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.

Sourced through Scoop.it from: www.redding.com

See on Scoop.itBiodefense News

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.

Sourced through Scoop.it from: www.nasdaq.com

See on Scoop.itBiodefense News

The Impact of Microfluidics/Lab-on-a-Chip Technologies on the Development of the POC Dx Markets | Insight & Intelligence™ | GEN

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.

Sourced through Scoop.it from: www.genengnews.com

See on Scoop.itBiodefense News

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.

Sourced through Scoop.it from: www.bna.com

See on Scoop.itBiodefense News

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.)

Sourced through Scoop.it from: thebulletin.org

See on Scoop.itBiodefense News

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.”

Sourced through Scoop.it from: www.nasdaq.com

See on Scoop.itBiodefense News

The world isn’t ready to face the consequences of technology’s new biological breakthroughs

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.

Sourced through Scoop.it from: techcrunch.com

See on Scoop.itBiodefense News

The Antibacterial Resistance Threat: Are We Heading Toward a Post-Antibiotic Era?

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.”

Sourced through Scoop.it from: www.huffingtonpost.com

See on Scoop.itBiodefense News

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.

Sourced through Scoop.it from: www.genomeweb.com

See on Scoop.itBiodefense News

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.

Sourced through Scoop.it from: www.executivegov.com

See on Scoop.itBiodefense News