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Report details chronic problems at Army anthrax facility - KTAR.com

Pentagon officials released a report Thursday detailing recurring problems at an Army bioterror facility that accidentally sent live anthrax to other labs for more than a decade.
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Relax about the Anthrax

Relax about the Anthrax | Biodefense News | Scoop.it
Deputy Secretary of Defense Bob Work held a late press brief on Thursday to announce the findings of a Department of Defense-sponsored investigative committee. Its job was to review the department’s laboratory processes that resulted in the inadvertent shipment of live Bacillus anthracis spores to 86 laboratories in eight nations, including the United States. Bacillus anthracis spores can cause the disease anthrax, which has a high mortality rate in exposed, untreated people. The highlights of the report focus on a review of laboratory processes within the four U.S. military labs that produced anthrax spores. As it turns out, half of the tested batches from Dugway Proving Ground had live spores in them, and investigators do not yet fully understand how the process failed.

The report did note that the gamma irradiation process — meant to kill live spores before they are shipped — was not at fault. The real problem was the post-irradiation viability testing, which was supposed to provide final verification that the spores were dead before they were shipped. The testing failed for some, but not all shipments. The report also notes that researchers do not fully understand how Bacillus anthracis can recover from radiation damage and continue to develop live cells. While the source of all of the live spores was from the Dugway lab, its procedures were not significantly different than the other three military laboratories. While the protocols did work at three of the four military labs, more quality assurance and quality control processes clearly should have been in place at Dugway.
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Congress skeptical of Homeland Security developing unified plan on WMD defense

Congress skeptical of Homeland Security developing unified plan on WMD defense | Biodefense News | Scoop.it
The Department of Homeland Security is planning on creating a “one-stop shop” that would centralize weapons of mass destruction defense, a restricting the long delay of which, lawmakers say, has left the U.S. vulnerable to an attack.

The new chemical, biological, radiological, and nuclear office would create “departmental unity” between the Office of Health Affairs, the Domestic Nuclear Detection Office and elements of the Science and Technology Directorate, said Reginald Brothers, DHS undersecretary for science and technology.
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Did North Korea Really Publish Pictures of a Biological Weapons Facility? | VICE News

North Korea might have just revealed that it has the capability to produce massive quantities of biological weapons.

On June 6, a North Korean scientist defected to Finland with 15 gigabytes of electronic evidence that he claims documents how the country is testing chemical and biological agents on its own citizens.

That same day, North Korea's state media released photos of Kim Jong-un touring what it described as a pesticide factory called the Pyongyang Bio-technical Institute — but experts tell VICE News that this same facility is likely meant to produce massive quantities of weaponized anthrax.
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PositiveID Successfully Tests 12 Different Assays on Its Firefly Dx Prototype System - NASDAQ.com

DELRAY BEACH, Fla., June 22, 2015 (GLOBE NEWSWIRE) -- PositiveID Corporation ("PositiveID" or "Company") (OTCQB:PSID), a developer of biological detection and diagnostics solutions, announced today that it has now successfully tested 12 different assays on its Firefly Dx breadboard prototype PCR (polymerase chain reaction) pathogen detection system. Using both its own as well as third-party assays, Firefly Dx successfully detected all the pathogens it tested for in less than 20 minutes.


All tests were performed on the Firefly Dx breadboard, which is significantly faster than standard laboratory equipment and protocols. 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.

PositiveID's Firefly Dx is designed to provide real-time, accurate diagnostic results in 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 screening in both domestic sectors and developing countries; and detection of biological agents associated with weapons of mass destruction. 

"We are very pleased with our progress with the testing and optimization of Firefly Dx, and are confident that with continued development success, we will be able to deliver a real-time PCR system that can revolutionize point-of-need biological detection from an ease of use, time and cost perspective," stated William J. Caragol, Chairman and CEO of PositiveID.
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Military Swore Its Anthrax Was Dead

Military Swore Its Anthrax Was Dead | Biodefense News | Scoop.it
The Defense Department revealed that it shipped live anthrax around the world for more than a decade. And somehow, the worst may be yet to come.
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Anthrax inquiry widens to 24 labs in 11 states, two foreign countries

Anthrax inquiry widens to 24 labs in 11 states, two foreign countries | Biodefense News | Scoop.it
A widening Pentagon investigation found late Friday that an Army biodefense facility in Utah has been mistakenly sending out live deadly anthrax samples to at least two dozen private and military laboratories around the world for the last seven years.
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Army chemical-biological center in Edgewood, private lab in Maryland received live anthrax samples

Army chemical-biological center in Edgewood, private lab in Maryland received live anthrax samples | Biodefense News | Scoop.it
— The Edgewood Area of Aberdeen Proving Ground was one of several facilities to which an Army bio-defense organization mistakenly sent samples of live anthrax, officials said Thursday, and a private commercial laboratory in Maryland was the first to report the problem to authorities.
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Homeland Security Today: Biological Terrorist Attack on US an 'Urgent and Serious Threat'

In the wake of the recent Ebola crisis, the House Committee on Homeland Security’s Subcommittee on Emergency Preparedness, Response and Communications convened a hearing Wednesday to examine US preparedness for a bioterrorist attack.
 
“The risk of a biological terrorist attack to America is an urgent and serious threat. A bioattack could cause illness and even kill hundreds of thousands of people, overwhelm our public health capabilities, and create significant economic, societal and political consequences,” said subcommittee chairman Martha McSally (R-Ariz). “Our nation’s capacity to prevent, respond to, and mitigate the impacts of biological terror incidents is a top national security priority.”
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Preparing for the next biosecurity threat

Being in the business of developing countermeasures and treatments for a biological outbreak or chemical or nuclear event is a lot like the story of the boy who cried wolf. How do we, as representatives of this industry, continuously convince our fellow citizens, the government and the world that we face a potential danger and we must all prepare in the unlikely event the unthinkable happens? That is our challenge – preparing for unthinkable and unpredictable events, while at the same time collectively hoping they won’t occur. 

Unfortunately we live in a world in which the potential for a biological outbreak, natural or man-made, is ever-present. It could be a resurgence of Ebola, an intentional release of smallpox or anthrax, or the use of a chemical or nuclear weapon. As weapons technologies have become easier to acquire, and as the human population experiences naturally emerging infectious diseases at a greater rate than ever before, we can never be sure what or when the next threat will be. We must, therefore, strive to be prepared for the most likely and the most disruptive potential threats. This is true at home and equally true around the globe.  
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Discover the biodefense market size, share, analysis and forecasts till 2020 - WhaTech

Global biodefense market is expected to reach USD 13.33 billion by 2020, according to a new study by Grand View Research, Inc. Growing R&D investments in the field of biotechnology coupled with increasing threat of bioterrorism and disease outbreaks is expected to drive market growth during the forecast period.
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To Protect Ourselves From Bioweapons, We May Have to Reinvent Science Itself

To Protect Ourselves From Bioweapons, We May Have to Reinvent Science Itself | Biodefense News | Scoop.it
In June 2012, a team of researchers from the University of Wisconsin published a paper in the journal Nature about airborne transmission of H5N1 influenza, or bird flu, in ferrets. The article changed the way the United States and nations around the world approached manmade biological threats.

This was not the researchers’ intent.

The team had altered the virus’s amino acid profile, allowing it to reproduce in mammal lungs, which are a bit colder than bird lungs. That small change allowed the virus to be transmitted via coughing and sneezing, and it solved the riddle of how H5N1 could become airborne in humans. 

The U.S. government initially supported the work through grants, but members of Congress, among other critics around the world, responded to the publication of the research with alarm and condemnation. A New York Times editorial described the experiment and similar research conducted in the Netherlands, eventually published in the journal as "An Engineered Doomsday." So the researchers agreed to a voluntary moratorium on their findings. In October, the White House Office of Science and Technology Policy announced that it would halt funding for research into how to make diseases more lethal — so-called “gain-of-function” studies — and asked anyone doing such research on deadly diseases to cease and desist.
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Homeland Security Today: Blue Ribbon Panel Hears How to Respond to Biological and Chemical Threats

If America were to be beset by a biological or chemical weapons attack, who would be in charge of responding?
 
According to the consensus of the post-9/11 Commission Blue Ribbon Study Panel on Biodefense arrived at during its fourth and final meeting last week, “The federal government doesn't have a good answer to that question.”
 
"The last thing we want to do is experience a successful bio-attack in the United States and not be in a position to respond," said former Rep. Mike Rogers (R-Mich.). "It's hard to get people's attention about biological and chemical threats that can't be seen or touched but have devastating consequences nonetheless. We have to make this a public health issue."
 
Following Rogers's testimony, panel co-chair Tom Ridge presided over five discussions that explored methods of responding to biological and chemical weapons attacks -- and the "leadership vacuum" that plagues response efforts – especially the response to a large-scale, mass casualty bio or chemical attack.
 
"The federal government has stated that a public health disaster or pandemic is one of the top strategic threats our country faces," said Dr. Kenneth Bernard, a former biodefense official in the Clinton and Bush administrations. "Yet, we were still largely unprepared for the Ebola outbreak this year. We're not managing our leadership properly."
 
Three veterans of the Clinton and Bush administrations spoke of a "balkanized" response to biological and chemical threats. They called for future presidents to make biodefense a bigger priority -- and to delegate authority to a White House official to coordinate the activities of federal agencies.
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CDC lacked key lab incident reporting policy despite scrutiny, promises

CDC lacked key lab incident reporting policy despite scrutiny, promises | Biodefense News | Scoop.it
Despite several serious, high-profile lab incidents and promises to Congress of reforms, the Centers for Disease Control and Prevention didn’t send out a policy until last week to ensure the agency’s top lab safety official received reports of mishap
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Homeland Security Today: NEW - Does This Prepare Us or Not? HHS's Selection of Nine Regional Special Pathogen Treatment Centers

Homeland Security Today: NEW - Does This Prepare Us or Not? HHS's Selection of Nine Regional Special Pathogen Treatment Centers | Biodefense News | Scoop.it
Last July, the Department of Health and Human Services (HHS) announced it had established a network of medical centers capable of responding to outbreaks of severe, highly infectious diseases as part of a larger effort to further strengthen the nation’s infectious disease response capability. HSS said it selected nine health departments and associated partner hospitals to become special regional treatment centers for patients with Ebola or other high morbidity infectious diseases.
 
But not all veteran public health authorities who’ve been involved in combating infectious disease outbreaks and developing response planning are completely supportive of HHS’ initiative, which we’ll get into.
 
HHS’ Office of the Assistant Secretary for Preparedness and Response (ASPR) awarded approximately $20 million through its Hospital Preparedness Program (HPP) to enhance the regional treatment centers’ capabilities to care for patients with Ebola or other highly infectious diseases. ASPR will provide an additional $9 million to these recipients in the subsequent four years to sustain their readiness.
 
Each awardee will receive approximately $3.25 million over the full five-year project period. The funding is part of $339.5 million in emergency funding Congress appropriated to enhance state and local public health and health care system preparedness following cases of Ebola in the United States stemming from the 2014 Ebola epidemic in West Africa.
 
HHS said the facilities will be continuously ready and available to care for a patient with Ebola or some other equally as dangerous and severe, highly infectious disease, whether the patient is medically evacuated from overseas or is diagnosed within the United States.
 
These regional facilities are part of a national network of 55 Ebola treatment centers, but will have enhanced capabilities to treat a patient with confirmed Ebola or other highly infectious diseases. Even with the establishment of the nine regional facilities, the other 46 Ebola treatment centers and their associated health departments will remain ready and may be called upon to handle one or more simultaneous clusters of patients, HHS emphasized.
 
“This approach recognizes that being ready to treat severe, highly infectious diseases, including Ebola, is vital to our nation’s health security,” said HHS Assistant Secretary for Preparedness and Response (ASPR) Dr. Nicole Lurie. “This added regional capability increases our domestic preparedness posture to protect the public’s health.”
 
HHS announced its new HPP Ebola Preparedness and Response Activities funding opportunity on February 20, stating that a total of $194,500,000 is to be awarded to states and other grantees for Ebola health care system preparedness and response, and the development of the regional Ebola treatment strategy.
 
This funding, in addition to the Ebola emergency funds awarded through the Public Health Emergency Preparedness (PHEP) program, provides a total investment of $339,500,000 to enhance state, local and health care system preparedness for Ebola through the emergency appropriations passed with bipartisan support in Congress last December. These funds are supposed to build on gains made in health care and public health preparedness efforts over the past decade through the HPP and PHEP cooperative agreements with states.
 
The Centers for Disease Control and Prevention’s (CDC) Office of Public Health Preparedness and Response, Division of State and Local Readiness, administers funds for preparedness activities to state and local public health systems through the PHEP cooperative agreement.
 
“I’d like to thank cities, states and hospitals across the country and the public health community for stepping up and taking action,” Lurie said. “We are building on the work we’ve already done and further investing in domestic preparedness to protect the public’s health from Ebola, as well as boosting preparedness for many other types of health threats.”
 
The nine awardees and their partner hospitals are:
 
 
Massachusetts Department of Public Health in partnership with Massachusetts General Hospital in Boston, Massachusetts;
New York City Department of Health and Mental Hygiene in partnership with New York City Health and Hospitals Corporation/HHC Bellevue Hospital Center in New York City;
Maryland Department of Health and Mental Hygiene in partnership with Johns Hopkins Hospital in Baltimore, Maryland;
Georgia Department of Public Health in partnership with Emory University Hospital and Children’s Healthcare of Atlanta/Egleston Children’s Hospital in Atlanta, Georgia;
Minnesota Department of Health in partnership with the University of Minnesota Medical Center in Minneapolis, Minnesota;
Texas Department of State Health Services in partnership with the University of Texas Medical Branch at Galveston in Galveston, Texas;
Nebraska Department of Health and Human Services in partnership with Nebraska Medicine - Nebraska Medical Center in Omaha, Nebraska;
Colorado Department of Public Health and Environment in partnership with Denver Health Medical Center in Denver, Colorado; and
Washington State Department of Health in partnership with Providence Sacred Heart Medical Center and Children’s Hospital in Spokane, Washington.
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GAO Says US Needs To Improve Biosurveillance Strategy - Law360

Law360, Washington (July 9, 2015, 3:56 PM ET) -- The U.S. Government Accountability Office said in a report Wednesday that there's still room for improvement when it comes to mapping out, coordinating and organizing a nationwide system for watching for biological threats, be they naturally occurring or the result of a terrorist attack.
There have been important strides in national biosurveillance, GAO director of Homeland Security and Justice Christopher P. Currie said in prepared remarks to the Senate Committee on Homeland Security and Governmental Affairs. However, the White House has yet to issue an implementation plan establishing a framework prioritizing resource investments or figure out how to leverage nonfederal resources from local and private actors, according to the report.

“Although the White House developed the National Strategy for Biosurveillance in July 2012, this strategy does not include information that identifies resource and investment needs as we previously recommended,” Currie said. “In June 2010, we found that there was no integrated approach to help ensure an effective national biosurveillance capability and to provide a framework to help identify and prioritize investments.”

The national strategy for biosurveillance was to be followed by an implementation plan within 120 days. That plan has yet to materialize, according to the report.
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Congressional watchdogs demand names, details of sanctioned bioterror labs

Congressional watchdogs demand names, details of sanctioned bioterror labs | Biodefense News | Scoop.it
Bipartisan leaders of a congressional oversight committee, citing a USA TODAY Network investigation, are demanding federal regulators provide the names of research laboratories that have faced sanctions for safety violations while working with potential bioterror viruses and bacteria, according to a letter the committee sent Monday.

USA TODAY's "Biolabs in Your Backyard" investigation revealed that more than 100 labs have faced enforcement actions since 2003 because of serious safety violations while working with "select agent" pathogens such as anthrax. Yet lab oversight is cloaked in secrecy, making it difficult to determine the effectiveness of the federal inspection and enforcement program.

Even when labs commit the most egregious safety violations, the investigation found, they often are allowed to keep operating and their names are kept secret by regulators.
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America Needs to Strengthen Biodefense Now | Commentary

The United Nations Security Council recently heard firsthand testimony from the victims of a chemical-weapons attack in Syria. A Syrian doctor spoke of his frantic efforts to treat more than 100 people who were hit by chlorine-filled bombs in the town of Sarmeen. Many were vomiting and suffering respiratory distress.
These kinds of attacks are becoming more common and will increasingly be a component of 21st-century warfare. America’s enemies are clearly equipped to carry them out. Terrorist groups such as al-Qaida and the Islamic State have said they intend to acquire biological and chemical weapons — and use them against America.
Unfortunately, our nation is dangerously unprepared to prevent or respond to such attacks. Whether the actor is another country, a terrorist organization or even Mother Nature, the consequences are potentially catastrophic. That is why we agreed to become co-chairmen of a new panel on biodefense, hosted by Hudson Institute and Inter-University Center for Terrorism Studies, whose members include former Secretary of Health and Human Services Donna Shalala, former Senate Majority Leader Tom Daschle, former Rep. Jim Greenwood and former Homeland Security Adviser Kenneth Wainstein.
Congress and the president must devote more attention to the threats posed by biological and chemical agents — formulating and executing a coherent and comprehensive plan to protect the American people from them now.
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FBI notifies crime labs of errors used in DNA match calculations since 1999

FBI notifies crime labs of errors used in DNA match calculations since 1999 | Biodefense News | Scoop.it
The errors are unlikely to reverse cases, the FBI says, but labs and attorneys want to know more.
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PositiveID Successfully Detects Influenza on Firefly Dx Breadboard System - NASDAQ.com

PositiveID Successfully Detects Influenza on Firefly Dx Breadboard System - NASDAQ.com | Biodefense News | Scoop.it
DELRAY BEACH, Fla., May 27, 2015 (GLOBE NEWSWIRE) -- PositiveID Corporation ("PositiveID" or "Company") (OTCQB:PSID), a developer of biological detection and diagnostics solutions, today announced that it has successfully detected influenza on its Firefly Dx breadboard prototype PCR (polymerase chain reaction) pathogen detection system.

Influenza is an RNA virus and requires a reverse transcription step to create cDNA prior to PCR being performed. The entire testing process was performed on the Firefly Dx breadboard, which is significantly faster than standard laboratory equipment and protocols, with results achieved in minutes instead of hours or days.

In testing, PositiveID ran a third-party Human Seasonal Influenza Virus and assay and detected the Type A virus, with no change to the assay's chemistry ratio or design. Other strains currently being tested include Influenza B, H1 and H3 strains. The Firefly Dx is designed with the capability to screen for and detect multiple strains of the virus simultaneously with a single test.

"These latest testing results are significant because testing for the influenza virus using existing standard PCR protocols requires additional sample preparation steps prior to performing PCR," stated William J. Caragol, Chairman and CEO of PositiveID. "With our Firefly Dx breadboard prototype we are able to deliver sample-to-result detection in one step in minutes. That time savings can be critical for point-of-need detection during an outbreak of any pathogen."
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PositiveID Successfully Expands Testing of Firefly Dx PCR Chip to Food Safety Market, Detecting E. coli in Less Than 20 Minutes

PositiveID Successfully Expands Testing of Firefly Dx PCR Chip to Food Safety Market, Detecting E. coli in Less Than 20 Minutes | Biodefense News | Scoop.it
DELRAY BEACH, Fla., May 6, 2015 (GLOBE NEWSWIRE) -- PositiveID Corporation ("PositiveID" or "Company") (OTCQB:PSID), a developer of biological detection and diagnostics solutions, today announced that it has successfully detected Escherichia coli (E. coli) bacteria on the PCR (polymerase chain reaction) chip of its Firefly Dx prototype handheld, real-time PCR pathogen detection system, in less than 20 minutes.
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WHO admits failings in dealing with the Ebola crisis | Al Jazeera America

The World Health Organization has admitted serious failings in its handling of the Ebola crisis and pledged reforms to enable it to do better next time, its leadership said in a statement posted on the WHO website on April 16, which was reported on Sunday by Reuters.

“We have learned lessons of humility. We have seen that old diseases in new contexts consistently spring new surprises,” said the statement, attributed to WHO Director-General Margaret Chan and the deputy director-general and regional directors.

“We have taken serious note of the criticisms of the Organization that, inter alia, the initial WHO response was slow and insufficient, we were not aggressive in alerting the world ... we did not work effectively in coordination with other partners, there were shortcomings in risk communications, and there was confusion of roles and responsibilities,” it said.

The statement listed eight lessons learned, including areas where the WHO's response to Ebola could have been better, such as information sharing and communication.
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New Laws for New Threats Like Drones and Bioterrorism

New Laws for New Threats Like Drones and Bioterrorism | Biodefense News | Scoop.it
You walk into your shower and see a spider. You don’t know whether it is venomous—or whether it is even a real spider. It could be a personal surveillance mini-drone set loose by your nosy next-door neighbor, who may be monitoring the tiny octopod robot from her iPhone 12. A more menacing possibility: Your business competitor has sent a robotic attack spider, bought from a bankrupt military contractor, to take you out. Your assassin, who is vacationing in Provence, will direct the spider to shoot an infinitesimal needle containing a lethal dose of poison into your left leg—and then self-destruct.

Meanwhile, across town, an anarchist molecular-biology graduate student is secretly working to re-create the smallpox virus, using ordinary laboratory tools and gene-splicing equipment available online. Not content to merely revive an extinct virus to which the general population has no immunity, he uses public-source academic research to make it more lethal. Then he infects himself and, just as his symptoms start, strolls around the airport to infect as many people as he can.
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System undergoes technical demonstration, heads to South Korea | Article | The United States Army

System undergoes technical demonstration, heads to South Korea | Article | The United States Army | Biodefense News | Scoop.it
DUGWAY PROVING GROUND, Utah (April 16, 2015) -- An innovative system to warn of a biological attack recently underwent an advanced technical demonstration at Dugway Proving Ground, or DPG, and is now in South Korea for an operations demonstration by Soldiers.

The Joint U.S. Forces Korea Portal and Integrated Threat Recognition, or JUPITR, system employs a variety of detectors working together to enhance biosurveillance, and reduce false positives.

"It's a system of systems approach toward biological detection," said Russ Bartholomew of DPG's Life Sciences Division, and test officer for the JUPITR advanced technical demonstration at DPG.

Detecting harmful microbes within a natural background of airborne materials is a daunting, complex task. Bartholomew said that JUPITR is an array of instruments that includes acoustic, seismic, motion and other sensors with chemical and biological detectors. In a suspected biological attack, data from each instrument is scrutinized determine whether an attack occurred, and what type.

The Department of Defense defines a system of systems approach as, "a set or arrangement of systems that results when independent and useful systems are integrated into a larger system that delivers unique capabilities."

Recently, at one of DPG's massive outdoor test grids, JUPITR's sensors were set in an array identical to the South Korea configuration. Benign microbes with characteristics similar to biological agents were released in varying scenarios, simulating biological attacks. Each scenario was electronically recorded, for playback at the South Korea operations demonstration.
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Let’s Hit ‘Pause’ Before Altering Humankind

Let’s Hit ‘Pause’ Before Altering Humankind | Biodefense News | Scoop.it
Modern biological research continues to generate new technology at a staggering pace, bringing to society new challenges and new opportunities. A recent appearance is the so-called CRISPR/Cas9 technology for altering genes in the body’s cells, including, most troublingly, early embryonic cells.

To understand the challenge brought by this technology it is important to make a distinction between somatic cells and germ-line cells. Somatic cells are the run-of-the-mill cells of our bodies: muscles, nerves, skin and the like. Germ-line cells are the egg and sperm cells that, when joined, give rise to offspring. Making gene changes in somatic cells can have dramatic effects, but they are not transmitted to the next generation and therefore fall comfortably into the category of pure therapeutics and generate minimal controversy. It is changes in germ-line cells that create heritable alterations.

The advent of CRISPR/Cas9 again sees a biomedical technology challenging norms and raising concerns. CRISPR/Cas9 makes it comparatively easy to modify germ-line inheritance by inserting, deleting or altering bits of DNA. It may be possible to make these alterations quite precise, with no undesired changes in the genome. Nevertheless, such changes would be inherited not only by the next generation but by all subsequent generations. Thus the decision to alter a germ-line cell may be valuable to offspring, but as norms change and the altered inheritance is carried into new genetic combinations, uncertain and possibly undesirable consequences may ensue.
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