News Scan for Feb 26, 2019

News brief

CDC, FDA, CMS create task force for diagnostic testing in an emergency

Today three federal agencies announced a partnership to advance the rapid development and deployment of diagnostic tests in US laboratories during public health emergencies.

The Tri-Agency Task Force for Emergency Diagnostics (TTFED) is a cooperative effort by the Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), and Centers for Medicare and Medicaid Services (CMS) to develop a process to collaborate on future emergency diagnostic response needs. During emergencies, the TTFED will convene quickly to provide timely recommendations to clinical and public health laboratories for rapid implementation of in vitro diagnostic assays authorized for use under the FDA's Emergency Use Authorization (EUA) process.

"Public health emergencies, like Ebola outbreaks, remind us that we're a global community when it comes to public health protection. Bacteria and viruses don't respect territorial boundaries," said Jeffrey Shuren, MD, JD, director of the FDA's Center for Devices and Radiological Health, in an FDA news release.

"It takes a sustained, robust and globally coordinated effort to protect our nation and the global community from various infectious disease threats. . . . We also believe that this task force could lead to more innovation for diagnostic tests as developers will see a more predictable federal regulatory response through the agencies."

Federal officials hope the TTFED process will help clarify uncertainty that lab professionals have had about how to implement diagnostic tests once they received an EUA.
Feb 26 FDA news release
Feb 26 TTFED charter


Chronic wasting disease spreads to more areas of Kansas

According to media reports and an update from the Kansas Department of Wildlife, Parks, & Tourism (KDWPT), chronic wasting disease (CWD) has been found in deer in southern counties of the state.

"While most positives are still coming from northwest Kansas, new counties were added to the list this year, including several that show the disease's spread to the south and east—Haskell, Edwards, Pratt, Osborne, and Reno," KDWPT said in a news release.

KDWPT has tested 360 deer so far this year for CWD, and 37 were positive. CWD was first detected in 2005 in Cheyenne County, Kansas, in a whitetail doe killed by a hunter. Cheyenne County is in the northwest corner of the state.

CWD is a fatal, progressive prion disease that's been found in North American whitetail and mule deer, elk, and moose. In late stages the disease causes infected cervids to become confused, have drooping heads, and lose their fear of humans.
Feb 22 KDWPT news release
Feb 24 Wichita Eagle article


Study finds chikungunya circulated in Brazil earlier than thought

The chikungunya virus in Brazil circulated for as long as a year before public health surveillance systems detected it, according to a genetic analysis of blood samples from Rio de Janeiro. Researchers from the Center for Infection and Immunity at Columbia University and the Oswaldo Cruz Institute in Brazil described their findings today in Scientific Reports.

The blood samples were collected over a 15-month period from March 2016 to June 2017, and 40 samples were positive via polymerase chain reaction for chikungunya, but negative for dengue and Zika virus. After confirming the findings with a more sensitive multiplex test, the team tested 14 samples using VirCapSeq-VERT—a method developed by CII that allow recovery of near-complete genetic sequences—and were able to identify the viruses as the East-Central-South African (ECSA) chikungunya genotype.

The team was able to identify circulation timing based on the pace of mutations between the samples, which hinted that the virus could have circulated as early as 2012 and was probably imported from Central Africa. However, chikungunya wasn't reported by public health surveillance systems until 2014, a similar pattern observed for Zika virus. Phylogenomic analysis suggests the ECSA genotype was likely introduced in a single event into Brazil in 2013, a year before previous estimates.

Thiago Moreno L. Souza, PhD, a professor of biochemistry at Oswaldo Cruz and the study's first author, said in a Columbia University Mailman School of Public Health, said in a press release from the school, "This study demonstrates the value of sensitive diagnostic technologies that can differentiate between these infectious diseases and provide insights into the origins of the chikungunya outbreak in Brazil."
Feb 26 Sci Rep abstract
Feb 26 Columbia University press release

Stewardship / Resistance Scan for Feb 26, 2019

News brief

Review finds short antibiotic course not tied to worse bacteremia outcome

A meta-analysis of five studies published today in Antimicrobial Agents and Chemotherapy determined that, in patients with bacteremia caused by Enterobacteriaceae, short- and long-course antibiotic treatment did not differ significantly in terms of clinical outcomes.

Experts from Brown University in Providence, Rhode Island, included four retrospective cohort studies and one randomized controlled trial comprising 2,865 patients overall in their analysis. They found that short and long courses (greater than 10 days) of antibiotics did not differ in terms of 30-day all-cause mortality (relative risk [RR], 0.99), 90-day all-cause mortality (RR, 1.16), clinical cure (RR, 1.02), or relapse at 90 days (RR, 1.0).

The authors noted, however, "Further well-designed studies are needed before treatment for 10 days or less is adopted in clinical practice."
Feb 26 Antimicrob Agent Chemother study


CARB-X adds 6 new organizations to its Global Accelerator Network

The public-private partnership CARB-X today announced it has added six new life sciences organizations from around the world, expanding its Global Accelerator Network to 10 groups, according to a CARB-X news release.

"We are expanding our accelerator network to increase support for the development of new antibiotics, rapid diagnostics, vaccines and other life-saving products that the world so urgently needs to fight the rise of drug-resistant bacteria," said Kevin Outterson, JD, CARB-X executive director.

"Antibacterial product development is challenging, and CARB-X's portfolio is growing rapidly. This new network will provide a broader range of scientific, technical, and business support our innovative projects need to progress and succeed." The six new groups add expertise in the development of drugs and rapid diagnostics, business and regulatory strategy, and other highly specialized areas, CARB-X said.

Hailing from six nations, the six organizations are:, the BioInnovation Institute, the Centre for Cellular and Molecular Platforms (C-CAMP), the Foundation for Innovative New Diagnostics (FIND), the German Center for Infection Research (DZIF), and the Institute for Life Sciences Entrepreneurship (ILSE). They join CLSI, MassBio, and RTI International in the United States and the Wellcome Trust in the United Kingdom as CARB-X accelerators.

Since it was established in 2016, CARB-X (the Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator) has awarded more than $107.4 million, plus additional funds if project milestones are met, to accelerate the development of antibiotics, rapid diagnostics and other life-saving antibacterial products. Its aim is to invest up to $500 million by 2021.
Feb 26 CARB-X news release

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