entered into an agreement to acquire the capital stock of Thermomedics, Inc. (“Thermomedics”), which manufactures and markets the FDA-cleared Caregiver® non-contact clinical-grade thermometer. This acquisition is a part of PositiveID’s overall growth strategy to add revenue-generating, complementary products with significant market penetration potential to its portfolio. PositiveID will continue to look at other opportunities to execute this growth strategy.
The Caregiver thermometer was developed by the inventors of tympanic thermometry and is the world’s first non-contact device with TouchFree™ technology. Caregiver is a clinical-grade, infrared thermometer for measurement of forehead temperature in adults, children, and infants, without contact. Since there is no skin contact and Caregiver does not require probe cover supplies, it reduces the risk of cross-contamination and saves the healthcare facility the cost of covers (as much as $0.05 to $0.15 per temperature), storage space, as well as waste disposal costs.
Due to its ability to provide TouchFree temperatures thereby helping to improve infection control efforts, Caregiver has been utilized recently by both government and commercial customers in the fight against the spread of Ebola.
The established distribution and customer channels for Caregiver are expected to provide synergies to PositiveID as it continues the development and testing of its Firefly Dx real-time pathogen detection system and prepares for commercialization. Thermomedics currently has agreements with the world’s leading healthcare product distributors.
“We believe that once completed, the acquisition of Thermomedics will bring an exciting product and management team to our portfolio as we continue toward commercialization of Firefly Dx,” stated William J. Caragol, Chairman and CEO of PositiveID. “Not only will Caregiver provide additional revenue for PositiveID, we believe it will also provide opportunities to fight against the spread of disease, while providing a pathway to customers and delivering proven manufacturing and FDA expertise.”

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PositiveID Corporation Meets Major Development Milestone: New Firefly Dx Prototype With Real-Time Optics for Pathogen Detection

DELRAY BEACH, Fla., Oct. 12, 2015 (GLOBE NEWSWIRE) — PositiveID Corporation (“PositiveID” or “Company”) (OTCQB:PSID), a developer of biological detection and diagnostics solutions, announced today that it has produced a new and upgraded version of the Firefly Dx polymerase chain reaction (“PCR”) breadboard prototype pathogen detection system (“prototype system”), which now incorporates real-time optics for pathogen detection in less than 20 minutes.

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, and produces an “S-shaped” curve that can be identified. The S-shaped curve helps first responders and healthcare professionals understand the quality of the test being performed and to quantify the amount of pathogen present in the sample, both of which are important in determining next steps (such as quarantine measures) following a positive result.

This latest development advancement also enables the Company to run its own and third-party assays directly on the Firefly Dx prototype system, without the need to use a commercial instrument for confirmation of results.

“This new prototype system is a big step forward in the development of a commercially available Firefly Dx unit as we move to capture a portion of the multi-billion dollar real-time PCR market,” said William J. Caragol, Chairman and CEO of PositiveID. “By incorporating real-time optics into our system, we can begin to measure the presence of a pathogen in real-time, which is an integral component of the Firefly Dx value proposition.”

PositiveID’s Firefly Dx is designed to provide real-time, accurate diagnostic results in less than 20 minutes from a handheld device, thereby leading to treatment scenarios at the point of need that are not possible with existing systems, which require lab-based equipment, highly trained personnel, and can take hours or even days to provide results. Firefly’s applications include point-of-need, lab-quality, detection of pathogenic organisms; agricultural and food screening in both domestic sectors and developing countries; and detection of biological agents associated with weapons of mass destruction.

The Company previously announced production of the Company’s first article, molded PCR chips for the Firefly Dx cartridge, which enables it to produce large quantities of PCR chips at a lower cost, thereby enabling higher throughput of testing data and cost-effective field applications. PositiveID is now able to incorporate and optimize additional assays on its Firefly Dx cartridge with a disposable PCR chip.

Firefly Dx is targeting the global PCR market, which is projected to reach approximately $27.4 billion this year, according to a Research and Markets’ report Polymerase Chain Reaction (PCR) – Products/Tools – A Global Market Watch, 2009-2015.

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