viernes, 8 de noviembre de 2013



Healthcare News

A Weekly Compilation of Clinical Laboratory and Related Information
from The Division of Laboratory Science and Standards


November 7, 2013

View Previous Issues - Healthcare News Archive

IBM and Swiss Hospital Test New Tool for Diagnosing Cancer

The compact and easy-to-use device may help unravel tumor heterogeneity and assist in personalized treatment strategies.
A critical step in the diagnosis of cancer is the analysis of a patient's biopsy tissue sample, which sometimes can be as small as a pinhead. Even with such a small sample, pathologists can test for the absence or presence of tumor cells and provide important information pertaining to the course of treatment to doctors. While this approach provides insights into the tumor, it is increasingly being realized that significant variations exist within the tumor itself; mapping these variations may help understand the drivers for each tumor, and consequently assist in personalizing treatment strategies.
Based on decades of experience in designing silicon computer chips, IBM scientists have developed an innovative technology called a microfluidic probe which can interact with tissue sections at the micrometer scale to help unravel some of the molecular variations within tumors.

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The Latest Weapon in the Fight Against Cancer

Decades ago cancer immunotherapy was considered by some to be voodoo medicine. "Initial studies were not very effective, and many doctors thought it was a lot of hype with very few results," says James Gulley, MD, PhD, director of the clinical immunotherapy group at the National Cancer Institute (NCI). All that began to change in 2010, when the FDA approved the cancer vaccine Provenge to treat metastatic prostate cancer. Today potentially more effective and longer-lasting vaccine immunotherapies are being tested in more than 600 clinical trials as treatments for many of the deadliest cancers, including those of the ovaries, lungs, and breast.

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New Biomarker May Help Guide Treatment of Melanoma Patients

A functional biomarker that can predict whether BRAF-mutant melanomas respond to drugs targeting BRAF could help guide the treatment of patients with these cancers, according to results presented… at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer TherapeuticsExternal Web Site Icon….
“Our study has identified decreased phosphorylation of the protein S6 after treatment with BRAF-targeted drugs as a functional biomarker that predicts sensitivity of BRAF-mutant melanomas to these drugs,” said Ryan B. Corcoran, M.D., Ph.D., a Damon Runyon clinical investigator and assistant professor at the Massachusetts General Hospital Cancer Center and Harvard Medical School in Boston, Mass. “Importantly, we have developed a minimally invasive way to rapidly monitor post-treatment changes in S6 phosphorylation in patients’ tumor cells. As a result, we think that we can quickly determine whether or not a patient is likely to respond to a BRAF-targeted drug and help speed up treatment decisions, although we need to verify this in larger clinical studies.”

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Molecule Identified That Could Aid Lung Cancer Detection, Treatment

Researchers at Boston University School of Medicine (BUSM) have discovered a molecule that could help lead to the non-invasive detection of lung cancer as well as its treatment. Using RNA sequencing, the team looked at airway epithelial cells and identified a regulatory molecule that was less abundant in people with lung cancer and inhibits lung cancer cell growth. The findings, which are published in the Proceedings of the National Academy of Sciences, suggest that this molecule may aid in diagnosing lung cancer in earlier stages and could potentially, when at healthy levels, aid in treating the disease.
"These results suggest measuring the levels of microRNAs like miR-4423 in cells that line the airway could aid in lung cancer detection through a relatively non-invasive procedure," said Avrum Spira, MD, MSc, the Alexander Graham Bell professor of medicine and chief of the division of computational biomedicine at BUSM, one of the study's senior authors.

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A Simple Blood Test May Catch Early Pancreatic Cancer

Reporting on a small preliminary study, Johns Hopkins researchers say a simple blood test based on detection of tiny epigenetic alterations may reveal the earliest signs of pancreatic cancer, a disease that is nearly always fatal because it isn’t usually discovered until it has spread to other parts of the body. The findings of their research, if confirmed, they say, could be an important step in reducing mortality from the cancer, which has an overall five-year survival rate of less than 5 percent and has seen few improvements in survival over the last three decades.
“We have mammograms to screen for breast cancer and colonoscopies for colon cancer but we have had nothing to help us screen for pancreatic cancer,” says Nita Ahuja, M.D., an associate professor of surgery, oncology and urology at the Johns Hopkins University School of Medicine and leader of the study described online this month in the journal Clinical Cancer Research.

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Recurrence of Thyroid Cancer 'Could Be Predicted' With MicroRNAs

New research has found that measuring sections of genetic material within papillary thyroid cancer tumors could predict the chance of recurrence following surgery. This is according to a study published in the journal Cancer. Researchers from Australia say they also discovered that elevated blood levels of this genetic material, known as microRNAs, could also indicate an increased chance of recurrence after thyroidectomy - the surgical removal of all or part of the thyroid gland. Explaining their findings, the researchers say: "In this study, we identified tumor miR-222 and miR-146b as strong predictors of PTC (papillary thyroid cancer) recurrence, and they may be useful in guiding adjuvant therapy and surveillance intensity.

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UC Develops Unique Nano Carrier to Target Drug Delivery to Cancer Cells

The first-of-its-kind nanostructure is unusual because it can carry a variety of cancer-fighting materials on its double-sided (Janus) surface and within its porous interior. Because of its unique structure, the nano carrier can do all of the following:
  • Transport cancer-specific detection nanoparticles and biomarkers to a site within the body, e.g., the breast or the prostate. This promises earlier diagnosis than is possible with today’s tools.
  • Attach fluorescent marker materials to illuminate specific cancer cells, so that they are easier to locate and find for treatment, whether drug delivery or surgery.
  • Deliver anti-cancer drugs for pinpoint targeted treatment of cancer cells, which should result in few drug side effects. Currently, a cancer treatment like chemotherapy affects not only cancer cells but healthy cells as well, leading to serious and often debilitating side effects.
This recently developed Janus nanostructure is unusual in that, normally, these super-small structures (that are much smaller than a single cell) have limited surface. This makes it difficult to carry multiple components, e.g., both cancer detection and drug-delivery materials. The Janus nanocomponent, on the other hand, has functionally and chemically distinct surfaces to allow it to carry multiple components in a single assembly and function in an intelligent manner.

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Scientists Capture Most Detailed Picture Yet of Key AIDS Protein

Collaborating scientists at The Scripps Research Institute (TSRI) and Weill Cornell Medical College have determined the first atomic-level structure of the tripartite HIV envelope protein—long considered one of the most difficult targets in structural biology and of great value for medical science. The new findings provide the most detailed picture yet of the AIDS-causing virus’s complex envelope, including sites that future vaccines will try to mimic to elicit a protective immune response.
“Most of the prior structural studies of this envelope complex focused on individual subunits; but we’ve needed the structure of the full complex to properly define the sites of vulnerability that could be targeted, for example with a vaccine,” said Ian A. Wilson, the Hansen Professor of Structural Biology at TSRI, and a senior author of the new research with biologists Andrew Ward and Bridget Carragher of TSRI and John Moore of Weill Cornell. The findings are published in two papers in Science Express, the early online edition of the journal Science, on October 31, 2013.

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Paper-based Device Could Bring Medical Testing to Remote Locales

In remote regions of the world where electricity is hard to come by and scientific instruments are even scarcer, conducting medical tests at a doctor’s office or medical lab is rarely an option. Scientists are now reporting progress toward an inexpensive point-of-care, paper-based device to fill that void with no electronics required. Their study on the extremely sensitive test, which simply relies on the user keeping track of time, appears in the ACS journal Analytical Chemistry.
They developed a new paper-based device that is about the size of a stick of gum. In initial experiments, they used it to detect a liver enzyme that in high amounts can suggest liver or bone problems, and another enzyme that is a marker for fecal contamination in water. After applying a sample to the device, a small white dot turns green if the enzyme is present. After a few seconds or minutes, another small white dot turns green. The longer it takes for the second dot to change color after the first, the higher the concentration of the enzyme. The device uses just a few inexpensive materials and can be altered to measure a wide range of enzymes to monitor many different conditions.

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Genomind, Emory Partner to Commercialize Alzheimer's Test

Genomind today announced a partnership with Emory University to commercialize a blood-based screening test for mild cognitive impairment and Alzheimer's disease. Under the terms of the deal, Genomind has attained the exclusive rights to commercialize blood-based protein biomarkers for assessment of the conditions.

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Researchers Identify 11 New Risk Loci for Alzheimer's

A large 2-stage meta-analysis of genome-wide association studies (GWAS) that included almost 75,000 individuals of European ancestry from the United States and 14 other countries has identified 11 new susceptibility loci for late-onset Alzheimer's disease (LOAD). With the 9 previously identified genes, this brings to 20 the number of genes linked by large datasets to AD. The new study, led by Jean-Charles Lambert of INSERM, Université Lille, and Institut Pasteur, Lille, France, was published onlineExternal Web Site Icon October 27 in Nature Genetics.
The analysis "opens the door" to investigate these new pathways, which may play a role in AD, as well as possible new targets for therapeutic development, said Heather M Snyder, PhD, director, medical and scientific operations, Alzheimer's Association. The most significant new genetic association was in the HLA-DRB5-DRBI region. This region is associated with immunocompetence and histocompatibility and also with both multiple sclerosis (MS) and Parkinson's disease (PD).

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Researchers ID How Cancer Metastasizes

Tumors become highly malignant when they acquire the ability to colonize other tissues and form metastases. Now Ludwig-Maximilians-Universitaet researchers have identified a factor that promotes metastasis of colon tumors – and presents a possible target for therapy.
“Using colorectal cancer as a model, we have asked whether the protein ZNF281, which we have shown to interact with c-MYC in an earlier study, plays a role in the process of metastasis,” says Prof. Heiko Hermeking of the Institute of Pathology at the LMU, whose work focuses on the molecular bases of carcinogenesis. Since little was known about the mechanisms that control the ZNF281 gene itself, he and his research group took a closer look at its regulatory segment, or promoter. Their findings revealed that ZNF281 is at the hub of a complex functional network that indeed has a significant influence on tumor metastasis.

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Blood Test Shows Promise in Gauging Risk for Pregnancy Complication

The new test checks levels of a protein called placental growth factor (PlGF), and was assessed in 625 British women. The 61 percent of participants who developed preeclampsia all had low levels of PlGF, the researchers said. They also found that if a woman's PlGF levels fell below a certain threshold before her 35th week of pregnancy, her baby was likely to be delivered within 14 days. In a normal pregnancy, levels of PlGF remain more stable, the researchers said. The study, partly funded by Alere, the test's maker, was published Nov. 4 in the journal Circulation.

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Greiner Bio-One Accelerates HPV Laboratory Diagnostics

At the international congress on HPV (human papilloma virus) and cervical cancer, Greiner Bio-One is presenting the latest clinical study on the PapilloCheck HPV test.  For what is now the seventh time, Greiner Bio-One GmbH will be presenting its products in the field of cervical cancer at the international EUROGIN congress. The new CheckExtractor is a leap in technology and a crucial step toward a fully automated HPV detection. The device replaces the manual process of extracting DNA from patient samples and preparing the PCR setup for subsequent analysis using PapilloCheck and PapilloCheck high-risk. This simplifies and cuts down on the work done by laboratory staff while simultaneously making it possible to process far more samples in consistently high quality.  The DNA test kit can analyse 18 high-risk types of HPV and 6 low-risk types in parallel, thus enabling early identification of a total of 24 carcinogenic virus types.

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Screening for HPV May Be Better Than Pap Test, Study Suggests

In this study, researchers analyzed data from four clinical trials in Europe that compared the Pap test and HPV-based screening. Both methods provided similar levels of protection against invasive cervical cancer for the first two and a half years after the screening tests. But for the remainder of the follow-up period, HPV screening offered 60 percent to 70 percent greater protection than Pap test screening, according to the study. The findings were published in the journal The Lancet and presented Saturday at a European meeting of experts in cervical cancer control and HPV-associated diseases.

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Dual-Stained Cytology Improves Detection of Cervical Cancer Precursors

Dual-stained cytology with the biomarker combination p16/Ki-67 improves the detection of cervical cancer precursors, especially in younger women, according to results from the PALMS study conducted in Europe. "There is growing data and evidence that specifically combining p16/Ki-67 dual-stain cytology with HPV testing may provide an attractive option to efficiently screen for cervical cancer precursor lesions," Dr. Ruediger Ridder from Ventana Medical Systems, Inc., Tucson, Arizona told Reuters Health by email. "The combination of both tests may rule out disease (negative prediction) and identify women with existing cancer precursors (positive prediction) very efficiently," Dr. Ridder said.
Dual-stained cytology was significantly more sensitive than Pap cytology in both age groups (18-29 years and 30 years and over), but HPV testing was significantly more sensitive (93.3%) than dual-stained cytology (84.7%) in the older group, although it was significantly less specific (93.0% versus 96.2%, respectively).

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Improving Cytology Lab Safety and Efficiency With Direct-to-Slide Printers

It can be difficult to manage specimen slide labels in a cytology laboratory environment. Slides can come into contact with strong chemicals that can peel off printed labels, smear handwritten information, and obscure printed data. Even if the slide stays dry, handwriting that is difficult to decipher can make identifying information difficult to read, which can result in clinical laboratory professionals matching specimens to the wrong patient.
Thanks to technical advances, it is now possible for labs to affordably purchase small direct-to-slide printers for each workstation, enabling clinical laboratory professionals to print patient information directly on the slide. Direct-to-slide printers completely eliminate errors caused by illegible handwriting. They also address the issue of harsh chemicals obscuring and degrading printed labels: direct-to-slide printers use specially formulated ink that resists the types of chemicals typically found in lab environments and are resistant to alcohol, reagent, stain, xylene heat, and light degradation.

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Validating Whole Slide Imaging for Diagnostic Purposes in Pathology. Guideline From the College of American Pathologists Pathology and Laboratory Quality Center

Clinical Specialty  Pathology
Intended Users  Allied Health Personnel, Clinical Laboratory Personnel, Health Care Providers,
Guideline Objective(s)  To recommend validation requirements for whole slide imaging (WSI) systems to be used for diagnostic purposes
Major Recommendations
  • All pathology laboratories implementing whole slide imaging (WSI) technology for clinical diagnostic purposes should carry out their own validation studies.
  • Validation should be appropriate for and applicable to the intended clinical use and clinical setting of the application in which WSI will be employed. Validation of WSI systems should involve specimen preparation types relevant to the intended use (e.g., formalin-fixed paraffin-embedded tissue, frozen tissue, immunohistochemical stains, cytology slides, hematology blood smears).
  • The validation study should closely emulate the real-world clinical environment in which the technology will be used.
  • The validation study should encompass the entire WSI system.
  • Revalidation is required whenever a significant change is made to any component of the WSI system.
  • A pathologist(s) adequately trained to use the WSI system must be involved in the validation process.
  • The validation process should include a sample set of at least 60 cases for one application (e.g., hematoxylin-eosin [H&E]-stained sections of fixed tissue, frozen sections, cytology, hematology) that reflects the spectrum and complexity of specimen types and diagnoses likely to be encountered during routine practice.
  • The validation study should establish diagnostic concordance between digital and glass slides for the same observer (i.e., intraobserver variability).
  • Digital and glass slides can be evaluated in random or nonrandom order (as to which is examined first and second) during the validation process.
  • A washout period of at least 2 weeks should occur between viewing digital and glass slides.
  • The validation process should confirm that all of the material present on a glass slide to be scanned is included in the digital image.
  • Documentation should be maintained recording the method, measurements, and final approval of validation for the WSI system to be used in the clinical laboratory.
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Automated Mass Spectrometry—Will it Revolutionize the Microbiology Lab?

On August 21, 2013, the U.S. Food and Drug Administration (FDA) granted 510(k) de novo clearance to the first clinical mass spectrometer for identifying disease-causing bacteria and yeast. According to Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health: “The ability for laboratories to use one device to identify almost 200 different microorganisms is a significant advance in the timely identification of pathogenic microorganisms. Rapid identification of harmful microorganisms can improve the care of critically ill patients.”
So, does this mean the end of the Petri dish? No, the Petri dish isn’t going anywhere. But, change is coming and microbiologists must prepare for it. In one way, the approval of MALDI-TOF mass spec reveals a lot about microbiology. After all, traditional mass spectrometry has been used in the clinical chemistry lab for a long time, and automation is the norm in hematology labs. What about micro makes it so slow to change?

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Push by ACOs to Give Patients a Stake in Their Healthcare Provides Opportunities for Engagement by Clinical Laboratories and Pathologists

With payouts riding on patient outcomes and value, ACO providers will welcome innovative services that clinical labs and pathologist could provide that improve patient outcomes. Both private health insurance companies and employers are betting on value-based insurance as the key to improving healthy behavior in patients. This will require more patient engagement in managing their chronic conditions. It will also include motivating patients to consider less expensive treatment options, particularly when the more expensive treatment path has limited benefits.
In this way, accountable care brings the patient into picture. It is a trend that opens the door for innovative clinical laboratories and anatomic pathology group practices to develop medical laboratory testing services that payers and employers recognize as contributing to improved patient outcomes—and for which they will adequately reimburse the laboratories providing these services.

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ASCO: 5 More Cancer Practices Should Stop

The American Society of Clinical Oncology (ASCO) has released another list of oncology practices that should be stopped because they are either not supported by evidence or are wasteful. The ABIM Foundation asked ASCO to contribute a second list this year, said list lead author Lowell Schnipper, MD, from the Beth Israel Deaconess Medical Center in Boston. The organization did so because the 2012 listExternal Web Site Icon was "well received" by oncologists and because "eliminating unnecessary testing or interventional procedures" is part of the mission of ASCO's Value in Cancer Care Task Force, he explained. "We felt it important to go further," Dr. Schnipper noted.
The list from Dr. Schnipper and his coauthors was published onlineExternal Web Site Icon October 29 in the Journal of Clinical Oncology.
Number 1 – Appropriate antiemetics for patients on chemotherapy regimens should be based on the regimens' risk of causing nausea and vomiting
Number 2 – Use single-drug chemotherapy when treating an individual for metastatic breast cancer unless the patient needs urgent symptom relief
Number 3 – Avoid using advanced imaging technologies — PET, CT, and radionuclide bone scans — to monitor for a cancer recurrence in patients who have finished initial treatment and have no signs or symptoms of cancer
Number 4 – Do not perform PSA testing for prostate cancer screening in men with no symptoms of the disease who are expected to live less than 10 years
Number 5 – Do not use a targeted therapy unless a patient's tumor cells have a specific biomarker that predicts a favorable response to that therapy

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American College of Physicians Recommends Against Screening for Chronic Kidney Disease in Adults Without Symptoms or Risk Factors

The American College of Physicians (ACP) recommends against screening for chronic kidney disease (CKD) in asymptomatic adults without risk factors. ACP’s new clinical practice guideline, “Screening, Monitoring, and Treatment of Stage 1-3 Chronic Kidney DiseaseExternal Web Site Icon”, was published today in Annals of Internal Medicine, ACP’s flagship journal. “There is no evidence that evaluated the benefits of screening for stage 1-3 chronic kidney disease,” said Molly Cooke, MD, FACP, president, ACP. “The potential harms of all the screening tests – false positives, disease labeling, and unnecessary treatment and associated adverse effects – outweigh the benefits.  Ordering lab tests is not going to have any impact on clinical outcomes of asymptomatic patients with CKD without risk factors but will add unnecessary costs to the health care system due to increased medical visits and unnecessary tests,” Dr. Cooke said.

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Electronic Public Health Reporting on the Rise

Clinical and public health laboratories have significantly stepped-up electronic reporting of reportable data to public health agencies, according to an analysis published by the Centers for Disease Control and Prevention (CDC). The report, “Progress in Increasing Electronic Reporting of Laboratory Results to Public Health Agencies—United States, 2013” found that the number of state and local health departments receiving electronic reports from labs has more than doubled since 2005. This represents good news for public health agencies in their quest to quickly receive and analyze disease outbreaks. It also shows the payoff for CDC in funding, 57 state, local, and territorial health departments since 2007 to assist with electronic laboratory reporting, defined as automated messaging of lab reports using HL7 or other formats and one or more electronic communication protocols.

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EHR Data Could Tailor Local Public Health Planning

Public health researchers in Indiana are trying to figure out if they can use data from a source that’s potentially hugely insightful but has typically been off-limits: electronic health records. Researchers from Indiana University and Purdue University are studying the feasibility of using deidentified EHR data to tailor regional public health planning for Marion County, home to greater Indianapolis, with a $200,000 grant from the Robert Wood Johnson Foundation.
“When there is a limited budget for, say, preventing diabetes, the county health department has to determine how to spend its resources,” principal investigator Brian Dixon, an assistant professor of health informatics in the IU School of Informatics, said in a media release. “One choice is to evenly divide the money across all communities within the county, some of which probably don’t have as much need as others. A second choice is to identify specific areas within the county that might need intervention the most,” said Dixon, also a researcher at the Regenstrief Institute and the Roudebush VA Medical Center.

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When Docs Make Mistakes, Should Colleagues Tell? Yes, Report Says

Medical mistakes are now estimated to kill up to 440,000 people in U.S. hospitals each year, making preventable errors the third leading cause of death in America behind heart disease and cancer.  New guidelines issued today are aimed at tackling that problem, and helping ease the thorny dilemma of whether, when — and how — doctors should disclose their colleagues’ mistakes.
“Progress on patient safety has been much more limited than anyone would like,” said Dr. Thomas Gallagher, a University of Washington professor of medicine and bioethics who led the team behind guidelines published in the New England Journal of Medicine. The new guidelines offer explicit direction to doctors and their hospitals. “Explore, don’t ignore,” the authors say. Talk to colleagues directly and respectfully, the guidelines say, and have a clear plan about who will talk to patients, too.

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Number of Joint Commission Top Hospitals Grows by 77%

America's hospitals are hustling to improve the quality of their care — even the illustrious Johns Hopkins Hospital in Baltimore, Maryland. This trend is borne out in the annual list of top-performing hospitalsExternal Web Site Icon published by the Joint Commission today. The number of institutions that made the cut by scoring high on quality measures for pneumonia, heart failure, and other conditions rose from 620 in 2012 to 1099 in 2013 — a 77% increase. The scores are based on hospital performance in the preceding year. The Joint Commission christens a hospital as a top performer if it earns that distinction in at least 1 of 9 "core measure sets" of care:
  • Heart attack
  • Heart failure
  • Pneumonia
  • Surgery
  • Children's asthma
  • Inpatient psychiatric services
  • Venous thromboembolism
  • Stroke
  • Immunization
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New Testing Strategy Detects Population-Wide Vitamin and Mineral Deficiencies

Johns Hopkins researchers have demonstrated that levels of certain proteins in the bloodstream may be used to estimate levels of essential vitamins and minerals without directly testing for each nutritional factor. The team's use of a new strategy allowed them to indirectly measure amounts of multiple nutrients in multiple people at the same time, an advance that should make it possible in the future to rapidly detect nutritional deficiencies of an entire population, apply remediation efforts and test their worth within months instead of years.  A summary of the study, which analyzed the levels of five vitamins and minerals in 500 undernourished Nepalese children, was published in the October issue of The Journal of Nutrition.
"Currently, levels of each vitamin or mineral are measured by different tests which are often performed in different labs, so the whole process can take three or four years to detect widespread deficiencies," says Keith West, Dr.P.H., M.P.H., the George G. Graham Professor of Infant and Child Nutrition. "That's too long to wait when the proper growth and cognitive development of children are on the line." According to West, there is reason to believe that other vitamins and minerals will also have good proxy proteins. Their goal is to create a simple, portable test kit that would measure many proxy proteins from a single sample in a single test for under $100 per sample.

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Number of U. S. Malaria Cases Highest in 40 Years. Have We Forgotten What it Takes to Prevent It?

Thanks to malaria elimination efforts in United States in the 1940s, most people in the U. S. today have never had any direct contact with the disease and most doctors have never seen a case. That success means it's easy to have a relaxed attitude about protecting ourselves. We're now seeing the result of that relaxed attitude -- the highest number of malaria cases in the United States in the past 40 years. Almost all the cases reported in the U.S. in 2011 were acquired overseas. Most cases originated in somewhere in Africa, although India was the individual country where the most cases were acquired. Clinicians can consult the CDC Guidelines for Treatment of Malaria and contact CDC's malaria hotline, 770-488-7788 or toll-free at 855-856-4713, for case management advice as needed.

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Genetic Diversity in the Brain

Genomic analyses of single human neurons—either from postmortem brains or those derived in culture—reveal a considerable degree of DNA copy number variation, according to a paper published today (October 31) in ScienceExternal Web Site Icon. It is likely that these genetic differences affect brain cell function, and they may even shape our personalities, academic abilities, and susceptibilities to neurological diseases.
“It’s an exciting paper. It’s a closer look at the single cell genomes of neurons . . . and it identifies another layer of genomic mosaic changes that are occurring amongst neurons,” said Jerold Chun, a professor of molecular and cellular neuroscience at The Scripps Research Institute in La Jolla, California, who was not involved in the work. The other genetic changes in neurons, to which Chun referred, are aneuploidy—changes in chromosome number—retrotransposition events—replications of short DNA elements that insert themselves across the genome—and the expression of DNA-altering enzymes, all of which are particularly abundant in the brain.

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New Software Traces Origins of Genetic Disorders 20 Times More Accurately

In a bioinformatics breakthrough, iMinds – STADIUS – KU Leuven researchers have successfully applied advanced artificial intelligence to enable the automated analysis of huge amounts of genetic data. Their new software suite, eXtasy, automatically generates the most likely cause of a given genetic disorder. The breakthrough directly impacts the treatment of millions of people with a hereditary disease.  At least 5% of the world population suffers from a rare, hereditary disease. Until recently, the origins of these genetic disorders could be correctly identified in only half of all cases. The lack of a conclusive diagnosis prolongs uncertainty for both the patients and their families and marks the beginning of a long search, and expensive, strenuous and even unnecessary treatments. This research was published in a recent edition of Nature MethodsExternal Web Site Icon

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New Genetic Errors Identified That Could Cause One of the Most Deadly Leukaemias

Acute dendritic leukaemia is a rare type of leukaemia, but one with the worst prognosis - the average patient survival rate is just 12-14 months - that is difficult to treat. Juan Cruz Cigudosa's team, from the Spanish National Cancer Research Centre's (CNIO) Molecular Cytogenetics Group, has for the first time sequenced the exome - the coding, or protein-generating, regions of the genome - of dendritic cell leukaemia. The analyses, published in Leukemia, the world's leading journal in onco- haematology, uncover new genetic pathways that could revolutionise treatment guidelines for these patients.  "These results suggests a change in the treatment guidelines for these patients, who were completely misplaced", says Juliane Menezes, the first author of the study.

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Biologically Heterogeneous Cancers

Breast cancers that are typically classified as triple-negative are in fact biologically heterogeneous and should be further classified into distinct molecular subtypes, according to a comprehensive study of breast cancer datasets. The study, published in the February issue of The Oncologist, was conducted by a team of scientists from the University of North Carolina at Chapel Hill and the Vall d'Hebron Institute of Oncology in Barcelona, Spain.
Perou and his colleagues suggest that recognizing the molecular diversity of triple-negative tumors and subclassifying them as separate entities could support efforts to identify new biomarkers, which might possibly result in tests for subtype specific responses to different treatments, and conduct more targeted research on the clinical importance of the various molecular subtypes.

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The Basis of a Diagnostic Test for Suspected TB

A set of RNA transcriptional signatures expressed in the blood of patients might provide the basis of a diagnostic test that can distinguish active tuberculosis (TB) from latent TB and also from other diseases that have similar clinical symptoms and signs according to research published in this week's PLOS Medicine.
While the results are promising, the authors acknowledge that further work is required before the findings can be used in the clinic. They note, "from a clinical perspective a simple transcriptome-based test that reliably diagnoses or excludes TB in the majority of patients undergoing investigation for suspected TB, using a single blood sample, would be of great value, allowing scarce hospital resources to be focused on the small proportion of patients where the result was indeterminate. The challenge for the academic research community and for industry is to develop innovative methods to translate multi-transcript signatures into simple, cheap tests for TB suitable for use in African health facilities."

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Roche to Pay Up to $548 Million for ‘Superbug’ Antibiotic

The treatment, known as POL7080, targets Pseudomonas aeruginosa, a bacterium that causes one in 10 hospital-acquired infections in the U.S., according to figures from the U.S. Centers for Disease Control and Prevention cited by Roche. Bacteria increasingly are growing resistant to antibiotics, leading to 25,000 deaths a year in the European Union alone, according to EU statistics.

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Mexico-US Genomics Partnership Launches Second Phase

SIGMA is an unprecedented partnership that aims to ensure that Latin Americans benefit from the genomic revolution by:
  • Promoting wider access to genomic medicine in Mexico and Latin America by supporting discovery programs that focus on health problems with particular relevance to the region, and leverage its unique population genetics, and
  • Enhancing genomic research capacity in Mexico through training of scientists and encouraging the development of genomic diagnostics and therapeutics in Latin America.
The partnership brings together three organizations — the Broad Institute, the Carlos Slim Health Institute, and the National Institute of Genomic Medicine of Mexico. The project yielded deep biomedical insights in each of its three core areas. These include:
  • In type 2 diabetes, scientists identified a common genetic variant predisposing Latin American populations to the disease. Because this genetic variant is absent in Europeans, it had been previously overlooked.
  • In cancer, researchers identified new genetic drivers of breast cancer, lymphoma, head and neck cancer, and other cancers.
  • In kidney disease, the Mexico-US team discovered the gene for medullary cystic kidney disease type 1 (MCKD1) — a rare disorder that ultimately requires dialysis or kidney transplantation.
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Walgreen and the Biggest Biotech Startup You've Never Heard Of

A potential blockbuster partnershipExternal Web Site Icon between Walgreen (NYSE: WAG ) and stealth lab diagnostic biotechnology firm Theranos recently went quietly under the radar as retail pharmacy chains continue to expand their service offerings into new territories. The billion-dollar question going into the future for this space is now: Who will roll out the next big thing in pharmacy?
What is known is that Theranos claims its handheld blood analysis device can process a wide range of lab tests in a matter of hours with only drops of blood. In short: The Walgreen-Theranos partnership could produce faster, less-invasive, and easily accessed blood tests in a large number of Walgreen drug stores. Most interestingly, in-store lab testing would open the door for Walgreen to dip into the lucrative lab diagnostic arena and contend with lab giants Laboratory Corp. of America (NYSE: LHExternal Web Site Icon ) and Quest Diagnostics (NYSE: DGXExternal Web Site Icon ) . Given the positioning and visibility of Walgreen's more than 8,000 pharmacies across the country, the ability to perform lab tests in even a relatively small group of Walgreen pharmacies could mean great news for Walgreen and potential competition for established companies.

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American Esoteric Laboratories Partners With the Department of Defense to Help Military Medical Laboratory Technicians Find Civilian Jobs

Returning veterans who are experienced medical lab technicians are having trouble finding employers that recognize and credit their military training and experience. Clinical laboratories now actively recruiting lab technicians will want to learn more about the availability of these qualified candidates in their communities. One medical laboratory company already partners with a Department of Defense (DoD) program to help match skilled veteran jobseekers with private sector employers. That is American Esoteric Laboratories, a division of Sonic Healthcare USA. The existence of this program means that pathologists and clinical laboratory managers may be overlooking a ready source of highly skilled laboratory workers.
Combat medics are hindered in the job market for an interesting reason. Often the military does not fully document their skills, noted Bloomberg News in a storyExternal Web Site Icon that discusses this situation. Adding to the problem, state licensing laws are inconsistent and don’t account for armed-forces job experience. Consequently, veterans are often unable to prove their ability to civilian employers.

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UPMC Opens Centralized Clinical Lab to Speed Diagnoses for Patients

Located at the site of the former Rangos Children’s Research Building on Fifth Avenue, the CLB [Clinical Lab Building] houses 13 state-of-the-art labs, which moved from [University of Pittsburg Medical Center] UPMC Presbyterian, UPMC Montefiore and Magee-Womens Hospital of UPMC. To effectively link UPMC’s hospitals and the CLB, tissue samples and other materials reach the facility through an expanded and modernized pneumatic tube system installed under the streets of Oakland. UPMC CLB by the numbers:
  • 30 employees
  • 18,000 samples every day
  • 8 mile pneumatic tube network
  • 107 tube stations in UPMC [hospitals]
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Get the Word Out: A Service, Not a Commodity

In the “Washington ReportExternal Web Site Icon” feature published in this issue (page 52), attorney Julie Scott Allen enumerates the converging economic challenges that clinical labs face in this difficult time:
  • annual cuts imposed by Congress on Medicare Part B laboratory reimbursement rates to pay for other healthcare-related costs;
  • a fiscal year 2014 White House budget proposal recommending cuts that could cut an average lab test by 29% by 2023;
  • a 2013 report by the Office of Inspector General (OIG) stating that substantial Medicare savings can result from cutting lab rates;
  • a proposal by the Centers for Medicare and Medicaid Services (CMS) to completely reassess payment rates under the Clinical Laboratory Fee Schedule;
  • a refusal by CMS and Medicare contractors to pay for new molecular and diagnostic tests; and
  • questioning by the Food and Drug Administration (FDA) and CMS about the safety and efficacy of lab developed tests.
Allen rightly points out that this death by one thousand cuts could mean extinction for many labs that operate with narrow profit margins. It is a worrying picture that she paints.

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Twelve Common Mistakes

Avoid These Pitfalls While Planning a New Laboratory or a Laboratory Renovation Project
All projects are started with the best of intentions and most involve smart people. We (as laboratory consultants and architects) often get called only after a project crashes and burns. I have come up with a list of the 12 most common mistakes I have witnessed. Many of these points are applicable to any technical space build-out.
  • Starting without they right people on board
  • Not hiring laboratory architects
  • Not involving front-line staff
  • Not having someone (capable) in charge
  • Working entirely with drawings and assuming everyone understands what is represented on a drawing
  • Letting key operational staff "coast" through the programming and design development phases
  • Not involving vendors
  • Try cutting costs before you have arrived at the optimal solution
  • Have your laboratory architect employed by the General Contractor
  • Leaving interior design entirely up to staff and ordering furniture from a catalog
  • Not planning for growth/flexibility
  • Not realizing running a major (or not so major) project is a full-time job
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The Ideal Lab Environment

There are many aspects to consider when finding the right workplace.
Trying to describe the "ideal" work environment for laboratorians can prove as challenging as knowing all of the latest test panels in front of the FDA. But it's a good idea to set some standards for your prospective workplace.
  • A culture of respect and appreciation
  • A well-defined career path
  • A simple and easy to understand organization chart
  • Space
  • Windows and natural light
  • New technology and new equipment
  • Training
  • Flexible/Fair scheduling
  • Adequate staffing
  • Vision/Communication
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Food Additive May Prevent Spread of Deadly New Avian Flu

A common food additive can block a deadly new strain of avian influenza virus from infecting healthy cells, researchers at the University of Illinois at Chicago [UIC] College of Medicine report in the online journal PLOS ONE. The compound, in wide use as a preservative, binds to a part of the flu virus that has never been targeted by any existing antiviral drug, raising hopes for its effectiveness against multi-drug-resistant flu viruses. UIC researchers, led by Caffrey, found that the FDA-approved food additive tert-butyl hydroquinone sticks to a specific region on the hemagglutinin molecule. The additive, he said, “attaches to the Achilles’ heel of the virus—a loop-shaped portion of hemagglutinin necessary for binding to cells, making cell infection impossible.”

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Novel Technique Addresses Antibiotic Resistance

JoVE, the Journal of Visualized Experiments has published a novel technique to confront the problem of antibiotic resistance. According to Dr. Joseph Ndieyira, one of the developers involved in the technique, "The use of this technology will allow scientists to understand how antibiotics work, how bacteria develop resistance, and what molecular mechanisms could be exploited to get around their defense mechanisms."
"We report a novel, nanomechanical approach to investigate the workings of vancomycin - one of the last powerful antibiotics used to combat increasingly-resistant infections such as methicillin-resistant Staphylococcus aureus (MRSA)," said Ndieyira.

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Groundbreaking Armbands Improve Patient Safety

Would it surprise you to learn that armbands, the very tool designed to improve patient safety and reduce risk of error, have the potential to do just the opposite? According to a survey by the Institute for Safe Medication Practices, coloured armbands can cause confusion. A separate U.S.-based study discovered that illegible information on armbands accounted for 24 per cent of all armband-related errors.
With all of this attention being paid to the wrist, a Canadian company is taking steps to solve patient identification issues, applying Canadian resources to develop a groundbreaking new armband….  Medirex Systems… has launched a SuperSoft armband that is water and chemical proof, and can be comfortably worn for up to 25 days longer than current armbands without causing skin irritation, cuts, nicks or sores, or losing legibility. As an added advantage, the Medirex armbands make barcode solutions affordable for those hospitals that have yet to implement bedside scanning due to the high cost of other products.
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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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