DLPSS|HEALTHCARE NEWS|March 06, 2014
Healthcare News
A Weekly Compilation of Clinical Laboratory and Related Information
from The Division Of Laboratory Programs, Standards And Services
March 06, 2014
News Highlights
Sen. Barbara Boxer Asks CDC to Investigate Cause of Polio-like Disease in Some California Children
CDRH Identifies Strategic Priorities for 2014—Laboratory Developed Tests Were Not on the List.
Quality Control Option Changing for Clinical Laboratories
Myth or Truth - Are Non-gyn Labs Really Regulated?
NIH Adds Substantial Set of Genetic, Health Information to Online Database
Children With Rare Diseases to Benefit From New Genetic Tests
Home Test Boosts Colon Cancer Screening
Cheap Urine Test for Cancer Steps Closer
Supercomputer Analyzes 240 Full Genomes in Two Days
Google Glass App Turns Anyone into Rapid Diagnostic Test Expert
MIT-Harvard Team Develops Immunoassay Version of Synthetic Biomarker Diagnostic Technology
Common Strep Bacteria May Be Morphing Into 'Superbug'
Rare Mutation Kills off Gene Responsible for Diabetes
A Powerful New Way to Edit DNA
Child Health Problems 'Linked to Father's Age'
The Breast Cancer Racial Gap
Take Blood Pressure in Both Arms
Feds Promise to Publish FDASIA Report on HIT Regulation in March
View Previous Issues - Healthcare News Archive
Sen. Barbara Boxer Asks CDC to Investigate Cause of Polio-like Disease in Some California Children
Sen. Barbara Boxer is asking the Centers for Disease Control and Prevention to initiate a formal investigation into what has caused polio-like paralysis in about 20 children in California over the past 18 months. Boxer says in a letter sent to CDC Director Thomas Frieden that "we need answers." In particular, Boxer wants the agency to look into whether a virus is the culprit or if environmental factors are involved. She also wants to know if the agency has any way of knowing if there are other unusual reports of paralysis nationally.
Source: http://www.dailynews.com/
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Senators Question Military Health Program’s New Lab-fee Policy
A bipartisan group of senators has raised concerns about a change to the Defense Department’s health-care reimbursement policies that will force troops and their families to pay the full cost of certain tests done outside military clinics. The lawmakers, led by Sens. Richard Burr (R-N.C.) and Kay Hagan (D-N.C.), asked Defense Secretary Chuck Hagel in a letter on to answer questions about how the Pentagon justified the change and communicated it to beneficiaries, as well as what the appeals process would look like for whose lab work is not covered.
Source: http://www.washingtonpost.com/
CDRH Identifies Strategic Priorities for 2014—Laboratory Developed Tests Were Not on the List.
The Food and Drug Administration Center for Devices and Radiological Health issued its priorities for 2014—laboratory developed tests were not on the list. The Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) issued its 2014 priorities. This year, the agency plans to focus its attention on three main areas: streamlining the clinical trials process; reforming the premarket and post-market data collection process; and improving its customer service. For more details, please visit the FDA website.
Source: http://www.aacc.org/
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Quality Control Option Changing for Clinical Laboratories
Individualized Quality Control Plan Replacing Equivalent Quality Control
The Centers for Medicare & Medicaid Services (CMS) introduced a new voluntary quality control option for clinical laboratories on January 1, 2014. The Individualized Quality Control Plan (IQCP) will replace existing Equivalent Quality Control (EQC) procedures after an education-and-transition period ending January 1, 2016. Under the IQCP, which applies to all specialties and subspecialties except pathology, organizations that meet manufacturers’ recommendations for quality control do not have to fully meet Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88) regulatory requirements. Because EQC will no longer be an acceptable option for CLIA ’88 quality control compliance in two years, organizations must decide whether they will follow the CLIA regulatory requirements as written or implement the IQCP by January 1, 2016.
Source: http://www.jointcommission.org/
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Myth or Truth - Are Non-gyn Labs Really Regulated?
There seems to be a misconception that if a lab is only processing and signing out non-gynecological (NG) samples, then they don't have nearly the regulatory load as labs that process Pap (gynecological) specimens. While it's true that some of the CLIA regulations apply only to Pap labs, many of the regulations apply to NG as well as Pap labs. In a lab that processes NG samples, there has to be a process to prevent cross-contamination between other NG samples. Cytotechnologists should be well trained in the practice of workload documentation and workload regulations. Those same regulations apply to pathologists that are doing primary screening, even if they are only screening NG cases.
This regulation does not distinguish between pathologists and cytotechnologists. While the adequacy criteria of Pap samples has been clearly defined, we don't have universal criteria for NG specimens. Therefore, the lab must determine what renders an NG case unsatisfactory. Some labs or pathology groups process samples in one facility and ship them to another for final sign-out. Evaluations of any cytology samples, including NG cases, must occur in a lab certified to conduct cytology.
Source: http://laboratory-manager.advanceweb.com/
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NIH Adds Substantial Set of Genetic, Health Information to Online Database
Researchers will now have access to genetic data linked to medical information on a diverse group of more than 78,000 people, enabling investigations into many diseases and conditions. The data, from one of the nation's largest and most diverse genomics projects -- Genetic Epidemiology Research on Aging (GERA) -- have just been made available to qualified researchers through the database of Genotypes and Phenotypes (dbGaP), an online genetics database of the National Institutes of Health. "Data from this immense and ethnically diverse population will be a tremendous resource for science," said NIH Director Francis S. Collins, M.D., Ph.D. "It offers the opportunity to identify potential genetic risks and influences on a broad range of health conditions, particularly those related to aging."
Source: http://www.nih.gov/
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Patterns of Cancer Screening in Primary Care From 2005 to 2010
Guidelines for cancer screening in the primary care setting vary, especially with regard to breast, skin, and prostate examinations. Recommendations for cervical screening are less controversial, although they are constantly evolving. Several organizations, including the American Cancer Society (ACS), the US Preventive Services Task Force (USPSTF), and major organizations within each field, offer recommendations guiding clinical care. The opinions of each professional society’s recommendations often differ with regard to age of initiation and discontinuation of screening, frequency of screening, and screening tool. The conclusion is that current cancer screening practices in primary care vary significantly. Cancer screening may not follow evidence-based practices and may not be targeting patients considered most at risk. Racial and socioeconomic disparities are present in cancer screening in primary care.
Source: http://onlinelibrary.wiley.com/
Children With Rare Diseases to Benefit From New Genetic Tests
UCD researchers at Our Lady’s Children’s Hospital Crumlin and the Children’s University Hospital, Temple Street, have developed new genetic tests that will speed up diagnosis of rare diseases in children and help avoid the need for invasive procedures. The tests which will be available at the National Centre for Medical Genetics were launched on European Rare Disease Day. The diagnostic tools include molecular genetics tests for: Anophthalmia (absence of one or both eyes, occurs in around 1 in 100,000 births), and its sister conditions Microphthalmia (small eye) and Coloboma (malformed eye); a DNA repair disorder which results in debilitating endocrine and haematological illness; and Infantile Liver Failure Syndrome.
Source: http://www.ucd.ie/
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Test Is Improved Predictor of Fetal Disorders
A test that analyzes fetal DNA found in a pregnant woman’s blood proved much more accurate in screening for Down syndrome and another chromosomal disorder than the now-standard blood test, a new study has found. The promising results may change how prenatal screening for genetic diseases is done, though the test is costly and generally not yet covered by insurance for women at low risk. The study, published in The New England Journal of Medicine, found that the fetal DNA test was 10 times better in predicting cases of Down syndrome than the standard blood test and ultrasound screening, and five times better in predicting the other disorder, Trisomy 18. It also greatly reduced the number of false-positive results.
Source: http://well.blogs.nytimes.com/
Home Test Boosts Colon Cancer Screening
Everybody's supposed to get screened for colon cancer starting at age 50, but many of us haven't gotten around to it. That's especially true in the Latino community, where about half of people are up to date on screening, compared to 66 percent of non-Latino whites. The numbers get even worse for people who don't have health insurance, with just 37 percent getting screened. So, researchers decided to see if something as simple as mailing free home colon-cancer test kits to patients of clinics that serve low-income residents in Portland, Ore., would help get more people screened for colon cancer. Short story, it did. A bit more than one-third of the 213 people who got the kits in the mail used them and mailed them back. Of the 81 patients who were tested, seven had a positive test result, indicating traces of blood in the stool. Those patients were referred for colonoscopies, and all but one patient went in for the procedure. About half of the participants were Hispanic, and most had household incomes below the federal poverty line.
Source: http://www.npr.org/
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Laboratory Launches More Accurate Carrier Screening Test for Spinal Muscular Atrophy
The Icahn School of Medicine at Mount Sinai announced the launch of a more accurate carrier screening test for spinal muscular atrophy (SMA), one of the most common and severe autosomal recessive disorders. This new test will help prospective parents more effectively identify whether they carry the mutation that will affect their offspring. The test screens for genetic variation discovered by Mount Sinai researchers, which has been demonstrated to identify silent carriers of SMA in certain populations with higher accuracy.
Source: http://www.healthcanal.com/
Gene Test Developed to Accurately Classify Brain Tumors
Scientists at The Wistar Institute have developed a mathematical method for classifying forms of glioblastoma, an aggressive and deadly type of brain cancer, through variations in the way these tumor cells "read" genes. Their system was capable of predicting the subclasses of glioblastoma tumors with 92 percent accuracy. With further testing, this system could enable physicians to accurately predict which forms of therapy would benefit their patients the most. Their research was performed in collaboration with Donald M. O'Rourke, M.D., a neurosurgeon at the University of Pennsylvania Brain Tumor Center, who provided the glioblastoma samples necessary to validate the Wistar computer model. Their findings were published online in the journal Nucleic Acids Research.
Source: http://www.medicalnewstoday.com/
Cheap Urine Test for Cancer Steps Closer
Non-infectious illnesses like cancer and cardiovascular diseases are rising globally, but they are hard to diagnose because of lack of biomarkers, and in countries with poor infrastructure, expensive diagnosis using mammograms and colonoscopy is not available to many. Now, a team has developed a test that uses injected nanoparticles that find diseased tissue and produce a biomarker in urine that can be detected within minutes using paper strips rather like a home pregnancy test. The researchers, from the Massachusetts Institute of Technology (MIT), Cambridge, report in the Proceedings of the National Academy of Sciences, PNAS, how they tested the new method in mice, using a single injection and a paper-strip urine analysis, to successfully detect diseases as diverse as solid cancer and blood clots.
Source: http://www.medicalnewstoday.com/
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IgE Falls Short As Marker for At-Home Allergen
Markers of allergic sensitization weren't great indicators of current exposure to the allergen, a national observational study of allergen-specific immunoglobulin E (IgE) showed. The level of IgE as a marker for sensitization generally didn't correlate strongly with levels of that allergen directly measured in the home, Herman Mitchell, PhD, of the contract research organization Rho in Chapel Hill, N.C., and colleagues found in preliminary analysis of 2005-2006 National Health and Nutrition Examination Survey (NHANES) data.
Source: http://www.medpagetoday.com/
Supercomputer Analyzes 240 Full Genomes in Two Days
A scientific team at the University of Chicago reports that genome analysis can be radically accelerated by relying on supercomputers such as the one they used. This computer, known as Beagle and based at Argonne National Laboratory, is able to analyze 240 full genomes in about two days, according to the researchers. “The supercomputer can process many genomes simultaneously rather than one at a time,” said first author Megan Puckelwartz, a graduate student in McNally's laboratory. “It converts whole-genome sequencing, which has primarily been used as a research tool, into something that is immediately valuable for patient care.”
Source: http://www.genengnews.com/
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Google Glass App Turns Anyone Into Rapid Diagnostic Test Expert
A study just published in ACS Nano discusses the development of a Google Glass app that lets a clinician simply look at the lines on a test strip and receive back the correct interpretation within seconds. The app is voice controlled and provides both yes/no, as well as quantitative results depending on the test. The strips are marked with individual QR codes to identify which test is being performed and the app is supported by a server that actually analyzes the images and sends results back to Google Glass.
Source: http://www.medgadget.com/
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MIT-Harvard Team Develops Immunoassay Version of Synthetic Biomarker Diagnostic Technology
A team led by researchers at the Massachusetts Institute of Technology and Harvard Medical School have developed a synthetic biomarker assay that they say could improve early detection and monitoring of a variety of diseases. In particular, the approach, which uses immunoassays run on inexpensive paper test strips as its read-out, could prove valuable in point-of-care and resource-constrained settings, Andrew Warren, an MIT researcher and one of the developers of the method, told ProteoMonitor. Detailed in a paper published in Proceedings of the National Academy of Sciences, the method uses ligand-encoded reporters linked to nanoparticles by synthetic peptide substrates. Upon injection into a patient, these conjugates are targeted via the nanoparticles to the site of interest, where native proteases linked to the disease process under investigation cleave the peptide substrate, freeing the reporter molecules.
Source: http://www.genomeweb.com/
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Quest Diagnostics Expands Hereditary Cancer Screening Offering With Lynch Syndrome Blood and Biopsy Testing for Colorectal Cancer
Quest Diagnostics announced new pathology and blood test offerings to help identify and assess an individual's risk of Lynch syndrome, also known as hereditary nonpolyposis colorectal cancer (HNPCC), an inherited genetic disorder that significantly increases the risk of colorectal and other cancers. The Lynch syndrome blood-test offering includes a comprehensive blood test panel that evaluates the genes MLH1, MSH2 (and EPCAM terminal deletions), MSH6 and PMS2 for inherited mutations that are responsible for the majority of Lynch syndrome cases. For individuals whose family history or tumor tissue results indicate targeting one or more of these genes, gene-specific tests are available. The offering also includes a menu of validated biopsy-tumor screening options for patients with a diagnosis of colorectal, endometrial or other Lynch-associated cancers.
Source: http://www.asianhhm.com/
C-Reactive Protein May Be Associated With PTSD Risk.
High levels of C-reactive protein (CRP), an inflammation marker, were seen in soldiers who later developed post-traumatic stress disorder, researchers said. Among U.S. Marines and Navy personnel who consented to participate in a prospective study, each 10-fold increment in CRP levels at pre-deployment baseline was associated with a 51% increased likelihood of showing at least one PTSD symptom after deployment to Iraq or Afghanistan (odds ratio 1.51, 95% CI 1.15-1.97, P=0.003), reported Dewleen Baker, MD, of the VA Healthcare System in San Diego, and colleagues. Writing online in JAMA Psychiatry, the researchers proposed that inflammation may predispose people to develop PTSD.
Source: http://www.medpagetoday.com/
Elevated Homocysteine not Gender-specific in Schizophrenia
Japanese researchers have demonstrated that both men and women with schizophrenia have significantly higher plasma homocysteine levels than healthy controls. The findings arise from a series of analyses investigating the effects of gender and methylenetetrahydrofolate reductase (MTHFR) C677T genotype on blood homocysteine levels in Japanese patients with schizophrenia.
Source: http://www.medwirenews.com/<img alt="External Web Site Icon" class="externalImg" src="http://www.cdc.gov/TemplatePackage/images/icon_out.png" style="border: none; display: inline; height: auto; left: 3px; margin: 0px 0.25em 0px 0px; padding: 0px; position: relative; verti