sábado, 26 de abril de 2014



Healthcare News

A Weekly Compilation of Clinical Laboratory and Related Information 
from The Division Of Laboratory Programs, Standards And Services


April 24, 2014


View Previous Issues - Healthcare News Archive


Most Laboratory Errors Happen Outside the Lab, ECRI Report Finds

Laboratory errors don't necessarily originate in the lab itself, contrary to what many hospitals might think, according to a new ECRI Institute patient-safety report studying the impact of lab-testing errors in the clinical setting. This misperception can have serious consequences because those who work outside the laboratory may not recognize their role in the issue, the report warned.

Only 4% of reported potentially harmful errors actually occurred in the laboratory, according to the report. However, hospitals who submitted events attributed errors to the laboratory setting 25% of the time. Close to 75% of mistakes occurred in the pre-analytic stage, which ECRI Institute defined as the time frame in which tests are selected and ordered, specimens are identified and transported, and patients are prepared. These mistakes were more likely to be associated with labels that had the wrong patient's name, the wrong specimen ordered, and incomplete or missing information. The other 22% of mistakes occurred in the post-analytic stage, when results were interpreted, reported or stored. Negative events were associated with either missing results, or a delay in getting results to the staff member who ordered them.

The report offered various recommendations, including prohibiting the “no news is good news” approach to test-results reporting; breaking down silos between care units and the lab; and conducting an event analysis to identify process breakdowns, among other recommendations.


1 in 20 Adult Outpatients Misdiagnosed, Study Reports

At least 1 in 20 adult outpatients receives an incorrect diagnosis from their doctor, according to a new study. Sometimes the consequences are minor -- calling something an “allergy” when it’s really a cold, for instance. But in more than 6 million patients a year in the United States, such misdiagnosis could have major consequences, such as a dangerous delay in cancer treatment.

“The question is, can we eliminate human error, and the answer is no,” said Hardeep Singh, lead author of the paper, which appeared in the journal BMJ Quality & SafetyExternal Web Site Icon. “We have just now begun to understand what [these errors] are and what we can do.” The patient, their care teams, and the health care system need to work together to reduce these mistakes, said Singh, a patient safety researcher at the Veterans Affairs Center for Innovations, and Baylor College of Medicine, both in Houston.


Tissue Testing During Breast Cancer Lumpectomies Prevents Need for Reoperation 96 Percent of Time

Unique laboratory testing during breast cancer lumpectomies to make sure surgeons remove all cancerous tissue spares patients the need for a repeat lumpectomy in roughly 96 percent of cases at Mayo Clinic in Rochester, a success rate much higher than the rate nationally, a Mayo study shows. During the years reviewed, 13.2 percent of breast cancer lumpectomy patients nationally had to return to the operating room within a month of their initial surgery, compared to 3.6 percent at Mayo in Rochester, which uses a technique called frozen section analysis to test excised tissue for cancer while patient are still on the operating table. The findings are published in the journalSurgeryExternal Web Site Icon.

"This intense pathological evaluation with the use of frozen section of the margins while the patient is asleep really drops down the re-excision rate," says first author Judy Boughey, M.D., a breast surgeon in the Mayo Clinic Cancer Center. "Achieving negative margins in one operation has a huge impact on the patient's satisfaction, decreases time away from work, time traveling back and forth to hospital appointments, and the financial cost to the patient, the insurance company and the hospital for a second operation."


Study Shows How Simple Changes in Reporting Medical Laboratory Test Results to Clinicians Improve Patient Safety and Reduce Inappropriate Use of Antibiotics

Researchers focused on whether different ways of reporting clinical laboratory test results would improve care for patients at low risk for developing urinary tract infections.  Simple changes in how clinical laboratory tests are reported to clinicians can contribute to improved patient safety and a reduction in the inappropriate use of antibiotics. These were the conclusions of a recent study published in the Infectious Diseases Society of America’s (IDSA) peer-reviewed medical journal,Clinical Infectious Diseases (CID).


Current and Novel Biomarkers for Diagnosis and Monitoring of Sepsis

Sepsis is a life-threatening condition affecting approximately 27 million people worldwide each year. Without appropriate treatment, sepsis can progress to severe sepsis and septic shock, which cause some eight million deaths each year. The risk of sepsis-related mortality increases with age and coexisting diseases such as diabetes or cancer; thus the incidence of sepsis has increased significantly, with hospitalizations and related costs doubling over the last 10 years.1

Clinical studies show that mortality is significantly reduced if septic patients are identified and treated at early stages of the disease process. However, early diagnosis is complicated by heterogeneity in clinical presentation, co-morbidities, and the scarcity of biomarkers that enable clinicians to accurately identify sepsis in early stages of disease. The recent revision and expansion of guidelines, with a deeper understanding of the pathophysiology of sepsis and availability of novel diagnostic and therapeutic tools, points to a better forecast for this severe disease in the future.


Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Novel Influenza A (H7N9) Virus; Availability

The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) for an in vitro diagnostic device for detection of the novel influenza A (H7N9) virus (detected in China in 2013). FDA is issuing this Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by Quidel Corporation. The Authorization contains, among other things, conditions on the emergency use of the authorized in vitro diagnostic device. The Authorization follows the April 19, 2013, determination by the Secretary of Health and Human Services (HHS) that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves the novel influenza A (H7N9) virus. On the basis of such determination, the Secretary of HHS also declared on April 19, 2013, that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection of the novel influenza A (H7N9) virus subject to the terms of any authorization issued under the FD&C Act. The Authorization, which includes an explanation of the reasons for issuance, is reprinted in this document.


Who's Protecting Whom From Deadly Toxin?

Questions are swirling around a science journal's decision last year to publish a description of a newly discovered botulinum toxin while omitting key genetic details that researchers would normally disclose. The unusual case highlights important unresolved issues in how to balance scientific openness with the worry that biological information could potentially be misused. NPR has learned that the scientist at the center of this controversy has not been sharing materials and information with other botulinum toxin researchers — and for two years he ignored entreaties from federal officials who wanted the microbe so that they could test vaccines and antitoxins.

"It is my understanding that there was no recommendation from that committee to withhold the sequence," says Robert Tauxe, deputy director of the division of foodborne, waterborne and environmental diseases at the CDC. The agency did not receive it until January 2014.  Now that CDC researchers finally do have access to the strain, important work can begin, says Tauxe. "The bottom line for us is, there's a lot more science to be done still," says Tauxe, "with questions that are still open about just how does this toxin differ from the standard known seven toxin types. ... Will the existing antitoxin that we have here in the United States protect against it, or not?"


New CDC/FDA Warning Against Unapproved Lyme Culture Test

Concerns about the purported Borrelia burgdorferi culture test marketed by Advanced Laboratory Services resulted this week in a blunt warning published in the Centers for Disease Control and Prevention's (CDC's) Morbidity and Mortality Weekly Report, advising use only of the 83 FDA-approved testsExternal Web Site Icon for diagnosis of Lyme disease.

"The Advanced Laboratory Services example highlights the problem of using tests that are unvalidated and not [US Food and Drug Administration (FDA)]-approved for diagnosing Lyme disease. We would caution clinicians and patients against the use of any unapproved tests," lead author Christina Nelson, MD, told Medscape Medical News. Dr. Nelson is from the CDC's Division of Vector-Borne Diseases, Fort Collins, Colorado. Study coauthors include Sally Hojvat, PhD, director of the FDA's Division of Microbiology Devices. Dr. Nelson emphasized that for Lyme disease diagnosis, the CDC recommends a 2-step process of serologic testing: first, an FDA-cleared enzyme immunoassay, followed in immunoassay-positive or equivocal cases by confirmatory Western blot. Only patients positive on both tests are considered to have Lyme disease. 


BaDx Portable Anthrax Detector From Sandia NL

Anthrax is a deadly bacterial disease and a weapon of war, typically found living in soil, that’s dangerous to both farm animals and humans that work with them. Farmers in developed nations regularly conduct tests for Bacillus anthracis, the bacterium responsible for anthrax, but that is often too expensive for poorer regions in the world.

Researchers at Sandia National Labs have simplified and put on a cassette what was previously a high tech process of detecting B. anthracis. Besides bringing down the price of testing from around $30 to around $6, the technology would prevent individual labs and lab techs from growing and working with substantial quantities of a deadly pathogen.


Will Forensic Biology Become Forensic Molecular Biology?

The article presents some examples of the potential for new molecular biology technologies to assist in the investigation of crime. Molecular biology has evolved far beyond that which could have been predicted at the time DNA identity testing was established. Indeed we should now perhaps be referring to "forensic molecular biology." This Commentary ponders some of these emerging issues, and presents some ideas on how they will affect the conduct of forensic molecular biology in the foreseeable future.


Sniffing Out Infection: Smell Test Speedier Than Urinalysis

An "electronic nose" can sniff the difference between healthy urine specimens and those infected with Escherichia coli, according to a pilot study. "The electronic nose can identify not just the organism but the particular strain of organism. It has a specificity of almost 100%, which is very encouraging," said Emmanuel Johnson, MD, from the Royal Liverpool and Broadgreen University Hospital NHS Trust in the United Kingdom.

"We started with E coli because 80% of urinary tract infections in the community and 50% in hospitals are from E coli, but the potential is limitless," Dr. Johnson told Medscape Medical News. The results of the pilot study were presented here at the European Association of Urology (EAU) 29th Annual Congress.


College of American Pathologists and ASC Sign MOU to Advance Delivery of Cytopathology Services

The College of American Pathologists (CAP) and the American Society of Cytopathology (ASC) announced today the signing of a memorandum of understanding (MOU) to collaborate on initiatives to advance the delivery of cytopathology services and improve patient care. The non-exclusive collaboration will enhance the relationship between the two organizations to advocate excellence in the practice of pathology and laboratory medicine and improve standards and quality of patient care. The agreement illustrates a united leadership on activities critical to the specialty of cytopathology while allowing each society to maintain its own identity and governance.

Some of the initial projects under consideration include:
  • Sponsored courses offered at each organization's annual meeting
  • Joint support of women's health issues through the CAP Foundation's See, Test & Treat® program, to improve the level of patient engagement with underserved women by providing free cervical and breast cancer screening, diagnosis, and follow-up care in a single visit
  • Improved communication and collaboration for the development and enhancement of the human papillomavirus (HPV) proficiency testing, evidence-based guidelines, and patient-centered advocacy outreach


Celebrate National Medical Laboratory Professionals Week!

It’s that time of year again: National Medical Laboratory Professionals Week (NMLPW) is underway—April 20 through April 26. It’s an opportunity, first of all, for clinical laboratory professionals to pat themselves on the back—to congratulate one another on the vitally important work they do for others day in and day out, often under increasingly challenging circumstances. The Clinical Laboratory Management Association (CLMA) is urging laboratorians to make the most of their week. CLMA organizes ways to do that under five categories:
  • “Spread the Word” (including via social media);
  • “Take Time for Professional Development” (including via available webinars);
  • “Open the Laboratory” (among other ways, by hosting a “laboraTOURy Open House”);
  • “Get Out Into the Community” (for example, through volunteerism or speaking before students); and
  • “Celebrate Your Team” (through a pot luck, awards ceremony, or many other ways to build team spirit).


Integrating Images With EHR at Cleveland Clinic: Lessons Learned

Three years ago, Cleveland Clinic integrated radiology images into its Epic enterprise electronic health records system. During the past 18 months the organization has integrated many other types of images into the EHR as well, using the Imaging Clinical Information System platform and vendor-neutral archive of Agfa Healthcare.

But the task is not done and no one can say when it will be, says Cheryl Petersilge, M.D., chair of radiology at Hillcrest Hospital in Ohio and medical director of the imaging integration initiative at Cleveland Clinic. More images from more places across the 10-hospital delivery system keep popping up. The integration initiative started with radiology and an early lesson was the need for having an indexing strategy so the archive wouldn’t simply house a bunch of unsearchable studies…. Other lessons from the project include:
  • When embarking on the journey, CMIOs, CIOs and physicians have to think about images beyond radiology and cardiology, and understand that the project will balloon considerably.
  • A governance mechanism is necessary to standardize indexing/naming strategies, and a robust physician advisory group must have influence. “Only your consumer can tell you what’s really important to them,” Petersilge says.
  • The project isn’t just about integrating the image management system, archive and EHR; it’s also about the workflow for all constituencies.


New Health IT Architecture Requires Interactive EHRs, Scientists Advise

To help create a new health-information architecture, the current crop of electronic health-record systems needs to be connected using interfaces that will allow them to communicate with each other, according to recommendations from a group of U.S. scientists reporting on the nation's health-information interoperability needs. The scientists' group, known as JASONExternal Web Site Icon, produced a 65-page report Adobe PDF fileExternal Web Site Icon, under contract with the Agency for Healthcare Research and QualityExternal Web Site Icon at HHS, advocating health IT infrastructure that provides “a migration pathway from legacy EHR systems,” the report stated. It calls for federal mandates to use what are known as application programming interfaces, or APIs, to connect legacy systems to each other.

“This pathway could be provided by published APIs mandated through the CMS Stage 3 Meaningful Use program,” the report's authors said.

Source: http://www.modernhealthcare.com/External Web Site Icon


Scientists Embark on Unprecedented Effort to Connect Millions of Patient Medical Records

Inside an otherwise ordinary office building in lower Manhattan, government-funded scientists have begun collecting and connecting together terabytes of patient medical records in what may be one of the most radical projects in health care ever attempted. Dubbed the Patient-Centered Outcomes Research Institute, or PCORI, and based in the District, the organization’s mandate is to launch, fund and coordinate research on “comparative effectiveness” — to find out which drugs, devices and treatment options are more effective than others. “We will be able to get answers with a degree of certainty that we’ve never had before,” said Joe V. Selby, PCORI’s executive director, who calls the patient records network “the holy grail” of health-care research.


Health Systems Get On Board With OpenNotes

Encouraged by the patient engagement spurred by giants such as Geisinger and the VA who've taken part, Kaiser Permanente Northwest and eight other health systems in the region have signed on to OpenNotes -- the first widespread adoption of the data sharing program. Kaiser Permanente began making clinician notes available to its members across the Pacific Northwest earlier this week. "Now, nearly 500,000 Kaiser Permanente members will, for the first time ever, be able to easily view the notes charted by their doctor during an office visit," said Michael McNamara, MD, chief medical information officer for Kaiser Permanente Northwest, in a press statement.

The findings were encouraging: nearly all the patients were in favor of seeing their medical notes, and no doctors opted to stop sharing them once the study was over. "To have 82 percent of patients open their notes is astonishing," said Jonathan Darer, MD, chief innovation officer for the division of clinical innovation at Geisinger, one of the pilot participants, in a 2013 press release.


Telehealth Gains Momentum in Obamacare Era

Once enmeshed in legal and insurance finger pointing and questions about reimbursement, telehealth is flourishing in the era of Obamacare, cost cutting, and consumer-driven healthcare. Telehealth will generate $2 billion in the US by 2018, Forbes reportedExternal Web Site Icon. Worldwide, revenue for telehealth products and services is expected to reach $4.5 billion in four years, compared with $440.6 million in 2013, according to IHS TechnologyExternal Web Site Icon.

Sources of growth include busy individuals who prefer the convenience of a video, phone, or other virtual consultation, as well as healthcare providers that use telehealth to augment traditional care. Today, 42% of hospitalsExternal Web Site Icon use telehealth, according to Health Affairs. Some employers offer telehealth as a benefit. Insurers increasingly incorporate this coverage to decrease the likelihood customers will unnecessarily (and expensively) visit an emergency room.


IP Law: Diagnostic Method Patents in Doubt

Are diagnostic methods patentable? Until quite recently, the answer to this question would have been an unqualified "yes." Recent court decisions concerning subject matter eligibility for patenting have changed the answer to this question to a hesitant "maybe." It worth noting that in Myriadthe court addressed only the patentability of claims to a natural product, genomic DNA, while inPrometheus the court addressed only the patentability of a diagnostic method. More recently a federal district court has combined the holdings of Myriad and Prometheus to reject claims for a diagnostic method that incorporated an unpatentable natural product, because the only additional steps in the process were routine and well-known. Ariosa Diagnostics Inc. v. Sequenom Inc. ….

Although the court's holding in Myriad was confined to DNA, the new USPTO [U.S. Patent and Trademark Office] guidelines include examiner rules for determining the patent eligibility of other natural products including isolated proteins. The new guidelines instruct the examiners to use a three-step process to determine whether a claim contains patent eligible subject matter under 35 USC §101. While the new USPTO guidance does not make all patents involving natural laws and products ineligible, it does require a narrowing of claims for use of any natural law or product, no matter how much effort and ingenuity was required to discover it, and this represents a change from USPTO policy prior to Prometheus. 


Guide for Sharing Laboratory Test Services

The Association of Public Health Laboratories published the new Laboratory Efficiencies Initiative “Policy Guide for Public Health Laboratory Test Service Sharing,” a resource that public health laboratory directors and their legal counsel can use in exploring legal questions related to public health laboratories’ sharing test services across states and other jurisdictions. Find more information and access the policy guide Adobe PDF fileExternal Web Site Icon 


ASU's Lindsay Broadening Recognition Tunneling Efforts to Include Protein Analysis

A team led by Arizona State University researcher Stuart Lindsay has applied recognition tunneling technology to the identification of amino acids and peptides. The approach, which Lindsay and his colleagues have previously applied to DNA sequencing, could enable single-molecule detection of proteins at picomolar and possibly femtomolar concentrations, he told ProteoMonitor. In repeating the measurement multiple times, the researchers are able to determine what signal features do and don't change from measurement to measurement, as well as which change or hold steady from sample to sample. The ASU researchers demonstrated the approach in a paperExternal Web Site Icon published this week in Nature Nanotechnology….

Since then, the researchers have moved to a chip-based device that offers significantly improved performance, Lindsay said, noting that "in the several generations of implementation since the [Nature Nanotechnology] paper was written, the technology has improved exponentially." Lindsay and ASU have licensed the technology to Roche for DNA sequencing purposes, and the company is currently funding efforts in his lab to develop a solid state recognition tunneling device for DNA.


Targeting Cancer With a Triple Threat

Delivering chemotherapy drugs in nanoparticle form could help reduce side effects by targeting the drugs directly to the tumors. In recent years, scientists have developed nanoparticles that deliver one or two chemotherapy drugs, but it has been difficult to design particles that can carry any more than that in a precise ratio. Now MIT chemists have devised a new way to build such nanoparticles, making it much easier to include three or more different drugs. In a paper published in the Journal of the American Chemical Society, the researchers showed that they could load their particles with three drugs commonly used to treat ovarian cancer.

“We think it’s the first example of a nanoparticle that carries a precise ratio of three drugs and can release those drugs in response to three distinct triggering mechanisms,” says Jeremiah Johnson, an assistant professor of chemistry at MIT and the senior author of the new paper. In the JACS paper, Johnson and colleagues demonstrated that the triple-threat nanoparticles could kill ovarian cancer cells more effectively than particles carrying only one or two drugs, and they have begun testing the particles against tumors in animals.


Medicare Considers Using NCCN Guides as Clinical Pathways

The Centers for Medicare and Medicaid Services (CMS) are reviewing a proposal from a major consulting company to use oncology clinical pathways in a pilot program designed to control costs and promote more uniform medical practice, according to a report publishedExternal Web Site Icon in a trade publication. A substantial portion of the proposed clinical pathways comes from the National Cancer Center Network (NCCN) oncology guidelines, and the pathways were developed in conjunction with that organization.

Other clinical pathways programs are already in use by individual practices, state oncology societies, integrated delivery networks, and private payors such CareFirst BlueCross BlueShield, as reportedExternal Web Site Icon by Medscape Medical News. However, they are not used by America's biggest payer — CMS. If the proposal is accepted, CMS could roll out a pilot project in select oncology practices and hospitals sometime in 2014, according to an official from the consulting company, McKesson Specialty Health, quoted in a report in Evidence-Based Oncology.


Toward a Faster, More Accurate Way to Diagnose Stroke

When someone suffers from a stroke, a silent countdown begins. A fast diagnosis and treatment can mean the difference between life and death. So scientists are working on a new blood test that one day could rapidly confirm whether someone is having a stroke and what kind. Their report appears in the ACS journal Analytical Chemistry.


Testing for Atypical Hemolytic Uremic Syndrome Goes NexGen

A patent pending genomic technique that rapidly sequences 12 genes associated with complement-mediated atypical hemolytic uremic syndrome (aHUS) is now being used to diagnose this rare disorder. Atypical hemolytic uremic syndrome (aHUS) is a very rare, life-threatening, progressive disease that frequently has a genetic component. In most cases it is caused by chronic, uncontrolled activation of the complement system.


DNA Data Could Help Doctors Treat MRSA Shows New Study

A team of scientists led by our researchers here at Bath has developed a new technique to predict the toxicity of an MRSA infection from its DNA sequence. With the MRSA superbug an increasing problem in hospitals and communities, this new technique could soon help clinicians better decide the best course of treatment for infections. Bacterial pathogens, such as MRSA, cause disease in part due to their toxicity, or the bacterium’s ability to damage a host’s tissue.

In a study published online today in Genome Research, researchers used the genome sequence of MRSA to predict toxicity levels for individual bacteria. This new technique should enable clinicians to personalise treatment for individual MRSA infections. In addition to examining genomes of other MRSA strains, such as the particularly virulent USA300 clone, the authors are working to apply their methodology to other bacterial pathogens, such as Streptococcus pneumonia, a leading cause of deaths in infants and children under the age of five. You can access the full research paper on the Genome Research websiteExternal Web Site Icon


Scientists Map DNA of Deadly Fungus

Researchers who sequenced the genome of a deadly fungus say their achievement offers a genetic map for finding weaknesses in the fungus in order to fight it. Cryptococcus neoformanscauses millions of cases of pneumonia and meningitis every year, says a team of scientists that spent 10 years decoding the DNA of one highly dangerous strain, called H99.

"We are beginning to get a grasp on what makes this organism tick," study co-author Dr. John Perfect, a professor of medicine at Duke University, said in a university news release. The study is published April 17 in the journal PLoS Genetics.


Researchers Develop Novel Molecular Blood Group Typing Technique

Scientists in France have designed a new system for molecular blood group typing that offers blood banks the possibility of extensive screening of blood donors at a relatively low cost. Their approach is described in The Journal of Molecular DiagnosticsExternal Web Site Icon. The standard technique, conventional hemagglutination, is a lengthy procedure and involves only a limited range of antigen testing. In this antibody-based agglutination, RBCs suspended in liquid collect into clumps when bound by the antigen-specific antibody.

The investigators therefore developed a new flexible DNA microarray platform for molecular blood group typing. This includes two robotic workstations that allow processing from blood sample to the genotype. A pilot study shows promising results for responding to blood donor laboratories' requirements for simple, low-cost screening. The purpose of this study was to set up and validate a flexible robotic platform using a 96-well DNA microarray for multiplex blood group genotyping.


Solution to Platelet ‘Puzzle’ Uncovers Blood Disorder Link

Melbourne researchers have solved a puzzle as to how an essential blood-making hormone stimulates production of the blood clotting cells known as platelets. Platelets are essential for stopping bleeding and are produced by small fragments breaking off their ‘parent’ cells, called megakaryocytes. The discovery, made by scientists at the Walter and Eliza Hall Institute, identified how bone marrow cells could become overstimulated and produce too many platelets. In blood diseases such as essential thrombocythemia, too many platelets can lead to clogging of the blood vessels, causing clots, heart attack or strokes.

The findings may have implications for human disease, Dr Ng said. “We know people with myeloproliferative disorders, such as essential thrombocythemia, produce too many megakaryocytes and platelets,” he said.


For Diabetics, Health Risks Fall Sharply

Federal researchers reported the first broad national picture of progress against some of the most devastating complications of diabetes, which affects millions of Americans, finding that rates of heart attacks, strokes, kidney failure and amputations fell sharply over the past two decades. The biggest declines were in the rates of heart attacks and deaths from high blood sugar, which dropped by more than 60 percent from 1990 to 2010, the period studied. While researchers had had patchy indications that outcomes were improving for diabetic patients in recent years, the study, published in The New England Journal of Medicine, documents startling gains.


Study on Mt. Everest Shows How People Get Type 2 Diabetes

Results of the study, conducted by researchers at the University of Southampton and University College London (UCL) in the UK, are published in the journal PLOS One. At the end of the study period, the researchers found that several insulin resistance markers were increased after long-term exposure to hypoxia at high altitude. The team says this change was connected to increased blood levels of markers of inflammation and oxidative stress.

Prof. Mike Grocott, professor at the University of Southampton and co-founder of UCL CASE Medicine, says their findings have given them a better understanding of insulin resistance: "Fat tissue in obese people is believed to exist in a chronic state of mild hypoxia because the small blood vessels are unable to supply sufficient oxygen to fat tissue."


TB Reach Project Results Show Need for New Approaches to Lift Case Detection Rates

For a decade and a half after the World Health Organization launched the expansion of directly observed treatment for tuberculosis, strides against the disease, highlighted by a nearly six-fold increase in cases documented, looked promising, an article released Thursday on PLOS One notes. But over the last half decade, with efforts largely reliant on “passive case finding” — that is waiting for people sick with TB to turn up at health facilities seeking care — the numbers of cases detected and acted on leveled off, leaving three million cases undiagnosed or untreated.

The article, A Multi-Site Evaluation of Innovative Approaches to Increase Tuberculosis Case Notification: Summary ResultsExternal Web Site Icon details outcomes of 28 projects that sought to improve TB detection rates by taking active measures and responding to local realities. The gains yielded by those projects show what added funding and “fresh thinking” can accomplish, says a release from Stop TB Partnership announcing the results. Funding for the projects came from the Canadian International Development Agency.


Reduction in HPV in Young Women in England Seen Following Introduction of National Immunisation Programme

A study conducted by Public Health England and presented at the Society for General Microbiology's Annual Conference shows a reduction in two High Risk human papillomavirus types in sexually active young women in England, following the introduction of a national immunisation programme.

Post-immunisation prevalence of HPV types 16 and 18 infection was lowest among women aged 16 to 18 year old, the age group with the highest vaccination coverage. Prior to the immunisation programme, this age group was shown to have the highest prevalence of infection.


DNA or Pap?

Some women's health advocacy groups are pushing the US Food and Drug Administration to not approveExternal Web Site Icon Roche's cobas HPV test to replace the Pap test as a first-line choice for cervical cancer screening, the AP reports. Groups like the American Medical Women's Association and Our Bodies Ourselves say that moving away from the well-tested Pap test would be "a radical shift" that could lead to higher medical costs, over treatment, and confusion.

"It replaces a safe and effective well-established screening tool and regimen that has prevented cervical cancer successfully in the US with a new tool and regimen not proven to work in a large US population," the groups say in a letter to FDA commissioner Margaret Hamburg. They also say the test is not very useful by itself because "so many women have HPV that will disappear without any treatment," Diane Zuckerman of the Cancer Prevention and Treatment Fund tells the AP.

But the cost is a concern, AP reports. The HPV test costs between $80 and $100, more than twice the $40 Pap, and Roche has proposed that women who test positive for HPV be referred for colposcopy, which can cost up to $500.


High-Risk HPV Prevalent in Oropharyngeal Cancers

A larger percentage of oropharyngeal cancers might be related to human papillomavirus (HPV) than previously thought. The Centers for Disease Control and Prevention (CDC) reports that in a large sample of invasive oropharyngeal squamous cell carcinomas, 72% were positive for HPV and 62% were positive for high-risk HPV types 16 and 18, which are covered by the 2 commercially available vaccines (Gardasil, Merck & Co.; Cervarix, GlaxoSmithKline). On the basis of these data, the CDC researchers suggest that vaccines could prevent most oropharyngeal cancers in the United States.


Affymetrix Provides Fresh Details on FDA Clearance Path for CytoScan Dx Assay

Affymetrix has provided more information about how it achieved US Food and Drug Administration clearance for its CytoScan Dx Assay chromosomal microarray analysis offering. The Santa Clara, Calif.-based array maker in January gained regulatory backingExternal Web Site Icon for the test as an in vitrodiagnostic, the first and only vendor to do so for an array-based assay. CytoScan is already widely used in CLIA-compliant laboratories as a laboratory-developed test, but the firm believes that FDA clearance will help it to win over new customers, better negotiate with payors, and enter foreign clinical markets, according to Eric Fung, vice president of R&D clinical applications at Affymetrix.

Alka Chaubey, director of GGC's cytogenetics laboratory, discussed these various studies during Affymetrix's ACMG workshop. She told BioArray News that there were multiple advantages to using the FDA-cleared CytoScan Dx platform over other array-based LDTs. "The fact that a board-certified cytogeneticist or molecular geneticist are the qualified individuals to perform the interpretation is also a win for the genetics community," she said, "by simply ensuring that this is a highly specialized test and cannot be offered as an off-the-shelf genetic test."


Researchers Find ‘Juno,’ a Key to Fertility, Discovery Could Help With IVF and Contraception

Fertilization takes place when the female egg and the male sperm fuse and create an embryo. That’s elementary. But the how the egg and the sperm recognize one another in the first place is a more complicated question. Only in 2005 did researchers in Japan identify a protein on the sperm that performed the function of recognizing the egg. They named the receptor protein “Izumo,” after a Japanese marriage shrine. Until now, however, its mate on the egg has been missing. In the latest edition of the journal Nature, researchers report identifying the corresponding receptor protein on the egg: They named it “Juno,” after the Roman goddess of fertility.


Researchers Clone Cells From Two Adult Men

After years of failed attempts, researchers have finally generated stem cells from adults using the same cloning technique that produced Dolly the sheep in 1996. The process, known as nuclear transfer, involves taking the DNA from a donor and inserting it into an egg that has been stripped of its DNA.

Reporting in the journal Cell Stem Cell, Dr. Robert Lanza, chief scientific officer at biotechnology company Advanced Cell Technology and his colleagues found that tweaking the Oregon team’s process was the key to success with reprogramming the older cells. The results also teach stem cell scientists some important lessons. First, that the nuclear transfer method that the Oregon team used is valid, and that with some changes it can be replicated using older adult cells. Second, the findings confirm that the key factor in making nuclear transfer work with human cells is not the age of the donor cell, as some experts have argued, but the quality of the donor egg.

That raises ethical concerns since the technique could produce human clones. That’s why research on nuclear transfer is not funded by the federal government, and scientists know less about these cells and their potential than they do about iPS cells [induced Pluripotent Stem cells].


Ebola Virus in Africa Outbreak is a New Strain

The Ebola virus that has killed scores of people in Guinea this year is a new strain — evidence that the disease did not spread there from outbreaks in some other African nations, scientists report. "The source of the virus is still not known," but it was not imported from nearby countries, said Dr. Stephan Gunther of the Bernhard Nocht Institute for Tropical Medicine in Hamburg, Germany. He led an international team of researchers who studied the genetics of the virus and reported results online… in the New England Journal of MedicineExternal Web Site Icon.


Ebola Outbreak Death Toll in West Africa Over 140

The World Health Organization says the current Ebola outbreak in West Africa has killed more than 140 people. In a statement on its website Tuesday [April 22], the U.N. health agency said at least 230 suspected or confirmed cases of Ebola have been recorded so far in Guinea and Liberia. Most of the cases are in Guinea. The statement said 129 deaths in Guinea and 13 in Liberia have been linked to the disease.


SARS-Like MERS Virus Spreads Among Health Care Workers

This month the World Health Organization (WHO) has confirmed 32 cases of the virus so far, including a cluster of 10 health care workers, all of whom worked with an infected patient who died on April 10. Nearly all the cases were located in the Middle East countries of Saudi Arabia, United Arab Emirates and Jordan. One case was found in Malaysia. Of the 32 cases reported this month, 19 were health care workers, according to the WHO.

Since the virus was first identified in April 2012, the WHO has found a total of 243 confirmed cases of the deadly virus and 93 people have died from it. The U.S. Centers for Disease Control and Prevention recommendsExternal Web Site Icon that travelers to the Arabian Peninsula monitor their health during the trip and in the weeks after. 


New MRSA Superbug Emerges in Brazil

An international research team led by Cesar A. Arias, MD, PhD, at the University of Texas Health Science Center at Houston, has identified a new bacterium that caused a bloodstream infection in a Brazilian patient. The report appeared recently in The New England Journal of MedicineExternal Web Site Icon. The new bacterium is part of a class of highly resistant bacteria known as methicillin-resistant Staphylococcus aureus (MRSA). It has also acquired high levels of resistance to vancomycin. Genomic analyses indicated that this novel vancomycin-resistant MRSA bacterium belongs to a genetic lineage that is commonly found outside hospitals (designated community-associated MRSA).

“This is the first-ever reported bloodstream infection caused by a highly vancomycin-resistant MRSA bacterium,” Arias says. “If we lose vancomycin, it would make it very difficult and expensive to treat these infections.”


Polio Hits Equatorial Guinea, Threatens Central Africa

Health officials are worried. After being free of polio for nearly 15 years, Equatorial Guinea hasreportedExternal Web Site Icon two cases of the disease. The children paralyzed are in two distant parts of the country. So the virus may have spread widely across the small nation. The outbreak is dangerous, in part, because Equatorial Guinea has the worst polio vaccination rate in the world: 39 percent. The Equatorial Guinea outbreak can be traced to neighboring Cameroon, where seven children have been paralyzed by polio since October.

"This is actually an outbreak from Cameroon that has been ongoing and has spread," says Oliver Rosenbauer, a spokesman for the WHO's polio eradication initiativeExternal Web Site Icon in Geneva. 


CDC Foundation and George W. Bush Institute to Partner in $3.6 Million Grant to Address Global Cervical Cancer

The grant, managed by the CDC Foundation, will enable the George W. Bush Institute, the U.S. Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) to work with the Pink Ribbon Red Ribbon® initiative to improve the monitoring and evaluation of cervical cancer screening and treatment programs.

Pink Ribbon Red Ribbon leverages the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR), created under President George W. Bush in 2003, to integrate cervical cancer prevention—including increased access to human papillomavirus (HPV) vaccinations, cervical cancer screenings and treatment, as well as cancer education in sub-Saharan Africa and Latin America.

Disclaimer- The information provided in this news digest is intended only to be general summary information. It does not represent the official position of the Centers for Disease Control and Prevention and is not intended to take the place of applicable laws or regulations.

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