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Bringing Testing In-House

Clinical laboratories are under the same pressures as other healthcare organizations to control costs. One cost-containment strategy laboratories have undertaken is to bring into their operations tests that previously have been sent out to reference labs. Still, the question of which tests to bring in-house does not always have a straightforward answer, explains Dr. Victoria Zhang in the June issue of CLN. Typically, labs begin performing tests themselves because of clinical need, strategic direction, financial benefit, or a combination of these considerations, according to Zhang, who is an assistant professor of pathology and laboratory medicine, director of the clinical mass spectrometry and toxicology lab, and associate director of the hematology and chemistry lab at the University of Rochester Medical Center in Rochester, New York. Cost reduction and fulfillment of clinical needs to offer patients the latest and best tests with reduced turnaround time make powerful arguments for bringing tests in-house. Performing testing in one’s own lab also increases control over sample handling and decreases transcription errors and sample losses, writes Zhang. In addition, in-house testing develops expertise within the lab, enabling it to become a local reference lab with the potential to bring new revenue streams to the institution.

Source: https://www.aacc.org/

Get Ready – More Mosquito Borne Disease Coming

Painful, mosquito-borne diseases are no longer limited to distant, exotic locales. As the climate warms, U.S.-based labs should expect more orders to test for the mosquito-borne viruses that cause chikungunya, dengue fever, and West Nile virus (WNV). Cases of the former two could skyrocket, due to warmer weather, air travel to areas where they are endemic—particularly the Caribbean and Central and South America—and Americans’ near-total lack of immunity, according to experts. Similarly, WNV, already the leading cause of domestically acquired arboviral disease in the U.S., is poised to propagate further. Aedes aegypti and Aedes albopictus mosquitoes transmit both chikungunya and dengue, while many more species serve as vectors for WNV; in 2012, the U.S. Centers for Disease Control and Prevention (CDC) identified 54 as carriers.

Testing Recommendations

Ideally, patients should have tests for both chikungunya and dengue, said Batterman. If cost is an issue, test for dengue first because it can be more serious, and supportive treatment is more time-sensitive, added Scott Weaver, PhD, director of the Institute for Human Infections and Immunity and scientific director of the Galveston National Laboratory at the University of Texas Medical Branch in Galveston. For both diseases, polymerase chain reaction (PCR) tests are useful in the first days of symptom onset, but less so after several days or a week because viral levels in the blood diminish. At that point, immunoglobulin M (IgM) is the better test for both diseases, according to Batterman and Weaver. Chikungunya RNA is detectable in the blood at symptom onset but declines to undetectable levels within 7 days, while IgM isn’t uniformly detectable until 5 days after onset. CDC recommends testing for both chikungunya and dengue in symptomatic patients returning from areas where these viruses have been detected. CDC’s testing algorithm includes PCR for acute specimens taken before day 5 or 6 of illness and IgM testing for samples taken after day 5 or 6, said Robert Lanciotti, PhD, chief of the Diagnostic and Reference Laboratory at CDC’s Arbovirus Diseases Branch in Fort Collins, Colorado.

Source: https://www.aacc.org/

Fetal DNA Test May Also Help Spot Mom's Cancer, Study Finds

Noninvasive genetic testing of fetuses may also detect early stage cancers in their mothers, a new study says. The testing -- normally used to determine whether a fetus has chromosomal abnormalities such as Down syndrome -- involves analysis of DNA from the fetus that's found in the mother's blood. A team of Belgian researchers set out to improve the accuracy of noninvasive prenatal testing (NIPT) so it could detect a larger number of chromosomal abnormalities in fetuses. While testing the improved version, the investigators found genetic abnormalities in three women. The researchers couldn't link these abnormalities to the genetic profiles of either the mothers or their fetuses. The scientists realized that the genetic abnormalities resembled those found in cancer and referred the women to cancer doctors. The women were found to have three different types of early stage cancer: ovarian, follicular lymphoma and Hodgkin's lymphoma. Without the prenatal testing, it's likely the cancers would not have been detected until they were at a much later stage, according to the authors of the study.

Blood Test That Predicts Likelihood of Complications after Major Surgery Hailed a Breakthrough

A simple blood test which can predict whether a patient is likely to suffer life-threatening complications after major surgery, has been developed by scientists, in a breakthrough that could save hundreds of lives. For the first time, researchers have identified how important differences in a person’s immune system – caused by a group of white blood cells called monocytes – can be used to predict who will recover well after surgery and who is likely to develop lethal illnesses. Dr William Alazawi, who led the study at Queen Mary University of London and is also an Honorary Consultant at Barts Health NHS Trust, said: “Complications after major surgery are unfortunately common and can result in death, so being able to predict who is at risk could be a real game-changer. “ We already know that monocytes are important triggers for our immune defences, but the particular aspects of the cells we looked at, and their use as accurate predictors of who will develop a serious illness after surgery, is a totally new concept.”

Source: http://www.telegraph.co.uk/

FDA Clears Roche HSV 1 and 2 Test

Roche announced that its cobas HSV 1 and 2 assay has received 510(k) clearance from the US Food and Drug Administration. The dual target test detects and differentiates herpes simplex virus 1 and 2 DNA in symptomatic patients' anogenital specimens. Differentiating HSV-1 from HSV-2 can impact patient management and treatment, but Herpes lesions can be confused with other conditions. Molecular testing is faster and is considered more sensitive than traditional viral culture.

Qiagen Brings Clinical Variant Interpretation, Reporting Software to Market

Qiagen announced the commercial launch of Qiagen Clinical Insight, a content and software platform that provides clinical testing laboratories with tools to interpret and report on genomic variants from next-generation sequencing based tests. The platform helps clinical researchers evaluate genomic variants in the context of published biomedical literature, professional association guidelines, publicly available databases and annotations, drug labels, and clinical trials. It offers tools for classifying variants, identifying potential treatment options, and matching patients to clinical trials located near them. Initial applications for the platform are for somatic and hereditary cancer testing.

Research and Development

A New Genome Map

The current human genome reference map is only one way of representing the human genome, and one that some researchers say is outdated,Technology Review reports. Instead, researchers like the University of Utah's Gabor Marth say a graph theory-based approach that takes the genomes of hundreds or thousands of people into consideration may be a better way. One hitch is that many researchers are heavily invested in the current map, but proponents of the graph theory-based approach say it will win out, as it will make interpreting genomes cheaper and more accurate. In addition, Tech Review notes that companies like 23andMe and Google are interested in graphs.

Sequencing Data from Ebola Virus Released

The first sequencing dataset containing information about the genetic structure of the Ebola virus that has ravaged West Africa has been released, Thermo Fisher Scientific said. The dataset is available on virological.org for use by the scientific community to monitor the evolution of the pathogen in real time and to conduct studies that may lead to more effective strategies against future outbreaks. "This important and timely effort to better understand Ebola's evolution at the molecular level would not have been possible without the active participation and support from each organization involved," Thermo Fisher's President of Genetic Sciences Chris Linthwaite said. "The valuable sequencing data now being shared globally will be critical to help researchers stay ahead of the virus."

Italian Team Uses Liquid Biopsy to Show Dynamic Nature of Tumor Response to Therapy

Tumor genomes are not static and clonal mutations expand and retract in response to therapy — a process that can be monitored via a liquid biopsy, according to researchers from the University of Torino in Italy. Reporting their results in Nature Medicine, the group used next-generation sequencing and droplet digital PCR blood-based assays to demonstrate that when patients acquire resistance mutations to a drug, those mutations may not remain permanently. Several weeks after stopping a targeted EGFR inhibitor, RAS mutations that metastatic colorectal cancer patients had acquired could no longer be seen in the blood and the drug once again became effective.

New Study Claims to Find Genetic Link between Creativity and Mental Illness

In a large study published, scientists in Iceland report that genetic factors that raise the risk of bipolar disorder and schizophrenia are found more often in people in creative professions. Painters, musicians, writers and dancers were, on average, 25% more likely to carry the gene variants than professions the scientists judged to be less creative, among which were farmers, manual labourers and salespeople. Kari Stefansson, founder and CEO of deCODE, a genetics company based in Reykjavik, said the findings, described in the journal Nature Neuroscience, point to a common biology for some mental disorders and creativity. “To be creative, you have to think differently,” he told the Guardian. “And when we are different, we have a tendency to be labelled strange, crazy and even insane.” The scientists drew on genetic and medical information from 86,000 Icelanders to find genetic variants that doubled the average risk of schizophrenia, and raised the risk of bipolar disorder by more than a third. When they looked at how common these variants were in members of national arts societies, they found a 17% increase compared with non-members.

Source: http://www.theguardian.com/

Genetic Differences Seen in Younger Colon Cancer Patients

Colon cancer is genetically different in older and younger patients, and young adults may require different treatments, a new study suggests. While the overall rate of colon cancer in the United States is falling, the rate is rising among younger adults. And previous research has shown that colon cancer is more aggressive in patients younger than 50 than in older people, the researchers noted. "We saw differences in two important gene signaling pathways, PPAR and IGF1R, which are involved in regulating cell development, metabolism, and growth," Dr. Christopher Lieu, an investigator at the University of Colorado Cancer Center, said in a university news release.

New Hope in the Fight against Tuberculosis

Scientists from the Helmholtz Institute for Pharmaceutical Research Saarland (HIPS) in Saarbrücken, the Helmholtz Centre for Infection Research (HZI) in Braunschweig and the German Center for Infection Research (DZIF) joined forces with scientists from Sanofi, a global health care company, and identified a new agent, which might potentially remedy these problems. The scientists just described this agent and its unique mechanism of action in the highly renowned scientific journal Science. Based on earlier reports, Müller, in collaboration with Prof Jacques Grosset from the Johns Hopkins University School of Medicine in Baltimore, and his colleagues from the HZI and Sanofi scientists, initially focused on the natural substance called griselimycin. The potential of this natural substance, was discovered in the 1960s. However, due to the success of other tuberculosis medications and its low efficacy in an infection model, the substance was not developed any further at the time. "We resumed the work on this agent and optimised it such that it shows excellent activity in the infection model - even against multi-resistant tuberculosis pathogens," says Müller. Importantly, cyclohexylgriselimycin was effective when administered orally, which is key in tuberculosis treatment, non-orally available drugs are extremely burdensome to administer daily during the many months of treatment. Moreover, combining this substance with current TB antibiotics increases the efficacy compared to the antibiotic cocktail that is usually administered.

Source: http://www.medicalnewstoday.com/releases/294923.php?tw

Is Salt Really the Key to Lowering Blood Pressure in Teens?

The trick to improving blood pressure in adolescent girls may not be reducing sodium intake, but increasing potassium consumption, according to results of a new prospective cohort study sponsored by the National Heart, Lung, and Blood Institute. For the research, the effect of dietary sodium, potassium, and the potassium-to-sodium ratio were studied in 2185 white and black girls from sites in Richmond, California; Cincinnati; and Washington, DC. All were aged 9 to 10 years at baseline and were followed for 10 years, from March 1987 through February 1999. Results were adjusted for race, height, activity, television/video time, energy intake, and any other dietary factors. Researchers concluded that consuming more than 3500 mg/d of sodium had no adverse impact on blood pressure. Instead, consuming foods rich in potassium may help suppress any adolescent increase in blood pressure, thanks to the beneficial effects of dietary potassium on both systolic and diastolic blood pressures.

Source: http://contemporaryobgyn.modernmedicine.com/

Public Health and Patient Safety

Sexually Transmitted Diseases Treatment Guidelines, 2015

These guidelines for the treatment of persons who have or are at risk for sexually transmitted diseases (STDs) were updated by CDC after consultation with a group of professionals knowledgeable in the field of STDs who met in Atlanta on April 30–May 2, 2013. The information in this report updates the Sexually Transmitted Diseases Treatment Guidelines, 2010 (MMWR Recomm Rep 2010;59 [No. RR–12]). These updated guidelines discuss 1) alternative treatment regimens for Neisseria gonorrhoeae; 2) the use of nucleic acid amplification tests for the diagnosis of trichomoniasis; 3) alternative treatment options for genital warts; 4) the role of Mycoplasma genitalium in urethritis/cervicitis and treatment-related implications; 5) updated HPV vaccine recommendations and counseling messages; 6) the management of persons who are transgender; 7) annual testing for hepatitis C in persons with HIV infection; 8) updated recommendations for diagnostic evaluation of urethritis; and 9) retesting to detect repeat infection. Physicians and other health-care providers can use these guidelines to assist in the prevention and treatment of STDs.

Source: http://www.cdc.gov/

CDC Tweaking Flu Vaccine for Better Protection

Having acknowledged that the 2014-2015 flu vaccine was mismatched to the circulating influenza strains, U.S. health officials have ramped up next season's shots for broader protection. Flu-vaccine makeup is determined months in advance so that manufacturers have time to make the millions of doses needed. Components of the coming "2015-16 season vaccine have been changed to more optimally match circulating viruses," the U.S. Centers for Disease Control and Prevention said in its June 5 Morbidity and Mortality Weekly Report. There also is a version of the flu vaccine called quadrivalent flu vaccine, designed to protect against four flu viruses; two influenza A viruses and two influenza B viruses. Last year, no one saw until summer that the H3N2 strain would predominate, said CDC epidemiologist Lynnette Brammer. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6421a5.htm

Joint Commission Joins White House Effort to Reduce Antibiotic Overuse

As part of the White House Forum on Antibiotic Stewardship, The Joint Commission announced its commitment today to increase its efforts to promote effective antibiotic stewardship within health care facilities. The Joint Commission joined representatives from more than 150 major health care organizations, food companies, retailers, and animal health organizations at the forum to announce their commitment to implementing changes over the next five years to slow the emergence of antibiotic-resistant bacteria, detect resistant strains, preserve the efficacy of existing antibiotics, and prevent the spread of resistant infections. As part of its commitment, The Joint Commission will begin by reviewing its current standards and work with accredited organizations and others to identify where new standards may be needed to promote effective antibiotic stewardship. The Joint Commission will develop any new standards as rapidly as possible and simultaneously provide new tools to help providers use antibiotics judiciously.

Source: http://www.jointcommission.org/

Here’s the Difference between MERS and Ebola

Currently, MERS doesn’t appear to be able to spread like Ebola can. Though it’s in the same family of viruses as SARS and the common cold—both highly contagious—MERS appears to be less transmittable. While Ebola spreads through direct contact with the bodily fluids of an infected person, MERS doesn’t spread easily from person to person, and though it spreads through the respiratory tract, very close contact is needed, which is why the risk is higher for health care workers. Both diseases have high fatality rates (around 3 to 4 of every 10 patients reported with MERS have died) and like Ebola, there is no vaccine or cure for MERS. But right now, MERS is more of a mystery to the medical community. “Ebola has been around for 40 years so we have a pretty good sense of how it functions and its genome has been pretty stable,” says Dr. Tom Frieden, director of the U.S. Centers for Disease Control and Prevention (CDC). “MERS emerged in 2012 and we are still learning about it, and it may still be learning about us and evolving. It’s believed that when SARS spent more time circulating among humans, it evolved and became more transmissible.” Frieden says they haven’t yet seen that in MERS, but they’re watching: the CDC is currently sequencing the genome of the virus to understand how it might be changing, and to track its course.

Source: http://time.com/

Health Experts Have Figured Out How Much Time You Should Sit Each Day

Experts now say you should start standing up at work for at least two hours a day -- and work your way toward four. That's a long-awaited answer for a growing number of workers who may have heard of the terrible health effects of prolonged sitting and been wondering whether they should buy standing desks or treadmill desks. Today, the average office worker sits for about 10 hours, first all those hours in front of the computer, plowing through e-mails, making calls or writing proposals — and eating lunch. And then all those hours of sitting in front of the TV or surfing the Web at home. Medical researchers have long warned that prolonged sitting is dangerous, associated with a significantly higher risk of heart disease, diabetes, obesity, cancer, and depression, as well as muscle and joint problems. Some have gone on to say that the office chair is worse for your health than smoking and kills more people than HIV. Even working out vigorously before or after work may not compensate for extending sitting. According to the expert statement released in the British Journal of Sports Medicine, Americans should begin to stand, move and take breaks for at least two out of eight hours at work. “Metabolism slows down 90 percent after 30 minutes of sitting. The enzymes that move the bad fat from your arteries to your muscles, where it can get burned off, slow down. The muscles in your lower body are turned off. And after two hours, good cholesterol drops 20 percent. Just getting up for five minutes is going to get things going again.

Source: http://www.washingtonpost.com/

Another Tick-Borne Illness Documented in Northeast

The same ticks that spread Lyme disease may also carry a rarer bacteria that's causing serious illness in the northeastern United States. Like Lyme disease, Borrelia miyamotoi disease causes flu-like symptoms such as headache, fever, chills and muscle pain. But at its most severe, it can lead to a serious brain infection -- meningoencephalitis, researchers say. And nearly one-quarter of patients treated for the disease require hospitalization, a new study suggests. "This is an emerging infection and a lot of people and doctors have not heard about it," said lead researcher Dr. Philip Molloy, medical director of Imugen Inc., a Norwood, Mass.-based company that develops blood tests for tick-borne diseases. Imugen funded the new study. Fortunately,B. miyamotoi disease (BMD) can be treated with the same antibiotics used to treat Lyme disease, experts said.

Breast-Fed Children at Lower Risk of Leukemia

Children who are breast-fed as infants have a lower risk of developing childhood leukemia, a new study suggests. Leukemia is one of the leading killers of children and adolescents. Scientists have long suspected that breast-feeding might have a protective effect against the blood cancer because breast milk contains many antibodies and immune-strengthening compounds. In the new study, published in JAMA Pediatrics, scientists found that children who were breast-fed for at least six months had a 19 percent lower risk of the disease compared with those who were not breast-fed at all or were breast-fed for shorter periods of time. The research showed only an association, not a cause and effect, and more research is needed to confirm the link and explain the biological mechanisms involved.

Source: http://well.blogs.nytimes.com/

Quest Diagnostics: Illicit Drug Positivity Rate Increases Sharply in Workplace Testing

The percentage of American workers testing positive for illicit drugs such as marijuana, cocaine, and methamphetamine has increased for the second consecutive year in the general U.S. workforce, according to insights from more than 10 million workplace drug test results released by Quest Diagnostics. The analysis suggests a potential reversal in the decades’ long decline in the abuse of illicit drugs in the United States workforce. The Quest Diagnostics Drug Testing Index analyzed urine, oral fluid, and hair drug tests performed by Quest Diagnostics workplace drug testing laboratories across the United States in 2014. Quest Diagnostics has analyzed annual workplace drug testing data since 1988.

Source: http://www.mlo-online.com/

Health IT

CMS Announces Entrepreneurs and Innovators to Access Medicare Data

The acting Centers for Medicare & Medicaid Services (CMS) Administrator, Andy Slavitt, announced a new policy that for the first time will allow innovators and entrepreneurs to access CMS data, such as Medicare claims. As part of the Administration’s commitment to use of data and information to drive transformation of the healthcare delivery system, CMS will allow innovators and entrepreneurs to conduct approved research that will ultimately improve care and provide better tools that should benefit health care consumers through a greater understanding of what the data says works best in health care. The data will not allow the patient’s identity to be determined, but will provide the identity of the providers of care. CMS will begin accepting innovator research requests in September 2015. “Data is the essential ingredient to building a better, smarter, healthier system. Innovators and entrepreneurs will access data via the CMS Virtual Research Data Center (VRDC) which provides access to granular CMS program data, including Medicare fee-for-service claims data, in an efficient and cost effective manner. Researchers working in the CMS VRDC have direct access to approved privacy-protected data files and are able to conduct their analysis within a secure CMS environment.

Source: http://www.cms.gov/

Digital Service for Mental Healthcare Growing in U.S.

Big White Wall, a digital mental health service created in the United Kingdom that has been used extensively with military families and others, is expanding to the United States. It's designed to empower people to seek assistance for their mental health challenges for the first time, and can be used as a stand-alone service, a wrap-around for those waiting for conventional care, to help with medication adherence and to prevent readmission for those leaving acute care. It complements and integrates with conventional care services, according to a Health Affairs Blog post.

Source: http://www.fiercehealthit.com/

Population Health: Closer Than We Think?

While many healthcare providers are still trying to figure out exactly what population health is, an intrepid few already have a full-blown program up and running. That’s according to a recent poll conducted by Midas+ Solutions, a Xerox company specializing in quality management. “Providers have an optimistic outlook on the growth of population health with 81 percent of polled providers believing their organizations will deliver fully scaled programs within 5 years, including 16 percent who indicated they already are,” said Justin Lanning, a senior vice president and managing director of Midas+. At its annual symposium, Midas+ polled C-level healthcare executives from 481 hospitals. A full 100 percent of the participants indicated that population health management will be a necessary foundation in the switch to value-based care.

Source: http://www.govhealthit.com/

5 Steps to Combat Health Alert Overload

With a combination of electronic health records, wireless connectivity, mobile devices and more, healthcare is ready for a solution to alert overload, according to Vitaly Herasevich, an associate professor of anesthesiology and medicine in the department of anesthesiology at the Mayo Clinic. It's time for ambient intelligence in the hospital, Herasevich wrote in an article at HIMSS News, who outlines five steps toward that end, including:

The new generation of alerts can be improved from massive amounts of data already collected in the EHR. Deep understanding of disease and pharmacological effects of treatment are essential to creating smart rules for alerts, he says.
Ambient systems need to recognize patient treatment processes to deliver alerts to the right person at the right time in the workflow process.
Real-time feedback to bedside providers is essential, Herasevich says. Alert systems should constantly analyze responses to alerts and adjust accordingly.
The fourth step in rules development is clinical validation against a gold standard, which requires clinical research similar as the study of new drug, he says.
Regulatory approval of complex smart rules should be the last, fifth step to ensure efficiency, safety and support any commercial claims.

Source: http://www.fiercehealthit.com/

IT Could Save $100B for U.S. Healthcare

New research from Accenture projects that digital health tools will save the U.S. healthcare industry more than $100 billion over the next four years. In 2014 alone, it calculates, technology such as Web-enabled devices, digital diagnostic tools and other FDA-approved IT help achieve some $6 billion in reduced costs – mostly thanks to things such as improved medication adherence, behavior modifications and fewer emergency room visits. Accenture expects that number to approach $10 billion this year and $18 billion next year – increasing to $30 billion in 2017 and $50 billion in 2018 as these technologies take hold, proliferate and evolve.

Source: http://www.healthcareitnews.com/

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