Bioterror Scan for May 11, 2016

CDC biosafety breaches
Rapid anthrax test

CDC discloses for first time its own labs faced biosecurity sanctions

An undisclosed number of labs operated by the Centers for Disease Control and Prevention (CDC) have been cited for serious biosecurity violations six times since 2003, and a CDC lab in Fort Collins, Colo., was suspended for lab safety breaches, the agency admitted for the first time to USA Today yesterday.

The admission was in response to a Freedom of Information Act request from the newspaper. Before USA Today gained access to records detailing lab suspensions due to biosafety issues, the CDC had repeatedly refused to discuss the enforcement histories of its own labs.

The CDC said suspension of the Fort Collins lab from the Federal Select Agent Program around 2007 involved a lead scientist and the labs associated with his or her research. Violations involved the Japanese encephalitis virus, a serious pathogen but no longer considered a select agent, which means a microorganism with high potential for use as a bioterror agent. The lab was reinstated in 2010.

Only five labs have been suspended from the Federal Select Agent Program since 2003, and another five have faced repeated referrals for enforcement actions, according to the story. The CDC did not provide the identity of the other CDC labs.

"There is no security rationale for withholding the identities of the suspended labs," said Richard Ebright, PhD, a Rutgers University biosafety expert.

The CDC said its own labs have been referred six times for select agent violations since 2003 to the Office of Inspector General at the Department of Health and Human Services but added, "None of these violations resulted in a risk to the public or illness in laboratory workers." Three referrals involved sending improperly killed select agent pathogens to unapproved lab, two involved select agents in unregistered spaces, and one involved inventory and oversight issues.
May 10 USA Today story


BARDA funds development of rapid, point-of-care anthrax test

SRI International of Menlo Park, Calif., has received $2.5 million to study the accuracy of its point-of-care patient anthrax detection system, according to a May 9 press release from the Department of Health and Human Services (HHS).

The anthrax detection test, which is based on a similar system developed at the CDC, reads a blood sample from a finger prick and displays results after 15 minutes. Anthrax blood tests from clinical settings currently are sent to off-site laboratories with results available in several days, a delay that can jeopardize prompt care of infected patients, HHS said.

The $2.5 million distributed by the Biomedical Advanced Research and Development Authority (BARDA) under the Assistant Secretary for Preparedness and Response (ASPR) will fund studies to determine the test's accuracy in detected anthrax in blood samples over the course of 18 months. Funding can be extended up to $7.8 million over 3 years, HHS said.

Additional studies are required before SRI International can apply for Food and Drug Administration clearance to market the detection system. The company is working with DCN Diagnostics of Carlsbad, Calif., and Web Industries of Holliston, Mass., to conduct regulatory, design, and manufacturing studies, HHS said.
May 9 HHS press release

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