DLS|HEALTHCARE NEWS|October 22, 2015
A Weekly Compilation of Clinical Laboratory and Related Information
From The Division Of Laboratory Systems
October 22, 2015
News Highlights
Leading News
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• Preliminary Study Finds That Ebola Virus Fragments Can Persist in the Semen of Some Survivors for at Least Nine Months
• The CDRH [Center for Devices and Radiological Health (FDA)] Regulatory Science Priorities for 2016
• The Troubling State of Laboratory Medicine Education
Laboratory Testing / Diagnostics
• Disappointing Results Seen Thus Far for Choosing Wisely
• Researchers Move Closer to Alzheimer's Blood Test
• Blood Test Could Match Cancer Patients to Best Treatments
Research and Development
• NIH-Funded Researchers Identify Safe Level to Treat Low Blood Sugar in Newborns
• California’s Massive Gene Sequencing Project Processed Genetic Data from More Than 100,000 Volunteers and Characterized 70 Billion Genetic Variants in 14 Months
• Potential New Diagnosis and Therapy for Breast Cancer
Public Health and Patient Safety
• State and Territorial Ebola Screening, Monitoring, and Movement Policy Statements — United States, August 31, 2015
• Ebola in West Africa—CDC’s Role in Epidemic Detection, Control, and Prevention
• Fears Grow Over Increased Antibiotic Resistance
Health IT and Other
• Projected Lab Growth to Impact Health Data Infrastructure
• NIST Guide Aims to Improve EHR Usability, Enhance Patient Safety
• Access to Doc's Notes Can Improve Patient Medication Adherence
View Previous Issues - Healthcare News Archive
Leading News
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Preliminary Study Finds That Ebola Virus Fragments Can Persist in the Semen of Some Survivors for at Least Nine Months
Preliminary results of a study into persistence of Ebola virus in body fluids show that some men still produce semen samples that test positive for Ebola virus nine months after onset of symptoms. The report, published in the New England Journal of Medicine, provides the first results of a long-term study being jointly conducted by the Sierra Leone Ministry of Health and Sanitation, the World Health Organization and the U.S. Centers for Disease Control and Prevention. The first phase of this study has focused on testing for Ebola virus in semen because of past research showing persistence in that body fluid. Better understanding of viral persistence in semen is important for supporting survivors to recover and to move forward with their lives. “These results come at a critically important time, reminding us that while Ebola case numbers continue to plummet, Ebola survivors and their families continue to struggle with the effects of the disease. This study provides further evidence that survivors need continued, substantial support for the next 6 to 12 months to meet these challenges and to ensure their partners are not exposed to potential virus, ” said Bruce Aylward, WHO Director-General’s Special Representative on the Ebola Response.
Source: http://www.cdc.gov/media/releases/2015/p1014-ebola-virus.html
The CDRH [Center for Devices and Radiological Health (FDA)] Regulatory Science Priorities for 2016
The CDRH [Center for Devices and Radiological Health (FDA)] regulatory science priorities serve to accelerate improving the safety, effectiveness, performance and quality of medical devices and radiation-emitting products, and to facilitate introducing innovative medical devices into the marketplace. The priorities help the Center address the most important regulatory science gaps or needs. These priorities will be reassessed and updated periodically to reflect current regulatory science needs.
The CDRH Regulatory Science Priorities for 2016 are:
Leverage “big data” for regulatory decision making
Leverage evidence from clinical experience and employ evidence synthesis across multiple domains in regulatory decision making
Improve the quality and effectiveness of reprocessing reusable medical devices
Develop computational modeling technologies to support regulatory decision making
Enhance performance of health information technology (HIT) and medical device cybersecurity
Incorporate human factors engineering principles into device design
Modernize biocompatibility / biological risk evaluation of device materials
Advance methods to predict clinical performance of medical devices and their materials
Advance the use of patient reported outcome measures (PROMS) in regulatory decision making
Collect and use patient experience/preference in regulatory decision making
Source: http://www.fda.gov/MedicalDevices/ScienceandResearch/ucm467550.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery
The Troubling State of Laboratory Medicine Education
A poll of academic leaders in laboratory medicine unveiled a number of barriers that might impede the ability of the laboratory medicine programs to thrive in U.S. medical schools. The study’s results were published in Academic Medicine, the journal of the Association of American Medical Colleges (AAMC). Medical schools over the last 20 years have stepped up their requirements on laboratory medicine course work. Yet, “the effectiveness of these courses to train physicians to practice efficient and safe diagnostic testing and ultimately serve the public remains uncertain,” the study’s authors concluded. They made this assessment after surveying deans, department chairs or undergraduate education directors at 131 medical schools. The study’s participants were queried about the current status of laboratory medicine curriculums, and what barriers the programs might be facing.
Source: https://www.aacc.org/publications/cln/cln-stat/2015/october/15/the-troubling-state-of-laboratory-medicine-education
American Cancer Society, in a Shift, Recommends Fewer Mammograms
The American Cancer Society, which has for years taken the most aggressive approach to screening, issued new guidelines on Tuesday, recommending that women with an average risk of breast cancer start having mammograms at 45 and continue once a year until 54, then every other year for as long as they are healthy and expected to live another 10 years. The organization also said it no longer recommended clinical breast exams, in which doctors or nurses feel for lumps, for women of any age who have had no symptoms of abnormality in the breasts.
Source: http://www.nytimes.com/2015/10/21/health/breast-cancer-screening-guidelines.html?emc=edit_na_20151020&nlid=9413737&ref=cta
23andMe Will Resume Giving Users Health Data
The genetic testing company 23andMe became a Silicon Valley sensation by providing consumers with health and ancestry information based on a sample of their saliva, but suffered a setback when the Food and Drug Administration told it to stop presenting health data in 2013. Now, after nearly two years, 23andMe is announcing on Wednesday that it will begin providing customers with health information again, though much less than before and with F.D.A. approval. The company hopes the information, which relates to the risk of passing certain inherited diseases to one’s children, will reignite growth in its subscriptions — even as the company evolves from being just a consumer testing service into a drug developer.
Source: http://www.nytimes.com/2015/10/21/business/23andme-will-resume-giving-users-health-data.html?_r=0
Laboratory Testing / Diagnostics
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Disappointing Results Seen Thus Far for Choosing Wisely
The Choosing Wisely campaign was designed as a starting point of sorts for a new approach to clinical decision-making and, according to new findings, it may be just that: a starting point. Authors of a study published in JAMA Internal Medicine found that, for seven treatment and testing services listed by the Choosing Wisely campaign as usually unnecessary, use of two had indeed declined, but use of the other five either did not change or had increased.
Source: http://www.medpagetoday.com/PublicHealthPolicy/GeneralProfessionalIssues/54096?xid=nl_mpt_DHE_2015-10-15&eun=g286483d0r
Researchers Move Closer to Alzheimer's Blood Test
Researchers say they have moved closer to developing a blood test for Alzheimer's disease. Such a test would enable doctors to diagnose patients at the earliest, most treatable stage so patients could make lifestyle changes that may slow progression of the brain disease, reported the team at the Rowan University School of Osteopathic Medicine in Stratford, N.J. "There are significant benefits to early disease detection because we now know that many of the same conditions that lead to vascular disease are also significant risk factors for Alzheimer's," lead researcher Robert Nagele said in an association news release. The scientists focused on use of autoantibodies in the blood as biomarkers for the presence and stage of Alzheimer's disease.
Source: http://consumer.healthday.com/cognitive-health-information-26/alzheimer-s-news-20/researchers-move-closer-to-alzheimer-s-blood-test-704323.html
Blood Test Could Match Cancer Patients to Best Treatments
UK scientists have developed a blood test that could help pair cancer patients with the most suitable therapy for their disease and then track the tumour's progress to see if the treatment is working, according to research published in Clinical Cancer Research. Using the blood test throughout a patient's treatment gives a 'running commentary' of what is happening to tumours - giving scientists the lowdown on how well the treatment is working, how the cancer is changing and whether it is becoming resistant to treatment. It is the first time a blood test has been used in this way during clinical trials of targeted drugs, proving that the technique can monitor cancer simply and quickly. The test filters out tumour DNA from a patient's blood to be analysed for genetic faults. Based on the results, researchers can match the faults to targeted cancer treatments which then home in on cancer cells carrying these mistakes. Tumour samples, known as biopsies, are usually only taken at the beginning of treatment, meaning that doctors may be using out-of-date information about how the genetic makeup of a patient's disease is changing in response to treatment. But this approach could provide real-time updates, as well as helping doctors identify patients who are suitable for clinical trials of new drugs.
Source: http://www.eurekalert.org/pub_releases/2015-10/cru-btc101315.php
Handheld DNA Reader Revolutionary and Democratising, Say Scientists
An inexpensive handheld device that can read strands of DNA has been hailed as revolutionary by scientists who tested the product. The palm-sized sequencer gives researchers the power to analyse DNA almost anywhere, and could help track disease outbreaks, run checks on food, and combat the trafficking of endangered animals. The gadget marks a major step towards what Mark Akeson, a co-inventor at the University of California Santa Cruz, called “the democratisation of sequencing”, where anyone can gather and process DNA samples for themselves. The device is not designed to read very long genomes, such as the 3bn letters that make up the instruction book for human life, nor read them with the accuracy of one of the small car-sized machines found in major genetics labs. But it can quickly identify bacteria and viruses from their DNA, tell one strain from another, and spot different gene variants in sections of human genetic code.
Source: Source: http://www.theguardian.com/science/2015/oct/15/handheld-dna-reader-revolutionary-and-democratising-say-scientists
Detecting HIV Diagnostic Antibodies with DNA Nanomachines
New research may revolutionize the slow, cumbersome and expensive process of detecting the antibodies that can help with the diagnosis of infectious and auto-immune diseases such as rheumatoid arthritis and HIV. An international team of researchers have designed and synthetized a nanometer-scale DNA “machine” whose customized modifications enable it to recognize a specific target antibody. Their new approach promises to support the development of rapid, low-cost antibody detection at the point-of-care, eliminating the treatment initiation delays and increasing healthcare costs associated with current techniques. The binding of the antibody to the DNA machine causes a structural change (or switch), which generates a light signal. The sensor does not need to be chemically activated and is rapid – acting within five minutes – enabling the targeted antibodies to be easily detected, even in complex clinical samples such as blood serum.
Source: http://www.technologynetworks.com/Diagnostics/news.aspx?ID=183920
Urine Tests Miss Sexually Transmitted Infections
The majority of gonorrhea and chlamydia infections are missed when only urine is used to screen HIV-positive men, according to new research presented at IDWeek 2015 in San Diego. "Many studies have shown that men who have sex with men have a higher risk for sexually transmitted infections than the general population, and a lot of these are extragenital infections that are asymptomatic," said Uriel Sandkovsky, MD, from the University of Nebraska Medical Center in Omaha. "If you are trying to detect asymptomatic STIs, you should be testing other anatomical sites, not just the convenient one," he told Medscape Medical News.
Source: http://www.medscape.com/viewarticle/852800
Novel Assay Detects TB in Early Stages of Disease
An assay using surface-enhanced Raman spectroscopy detected low concentrations of tuberculosis in early stages of infection, according to data presented at IDWeek 2015. Jennifer Granger, PhD, from the Nano Institute of Utah, and colleagues developed a diagnostic platform that can be used in resource-limited settings that is capable of detecting TB infection in very early stages. The assay is designed to capture low concentrations (roughly 1 nM) of antigenic TB biomarkers, specifically lipoarabinomannan (LAM), from serum samples. “Our assay is very similar to [the enzyme-linked immunosorbent assay (ELISA)], but we can get enhancement in our readout by taking advantage of surface-enhanced Raman spectroscopy, or SERS,” Granger told Infectious Disease News. “It gives us the opportunity to develop unique labels on nanoparticles. When you bring them closer to the surface, you see an enhancement of those labels, which allows us to detect things at very low levels.”
Source: http://www.healio.com/infectious-disease/respiratory-infections/news/online/%7Bc3837a71-6a73-437d-8175-993ccd395e5a%7D/novel-assay-detects-tb-in-early-stages-of-disease
Sequenom, UC School of Medicine to Assess Liquid Biopsy Technology
Sequenom announced a collaboration with the University of Colorado Denver, School of Medicine to investigate the use of the company's liquid biopsy assay in melanoma patients. As part of the collaboration, the partners will evaluate Sequenom's technology to determine whether circulating tumor DNA profiling has use for monitoring treatment response and relapse in melanoma patients. Sequenom is currently developing its research-use-only assay with an initial focus on detecting and molecularly profiling late-stage non-hematologic malignancies.
Source: https://www.genomeweb.com/sequencing-technology/sequenom-uc-school-medicine-assess-liquid-biopsy-technology
WSJ Report: Theranos Is Struggling with its Blood Test Technology
The blood test company Theranos, which has received widespread acclaim for its development of a cheaper test mainly relying on finger pricks, might not be all that it’s cracked up to be. According to a report published by the Wall Street Journal, based on interviews with anonymous former Theranos employees, only a fraction of the blood samples Theranos handles are actually processed with the company’s proprietary analyzer, which the Journal’s sources referred to as the “Edison” device. The rest, according to the report, are processed with traditional machines. The article’s sources also suggest that the small samples Theranos uses, whether collected by finger stick or by venipuncture using smaller than ordinary needles, do not always produce accurate results. Theranos released a statement calling the report “factually and scientifically erroneous and grounded in baseless assertions by inexperienced and disgruntled former employees and industry incumbents.”
Source: http://fortune.com/2015/10/15/theranos-blood-tests-wsj/
Theranos, a Blood Test Start-Up, Faces F.D.A. Scrutiny
Theranos, a closely watched start-up that vowed to revolutionize medical testing, said that because of questions raised by the Food and Drug Administration, it had temporarily halted its trademark practice of collecting tiny blood samples from finger pricks. The privately held Theranos has reportedly been valued at more than $9 billion, roughly akin to the laboratory giants Quest and LabCorp. That is based on Theranos’s purported ability to perform dozens of medical tests using only drops of blood from a finger, rather than the conventional larger vials collected from the crook of the arm.
Source: http://www.nytimes.com/2015/10/17/business/theranos-a-blood-test-start-up-faces-fda-scrutiny.html?_r=1
Research and Development
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NIH-Funded Researchers Identify Safe Level to Treat Low Blood Sugar in Newborns
Researchers funded by the National Institutes of Health have shown that treating hypoglycemia, or low blood glucose, in newborns according to current recommendations is safe and appears to prevent brain damage. Glucose levels that are too low — or too high — may lead to brain injury in newborns and possibly result in severe intellectual and developmental disabilities. Until now, the threshold for blood sugar had only been an estimate, never having been verified by a research study in people. According to the latest study, infants treated for hypoglycemia at the recommended threshold level were no more likely to experience neurological problems by two years of age than those in a comparable group who did not need treatment.
The study, appearing in the New England Journal of Medicine, was conducted by Jane E. Harding, D. Phil, of the Liggins Institute at the University of Auckland, New Zealand, and colleagues at institutions in New Zealand and Canada. According to the authors, hypoglycemia may affect 15 percent of newborns, but the exact level at which to treat the condition is unknown. Newborns have blood glucose levels far lower than would be tolerable for adults and older children, yet most do not experience any ill effects. For example, in older children and adults, a blood glucose level below 60 mg per dl (deciliter) is considered low. But at birth, it’s common for a newborn to have a blood glucose level as low as 30 mg per dl, which will gradually increase to 54 to 72 mg per dl. According to guidelines from the American Academy of Pediatrics, the generally accepted blood glucose level for treating newborn hypoglycemia is 47 mg per dl.
Source: http://www.nih.gov/news/health/oct2015/nichd-14.htm
California’s Massive Gene Sequencing Project Processed Genetic Data from More Than 100,000 Volunteers and Characterized 70 Billion Genetic Variants in 14 Months
Trailblazing methods used to create a treasure trove of genetic data from 100,000 Californians could pay dividends for clinical laboratories and pathology groups if similar projects identify novel biomarkers and fuel the development of new clinical laboratory tests and therapeutic drugs. In fact, California is once again in the forefront, this time with a major program to create a big database of genetic data. The program is called the Genetic Epidemiology Research on Adult Health and Aging (GERA). It is a collaboration between the Kaiser Permanente Northern California Research Program on Genes, Environment, and Health (RPGEH) and the Institute for Human Genetics at the University of California, San Francisco (UCSF) that began in 2009. The genetic data will be collected from more than 100,000 Californians who are part of the Kaiser Permanente Medical Care plan. These individuals consented to anonymously share their DNA—via saliva samples—along with their medical records and answers to survey questions on their behavior and background with researchers.
Source: http://www.darkdaily.com/californias-massive-gene-sequencing-project-processed-genetic-data-from-more-than-100000-volunteers-and-characterized-70-billion-genetic-variants-in-14-months-1019#axzz3p276snWk
Potential New Diagnosis and Therapy for Breast Cancer
Scientists at the University of York, using clinical specimens from charity Breast Cancer Now’s Tissue Bank, have conducted new research into a specific sodium channel that indicates the presence of cancer cells and affects tumour growth rates. Led by Dr Will Brackenbury, a Medical Research Council Fellow in York’s Department of Biology, a team studied a particular protein, or sodium channel, known as Nav1.5. Sodium channels, also known as VGSCs, exist in the membranes of excitable cells, such as neurons, where they are involved in the transmission of electrical impulses. Also present in breast cancer cells, research indicates they play a significant role in the growth and spread of tumours. Studying tissue specimens taken from patients with breast cancer, Dr Brackenbury found a significantly higher prevalence of Nav1.5 in tumour cells than levels found in normal breast tissue.
Source: http://www.technologynetworks.com/Diagnostics/news.aspx?ID=184041
Microbiome May Predict Colon Cancer Tumor Mutational Status
Analysis of the microbiome surrounding colon cancer tumors could be used as a noninvasive screening test that is more sensitive and specific than fecal occult blood testing, according to the results of a new study. "This is something that could be critical in colon cancer, because each tumor may have a different mutational landscape with different genes mutated, and that might have an effect on the microbiome," said Ran Blekhman, PhD, from the University of Minnesota in Minneapolis. The results of the study were presented at the American Society of Human Genetics 2015.
Source: http://www.medscape.com/viewarticle/852544
Discovery about Protein Structure Opens Window on Basic Life Process
Biochemists at Oregon State University have made a fundamental discovery about protein structure that sheds new light on how proteins fold, which is one of the most basic processes of life. The findings, announced in Science Advances, will help scientists better understand some important changes that proteins undergo. It had previously been thought to be impossible to characterize these changes, in part because the transitions are so incredibly small and fleeting. A powerful tool called X-ray crystallography has been able to capture images of proteins in their more stable shapes, but what was unknown is exactly how they got from one stable form to another. The changes in shape that are needed for those transitions are fleeting and involve distortions in the molecules that are extreme and difficult to predict. What the OSU researchers discovered, however, is that the stable shapes adopted by a few proteins actually contained some parts that were trapped in the act of changing shape, conceptually similar to finding mosquitos trapped in amber.
Source: http://www.medicalnewstoday.com/releases/301165.php?tw
Camels Test Positive for Respiratory Virus in Kenya
A new study has found that nearly half of camels in parts of Kenya have been infected by the virus that causes Middle East Respiratory Syndrome (MERS) and calls for further research into the role they might play in the transmission of this emerging disease to humans. Although the majority of human cases of MERS have been attributed to human-to-human infections, camels are likely to be a major reservoir host for the virus and an animal source of MERS infection in humans. The full study is published in PLOS ONE.
Source: http://www.medicalnewstoday.com/releases/301166.php?tw
Public Health and Patient Safety
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State and Territorial Ebola Screening, Monitoring, and Movement Policy Statements — United States, August 31, 2015
By August 31, 2015, 30 percent of states and territories had Ebola monitoring and movement policies that were more restrictive than CDC recommendations, 62.5 percent were equivalent to CDC guidance, and none were less restrictive; the remainder were either unclear or did not have publically available policies. Shortly after CDC provided updated guidance on the monitoring and movement of people who might have been exposed to Ebola last fall, states began announcing state-specific policies. Because of concerns about the potential impact of inconsistencies between state policies and federal guidance, CDC’s Public Health Law Program (PHLP) evaluated publically available Ebola policies for each state and territory. PHLP found that as of August 31, 2015, 17 states and the District of Columbia had policies that were more restrictive than CDC guidance, 35 states and territories were equivalent to CDC guidance, none were less restrictive, 1 territory had an unclear policy, and 2 territories did not have publicly available monitoring and movement policies.
Source: http://www.cdc.gov/media/mmwrnews/2015/1015.html
Ebola in West Africa—CDC’s Role in Epidemic Detection, Control, and Prevention
Since Ebola virus disease was identified in West Africa on March 23, 2014, the Centers for Disease Control and Prevention (CDC) has undertaken the most intensive response in the agency’s history; >3,000 staff have been involved, including >1,200 deployed to West Africa for >50,000 person workdays. Efforts have included supporting incident management systems in affected countries; mobilizing partners; and strengthening laboratory, epidemiology, contact investigation, health care infection control, communication, and border screening in West Africa, Nigeria, Mali, Senegal, and the United States. All efforts were undertaken as part of national and global response activities with many partner organizations. CDC was able to support community, national, and international health and public health staff to prevent an even worse event. The Ebola virus disease epidemic highlights the need to strengthen national and international systems to detect, respond to, and prevent the spread of future health threats. The unprecedented epidemic of Ebola virus disease (Ebola) in West Africa highlights the need for stronger systems for disease surveillance, response, and prevention worldwide. After a preventable and costly local and global delay, heroic efforts by clinicians and public health personnel and organizations from West Africa and throughout the world broke the cycle of exponential growth of the epidemic and prevented many deaths. As of late 2015, this response, conducted at great expense and personal risk, continues. Here we summarize the experience of the Centers for Disease Control and Prevention (CDC), which complements efforts by the affected countries, the international community, and many partner organizations.
Source: http://wwwnc.cdc.gov/eid/article/21/11/15-0949_article?utm_campaign=KFF%3A+Global+Health+Report&utm_source=hs_email&utm_medium=email&utm_content=22922998&_hsenc=p2ANqtz-8hv-Nh52cf-
Fears Grow over Increased Antibiotic Resistance
More than 6,000 deaths a year could be caused by a 30% fall in the effectiveness of antibiotics in the U.S., a report in The Lancet suggests. It said most of the extra deaths would happen in patients having colorectal surgery, blood cancer chemotherapy and hip replacements. UK experts said the study confirmed their fears that antibiotic resistance would affect routine surgery. England's chief medical officer has called the issue a "ticking time bomb". In this report, a team of scientists from a number of different American institutions estimated that as many as half of all bacteria that cause infections after surgery are resistant to antibiotics in the U.S. They also estimated that one in four infections treated with antibiotics after chemotherapy treatment was now drug-resistant.
Source: http://www.bbc.com/news/health-34541253
MSSA Mortality Similar to MRSA in Infants
Infant mortality rates after invasive methicillin-resistant Staphylococcus aureus (MRSA) are similar to infant mortality rates after infection with methicillin-susceptible S aureus (MSSA), according to a new study. However, MSSA causes more infections than MRSA and, therefore, takes a larger toll on infants. "The absolute numbers of infections and deaths due to MSSA exceed those due to MRSA. Consideration should be given to expanding hospital infection control efforts targeting MRSA to include MSSA as well, write Jessica E. Ericson, MD, from Duke University School of Medicine, Durha