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The superbug that doctors have been dreading just reached the U.S.

The superbug that doctors have been dreading just reached the U.S. | Biodefense News | Scoop.it

For the first time, researchers have found a person in the United States carrying bacteria resistant to antibiotics of last resort, an alarming development that the top U.S. public health official says could mean "the end of the road" for antibiotics.

The antibiotic-resistant strain was found last month in the urine of a 49-year-old Pennsylvania woman. Defense Department researchers determined that she carried a strain of E. coli resistant to the antibiotic colistin, according to a study published Thursday in Antimicrobial Agents and Chemotherapy, a publication of the American Society for Microbiology. The authors wrote that the discovery "heralds the emergence of a truly pan-drug resistant bacteria."

[Superbug known as ‘phantom menace’ on the rise in U.S.

Colistin is the antibiotic of last resort for particularly dangerous types of superbugs, including a family of bacteria known as CRE, which health officials have dubbed "nightmare bacteria." In some instances, these superbugs kill up to 50 percent of patients who become infected. The Centers for Disease Control and Prevention has called CRE among the country's most urgent public health threats.

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Blue Ribbon Study Panel on Biodefense applauds legislation to establish national biodefense strategy - Homeland Preparedness News

The Blue Ribbon Study Panel on Biodefense on Wednesday applauded legislation advanced by the Senate Committee on Homeland Security to ensure that the U.S. is prepared for biological threats, including the Zika virus.

The National Biodefense Strategy Act of 2016, S. 2967, introduced by U.S. Sen. Ron Johnson (R-WI) would enact key recommendations from the bipartisan Blue Ribbon Study Panel on Biodefense, which provides recommendations to improve defense against bioterrorism, pandemics and accidental releases, to ensure that the U.S. is prepared for emerging biological threats.

The legislation would also amend the Homeland Security Act of 2002 to require the execution of a national biodefense strategy.

“HSGAC (Homeland Security and Governmental Affairs Committee) has taken a very important step in requiring the administration to harmonize a trove of directives and policies that direct a $6 billion biodefense system,” former U.S. Sen. Joe Lieberman (I-CT), the co-chair of the Blue Ribbon Panel, said. “The lack of a comprehensive, cohesive, and regularly updated strategy has undoubtedly resulted in pervasive stovepipes, duplicative spending and unmet needs. 

“I am especially concerned that we have separate presidential directives for human biodefense and for defense of agriculture. We cannot expect to handle diseases that spread easily between people and animals when our governance is not aligned optimally. Zika virus very likely has an animal reservoir, and we need all of our agencies on the same page to prevent its spread. This is just one area in which I think this bill will do an enormous amount of good.”

An October report by the Blue Ribbon Panel found that the lack of a comprehensive, cohesive and regularly updated strategy has caused disorganization and confusion, especially as administrations change, taking institutional knowledge with them. The report also identified capability gaps and recommended changes to U.S. policy and law to increase national biodefense capabilities while optimizing resource investments.

“The major presidential directives, public laws and international treaties and partnerships directing federal biodefense efforts number no less than 25, and that is an extremely conservative estimate,” former Pennsylvania Governor Tom Ridge, the Blue Ribbon Panel co-chair, said. “Like many aspects of homeland security, I believe this proliferation reflects a well-intentioned system that has become too fragmented to be enforced and implemented in a coherent, prioritized and unitary fashion. I strongly urge the full Senate to take up this bill, and believe the strategic approach it requires will save both lives and dollars.”

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Energy and Commerce subcommittee examines U.S. biological threat preparedness - Homeland Preparedness News

Energy and Commerce subcommittee examines U.S. biological threat preparedness - Homeland Preparedness News | Biodefense News | Scoop.it

The Energy and Commerce Committee Subcommittee on Health held a hearing entitled “Examining H.R. 3299, Strengthening Public Health Response Act” on Thursday to examine legislation meant to better prepare the U.S. to fight biological threats.

The Strengthening Public Health Emergency Response Act of 2015, H.R. 3299, introduced by U.S. Reps. Susan Brooks (R-IN) and Anna Eshoo (D-CA), was written in response to an October report by the Blue Ribbon Study on Biodefense that warned that the U.S. was not prepared for emerging biological threats.

“The nation has not come to fully appreciate the severity of the biological threat and our leaders have not demonstrated the political will to fully address it,” the Blue Ribbon Study report said. “We must address these shortcomings by prioritizing the following ares: 1) coordination and accountability among federal departments and agencies; 2) collaboration between federal and non-federal stakeholders; and 3) innovation that addresses both lingering and novel problems.”

H.R. 3299 legislation would streamline decision-making procedures while incentivizing investment in vaccines and treatments for dangerous and deadly diseases and pathogens.

“When biological threats are considered, the most important part of our preparedness is the successful development of vaccines and treatments before a biological threat or attack occurs,” Brooks said. “Having treatments and vaccines ready when a biological threat like Ebola strikes has immeasurable benefits, not the least of which is significantly limiting the scope of the outbreak. Given reports that ISIS is pursuing chemical and biological weapons, we must act now to prepare ourselves for the challenges that these kinds of weapons pose to our collective health and security.” 

Thirty-three recommendations to improve the U.S. response to biological threats were made by the Blue Ribbon Study on Biodefense, which was led by former U.S. Sen. Joe Lieberman (I-CT) and former Pennsylvania Gov. Tom Ridge, the first Secretary of Homeland Security. The panel’s report was based on meetings, interviews and research.

“Securing our nation against biological threats is a challenging endeavor,” Acting Biomedical Advanced Research and Development Authority (BARDA) Director Dr. Richard Hackett said. “The array of threats for which we must be prepared is vast. Such threats include bioterrorist agents such as anthrax, smallpox and botulism; evolving and emerging threats causing substantial regional disruption such as Ebola and Zika; and highly communicable diseases with pandemic potential such as influenza.”

One impediment to preparing for biological threats, according to U.S. Rep. Joe Pitts (R-PA), is the lack of demand in the private market for medical countermeasures to biological threats.

“The 2006 Pandemic and All Hazardous Preparedness Act was authorized through 2011,” Pitts testified. “It established research and development through BARDA at HHS to coordinate and accelerate the development of medical countermeasures. There is virtually no demand in the private market for these medical countermeasures, so BARDA bridges the funding gap between early-stage funding and the ultimate procurement of products for the national stockpile.

“By partnering with the private sector, BARDA can reduce the risk entailed in medical countermeasure research, thereby helping to mitigate the disincentives associated with countermeasure spending.”

Hackett pointed to the response to the Zika virus as an example of how production can be ramped up in the event of an emergency.

“When it is an emergency, like with Zika, we can act extremely quickly and responsively,” Hatchett said. “Operationally, the PHEMCE (Public Health Emergency Medical Countermeasures Enterprise) establishes product-specific requirements for CBRN medical countermeasures based on Material Threat Assessments developed by DHS. NIH and DoD support discovery and early-stage development of product candidates, often in collaboration with academic and industry partners, and prepare them for the transition to BARDA.

“In turn, BARDA supports and assists product candidates through advanced research and development, including preparation for FDA review, until they are ready for acquisition under Project BioShield. After procurement, medical countermeasures are maintained at CDC’s Strategic National Stockpile (SNS) location or within virtual stockpiles maintained by commercial vendors…If advanced development data lead to FDA approval of a marketing application, the financial responsibility for purchasing medical countermeasures for stockpile and delivery transfers from BARDA under Project BioShield to SNS. Items that have not yet received FDA licensure can also be procured for the stockpile if they are eligible for use during an emergency under an Emergency Use Authorization.”

H.R. 3299 would also expand the Priority Review Voucher program to allow for material threats identified by the Department of Homeland Security.

“Our national readiness and biodefense capabilities are underprepared,” Brooks said. “The threat to our national security posed by dangerous and deadly diseases and pathogens, like Ebola or anthrax, is constant and cannot be under estimated. The legislation we considered today is the result of more than a year of bipartisan work at this committee, and I look forward to further consideration of this proposal to better protect the health and safety of the American people.”

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The NIH Needs To Increase Efforts To Fight Drug Resistant Bacteria - Forbes

The NIH Needs To Increase Efforts To Fight Drug Resistant Bacteria - Forbes | Biodefense News | Scoop.it
While the emergence of bacteria that are resistant to current antibiotics has long been a topic of discussion, a new report from the UK has heightened concerns. The “Review on Antimicrobial Resistance” resulted from a project initiated by UK Prime Minister David Cameron and financed by the Welcome Trust. As summarized by Maryn McKenna in her “Germination” blog, the review provides pretty alarming statistics. The global toll due to resistance is roughly 700,000 deaths per year. Even worse, this is projected to grow to 10 MILLION deaths per year if nothing is done to reverse this trend.

The UK Review makes a number of suggestions on how to better cope with resistant bugs. These include better hygiene, more judicious use of existing drugs, greater use of vaccines, better diagnostic tools and better economic incentives to foster research into new drugs. The latter is a key issue. While some major companies like GSK and AstraZeneca remain committed, others like Pfizer have gotten out of antibiotic R&D because any new drug would be put on the shelf to be used only as a last resort should all other antibiotics fail. Such a strategy is necessary to minimize antibacterial resistance to the new drug. But the economic rewards that one might hope for with a new breakthrough are severely lessened in such a scenario.

Let’s envision, however, that a system can be worked out where appropriate incentives are put in place. There still remains the major issue in the search for new effective antibiotics – new targets against the emerging drug resistant bacteria. Biopharmaceutical industry R&D, for the most part, is applied research; that is, it studies the basic science that emerges from academic labs and research institutes and looks to find potential drugs that prove or disprove the medical hypotheses that are produced by these academic efforts. These basic research efforts are funded predominantly by the National Institutes of Health (NIH). In effect, the priorities set by the NIH dictate those therapeutic areas that scientists focus on. The NIH’s influence is substantial: in 2015, it allocated its $30.4 billion budget across 265 Research and Disease areas. 

The National Institute of Allergy and Infectious Diseases (NIAID) is that section of the NIH responsible for infectious diseases. In 2015, its budget was almost $4.4 billion, one of the biggest budgets of any of the Institutes that comprise the NIH. While this shows the importance that the NIH and the U.S. puts on this area of research, the remit of the NIAID is very broad and includes funding programs in: AIDS, TB, Ebola, Biodefense, MERS, etc. Amid all of these priorities, research into antimicrobial resistance seems to be getting squeezed out with only $310 million spent in 2015. It’s hard to argue against spending money on AIDS, Ebola and the newly emerging Zika virus. But given the looming crisis with drug resistant organisms, shouldn’t a greater emphasis be put on funding more work into understanding how bacteria are learning to evade current drugs?

The NIH sets the agenda for research priorities in the U.S. By increasing, perhaps even doubling, the funds it allots to antimicrobial resistance, it could provide a big stimulus to the fight against the “antibiotic apocalypse”. It is a step it needs to take.
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Haynes lab co-authors Synthetic Biology Text Book

Haynes lab co-authors Synthetic Biology Text Book | Biodefense News | Scoop.it
A new educational resource for the growing field of synthetic biology, the "Synthetic Biology Handbook," has just been released. The chapter on mammalian synthetic biology was co-authored by Dr.
Via Gerd Moe-Behrens
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Haynes lab co-authors Synthetic Biology Text Book

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PositiveID to Exhibit its Caregiver Non-Contact Thermometer at the American Association of Critical-Care Nurses Exposition May 16-19 - NASDAQ.com

Caregiver, FDA-cleared for clinical use, reduces the risk of cross-contamination and costs for healthcare facilities
DELRAY BEACH, Fla., May 10, 2016 (GLOBE NEWSWIRE) -- PositiveID Corporation ("PositiveID" or "Company") (OTCQB:PSID), a life sciences company focused on detection and diagnostics, announced today announced that its Thermomedics subsidiary will exhibit the FDA-cleared Caregiver® non-contact thermometer at the American Association of Critical-Care Nurses ("AACN") National Teaching Institute and Critical Care Exposition from May 16-19, at the New Orleans Ernest N. Morial Convention Center in New Orleans, LA.


Caregiver is a clinical grade, infrared thermometer for measurement of forehead temperature in adults, children, and infants, without contact. It delivers an oral-equivalent temperature directly from the forehead in one to two seconds. Since there is no skin contact and Caregiver does not require probe cover supplies, it reduces the risk of cross-contamination, which is an increasing concern, and saves healthcare facilities the cost of covers (as much as $0.05 to $0.10 per temperature), storage space, and waste disposal costs. It is estimated that Caregiver can offer savings of $250 or more per year per device in probe cover supplies alone.

PositiveID's Thermomedics team is featuring Caregiver at the AACN exposition to increase exposure and awareness for Caregiver and immediately generate qualified leads for dealer follow up.

The AACN National Teaching Institute and Critical Care Exposition is the largest and most comprehensive trade show for high acuity and critical care nurses. The turnout at last year's exposition was estimated at 7,000 attendees. AACN, a 501(c)(3) nonprofit association, is the largest specialty nursing organization in the world, representing the interests of more than 500,000 nurses who are charged with the responsibility of caring for acutely and critically ill patients.
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GOP Lawmakers Slam Obama Plan to 'Raid' Bioterror Fund for Zika

April 28 — The Obama administration's plan to “raid” medical countermeasures funding to combat the Zika virus may deplete the U.S.'s ability to respond to bioterror threats, Republican lawmakers said in an April 28 letter.

The administration's proposal “risks further damaging fragile public-private partnerships by eroding confidence in the federal government’s commitment to procure medical countermeasures,” the letter to Health and Human Services Secretary Sylvia M. Burwell said.

It asked that the legislative proposal to change the requirements for procuring money from the BioShield Special Reserve Fund (SRF) be removed from President Barack Obama's Zika emergency funding request. The letter was signed by House Energy and Commerce Committee Chairman Fred Upton (R-Mich.); Rep. Susan Brooks (R-Ind.); Senate Health, Education, Labor and Pensions Committee Chairman Lamar Alexander (R-Tenn.); and Senate Select Committee on Intelligence Chairman Richard Burr (R-N.C.).

An HHS spokesman didn't respond to Bloomberg BNA's e-mail request for comment.
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PositiveID’s E-N-G Mobile Systems Ships Mobile Lab in Excess of $700,000 to Customer - NASDAQ.com

E-N-G has delivered more than 400 mobile labs to domestic and international customers
DELRAY BEACH, Fla., April 25, 2016 (GLOBE NEWSWIRE) -- PositiveID Corporation ("PositiveID" or "Company") (OTCQB:PSID), a life sciences company focused on detection and diagnostics, announced today that its E-N-G Mobile Systems ("ENG") subsidiary has shipped a 40-foot BSL-3 compliant mobile laboratory valued in excess of $700,000. Due to the nature and location of the mobile lab, the customer is being kept confidential. Since its inception, ENG, a specialty vehicle manufacturer acquired by PositiveID in December 2015, has delivered more than 400 mobile labs to customers around the world.


The largest and fastest growing aspect of ENG's business over the last decade has been its mobile labs segment, which includes government and corporate laboratories for chemical, biological, nuclear, radiological and explosives testing in the field. ENG has delivered more than 100 mobile labs for the U.S. Army, plus numerous laboratories to other government agencies including U.S. Customs and Border Protection, U.S. Navy, U.S. Air Force, prominent national laboratories, and nine of the 10 regions of the Environmental Protection Agency.

"ENG is an industry leader in designing mobile labs for chemical and biological detection, monitoring, and analysis," stated William J. Caragol
, Chairman and Chief Executive Officer of PositiveID. "This mobile lab, developed under a large contract that will generate significant revenue for PositiveID during the second quarter and keep us on track to reach our revenue goals for 2016, is the latest example of our robust capabilities, expertise and best-in-class products."
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The Antibacterial Resistance Threat: Are We Heading Toward a Post-Antibiotic Era?

The Antibacterial Resistance Threat: Are We Heading Toward a Post-Antibiotic Era? | Biodefense News | Scoop.it

In the US alone, the daily consumption of antibiotics amounts to 51 tons, of which around 80% is used in livestock, a little under 20% is for human use, and the rest is split between crops, pets, and aquaculture [3]. A meta-analysis published last year in PNAS [6] found that between 2000 and 2010 the global use of antibiotic drugs increased by 36%, with 76% of the increase coming from developing countries. The researchers projected that worldwide antibiotic consumption would rise by 67% by 2030 due to population growth and the increase in consumer demand.

These frightening statistics prompted CDC director Tom Frieden to issue a warning: “If we are not careful, we will soon be in a post-antibiotic era.” An era when common infections are deadly again.

“We need to be very careful in using antimicrobial agents for everything from hand washing to toothpaste,” Harshini Mukundan, microbiologist at Los Alamos National Laboratory, explains. “Increased selection of drug resistant organisms means that future generations will be helpless in fighting even the most common bacterial infections.”

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GAO: US Biodefense Enterprise Needs Central Leadership, Oversight - Executive Gov

The Government Accountability Office has said in a new report to the Senate Homeland Security Committee that the U.S. biodefense enterprise needs an established leadership strategy.

GAO said in the report published Thursday it found that there is no unifying biodefense leadership and oversight structure to facilitate accountability and operational efficiency.

The agency said past reports from GAO and other review bodies called for the establishment of a focal point for government biodefense coordination and the formation of a national strategy that will work to identify and address risks systematically.

Biosurveillance efforts also need a national strategy as GAO previously recommended a central leadership and action to address various challenges, GAO noted.

GAO further said increased threats of disease outbreak and acts of bioterrorism, such as anthrax attacks, reflect a need for early detection and warning through biosurveillance systems.
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Zilinskas: U.S. biodefense needs improvement - Homeland Preparedness News

Zilinskas: U.S. biodefense needs improvement - Homeland Preparedness News | Biodefense News | Scoop.it
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

Senate Homeland Security Committee hears testimony on biodefense preparedness - Homeland Preparedness News | Biodefense News | Scoop.it
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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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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Can CRISPR make cheap, GM-based WMDs? | Genetic Literacy Project

Here’s a quiz. What do these items have in common:

  • Development of nuclear ballistic missiles in North Korea
  • Russia’s new ground-launched cruise missile, which might violate the 1987 INF treaty
  • Chemical weapons in Syria and Iraq
  • CRISPR-Cas9

Stumped? They were all cited as weapons of mass destruction and a “major threat to the security of the United States, its deployed troops, and allies,” according to the latest Worldwide Threat Assessment of the U.S. Intelligence Community. National Intelligence Director James Clapper presented the report to the U.S. Senate Armed Services Committee in February.

The report, while not naming CRISPR directly, clearly implicates the new gene editing technique for possible “dual use,” which means it could be used to advance science and medicine, but also could advance a terrorist’s more nefarious motives:

Research in genome editing conducted by countries with different regulatory or ethical standards than those of Western countries probably increases the risk of the creation of potentially harmful biological agents or products. Given the broad distribution, low cost, and accelerated pace of development of this dual-use technology, its deliberate or unintentional misuse might lead to far-reaching economic and national security implications. Advances in genome editing in 2015 have compelled groups of high-profile US and European biologists to question unregulated editing of the human germline (cells that are relevant for reproduction), which might create inheritable genetic changes. Nevertheless, researchers will probably continue to encounter challenges to achieve the desired outcome of their genome modifications, in part because of the technical limitations that are inherent in available genome editing systems.

Though Clapper and the latest Threat Assessment both state that genetic engineering has been a prime suspect for “dual use” by terrorists and scientists, this is the first time a GM technique has been targeted as a WMD.

CRISPR, short for clustered, regularly interspaced, short palindromic repeat, when combined with an nuclease enzyme like Cas9, is able to precisely cleave junctions in strips of nucleic acids, making it easier, faster and more efficient to make changes to genes. While the technique has not been perfected (Cas9 has made a few errors, which scientists are working on reducing), it has opened the door for a wider array of possible changes to genomes. And that’s scared some people: a meeting last summer concluded that the technique should not be applied to human germlines (at least not yet, anyway).

Now, the questions have become: Can CRISPR-Cas9 be harnessed by terrorists? Can it be used to make a cheap biological weapon?

The answer is; technically yes, but making such a weapon would be very, very difficult. CRISPR is simply another technique for working with genomes; in itself, it does not discover novel sequences like PCR or sequencing might. Even then, producing an enhanced pathogen would require a deep knowledge of that pathogen’s genetics. Most terrorist organizations would probably not have many scientists with that knowledge, but a sovereign government might.

Clapper’s Senate testimony took a number of scientists and even intelligence experts by surprise.

Piers Millet, an expert on bioweapons at the Woodrow Wilson Center in Washington, D.C., said that making a bioweapon—even with the cheaper, easier techniques offered by CRISPR—requires mastering a “wide raft of technologies.”

Any development of bioweapons—by any person, state or institution—is banned by the Biological and Toxin Weapons Convention, a treaty signed in 1972 by the U.S., China, Russia and 172 other countries. Meetings of intelligence experts have so far resulted in assessments that concluded that terrorist groups don’t have the capacity to develop a virulent form of anthrax, or an enhanced Ebola virus.

Other scientists, though, agree with Clapper’s warning. Robin Lovell-Badge, a scientist at Great Britain’s Francis Crick Institute who co-discovered the SRY gene on the human Y chromosome, recently shared his concerns that some rogue researchers might be doing gene editing work outside the bounds of treaties and the law. And Dalhousie University bioethicist Francoise Baylis warned that “I think bioterrorism is a reality, and a risk factor we need to take into consideration. It’s like any dual-use technology that can be used for good or evil.”

So, who would these rogue scientists be? Is there terrorism in the lab?

Some information identifying terrorists with CRISPR capabilities is no doubt classified, and so far, groups like ISIL or Al-Qaeda have not introduced any such bioweapon (that we know of). But, a number of “DIY” science groups have sprung up worldwide, for another dual use: to take advantage of cheaper, easier techniques like CRISPR-Cas9, and to introduce scientific experimentation to a larger group of people.

Also called “biohackers,” a number of these groups allow amateur scientists to attend lectures on biotechnology, discuss lab techniques and even perform some experiments using those techniques. All known “DIY” labs are at a biosafety level of 1 (meaning they can’t work with pathogens or even mammalian cells). In addition, some of these organizations have reported formal visits from the FBI and Department of Defense.

But biohacking and WMD-conspiracies aside, it’s important to remember that the last—and so far, only—act of bioterrorism that caught public attention was the development and mailing of anthrax spores to several destinations in the United States. The culprit? Prosecutors insist that it was Bruce Ivins, a scientist working at the high-security U.S. Army biodefense facility in Fort Detrick, Maryland (Ivins committed suicide before he could face trial).

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PositiveID Successfully Detects the Zika Virus on its Firefly Dx Prototype System

DELRAY BEACH, Fla., May 25, 2016 (GLOBE NEWSWIRE) -- PositiveID Corporation (“PositiveID” or “Company”) (PSID), a life sciences company focused on detection and diagnostics, announced today that it has successfully detected the Zika virus on its Firefly Dx polymerase chain reaction (“PCR”) breadboard prototype pathogen detection system (“prototype system”). Zika is a fever-causing virus transmitted by the Aedes Aegypti mosquito that can cause microcephaly, a serious congenital condition in which babies are born with head and brain abnormalities, and Guillain-Barre syndrome, a rare neurological disorder that can result in paralysis.

PositiveID used assay partner GenArraytion, Inc.’s Aedes Aegypti MultiFLEX™ Bioassay test, which targets four genetic regions of the Zika virus, on PositiveID’s Firefly Dx prototype system. The Zika virus test works with an existing GenArraytion MultiFLEX™ Bioassay panel that targets viruses that cause dengue fever, yellow fever and Chikungunya, which are also carried by the same mosquito and are known to cause febrile disease in humans.  This test both identifies and discriminates between the Zika African and Brazilian lineages.

PositiveID is developing the Firefly Dx prototype system to be a handheld, fully automated, lab quality, real-time device able to detect bio-threats at the point of need. Currently, PCR tests are run on large lab equipment and take a minimum of four hours to deliver results. A design advantage of Firefly Dx is that it does not require additional equipment or separate steps for sample preparation and purification, unlike current lab-based equipment, thus reducing time to results as well as cost per test. In addition, there is significantly less chance of sample contamination compared to existing testing methods.

“Rapid identification of Zika at the source could drastically help containment measures and therefore control transmission of the virus,” stated William J. Caragol, Chairman and CEO of PositiveID. “With grave concerns about the effects of Zika on pregnant women, having the ability to quickly and accurately identify Zika and other bio-threats at the point of need without having to take samples back to a lab, which is the fundamental value proposition of Firefly Dx, could help protect the lives of unborn children.”

The Firefly Dx prototype system has also successfully detected a number of other pathogenic organisms including E.coli, influenza, MRSA, MSSA, C. diff and others.
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When the drugs don’t work

When the drugs don’t work | Biodefense News | Scoop.it

SOME people describe Darwinian evolution as “only a theory”. Try explaining that to the friends and relatives of the 700,000 people killed each year by drug-resistant infections. Resistance to antimicrobial medicines, such as antibiotics and antimalarials, is caused by the survival of the fittest. Unfortunately, fit microbes mean unfit human beings. Drug-resistance is not only one of the clearest examples of evolution in action, it is also the one with the biggest immediate human cost. And it is getting worse. Stretching today’s trends out to 2050, the 700,000 deaths could reach 10m.

Cynics might be forgiven for thinking that they have heard this argument before. People have fretted about resistance since antibiotics began being used in large quantities during the late 1940s. Their conclusion that bacterial diseases might again become epidemic as a result has proved false and will remain so. That is because the decline of common 19th-century infections such as tuberculosis and cholera was thanks to better housing, drains and clean water, not penicillin.

The real danger is more subtle—but grave nonetheless. The fact that improvements in public health like those the Victorians pioneered should eventually drive down tuberculosis rates in India hardly makes up for the loss of 60,000 newborn children every year to drug-resistant infections. Wherever there is endemic infection, there is resistance to its treatment. This is true in the rich world, too. Drug-resistant versions of organisms such as Staphylococcus aureus are increasing the risk of post-operative infection. The day could come when elective surgery is unwise and organ transplants, which stop rejection with immunosuppression, are downright dangerous. Imagine that everyone in the tropics was vulnerable once again to malaria and that every pin prick could lead to a fatal infection. It is old diseases, not new ones, that need to be feared.

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Metabiota Focuses on Global Expansion with Addition of Three Hires to Executive Team

Today Metabiota, the pioneer in comprehensive risk analytics that improve the world's resilience to epidemics, announced it has hired three global business leaders to further the company's strategic presence worldwide. The appointments include former Deputy Coordinator for Ebola Response at the U.S. Department of State, the Honorable Andrew Weber as Head of Global Partnerships, along with Michael Bell as Chief Financial Officer; and Aon Benfield's Keith Moore as Global Head of Business Development.

"From the beginning, we've been focused on bringing the best and brightest minds to Metabiota, and the addition of Andy, Michael and Keith to our team of industry visionaries further solidifies our unwavering commitment to this focus as we grow," said Robert Mann, president of Metabiota. "With these hires, we are building our network of international partners to strengthen our position worldwide, while we continue to innovate the way epidemic risk is managed and mitigated."

Metabiota's unique understanding of infectious diseases helps organizations and countries respond to emerging threats efficiently by managing financial risk. Combining an extensive network of in-country partners and experts in infectious disease with real-time bio-surveillance and data analysis, Metabiota delivers insights aimed at helping manage and mitigate economic risk before outbreaks occur.

"Metabiota's approach is truly game changing and it's an exciting time to be part of this company," said Weber. "The world needs a better way to identify and manage epidemics and there is demand for a new approach that will stray from the norm. I've seen first-hand what's needed and truly believe Metabiota is the company to bring it to fruition."

Weber served thirty years in the US Government, most recently as the Deputy Coordinator for Ebola Response at the U.S. Department of State. Previously, he was the Assistant Secretary of Defense for Nuclear, Chemical & Biological Defense Programs appointed by President Obama in 2009. At Metabiota, he will focus on establishing new strategic global relationships with public and private partners including foreign governments, the philanthropic sector, and international organizations.

Keith Moore joins Metabiota as Global Head of Business Development, focusing on developing strategic relationships worldwide. Previously, Moore spent over 20 years at the global reinsurance intermediary, Aon Benfield, where he deepened the company's relationship with strategic partners and served as an Executive Managing Director, and U.S. Chief Business Development Officer as part of the leadership team.

CFO Michael Bell brings over 20 years of international finance and accounting experience and is the former CFO of Singulex, a clinical diagnostics company, where he led the business through a period of significant growth and strategic transformation. He also served as CFO of Novartis Diagnostics, a global provider of blood screening solutions. He will ensure Metabiota continues its high-growth trajectory, while optimizing its opportunities in the market.

Metabiota has raised over $33 million in funding from top investors including RSTP, Google Ventures, VCDC, Capricorn Health & Special Opportunities, Industry Ventures, and WP Global Partners.
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CDC labs repeatedly faced secret sanctions for mishandling bioterror germs

By Alison Young, USA TODAY

A laboratory operated by the Centers for Disease Control and Prevention is among the handful of facilities that have secretly had their permits suspended in recent years for serious safety violations while working with bioterror pathogens, according to documents obtained by USA TODAY after winning a Freedom of Information Act appeal.

The CDC's own labs also have been referred for additional secret federal enforcement actions six times because of serious or repeated violations in how they've handled certain viruses, bacteria and toxins that are heavily regulated because of their potential use as bioweapons, the CDC admitted for the first time on Tuesday. Before USA TODAY won access to records of the lab suspension, the CDC had repeatedly refused to answer questions about its own labs' enforcement histories.

The revelations show the CDC's facilities are among a small group of biolab operators that have the worst regulatory histories in the country, receiving repeated sanctions under federal regulations.

Citing security reasons and a federal bioterrorism law, the names of labs that have been suspended or faced other enforcement actions have been a closely guarded secret by the CDC and the U.S. Department of Agriculture. The two agencies not only operate high-security biolabs, but they also co-run the Federal Select Agent Program that regulates government, university, military and private labs that work with bioterror pathogens such as anthrax, plague and Ebola. The government calls these kinds of pathogens "select agents."

Only five labs have been suspended from the Federal Select Agent Program since 2003 and another five labs have faced repeated referrals for enforcement actions, according to information the CDC provided last year to USA TODAY and later to congressional investigators. The revelation that CDC's own labs are among these small groups that have faced serious and repeated sanctions raised questions among some lab safety watchdogs about the agency’s secrecy motives.

“There is no security rationale for withholding the identities of the suspended labs,” Richard Ebright, a biosafety expert at Rutgers University in New Jersey who has testified before Congress. “The sole rationale is a CYA rationale, in which the CDC seeks to cover its derriere by covering up violations and shielding staff and management responsible from accountability for violations.”

A heavily redacted USDA letter obtained by USA TODAY shows a CDC-operated lab was suspended from doing select agent research around 2007 and reinstated in 2010 because of federal violations in the handling and transfer of a virus. The USDA blacked out the name of the virus.

The CDC said Tuesday the suspension involved an individual lead scientist and the labs associated with that scientist's research, which was located at the agency's lab complex in Fort Collins, Colo. The violations involved research with Japanese encephalitis virus, which can cause a deadly inflammation of the brain and is often transmitted by mosquitos. As a result of the USDA inspection and findings that the research was not in compliance, the remaining samples of the virus were destroyed or transferred to another facility that was registered to possess them. The CDC noted in its statement that as of 2012, Japanese encephalitis virus was no longer considered by the federal government to be a select agent.

In response to USA TODAY's questions about how many CDC labs have faced select agent sanctions, the CDC said its own labs have been referred six times since 2003 to the Office of Inspector General at the U.S. Department of Health and Human Services, which handles enforcement actions for select agent violations.
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The Impact of Microfluidics/Lab-on-a-Chip Technologies on the Development of the POC Dx Markets | Insight & Intelligence™ | GEN

The Impact of Microfluidics/Lab-on-a-Chip Technologies on the Development of the POC Dx Markets | Insight & Intelligence™ | GEN | Biodefense News | Scoop.it
Over the past decade we have been observing a steady increase in interest in microfluidics and lab-on-a-chip technologies.  This increase has been driven in large part by the plethora of applications that are being developed utilizing microfluidics-based approaches. We sought to understand and quantify expanding interest in the microfluidics and lab-on-a-chip space by examining the entire publications landscape of this field and seeking to understand the utilization of microfluidics and lab-on-a-chip technologies in the development of point-of-care (POC) diagnostics and global health.
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How genetic editing became a national security threat

Director of National Intelligence James R. Clapper sent shock waves through the national security and biotechnology communities with his assertion, in his Worldwide Threat Assessment testimony to the Senate Armed Services Committee in February, that genome editing had become a global danger. He went so far as to include it in the report’s weapons of mass destruction section, alongside threats from North Korea, China’s nuclear modernization, and chemical weapons in Syria and Iraq. The new technology, he said, could open the door to “potentially harmful biological agents or products,” with “far-reaching economic and national security implications.”

So what has warranted this warning, and what can be done to mitigate the threat?

Since the discovery of the double helix in 1953, biotechnology has made progress exceeding that of arguably any other technology in human history. Genome editing is not a new process; it was the subject of the 1975 Asilomar Conference, convened to establish standards that would allow geneticists to conduct cutting-edge research without endangering public health. Since then, advances like the polymerase chain reaction process, the human genome project, and the Encyclopedia of DNA Elements project have fueled our understanding of the human genome, accelerated through advances in computing power, data storage, and big data algorithm development. Landmark results include the first synthesis of a virus in 2002 and the first synthetic cell in 2010. Now along comes clustered regularly-interspaced short palindromic repeats—Crispr for short—which is changing everything.

Other editing techniques have been around for more than a decade but they are laborious, less accurate, and quite expensive. Before that, previous traditional methods required generations to see results. While some techniques can recognize longer DNA sequences and have better specificity than Crispr, they are costly ($5,000 for each order versus $30 for Crispr) and difficult to engineer, sometimes requiring several tries to identify a sequence that works. Hence the rise of Crispr, which, along with Crispr associated proteins (Cas), provides a precise way to target, snip, and insert exact pieces of a genome. (The Crispr-Cas9 protein has received the most attention in this recent discussion, yet other enzymatic proteins such as the Crispr-Cpf1 use a different type of “scissors” and might be just as effective.)
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The world isn’t ready to face the consequences of technology’s new biological breakthroughs

The world isn’t ready to face the consequences of technology’s new biological breakthroughs | Biodefense News | Scoop.it
With the advent of synthetic biology and gene editing tools, there are amazing breakthroughs being made in medicine, energy and food. Within a few years, we will see cures for debilitating diseases, new biofuels and grains that can be grown in extreme climates.

We will also have many new nightmares: bioterrorism and well-meaning experiments that get out of hand. Imagine a superbug that can cure — or kill — millions of people or a virus that targets one person, say, a U.S. president. This is not science fiction; it is happening.
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PositiveID 2015 Revenues Balloon on License Fee, Recent Acquisitions

NEW YORK (GenomeWeb) – Biological detection systems firm PositiveID today reported a greater than 200 percent jump in revenues for 2015, primarily due to the receipt of a previously deferred licensee fee. However, the company still fell short of its own guidance.

For the 12-month period ended Dec. 31, PositiveID's revenues ballooned to $2.9 million from $945,000 in 2014.

Approximately 90 percent of revenues for the year came from the license fee paid by Boeing, which agreed in late 2012 to pay $2.5 million for the exclusive rights to PositiveID's M-BAND airborne bio-threat detector in North America. The remainder of the company's revenues for 2015 were derived from the operations of laboratory and communication vehicle maker ENG Mobile Systems and non-contact thermometer developer Thermomedics, both of which PositiveID acquired in 2015.

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SAS: Understanding Zika with Zetabytes

SAS: Understanding Zika with Zetabytes | Biodefense News | Scoop.it
SAS product marketing consultant Steve Bennett will discuss biosurveillance, big data, old fashioned analytics, predictive analytics and advanced analytics.
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Brooks leads biodefense exercise to gauge response capabilities - Ripon Advance

Brooks leads biodefense exercise to gauge response capabilities - Ripon Advance | Biodefense News | Scoop.it
U.S. Rep. Susan Brooks (R-IN) hosted a biodefense exercise on Monday in Fishers, Indiana, that simulated a smallpox outbreak to gauge response capabilities in the Hoosier State. During the tabletop exercise, 35 local and state officials made a series of Rea
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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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