Clinical Microbiology Issues Update - January/February 2015

PSAB ACTIVITIES

  • ASM President Attends White House Briefing on Precision Medicine Initiative
  • ASM Participates in CDC Measles Briefing
  • ASM Applauds FY 2015 Budget’s Increased Funding to Fight Antibiotic Resistance
  • ASM Endorses American Cures Act of 2015
  • ASM and PASCV Issue Joint Statement on FDA LDT Guidance
  • ASM Participates in CDC Telebriefing on the Ebola Outbreak in West Africa
  • ASM Attends December CCCLW Meeting
  • ASM Signs Implementation Letter on Combatting Antimicrobial Resistance
  • ASM attends FDA Anti-Infective Drugs Advisory Committee Meeting
  • ASM Meets with Officials from WRAIR
  • Minority Microbiology Mentor Newsletter

ASM NEWS, JOURNAL ARTICLES AND UPDATES

  • Clinical Microbiology Portal Hot Topic
  • Clinical Microbiology Portal Q & A
  • ASM Conferences
  • ASM Journal Articles of Interest
  • ASM Press
  • Articles of Interest

FEDERAL AGENCY UPDATES

  • CDC Updates Laboratory Guidance for Routine Laboratory Testing When EVD is Suspected
  • FDA Grants First CLIA Waiver for Nucleic Acid-Based Flu Diagnostic Test
  • Emergency Use Authorizations of In Vitro Diagnostic Devices for Detection of Ebola Zaire Virus
  • Optimizing FDA’s Regulatory Oversight of Next Generation Sequencing Diagnostic Tests
  • FDA Approves a Second Vaccine to Prevent serogroup B Meningococcal Disease
  • FDA Approves New Antibacterial Drug Zerbaxa
  • FDA Approves Pathogen Reduction System to Treat Platelets
  • FDA Approves First Pathogen Reduction System to Treat Plasma
  • FDA Grants CLIA Waiver Expanding the Availability of Rapid Screening Test for Syphilis
  • Progress Seen in Infection Control in U.S. Hospitals; Continued Improvements Needed
  • Early Data Suggests Potentially Severe Flu Season
  • MMWR Articles of Interest

OTHER INFORMATION AND UPDATES

  • Webinar: Viral Load Testing Diagnostic Principles and Clinical Practice
  • Third International Molecular Diagnostics Europe Advanced Diagnostics for Infectious Disease
  • Articles of Interest

PSAB ACTIVITIES

ASM President Attends White House Briefing on Precision Medicine Initiative
On January 30, The White House held an event in the East Room rolling out the Precision Medicine Initiative, which was attended by ASM President Timothy Donohue. You can see an explanation of the initiative by Associate Director for Science at the Office of Science and Technology Policy and former ASM President Jo Handelsman here: http://www.whitehouse.gov/blog/2015/01/30/precision-medicine-initiative-data-driven-treatments-unique-your-own-body.  

ASM Participates in CDC Measles Briefing
On January 29, ASM staff participated in the Centers for Disease Control and Prevention (CDC) telebriefing providing information on current U.S. measles outbreak and guidance for health protection. Anne Schuchat, Assistant Surgeon General, United States Public Health Service; Director, CDC’s National Center for Immunization and Respiratory Diseases discussed both imported and Disneyland-associated cases. To read the transcript, go to http://www.cdc.gov/media/releases/2015/t0129-measles-in-us.html.

ASM Applauds FY 2015 Budget’s Increased Funding to Fight Antibiotic Resistance
The ASM posted a statement of support for the Administration’s January 27 announcement that its FY 2016 budget would increase funding for provisions that combat and prevent antibiotic resistance in among microbial pathogens. You can find the full statement of support at http://www.asm.org/index.php/public-policy-2/137-policy/documents/statements-and-testimony/93355-ar-2015.

ASM Endorses American Cures Act of 2015
ASM endorsed the American Cures Act, which would provide a five percent increase in funding for research supported by the National Institutes of Health and other federal agencies. To see the endorsement, go to http://www.asm.org/index.php/public-policy-2/137-policy/documents/statements-and-testimony/93354-ac-act-2015.

ASM and PASCV Issue Joint Statement on FDA LDT Guidance
ASM, in collaboration the Pan American Society for Clinical Virology (PASCV), commented on the implementation of the FDA’s plan to regulate Laboratory Developed Tests (LDTs). The “Food and Drug Administration Notification and Medical Device Reporting for Laboratory Developed Tests; Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories;” was published October 3, 2014, and a public workshop was held January 8-9, 2015 to gather input from stakeholders. The full statement can be viewed at http://www.asm.org/index.php/component/content/article/137-policy/documents/statements-and-testimony/93344-ldt-2015.

ASM Participates in CDC Telebriefing on the Ebola Outbreak in West Africa
ASM staffers participated in a telebriefing on December 22 to apprise stakeholders of conditions in the three West African countries affected most severely by the Ebola virus disease outbreak. Director Thomas Frieden returned from West Africa, where he spoke with patients and staff; met with many of CDC’s 170 staff working in each of the countries; and met with the presidents, health ministers, and Ebola leadership of each country. To read the transcript, click the following link http://www.cdc.gov/media/releases/2014/t1222-ebola-response.html.

ASM Attends December CCCLW Meeting
On December 8, Janice Matthews-Greer, member of the PSAB Professional Affairs Committee, represented the ASM at the Coordinating Council on the Clinical Laboratory Workforce (CCCLW) meeting in near Chicago. The CCCLW is a coalition of laboratory organizations engaged in promoting the professions of laboratory sciences and is currently focused on the value of laboratory testing in patient outcomes. You can read more about CCCLW past projects by going to http://www.ccclw.org/default.html.  

ASM Signs Implementation Letter on Combatting Antimicrobial Resistance
The ASM joined 27 other organizations in sending a letter to Food and Drug Commissioner Dr. Margaret Hamburg regarding implementation of the National Action Plan on Combating Antimicrobial Resistance. Specifically, the organizations were requesting that FDA focus on data collection of antibiotic sales. To see the letter in full, please go to http://www.asm.org/images/PSAB/FinalDataCollection.pdf.

ASM attends FDA Anti-Infective Drugs Advisory Committee Meeting
ASM staff attended the December 4 meeting of the Food and Drug Administration (FDA) Anti-Infective Drugs Advisory Committee. FDA officials focused on the history of antibacterial drug development, current approaches to unmet medical need, statistical considerations in evaluation of unmet medical needs and trial considerations. Later, members of the public addressed the committee and several stakeholders presented before the committee. To see the materials from this meeting, please go to http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Anti-InfectiveDrugsAdvisoryCommittee/ucm385739.htm.  

ASM Meets with Officials from WRAIR
On December 4, Ronald Atlas, Chair of the Public and Scientific Affairs Board, Kenneth I. Berns, Chair of the PSAB Committee on Biodefense and Janet Shoemaker, Director, Office of Public Affairs visited the Walter Reed Army Institute of Research (WRAIR). The three toured the WRAIR facility and were introduced to program areas including Viral Diseases, Bacterial Diseases, the U.S. Military HIV Research Program and the Military Malaria Research Program. Following the tour, they met with WRAIR Commander, COL. Steven Braverman.

Minority Microbiology Mentor Newsletter
The January issue of the Minority Microbiology Newsletter has been published by the Committee on Microbiological Issues Impacting Minorities (CMIIM). You can read the newsletter by going to this link: http://www.asm.org/index.php/public-policy-2/135-policy/documents/newsletters/minority-microbiology-mentor-newsletter/93347-mmm-1-2015.

ASM NEWS, JOURNAL ARTICLES AND UPDATES

Clinical Microbiology Portal Hot Topic
The December Hot Topic discussion was "Detection of Gastrointestinal Viruses" and was presented by Karen Frank, M.D., Ph.D., D(ABMM), National Institutes of Health on December 1. The discussion can be found by going to http://clinmicro.asm.org/index.php/portal/hot-topics.

Clinical Microbiology Portal Q & A
ASM members can submit questions to the Clinical Microbiology Portal for an expert's response and search an existing database of questions that have already been answered. To see these, go to https://clinmicro.asm.org/index.php/component/content/article?id=417:question-and-answer.

ASM Conferences

@ASM Conference on Mechanisms of Interbacterial Cooperation and Competition
March 13 - 16, 2015
Washington, DC

4th ASM Conference on Antimicrobial Resistance in Zoonotic Bacteria and Foodborne Pathogens
May 8 - 11, 2015
Washington, DC

For a complete list of upcoming ASM conferences, please see http://conferences.asm.org/.

ASM Journal Articles of Interest

Commensal Bacteria Shaped Early Human Populations
Researchers Martin Glaser and Glenn Webb have shown that commensal bacteria that cause problems later in life most likely played a key role in stabilizing early human populations. The findings were published in mBio®, and offers an explanation as to why humans co-evolved with microbes that can cause or contribute to cancer, inflammation, and degenerative diseases of aging. See https://www.asm.org/index.php/journal-press-releases/93130-commensal-bacteria-were-critical-shapers-of-early-human-populations to read more.

Dynamics of Lewis b Binding and Sequence Variation of the babA Adhesin Gene during Chronic H. pylori Infection in Humans
H. pylori displays rapid genetic variability during chronic infection, but little is known about how this affects host interaction. The adhesin BabA mediates binding to the blood group antigen Lewis b [Le(b)]. Authors asked whether babA evolves during chronic infection and how mutations or recombination in babA affect binding to human RBCs. See http://mbio.asm.org/content/5/6/e02281-14 for more information.

Seasonal Flu Vaccines Boost Immunity to Many Types of Flu Viruses
Seasonal flu vaccines may protect individuals not only against the strains of flu they contain but also against many additional types, according to a study published in mBio®. Researchers at St. Jude Children’s Research Hospital found that some study participants had a strong immune response not only against the seasonal H3N2 flu strain from 2010, but also against flu subtypes never included in any vaccine formulation. Read more at http://www.asm.org/index.php/asm-newsroom2/press-releases/92-news-room/press-releases/93304-seasonal-flu-vaccines-boost-immunity-to-many-types-of-flu-viruses

Restrooms: Not as Unhealthy as You Might Think
Microbial colonization in a sterilized restroom begins with bacteria from the gut, the vagina, and is followed shortly by skin flora. Restrooms are dominated by a stable community structure of skin and outdoor associated bacteria, with few pathogenic bacteria making them similar to other built environments such as your home. This research, from San Diego State University, is published in Applied and Environmental Microbiology. Read more about the study here http://www.asm.org/index.php/asm-newsroom2/press-releases/92-news-room/press-releases/93303-restrooms-not-as-unhealthy-as-you-might-think.

ASM Press

Principles of Microbial Diversity
Author: James W. Brown
Paperback, 416 pages, full color, illustrations, glossary, index
(ISBN: 9781555814427) for more information, please visit the e-store at:
http://www.asmscience.org/content/book/10.1128/9781555818517

Articles of Interest

Limits to Compensatory Adaptation and Persistence of Antibiotic Resistance in Pathogenic Bacteria
Antibiotic resistance carries a cost that could potentially limit the spread of resistance in pathogens. In spite of this cost, a large number of experimental evolution studies have found that resistance is stably maintained in the absence of antibiotics. Clinical studies, on the other hand, have found that resistance in pathogens usually declines after antibiotic use ends, suggesting that compensatory adaptation is not effective in vivo. In this paper, authors argue this discrepancy arises because there are limits to compensatory mutations in nature that are not captured by the design of current laboratory selection experiments. Read more at http://www.ncbi.nlm.nih.gov/pubmed/25535278.  

FEDERAL AGENCY UPDATES

CDC Updates Laboratory Guidance for Routine Laboratory Testing When EVD is Suspected
The Centers for Disease Control and Prevention has posted “Guidance for U.S. Laboratories for Managing and Testing Routine Clinical Specimens When There is a Concern About Ebola Virus Disease” which provides information for clinical laboratories on testing needed for the assessment and care of patients for which Ebola Virus Disease (EVD) is a concern, while minimizing risk to laboratory personnel. This document updates and replaces the previously posted document “How U.S. Laboratories Can Safely Manage Specimens from Persons Under Investigation for Ebola Virus Disease.”

FDA Grants First CLIA Waiver for Nucleic Acid-Based Flu Diagnostic Test
On January 6, the U.S. Food and Drug Administration granted the first waiver to allow a nucleic acid-based test, the Alere i Influenza A & B test, to be used in a greater variety of health care settings. Because of that waiver, granted under the Clinical Laboratory Improvement Amendments (CLIA), the test can be distributed to a broad variety of non-traditional laboratory sites, like physicians’ offices, emergency rooms, and health department clinics. To read more, please go to http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm429127.htm.  

Emergency Use Authorizations of In Vitro Diagnostic Devices for Detection of Ebola Zaire Virus
On December 24, 2014, he Food and Drug Administration (FDA) announced the issuance of two Emergency Use Authorizations (EUAs) for two in vitro diagnostic devices for detection of the Ebola Zaire virus. To see the authorizations, go to http://www.gpo.gov/fdsys/pkg/FR-2014-12-24/pdf/2014-30108.pdf.

Optimizing FDA’s Regulatory Oversight of Next Generation Sequencing Diagnostic Tests
On February 20, 2015, the Food and Drug Administration will hold a public workshop on the NIH Campus in Bethesda, MD. The workshop discussion will focus on regulatory strategies to assure the analytical and clinical validity of Next Generation Sequencing (NGS) tests. Specific topics to be discussed at the workshop are outlined in the discussion paper entitled “Optimizing FDA's Regulatory Oversight of Next Generation Sequencing Diagnostic Tests” available at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm427296.htm.  

FDA Approves a Second Vaccine to Prevent serogroup B Meningococcal Disease
The U.S. Food and Drug Administration approved Bexsero, a vaccine to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age.  Bexsero is the second vaccine approved by the FDA in the past three months to prevent this disease. To read more, see http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm431370.htm.    

FDA Approves New Antibacterial Drug Zerbaxa
The U.S. Food and Drug Administration (FDA) approved Zerbaxa (ceftolozane/tazobactam), a new antibacterial drug product, to treat adults with complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI) on December 19. Zerbaxa is used to treat cUTI, including kidney infection (pyelonephritis). It is used in combination with metronidazole. Read more at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm427534.htm.

FDA Approves Pathogen Reduction System to Treat Platelets
The FDA approved the Intercept Blood System for platelets on December 16. The system is for use by blood establishments that collect and manufacture blood and blood components to prepare pathogen reduced platelets for transfusion to reduce the risk of transfusion-transmitted infections. The Intercept System for platelets has been shown to reduce the number of a broad range of viruses, bacteria and other pathogens that may contaminate platelets, including HIV, hepatitis B and C viruses, West Nile virus and gram-negative and gram-positive bacteria. To read more, go to http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm427500.htm.

FDA Approves First Pathogen Reduction System to Treat Plasma
On December 16, the FDA approved the Intercept Blood System for plasma, the first pathogen reduction system for use by blood establishments in the preparation of plasma in order to reduce the risk of transfusion-transmitted infections (TTI). See the press release at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm427111.htm.

FDA Grants CLIA Waiver Expanding the Availability of Rapid Screening Test for Syphilis
The U.S. Food and Drug Administration announced December 15 that it granted the first-ever waiver, under certain laboratory regulations, for a rapid screening test for syphilis, which will allow the Syphilis Health Check test to be used in a greater variety of health care settings. See the announcement at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm426843.htm.

Progress Seen in Infection Control in U.S. Hospitals; Continued Improvements Needed
Progress has been made in the effort to eliminate infections that commonly threaten hospital patients, including a 46 percent decrease in central line-associated bloodstream infections (CLABSI) between 2008 and 2013, according to a report released Jan 14 by Centers for Disease Control and Prevention. However, additional work is needed to continue to improve patient safety. Read about it by clicking http://www.cdc.gov/media/releases/2015/p0114-mrsa-hospitals-report.html.

Early Data Suggests Potentially Severe Flu Season
Early data suggests that the current 2014-2015 flu season could be severe. The Centers for Disease Control and Prevention (CDC) urges immediate vaccination for anyone still unvaccinated this season and recommends prompt treatment with antiviral drugs for people at high risk of complications who develop flu. So far this year, seasonal influenza A H3N2 viruses have been most common. To read more, go to http://www.cdc.gov/media/releases/2014/p1204-flu-season.html.  

MMWR Articles of Interest

Investigation of Contacts of a HCW Who Worked While Ill with Pertussis: Maryland, Fall 2014
In September 2014, the public health department of a Maryland hospital was notified of a case of Bordetella pertussis infection confirmed by polymerase chain reaction (PCR) in a staff health care worker (HCW). The HCW experienced onset of nonrespiratory symptoms atypical of the catarrhal phase of pertussis in August, but by September, paroxysms of coughing led the HCW to consult a colleague, who ordered the PCR test, prescribed a 5-day course of azithromycin, and advised avoidance of patient care until treatment completion. 

Pertussis Epidemic: California, 2014
On June 13, 2014, the California Department of Public Health (CDPH) declared that a pertussis epidemic was occurring in the state when reported incidence was more than five times greater than baseline levels. The incidence of pertussis in the United States is cyclical, with peaks every 3–5 years, as the number of susceptible persons in the population increases. 

Aseptic Meningitis Outbreak Associated with Echovirus 30 Among High School Football Players
On August 4, 2014, the Acute Communicable Disease Control Program of the Los Angeles County Department of Public Health received a report of three aseptic meningitis cases among football players at a county high school. Ten cases were identified; nine in males, and one in a female; patient ages ranged from 13 to 17 years.

OTHER INFORMATION AND UPDATES

Webinar: Viral Load Testing Diagnostic Principles and Clinical Practice
March 11, 2015 2:00 PM - 03:00 PM
Viral load testing now plays an integral role in the diagnosis and management of patients with viral infections, including HIV-1, hepatitis C, and hepatitis B viruses, cytomegalovirus, and others. During this webinar, Frederick Nolte will provide an update on current challenges in viral load testing, and discuss new technologies that may help labs address some of these issues. To register, go to https://www.aacc.org/store/webinars/9700/viral-load-testing-diagnostic-principles-and-clinical-practice.

Third International Molecular Diagnostics Europe Advanced Diagnostics for Infectious Disease: Latest Technologies and Impact on Clinical Outcome
April 15-16, 2015
Lisbon, Portugal
To see more, click http://www.moleculardxeurope.com/Infectious-Disease-Dx.

Articles of Interest

The Ebola Virus Is Mutating, Say Scientists
Time
January 29, 2015
Scientists at the Institut Pasteur say the Ebola virus has mutated and they are studying whether it may have become more contagious. Researchers are analyzing hundreds of blood samples from Guinean Ebola patients in an effort to determine if the new variation poses a higher risk of transmission.

Arizona Measles Outbreak Reaches 'Critical Point'
USA Today
January 28, 2015
Two more cases of measles were confirmed in Arizona and are linked to a family of four whose measles cases were confirmed following travel to Disneyland. Public health officials have warned that hundreds more people in the state may have been exposed this month.

Botswana Doctor Is Named to Lead WHO in Africa
New York Times
January 27, 2015
Dr. Matshidiso Moeti ran tuberculosis and H.I.V. programs in Botswana and has worked for three United Nations agencies before being named the new Regional Director for the World Health Organization’s (WHO) Africa Region.

Deadly Bacteria on Medical Scopes Trigger Infections
USA Today
January 27, 2015
A deadly pattern of illnesses emerged in 2012 at hospitals in Seattle, Pittsburgh, Chicago and in each case, the culprit was CRE. And in each case, investigators identified the source of transmission: a specialized endoscope, threaded down the throat of a half-million patients a year to treat gallstones, cancers and other disorders of the digestive system.

W.H.O. Members Endorse Resolution to Improve Response to Health Emergencies
New York Times
January 25, 2015
On Sunday, the World Health Organization’s executive board, representatives of 34 member states elected to help guide the agency, unanimously endorsed a resolution aimed at overhauling its capacity to head off and respond to outbreaks and other health emergencies.

NIH to Start Ebola Vaccine Study with Glaxo, Merck
Wall Street Journal
January 23, 2015
The NIH detailed its plans to test an Ebola vaccine on thousands of Liberians, with the help of two major drug companies. The NIH, GlaxoSmithKline PLC and Merck & Co. plan to enlist up to 27,000 people for the study at a rate increasing to as many as 3,000 a week in the immediate vicinity of Monrovia.

Fast Track on Drug for Ebola Has Faltered
New York Times
January 26, 2015
Six months later after the initial use of ZMapp in critically ill Ebola patients, very little has been produced, diminishing the chances that the drug can be used to treat large numbers of patients in the current outbreak.

 

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