A Weekly Compilation of Clinical Laboratory and Related Information
from The Division Of Laboratory Programs, Standards And Services
February 05, 2015
- AT PMWC, FDA Commissioner Hamburg Discusses LDT Regulation, Personalized Medicine Advancements
- FDA Rethinks Regulatory Approach for Next-generation Sequencing
- More Than 100 Confirmed Cases of Measles in the U.S., CDC Says
- Guidance for Collection, Transport and Submission of Specimens for Ebola Virus Testing
- How People Try to Beat Drug Testing
- Trust in Cervical Cancer Screening Is Strong - Extending Time between Tests Triggers Concern
- Human Proteome Mapped Again
- In the Way Cancer Cells Work Together, a Possible Tool for Their Demise
- Researchers Claim Breakthrough in Treating Peanut Allergies
- Trial Finds GSK Ebola Shot is Safe and Provokes Immune Response
- CMS Relaxes Meaningful Use Data Exchange Requirement
- Industry Professionals Create Framework for Measuring HIT Value
- ONC Unveils Interoperability Roadmap for Public Comment
View Previous Issues - Healthcare News Archive
AT PMWC, FDA Commissioner Hamburg Discusses LDT Regulation, Personalized Medicine Advancements
At the Personalized Medicine World Conference, US Food and Drug Administration Commissioner Margaret Hamburg said that the agency will carefully review the public comments it receives in response to its draft proposal to regulate laboratory-developed tests [LDTs]. However, she couldn't predict when the agency would finalize the document. In moving to regulate LDTs, Hamburg noted that the agency's aim is to ensure that diagnostics that are important to patient care are safe and effective, and physicians and patients can rely on them. "That matters because we want patients to be able to get an accurate diagnosis and get the treatments that they need," she added. "We certainly don't want an inaccurate diagnostic that might result in inappropriate treatment or lack of treatment when treatment might be indicated." Ensuring the safety and efficacy of diagnostics is also important for advancing personalized medicine research, she said. "As we explore the opportunities for more targeted therapies ... the hub of personalized medicine is getting the target right." Hamburg said that she's often asked why advances in personalized medicine aren't coming faster. "But a lot has happened," she reflected, even though it hasn't been that long since the sequencing of the human genome. In the early 1990s, she noted that only 5 percent of approved drugs were targeted treatments, a number that in 2013 rose to 45 percent.
FDA Rethinks Regulatory Approach for Next-generation Sequencing
Amid President Barack Obama's planned Precision Medicine Initiative, the U.S. Food and Drug Administration is evaluating its regulatory approach to next-generation sequencing (NGS). While most diagnostic tests fit the FDA's "one-test, one-disease paradigm" for evaluating a test's analytical and clinical performance, NGS produces a massive amount of data that might require a new approach, FDA Commissioner Margaret Hamburg writes in a blog post. The genetic sequencing might be used to predict a person's risk of developing various conditions and might help physicians and patients determine what course of treatment.
More Than 100 Confirmed Cases of Measles in the U.S., CDC Says
The measles outbreak that originated at a California theme park continues to grow, causing increased concern among public-health authorities. There are 102 confirmed cases of measles in 14 states across the country, the Centers for Disease Control and Prevention said Monday. In addition, there are also hundreds of other people being monitored for possible exposure. The large number of cases so far this year has already eclipsed the number typically reported each year, according to Anne Schuchat, director of the CDC's National Center for Immunization and Respiratory Diseases.
CMS Proposes Broader Medicare Coverage for HIV Screening
The CMS has granted tentative coverage for HIV screening of all beneficiaries without regard to perceived risk behavior, it announced via a proposed national coverage memo. “CMS concludes that screening for HIV infection provides direct benefit to the Medicare population,” the agency says in its decision memo. “Evidence is adequate to conclude that screening for HIV infection for all individuals between the ages of 15 and 65 years … is reasonable and necessary for the early detection of HIV.” Testing had been covered only for pregnant woman and those at high risk for the virus. The proposed national coverage decision brings Medicare policy in line with a 2013 U.S. Preventive Services Task Force recommendation, although that recommendation applies only to people between ages 15 and 65.
World leaders Make Record-breaking Commitment to Protect Poorest Children With Vaccines
Hundreds of millions of children living in the world’s poorest countries will receive life-saving vaccines as a result of record-breaking financial commitments made at the Gavi Pledging Conference, hosted in Berlin by German Federal Chancellor Angela Merkel. The new pledges, totalling US$ 7.5 billion, will enable countries to immunise an additional 300 million children, leading to 5 to 6 million premature deaths being averted and economic benefits of between US$ 80 and US$ 100 billion for developing countries through productivity gains and savings in treatment and transportation costs and caretaker wages.
Guidance for Collection, Transport and Submission of Specimens for Ebola Virus Testing
To provide guidance for laboratory workers on collecting, transporting and submitting specimens for Ebola virus testing.
This guidance document replaces the previously posted document: “Interim Guidance for Specimen Collection, Transport, Testing, and Submission for Persons Under Investigation (PUIs) for Ebola Virus Disease (EVD) in the United States.”
This document complements the updated CDC “Guidance for U.S. Laboratories for Managing and Testing Routine Clinical Specimens When There is a Concern About Ebola Virus Disease(http://www.cdc.gov/vhf/ebola/healthcare-us/laboratories/safe-specimen-management.html)” which provides guidance for clinical laboratories on testing needed for assessment and care of patients for whom Ebola Virus Disease (EVD) may be a concern, while minimizing risk to laboratory personnel. This guidance is based on input received from numerous hospital and laboratory directors, infectious disease physicians, CDC Ebola response teams, and state health officials.
How People Try to Beat Drug Testing
Illicit drug abuse remains a serious public health issue. According to the 2013 National Survey on Drug Abuse and Health, an estimated 24.6 million Americans age 12 years and older were current illicit drug users—9.4% of the U.S. population. Marijuana was the most commonly abused illicit drug, followed by cocaine, heroin, and hallucinogens. Federal guidelines define an adulterated specimen as a urine specimen containing either a substance that is not a normal constituent or an endogenous substance at a concentration that is not a normal physiological concentration. Pre-employment screening programs typically do not involve direct supervision of specimen collection, so employment candidates may attempt to cheat drug testing by adulterating specimens. This makes it essential for laboratories to identify pre-analytically any such adulterated specimens.
Ways of Cheating a Drug Test
Usually people try to cheat drug testing by three different ways: substituting their urine with synthetic urine or drug-free urine purchased from a clandestine source; drinking a commercially available product to flush out drugs; or adding an adulterant in vitro to the urine specimen after collection.
Trust in Cervical Cancer Screening Is Strong - Extending Time between Tests Triggers Concern
A National Survey of Attitudes and Behaviors, paints a picture of women and their healthcare providers as resistant to changes in one of the most successful cancer prevention programs in U.S. history: cervical cancer screening. The survey, conducted jointly by the National Association of Nurse Practitioners in Women's Health (NPWH) and HealthyWomen (HW), explored the attitudes and decisions in the exam room of more than 2,000 women and 750 healthcare providers nationwide. Women and Healthcare Providers Rely on the Pap test.
The Benefit of Pap and HPV Tests
According to the survey, co-testing has been widely adopted by healthcare providers, especially among nurse practitioners and OB-GYNs, 83 percent of whom say it adds value to their patients' health. Further, 74 percent of healthcare providers believe the majority of their patients would be most comfortable with receiving both Pap and HPV tests versus either alone (12 percent and 2 percent, respectively). Survey respondents showed lower levels of understanding surrounding HPV, which, coupled with their overwhelming trust in the Pap test, may contribute to their unwillingness to embrace changes in screening patterns.
Portable Microfluidic Device Detects Dengue in Minutes
Dengue fever can be difficult to differentiate from other viral diseases early in its progression. It’s typically diagnosed based on symptoms, but researchers at Singapore’s A*STAR research agency have created a field detector that spots the dengue virus from a drop of saliva. Not only can it detect the virus, but it’s able to pinpoint whether it’s a secondary infection that often causes dengue hemorrhagic fever or dengue shock syndrome. The test takes about 20 minutes to run and the kit doesn’t require much training to operate.
Do we Need Procalcitonin for Sepsis?
In order to prove the presence of bacterial infection, serum biomarkers like procalcitonin (PCT) are considered useful. Biochemically, PCT is the prohormone of the hormone calcitonin, released into the circulation in response to bacterial infection. PCT is the best-studied sepsis biomarker for clinical use. Among all sepsis markers, only PCT has achieved universal use throughout developed countries in the last decade. One major advantage of PCT compared with other biomarkers is its early and rapid increase in response to bacterial infections and sepsis. High PCT concentrations are commonly found in bacterial infection, in contrast to much lower levels in viral infection. However, even though PCT is virtually undetectable (less than 0.1 ng/mL) in healthy individuals, elevated serum PCT concentrations are not always specific for sepsis. Many studies have linked elevated PCT to SIRS, localized bacterial infection, autoimmune disease, burns, severe trauma, surgery, pancreatitis, as well as viral, parasitic, and fungal infections.
AMP Submits Written Comments to FDA on Proposed Regulation of Laboratory Developed Tests
The Association for Molecular Pathology (AMP), a global, non-profit organization serving molecular laboratory professionals, recently announced that it has submitted written comments to the U.S. Food and Drug Administration (FDA) in response to its request for feedback on the proposed draft guidance titled, “Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories; Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs).”
Human Proteome Mapped Again
Researchers in Sweden have completed an exhaustive map of protein and RNA expression across 32 human tissues and organs. Mathias Uhlén of the Royal Institute of Technology in Stockholm and his colleagues report their findings) in Science. The Human Protein Atlas joins the Human Proteome Map, among other publicly available proteomics resources. The team generated this latest catalog of the human proteome using more than 24,000 polyclonal antibodies to visualize the locations of each of 16,975 unique proteins, corresponding to 85 percent of all genes in the genome. The result is more than 13 million antibody-stained immunohistochemistry images. To add a quantitative layer, the team supplemented its spatial protein mapping with quantitative RNA-sequencing data for 32 tissues types. Users of the Human Protein Atlas can search for and download information for a protein or gene or a subset of the proteomic data.
In the Way Cancer Cells Work Together, a Possible Tool for Their Demise
A tumor, as strange as it may sound, is a little society. The cancer cells that make it up cooperate with one another, and together they thrive. Scientists are only starting to decipher the rules of these communities. But if they can understand how these cells work together, then they may be able to stop the tumor. “You can drive it to collapse,” said Marco Archetti, a biologist at the University of East Anglia and at the Icahn School of Medicine at Mount Sinai. Cancer starts when healthy cells mutate and lose the safeguards that normally keep their growth in check. As tumors rapidly develop, they outgrow their blood supply, and stores of nutrients and growth-stimulating chemicals, known as growth factors, run low. As it turns out, cancer cells survive this harsh new environment by helping one another. New mutations can cause cancer cells to start making their own growth factors, and they don’t keep these essential chemicals to themselves. Growth factors seep throughout the tumor, affecting all the cells. “It’s one of the hallmarks of cancer,” Dr. Archetti said. Last year, Dr. Gunther and his colleagues discovered a compound produced by one type of cancer cell that stimulates the growth of the other. He suspects that the other cells produce a growth factor of their own, creating “a reciprocal cross-talk,” as he put it. Dr. Archetti and his colleagues have found evidence that cancer cells cheat one another, too. They reported their research in Proceedings of the National Academy of Sciences.
Babies' Genes May Hold Clues to Preterm Birth
Much of the existing research on babies who are born preterm, or before 37 weeks of pregnancy, has focused on their mothers, investigating what causes some women to deliver early. But that conversation could soon begin to shift, based on a preliminary new piece of research suggesting that a fetus' DNA -- not a mother's -- may contribute to at least some premature births. The findings will be presented this week at the annual Society for Maternal-Fetal Medicine meeting. The study compared the DNA of some 900 babies born before 34 weeks and their mothers with a comparably-sized control group of babies born full-term and their mothers. (Though a premature baby is technically defined as one born before the 37th week of pregnancy, the researchers used a baseline of 34 weeks. Generally speaking, the earlier a baby is born, the greater his or her risk of serious problems, including death.) Using blood and saliva samples, the study's researchers, led by Dr. Joseph Biggio, director of the University of Alabama at Birmingham's Division of Maternal-Fetal Medicine, looked for copy number variations, or areas where the DNA had duplications or deletions. In the women's genes, the researchers found no clear link between copy number variations and increased risk of preterm birth. However, there was a twofold to elevenfold increase in preterm birth among infants who had any four gene duplications or seven gene deletions.
Prostate Cancer Androgen Receptor Activates a Different Gene Set When Bound to Antiandrogens
The androgen receptor in prostate cancer cells can activate different sets of genes depending on whether it binds with an androgen hormone or an antiandrogen drug, according to a new study led by researchers at The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC – James). The study found that when androgen receptor (AR) binds with testosterone or dihydrotestosterone, the activated receptor binds, as expected, to segments of DNA called androgen response elements. The researchers called these newly discovered AR binding sites on DNA “antiandrogen response elements” and showed that they activate genes that might enable tumor progression during antiandrogen treatment. The findings, reported in EMBO Journal, suggest that the treatment of prostate cancer with antiandrogenic drugs should include agents that target antiandrogen-regulated oncogenes.
Methylation Predicts Mortality
Through a study involving 5,000 individuals, researchers have found that methylation patterns are linked with age, and that older-looking methylation states may predict how much longer people will live. The finding “is exciting as it has identified a novel indicator of aging, which improves the prediction of life span over and above the contribution of factors such as smoking, diabetes and cardiovascular disease,” Ian Deary, the study’s senior author and a researcher at the University of Edinburgh, said in a press release. Deary’s study, published in Genome Biology (January 30), used two established measures that compare a person’s chronological age to the age predicted by DNA methylation to see how those metrics correlate with longevity.
Researchers Claim Breakthrough in Treating Peanut Allergies
A daily combination of peanut protein and a probiotic helped 80% of children in a study Researchers say they are one step closer to finding a cure for people with severe peanut allergies. Around 80% of a group of 30 children had no allergic reaction to peanuts after scientists gave them a daily combination of peanut protein and a probiotic in increasing amounts over an 18-month period, according to a new study.
Trial Finds GSK Ebola Shot is Safe and Provokes Immune Response
First results from a human trial of an Ebola vaccine from GlaxoSmithKline show it is safe and generates an immune response, scientists said, but larger trials are needed to see if it protects and if a booster is needed. The vaccine is being developed by the U.S. National Institutes of Health (NIH) and GSK against the Zaire strain of Ebola -- the one circulating in West Africa -- and the first doses for a larger trial arrived in Liberia last week. That trial is the first of several mid-stage studies planned for West Africa and aims to test GSK's vaccine and one from Merck and NewLink. Johnson & Johnson and Bavarian Nordic have a vaccine in early-stage clinical tests. The early-stage Phase I trial of GSK's vaccine was primarily designed to test safety, but Adrian Hill, who led the work at Oxford's Jenner Institute, said it was "encouraging" that the shot also prompted responses from the immune system.
CDC Warns of MERS
Middle East respiratory syndrome-coronavirus was found in only two people in the U.S. last year, but health officials appear concerned that the virus could have more of an effect in the country in 2015: A new advisory from the Centers for Disease Control and Prevention tells doctors to look out for signs of infection in Americans who have traveled to or near the Arabian Peninsula. More than 500 people in the U.S. from 45 states have been screened and tested negative for the virus to date, the CDC said. The two patients in the U.S. who tested positive last May were both health care workers who lived in Saudi Arabia and were visiting the U.S. One case occurred in Indiana, and the other in Florida. The patients were not linked to each other; both were hospitalized and discharged, and did not spread the virus to anyone else.
Low Influenza Vaccination Rates Among Nursing Home Employees Put Residents At Risk, Study Finds
Influenza is associated with as many as 7,300 deaths annually in nursing home residents, but the vaccination rate for nursing home staff is only 54 percent, according to a study in the American Journal of Infection Control, the official publication of the Association for Professionals in Infection Control and Epidemiology (APIC). Researchers from the Emory University Rollins School of Public Health and Florida Health Care Association surveyed 1,965 nursing home employees to determine influenza vaccination rates and beliefs. This study included 37 nursing homes in Florida, Georgia, and Wisconsin.
Influenza Sending Record Number of Seniors to the Hospital
For the week ending January 24, the number of hospitalizations associated with a laboratory-confirmed case of influenza for adults aged 65 years or older was a cumulative 198 per 100,000 population since the flu season began last fall, the CDC said in its weekly FluView summary. A CDC spokesperson said that number was the highest since the agency began tracking influenza-related hospitalizations among adults in the 2005-2006 season. The previous high occurred in the 2012-2013 season, when the hospitalization rate for this demographic was 183 per 100,000.
Shared Symptoms of Chikungunya Virus, Rheumatoid Arthritis may Cloud Diagnosis
Researchers at Washington University School of Medicine in St. Louis also found that blood tests of patients with the Chikungunya virus and those with rheumatoid arthritis can produce similar results. This may lead some patients with the virus to be misdiagnosed. The findings, reported in the January issue of Arthritis and Rheumatology, underscore the need for doctors to obtain detailed travel and medical histories from patients being evaluated for rheumatoid arthritis. Such details could help distinguish between the two conditions.
The Way we Use Antibiotics is Broken. Blame Nearly a Century of Drug Marketing.
When our throats burn, we’re conditioned to reach for antibiotics. When our noses run, we hound doctors for antibiotics. When we’re too groggy to drive to the doctor, we search our medicine cabinets for leftover antibiotics. Four out of five Americans are prescribed the drugs every year, according to the Centers for Disease Control and Prevention. Up to half of the estimated 258 million prescriptions are unnecessary, the agency reports.
CMS Relaxes Meaningful Use Data Exchange Requirement
The Centers for Medicare & Medicaid Services (CMS), which just announced it plans to shorten this year's reporting period for meaningful use from a full year to 90 days, is trying to lighten the burden on healthcare providers in other ways, too. Late last week, CMS gave a reprieve to eligible hospitals and professionals who have found it difficult to meet the transition-of-care requirements in meaningful use stage 2. Addressing this difficulty in a new Frequently Asked Questions file, CMS says that if a provider cannot exchange a care summary with a different type of certified EHR than the one the sender uses and does not have an EHR linked to a DirectTrust-accredited HISP, the eligible hospital or professional can perform the necessary test outside of the EHR reporting period, as long as they do it by the end of the reporting year.
Industry Professionals Create Framework for Measuring HIT Value
Healthcare professionals have created a framework for measuring health information technology with a goal of making "HIT evaluations more relevant to the current needs of the healthcare system," according to a paper published at the American Journal of Managed Care. In the paper, sponsored by the Office of the National Coordinator for Health IT, the researchers--from RAND Health, Harvard Medical School and Brigham and Women's Hospital--say that HIT should take into account three principles. Those principles are:
- Value includes costs and benefits:
- Value accrues over time:
- Value depends on stakeholder's perspective:
"Making these changes may require especially imaginative study designs, and research teams that have both quantitative and qualitative expertise," according to the authors.
ONC Unveils Interoperability Roadmap for Public Comment
The Office of the National Coordinator for Health IT [ONC] has released for public comment its shared nationwide roadmap for interoperability. The roadmap's goal is to provide steps to be taken in both the private and public sectors to create an interoperable health IT ecosystem over the next 10 years, according to ONC. One of the main focuses on the roadmap is to enable "a majority of individuals and providers across the care continuum to send, receive, find and use a common set of electronic clinical information at the nationwide level by the end of 2017."
ONC's 10 'principles' of Interoperability
As 2014 was winding down, the Office of the National Coordinator for Health IT was gearing up its 10-year roadmap to interoperability and promising to publish a draft and open it for public comments in January. ONC outlines what it called principles of interoperability:
1. Build upon existing health IT infrastructure
2. Maintain modularity
3. One size does not fit all
4. Consider the current environment and support multiple levels of advancement
5. Empower individuals
7. Protect privacy and security
8. Leverage the market
9. Focus on value
10. Scalability and universal access
2. Maintain modularity
3. One size does not fit all
4. Consider the current environment and support multiple levels of advancement
5. Empower individuals
7. Protect privacy and security
8. Leverage the market
9. Focus on value
10. Scalability and universal access
Setting Data Exchange on FHIR
As health care organizations strive for greater interoperability, the industry is poised to make a quantum leap with the introduction of HL7’s next generation standard, Fast Healthcare Interoperability Resources (FHIR). Pronounced “fire,” this robust health care data sharing standard fits many architectures and aims to broaden the scope of data sharing and help organizations exchange more granular, focused and timely information. Those entities that embrace FHIR will ultimately be able to communicate up-to-the minute data across disparate systems, fostering greater collaboration along the care continuum.
Because of this flexibility and scalability, FHIR has the potential to chip away at interoperability barriers more than any other interoperability standard to date.
Quest Diagnostics and CDC Expand Public Health Collaboration
Quest Diagnostics recently announced that it will collaborate with the Centers for Disease Control and Prevention (CDC) to identify trends in screening, diagnosis and treatment for four strains of viral hepatitis in the United States, based on insights revealed by analysis of Quest’s national testing database. Under terms of the multi-year contract, Quest Diagnostics will provide CDC researchers with analytics expertise and access to the company’s national Quest Diagnostics Health Trends database of de-identified clinical testing hepatitis data. The agreement is the first fee-based contract for hepatitis-related research awarded by CDC to a diagnostic information services provider.
Millions of DNA Samples Stored in Warehouse Worry Privacy Advocates
Privacy advocates are calling for more safeguards related to a state collection of DNA samples from 16 million Californians in a nondescript government warehouse in the Bay Area. The biobank holds blood taken with the prick of a heel from almost every baby born in California for the last three decades. It is used to screen for 80 health disorders, such as cystic fibrosis and sickle cell anemia. Unlike most states, California keeps the frozen samples indefinitely and shares them with genetic researchers, for a fee.
Burnout Grows Among Physicians
The number of burned-out physicians is on the rise, with nearly half of American doctors reporting a loss of enthusiasm for work, feelings of cynicism and a low sense of personal accomplishment, according to a new survey from Medscape. The burnout rates are highest among critical care and emergency department physicians, 53 and 52 percent of whom, respectively, report being burned out, the 2015 Physician Lifestyle Report found. Across all types of physicians surveyed, 46 percent described themselves as burned out, compared to 39.8 percent of doctors surveyed in 2013 for the 2014 report.
In the United Kingdom, Medical Laboratory Professionals Gather to Explore Disruptive Diagnostic Technology, ISO 15189, and How Labs Can Add Value
In Birmingham, England pathologists and medical laboratory professionals gathered for the 13th Annual Frontiers in Laboratory Medicine (FiLM) conference. The hot topics were new quality management standards for labs in the UK, innovative ways to improve utilization of clinical laboratory tests, and how first mover laboratories in the United Kingdom are using such disruptive technologies as digital pathology and MALDI-TOF mass spectrometry. Currently, medical laboratories in the United Kingdom are adapting to changes in accreditation and external quality assurance (EQA—known as proficiency testing in the United States). By 2018, all labs in the UK will need to be accredited to the standards of ISO 15189: Medical Laboratories. As this happens, the United Kingdom will join a growing list of nations that now use ISO 15189 as a basis for licensure and accreditation of histopathology and medical laboratories.
Britain Set to Approve Technique to Create Babies from 3 People
Despite warnings that a new ethical threshold was being crossed, British lawmakers on Tuesday voted to allow the in vitro creation of babies using the DNA of three people, a procedure that could prevent the inheritance of genetic diseases. The move would make Britain the first country to authorize an in vitro fertilization technique that involves altering a human egg or embryo before transferring it to the womb. The issue provoked fierce debate, with some opponents likening the procedure to genetic modification and arguing that it would open the way to the creation of so-called designer babies.
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.
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