DLPSS|HEALTHCARE NEWS|June 5, 2014
Healthcare News
A Weekly Compilation of Clinical Laboratory and Related Information
from The Division Of Laboratory Programs, Standards And Services
June 05, 2014
News Highlights
The Essential Role of Laboratory Professionals: Ensuring the Safety and Effectiveness of Laboratory Data in Electronic Health Record Systems
Cleveland Clinic Initiative Prevents Unnecessary Tests and Improves Patient Care
Assessing Accuracy on the Front Lines: A Pragmatic Approach for Single-Donor Proficiency Testing
The Continuing Search for Alzheimer’s Biomarkers
FDA Okays Noninvasive Kidney Test
A Breathalyzer That Can Diagnose Cancer
Study Affirms Value of Epigenetic Test for Markers of Prostate Cancer
Hounds Astound: Prostate Cancer Found 100% (Around)
Promising Discovery in the Fight Against Antibiotic-Resistant Bacteria
Fully Automated Artificial Pancreas Finally Within Reach
World's Best Thermometer Made From Light
See Doctor Before Heading to the World Cup: Health Officials
FDA Launches Data Platform
View Previous Issues - Healthcare News Archive
The Essential Role of Laboratory Professionals: Ensuring the Safety and Effectiveness of Laboratory Data in Electronic Health Record Systems
The CDC has announced the availability of a report titled, The Essential Role of Laboratory Professionals: Ensuring the Safety and Effectiveness of Laboratory Data in Electronic Health Record Systems. The announcement appeared in Morbidity and Mortality Weekly Report’s May 16, 2014 edition. The report was written by CDC’s LabHIT Team following a recommendation from theClinical Laboratory Improvement Advisory Committee (CLIAC) to identify issues and opportunities associated with the use of laboratory data in electronic health records.
The LabHIT Team is in the Division of Laboratory Programs, Standards and Services in the Center for Surveillance, Epidemiology and Laboratory Services (CSELS) at the CDC. The Division works in partnership with CMS and FDA, providing scientific and technical expertise in support of the Clinical Laboratory Improvement Amendments (CLIA) program.
Source: http://www.cdc.gov/
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Cleveland Clinic Initiative Prevents Unnecessary Tests and Improves Patient Care
A program at Cleveland Clinic reduced the number of unnecessary lab tests by blocking physicians from ordering the same test for hospitalized patients more than once a day. According to a recent study published in the American Journal of Clinical Pathology, the initiative prevented nearly 12,000 unnecessary tests over a two-year period. The program aimed to improve patient satisfaction by preventing unnecessary needle sticks, as well as to reduce anemia caused by excess blood draws. As an added benefit, the reduction in tests resulted in a cost saving of more than $183,000.
Source: http://www.mlo-online.com/
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Assessing Accuracy on the Front Lines: A Pragmatic Approach for Single-Donor Proficiency Testing
Proficiency testing (PT), also known as external quality assessment (EQA), has earned a well-deserved position as one of the most important elements of a laboratory's quality management program. By assessing its performance on blinded samples, a laboratory can determine to what extent its results agree with those of its peers or, ideally, with the reference method. Unfortunately, as has been emphasized recently, the most frequently used PT materials are noncommutable, meaning that they do not behave exactly like real patient samples. Conclusions drawn from such materials are, of necessity, limited to understanding how well any given peer group performs rather than knowing whether the results on patient samples are, in fact, accurate. In the case of a method lacking a true peer group (including, for example, the overwhelming majority of mass spectrometry methods and other laboratory developed tests), even this limited type of comparison may not be possible. Additionally, when there are differences between peer groups comprising laboratories that use homogeneous systems (single manufacturer's instruments, calibrators, and reagents), the differences are often ascribed to lack of commutability (matrix effects) of the materials, although the differences may in fact be real and reflected in patient samples as well.
Source: http://www.clinchem.org/
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The Continuing Search for Alzheimer’s Biomarkers
Despite extensive research on Alzheimer’s disease (AD), this devastating neurodegenerative condition is an enormous continuing social and public health problem. More than 5 million Americans live with AD, and the total national cost of caring for people with AD and other dementias is projected to reach $214 billion during 2014, according to the Alzheimer’s Association. The disease also takes a huge toll on the nation’s 15.5 million caregivers—usually family members—who, as the disease progresses, provide nearly constant unpaid care. Without medical advances leading to viable treatments, the already substantial burden of AD is expected to continue to weigh down society and the healthcare system. Imagine three times more AD patients, a figure the Alzheimer’s Association predicts could materialize by 2050 absent significant diagnostic and treatment strides. The Food and Drug Administration has approved five drugs that temporarily offset memory and other cognitive loss and three agents for use with positron emission tomography (PET) of the brain. PET estimates amyloidβ (Aβ) plaque density in cognitively impaired patients who are being evaluated for AD and other causes of cognitive decline. But a more cost-effective test to spot early AD remains elusive.
Source: http://www.aacc.org/
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FDA Okays Noninvasive Kidney Test
The FDA has approved a new noninvasive test to help determine whether patients have primary membranous glomerulonephritis (pMGN). The Euroimmun Anti-PLA2R IFA blood test detects the antibody specific to pMGN, which helps determine whether patients need aggressive treatment. In the past, diagnosis could only be done via kidney biopsy -- although the FDA notes that the test shouldn't be used alone to diagnose pMGN and that symptoms and laboratory work should also be used to confirm the diagnosis. Additionally, "a negative result from the test does not rule out a diagnosis of pMGN," the agency noted, adding that the test shouldn't yet be used to monitor the stage of disease or response to treatment.
Source: http://www.medpagetoday.com/
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Study Compares Ability of Expression Arrays, RNA-seq to Profile Cell-free Fetal RNA Transcriptome
A team of researchers from Tufts Medical Center recently assessed the ability of microarrays and next-generation sequencing to profile gene expression in cell-free fetal RNA obtained from amniotic fluid supernatant. They found that expression microarrays provided a broader view of gene expression, particularly in low-concentration or degraded samples, an area where RNA-seq suffered from "technical challenges." At the same time, they noted that RNA-seq data provided a better focus on alternative splicing and specific biological pathways relevant to the developing fetus. The results are detailed in a paper published last week in the journal Prenatal Diagnosis.
Source: http://www.genomeweb.com/
Compact and Extremely Small-Scale Incubator Microscope to Examine Cells in Time Lapse
Biologists and doctors rely heavily on incubators and microscopes. Now the Fraunhofer Institute for Biomedical Engineering IBMT has come up with a novel solution that combines the functions of both these tools in a compact and extremely small-scale system. It is ideally suited for time-lapse examination over a number of weeks and for automatic observation of cell cultures. The incubator microscope is no bigger than a soda can and costs 30 times less than buying an incubator and a microscope separately. Prototype versions are already in use in a variety of research projects. “The system is stable and can be used for time-lapse observation spanning several weeks,” says Dr. Thomas Velten, head of the Biomedical Microsystems department.
Source: http://www.fraunhofer.de/
A Breathalyzer That Can Diagnose Cancer
If a fingerprint can tell someone who you are, a "breathprint" could reveal how you're doing. That's according to Raed Dweik, the doctor who runs the pulmonary vascular program at the Cleveland Clinic's Respiratory Institute. For the past two decades, Dweik has been studying the molecular patterns in breath that can reveal what's happening inside the body. Though Dweik believes breath testing is the "next frontier" in medical diagnoses, technological advancements lag behind clinical ones. The "Holy Grail of breath testing" would be a Breathalyzer-style device that a person could carry in her pocketbook and use any time, Dweik says. Manufacturers are already working on it. Vantage Health is using NASA technology to develop cancer-screening breath-test devices that could be attached to a smartphone and would relay data to an app.
Source: http://www.nextgov.com/
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Study Affirms Value of Epigenetic Test for Markers of Prostate Cancer
A multicenter team of researchers report that a commercial test designed to rule out the presence of genetic biomarkers of prostate cancer may be accurate enough to exclude the need for repeat prostate biopsies in many — if not most — men. “Often, one biopsy is not enough to definitively rule out prostate cancer,” says study researcher Jonathan Epstein, M.D., director of the Division of Surgical Pathology and a professor of pathology, urology and oncology at the Johns Hopkins University School of Medicine. “Our research finds that by looking for the presence or absence of cancer in a different way, we may be able to offer many men peace of mind without putting them through the pain, bleeding and risk of infection that can come with a repeat biopsy.” The new research, called the Detection of Cancer Using Methylated Events in Negative Tissue (DOCUMENT) study, suggests that an initial biopsy complemented with an epigenetic diagnostic test accurately rules out the existence of cancer up to 88 percent of the time. The test, developed by MDxHealth, which paid for the study, was described online in April in The Journal of Urology. The epigenetic biomarkers the test detects reflect a process called DNA hypermethylation, in which a methyl group is chemically attached to DNA — in this case, to genes called GSTP1, APC and RASSF1. These genes are known to play prominent tumor suppressive roles in key cancer-related pathways. When these genes are hypermethylated, they are commonly silenced, which can lead to a loss of this tumor-suppressing function and the emergence of cancer.
Source: http://www.hopkinsmedicine.org/
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Hounds Astound: Prostate Cancer Found 100% (Around)
With an accuracy rate of nearly 100%, 2 specially trained dogs were able to detect prostate cancer with their olfactory system — by sniffing urine samples, according to a new study that is the largest of its kind. Italian researchers tested each dog's ability to sniff out prostate cancer in urine samples from 362 men with prostate cancer and 540 men with either non-neoplastic prostate disease or nonprostatic tumors. The dogs, German Shepherds named Liu and Zoey, had their day, time and again. Liu had an accuracy rate of 99.0%, with a sensitivity of 100.0% and specificity of 97.8%. Zoey had an accuracy rate of 97.0%, with a sensitivity of 98.6% and specificity of 95.9%. "This is a real clinical opportunity," said lead researcher Gianluigi Taverna, MD, chief of the prostatic disease unit at Humanitas Research Hospital in Milan, about the results. The opportunity includes the possibility that specially trained dogs could provide a noninvasive method of cancer detection. He spoke during a press conference at the American Urological Association (AUA) 2014 Annual Scientific Meeting.
Source: http://www.medscape.com/
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Medical Devices; Immunology and Microbiology Devices; Classification of Dengue Virus Serological Reagents
The Food and Drug Administration (FDA) is classifying dengue virus serological reagents into class II (special controls). The special controls that will apply to the device are identified in this order, and the codified language for the dengue serological reagents classification will include the identification of the special controls that will apply to this device. The Agency is classifying the device into class II (special controls) because special controls, in addition to general controls, will provide a reasonable assurance of safety and effectiveness of the device.
Source: http://www.gpo.gov/
Microbiology Devices; Reclassification of Nucleic Acid-Based Systems forMycobacterium tuberculosis Complex in Respiratory Specimens
The Food and Drug Administration (FDA) is reclassifying nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex in respiratory specimens from class III (premarket approval) into class II (special controls). FDA is also issuing the special controls guideline entitled Class II Special Controls Guideline: Nucleic Acid-Based In Vitro Diagnostic Devices for the Detection of Mycobacterium tuberculosis Complex in Respiratory Specimens. These devices are intended to be used as an aid in the diagnosis of pulmonary tuberculosis.
Source: http://www.gpo.gov/
FDA Issues Not Approvable Letter to Epigenomics for Colorectal Cancer Test
EpiGenomics said that it has received a "not approvable letter" from the US Food and Drug Administration for its Epi proColon screening test for colorectal cancer. According to the Berlin, Germany-based molecular diagnostics firm, "the FDA determined that while the studies performed so far have established the clinical performance characteristics of the test, the [Premarket Approval] application does not yet contain sufficient evidence to warrant an approval for Epi proColon." Specifically, Epigenomics said that the FDA is seeking additional data demonstrating that the test will increase compliance to colorectal cancer screening in its intended use population, which are those patients who currently don't undergo CRC screening by guideline-recommended methods, such as colonoscopy or fecal immunochemical testing.
Source: http://www.genomeweb.com/
Physicians Use Fitness Trackers to Monitor Patients in Real-time, Even as Developers Work to Incorporate Medical Laboratory Tests Into the Devices
Swift advances in technology devoted to fitness-tracking devices used by consumers are creating opportunities for physicians to tap that data to remotely monitor their patients. These pioneering efforts show how even medical laboratory testing functions might eventually be incorporated in these fitness tracking products. Of course, these devices were created for non-clinical functions. But they do allow doctors to get real-time looks at a patient’s vital signs outside of the traditional office visit. Using these consumer electronic devices for medical purposes is part of the larger trend of marshalling technology to produce better patient outcomes and reduce healthcare costs.
Source: http://www.darkdaily.com/
Many PAs Noncompliant With HIV Screening Recommendations
Physician assistants' knowledge of and compliance with the CDC's routine universal HIV screening guidelines varies by specialty, according to researchers. “In order for health-care providers to assist in preventive efforts and provide appropriate care to those living with HIV, it is imperative to increase PAs understanding of HIV testing and guidelines provided by the CDC,” said Mary E. Springston MSEd, PA-C, during a poster session at the American Academy of Physician Assistants 2014 IMPACT meeting.
Source: http://www.clinicaladvisor.com/
Roche to Pay Up to $350 Million for DNA Sequencing Business
Roche, the Swiss drug and health care diagnostics maker, said that it would pay as much as $350 million for Genia Technologies, a privately held DNA sequencing company. The addition of Genia’s technology is expected to strengthen Roche’s “next generation sequencing pipeline,” Roland Diggelmann, the chief operating officer of the Roche Diagnostics unit, said in a statement. Genia, founded in 2009, is developing proprietary technology that is expected to reduce the price of DNA sequencing while increasing the speed and sensitivity of such sequencing, Roche said.
Source: http://dealbook.nytimes.com/
Hidden Novel Proteins Found That May Aid Against Disease
Scientists have discovered 193 hidden human proteins in an initiative that has produced the first comprehensive map of the human proteome, a research tool that may help drive new findings against disease. Proteins are complex molecules that carry out the instructions of genes, performing the work needed to build and regulate the body’s tissues and organs. A directory of the body’s proteins may help refine research in diagnostics and drug development, building on the work from the Human Genome Project years earlier, the scientists said. The research, reported in the journal Nature, studied tissue from both adults and fetuses, potentially opening a new window into diseases that begin early in life. The 193 novel proteins identified were a surprise, found in regions of the genome not normally thought to include them. “Some of the proteins expressed during development in ovary and testis can serve as potential biological markers for identifying cancers of different lineages in the future,” the researchers wrote in the paper.
Source: http://www.bloomberg.com/
Promising Discovery in the Fight Against Antibiotic-resistant Bacteria
Researchers at the University of British Columbia have identified a small molecule that prevents bacteria from forming into biofilms, a frequent cause of infections. The anti-biofilm peptide works on a range of bacteria including many that cannot be treated by antibiotics. "Currently there is a severe problem with antibiotic-resistant organisms," says Bob Hancock, a professor in UBC's Dept. of Microbiology and Immunology and lead author of the study published in PLOS Pathogens. “Our entire arsenal of antibiotics is gradually losing effectiveness.”
Hancock and his colleagues found that the peptide known as 1018 - consisting of just 12 amino acids, the building blocks of protein - destroyed biofilms and prevented them from forming. Bacteria are generally separated into two classes, Gram-positives and Gram-negatives, and the differences in their cell wall structures make them susceptible to different antibiotics. 1018 worked on both classes of bacteria as well as several major antibiotic-resistant pathogens, including E. coli,Pseudomonas aeruginosa and MRSA.
Source: http://news.ubc.ca/
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Nobel Laureate-led Team Using Genetics to Prospect for Cattle Viruses With Possible Colorectal Cancer Links
A German team led by Nobel Laureate Harald zur Hausen is using DNA and RNA sequencing as part of its search for unknown animal pathogens with possible roles in human cancer. In particular, zur Hausen — a German Cancer Research Center investigator best known for discovering a role for high risk human papillomaviruses in cervical cancer — contends that the consumption of beef-borne viruses carried by some types of cattle could theoretically be contributing to rising colorectal cancer rates in some countries. Roughly one-fifth of cancer cases worldwide are linked to some manner of infectious event, zur Hausen explained, from hepatitis B viruses causing liver cancer and high-risk forms of HPV in cervical cancer to bladder cancer-causing schistosome parasites. Along with looking at types of cancer that are more or less common in individuals with immunosuppression, he argued that there may be situations where infectious agents are behind apparent nutritional cancer risks.
Source: http://www.genomeweb.com/
Chronic Inflammation Linked to High-grade Prostate Cancer
Men who show signs of chronic inflammation in non-cancerous prostate tissue may have nearly twice the risk of actually having prostate cancer than those with no inflammation, according to results of a new study led by researchers from the Johns Hopkins Kimmel Cancer Center. The link between persistent inflammation and cancer was even stronger for men with so-called high-grade prostate cancer — those with a Gleason score between 7 and 10 — indicating the presence of the most aggressive and rapidly growing prostate cancers. “What we’ve shown in this observational study is a clear association between prostate inflammation and prostate cancer, although we can’t prove that inflammation is a cause of prostate cancer,” said Elizabeth A. Platz, Sc.D., M.P.H., a professor in the Department of Epidemiology at the Johns Hopkins University Bloomberg School of Public Health and in the School of Medicine.
Source: http://www.hopkinsmedicine.org/
1 in 4 Smokers With Gene Defect May Get Lung Cancer
Study finds smokers with gene normally linked to breast cancer appear to have a much higher risk of lung cancer. Up to one in four smokers with a particular genetic defect will develop lung cancer, researchers report. "Smokers in general have nearly a 15 percent chance of developing lung cancer, far higher than in nonsmokers. Our results show that some smokers with BRCA2 mutations are at an enormous risk of lung cancer -- somewhere in the region of 25 percent over their lifetime," said study leader Richard Houlston. He's a professor of molecular and population genetics at the Institute of Cancer Research in the United Kingdom.
Source: http://consumer.healthday.com/
Fully Automated Artificial Pancreas Finally Within Reach
Even with increasingly effective treatments and glucose monitors, most individuals with type 1 diabetes still cannot achieve recommended glucose control goals. Many experts believe that the best near-term solution for patients will be a system that can independently restore insulin and glucose balance. “Artificial pancreas systems will be the most revolutionary advance in diabetes care since the discovery of insulin,” said Aaron Kowalski, PhD, a vice president at the Juvenile Diabetes Research Foundation (JDRF), a global organization that funds type 1 diabetes research. An artificial pancreas is based on a simple concept: an automated system to dispense insulin and other pancreatic hormones based on real-time changes in blood sugar levels. But researchers face numerous challenges in turning the concept into reality.
Source: http://jama.jamanetwork.com/
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Autism Linked to 'Male Hormones'
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