viernes, 17 de julio de 2015



A Weekly Compilation of Clinical Laboratory and Related Information
From The Division Of Laboratory Systems

July 16, 2015

News Highlights

  • CDC Versus Ebola: The Road to Zero
  • NIH-Funded Vaccine for West Nile Virus Enters Human Clinical Trials
  • Survey Finds Clinicians Report to Work Sick despite Risks to Patients
  • ASHG Position Statement Provides Guidance for Genetic Testing in Children and Adolescents
  • Sepsis Diagnostics
  • New Biopsy Techniques for Tumors
  • Researchers Develop World's Most Sensitive Test to Detect Infectious Disease, Superbugs
  • Researchers Building Microchips That Mimic Live Human Organs
  • Could Bacteria Be Turned into Living Medical Devices?
  • Study Reignites Calls for Worldwide Controls on Sugary Drinks
  • Study Identifies Factors Affecting Prescription Pain Reliever Misuse
  • CDC: Opioid Prescribing Has 'Primed' Americans for Heroin Addiction
  • New Standard Seeks to Alleviate Challenges of Sharing Bioinformatics Tools and Workflows
  • Congress Gets Another Chance to Advance Telemedicine
  • CMS Encourages EHR Adoption in CY 2016 Home Health PPS Proposed Rule

View Previous Issues - Healthcare News Archive

Leading News

CDC Versus Ebola: The Road to Zero
The Ebola epidemic that began in West Africa in early 2014 continues today. With more than 27,000 reported Ebola cases and more than 11,000 deaths, the scope has been unprecedented. Equally extraordinary is the scale and duration of the response by the Centers for Disease Control and Prevention and partners. Today, CDC is releasing a multimedia report describing the experiences of the agency’s Ebola responders. Since the outbreak began, CDC has sent more than 1,200 experts in various disciplines to Guinea, Liberia, Sierra Leone, and surrounding countries. Many deployed more than once and also volunteered to return as long as the epidemic persists. Thousands more CDC staff have worked on the response from the agency’s Atlanta headquarters, as well as in hospitals, labs and airports; other CDC campuses in the U.S., and CDC country offices around world. “The global response to the Ebola epidemic in West Africa is unprecedented, and hard work by thousands has helped contain the virus in most of the region,” said CDC Director Tom Frieden, M.D., M.P.H. “We will never forget either those impacted by this terrible epidemic or the heroic public health professionals who responded.”
The report highlights CDC employees’ work testing blood samples in field laboratories, traveling remote trails and rivers to track case contacts, teaching Ebola prevention strategies in local communities, protecting borders by screening and monitoring travelers, and strengthening hospital infection control practices.
NIH-Funded Vaccine for West Nile Virus Enters Human Clinical Trials
A clinical trial of a new investigational vaccine designed to protect against West Nile Virus infection will be sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. The experimental vaccine was discovered and developed by scientists at the Oregon National Primate Research Center at Oregon Health & Science University (OHSU) in Portland. The new vaccine is being tested in a Phase 1 clinical trial at Duke University in Durham, North Carolina, one of NIAID’s Vaccine and Treatment Evaluation Units (VTEUs). The OHSU research team, led by senior scientist Mark Slifka, Ph.D., created the investigational vaccine, called HydroVax-001, with a novel, hydrogen peroxide-based process that renders the virus inactive while still maintaining key immune-system triggering surface structures. The virus used to make the vaccine is inactivated and cannot cause WNV infection. Because it is inactivated, the experimental vaccine likely could be used in a diverse population, including immunologically vulnerable groups, such as the elderly. The clinical trial is being conducted by researchers at Duke University, one of nine NIAID VTEUs. Enrollment is expected to be completed by December 2015.
Survey Finds Clinicians Report to Work Sick despite Risks to Patients
Many physicians, registered nurse practitioners, midwives and physician assistants go to work sick even though they are aware it puts patients at risk, according to a small survey published by JAMA Pediatrics. The researchers received survey responses from 280 attending physicians and 256 advanced practice clinicians (APCs). The survey found that about 95 percent of them believe that working while sick puts patients at risk but that 83 percent have done it at least once in the past year and about 9 percent have at least six times.
In a related editorial, Dr. Jeffrey R. Starke of Baylor College of Medicine and Dr. Mary Anne Jackson of the University of Missouri-Kansas City School of Medicine recommended that institutions develop policies and programs that allow temporary replacement of sick staff who care for high-risk patients. Occupational health and infection control departments also need to clarify what constitutes being too sick to work.

Laboratory Testing / Diagnostics

ASHG Position Statement Provides Guidance for Genetic Testing in Children and Adolescents
In a position statement on genetic testing in children and adolescents published today, the American Society of Human Genetics pointed to a variety of ethical and other issues arising from such testing, both in clinical and research contexts, and made a number of recommendations. The report touches on genome-scale, carrier, direct-to-consumer, pharmacogenomic, newborn, and pre-adoption testing, and covers the reporting of secondary findings, adult-onset conditions, incest, and non-paternity results. ASHG also made suggestions on how to improve professional education in order to enhance providers' understanding of genomic medicine. The position statement, published by ASHG's workgroup on pediatric genetic and genomic testing in the American Journal of Human Genetics today, is an update of a 1995 joint statement from the American Society of Human Genetics and the American College of Medical Genetics and Genomics on the same topic.
Sepsis Diagnostics
Sepsis is among the most common causes of death with a mortality rate that exceeds even myocardial infarction. Whereas the symptoms of sepsis are fairly easy to identify, confirmation of the disease is more problematic as it depends on proving the presence of an infection. To treat these patients appropriately, the common practice is to rely on blood culture (BC) as the diagnostic foundation for pathogen identification. This is a problematic diagnosis and treatment strategy because blood culture itself is a slow and insensitive method, and the post-culture diagnostic techniques will never be faster or more accurate than the system on which they are based.
T2MR is the most recent technology product to address sepsis, and the only one to provide species identification directly from a whole blood sample. T2MR employs nanotechnology and magnetic resonance for rapid and accurate species identification directly from whole blood without the need for DNA extraction or sample manipulation. The T2Candida Panel and T2Dx Instrument are the first FDA-cleared diagnostic products that incorporate the T2MR technology. The median time to negative result for the T2Candida Panel was 4.4 hours, compared to a median time to result of less than 120 hours for BC-based methods.
New Biopsy Techniques for Tumors
Solid cancer tumors typically are diagnosed, graded, and staged using tissue biopsy in which all or part of a neoplasm—usually the primary tumor—is removed for histological examination and genetic and molecular analysis, writes Curtis Balmer, PhD, in the July issue of CLN. While tissue biopsy provides important diagnostic and therapeutic information, it has several inherent drawbacks that limit its clinical utility. To overcome these, new biopsy techniques are being developed and evaluated, Balmer indicates in the article.
A particularly promising method is liquid biopsy, which exploits the presence of tumor cells in the bloodstream. As Bert Gold, PhD, FACMG, a staff scientist with the National Cancer Institute’s Center for Cancer Research, explained, “Circulating tumor cells are cells of origin from a usually solid tumor that have gone into the general circulation and can be viewed in peripheral blood.” Enthusiasm for this approach reflects its potential to sidestep the limitations of tissue biopsy. For example, tissue biopsy is invasive, poses some risk to patients, and is often painful, slow, and costly, and therefore not practical for closely monitoring a patient’s disease progression and treatment response. In contrast, liquid biopsy requires only a simple blood draw; therefore, it poses little risk and is quick, painless, and cost-effective. As such, it may enable clinicians to closely monitor disease progression and treatment response in near-real time without unduly burdening the patient.
Liquid Biopsies Uncover Mutations That Develop During Tumor Progression
Researchers from the CORRECT trial have provided additional evidence that genomic analysis of liquid biopsies could be a viable approach for keeping tabs on tumor genotype evolution and matching clinically relevant mutations to therapeutics. As reported in the Lancet Oncology yesterday, this international team of researchers compared certain genetic mutations in DNA obtained from more than 500 plasma samples from patients with metastatic colorectal cancer with those uncovered in DNA obtained from tissue biopsies.
"This is the first large clinical trial to compare liquid versus conventional tissue biopsy data, and the results show the former obtains more data on tumor mutations throughout the course of the disease, enabling us to better target therapy to the specificities of a patient's tumor," Josep Tabernero, head of the medical oncology department of Hospital Universitario Vall d'Hebron and study author, said in a statement. This suggests that liquid biopsies "could be a viable approach for non-invasive analysis of tumor genotype in real time and for the identification of potentially clinically relevant mutations that are not detected in archival tissue," Tabernero and his colleagues said in their paper.
Autoantibody Profiling May Pinpoint Sjogren's Sooner
Autoantibodies can be detected as early as two decades before a diagnosis of primary Sjögren's syndrome (pSS), and the finding may represent a potential for early testing and intervention in at-risk people, according to Swedish researchers. In a nested case-control study, at least one autoantibody specificity was detected in 81% of pSS patients who were antibody positive up to 20 years before the diagnosis, reported Elke Theander, MD, PhD, from Lund University in Malmö, and colleagues. "In 95% of the included patients with pre-diagnostic autoantibodies the production of these had started unknown long time before our first assessment," they wrote in Arthritis and Rheumatology. "Thus, clearly the antibodies were present earlier than our calculations can prove, i.e., even earlier than two decades before diagnosis." They said they envision risk gene analysis and autoantibody profiling for detection of autoantibodies in individuals with a genetic susceptibility to pSS due to a strong family history of autoimmunity as a means to counsel patients to avoid potential triggers when identified.

Research and Development

Researchers Develop World's Most Sensitive Test to Detect Infectious Disease, Superbugs
Infectious diseases such as hepatitis C and some of the world's deadliest superbugs—C. difficile and MRSA among them—could soon be detected much earlier by a unique diagnostic test, designed to easily and quickly identify dangerous pathogens. Researchers at McMaster University have developed a new way to detect the smallest traces of metabolites, proteins or fragments of DNA. In essence, the new method can pick up any compound that might signal the presence of infectious disease, be it respiratory or gastrointestinal. "The method we have developed allows us to detect targets at levels that are unprecedented," says John Brennan, director of McMaster's Biointerfaces Institute, where the work was done. This new method is described online in the journal Angewandte Chemie International Edition.
Researchers Building Microchips That Mimic Live Human Organs
The Human Organs-on-a-Chip, designed to revolutionize clinical testing and research, bested 75 other finalists in the 2015 Design of the Year by theDesign Museum in London. The contenders included the Google self-driving car, Norway’s new banknotes, and Rodarte’s covetable couture Star Wars gowns. Human Organs-on-a-Chip acts like lab surrogates for actual human organs, like lab test animals. Invented by Donald Ingber and Dan Dongeun Huh at Harvard University’s Wyss Institute for Biologically Inspired Engineering, these special chips, about the size of a computer memory stick, recreate the biochemistry and the mechanical function of human organs in a piece of rubber.
Could Bacteria Be Turned into Living Medical Devices?
When it comes to bacteria, not all types are our enemy. Some bacteria can even be exploited for the forces of good. So what if we could find a way to upgrade some of these “friendly” bacteria—programming them to detect some of the cancers and infectious diseases that cross their path to enable early treatment? Researchers from MIT believe they’ve developed basic computing elements that could make such a reality possible. In a recent project, researchers created a series of sensors, memory switches, and circuits that can be encoded in a common human bacterium found in the intestines known as Bacteroides thetaiotaomicron. Their research indicates that these basic computing elements will allow the bacteria to sense, memorize, and respond to signals from the bacteria that could lead to early detection and treatment of inflammatory bowel disease and colon cancer. Ultimately the team believes that more advanced genetic computing circuits could be built in the future in effort to create a whole new line of noninvasive diagnostic and therapeutic mechanisms.
PSA Errors in SEER Database Less Ominous
Fewer errors in prostate specific antigen (PSA) values than initially feared have turned up in a study of the National Cancer Institute (NCI) Surveillance, Epidemiology, and End Results (SEER) registries, according to preliminary data. Initially pegged at 17% to 18%, the error rate now appears lower, possibly as low as 5% or less. The true error rate won't be known until the study is completed in the fall, but early results have offered a measure of reassurance, according to Lynne Penberthy, MD, associate director of the SEER surveillance research program. The outcome of the review has potentially wide-ranging implications. Hundreds (if not thousands) of clinical studies – and associated journal articles and meeting abstracts – have relied on SEER-derived PSA data since PSA values were added to the database in 2004.
Simply Observing Men with Very Low- and Low-Risk Prostate Cancer Very Effective and Underused
Since the initiation of PSA screening tests, most men with prostate cancer are now diagnosed with localized, low-risk prostate tumors that are unlikely to kill them. However, nearly all of these men undergo surgery or radiation, putting them at risk for ongoing side effects such as erectile dysfunction and impaired urinary function. As many as 40 percent of patients may currently be overtreated, said review senior author Dr. Mark Litwin, professor and chair of UCLA Urology. “This study is the most up-to-date and comprehensive review of expectant management of prostate cancer patients worldwide. This represents an important resource for patients and providers considering surveillance for prostate cancer,” Litwin said. “Active surveillance and other observational strategies have produced excellent, long-term disease-specific survival and minimal morbidity for men with prostate cancer. Despite this, expectant management remains underused for men with localized prostate cancer.” The study appears in the July/August 2015 issue of the peer-reviewed journal CA: A Cancer Journal for Clinicians.
Adding Biopsy Factors to PRIAS Criteria May Help Predict Unfavorable Prostate Cancer
Adding biopsy factors to existing Prostate Cancer Research International: Active Surveillance (PRIAS) criteria may boost the ability to detect prostate cancer that is unfavorable for active surveillance, researchers from Italy report. "The risk of misclassification of patients on active surveillance based on PRIAS criteria is 26%," Dr. Giorgio Ivan Russo from the University of Catania told Reuters Health by email. "We proposed to incorporate some biopsy features in order to reduce that risk." Dr. Russo's team assessed performance capabilities of biopsy factors when added to the PRIAS criteria in 143 men who underwent radical prostatectomy but were eligible for active surveillance. Two-thirds of these men had favorable disease and one-third had unfavorable disease, the researchers report in Prostate Cancer and Prostatic Disease, online June 2.
Genomic Profiling of Small Cell Lung Cancer Highlights Importance of Inactivated TP53, RB1 Genes in Disease Development
Nearly every small cell lung cancer harbors inactivated TP53 and RB1 genes, according to a comprehensive genomic analysis of the disease. An international team of researchers led by Roman Thomas at the University of Cologne sequenced 110 small cell lung cancer samples to find that all but two of them had inactivated TP53 and RB1 genes, as they reported today in Nature. Their survey of the genomic landscape of the disease also found that quite a few tumors had genomic rearrangements or mutations involving the TP73 gene as well as kinase gene mutations and inactivating mutations in Notch family genes. "In summary, we have provided the first, to our knowledge, comprehensive genomic analysis of SCLC, implicating several previously unknown genes and biological processes in the pathogenesis of this disease as possible targets for more efficacious targeted therapeutic intervention against this deadly cancer," Thomas and his colleagues wrote in their paper.
Saliva as a Diagnostic Tool
Salivary diagnostics holds tremendous potential for the diagnosis, prognosis, and monitoring of cancer.1 The specimen can be obtained simply, inexpensively, and less invasively than blood and thus can be collected without special training.1-3 Saliva is a complex mixture including components such as salivary gland secretions, mucosal transudations, desquamated epithelial cells, expectorated bronchial and nasal secretions, bacteria and bacterial products, viruses, and food debris.1 Due to this complexity, saliva contains a rich variety of potential biomarkers including proteins, enzymes, antibodies, DNA, RNA, and cytokines.2,4  Whole saliva contains serum components and therefore may be used for diagnosis, monitoring, and prognostic determination of cancers outside the mouth and throat, as recently reviewed by Malathi et al.1 In a study involving patients in India, oral cancer screening reduced oral cancer mortality by more than 80 percent in tobacco and/or alcohol users.5 Prior work shows that the combination of solCD44 and protein levels in oral rinses can distinguish head and neck squamous cell carcinoma (HNSCC) cases from controls.22-23
Vanderbilt Researchers Develop Antibodies to Fight Chikungunya Virus
Vanderbilt University Medical Center’s James Crowe, M.D., Ann Scott Carell Professor and director of the Vanderbilt Vaccine Center, and his team are reporting the first large panel of antibody treatments against this disease in the current issue of Cell Host and Microbe. With a few ounces of blood from a previously infected person, researchers find chikungunya antibody- secreting cells, and then those cells are processed to retrieve their DNA and antibody genes. The team started about two years ago acquiring blood from people who had chikungunya as children and has isolated 3 dozen chikungunya antibodies so far. “Amazingly even decades after an infection, people still have cells in their blood making antibodies for chikungunya,” Crowe said. Crowe’s lab is also working on antibodies to Ebola and Marburg viruses.
Blood Test Could Identify Diabetes Decades Before It Develops
Scientists at the MRC’s Clinical Sciences Centre (CSC) in West London are the first to show that a small molecule circulates in the blood of people who are in the early stages of type 1 diabetes. A simple blood test could detect this biological marker years, maybe decades, before symptoms develop. “If we can identify and treat patients earlier, we may be able to help them to avoid secondary complications. This could ultimately extend a patient’s life,” said Mathieu Latreille, who leads the CSC’s Cellular Identity and Metabolism research group, and who carried out the research in collaboration with scientists at the Swiss Federal Institute of Technology. Latreille presented the results to doctors at Hammersmith Hospital this month. Until now, scientists have been unable to identify a microRNA that is linked to the pancreas. But Latreille and team have shown that a particular molecule, called microRNA 375, is released by the very cells in the pancreas that produce insulin.
Genetic Test May Help Spot Male Fertility Problems
A new genetic test for sperm could help determine whether a couple should resort to in vitro fertilization to conceive a child, researchers say. Men whose sperm lack critical RNA elements tend to have lower chances of naturally conceiving a child, according to study findings published July 8 in the journalScience Translational Medicine. An RNA analysis of a potential father's sperm can tell fertility doctors whether a couple should skip less-invasive treatments and go straight to assisted reproductive technology (ART), in which eggs are combined with sperm in the laboratory to achieve fertilization, the study's authors said. "The absence of one or more of these RNA elements was indicative of those who would be successful by ART, which is a more invasive technique, versus those who would be successful by timed intercourse or intrauterine insemination, which is less invasive," said study lead author Stephen Krawetz. He is a professor of fetal therapy and diagnosis and associate director of the C.S. Mott Center for Human Growth and Development at Wayne State University School of Medicine in Detroit.
Mayo Researchers Develop MP-seq Test to Detect Rearrangements in Cancers, Genetic Disease
Researchers at the Mayo Clinic have devised a next-generation sequencing technique for detecting rearrangements and are in the process of developing clinical tests for hematological malignancies, breast cancer, and constitutional disease. George Vasmatzis, co-director of the biomarker discovery program at Mayo's Center for Individualized Medicine, described the strategy at last month's Clinical Genome Conference in San Francisco. He told GenomeWeb in a follow-up interview that Mayo would launch a clinical test based on the technique in the next six months to a year for hematological and constitutional diseases, and a year later for solid tumors. Currently, multiple techniques, including FISH, PCR, and array CGH, are used to identify such rearrangements and fusions in blood-based cancers. But, MP-seq "can replace all three techniques and resolve very well what's going on in the genome," Vasmatzis said.
“Safer” Replacements for Harmful Chemical in Plastics May Be as Risky to Human Health, Studies Suggest
According to a new series of studies out of NYU Langone Medical Center, two chemicals increasingly used during manufacturing to strengthen plastic wrap, soap, cosmetics, and processed food containers have been linked to a rise in risk of high blood pressure and diabetes in children and adolescents. “Our research adds to growing concerns that environmental chemicals might be independent contributors to insulin resistance, elevated blood pressure and other metabolic disorders,” says study lead investigator Leonardo Trasande, MD, an associate professor of pediatrics, environmental medicine, and population health at NYU Langone. Trasande says the series of studies are believed to be the first to examine potential health risks from DEHP replacements. In the most recent one, described in the journal Hypertension online July 8, the investigators report a “significant association” between high blood pressure and the presence of DINP and DIDP levels in study subjects. In the earlier study, published in May in the Journal of Clinical Endocrinology and Metabolism, the same NYU Langone investigators found an association between DINP and DIDP concentrations and increased insulin resistance, a precursor to diabetes. “Alternatives to DIDP and DINP include wax paper and aluminum wrap; indeed, a dietary intervention that introduced fresh foods that were not canned or packaged in plastic reduced phthalate metabolites substantially,” says Trasande.
The Iron Alzheimer’s Connection
Levels of ferritin in cerebrospinal fluid (CSF) are independently related to cognitive performance and predict progression from mild cognitive impairment (MCI) to Alzheimer’s disease, according to a new study by Australia-based Alzheimer’s disease Neuroimaging Initiative (ADNI) researchers published in Nature Communications. Ferritin levels also were strongly associated with apolipoprotein E (APOE) levels and were elevated by the Alzheimer’s risk allele, APOE-ε4. The findings introduce brain iron elevation as a possible mechanism for APOE-ε4 being the major genetic risk factor for Alzheimer’s disease, according to the researchers.

Public Health and Patient Safety

Study Reignites Calls for Worldwide Controls on Sugary Drinks
A report that blames sugary drinks for almost 200,000 deaths worldwide every year has just been published in Circulation, with the authors emphasizing "a need for strong, global prevention programs. This isn't just rich countries," said senior author Dariush Mozaffarian, MD, Dr PH, dean of the Friedman School of Nutrition Science and Policy at Tufts University, in Boston, Massachusetts. "It's especially happening in the middle-income countries." The research, based on surveys of more than 600,000 people, was first presented as an abstract at the American Heart Association Council on Epidemiology and Prevention in 2013, as reported by Medscape Medical News.
Study Identifies Factors Affecting Prescription Pain Reliever Misuse
People who misuse prescription pain relievers all have one thing in common, University of Georgia researchers have discovered: a history of recent illicit drug use. How they acquire such drugs varies according to age, however. The findings, published in the journal Addictive Behaviors, may help health care providers and others curb painkiller misuse. In a nationwide study, researchers from the UGA School of Social Work found that individuals of any age who used illicit drugs such as marijuana, cocaine or heroin within the past year had a higher likelihood of misusing prescription pain relievers as well. A study just released by the Centers for Disease Control, which found that heroin use was highest among those who abused cocaine or opioid pain relievers within the past year, buttressed the UGA research. "Male or female, black or white, rich or poor, the singular thing we found was that if they were an illicit drug user, they also had many, many times higher odds of misusing prescription pain relievers," said Orion Mowbray, an assistant professor in the School of Social Work and the UGA study's lead author.
CDC: Opioid Prescribing Has 'Primed' Americans for Heroin Addiction
CDC Director Dr. Thomas Frieden said there's an incorrect perception that reducing opioid-painkiller prescriptions leads to a rise in heroin addiction. Both drugs are “essentially the same chemical” and have the same effect on the brain, but the street price of heroin has been about five times less than the price of opioids. “It's heartbreaking,” Frieden said of the resurgence of injected drugs. The CDC issued a Vital Signs report Tuesday that compares heroin trends from 2002 through 2013. The good news, Frieden said, is that treatment works—but it requires a society-wide effort. States need to improve prevention and treatment, and make overdose intervention drugs such as Narcan (or naloxone) more widely available. In New Jersey, several hospitals provide free Narcan to police departments so officers have the drug when they encounter someone suffering an overdose. Patients with terminal cancer pain or acute pain from a car accident need to have access, Frieden said. But he said other methods such as heat, ice, “localized measures,” or physical therapy should be tried first for chronic, non-cancer-related pain. Jones said opioids should be considered if those methods are not effective, not tolerated or not adequate.
New Law Expands List of Vaccines Available in Pharmacies
You can go to your local pharmacy to get a tetanus shot or get vaccinated for foreign travel, thanks to a new law that took effect July 1. So far, Florida pharmacists could only administer vaccines for flu, pneumonia and shingles. The new law allows them to administer all adult vaccines that are recommended by the Centers for Disease Control and Prevention, such as measles, mumps, rubella (MMR); the tetanus, diphtheria and pertussis (Tdap) vaccine; human-papillomavirus vaccines; hepatitis A and B vaccines; and vaccines needed for travel or in case of an emergency. The law brings Florida in line with 42 other states that already give such authorization to pharmacists. "The society gets its biggest health benefit from clean water, good prenatal care and vaccination. So this is one of those things we should have accessible," said Rep. Cary Pigman, R-Sebring, who sponsored House Bill 279. "If you're a healthy person and you want to get a measles vaccine, why do we require you to see a doctor before you do that?" said Pigman, who is a practicing emergency physician.
Is There a Killer Squirrel Virus?
Three squirrel breeders in Germany likely died of a novel virus they caught from the animals, researchers said. Over a 2-year period, the three men developed progressive encephalitis or meningoencephalitis that led to death within 2 to 4 months, according to Martin Beer, DVM, of the Friedrich-Loeffler-Institut in Greifswald-Insel Riems, Germany, and colleagues. The men, all from the German state of Saxony-Anhalt, bred variegated squirrels, a species native to Central and southern North America that is kept as an exotic pet in Europe, Beer and colleagues reported in the New England Journal of Medicine. Genomic analysis found a previously unknown bornavirus in a contact squirrel and in brain tissue from the three men, the researchers reported, and it is the "likely causative agent" in their deaths. The known bornavirus species infect a range of warm-blooded animals, from birds to primates, and are currently not thought to be responsible for human disease, Beer and colleagues noted.
Promise Is Seen in an Inexpensive Cholera Vaccine
An inexpensive, little-known cholera vaccine appears to work so well that it can protect entire communities and perhaps head off explosive epidemics like the one that killed nearly 10,000 Haitians in 2010. A major study published in The Lancet found that the vaccine gave individuals more than 50 percent protection against cholera and reduced life-threatening episodes of the infection by about 40 percent in Bangladesh, where the disease has persisted for centuries. In a result that surprised researchers, the vaccine worked far better than supplying families with chlorine for their water and soap for hand-washing. “In the last five years, the conversation has switched from ‘We shouldn’t use vaccine’ to ‘How can we use it best?’ ” Dr. Eric Mintz, a cholera expert at the Centers for Disease Control and Prevention, said the study “shows that the vaccine is feasible for government medical care.”
DNA Sequencing Helps FDA Project Combat Seafood Fraud
In the 1990s, the U.S. Food and Drug Administration (FDA) used proteins to identify seafood, but the profiling method could only match to a standard sample. They had to have frozen tissues from all of the species they wanted to compare and the agency did have a collection to work with, but no matter how well you store the fish used as standards, their proteins tend to break down after about 10 years, so FDA began to lose the ability to identify seafood species in 2000. At the end of June, the U.S. Department of Health and Human Services awarded one of its seven 2015 innovation awards to FDA’s Fish SCALE (Seafood Compliance and Labeling Enforcement) project for transitioning the agency toward new DNA barcoding. The FDA team collaborated with Guelph and the Smithsonian’s Laboratories of Analytical Biology to standardize, validate, and publish a protocol for DNA barcoding for fish species. They then implemented it throughout the agency so that nine of FDA’s field laboratories across the country now use the identification method. The patterns in DNA don’t change. “So now, instead of a frozen tissue standard, all you have is that reference sequence, which can be attached to an email,” says Jonathan Deeds, principal investigator for Fish SCALE.
Hospital Death Rates Support the 'Weekend Effect' Phenomenon
Patients in several developed countries who are admitted to hospitals on Saturdays and Sundays are more likely to die within 30 days than patients with similar conditions who are hospitalized during the week, according to a new study published in BMJ Quality & Safety. The weekend effect phenomenon is well-known in the United States but also occurs in other countries, researchers found. This study used data from the Global Comparators Project to examine nearly three million admissions during the weekend between 2009 and 2012 from 28 hospitals in England, the United States, Australia and The Netherlands, focusing on deaths that occurred within 30 days of emergency admission or planned surgery. The chance of death was 8 percent higher in 11 hospitals in England, 13 percent greater in five hospitals in the United States and 20 percent more likely in six Dutch hospitals. In Australia, the link between emergency admissions and weekends was apparent within seven days but not weeks later.

Health IT

New Standard Seeks to Alleviate Challenges of Sharing Bioinformatics Tools and Workflows
Hoping to alleviate some of the difficulties associated with accessing and running bioinformatics resources, a group of researchers within the computational community came together last year, volunteering their time and expertise to develop standardized language for describing tools and workflows. The Common Workflow Language (CWL) provides standard specifications for describing analysis tools and workflows that frees them from ties to single platforms and systems based on more restrictive formats. If the standard is picked up and adopted by the community, it could make it easier and less tedious for tool authors to pass their pipelines around as well as to install and run them on multiple workflow platforms. The CWL working group, which spans both industry and academia, met for the first time last year during Codefest, an informal two day coding meeting that takes place annually prior to the start of the Bioinformatics Open Source Conference, one of several special interest group meetings that are part of the Intelligent Systems for Molecular Biology conference. 
Congress Gets another Chance to Advance Telemedicine
A new version of a bill designed to phase in telemedicine for Medicare beneficiaries is back on the table in Washington. Rep. Mike Thompson, D-Calif., introduced the Medicare Health Parity Act of 2015 on July 7. Co-sponsors of the bill are Reps. Gregg Harper, R-Miss., Diane Black, R-Tenn., and Peter Welch, D-Vt. “Both patients and providers want telehealth for two simple reasons – it saves money and saves lives,” Thompson said in a press release. “Telehealth allows physicians to provide more patients with better healthcare, but while we’ve witnessed much advancement in the field of telemedicine, our policies still lag behind. By passing this commonsense, bipartisan bill we can expand telehealth services and make sure the best care and the best treatments are available to all Americans, no matter where they live.” According to Thompson, it would
  • Remove geographic barriers and push telehealth into rural, underserved and metropolitan regions;
  • Add respiratory therapists, physical therapists, occupational therapists, speech language pathologists and audiologists to the list of providers eligible to provide telehealth services;
  • Enable patients with chronic conditions such as diabetes, heart failure and COPD to take advantage of remote patient monitoring services;
  • Expand access to telestroke services; and
  • Include the patient's home as an allowable site of care for home health services, certain outpatient mental health services, hospice care and home dialysis.
CMS Encourages EHR Adoption in CY 2016 Home Health PPS Proposed Rule
At the end of June, CMS released a proposed rule outlining the CY 2016 Home Health Prospective Payment System update. Included in the proposed rule is another push for EHR adoption. Home health providers can't receive federal incentives for meaningful use of EHRs and health IT systems, but CMS says that the adoption and implementation of health IT tools even in this setting will help foster and support healthcare quality improvement. The rule points to the ONC's Interoperability Roadmap and the 2015 Interoperability Standards Advisory as tools for home health providers to implement IT systems and exchange data.

Other News

Eurofins Continues Purchases with Emory Genetics Joint Venture
Global bioanalytical testing giant Eurofins Scientific (Luxembourg) and Emory University’s Emory Genetics Laboratory (EGL; Atlanta, Ga.) have entered into a joint venture.  As part of the deal, Eurofins will acquire a 75 percent stake in EGL for approximately $40 million. Post-closing, the joint venture company will be renamed EGL Genetic Diagnostics. EGL performs testing for rare genetic disorders, including gene panel testing for inherited genetic diseases, cancer testing, and exome sequencing for personalized medicine. It also serves as the follow-up laboratory for Georgia’s newborn screening program. The laboratory conducts over 35,000 tests annually for genetic diseases, carrier testing, and prenatal testing, with more than 80 percent of its analytical portfolio consisting of "first-to-market tests." EGL claims to have been the first academic laboratory to bring next-generation sequencing to the genetic testing market. The laboratory has a staff of 100 and currently serves 400 institutional clients, including hospitals and commercial laboratories.
Proteus Swallowable Smart Pills FDA Approved to Measure Medication Adherence
Proteus Digital Health won FDA approval for what the company calls “the only device with an FDA-sanctioned claim for measuring medication adherence.” Proteus technology uses tiny ingestible sensors attached to drug tablets and a patch that can detect when they’ve been swallowed. The patch then uses its built-in Bluetooth antenna to share when every pill was swallowed with the matching smartphone app, which in turn passes the readings to family, caretakers, and the patient’s physician. The underlying technology has been approved by the FDA since 2012, but the ability to accurately record when every pill was swallowed has only now been FDA-sanctioned to be used to measure medication adherence.
European Scientists Separate Medical Benefits of Cannabis from Some Unwanted Side Effects
Scientists at the University of East Anglia, University of Barcelona, University Pompeu Fabra and several other European institutions have found a way to separate the medical benefits of cannabis from some of its unwanted side effects. The research comes from the team that had previously discovered how the main psychoactive ingredient in cannabis, known as tetrahydrocannabinol or THC, reduces tumour growth in cancer patients. Their latest findings, publishing on in the Open Access journal PLOS Biology, reveal how some detrimental cognitive effects of THC are triggered by a pathway which is separate from some of its other effects. That pathway involves both a cannabinoid receptor and a serotonin receptor. When it is blocked, THC can still exert several beneficial effects - including pain relief - while avoiding impairment of memory. The research was carried out in mice, but it is hoped that the breakthrough will pave the way for safe cannabis-based therapies that do not cause alterations in mood, perception or memory.

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