DLPSS|HEALTHCARE NEWS|March 13, 2014
Healthcare News
A Weekly Compilation of Clinical Laboratory and Related Information
from The Division Of Laboratory Programs, Standards And Services
March 13, 2014
News Highlights
FDA Panel: Roche's DNA Test Can Replace Pap Smear
Bid to Replace Pap Test Goes to FDA Panel
CDC Plans to Map DNA of Disease-Causing Viruses
International Panel of Pathology Leaders Develop Principles for Patient Safety
AACC Calls for Uniformity in Lab Test Results
Stanford Bioengineer Develops a 50-Cent Paper Microscope
Doctors Often Uncertain in Ordering, Interpreting Lab Tests
Appropriate Testing
Bioethicists Urge More Research as They Consider Recommendations for Genomic Testing of Children
High-Tech TB Test Fails to Cut Mortality
Blood Test Can Predict Alzheimer's, say Researchers
'Glow Test' for Anthrax Could Speed Up Bioterror Response
Test May Some Day Predict 5-Year Risk of Death
Whole-Genome Data Not Ready for Prime Time
Early Treatment Is Found to Clear H.I.V. in a 2nd Baby
The Fat Drug
Hospitals Lack Universal Plan for Drug-resistant Bacteria
GAO Hits EHR Incentive Program Hard
S. Korea Regulators may Rule Samsung Smartphone a Medical Device
View Previous Issues - Healthcare News Archive
FDA Panel: Roche's DNA Test Can Replace Pap Smear
An FDA advisory committee voted unanimously Wednesday to recommend that the Pap smear be replaced with a human papillomavirus (HPV) test as the first-line standard of care for cancer screening. The FDA's Medical Devices Advisory Committee Microbiology Panel agreed by a vote of 13-0 in each of three successive votes that the cobas viral DNA test for HPV – made by Roche Molecular Systems – was safe and effective for cervical cancer screening, and that the benefits of the tests outweighed the risks.
According to the summary submitted by FDA staff members, "The data show that the proposed primary screening indication for the cobas HPV test detects more women with disease and requires fewer women without disease to go to colposcopy than cytology alone." The staff summary included the following performance characteristics of the cobas test versus cytology in
Sensitivity for ≥cervical intraepithelial neoplasia (CIN3) -58 the prospective cohort study: 26% versus 42.63%
Positive predictive value -12.25% versus 6.47%
Negative predictive value -0.42% versus 0.59%
False-positive rate -4.09% versus 6.04%
Benefit-risk analyses favored the HPV DNA test whether expressed in terms of number of cases of high-grade cervical disease per 10,000 women screened or per 100 colposcopy procedures. The FDA is not bound to follow its advisory committees' recommendations, but does so in most cases.
Source: http://www.medpagetoday.com/
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Bid to Replace Pap Test Goes to FDA Panel
An FDA advisory committee will hear the case for replacing the Pap smear with a viral DNA test as the first-line standard for cervical cancer screening. FDA's Medical Devices Advisory Committee Microbiology Panel will weigh evidence presented by agency staff members and test manufacturer Roche Molecular Systems and then vote for or against a proposal to extend the indication for the cobas test for human papillomavirus (HPV) to first-line screening for cervical cancer. The cobas test currently has approval as a follow-up assessment for women 21 and older who have abnormal Pap tests and as a co-test with the Pap smear to screen for the high-risk p16 and p18 HPV strains in women 30 to 65. The test comprises genotyping for HPV16 and 18 and pooled assessment of 12 additional high-risk HPV strains. According to the proposal submitted by Roche, women who test positive for HPV16 or 18 would proceed directly to colposcopy for further assessment. Patients who test negative for HPV16 or 18 but positive for the other high-risk strains would have a Pap test to determine the need for colposcopy. Women who have a completely negative test would be followed at their physicians' discretion.
Source: http://www.medpagetoday.com/
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CDC Plans to Map DNA of Disease-Causing Viruses
Many public health experts see the Centers for Disease Control and Prevention as the premier disease detection agency not just for the United States but for the entire planet. Yet when it comes to employing the fastest and most precise method of spotting outbreaks of illness, the CDC is no longer at the cutting edge — and won’t be for years. Centers for Disease Control and Prevention Director Thomas Frieden along with public health and provider groups want to turn that around by investing in a sophisticated technology called “advanced molecular detection” that determines the genetic map of the viruses, bacteria and parasites that cause disease. The effort began paying off early this year. Appropriators for the first time in several years decided to rewrite Labor-HHS-Education spending provisions. In doing so, they included $30 million for the AMD technology in the omnibus spending measure funding the government through the end of fiscal 2014. But Frieden must still persuade lawmakers to continue such annual funding for the five-year program for four more years. And he’ll be doing it even as he seeks additional funds for other programs.
Source: http://www.rollcall.com/
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Obama's FY15 Budget Proposes Reimbursement Changes Including More Cuts to Clinical Laboratory Services
President Obama's FY15 budget request includes proposed changes to Medicare payment rates for drugs and diagnostics. According to HHS's summary, the White House is proposing to set the payment rate for drugs covered under Medicare Part B -- those administered in a physician office or hospital outpatient setting -- at 103% of the average sales price (ASP) starting in 2015, down from 106% of ASP currently. The budget also includes a proposal to lower Medicare's payment rates under its clinical laboratory fee schedule by 1.75% each year for 2016-23 to "better align Medicare payments with private sector rates." Most molecular diagnostics are reimbursed through the lab fee schedule. The change would save Medicare an estimated $7.9 billion over 10 years.
Source: http://www.biocentury.com/
Advancing Regulatory Science for High Throughput Sequencing Devices for Microbial Identification and Detection of Antimicrobial Resistance Markers
The Food and Drug Administration (FDA) is announcing the following public workshop entitled “Advancing Regulatory Science for High Throughput Sequencing Devices for Microbial Identification and Detection of Antimicrobial Resistance Markers.” The purpose of the public workshop is to discuss the clinical and public health applications and performance validation of these devices, the quality criteria for establishing the accuracy of reference databases for regulatory use and ways to streamline clinical trials for microbial identification. This discussion is essential to establish the safety and effectiveness of high throughput sequencing devices when used to test human specimens or clinical isolates for the diagnosis of infectious diseases and detection of antimicrobial resistance markers. The public workshop will be held on April 1, 2014, from 9 a.m. to 4:30 p.m.
Source: http://www.gpo.gov/
International Panel of Pathology Leaders Develop Principles for Patient Safety
An international panel of leaders in the pathology community has announced its support of four principles designed to drive positive change and improve patient safety in the anatomic pathology laboratory. The group, known as the International Pathology Patient Safety Advisory Board, concluded its work with this shared vision:
1. All patients around the globe deserve standardized, high quality pathology services.
2. As patient advocates, to support accurate diagnosis and enable personalized medicine, the International Pathology Patient Safety Advisory Board identifies significant opportunities to improve patient safety by developing and implementing solutions to enhance:
tissue preservation
specimen/slide identification and tracking; and
prevention of tissue contamination
3. We, the members of the International Pathology Patient Safety Advisory Board, find further opportunity to define standardized parameters for data collection and sharing in the assessment of these processes leading to quality measures for laboratory improvement.
4. We call upon the pathology profession to collaborate with laboratory and hospital administrative partners, clinician colleagues, and the laboratory diagnostics industry to address these opportunities to achieve excellence in patient care.
Source: http://laboratory-manager.advanceweb.com/
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AACC Calls for Uniformity in Lab Test Results
AACC has released a position statement on harmonization of -or ensuring uniformity among-clinical laboratory test results to help patients receive appropriate diagnoses and medical treatment. With this statement, the association aims to raise awareness about this essential healthcare issue and urge the medical community to work together to make harmonization a reality. The few laboratory tests that have been harmonized to date, such as those for cholesterol, glucose, and hemoglobin A1c, have made a marked positive impact on diagnosis and treatment of heart disease and diabetes. In addition to improved patient care, harmonizing these tests may also lead to reductions in healthcare spending.
Source: http://healthcare-executive-insight.advanceweb.com/
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Stanford Bioengineer Develops a 50-Cent Paper Microscope
When Manu Prakash, PhD, wants to impress lab visitors with the durability of his Origami-based paper microscope, he throws it off a three-story balcony, stomps on it with his foot and dunks it into a water-filled beaker. Miraculously, it still works. Even more amazing is that this microscope — a bookmark-sized piece of layered cardstock with a micro-lens — only costs about 50 cents in materials to make. In the video, you can see his “Foldscope” being built in just a few minutes, then used to project giant images of plant tissue on the wall of a dark room.
Prakash’s dream is that this ultra-low-cost microscope will someday be distributed widely to detect dangerous blood-borne diseases like malaria, African sleeping sickness, schistosomiasis and Chagas.
Source: https://scopeblog.stanford.edu/
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Doctors Often Uncertain in Ordering, Interpreting Lab Tests
A survey of primary care physicians suggests they often face uncertainty in ordering and interpreting clinical laboratory tests, and would welcome better electronic clinical decision support tools. The results of the survey, sponsored by the U.S. Centers for Disease Control and Prevention, were published in the March-April issue of The Journal of the American Board of Family Medicine.“The optimal testing pathways to arrive at correct diagnoses is changing, so it is difficult for primary care physicians to keep up with new and efficient testing algorithms,” says Dr. John Hickner, professor and head of family medicine at the University of Illinois at Chicago College of Medicine, the corresponding author on the paper. “This is a situation that clearly fosters uncertainty, so the results of the survey are not all that surprising.” Over the past 20 years, the number of laboratory tests available to physicians has doubled, to more than 3,500 tests, Hickner said. Primary care physicians are challenged by the quantity of tests available, many of which are similar to others or rolled into panels with other diagnostic tests, he said.
Source: http://www.rdmag.com/
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Appropriate Testing
A new online toolkit puts resources in the hands of pathologists and medical laboratory scientists to promote conversations between physicians and patients about which diagnostic tests are appropriate. The online toolkit, part of ASCP's Choosing Wisely initiative, seeks to raise public awareness about appropriate test usage and to assist patients in taking an active role in choosing care that is truly necessary. Approximately 30 percent of U.S. health care is duplicative or unnecessary, according to an Institute of Medicine Report, which estimates that inappropriate or over-utilized medical tests account for nearly $300 billion in medical expenditures in the United States each year.
Source: http://laboratory-manager.advanceweb.com/
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Diagnostic Point-of-care Tests in Resource-limited Settings
The aim of diagnostic point-of-care testing is to minimise the time to obtain a test result, thereby allowing clinicians and patients to make a quick clinical decision. Because point-of-care tests are used in resource-limited settings, the benefits need to outweigh the costs. To optimise point-of-care testing in resource-limited settings, diagnostic tests need rigorous assessments focused on relevant clinical outcomes and operational costs, which differ from assessments of conventional diagnostic tests.
Source: http://www.sciencedirect.com/
Bioethicists Urge More Research as They Consider Recommendations for Genomic Testing of Children
A range of ethical questions are being considered as genome and exome sequencing trickles into clinical care. But children pose a unique problem for this fledgling field, and a group of bioethicists has suggested in an article published in the American Journal of Bioethics that more research must be done before consistent and sound guidelines will be developed. The senior author of the study, Ellen Wright Clayton, who is director of Vanderbilt University's Center for Biomedical Ethics and Society and co-chair of the Clinical Sequencing Exploratory Research Pediatric working group of NHGRI, noted that the only two sets of recommendations proposed for addressing clinical sequencing for children – those looking in particular at whether and what kind of genetic findings should be returned to parents – are not in harmony.
Source: http://www.genomeweb.com/
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High-Tech TB Test Fails to Cut Mortality
High technology can't compensate for poorly organized health care. That appears to be the central lesson of a clinical trial comparing a new automated molecular diagnostic test for tuberculosis (TB) to standard sputum microscopy, researchers said. The new device, dubbed Xpert MTB/RIF, can deliver a result in 2 hours and is also able to give an immediate answer on the presence or absence of resistance to rifampin, according to Alison Grant, MBBS, PhD, of the London School of Hygiene and Tropical Medicine. In the lab, Xpert outperforms traditional microscopy, but "we wanted to see if it also makes a difference to patients in a real-world setting," Grant told reporters at the annual Conference on Retroviruses and Opportunistic Infections. The answer was not much, Grant said -- the Xpert system detected more cases of TB, but there was no change in TB mortality and no difference in the proportion of people who did not get treated.
Source: http://www.medpagetoday.com/
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Blood Test Can Predict Alzheimer's, say Researchers
A blood test can accurately predict the onset of Alzheimer's disease, according to US researchers. They showed that testing levels of 10 fats in the blood could predict - with 90% accuracy - the risk of the disease coming on in the next three years. Their findings, published in Nature Medicine, will now be tested in larger clinical trials. Experts said the results needed to be confirmed, but such a test would be "a real step forward". The number of people living with dementia stands at 44 million around the globe and is expected to treble by 2050.
Source: http://www.bbc.com/
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Study Examines Blood Test to Screen for Fatal Variant Creutzfeldt-Jakob Disease
The researchers previously developed a test to detect low levels of prion protein in the blood. In this study, they used the test on samples from national blood collection and prion disease centers in the U.S. and the U.K. to see if it was accurate enough to screen large numbers of people. The test was perfectly specific, meaning it was always negative in negative American donor samples and healthy U.K. patient samples. No samples tested positive from patients with nonprion neurodegenerative disorders. The test found 71.4 percent of patients with vCJD correctly tested positive.
Source: http://www.medicalnewstoday.com/
'Glow Test' for Anthrax Could Speed Up Bioterror Response
Researchers at the University of Missouri in the US have proved a "glow test" can detect the presence of deadly anthrax bacteria in hours instead of the usual days, promising to significantly cut the time it takes to respond to a potential bioterrorism attack. George Stewart, professor and medical bacteriologist at MU's Bond Life Sciences Center, explains: "Normally to identify whether an organism is present, you have to extract the material, culture it, and then pick colonies to examine that might turn out to be anthrax bacteria. Then you conduct chemical testing which takes some time - a minimum of 24 to 48 hours. Using this newly-identified method, we can reduce that time to about five hours."
Source: http://www.medicalnewstoday.com/
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Need More Than Lab Test to Determine Low Testosterone
Limitations of current laboratory tests for testosterone deficiency have led to poor reliability that preclude use of any test as the sole basis for diagnosis, authors of a review concluded. Performance characteristics and diagnostic parameters of the tests lack standardization. Combined with inherent fluctuations in testosterone levels, the limitations mandate a diagnostic approach that relies on clinical signs and symptoms of hypogonadism as much as it does laboratory results, according to an article published online in Urology. "Until such standardization is commonplace in clinical laboratories, the decision to treat should be based on the presence of signs and symptoms in addition to serum testosterone measurements," Darius A. Paduch, MD, of Weill Cornell Medical College in New York City, and co-authors concluded.
Source: http://www.medpagetoday.com/Urology/Urology/44659
Test May Some Day Predict 5-Year Risk of Death
Will you be alive five years from now? New research suggests it might be possible to predict if you’ll die from a medical condition in the next half-decade. How, you ask? With a simple blood test.
According to a recent study published in the journal PLOS Medicine, if your blood registers high levels of four “biomarkers,” biological molecules found in your blood, body fluids, or tissues, you are at a substantially higher risk of dying in the next five years. Researchers from Finland and Estonia followed more than 17,000 people between the ages of 18 and 103 to determine causes of death, tracking them in what is called a prospective cohort study. The researchers first looked at more than 100 components of blood taken from the Estonian group. They found that high levels of four different molecules (naturally present in everyone's blood) - albumin, alpha-1-acid glycoprotein, citrate and very low-density lipoprotein particles — predicted imminent death.
Source: http://thechart.blogs.cnn.com/<img alt="External Web Site Icon" class="externalImg" src="http://www.cdc.gov/TemplatePackage/images/icon_out.png" style=