DLS|HEALTHCARE NEWS|April 16, 2015
A Weekly Compilation of Clinical Laboratory and Related Information
From The Division Of Laboratory Systems
April 16, 2015
News Highlights
Leading News
Clinical Laboratories and Research Organizations Are Racing to Get Low-Cost, Handheld DNA Analyzers to Market
Data Holds Key to Unlocking Population Health
African CDC to Open in 2015
Laboratory Testing / Diagnostics
Aetna, Cigna Balk as Angelina Effect Spurs Genetic Cancer Testing
Genetic Screening Could Improve Breast Cancer Prevention
Lymph Node Dissection Rates High for Some Women with DCIS
Research and Development
Kaiser Enrolling 15,000 Participants in Autism Family Research Bank to Study Gene, Environment Links
Which Came First – The Egg or the Diabetes?
Metagenomic Analysis Finds Ancient TB Victims Harbored Multiple Bacterial Strains
Public Health and Patient Safety
FDA Plans to Speed Device Approvals for Sickest Patients
California Drought Leads to Increase in West Nile Virus Cases
FDA Advisory Committee Hesitates to Endorse Message of Safe Smokeless Tobacco
Health IT and Other
ONC Targets 'Information-Blocking' but Has Few Weapons for the Fight
Why Patient Engagement May Just Save Your Life
Connected Medical Devices Remain Vulnerable to Cyber Attacks
View Previous Issues - Healthcare News Archive
Leading News
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Clinical Laboratories and Research Organizations Are Racing to Get Low-Cost, Handheld DNA Analyzers to MarketIn the past year, four research organizations, including one in the United States, one in New Zealand, and two in the U.K., have unveiled several devices that will analyze DNA in the field. This line of research is of particular interest in developing countries where resources such as electricity for refrigeration are scarce. Some of the DNA testing devices will produce results in minutes to hours, eliminating the need to return to a clinical laboratory to analyze samples. Collectively, these research and development initiatives demonstrate the rapid pace of development of portable devices that can analyze DNA. The obvious target for these researchers is to make DNA sequencing a point-of-care tool for use in developing countries and other areas where medical care is scarce.
Source: http://www.darkdaily.com/
Data Holds Key to Unlocking Population Health
"No longer is the data storage repository in healthcare the doctor's brain," said Paul Grundy, MD, founding president of the Patient-Centered Primary Care Collaborative and IBM’s Director of Global Healthcare Transformation. Grundy delivered the opening keynote of the day-long Clinical & Business Intelligence Symposium at HIMSS15 on Sunday, which explored the ways patient and claims data are being put to work driving efficiencies and improving care for populations. Known as the "godfather of the patient-centered medical home," Grundy made the case that unsustainable costs and unacceptable patient safety numbers ("we lose two 747 planeloads of people a day in this country because of medical errors") mean it's imperative to start putting electronic health records to work on a wide scale.
Source: http://www.healthcareitnews.com/
African CDC to Open in 2015
Secretary of State John Kerry signed an agreement Monday to help establish a Centers for Disease Control and Prevention (CDC) in Africa. The memorandum of cooperation, signed by Kerry and African Union Commission (AUC) Chairperson Nkosanzana Dlamini Zuma, makes formal the relationship between the United States CDC and AUC, and mandates the establishment of an African CDC. The new institute, set to launch in 2015, will work to prevent and respond to future outbreaks in the continent, like the Ebola epidemic.
An African Surveillance and Response Unit will be established with an emergency operations center. Five regional centers will also be identified with a coordinating center in Ethiopia’s capital, Addis Ababa.
Source: http://time.com/
Laboratory Testing / Diagnostics
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Aetna, Cigna Balk as Angelina Effect Spurs Genetic Cancer Testing
Medical researchers call it the "Angelina Effect," the surge in demand for genetic testing attributable to movie star Angelina Jolie's public crusade for more aggressive detection of hereditary breast and ovarian cancer. But there's a catch: Major insurance companies are declining to pay for the latest generation of tests, known as multi-gene panel tests, Reuters has learned. All insurers cover screenings for BRCA1 and BRCA2 and for certain other genes for women who have family histories of cancer. Indeed, such coverage is mandated by the Affordable Care Act, known as Obamacare. "The utility of panel testing is that we know there are a lot more genes beyond BRCA1 and BRCA2 that are associated with cancer predisposition," said Colin Pritchard, a University of Washington geneticist. "In general, the trend is moving toward more genes,” said Carin Espenschied, a senior products manager at Ambry and a genetic counselor. "Research and insurance companies kind of just have to catch up."
Source: http://www.reuters.com/
Genetic Screening Could Improve Breast Cancer Prevention
A test for a wide range of genetic risk factors could improve doctors’ ability to work out which women are at increased risk of developing breast cancer, a major study of more than 65,000 women has shown. Improving the accuracy of risk analysis using genetic screening could guide breast cancer prevention in several ways – for instance by offering high-risk women increased monitoring, personalised advice and preventative therapies. The research, a collaboration of hundreds of research institutions led by The Institute of Cancer Research, London, and The University of Cambridge, showed that a test for differences in 77 separate letters of DNA code could indicate a woman’s risk of developing breast cancer.
A woman in the top 1 per cent for the polygenic risk score was more than three times more likely to develop breast cancer than average – corresponding to a risk for these women of around one in three. Lifetime risk of breast cancer for women with a history of breast cancer in their close family was 24.4 per cent if they were in the highest-scoring fifth – compared with 8.6 per cent if they were in the lowest fifth.
Source: http://www.technologynetworks.com/
Lymph Node Dissection Rates High for Some Women with DCIS
There has been an increase in the incidence of ductal carcinoma in situ (DCIS) on screening mammography. However, some women undergoing mastectomy or breast conservation surgery (BCS) following a DCIS diagnosis also undergo axillary lymph node evaluation — against National Comprehensive Cancer Network (NCCN) and the American Society of Clinical Oncology (ASCO) guidelines. In an article published online April 9 inJAMA Oncology, researchers from the Columbia University Medical Center, in New York City, report on the prevalence of axillary lymph node evaluation in women with a biopsy-proven diagnosis of DCIS. They report that 29.2% of 35,591 women with DCIS undergo an axillary evaluation — sentinel lymph node biopsy (SLNB) or full axillary lymph node dissection (ALND).
"This was an eye-opener," corresponding author Dawn L. Hershman, MD, of the Herbert Irving Comprehensive Cancer Center at Columbia University, told Medscape Medical News. "Almost 1 in every 5 women undergoing BCS received axillary evaluation despite recommendations against this practice by both NCCN and ASCO." "We need a better understanding of who needs these procedures," she added.
Source: http://www.medscape.com/viewarticle/842885
Future Blood Test for Osteoarthritis Uses Current Assays
Elevated citrullinated proteins (CPs), a biomarker linked to early rheumatoid arthritis (RA), are also found in patients with early-stage osteoarthritis (OA) – and could be used in a blood test to detect OA years before radiographic damage appears, say these authors. Research at the University of Warwick UK finds high levels of CPs in patients with early OA and early RA, but autoimmune-linked anti–CCP antibodies (anti-CCPs) occur mostly in early RA. Anti-CCPs are not present in even advanced OA. Combined in a single assay, three biomarkers—CPs, anti-CCPs, and the bone-derived substancehydroxyproline (Hyp)—could help distinguish between OA and RA early enough to prevent joint damage, the researchers say.
Source: http://www.rheumatologynetwork.com/
Mayo Clinic Launches Eight Genetic Testing Panels for Cardiac Disorders
Mayo Clinic’s launch of eight new next-generation sequencing (NGS) panels is intended to improve the lives of patients and families living with inherited cardiac conditions by aiding in the diagnosis and management of these complex disorders. These disorders include hypertrophic cardiomyopathy, dilated cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, Noonan syndrome, Marfan syndrome, long QT syndrome, and Brugada syndrome. The tests, which identify inherited variants across numerous genes associated with cardiac disorders, are now available to Mayo Clinic patients and to providers worldwide through Mayo Clinic via Mayo Medical Laboratories. Collaboration among clinicians and laboratory scientists has also been central to the development of these tests. Testing is conducted in two CLIA-certified laboratories at Mayo: the Clinical Genome Sequencing Laboratory and the Personalized Genomics Laboratory within the Mayo Clinic Department of Laboratory Medicine and Pathology.
Source: http://newsnetwork.mayoclinic.org/
Sensory Pen Diagnoses Parkinson's Disease
Manus Neurodynamics (Newcastle-upon-Tyne) has created a unique sensory pen that has the ability to analyse voluntarily movements for the presence of Parkinson's disease and essential tremor. The research group uses a simple diagnostic test that entails patient completion of writing and drawing tasks on an adapted tablet computer. Currently, Parkinson's disease is diagnosed via a DaTSCAN, which involves injection of a visual imaging agent in order to facilitate differentiation between Parkinson's syndrome and other essential tremors. It is only available in a hospital setting and requires scanning equipment and highly trained staff. The sensory pen, on the other hand, has the potential to provide a low cost, noninvasive test that can be used with minimal training, according to the developers.
Source: http://www.emdt.co.uk/print/3992
Research and Development
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Kaiser Enrolling 15,000 Participants in Autism Family Research Bank to Study Gene, Environment Links
Kaiser Permanente has unveiled an ambitious plan to corral 15,000 individuals into a database over the next three years that researchers can use to investigate the genetic and environmental factors involved in autism spectrum disorders. Last week Kaiser announced that its Autism Research Program received a $4.6 million grant from the Simons Foundation to create a database of 5,000 family trios — an autistic individual under age 26 and his or her biological parents — over the next 36 months. The so-called Autism Family Research Bank will contain de-identified genetic, medical, and environmental information on these trios that researchers can use to advance their understanding of the complex condition and possibly apply to the development of treatments. Another effort, the MSSNG project, being conducted by Autism Speaks, The Hospital for Sick Children in Toronto, and Google, is aiming to collect whole-genome sequencing and phenotypic data on 10,000 individuals from families affected by autism.
Source: https://www.genomeweb.com/
Which Came First – The Egg or the Diabetes?
Men who ate more than five eggs a week had a lower risk of developing type 2 diabetes than men who ate about one a week only, according to researchers in Finland. In a study with an average follow-up of almost 20 years with 2,332 participants, researchers noticed that those in the highest quartile for egg intake had a lower risk of developing diabetes than those in the lowest quartile (hazard ratio 0.55, 95% CI 0.38-0.79; P=0.001) when cholesterol and other factors were controlled for. Four hundred and thirty two men were found to have developed diabetes. "These findings suggest that the recommendations to limit the consumption of eggs (or any food) in a general health population should not be based on a single component in food, such as the cholesterol in eggs," wrote the authors, led by Jyrki Virtanen, PhD, an adjunct professor at the University of Eastern Finland. They published their results last week in The American Journal of Clinical Nutrition.
Source: http://www.medpagetoday.com/
Metagenomic Analysis Finds Ancient TB Victims Harbored Multiple Bacterial Strains
As they reported in Nature Communications today, Warwick's Mark Pallen and his colleagues collected DNA samples from more than two dozen people buried in a Hungarian churchyard in the 1700s. After aligning sequences obtained from TB victims against the Mycobacterium tuberculosisgenome and constructing a phylogenetic tree, the researchers found that the most common ancestor of this lineage could be traced back to the late Roman period. These 14 historical tuberculosis sequences all harbored a seven-basepair deletion that's found in the Euro-American M. tuberculosislineage, also known as Lineage 4. With a new algorithm called MGplacer, the researchers then added the low-coverage historical genomes onto the phylogenetic tree. Their results, they noted, indicated that there were at least 12 different strains of tuberculosis circulating in 18th century Hungary.
Source: https://www.genomeweb.com/
Single POC Test Detecting HIV Antibodies, Viral RNA in Development
The NIH has awarded $335,000 to the New York University College of Dentistry for the development of a single point-of-care test able to detect HIV/AIDS antibodies and viral RNA from one specimen, according to a press release.
“Current HIV corroborative testing requires considerable time and cost, and is often not available in remote geographic areas,” Daniel Malamud, PhD, professor of basic science and craniofacial biology and director of the HIV/AIDS Research Program at NYUCD, said in the press release. “As a result, many individuals with a positive antibody screening test opt out of taking the corroborative test. Our research aims to address this problem through the development of an affordable, easy to use POC test, capable of detecting pathogen nucleic acids and antibodies to the pathogens in less than one hour.”
Source: http://www.healio.com/
HIV: New Approach against Virus 'Holds Promise'
The first human trial of a new type of HIV therapy suggests it could be a promising weapon in the fight against the virus. Reports in the journal Natureshow infusions of so-called broadly neutralising antibodies could suppress the amount of HIV in a patient's blood. The approach uses clones of immune proteins taken from a rare individual who has natural control of the disease. Scientists hope with further work this could bolster current treatments.
People naturally mount a defence against the virus by producing an army of protein based weapons - antibodies. But in most cases these are not powerful enough to defeat it. The international research team harvested copies of unusually potent ones, capable of neutralising many different strains of HIV. In the journal the authors said: "Our data establish that passive infusion of single broadly neutralising antibodies can have profound effects on HIV viraemia in humans." They are now exploring whether the infusion could shield people from getting the disease in the first place.
Source: http://www.bbc.com/
New Ebola Study Points to Potential Drug Target
Opening the door to potential treatments for the deadly Ebola virus, scientists have found that a protein made by the virus plays a role similar to that of a coat-check attendant. The protein removes a protective coat from the virus’s genetic material, exposing the viral genome so that it can be copied, and then returns the coat, according to a new study led by scientists at Washington University School of Medicine in St. Louis. The research, in cell cultures, showed that interfering with this process kills the virus. As part of the study, the researchers introduced rogue coat-check attendants into Ebola-infected cells. These rogue attendants carried a short chain of amino acids that forms the part of the protein that removes the coat. But they lacked the ability to return the coat, disrupting the emergence of newly created viruses from infected cells. Consequently, the virus did not survive.
“This coat-check protein, known as VP35, has a great deal of potential as a new target for Ebola treatments,” said senior author Gaya Amarasinghe, PhD, assistant professor of pathology and immunology at the School of Medicine. “If we can block this process, we can stop Ebola infection by blocking viral replication.” The study appears April 9 in Cell Reports.
Source: http://news.wustl.edu/
Cornell Researchers Identify Gut Microbes that May Help Some People Remain Thin; Findings Could Result in Clinical Laboratory Tests to Analyze the Microbiomes of Individuals
The Cornell study was published in November 2014 in the journal Cell. It spotlights one bacterial taxon, the family Christensenellaceae, which was only named in 2012. That makes it a relatively new subject for researchers in the booming human microbiome sector. Ruth Ley, Ph.D., is a Cornell University Associate Professor of Microbiology, and the research paper’s senior author. She believes the new Cornell study makes clear the connection between the human genotype and health-associated gut bacteria. “If you look across the population [of gut bacteria] and explain abundances, there is a host genetic component,” Ley said in a Cornell University news release. “Up until now there had been no direct evidence that anything in the human gut is under that kind of [genetic] influence.”
In addition to identifying many microbes, such as Christensenellaceae and its partners that were enriched in people with low body mass index researchers were able to reduce weight in germ-free mice by introducing the gut bacteria Christensenellaceae minuta. While the Cornell study is one of the first to show that genetics plays a role in the bacteria that regulate weight gain, the scientific community says more research is needed to prove a connection between specific bacteria and weight gain.
Source: http://www.darkdaily.com/
Public Health and Patient Safety
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FDA Plans to Speed Device Approvals for Sickest Patients
“In weighing the benefits and risks of new technologies for [patients with life-threatening or irreversibly debilitating conditions], we understand the need to place greater weight on the benefit of earlier access, and to also account for the risks of delayed access,” writes CDRH director Jeffrey Shuren, MD on the FDA website. To address the problem, the agency is developing an Expedited Access Program (EAP), which is designed to accelerate the path to market for devices intended to treat the sickest patients. The agency states that the EAP does not constitute a new pathway to market. Instead, it is a new approach intended to both speed premarket review and product development timelines. If a product qualifies for the program, the agency will commit to working with the device maker earlier and more often than it ordinarily would.
Source: http://www.qmed.com/
Total Annual Hospital Costs Could Be Reduced by Rapid Candidemia Identification
A new study describes a model that estimates the economic consequences of using the T2Candida® Panel (a novel diagnostic product that provides Candida detection) as an adjunct to the current blood culture-based diagnostic strategy in a high-risk hospital patient cohort. The T2Candida Panel is the first diagnostic test to provide species-specific Candida detection and identification directly from whole blood in 3 to 5 hours, without the need for blood culture. It estimates that a typical hospital could save as much as $5,858,448 in total annual hospital costs. Using a decision tree model, the economic effect of using this diagnostic strategy over 1 year in a hospital setting was calculated. It also calculated Candida-related deaths per hospital could be reduced by 60.6%. The study was published online ahead of print in Future Microbiology.
Source: http://www.medicalnewstoday.com/
California Drought Leads to Increase in West Nile Virus Cases
The drought may be to blame, due to limited water sources for birds and disease-carrying mosquitoes. “As birds and mosquitoes sought water, they came into closer contact and amplified the virus, particularly in urban areas," said Karen Smith, director and state health officer of the California Department of Public Health. "The lack of water could have caused some sources of water to stagnate, making the water sources more attractive for mosquitoes to lay eggs.” Of the 801 total cases in California, 561 patients developed a serious neurological form of the disease, which can often result in swelling of the brain. Thirty-one cases were fatal, a rate exceeding previous years.
Source: http://www.latimes.com/
FDA Advisory Committee Hesitates to Endorse Message of Safe Smokeless Tobacco
In a key vote, the eight-member FDA's Tobacco Products Scientific Advisory Committee split 4-4 on whether the claim that snus offers a "substantially lower risk" claim relative to cigarettes is justified. The committee was unmoved by the firm's evidence related to gum disease and tooth loss and voted 8-0 against supporting a conclusion that snus products "do not pose a risk of gum diseases or tooth loss." Or as Thomas Novotny, MD, MPH, the graduate school of public health at the University of California San Diego State said, when explaining his vote, "It’s not causal relationships that we're after, it's perception of risk and the studies don't rule that out." Pebbles Fagan, PhD, MPH, associate professor and member of the Cancer Prevention and Control Program at the University of Hawaii, said that based on the absence of women in the larger cohort studies, she was not comfortable claiming that snus products posed no risk of oral cancer. Another subpopulation of obvious concern is adolescents. Timothy McAfee, PhD, MPH, director of the Office on Smoking and Health at the CDC, cited animal studies on tobacco addiction that showed "deleterious effects on adolescent brain development." On the plus side for Swedish Match, the majority of the committee felt it unlikely that nonusers of tobacco would pick up the snus habit, although three committee members abstained from this question because they did not believe there was enough data to support such a scenario.
Source: http://www.medpagetoday.com/
What's Next for the Thousands of Angry Men Suing over Testosterone?
More than 1,340 angry men who tried testosterone supplementation to treat their “Low T”—and who believe they were harmed as a result—have joined a collection of lawsuits pending in the U.S. District Court in the Northern District of Illinois against seven companies involved in the marketing of the hormone. Now what? Although the consolidated suit against testosterone makers is a massive 128 pages, the major complaint can be summed up in one sentence: Testosterone is only FDA-approved to treat hypogonadism, a drastic hormonal decline caused by injury or disease, and by marketing it beyond that use, the suits allege, the companies endangered healthy men.
The FDA has already made some of the changes that lawyers representing testosterone patients hoped would come out of the suits, Johnson says. In March, the agency ordered that labels be revised to clarify what the proper use of testosterone is, and to include the increased risk of cardiovascular events. The FDA is also requiring testosterone makers to conduct clinical trials to better define those risks.
Source: http://www.forbes.com/
Ebola Survivors at Risk of Eye and Joint Problems Say WHO
Many Ebola survivors are likely to face further health issues including eye and joint problems, the World Health Organization warns. The organization said this had not received enough attention so far. It added there had been "real, substantive progress" in the drive to end the outbreak in the last few weeks. But the crisis still constitutes a public health emergency of international concern, according to WHO experts. The WHO also announced it had set up clinics in Sierra Leone, Liberia and Guinea to monitor the health consequences Ebola survivors face.
Source: http://www.bbc.com/
Rise of Deadly Radon Gas in Pennsylvania Buildings Linked to Fracking Industry
Writing in the journal Environmental Health Perspective, researchers analyzed levels of radon — a colorless, odorless gas that is radioactive and has been linked to lung cancer — in 860,000 buildings from 1989 to 2013. They found that those in the same areas of the state as the fracking operations generally showed higher readings of radon. About 42 percent of the readings were higher than what is considered safe by federal standards. Moreover, the researchers discovered that radon levels spiked overall in 2004, at about the same time fracking activity began to pick up. In response to the Pennsylvania study, Energy in Depth, a program of the Independent Petroleum Association of America, issued a statement pointing out issues with the research.
Source: http://www.washingtonpost.com/
Asbestos Use in Asia Poses Serious Health Dangers
The use of asbestos continues to increase in Asia despite clear health hazards. A recent Respirology review notes that with approximately 4.3 billion people and a growing population, Asia will likely see a large crop of asbestos-related lung diseases in the next few decades.
Source: http://www.medicalnewstoday.com/
Health IT
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ONC Targets 'Information-Blocking' but Has Few Weapons for the Fight
Federal health IT officials are calling out providers and technology vendors for business practices that block the electronic transfer of patient information. HHS' Office of the National Coordinator for Health IT issued a report to Congress (PDF) saying that a variety of practices it dubs “information blocking” are common. But the ONC also says it can't quantify the extent of the problem and is limited in its ability to respond to it. The agency said it received about 60 unsolicited reports of information blocking in 2014. The practices include excessive costs for information-sharing; a lack of contract transparency for technology buyers, who may not appreciate the costs of sharing information; efforts by vendors to make it difficult to download information from EHRs and port their systems to competitors' systems; and collusion between providers and vendors to prevent information from following to other software systems or healthcare providers. But, acknowledged ONC head Dr. Karen DeSalvo, we "don't have a lot of quantified information right now.”
“To the degree there's information blocking, and that it can be exposed, that's a good thing,” said Jitin Asnaani, the executive director of the CommonWell Health Alliance, a group of EHR vendors formed to promote data-sharing in the healthcare system.
Source: http://www.modernhealthcare.com/
Why Patient Engagement May Just Save Your Life
If you request a copy of your medical records, chances are it won't take long to find a mistake – a mistake that could cost you big time down the road. Lana Moriarty, director of ONC's office of consumer eHealth, hears stories like this all too often. Speaking at the HIMSS15 Patient EngagementSymposium on April 12, Moriarty recounted a recent letter she received from the mother of a 15-year-old child that chronicled a familiar narrative. And the chilling reality here? Most often, portions of medical records are just plain wrong. A staggering 85 percent to 90 percent of medical records contain errors, in fact, Moriarty said, citing a literature review on the topic. So patient engagement here proves absolutely crucial in catching these errors. "While presently consumers have and will continue to shoulder the burden to make sure information is available when and where it's needed, it is unsustainable," Moriarty said.
Source: http://www.healthcareitnews.com/
Connected Medical Devices Remain Vulnerable to Cyber Attacks
Many medical devices have weak and easy-to-hack passwords that “permit privileged access to devices” and would normally “only be used by a service technician,” the NCCIC [National Cybersecurity and Integration Center] says. “In some devices, this access could allow critical settings or the device firmware to be modified,” the NCCIC says. Devices at risk include surgical and anesthesia devices, ventilators, drug infusion pumps, external defibrillators, patient monitors, and laboratory and analysis equipment, according to the NCCIC. The NCCIC report follows a warning by FDA that says implanted devices as well as healthcare networks were at risk for cyberattacks. In addition to password vulnerabilities, medical devices often lack firmware update capabilities that could patch vulnerable code.
Source: http://www.emdt.co.uk/
PierianDx Plans Software Update to Improve Variant Prioritization, Clinical Relevance Assessment
This summer, PierianDx plans to add a so-called PDx score to the next iteration of Clinical Genomicist Workstation (CGW), the company's proprietary next-generation sequence data analysis platform, that it claims will help clinicians prioritize actionable variants in somatic cancers and constitutional disorders such as cardiomyopathy. In addition, the company is expanding its underlying knowledgebase to include additional information on clinical trials and treatment guidelines culled and curated from multiple sources, the company said. The CGW provides applications for processing, analyzing, storing, and reporting on genes and variants identified by clinical next-generation sequencing-based tests. The system also includes a database of curated literature, biological information, computation predictions, population frequency data, clinical research correlations, and disease variants. The PDx score is calculated using a proprietary algorithm that sorts through all of the information contained PierianDx's internally developed knowledgebase and generates individualized variant scores based on patients' clinical and genetic data as well as the testing assays used.
Source: https://www.genomeweb.com/
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