domingo, 22 de junio de 2014

DLPSS|HEALTHCARE NEWS|June 19, 2014 ▲ Division of Laboratory Programs, Standards, and Services (DLPSS)


Healthcare News

A Weekly Compilation of Clinical Laboratory and Related Information 
from The Division Of Laboratory Programs, Standards And Services


June 19, 2014


View Previous Issues - Healthcare News Archive


For Clinical Labs, Data Interpretation Remains Key Challenge of Next-Gen Sequencing

Next-generation sequencing (NGS), a high-throughput technology that parallelizes sequencing processes, emerged as an early focus of sessions at G2 Intelligence’s “Molecular Diagnostics at the Crossroads” conference[....] “I think the biggest challenge facing the practice of molecular diagnostics is data interpretation,” said Sherri J. Bale, Ph.D., FACMG, managing director of GeneDx and senior vice president at BioReference Laboratories, in a presentation focused on the applications of NGS in inherited disease. In situations where the stakes couldn’t be higher—involving test results that are used to make diagnoses, determine treatment, develop surveillance guidelines, and to inform pregnancy and family planning decisions—laboratory directors and clinicians are confronted by a variety of variants, including those they’ve never seen before, and need better tools to predict whether they are benign or pathogenic. 


Whooping Cough Reaches Epidemic Level in California

For the first time in four years, California is experiencing a statewide epidemic of pertussis, or whooping cough, with infants under the age of 6 months facing the greatest risk of hospitalization or death, according to state health authorities. "We urge all pregnant women to get vaccinated," said Dr. Ron Chapman, director of the California Department of Public Health. "We also urge parents to vaccinate infants as soon as possible." California counties have reported 3,458 cases of the disease this year, including two infant deaths. While that figure is less than the 9,163 cases reported in 2010 — the last epidemic year — health officials say this year's caseload is on track to meet that level. "The summer months are usually the worst," said Dr. Gil Chavez, an epidemiologist and deputy director at the department. Unlike the measles vaccine, pertussis vaccines do not provide lifelong immunity. 


Measles – United States, January 1 – May 23, 2014

Measles is a highly contagious, acute viral illness that can lead to serious complications and death. Although measles elimination (i.e., interruption of year-round endemic transmission) was declared in the United States in 2000, importations of measles cases from endemic areas of the world continue to occur, leading to secondary measles cases and outbreaks in the United States, primarily among unvaccinated persons. Patients with reported measles cases this year have ranged in age from 2 weeks to 65 years; [....] No cases of encephalitis and no deaths have been reported. Fifteen outbreaks have accounted for 227 (79%) of the 288 cases. The median outbreak size has been five cases (range: 3–138 cases). Most of the 288 measles cases reported this year have been in persons who were unvaccinated (200 [69%]) or who had an unknown vaccination status (58 [20%]); 30 (10%) were in persons who were vaccinated. 


Bacteria Spark Heart Attacks When Stressed, Scared

Scientists believe they have an explanation for the axiom that stress, emotional shock or overexertion may trigger heart attacks in vulnerable people. Hormones released during these events appear to cause bacterial biofilms on arterial walls to disperse, allowing plaque deposits to rupture into the bloodstream, according to research published in published in mBioExternal Web Site Icon, the online open-access journal of the American Society for Microbiology. "Our hypothesis fitted with the observation that heart attack and stroke often occur following an event where elevated levels of catecholamine hormones are released into the blood and tissues, such as occurs during sudden emotional shock or stress, sudden exertion or over-exertion" says David Davies of Binghamton Univ., an author on the study. 
To test this theory they added norepinephrine, at a level that would be found in the body following stress or exertion, to biofilms formed on the inner walls of silicone tubing. "At least one species of bacteria — Pseudomonas aeruginosa — commonly associated with carotid arteries in our studies, was able to undergo a biofilm dispersion response when exposed to norepinephrine, a hormone responsible for the fight-or-flight response in humans," says Davies.


Microbes of the Skin

New evidence suggests that commensal skin bacteria both directly protect humans from pathogenic invaders and help the immune system maintain that delicate balance between effective protection and damaging inflammation.  “None of us in the field—and this is true for the gut, this is true for the skin—none of us can actually tell how our experimental observations really relate to human disease, but we’re getting, all of us, closer to mechanistic insights,” said immunologistYasmine BelkaidExternal Web Site Icon, chief of mucosal immunology at the National Institute of Allergy and Infectious Disease (NIAID).
To more fully understand how the skin’s microbial residents influence host immunity, NIAID’s Belkaid turned to germ-free mice. In the summer of 2012, she and colleagues published a ScienceExternal Web Site Icon study that demonstrated the addition of S. epidermidis to the skin of the sterile mice altered T-cell function to boost host immunity. While there are now a handful of skin probiotics are on the market, none are regulated by the US Food and Drug Administration as therapeutics, and thus cannot make claims about treating or preventing disease. And most scientists will tell you there’s not enough evidence yet to know one way or the other whether such probiotic cosmetics work. But Belkaid and others do see microbiome manipulations as a way of the future. 


Doctors Urge Quick Action on Bill to Develop New Antibiotics

Several major medical societies are telling Congress to act quickly on a bill that would spur the creation of new antibiotics in the face of antibiotic resistance. The bill, called the Antibiotic Development to Advance Patient Treatment Act, would enable the US Food and Drug Administration (FDA) to approve antibacterial or antifungal drugs to treat a serious or life-threatening condition in a limited number of patients whose medical options are nil or few. Under the bill, the FDA could base its decision on clinical trials much smaller — and presumably less expensive — than what drug manufacturers are accustomed to. To avoid inappropriate prescribing, the labels for such antibiotics would caution clinicians that the drug "is indicated for use in a limited and specific population."


Disinfection Caps Are Included in New Recommendations From Infection Control Organizations

The use of disinfection caps is included in major new infection-control recommendations sponsored by the Society for Healthcare Epidemiology of America (SHEA) and other top infection-control organizations. The recommendations, published in the journal Infection Control and Hospital Epidemiology (ICHE), include the use of “an antiseptic-containing hub/connector cap/port protector to cover connectors” when a hospital has an unacceptable rate of central line-associated bloodstream infections (CLABSIs) after implementing basic prevention strategies. The SHEA authors placed the quality of evidence to support the use of disinfection caps in Category I, which is the highest ranking possible in the document.


Microbiology, Advanced Tests Projected to Keep U.S. IVD Market Afloat

Although cuts to lab reimbursement and other variables have dampened the growth of the U.S. in vitro diagnostics (IVD) market, its microbiology and advanced testing segments are still projected to experience above-average market development through 2018. Those were among the findings of “The United States Market for In Vitro Diagnostic Tests,” a report by Kalorama Information analyst Emil Salazar. Kalorama reached this conclusion by comparing each IVD market segment’s actual or projected monetary share of IVD market volume between 2013 and 2018 with the segment’s current share of the market. Several factors have also kept market growth robust for microbiology diagnostics. These include, among others, hospital investment in microbiology for healthcare-acquired infection testing and market penetration by higher-priced molecular infectious diseases tests.


ANA Testing: From Microscopy to Multiplexing

The chronic nature of AID [autoimmune disease(s)] has a significant impact on medical care utilization, direct and indirect economic costs, and quality of life. AID are among the leading causes of death among those younger than age 65 in the United States. Laboratory testing is of great value when evaluating a patient with a suspected AID. However, not a single laboratory test establishes such a diagnosis. Typically, the diagnostic work-up involves multiple tests, including complete blood count, inflammatory markers, flow cytometry, and autoantibodies. 
Anti-nuclear antibodies (ANA) are hallmarks of many autoimmune connective tissue diseases. The term ANA is now obsolete and even puzzling, as this historical label has come to include antibodies directed at various cellular compartments including nuclear constituents, components of the nuclear envelope, mitotic spindle apparatus, cytosol, cytoplasmic organelles, and cell membranes. ANA testing is used extensively for diagnosing and monitoring various AID such as systemic lupus erythematosus (SLE), Sjogren’s syndrome, scleroderma, mixed connective tissue disease, polymyositis, and dermatomyositis. Multiplex technology represents a real improvement of the diagnostic power of autoantibody testing. ANA testing by multiplexing has good concordance with the comparative methods. 


For Diagnosis of Rare Adrenal Tumors, Experts Recommend Blood, Urine Testing

The Endocrine Society has issued a Clinical Practice Guideline (CPG) for the diagnosis and treatment of two types of rare adrenal tumors - pheochromocytomas and paragangliomas - that can raise the risk of cardiovascular disease and even death if left untreated. The CPG, entitled "Pheochromocytoma and Paraganglioma: An Endocrine Society Clinical Practice Guideline," appeared in the June 2014 issue of the Journal of Clinical Endocrinology and Metabolism (JCEM), a publication of the Endocrine Society. Experts estimate between 0.1 and 1 percent of patients treated for high blood pressure have pheochromocytomas, according to the National Institutes of Health's National Cancer Institute. In the CPG, the Endocrine Society recommends that initial testing for pheochromocytomas and paragangliomas include blood or urine tests for metanephrines - the products left behind when the body metabolizes epinephrine and norepinephrine. 


Upgrading Urinalysis to Support the Goals of Healthcare Reform

Historically, urinalysis has been a manual, labor-intensive set of procedures. Microscopy was still a manual process until the 1980s and 1990s, when digital imagery and flow cytometry were introduced for automated urine microscopy. Today, there are fully integrated urinalysis systems that combine automated chemistry with automated microscopy for true walkaway capability. Digital imaging systems utilize a flow cell, strobe lamp, and digital camera along with software to classify and quantitate cells and formed elements in uncentrifuged urine. Approximately 500 images per sample are collected as the software classifies particles into categories including RBC, WBC, WBC clumps, hyaline casts, pathological casts, squamous epithelial cells, non-squamous epithelial cells, bacteria, yeast, crystals, mucus, and sperm. A trained operator reviews and manually reclassifies representative images as needed, using an elaborate review process flow diagram. A manual microscopy evaluation of the sample may be needed to confirm certain particles. 
Automation at the urinalysis bench has the potential to aid the clinical laboratory in achieving quality metrics for incentive payments. Labs can lead the way to smarter, more cost-effective testing by evaluating urinalysis automation as a tool for reducing the number of urine cultures. Fully automated urinalysis provides the ability to streamline workflow and create a high level of standardization for the lab. 


The Reliability of Melanoma Diagnosis Improved by Myriad Mypath Melanoma Test

Myriad Genetics [...] has presented results from a pivotal clinical validation study of the Myriad myPath™ Melanoma test at the 2014 American Society of Clinical Oncology (ASCO) annual meeting in Chicago, Ill. The Myriad myPath Melanoma test is a novel molecular test that accurately differentiates malignant melanoma from benign skin lesions with a high level of accuracy and helps physicians deliver a more objective and confident diagnosis for patients. 
"Unfortunately, some melanomas mimic benign skin lesions, making them very difficult to diagnose and an uncertain result is confusing for patients and clinicians. What we need is a new tool to help us make a more definitive diagnosis," said Sancy Leachman, M.D., Ph.D, chair of the Department of Dermatology at the Oregon Health & Science University (OHSU) School of Medicine and director of the Melanoma Research Program at the Knight Cancer Institute. "In the validation study, Myriad myPath Melanoma was shown to differentiate malignant melanoma from benign skin lesions using traditional dermatopathology as a gold standard. This represents a significant contribution toward making a prompt and accurate diagnosis of potentially fatal melanoma." 


Cervical Cancer Rates in Older Women: Rates Higher Than Previously Thought Contrast With Current Recommendations to Stop Screening At Age 65

Rates of cervical cancer are higher than previously thought among African American and 65- to 69-year-old women in general, according to a study published online in May in the journal Cancer and led by a researcher at the University of Maryland School of Medicine in Baltimore. The study’s results drew particular attention because current guidelines do not recommend Pap smears to screen for cervical cancer in women older than age 65 if they’ve previously had normal test results. Incidence of cervical cancer was 27.4 cases per 100,000 women age 65-69 in the study—which was 84% higher than calculations for the uncorrected rate of 14.8 cases per 100,000 women. 


Pap vs HPV Testing: Any Screening Is Better Than None

Does a standalone HPV screening test for cervical cancer carry any benefit over cotesting with a Papanicolaou (Pap) test or a Pap test alone? All 3 approaches are adequate for testing, Rebecca B. Perkins, MD, and Elizabeth A. Stier, MD, from Boston University School of Medicine, Massachusetts, write in an article published onlineExternal Web Site Icon June 10 in the Annals of Internal Medicine.
"Although the relative merits of screening tests and screening intervals warrant additional discussion, we cannot lose sight of the fact that most cervical cancer occurs in women who have not had any recent screening," they write. They emphasize that efforts to decrease cervical cancer should focus on increasing screening rates, regardless of which test is used. The most recent cervical cancer screening guidelines were published before its approval, in 2012: a set from the US Preventive Services Task Force and a similar set of guidelines issued jointly by the American Cancer Society, the American Society for Colposcopy and Cervical Pathology, and the American Society for Clinical Pathology. A panel convened by the Society of Gynecologic Oncology and the American Society for Colposcopy and Cervical Pathology intends to publish interim guidelines on the use of the new test.


Our Own Treacherous Immune Genes Can Cause Cancer After Viral Infection

HPV (human papillomavirus) infection is widely known to induce cancer. Many of the mutations that cause this virally-induced cancer are caused by a family of genes that normally combats viral infections, finds new UCL research. This raises the possibility of developing drugs to regulate the activity of these genes to prevent HPV-associated cancers from developing and reduce the ability of existing cancers to evolve resistance to treatments. The research, published in Cell Reports, shows for the first time that genes from the ‘APOBEC’ family, which help to fight off viral infection, actually cause mutations that lead to HPV-associated cancer. 


Needle Biopsies May Be Underused for Breast Cancer Patients

“Needle biopsy really is the standard of care,” said senior study author Dr. Benjamin D. Smith of The University of Texas MD Anderson Cancer Center in Houston. “Having a three or four centimeter (surgical) incision in the skin is going to hurt more and take longer to heal than inserting a needle,” Smith told Reuters Health by phone. “Excisional biopsy has more complications than needle biopsy.”
It may seem like a waste of time to test a lump of tissue that’s bound to be removed anyway, but the results of the test have important implications for treating the cancer, said Dr. Katharine A. Yao, a breast surgery specialist at NorthShore Medical Group in Evanston, Illinois. “Some patients will ask if their mammogram or breast mass is so suspicious on imaging and on exam and it is going to come out anyway, why do a biopsy?” Yao told Reuters Health by email. “It is important to do the biopsy so that if the mass or abnormality on mammogram is cancer, there can be a full discussion of the treatment plan including different types of surgery, adjuvant treatments and the use of neoadjuvant therapy.” Women who did not have a needle biopsy were twice as likely to undergo multiple surgeries for their cancers than women who did.


FDA Approves Lymphoseek to Help Determine the Extent of Head and Neck Cancer in the Body

The U.S. Food and Drug Administration today approved a new use for Lymphoseek (technetium 99m tilmanocept) Injection, a radioactive diagnostic imaging agent used to help doctors determine the extent a type of cancer called squamous cell carcinoma has spread in the body’s head and neck region. With today’s approval, Lymphoseek can now be used to guide testing of lymph nodes closest to a primary tumor for cancer, called a “sentinel” lymph node biopsy, in patients with cancer of the head and neck. This new indication will allow for the option of more limited lymph node surgery in patients with sentinel nodes negative for cancer.


Blood Test Predicts Breast Cancer Relapse

Relapse after the treatment of primary breast cancer can be reliably predicted well in advance of clinical indications with a circulating free DNA (cfDNA) test, according to a new study. Results were presented here at the 2014 Annual Meeting of the American Society of Clinical Oncology. Tumor-specific mutations were present 6 months after primary treatment in 4 of 5 patients who relapsed after surgery, but in 0 of the 26 patients who did not relapse. The relapses occurred at a median of 8.1 months after surgery. To identify tumor-specific mutations, the researchers performed targeted next-generation sequencing on the baseline tumor biopsy. At least 1 of the known breast-cancer driver mutations was detectable at baseline in 75% of the patients. There is a need for some type of "liquid biopsy" to help guide cancer treatment, because repeated tumor biopsies are often not feasible, said Minetta C. Liu, MD, from the Department of Laboratory Medicine and Pathology at the Mayo Clinic in Rochester, Minnesota. "This study provides preliminary evidence that tracking mutations over time can help predict relapse," she said. "But will acting on what we find make a difference for our patients?" Dr. Liu said that an important next stage will be to standardize the processes for monitoring cfDNA.


Interactome Analysis

Genes that cause hereditary diseases are often expressed across a wide range of cells in the human body, but the diseases they cause can be specific to a few tissues or organs. Many of these genes are expressed at higher levels in diseased tissues, and their proteins have a significantly greater tendency for tissue-specific protein interactions, according to a study published last week (June 12) in PLOS Computational BiologyExternal Web Site Icon. The researchers suggested that these tissue-specific interactions, known as an interactome, highlight disease mechanisms, and can provide an efficient filter to identify causal genes within diseased tissues. “The distinct features we identified provide a starting point for elucidating the molecular basis of many hereditary diseases,” the authors wrote.


Enterome Teams With Mayo Clinic on Gut Microbiome Tests

Enterome Bioscience today said that it has signed an agreement with the Mayo Clinic to collaborate on the discovery and validation of microbiome-based tests for predicting response to medical nutritional intervention in obese and overweight patients. The Mayo Clinic is currently conducting a study of the gut microbiome before and after dietary intervention. The aim of the research is commercialize a personalized nutrition test for obese patients with low-grade inflammation and certain metabolic risk factors. Meanwhile, Paris-based Enterome has collaborated with researchers at the French National Institute for Agriculture Research (INRA) and the Institute of Cardiometabolism and Nutrition to identify a panel of bacterial biomarkers from the gut microbiome that enables stratification of patients based on the health and diversity of their gut microbiome, according to the firm.


Mass Spectrometry Reveals Dynamics of the Pervasive Pathogen Cytomegalovirus

Once you have it, you have it for life. If you have any medical condition that dampens your immune system, such as HIV infection or a recent organ transplant, the virus can assert itself with a vengeance. The results, sometimes, are life-threatening. Researchers in the lab of Steven Gygi, professor of cell biology at Harvard Medical School, report that they have discovered a menu of tactical secrets CMV employs. "This is an entirely new way of studying the behavior and tactics of viruses," said Gygi. These results are published in Cell. 
The researchers were able to study approximately 8,000 total proteins, identifying not only ways that CMV evades the immune system, but also discovering a number of new therapeutic targets. Most notably, they were able to look closely at proteins that live on the cell surface. This is especially crucial since most drugs target cell surface proteins, yet these proteins are harder to study than proteins inside the cell due to their low numbers. 


CLSI Releases a New Edition of Standard on Protection of Lab Workers From Occupationally Acquired Infections

The Clinical and Laboratory Standards Institute (CLSI) has released an updated edition of its standard Protection of Laboratory Workers From Occupationally Acquired Infections; Approved Guideline—Fourth Edition (M29-A4). This standard is based on U.S. regulations and provides guidance on reducing or eliminating the risk of transmission of infectious agents in a laboratory setting. This document has been reorganized to provide guidance on standard laboratory precautions and best practices for working safely with infectious patient specimens and biohazardous agents derived from them. This edition contains new information on a process for assessing the risks associated with procedures performed within a laboratory’s scope of practice that will then guide policy, procedure, and work instruction review as a component of continual improvement.


ADA: Bionic Pancreas Betters T1D Glycemic Levels

A bihormonal "artificial pancreas" improved glycemic control and led to less hypoglycemia in type 1 diabetes patients, researchers reported here. In two crossover studies -- one in adults, one in adolescents -- mean plasma glucose levels fell over the 5 days that patients wore the closed-loop system and went about their normal lives, Edward Damiano, PhD, of Boston University, and colleagues reported online in the New England Journal of MedicineExternal Web Site Icon and at the American Diabetes Association meetingExternal Web Site Icon. The device -- described as a "wearable, automated, bihormonal, bionic pancreas" -- also lowered the mean amount of time that patients registered a low glucose reading, they reported. Betul Hatipoglu, MD, an endocrinologist at Cleveland Clinic who was not involved in the study, called the results "promising." "The use of a device to treat type 1 diabetes is significant and exciting," Hatipoglu told MedPage Today. "The bionic pancreas in this research was able to deliver insulin and glucagon, two hormones that patients with type 1 diabetes need."


Is Celiac Screening for Kids With Type 1 Diabetes Adequate?

Current guidelines for celiac disease screening in patients with type 1 diabetes may miss a significant proportion of asymptomatic cases, a new study suggests. But screening every type 1 patient presents a clinical challenge, session moderator Michael Haller, MD, associate professor of pediatrics at the University of Florida, Gainesville, told Medscape Medical News in an interview. "I think the question is really about how to apply it clinically," he added. Physicians are often confused about whether or not to screen in their own practices "because the frequency of finding folks with positive antibodies who are unaffected by the disease is pretty high, and a lot of those families choose not to go forward with biopsies or follow a gluten-free diet. It makes it challenging for a treating physician to know the best thing to do for the patient if you're not going to do anything about the information." Most patients did not have symptoms of celiac disease, and none of the patients with biopsy-confirmed disease had high clinical suspicion prior to diagnosis, Dr. Graber noted.


Could Hepatitis B Vaccination Prevent Diabetes?

Provocative new data support an intriguing hypothesis: that vaccinating people against hepatitis B may prevent diabetes from developing, at least in some individuals. Using participants from the NHANES study 2005–2010, researchers from California examined more than 7000 subjects without a prior history of diabetes; around 1400 of them had previously been vaccinated with hepatitis B, and these individuals had a 52% reduction in the risk for subsequent diabetes compared with individuals not vaccinated, even after adjustment for all potential confounders.
Horng-Yih Ou, MD, from City of Hope National Medical Center, Duarte, California, reported the findings during a guided poster session at the American Diabetes Association (ADA) 2014 Scientific SessionsExternal Web Site Icon. "To our knowledge this is the first report that hepatitis B vaccination could reduce the risk of diabetes in multiple racial/ethnic groups," Dr. Ou told attendees, adding that "a prevention trial is warranted."


Light Non-invasively Monitors Glucose, Dehydration, Pulse

Monitoring a patient's vital signs and other physiological parameters is a standard part of medical care, but, increasingly, health and fitness-minded individuals are looking for ways to easily keep their own tabs on these measurements. Enter the biometric watch. In a pair of papers published inThe Optical SocietyExternal Web Site Icon's (OSA) open-access journal Biomedical Optics ExpressExternal Web Site Icon, groups of researchers from the Netherlands and Israel describe two new wearable devices that use changing patterns of scattered light to monitor biometrics: one tracks glucose concentration and dehydration levels, and the other monitors pulse.
Both of the watches described in the two papers make use of the so-called "speckle" effect, the grainy interference patterns that are produced on images when laser light reflects from an uneven surface or scatters from an opaque material. When the material that is scattering the light is moving — say, in the case of blood flowing through the circulatory system — "the speckle pattern changes with changes in the flow," explains biomedical engineer Mahsa Nemati, a graduate student in the Optics Research Group at the Delft Univ. of TechnologyExternal Web Site Icon and the lead author of the Biomedical Optics Express paper on monitoring pulse. 


Molecule Enables Quick Drug Monitoring

Scientists at EPFLExternal Web Site Icon have invented a molecule that can easily and quickly show how much drug is in a patient’s system. The molecule, now the basis of a start-up company, is expected to enable point-of-care therapeutic drug monitoring. Monitoring the drug concentration in patients is critical for effective treatment, especially in cases of cancer, heart disease, epilepsy and immunosuppression after organ transplants. However, current methods are expensive, time-consuming, and require dedicated personnel and infrastructure away from the patient. Publishing in Nature Chemical BiologyExternal Web Site Icon, scientists at EPFL introduce novel light-emitting sensor proteins that can quickly and simply show how much drug is in a patient’s bloodstream by changing the color of their light. The method is so simple that it could be used by patients themselves.


Poll: Fixing VA Health Care Top Issue

The most widespread legislative concern for Americans is improving health care for veterans, a new poll says. According to a Gallup pollExternal Web Site Icon released [June 13], 87 percent of Americans say it is extremely or very important for the White House and Congress to address health care services for veterans. Among the nine options presented in the survey, improving care for veterans scored 15 percent higher than the second-place issue, equal pay legislation for women.


FDA Prepping Long-Awaited Plan to Reduce Salt

Food companies and restaurants could soon face government pressure to make their foods less salty — a long-awaited federal effort to try to prevent thousands of deaths each year from heart disease and stroke. The Food and Drug Administration is preparing to issue voluntary guidelines asking the food industry to lower sodium levels, FDA Commissioner Margaret Hamburg told The Associated Press. Hamburg said in a recent interview that the sodium is "of huge interest and concern" and she hopes the guidelines will be issued "relatively soon." "We believe we can make a big impact working with the industry to bring sodium levels down, because the current level of consumption really is higher than it should be for health," Hamburg said.
Those pushing for sodium limits say it's pointless to debate how low the recommendations should go — Americans are still eating around 3,400 milligrams a day. Levels can vary widely. According to the Centers for Disease Control and Prevention, sodium in a slice of white bread ranges from 80 milligrams to 230 milligrams. Three ounces of turkey deli meat can have 450 milligrams to 1,050 milligrams. Those ranges give health advocates hope.


Cohera Medical Wins FDA Panel Date for TissuGlu Surgical Adhesive

Cohera Medical said it's won a date with an FDA advisory panel in August for its TissuGlu surgical adhesive. Cohera said the FDA's General & Plastic Surgery panel is slated to convene August 1 to review its pre-market approval application for TissuGlu, which is designed "for the approximation of tissue layers where subcutaneous dead space exists between the tissue planes in large flap surgical procedures such as abdominoplasty." Early this year Cohera closed on a $26 million Series D round, saying it plans to use the proceeds to advance TissuGlu through the PMA process and to secure CE Mark approval in the European Union for Sylys, another surgical sealant designed for intestinal anastomosis procedures. 


Alere Gets FDA Clearance for Molecular Flu A/B Test

Alere said [...] that it has received US Food and Drug Administration Clearance for the Alere i Influenza A&B test. According to Alere, the new assay is the only molecular test to detect and differentiate influenza A and B virus in less than 15 minutes. Alere established the assay's clinical performance in a multi-center, prospective study conducted on 585 nasal swab specimens collected at eight US trial sites during the 2012-2013 flu season. The company has also completed clinical trials for CLIA waiver of the test, and expects to submit a CLIA waiver filing to the FDA in the third quarter. 


Feds Prepare to Make More Health Data Public

Two U.S. lawmakers are looking to health care providers, insurance companies and consumers for advice on how to make digital health data easier to use. Sens. Ron Wyden, D-Ore., and Chuck Grassley, R-Iowa, have sent a letter to approximately 200 organizations seeking input on what reforms they’d like to see in transparency rules for health information. Responses are due by Aug. 12. The disclosures will be the first batch of data required by the Physician Sunshine Act which was part of the national health reform law. That information will be released online on Sept. 30. 


Power to the Health Data Geeks

A computer programmer and a kid in a Batman suit walk into a pancake house....  It sounds like a joke, but it really happened, and now the programmer — Dave Vockell — has a new product to bring to market. It's an app to help seniors talk to their doctors about medical care. "Like all great health care breakthroughs, it happened at the International House of Pancakes," he says, half-jokingly. Vockell's endeavor started back in April, when Medicare released a huge database detailing how much it pays individual doctors. The government health plan for the disabled and for adults ages 65 and older had kept that payment information secret for decades. So when Medicare suddenly dumped an entire year's worth of data, finally making public millions of transactions, coders like Vockell tried to figure out how to make it useful for seniors.
Dr. Omar Alvi is with a startup called Accordion Health. This firm's big idea is to help families estimate future health care spending. So you could type in that Grandpa has hypertension, Mom has diabetes, and one of the kids has asthma, and then get some idea of how much that's all going to cost — and maybe even shop for the best price. 


Computer-assisted Coding and Encoder Technology Are Changing Workflow for ICD-10 Readiness

The medical coding career has not experienced a significant change event since the introduction of DRGs in 1984. For decades, processes and technology have remained widely unchanged. ICD-10 is forcing many to reconsider their current workflow and deploy new technology to face the upcoming challenge. Computer-assisted coding (CAC) is proving to better equip coders for the challenge. CAC is software that reads the patient chart and, using natural language processing (NLP) and how language relates to medical codes, suggests codes and highlights relevant documentation before the coder has read a single word. This coding head start gives the coder the ability to see the patient story as a coded event right away. Through a process of validation, or rather accepting and deleting suggested codes, coders are faster and, some research suggests, more accurate.


Will Federal Privacy Laws Impede Health-Care Consumerization?

Mobile apps, new devices and cloud computing may soon end the doctor’s reign as the be-all, end-all of medical care by making patients equal partners in the healthcare process. But current privacy laws around medical information could hinder the usefulness of data generated by emerging health monitoring apps and wearables, according to experts meeting at a two-day technology conference [....] 


Amazon Takes Up role

Big changes are in store for when the next open enrollment period begins in November, according to two articles that offer inside looks into the coding and infrastructure work on the site. One of the biggest changes is taking place behind the scenes. Amazon Web Services is being brought in to handle cloud hosting for parts of, as a subcontractor of HP. AWS capacity will be applied to back-end systems for insurance carrier data, risk assessment data, and parts of the user interface for the front door of 
Among the changes is a faster, more stable plan comparison tool, an upgraded identity management system, a new simplified shopping system dubbed "EZ App" that could guide individuals and families with relatively uncomplicated applications through the process with less friction than the original application. According to Wired, most applicants would be able to enroll via the EZ App.


Major Medical Records Breaches Pass 1,000 Milestone as Enforcement Ramps Up

Nearly 31.7 million individuals, a number equal to one in 10 people in the U.S., have had their medical records exposed through known and reported major data breaches by healthcare providers and their business associates, and with 34 publicly reportable breaches coming in June alone, the total number of breaches on the federal “wall of shame” website topped the 1,000 mark this month. A total of 1,026 breaches have been reported to HHS involving 500 or more individuals since the federal reporting requirement went into effect in September 2009 under the American Recovery and Reinvestment Act, according to the public siteExternal Web Site Icon kept by HHS' Office for Civil Rights.


NHS Scan and Test Delays 'Worrying'

Health charities have called for urgent action to tackle delays in access to diagnostic tests in England. The latest figures show that in April, nearly 17,000 patients had been waiting more than six weeks for scans and investigations - including for cancer.  NHS England says most patients are investigated promptly, despite a big rise in demand for tests. The NHS constitution says no one should have to wait more than six weeks for a diagnostic test. Macmillan Cancer Support said the NHS was "under strain" and there was a danger of cancer being "overlooked". Ciaran Devane, Macmillan's chief executive, said: "It is extremely worrying that the proportion of people who face delays in receiving vital tests which can diagnose cancer has doubled since this time last year, from 1.1% to 2.2%. 


CDC Report: Patients Harmed After Health Care Providers Steal Patients' Drugs

A report authored by experts from the Centers for Disease Control and Prevention (CDC) - published in Mayo Clinic Proceedings - outlines outbreaks of infections that have occurred as a result of health care providers stealing or tampering with their patients' medications. These outbreaks revealed gaps in prevention, detection, and response to drug diversion. "Patient harm stemming from diverting injectable drugs can include patients not obtaining adequate pain management, exposure to substandard care from an impaired provider, and exposure to life-threatening infections," according to study co-authors Melissa K. Schaefer, MD, and Joseph F. Perz, DrPH, of the Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, CDC, Atlanta, GA. CDC provides several important resources for health care providers devoted to drug diversion:


CDC’s Welcome Recommendation of Drug to Prevent HIV

Remember AIDS? Fifty thousand people a year are still infected with the virus. But perhaps because the disease is no longer a death sentence, thanks to post-infection drug regimens, vulnerable people have relaxed their vigilance. The percentage of gay men who report having had unprotected sex crept up from 48 in 2005 to 57 in 2011 Adobe PDF file. With that reality staring it in the face, the Centers for Disease Control and Prevention last month recommended the people at serious risk of infection take a daily pill called Truvada, which reduces transmission of the HIV virus dramatically. 


Walgreens and Greater Than AIDS Team With Health Departments and Local AIDS Service Organizations to Offer HIV Testing in Support of National HIV Testing Day

In support of National HIV Testing Day, June 27, Walgreens (NYSE: WAG) (Nasdaq: WAG), the nation’s largest drugstore chain, and Greater Than AIDS, a coalition of about 200 public and private sector partners united in response to the domestic AIDS epidemic, are teaming with health departments and local AIDS service organizations across the country to encourage community members to take advantage of free HIV testing.                         
Free HIV tests will be available June 26-28 at select Walgreens in more than 140 cities including Atlanta, Chicago, Houston, Los Angeles, Miami, New Orleans, New York City, San Francisco and Washington, D.C.  Nearly 200 state and local health departments and AIDS service organizations (ASOs) will lead testing events and will provide results on-site within minutes. BioLytical Laboratories donated 10,000 INSTI HIV one-minute, finger-prick test kits to support the effort at select testing sites.  Other locations will offer rapid results using available oral fluid or blood-based HIV testing technologies.
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