A Weekly Compilation of Clinical Laboratory and Related Information
from The Division Of Laboratory Programs, Standards And Services
August 28, 2014
- ASCP Special on PBS Highlights the Importance of Laboratory Medicine to Build the Future Workforce
- NIH, NSF, USDA Lead $12M Program for Infectious Disease Transmission Studies
- Many Patients Don't Understand Electronic Lab Results
- HIV Testing in Emergency Settings: Study Shows Rapid Testing Using an Opt-out Method May Lead to Earlier Diagnosis
- Ebola Diagnostic Device Prototype — Rapid and Inexpensive
- Microchip Test for Diabetes: Stanford University Researchers Develop a New Rapid Method for Detecting Type 1 Diabetes From a Drop of Blood
- Non-Invasive Brain Acoustic Drug Delivery
- Levels of Disease Biomarkers Influenced by Genetics, Lifestyle Factors
- Epigenetic Study Bolsters Alzheimer's Understanding
- Ebola Virus Tracked With CDC App
- California Trees Nailed as the Source of Mystery Infections
- Is Antibacterial Soap Safe for Healthcare Workers?
- Deaths by Medical Mistakes Hit Records
- HIEs and Interoperability: 6 Statistics on Quality, Efficiency
- Supporters Say Telemedicine Poised for Major Gains
View Previous Issues - Healthcare News Archive
ASCP Special on PBS Highlights the Importance of Laboratory Medicine to Build the Future Workforce
The critical importance of pathology and the medical laboratory as part of the medical team will be front and center in a public television show, “Leading Edge,” that will air next month.
Pathologists and lab professionals are vital to providing patients with quality healthcare, but many people do not know the important role the lab plays in diagnosing and treating medical conditions. The critical importance of pathology and the medical laboratory as part of the medical team will be front and center in a public television show, “Leading Edge,” that will air next month.
NIH, NSF, USDA Lead $12M Program for Infectious Disease Transmission Studies
Three US funding agencies, along with partners in the UK and Israel, will provide up to $12 million next year to support multidisciplinary research projects that will use genomics and a wide range of other methods to better understand how infectious disease pathogens are transmitted and evolve.
These projects will be funded under the Ecology and Evolution of Infectious Diseases (EEID) program, and will aim to create quantitative or computational knowledge about and models of infectious disease transmission among humans, non-humans, or plants, the National Institutes of Health said in a funding notice this week. The studies will involve multidisciplinary teams that include researchers specializing in genomics, bioinformatics, epidemiology, microbiology, virology, social sciences, pathology, and other areas.
Many Patients Don't Understand Electronic Lab Results
While it's becoming commonplace for patients to see the results of lab work electronically, a new University of Michigan study suggests that many people may not be able to understand what those numbers mean. Research conducted by a team at the U-M schools of Public Health and Medicine found that people with low comprehension of numerical concepts—or numeracy—and low literacy skills were less than half as likely to understand whether a result was inside or outside the reference ranges. They also were less able to use the data to decide whether or not to call their doctor.
"If we can design ways of presenting test results that make them intuitively meaningful, even for people with low numeracy and/or literacy skills, such data can help patients take active roles in managing their health care," he said. "In fact, improving how we show people their health data may be a simple but powerful way to improve health outcomes." The study is reported online in the Journal of Medical Internet Research.
HIV Testing in Emergency Settings: Study Shows Rapid Testing Using an Opt-out Method May Lead to Earlier Diagnosis
An opt-out approach to testing for HIV in the emergency department (ED) is feasible using a fourth-generation antigen/antibody laboratory test, finds a study recently published in Annals of Emergency Medicine and funded by the Centers for Disease Control and Prevention (CDC). “The main implication from this study is that fourth-generation HIV testing, which identifies both HIV antigen and antibody, allows for earlier diagnosis of HIV,” explains Kara I. Geren, MD, MPH, lead author of the paper. “Patients present to the ED with symptoms of acute HIV infection but, in the past, due to imperfect technology, these infections were missed. Now patients, both symptomatic and asymptomatic, can be diagnosed with HIV.”
Ebola Diagnostic Device Prototype — Rapid and Inexpensive
PositiveID, a company in the San Francisco Bay area, has been developing a rapid, on-site test system that will help public health and transportation officials screen for disease at ports of entry. In addition to screening for people who may be ill when coming into the country, this technology may help contain a disease at the site where it develops.
According to the KTVU report, the test kit from PositiveID is currently under development, and it is capable of analyzing a sample in about 15 minutes. The speed of this device combined with its design, which is highly focused on ease-of-use, makes it possible for just about anyone to operate. The system makes use of a disposable cartridge with a small hole in the center where the biological sample is placed. To perform the analysis, there is a single button that gets pushed by the operator. Each test costs $25 to perform, while the test device itself has a target cost between $3,000 and $5,000.
Microchip Test for Diabetes: Stanford University Researchers Develop a New Rapid Method for Detecting Type 1 Diabetes From a Drop of Blood
If a new microchip test wins approval from the Food and Drug Administration (FDA), there could soon be a new, simple, and cheap way to test for type 1 diabetes. Recently, Stanford University researchers successfully used a small, inexpensive microchip to diagnose the disease. The new test involves a plasmonic gold chip used for near-infrared fluorescence-enhanced (NIR-FE) detection of islet cell-targeting autoantibodies. The test arrives amid the changing demographics of diabetes, as well as an evolving understanding of the natural history of type 1 diabetes. The incidence of both type 1 and type 2 diabetes is on the rise. Type 1 diabetes was once thought to exclusively develop in childhood, but today, about one-quarter of affected individuals are diagnosed with the disease as adults. Conversely, children now are being diagnosed with type 2 diabetes, something that occurred quite rarely in the past. At the same time, emerging but promising research also shows that immune-modulating and antigen-specific therapies could fundamentally alter the progression of type 1 diabetes.
EndoType: A New Bar for T1D Antibody Tests?
Endocrinologists have been using antibody tests to distinguish type 1 diabetes in tough cases for a long time, so it's no wonder the FDA's approval earlier this week of the ZnT8 antibody test as the "first" raised eyebrows. The approval was part of the FDA's recent move to require approval of all "laboratory-developed tests" (LDTs) -- even those that have already been on the market for years. FDA unveiled its draft guidance for regulating these tests at the end of July. Stephanie Yao, an FDA spokesperson, said there's no grandfather clause in the proposed framework, and once it's finalized, "all LDTs will need to undergo FDA review."
In a blog released with the guidance, the FDA's Jeffrey Shuren, MD, JD, said his agency has had enforcement authority of LDTs since 1976, but more regulation is required because these tests have become more complex.
Thomas Jefferson University Study Finds Critical Weakness in Commercially Manufactured Exome-Capture Test Kits Used by Some Medical Laboratories
The four exome test kits examined as part of this study failed to deliver quality results, particularly because they often missed some disease-causing mutations altogether. Human exome sequencing is gaining favor among medical laboratories wanting to use this information for clinical purposes. However, the accuracy of some exome-capture test kits available on the market today has come under question. A team from the Thomas Jefferson University in Philadelphia surveyed the potential false-negative rate of mutations in 56 disease-causing genes produced by four different commercially available human exome-capture test kits. The researchers found that these test kits failed to deliver quality results, sometimes missing mutations altogether, noted a report published by Medical Daily. This study is of particular interest to pathologists and other diagnostic clinicians because exome sequencing, which analyzes sequences of the protein-coding regions of the human genome (that make up about 1% of the genome’s 3 billion base pairs), is commonly used for diagnosing genetic disorders. Exome sequencing has gained favor because it is significantly less expensive and faster than sequencing a person’s complete genome.
Test Reliably Detects Inherited Immune Deficiency in Newborns
A newborn screening test for severe combined immunodeficiency (SCID) reliably identifies infants with this life-threatening inherited condition, leading to prompt treatment and high survival rates, according to a study supported by the National Institutes of Health (NIH). The research, led by Jennifer Puck, MD, was published recently in the Journal of the American Medical Association. The SCID newborn screening test, originally developed at the NIH, measures T-cell receptor excision circles (TRECs), a byproduct of T-cell development. Infants with SCID have few or no T cells, regardless of the underlying genetic defect, and the absence of TRECs may indicate SCID.
Serum Calcium Predicts Type 2 Diabetes Development
Increased serum calcium levels independently predict the risk for type 2 diabetes, a new analysis from the ongoing Prevención Dieta Mediterránea (PREDIMED) study suggests. The results were published online August 19 in Diabetes Care by dietician and predoctoral student Nerea Becerra-Tomás, of the Institute of Health Carlos III, Madrid, Spain, and colleagues.
"Fasting glucose is, at the moment, the main risk factor for type 2 diabetes, and the diagnosis is based on it. However, after adjusting for glucose, our results demonstrated a role for serum calcium independent of glucose.... Measurement [of serum calcium] could add significance to measurement of fasting glucose," study coauthor Mònica Bulló, PhD, professor in the Faculty of Medicine and Health Sciences at the Universitat Rovira i Virgili, Reus, Spain, told Medscape Medical News.
Cancer Screening is Losing 'Luster,' Says Critic
After 50 years of being enthusiastically promoted and used, cancer screening has entered an era that is characterized by "skepticism," according to a commentary published online August 18 in JAMA Internal Medicine. "The second half of the 20th century was truly an age of wonder for cancer screening," writes essayist Cary Gross, MD, from Yale University in New Haven, Connecticut. Screening for cervical cancer with the Pap test highlighted this golden period; in the United States, the related incidence and mortality dropped by 60% from the 1950s to the 1990s.The screening of Americans accelerated in the 1960s as other screening methods were introduced, such as mammography in 1963 and colonoscopy in 1969. But American clinicians are now full of "wonder" about screening in a very different way, says Dr. Gross. They wonder whether screening helps or hurts patients, what public health messaging should be, and how to relate relevant data. Prostate cancer screening is emblematic of this shift, he notes, having gone from being "straightforwardly recommended" to being "discouraged by many experts."
Independent Study Validates Simplexa Dengue Test as Focus Diagnostics Expands Menu
An independent study by researchers in Indonesia has shown that Focus Diagnostics' Simplexa Dengue test has a higher detection rate than conventional RT-PCR or SYBR Green real-time RT-PCR methods in clinical samples. The Focus test, which simultaneously detects and serotypes dengue virus, could be used for future dengue surveillance studies, the authors concluded. The study of Simplexa Dengue, published in PLoS One..., used 184 ELISA-confirmed clinical samples taken in eight different cities in Indonesia, a dengue-endemic country. In this sample, the detection rate for conventional RT-PCR was about 29 percent. SYBR green real-time RT-PCR had a rate of 44 percent, while the Simplexa test had a rate of about 76 percent. Using virus isolation as the gold standard for viremia, the researchers then tested the three assays again on a subset of 40 samples. The Simplexa test achieved 100 percent sensitivity, while the conventional and SYBR green methods were around 95 and 98 percent sensitive.
Thermo Fisher Scientific Launches Clinical Next-Generation Sequencing Oncology Quality Control
Thermo Fisher has made the AcroMetrix Oncology Hotspot Control available to customers in the United States and Europe. This product provides a common quality control material that can be used across laboratories with different next-generation sequencing (NGS) instrument platforms, assays, and bioinformatics pipelines to test precision and detect analytical deviations that may arise from reagent and instrument variation.
Exact Sciences Readies Cologuard for Market; Lauds Parallel FDA, CMS Review Process
After having gained regulatory approval and reimbursement backing under Medicare on the same day last week for its stool DNA-based colorectal cancer screening test, Exact Sciences is hoping to begin marketing its first commercial diagnostic with an 80-person sales team. Last week, the US Food and Drug Administration approved Exact's Cologuard, a non-invasive test that gauges DNA and blood biomarkers and determines whether a patient has pre-cancerous polyps or cancer. Simultaneously, the Centers for Medicare & Medicaid Services issued a memorandum proposing to cover the test as a screening option once every three years for asymptomatic Medicare beneficiaries between ages 50 and 85 years who are at average risk for developing colorectal cancer. CMS is seeking comments on this proposal for 30 days and will issue a final decision after that. While Cologuard is Exact's first commercial product, the company is also developing tests for pancreatic, esophageal, and stomach cancers.
Genomic Vision Has Presented the First Results of Its HPV Detection Test at the HPV 2014 Conference in Seattle
So far, the screening, diagnosis and survival of patients have been essentially based on cervical smears, colposcopies and biopsies. The integration of HPV viral DNA in the genome of the infected cell being a major stage in the progression of tumors, the test currently being developed by Genomic Vision aims to directly detect not only the presence of viral DNA, but also its integration in the infected cell genome. This HPV integration cannot be directly detected by existing tests. The preliminary results have shown that molecular combing technology allows the direct and high-resolution visualization of the integration of high-risk HPV genomes (HPV16 and HPV18 as unique or tandem array) in the cervical-cancer-derived cell lines and in the cervical smears of patients with lesions at various stages of the disease’s evolution.
New Genetic Test May Change How Brain Cancer is Treated, Researchers Say
Scientists at Virginia Tech's Virginia Bioinformatics Institute working with the Center for Cancer and Blood Disorders at Children’s National Medical Center have found a new way to diagnose brain cancer based on genetic markers found in "junk DNA." The finding, recently published in Oncotarget, could revolutionize the way doctors treat certain brain cancers. Brain cancer is the second leading cancer-related cause of death in children. Overall, 70,000 new patients were diagnosed with primary brain tumors in 2013, according to the American Brain Tumor Association. However, only about a third turn out to be malignant. Ordinarily, when a patient shows symptoms of a brain tumor, an MRI is performed to locate tumors, but it cannot determine whether the tumor is benign or malignant, often necessitating costly and occasionally dangerous or inconclusive biopsies. A simple blood test to detect genetic markers could change all that.
Non-Invasive Brain Acoustic Drug Delivery
Dr. Elisa Konofagou, professor of biomedical engineering and radiology at Columbia University, has shown for the first time that the size of molecules crossing the blood brain barrier (BBB) can be manipulated through acoustic pressure generated by an ultrasound beam. Delivering drugs to the brain is exceptionally difficult as most small molecules and all large molecules cannot cross.
By choosing a specific pressure, Konofagou was able to cause the microbubbles to oscillate and create openings in the BBB with minimal microscopic damage.
Levels of Disease Biomarkers Influenced by Genetics, Lifestyle Factors
The plasma levels of a number of disease biomarkers are influenced by genetic and lifestyle factors, a new study in Nature Communications reported today. A team of researchers from Uppsala University in Sweden studied more than 90 protein biomarkers in a thousand healthy people. They further examined whether the plasma levels of those disease biomarkers were influenced by environmental and lifestyle factors like age, blood pressure, or smoking status, and whether the levels of the biomarkers in plasma were heritable. Some three quarters of the biomarkers the researchers studied were swayed by such factors.
Epigenetic Study Bolsters Alzheimer's Understanding
The current study found that chemical modifications to DNA within the ANK1 gene are strongly associated with measures of neuropathology in the brain. A team of researchers at the Institute of Psychiatry, King’s College London and the University of Exeter has uncovered some of the strongest evidence yet that epigenetic changes in the brain play a role in Alzheimer’s disease. Epigenetic changes affect the expression or activity of genes without changing the underlying DNA sequence and are believed to be one mechanism by which the environment can interact with the genome. Importantly, epigenetic changes are potentially reversible and may therefore provide targets for the development of new therapies.
Follow That Cell
The National Institutes of Health is challenging science innovators to compete for prizes totaling up to $500,000, by developing new ways to track the health status of a single cell in complex tissue over time. The NIH Follow that Cell Challenge seeks tools that would, for example, monitor a cell in the process of becoming cancerous, detect changes due to a disease-causing virus, or track how a cell responds to treatment. “Advances in cellular analysis promise earlier diagnosis and improved therapies for diseases, from cancer to Alzheimer’s,” said James Anderson, M.D., Ph.D., director of NIH’s Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI). “These prizes will also help to stimulate new businesses and economic growth in our biomedical communities.” The challenge aims to generate creative ideas and methods for following and predicting a single cell’s behavior and function over time in a complex multicellular environment – preferably using multiple integrated measures to detect its changing state.
Roche, Garvan Institute to Collaborate on Epigenomic Technology
Roche will collaborate with the Garvan Institute of Medical Research in Sydney to develop technology for targeted next-gen sequencing-based epigenomic analysis, the company said today. Although the company said last year that it would close down its 454 Life Sciences sequencing operation by 2016, Roche has recently made a number of investments in the next-gen sequencing space. In June, it invested in nanopore sequencing startup Stratos Genomics and also acquired nanopore sequencing firm Genia Technologies. In addition, it forged a deal with Pacific Bioscienceslast year to develop a sequencing system and assays for clinical diagnostics.
Tuberculosis is Newer Than Thought, Study Says
After a remarkable analysis of bacterial DNA from 1,000-year-old mummies, scientists have proposed a new hypothesis for how tuberculosis arose and spread around the world. The disease originated less than 6,000 years ago in Africa, they say, and took a surprising route to reach the New World: It was carried across the Atlantic by seals. The new study, published in the journal Nature, has already provoked strong reactions from other scientists. “This is a landmark paper that challenges our previous ideas about the origins of tuberculosis,” said Terry Brown, a professor of biomolecular archaeology at the University of Manchester. “At the moment, I’m still in the astonished stage over this.” But Helen Donoghue, an expert on ancient DNA at the University College London, rejected the idea that tuberculosis could have emerged so recently. “It just cannot be right,” she said, citing earlier fossil evidence of the disease.
Ebola Virus Tracked With CDC App
Centers for Disease Control and Prevention (CDC) officials have turned to technology in an effort to more effectively manage the recent West African Ebola outbreak. By using a new computer application, the CDC is focusing on an area of disease detection that has historically been one of the most difficult — finding potentially infected people who were exposed to the disease. “As Ebola outbreaks are rare, this is the first time we’re getting to put this tool through its paces,” said CDC Epi Info team lead Asad Islam, M.S., in the press release. “Given that the Epi Info VHF tool has a tiny IT footprint and easily works in places with limited network connectivity, that it automatically updates as new information is added, and that it offers daily reports to guide follow-up, we are cautiously optimistic that it will make a significant difference.”
The Epi Info VHF application is specifically designed for use with viral hemorrhagic fevers like Ebola, Marburg, Rift Valley, Lassa, and the Crimean Congo fevers. The Ebola virus is a fluid born pathogen, transmitted through body fluids like blood, saliva, stool, urine, and sweat. Direct contact with objects that have been exposed to fluids may also lead to the transmission of the virus. The VHF app is particularly important because outbreaks can spread rapidly as early symptoms are easily misdiagnosed. The West African Ebola outbreak is a serious affair and has required unusual measures to be taken like the use of unapproved diagnostic tests. Rapid test prototypes have also been developed and are being aggressively pursued.
California Trees Nailed as the Source of Mystery Infections
A fungus called Cryptococcus gattii can cause life-threatening infections, especially in people with compromised immune systems. A different form of the fungus has been making people sick in the Pacific Northwest, where it grows on Douglas fir trees. But there are no Doug firs in Los Angeles. "We had a good idea that the fungus was going to be associated with trees," says Deborah Springer, a postdoctoral fellow at Duke University who studies C. gatti. "We just didn't know what trees."
Elan Filler and Springer connected on email and figured out a plan. Soon Elan was making her way around greater Los Angeles, swabbing tree trunks and growing out the fungus in Petri dishes. And the tree samples matched not just those from recent patients but from people who were sick 10 to 12 years ago. Thus this strain of C. gattii has been causing health problems in California for at least that long. The results were published [...] in PLOS Pathogens.
Is Antibacterial Soap Safe for Healthcare Workers?
Despite the proven benefits of hand-washing, use of antibacterial soap may expose healthcare workers to "potentially unsafe levels" of a common chemical currently under Food and Drug Administration (FDA) scrutiny, according to a new study published in the Journal of Occupational and Environmental Medicine. The FDA is currently reviewing the effect of triclosan—an antibacterial agent commonly found in soap, cosmetics, skin creams and some brands of toothpaste—on hormone levels. The agency is concerned it may cause side effects, such as interference with hormones and fetal development problems, according to researchers from the University of California at San Francisco (UCSF).
CDC: Salmonella Outbreak Blamed on Bearded Dragons is Over
The Salmonella outbreak blamed on pet bearded dragons is over, but the federal Centers for Disease Control and Prevention (CDC) in Atlanta expects that a lower level of infections from the reptiles will continue. In a final update on the outbreak involving both the Salmonella Cotham and the Salmonella Kisarawe strains, CDC reported that 166 cases were recorded in 36 states, with a 37-percent hospitalization rate. No related deaths were reported. The final numbers increased by 16 cases and just one state since CDC’s previous interim report on June 12, indicating the outbreak slowed during the summer.
MRSA: Experts Question the Value of Some Control Precautions
Uncertainties exist about the benefits of screening and contact isolation in controlling methicillin-resistant Staphylococcus aureus (MRSA), and some even contend these practices might be harmful, according to a viewpoint article published online August 21 in the Lancet. "Legal mandates dictating specific infection-control practices for MRSA should be abandoned," write Gerd Fätkenheuer, MD, president of the German Society of Infectious Disease, from Department I of Internal Medicine, University Hospital Cologne, and the German Centre for Infection Research, Bonn-Cologne, Germany; Bernard Hirschel, MD, president of the Swiss Society of Infectious Disease, from the Division of Infectious Diseases, Geneva University Hospitals and Faculty of Medicine, Switzerland; and Stephan Harbarth, MD, professor and chief of the Infection Control Program, Geneva University Hospitals and Faculty of Medicine, Switzerland.
Cronobacter Infections May Be More Common Than Previously Thought
Infections from a lesser-known foodborne pathogen most commonly associated with infants may be more common in elderly populations — and even adults and adolescents — than previously thought, according to a new study by researchers at the U.S. Centers for Disease Control and Prevention. The study, set to be published in the September issue of Emerging Infectious Diseases, was intended to define the impact of Cronobacter on various demographics in the U.S. using data collected by FoodNet, the CDC’s foodborne illness surveillance network in 10 states. It was the first study to look at rates of Cronobacter infections in groups other than infants, said Dr. Anna Bowen, CDC epidemiologist and one of the study’s authors.
Arrest Warrant Issued for Santa Barbara Tuberculosis Patient
Santa Barbara County officials issued an arrest warrant Friday for a 24-year-old man who stopped treatment for tuberculosis and who they say poses a public health risk. He has not been seen for two weeks. Authorities checked his last known address but have not been able to locate him, said Susan Klein-Rothschild, a spokeswoman for the Santa Barbara County Health Department. If he does not continue his treatment, she said his lung condition could worsen, he could die or he could pose a threat to anyone who comes in contact with him.
Deaths by Medical Mistakes Hit Records
It's a chilling reality – one often overlooked in annual mortality statistics: Preventable medical errors persist as the No. 3 killer in the U.S. – third only to heart disease and cancer – claiming the lives of some 400,000 people each year. At a Senate hearing Thursday, patient safety officials put their best ideas forward on how to solve the crisis, with IT often at the center of discussions. Hearing members, who spoke before the Subcommittee on Primary Health and Aging, not only underscored the devastating loss of human life – more than 1,000 people each day – but also called attention to the fact that these medical errors cost the nation a colossal $1 trillion each year.
HIEs and Interoperability: 6 Statistics on Quality, Efficiency
ONC's National Health Information Exchange and Interoperability Landscape report.
1. One-quarter of providers reported HIEs increase the practice's liability due to other providers lacking adequate privacy and/or security safeguards.
2. Thirty-eight percent of providers said electronically exchanging data decreases their ability to separate sensitive health information from other data being exchanged.
3. Vendor costs are concerning for some providers, as 42 percent indicated seeing increased costs.
4. Sixty-four percent of providers said HIEs required multiple systems or portals.
5. However, 80 percent of providers reported electronic data exchanges increase their practice's efficiency.
6. Furthermore, 89 percent of providers said electronic data exchanges improve the patient's quality of care.
Supporters Say Telemedicine Poised for Major Gains
Says one article, "With parity reimbursement laws in place in 19 states, and a bevy of bipartisan supported telemedicine legislation introduced in this session of Congress, including the proposed Medicare Parity Act of 2014, the financial obstacles relating to payment for telemedicine services are starting to crumble." To see the effects, head to the countryside. As one healthcare stakeholder in Montana explains, "there are only 17 licensed pediatricians in Montana, all of whom practice in the state's five largest cities.
New Contact Lens Microbiology Workshop Aims at Preventing Acanthamoeba Keratitis
The American Academy of Ophthalmology today announced a contact lens microbiology workshop on Sept. 12 aimed at preventing Acanthamoeba keratitis, a rare infection among contact lens wearers that causes severe eye pain, redness, light sensitivity and potential vision loss. The event is jointly sponsored by the Academy, the U.S. Food and Drug Administration (FDA), the Contact Lens Association of Ophthalmologists, the American Academy of Optometry and the American Optometric Association.
FDA Pilot Program for Medical Device Review Tool Development in the Works
A new pilot program planned by the US Food and Drug Administration is being planned to develop tools for more effective and efficient reviews of medical device premarket applications. According to new guidance, the agency will begin seeking participants for its Medical Device Development Tools (MDDT) Pilot Program in September 2014. Qualified MDDT program participants would develop tools for use by both regulators and manufacturers to evaluate performance, safety and effectiveness of devices before and during their US premarket registrations. Appropriate tools for participation in the MDDT program include clinical outcome assessments; nonclinical in vitro, animal and computer assessment models; tools to determine how innovative devices may impact public health; and tools that would boost efficiencies in device development and commercialization time frames.
Controversy Aside, New Lipid Guidelines Prove Superior
The contentious American Heart Association and American College of Cardiology guidelines more accurately matched statin assignment to plaque burden compared with older guidance, researchers said, leading to a "modest" increase in the number of patients who were prescribed statins. In the single-center, retrospective study of 3,076 adults who underwent undergoing CT angiography, the probability of prescribing statins rose with increasing plaque burden under the 2013 Guidelines on the Assessment of Cardiovascular Risk (GACR) compared with the 2001 National Cholesterol Education Program (NCEP) Adult Treatment Panel III recommendations, according to Kevin M. Johnson, MD, of Yale School of Medicine, and David A. Dowe, MD, of Atlantic Medical Imaging in Galloway, New Jersey.
"The use of low-density lipoprotein targets seriously degraded the accuracy of the NCEP guideline for statin assignment," they wrote. "The proportion of patients assigned to statin therapy was 15% higher under the GACR. The GACR and NCEP methods partition patients into risk groups in similar ways, but the NCEP method then applies LDL targets to decide who gets statin therapy." Johnson told MedPage Today that when he and Dowe excluded the LDL targets from the 2001 guideline in their analysis, the number of patients assigned to statin therapy was almost identical to the new guidelines.
Missing Protein Restored in Patients With Muscular Dystrophy
Advances in the treatment of muscular dystrophy: For the first time, a research team has succeeded in restoring a missing repair protein in skeletal muscle of patients with muscular dystrophy. Researchers from the University and the University Hospital of Basel, Department of Biomedicine and Clinic of Neurology, report their recent findings in the scientific journal Science Translational Medicine. For Head of Research Michael Sinnreich, the new findings serve as groundwork for future long-term clinical trials: "These findings could be of importance for the treatment of patients with muscular dystrophy as well as other, previously incurable genetic diseases."
U.S. Has Seen Widespread Adoption of Robot-Assisted Cancer Surgery to Remove the Prostate
A new study reveals that the U.S. has experienced widespread adoption of robot-assisted prostate removal surgery to treat prostate cancer in recent years. The BJU International study also found that while such surgeries are more expensive than traditional surgeries, their costs are decreasing over time.
In 2001, surgeons began using robotic technologies in operations to remove the prostate. To examine trends in the use of such robotic-assisted radical prostatectomy (RARP) procedures for prostate cancer patients, Steven Chang, MD, MS, of Harvard Medical School, the Dana-Farber Cancer Institute, and Brigham and Women's Hospital, led a team that analyzed 489,369 men who underwent non-RARP (i.e., open or laparoscopic radical prostatectomy) or RARP in the United States from 2003 to 2010.
Severe Infections After Prostate Biopsy on the Rise
Rates of severe infection after transrectal ultrasound-guided (TRUS) prostate biopsy that require hospitalization are on the rise, a population-based Swedish study shows. "Over 100,000 biopsies are done in Europe and the United States each year, so small increases in the risk of complications affect many individuals," said investigator Karl-Johan Lundström, MD, a consultant urologist at Umeå University in Östersund, Sweden. "It's therefore of paramount importance to monitor men carefully for complications to ascertain whether the incidence of these complications is increasing and, if it is, to identify specific risk factors that might explain it," he told Medscape Medical News.
Markey Researchers Develop Web-Based App to Predict Glioma Mutations
A new web-based program developed by University of Kentucky Markey Cancer Center researchers will provide a simple, free way for healthcare providers to determine which brain tumor cases require testing for a genetic mutation. Gliomas – a type of tumor that begins in the brain or spine – are the most common and deadly form of brain cancer in adults, making up about 80 percent of malignant brain cancer cases. In some of these cases, patients have a mutation in a specific gene, known as an IDH1 mutation – and patients who have this tend to survive years longer than those who do not carry the mutation.
The program, developed by UK researchers Li Chen, Eric Durbin, and Craig Horbinski, uses a statistical model to accurately predict the likelihood that a patient carries the IDH1 mutation and requires screening.
Connecticut Official Named CEO of Healthcare.Gov
Kevin Counihan, who until recently headed Connecticut's state health insurance exchange, has been hired by the Centers for Medicaid and Medicare Services as Marketplace Chief Executive Officer – essentially head of HealthCare.gov and the Center for Consumer Information and Insurance Oversight division of CMS. He will report to CMS administrator Marilyn Tavenner.
Disclaimer- The information provided in this news digest is intended only to be general summary information. It does not represent the official position of the Centers for Disease Control and Prevention and is not intended to take the place of applicable laws or regulations.
This symbol means you are leaving the CDC.gov Web site. For more information, please see CDC's Exit Notification and Disclaimer policy.
- Subscribe to
Health Care News
- Click to subscribe
Centers for Disease Control and Prevention
Division of Laboratory Programs, Standards, and Services
1600 Clifton Road
Atlanta, GA 30333, USA
TTY: (888) 232-6348
New Hours of Operation