Healthcare News
A Weekly Compilation of Clinical Laboratory and Related Information
from The Division Of Laboratory Programs, Standards And Services
September 04, 2014
- Human Trial of Experimental Ebola Vaccine Begins This Week
- Ebola Virus Has Mutated During Course of Outbreak
- CDC Laboratories Produce First Genomic Sequence of Liberian Ebola
- NIH Issues Finalized Policy on Genomic Data Sharing
- Understanding the Value of Laboratory Medicine
- Are We Ready for a Blood-Based Test to Detect Colon Cancer?
- New Blood Test to Detect TB in Kids
- New Method for Non-Invasive Prostate Cancer Screening
- Using Niacin to Modify Cholesterol Levels—Think Again: New Study Shows Harms of This Approach Outweigh its Benefits.
- Researchers Find New Way to Prevent Dangerous Blood Clots
- CDC: Toddlers' Vaccine Coverage Holds Steady
- Experimental Ebola Drug Halts Virus in Monkeys Five Days After They Were Infected
- EHRs Boost Routine HIV Screening Rates
- CMS Finalizes EHR Meaningful-Use Rule, Adds Some Flexibility
View Previous Issues - Healthcare News Archive
Leading News
Human Trial of Experimental Ebola Vaccine Begins This Week
A highly anticipated test of an experimental Ebola vaccine will begin this week at the National Institutes of Health, amid mounting anxiety about the spread of the deadly virus in West Africa. After an expedited review by the U.S. Food and Drug Administration, researchers were given the green light to begin what's called a human safety trial, said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases. It will be the first test of this type of Ebola vaccine in humans. The experimental vaccine, developed by the pharmaceutical company GlaxoSmithKline and the NIAID, will first be given to three healthy human volunteers to see if they suffer any adverse effects. If deemed safe, it will then be given to another small group of volunteers, aged 18 to 50, to see if it produces a strong immune response to the virus. All will be monitored closely for side effects. The vaccine will be administered to volunteers by an injection in the deltoid muscle of their arm, first in a lower dose, then later in a higher dose after the safety of the vaccine has been determined. Some of the preclinical studies that are normally done on these types of vaccines were waived by the FDA during the expedited review, Fauci said, so "we want to take extra special care that we go slowly with the dosing." The vaccine did extremely well in earlier trials with chimpanzees, Fauci said. He noted that the method being used to prompt an immune response to Ebola cannot cause a healthy individual to become infected with the virus.
A highly anticipated test of an experimental Ebola vaccine will begin this week at the National Institutes of Health, amid mounting anxiety about the spread of the deadly virus in West Africa. After an expedited review by the U.S. Food and Drug Administration, researchers were given the green light to begin what's called a human safety trial, said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases. It will be the first test of this type of Ebola vaccine in humans. The experimental vaccine, developed by the pharmaceutical company GlaxoSmithKline and the NIAID, will first be given to three healthy human volunteers to see if they suffer any adverse effects. If deemed safe, it will then be given to another small group of volunteers, aged 18 to 50, to see if it produces a strong immune response to the virus. All will be monitored closely for side effects. The vaccine will be administered to volunteers by an injection in the deltoid muscle of their arm, first in a lower dose, then later in a higher dose after the safety of the vaccine has been determined. Some of the preclinical studies that are normally done on these types of vaccines were waived by the FDA during the expedited review, Fauci said, so "we want to take extra special care that we go slowly with the dosing." The vaccine did extremely well in earlier trials with chimpanzees, Fauci said. He noted that the method being used to prompt an immune response to Ebola cannot cause a healthy individual to become infected with the virus.
Source: http://www.cnn.com/
Ebola Virus Has Mutated During Course of Outbreak
The Ebola virus sweeping through West Africa has mutated repeatedly during the current outbreak, a fact that could hinder diagnosis and treatment of the devastating disease, according to scientists who have genetically sequenced the virus in scores of victims. The findings, published in the journalScience, also offer new insights into the origins of the largest and most deadly Ebola outbreak in history, which has killed more than 1,500 people in four countries and shows few signs of slowing. It also provided another reminder of the deep toll the outbreak has taken on health workers and others in the affected areas, as five of the paper’s more than 50 co-authors died from Ebola before publication. In a collaboration led by scientists at Harvard University and aided by officials at Sierra Leone’s health ministry, researchers sequenced Ebola virus genomes from 78 patients beginning in the early days of the outbreak this spring. Those 99 samples — some patients were tested more than once — suggested that the outbreak began with a single human infection before spreading rapidly, like a spark that grows into a wildfire.
“The fact that we can do this in real time while the outbreak is still going is breathtaking,” said Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health, said of the group’s rapid genomic sequencing of the virus, which he said could have taken two years or longer in the past. “We didn’t have this technology years ago. What they did was really extraordinary.”
The Ebola virus sweeping through West Africa has mutated repeatedly during the current outbreak, a fact that could hinder diagnosis and treatment of the devastating disease, according to scientists who have genetically sequenced the virus in scores of victims. The findings, published in the journalScience, also offer new insights into the origins of the largest and most deadly Ebola outbreak in history, which has killed more than 1,500 people in four countries and shows few signs of slowing. It also provided another reminder of the deep toll the outbreak has taken on health workers and others in the affected areas, as five of the paper’s more than 50 co-authors died from Ebola before publication. In a collaboration led by scientists at Harvard University and aided by officials at Sierra Leone’s health ministry, researchers sequenced Ebola virus genomes from 78 patients beginning in the early days of the outbreak this spring. Those 99 samples — some patients were tested more than once — suggested that the outbreak began with a single human infection before spreading rapidly, like a spark that grows into a wildfire.
“The fact that we can do this in real time while the outbreak is still going is breathtaking,” said Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health, said of the group’s rapid genomic sequencing of the virus, which he said could have taken two years or longer in the past. “We didn’t have this technology years ago. What they did was really extraordinary.”
Source: http://img.washingtonpost.com/
CDC Laboratories Produce First Genomic Sequence of Liberian Ebola
With the largest Ebola outbreak in history raging through West Africa, understanding whether the virus is changing as it spreads through different populations can help responders know what treatments to use and also help research laboratories develop new tools to speed diagnosis in the field. CDC scientists had access to genetic sequences from Guinea and Sierra Leone that had been published by other scientists. But the return to the United States of two American patients with Ebola infection underscored that no genetic sequences existed of the Liberian virus. The first patient was admitted to an Atlanta area hospital on August 3; CDC received samples on August 6. Scientists immediately applied diagnostic tests and also began the process of sequencing the genetic material in the samples. Less than 72 hours after the first samples arrived, scientists had not only initial test results confirming that the patients were, indeed, infected with Ebola, but also the first detailed genetic sequencing of the Liberian virus. The genetic sequence information confirmed the Liberian viral samples were 99% identical to the virus circulating in Guinea and Sierra Leone. As important, CDC could see that the virus in the 2014 epidemic is 97% similar to the virus that first emerged in 1976.
With the largest Ebola outbreak in history raging through West Africa, understanding whether the virus is changing as it spreads through different populations can help responders know what treatments to use and also help research laboratories develop new tools to speed diagnosis in the field. CDC scientists had access to genetic sequences from Guinea and Sierra Leone that had been published by other scientists. But the return to the United States of two American patients with Ebola infection underscored that no genetic sequences existed of the Liberian virus. The first patient was admitted to an Atlanta area hospital on August 3; CDC received samples on August 6. Scientists immediately applied diagnostic tests and also began the process of sequencing the genetic material in the samples. Less than 72 hours after the first samples arrived, scientists had not only initial test results confirming that the patients were, indeed, infected with Ebola, but also the first detailed genetic sequencing of the Liberian virus. The genetic sequence information confirmed the Liberian viral samples were 99% identical to the virus circulating in Guinea and Sierra Leone. As important, CDC could see that the virus in the 2014 epidemic is 97% similar to the virus that first emerged in 1976.
Source: http://www.cdc.gov/
NIH Issues Finalized Policy on Genomic Data Sharing
The National Institutes of Health has issued a final NIH Genomic Data Sharing (GDS) policy to promote data sharing as a way to speed the translation of data into knowledge, products and procedures that improve health while protecting the privacy of research participants. The final policy was posted in the Federal Register Aug. 26, 2014 and published in the NIH Guide for Grants and Contracts Aug. 27, 2014. “Everyone is eager to see the incredible deluge of molecular discoveries about disease translated into prevention, diagnostics, and therapeutics for patients,” said Kathy Hudson, Ph.D., NIH deputy director for science, outreach and policy. “The collective knowledge achieved through data sharing benefits researchers and patients alike, but it must be done carefully. The GDS policy outlines the responsibilities of investigators and institutions that are using the data and also encourages researchers to get consent from participants for future unspecified use of their genomic data.” NIH expects any institution submitting data to certify that the data were collected in a legal and ethically appropriate manner and that personal identifiers, such as name or address, have been removed.
The National Institutes of Health has issued a final NIH Genomic Data Sharing (GDS) policy to promote data sharing as a way to speed the translation of data into knowledge, products and procedures that improve health while protecting the privacy of research participants. The final policy was posted in the Federal Register Aug. 26, 2014 and published in the NIH Guide for Grants and Contracts Aug. 27, 2014. “Everyone is eager to see the incredible deluge of molecular discoveries about disease translated into prevention, diagnostics, and therapeutics for patients,” said Kathy Hudson, Ph.D., NIH deputy director for science, outreach and policy. “The collective knowledge achieved through data sharing benefits researchers and patients alike, but it must be done carefully. The GDS policy outlines the responsibilities of investigators and institutions that are using the data and also encourages researchers to get consent from participants for future unspecified use of their genomic data.” NIH expects any institution submitting data to certify that the data were collected in a legal and ethically appropriate manner and that personal identifiers, such as name or address, have been removed.
Source: http://www.nih.gov/
Ebola in Mind, US Colleges Screen Some Students
College students from West Africa may be subject to extra health checks when they arrive to study in the United States as administrators try to insulate campuses from the worst Ebola outbreak in history. With the virus continuing to kill in Guinea, Liberia, Sierra Leone and Nigeria, the expected arrival of thousands of students from those countries has U.S. authorities on alert but cautioning against alarm.
College students from West Africa may be subject to extra health checks when they arrive to study in the United States as administrators try to insulate campuses from the worst Ebola outbreak in history. With the virus continuing to kill in Guinea, Liberia, Sierra Leone and Nigeria, the expected arrival of thousands of students from those countries has U.S. authorities on alert but cautioning against alarm.
Source: http://hosted.ap.org/
HHS Approves Drug-testing Labs for Federal Workers
The Department of Health and Human Services (HHS) is certifying dozens of laboratories that are now authorized to test federal employees for drugs, the agency said. HHS's Substance Abuse and Mental Health Services Administration (SAMHSA), which certifies the drug-testing labs, announced a list of 31 facilities around the country and in Canada that are authorized to test federal workers for drugs. The agency vetted these labs to make sure they meet federal drug-testing guidelines. Federal agencies must go through one of these certified labs to test their employees for drugs.
Source: http://thehill.com/The Department of Health and Human Services (HHS) is certifying dozens of laboratories that are now authorized to test federal employees for drugs, the agency said. HHS's Substance Abuse and Mental Health Services Administration (SAMHSA), which certifies the drug-testing labs, announced a list of 31 facilities around the country and in Canada that are authorized to test federal workers for drugs. The agency vetted these labs to make sure they meet federal drug-testing guidelines. Federal agencies must go through one of these certified labs to test their employees for drugs.
Laboratory Testing / Diagnostics
Understanding the Value of Laboratory Medicine
Deciding what is valuable in healthcare—and how to identify, leverage, and deliver care—is an important topic. A recently published review in Clinica Chimica Acta drills down on the value of services provided by laboratories. The authors clarify that the inherent value of laboratory medicine relies on the person who initiates the laboratory test—typically the patient’s treating doctor—to follow through after the results are available. “Laboratory medicine is one part of a complex intervention, and so the value proposition should encompass the breadth of that intervention—from addressing the unmet need through the generation of clinical, operational and economic outcomes,” the authors write.
Deciding what is valuable in healthcare—and how to identify, leverage, and deliver care—is an important topic. A recently published review in Clinica Chimica Acta
drills down on the value of services provided by laboratories. The authors clarify that the inherent value of laboratory medicine relies on the person who initiates the laboratory test—typically the patient’s treating doctor—to follow through after the results are available. “Laboratory medicine is one part of a complex intervention, and so the value proposition should encompass the breadth of that intervention—from addressing the unmet need through the generation of clinical, operational and economic outcomes,” the authors write.
Source: http://www.aacc.org/
Are We Ready for a Blood-Based Test to Detect Colon Cancer?
Colorectal cancer (CRC) remains one of the leading causes of death in the US despite improvements in early detection, changes in risk factors (e.g., decreased rates of smoking, decreased red meat consumption, and increased use of aspirin), and improved treatments . The US Preventive Services Task Force (USPSTF) and the National Comprehensive Cancer Network (NCCN) recommend that an individual age ≥50 years with no family history for CRC be screened. The gold standard screening method for CRC is colonoscopy. Part of the barrier to widespread utilization of CRC screening is the “ick factor.” For colonoscopy, patients expressed the following reasons they did not undergo a colonoscopy: volume of bowel preparation, inadequate analgesia, no recommendation from primary physician, and embarrassment. Other CRC screening methods also have the ick factor, as they are stool-based [e.g., guaiac-based fecal occult blood test (FOBT), fecal immunochemical test (FIT), or stool DNA].
Circulating cell-free DNA (ccfDNA) testing is gaining momentum in clinical testing because ccfDNA can easily be isolated from the circulation (e.g., plasma) and other body fluids of patients. The largest uptake of ccfDNA testing has been in the arena of noninvasive prenatal testing as an alternative to maternal serum screening. ccfDNA is also a promising candidate for cancer testing since ccfDNA has genetic and epigenetic features similar to those of tumor DNA.
Colorectal cancer (CRC) remains one of the leading causes of death in the US despite improvements in early detection, changes in risk factors (e.g., decreased rates of smoking, decreased red meat consumption, and increased use of aspirin), and improved treatments . The US Preventive Services Task Force (USPSTF) and the National Comprehensive Cancer Network (NCCN) recommend that an individual age ≥50 years with no family history for CRC be screened. The gold standard screening method for CRC is colonoscopy. Part of the barrier to widespread utilization of CRC screening is the “ick factor.” For colonoscopy, patients expressed the following reasons they did not undergo a colonoscopy: volume of bowel preparation, inadequate analgesia, no recommendation from primary physician, and embarrassment. Other CRC screening methods also have the ick factor, as they are stool-based [e.g., guaiac-based fecal occult blood test (FOBT), fecal immunochemical test (FIT), or stool DNA].
Circulating cell-free DNA (ccfDNA) testing is gaining momentum in clinical testing because ccfDNA can easily be isolated from the circulation (e.g., plasma) and other body fluids of patients. The largest uptake of ccfDNA testing has been in the arena of noninvasive prenatal testing as an alternative to maternal serum screening. ccfDNA is also a promising candidate for cancer testing since ccfDNA has genetic and epigenetic features similar to those of tumor DNA.
Source: http://www.clinchem.org/
New Blood Test to Detect TB in Kids
Researchers have developed a new reliable and highly specific blood test to diagnose tuberculosis in children within 24 hours. The newly developed test (TAM-TB assay) is the first reliable immunodiagnostic assay to detect active tuberculosis in children, researchers said. The test features excellent specificity, a similar sensitivity as culture tests in combination with speed of a blood test, they said. It makes use of an immunological phenomenon during tuberculosis disease: During an active infection, the expression of CD27 - a surface marker expressed on mycobacteria specific CD4+ T cells - is lost. Using standard intracellular cytokine staining procedures and polychromatic flow cytometry, the test result is available within 24 hours after blood sampling.
Researchers have developed a new reliable and highly specific blood test to diagnose tuberculosis in children within 24 hours. The newly developed test (TAM-TB assay) is the first reliable immunodiagnostic assay to detect active tuberculosis in children, researchers said. The test features excellent specificity, a similar sensitivity as culture tests in combination with speed of a blood test, they said. It makes use of an immunological phenomenon during tuberculosis disease: During an active infection, the expression of CD27 - a surface marker expressed on mycobacteria specific CD4+ T cells - is lost. Using standard intracellular cytokine staining procedures and polychromatic flow cytometry, the test result is available within 24 hours after blood sampling.
New Method for Non-Invasive Prostate Cancer Screening
Now a team of researchers led by Shaoxin Li at Guangdong Medical College in China has demonstrated the potential of a new, non-invasive method to screen for prostate cancer, a common type of cancer in men worldwide. They describe their laboratory success testing an existing spectroscopy technique called surface-enhanced Raman scattering (SERS) with a new, sophisticated analysis technique called support vector machine (SVM). As they described in a new paper in Applied Physics Letters, from AIP Publishing, they combined SERS and SVM and applied them to blood samples collected from 68 healthy volunteers and 93 people who were clinically confirmed to have prostate cancer. They found their technique could identify the cases of cancer with an accuracy of 98.1 percent
Now a team of researchers led by Shaoxin Li at Guangdong Medical College in China has demonstrated the potential of a new, non-invasive method to screen for prostate cancer, a common type of cancer in men worldwide. They describe their laboratory success testing an existing spectroscopy technique called surface-enhanced Raman scattering (SERS) with a new, sophisticated analysis technique called support vector machine (SVM). As they described in a new paper in Applied Physics Letters, from AIP Publishing, they combined SERS and SVM and applied them to blood samples collected from 68 healthy volunteers and 93 people who were clinically confirmed to have prostate cancer. They found their technique could identify the cases of cancer with an accuracy of 98.1 percent
Source: http://www.newswise.com/
Cancer Genetics and Leading Pathologist Will Evaluate and Optimize Genomic Panel for Lymphoma
Cancer Genetics, Inc (CGI) and University of Southern California (USC) pathologist Imran Siddiqi, MD, PhD, have entered into a collaboration to identify and evaluate genomic markers for the prognosis of diffuse large B-cell lymphoma (DLBCL). CGI has developed a proprietary genomic test, MatBA-DLBCL, which offers prognosis of DLBCL based on genomic copy number changes. The company’s collaboration with Siddiqi, assistant professor of clinical pathology at the Keck School of Medicine of USC, involves the further identification and evaluation of unique genomic copy number changes that can serve as additional prognostic markers in DLBCL. A number of gains have recently been made in the treatment of B-cell malignancies, including this summer’s FDA approval of Gilead’s Zydelig for chronic lymphocytic leukemia, follicular lymphoma, and small lymphocytic lymphoma.
Cancer Genetics, Inc (CGI) and University of Southern California (USC) pathologist Imran Siddiqi, MD, PhD, have entered into a collaboration to identify and evaluate genomic markers for the prognosis of diffuse large B-cell lymphoma (DLBCL). CGI has developed a proprietary genomic test, MatBA-DLBCL, which offers prognosis of DLBCL based on genomic copy number changes. The company’s collaboration with Siddiqi, assistant professor of clinical pathology at the Keck School of Medicine of USC, involves the further identification and evaluation of unique genomic copy number changes that can serve as additional prognostic markers in DLBCL. A number of gains have recently been made in the treatment of B-cell malignancies, including this summer’s FDA approval of Gilead’s Zydelig for chronic lymphocytic leukemia, follicular lymphoma, and small lymphocytic lymphoma.
Source: http://www.mlo-online.com/
Could Cystatin C Replace Creatinine?: Recent Research Reinforced Value of Cystatin C in Assessing Kidney Function, but Further Studies are Needed to Establish a Firm Role for it in Clinical Practice.
While creatinine is likely to be the routine biomarker used to assess renal function for the forseeable future, cystatin C also shows promise because it is not affected by muscle metabolism, suggests an article recently published in Clinical Chemistry. Because of this, equations that calculate glomerular filtration rate (GFR) using cystatin C might be more reliable, especially for people who have abnormal muscle mass—such as the very elderly or those who are malnourished. “Cystatin C also provides an advantage for risk stratification.
While creatinine is likely to be the routine biomarker used to assess renal function for the forseeable future, cystatin C also shows promise because it is not affected by muscle metabolism, suggests an article recently published in Clinical Chemistry. Because of this, equations that calculate glomerular filtration rate (GFR) using cystatin C might be more reliable, especially for people who have abnormal muscle mass—such as the very elderly or those who are malnourished. “Cystatin C also provides an advantage for risk stratification.
Source: http://www.aacc.org/
Identification of 102 Genes May Help Classify, Treat Patients With Polycythemia Vera
Analyses of peripheral blood cells from patients with polycythemia vera identified 102 genes concordantly expressed in men and women that may help classify patients independently of their JAK2 V617F allele burden, according to study results. These genes also may provide novel targets for therapy, researchers wrote. Jerry L. Spivak, MD, director of the Center for Chronic Myeloproliferative Disorders at Johns Hopkins Medicine, and colleagues used oligonucleotide microarray technology to analyze the gene expression of CD34-positive peripheral blood cells from 19 patients with polycythemia vera.
Analyses of peripheral blood cells from patients with polycythemia vera identified 102 genes concordantly expressed in men and women that may help classify patients independently of their JAK2 V617F allele burden, according to study results. These genes also may provide novel targets for therapy, researchers wrote. Jerry L. Spivak, MD, director of the Center for Chronic Myeloproliferative Disorders at Johns Hopkins Medicine, and colleagues used oligonucleotide microarray technology to analyze the gene expression of CD34-positive peripheral blood cells from 19 patients with polycythemia vera.
Source: http://www.healio.com/
MIT Scientists Create New Method of Sorting Cells Using Sound Waves
Researchers from MIT, Carnegie Mellon University and Pennsylvania State University have developed a novel technique of separating cells with the use of a gentle sound wave. The technique could potentially be used to screen a patient's blood, allowing medical practitioners to isolate rare tumor cells synonymous with diseases such as cancer. The concept behind the new method involves placing two acoustic transducers on either side of a microfluidic device. Each transducer creates a sound wave, and when these waves impact on each other they combine to form a single static wave across a fluid channel running through the device. As the abnormal cells pass through the fluid channel and hit the pressure points created by the sound wave, they are pushed to the side of the channel, away from the mass of ordinary cells accompanying them through the fluid. The amount of deviation created by the wave depends on cell characteristics such as size and density.
Researchers from MIT, Carnegie Mellon University and Pennsylvania State University have developed a novel technique of separating cells with the use of a gentle sound wave. The technique could potentially be used to screen a patient's blood, allowing medical practitioners to isolate rare tumor cells synonymous with diseases such as cancer. The concept behind the new method involves placing two acoustic transducers on either side of a microfluidic device. Each transducer creates a sound wave, and when these waves impact on each other they combine to form a single static wave across a fluid channel running through the device. As the abnormal cells pass through the fluid channel and hit the pressure points created by the sound wave, they are pushed to the side of the channel, away from the mass of ordinary cells accompanying them through the fluid. The amount of deviation created by the wave depends on cell characteristics such as size and density.
Source: http://www.gizmag.com/
Getting Sample Hemolysis Under Control
Hemolysis has been cited as the most common cause of preanalytical error. How can sample hemolysis be avoided?
Many variables contribute to the ability to obtain a high quality, non-hemolyzed blood sample. Controlling the flow of blood between the vein and the tube is really the basis of a good sample collection. Factors that influence the flow of blood include needle gauge, force of suction, size and quality of the vein, and the device used for collection. Direct transfer into vacutainer tubes will control the flow from the needle into the tube, minimizing hemolysis during transfer. When drawing blood into a syringe, the force of suction should be minimal. A good tip is to pull the syringe back and fill it a bit at a time to control the flow. The same goes for transferring from syringes into collection tubes. Allowing the vacutainer to pull the blood into the tube—rather than pushing—maintains appropriate pressure.
Hemolysis has been cited as the most common cause of preanalytical error. How can sample hemolysis be avoided?
Many variables contribute to the ability to obtain a high quality, non-hemolyzed blood sample. Controlling the flow of blood between the vein and the tube is really the basis of a good sample collection. Factors that influence the flow of blood include needle gauge, force of suction, size and quality of the vein, and the device used for collection. Direct transfer into vacutainer tubes will control the flow from the needle into the tube, minimizing hemolysis during transfer. When drawing blood into a syringe, the force of suction should be minimal. A good tip is to pull the syringe back and fill it a bit at a time to control the flow. The same goes for transferring from syringes into collection tubes. Allowing the vacutainer to pull the blood into the tube—rather than pushing—maintains appropriate pressure.
Source: http://www.aacc.org/
Reporting HbA1c: Which Is Better—Percent or SI Units?
Considerable international effort has gone into standardizing HbA1c measurements and how they are reported. In the United States, most labs report HbA1c results in percentages only, whereas globally many labs report HbA1c results in Système International (SI) units (mmol/mol) only, or in both SI units and as a percentage. Respected authorities on this subject, Ian Young, MB BCh, MD, FRCPath, and David Sacks, MB ChB, FRCPath, recently shared their views on how HbA1c should be reported.
Considerable international effort has gone into standardizing HbA1c measurements and how they are reported. In the United States, most labs report HbA1c results in percentages only, whereas globally many labs report HbA1c results in Système International (SI) units (mmol/mol) only, or in both SI units and as a percentage. Respected authorities on this subject, Ian Young, MB BCh, MD, FRCPath, and David Sacks, MB ChB, FRCPath, recently shared their views on how HbA1c should be reported.
Source: http://www.aacc.org/
World Health Organization Recommends Use of p16 IHC to Help Diagnose High-grade Cervical Disease
Ventana Medical Systems, Inc., a member of the Roche Group, has announced that the World Health Organization (WHO) has issued new guidance recommending the use of p16 immunohistochemistry (IHC) testing to improve the detection of pre-cancerous cervical disease. In doing so, the WHO is the first global organization to issue written recommendations on the use of p16 after the College of American Pathologists (CAP) and the American Society for Colposcopy and Cervical Pathology (ASCCP) provided similar guidance in 2012. Traditionally, the evaluation of cervical tissue samples has been performed using the slide-based hematoxylin and eosin (H&E) stain; however, this method of interpretation is subjective and diagnostic variability from pathologist to pathologist is well documented. In some cases this variability may lead to unnecessary procedures or even false negative results.
Ventana Medical Systems, Inc., a member of the Roche Group, has announced that the World Health Organization (WHO) has issued new guidance recommending the use of p16 immunohistochemistry (IHC) testing to improve the detection of pre-cancerous cervical disease. In doing so, the WHO is the first global organization to issue written recommendations on the use of p16 after the College of American Pathologists (CAP) and the American Society for Colposcopy and Cervical Pathology (ASCCP) provided similar guidance in 2012. Traditionally, the evaluation of cervical tissue samples has been performed using the slide-based hematoxylin and eosin (H&E) stain; however, this method of interpretation is subjective and diagnostic variability from pathologist to pathologist is well documented. In some cases this variability may lead to unnecessary procedures or even false negative results.
Source: http://www.medicalnewstoday.com/
CLSI Releases New Microbiology Standard for Detection of Anaerobes in Clinical Specimens
The Clinical and Laboratory Standards Institute (CLSI) released a new microbiology standard,Principles and Procedures for Detection of Anaerobes in Clinical Specimens; Approved Guideline (M56-A). This document presents standardized, cost-effective, and efficient best practice processes for anaerobe bacteriology to assist clinical laboratories in selecting those methods that lead to improved patient care. "M56-A is an up-to-date manual for anaerobic bacteriology written to guide the novice microbiologist as well as those experienced with anaerobes," notes Document Development Committee Chairholder, Maria D. Appleman, PhD, Professor of Clinical Pathology at the University of Southern California in Los Angeles, California, USA.
Source: http://laboratory-manager.advanceweb.com/The Clinical and Laboratory Standards Institute (CLSI) released a new microbiology standard,Principles and Procedures for Detection of Anaerobes in Clinical Specimens; Approved Guideline (M56-A). This document presents standardized, cost-effective, and efficient best practice processes for anaerobe bacteriology to assist clinical laboratories in selecting those methods that lead to improved patient care. "M56-A is an up-to-date manual for anaerobic bacteriology written to guide the novice microbiologist as well as those experienced with anaerobes," notes Document Development Committee Chairholder, Maria D. Appleman, PhD, Professor of Clinical Pathology at the University of Southern California in Los Angeles, California, USA.
Research and Development
Using Niacin to Modify Cholesterol Levels—Think Again: New Study Shows Harms of This Approach Outweigh its Benefits
A new study, published in The New England Journal of Medicine, makes the case that while niacin, also known as vitamin B3, has been shown in observational studies to raise high-density lipoprotein-cholesterol (HDL-C) levels and lower low-density lipoprotein-cholesterol (LDL-C) levels, taking it in an effort to modify cardiovascular disease (CVD) risk carries more harms than benefits. The study’s findings led prominent cardiologist Donald Lloyd-Jones, MD, to assert in an accompanying editorial, that “it is time to face the fact that increasing the HDL cholesterol level in isolation seems unlikely” to confer the same protections as innately high HDL-C levels. Professor and chair of preventive medicine at the Northwestern University Feinberg School of Medicine in Chicago, Lloyd-Jones served on committees of the American Heart Association and American College of Cardiology that released new guidelines on assessing CVD risk and on treating blood cholesterol to lower CVD risk.
A new study, published in The New England Journal of Medicine, makes the case that while niacin, also known as vitamin B3, has been shown in observational studies to raise high-density lipoprotein-cholesterol (HDL-C) levels and lower low-density lipoprotein-cholesterol (LDL-C) levels, taking it in an effort to modify cardiovascular disease (CVD) risk carries more harms than benefits. The study’s findings led prominent cardiologist Donald Lloyd-Jones, MD, to assert in an accompanying editorial, that “it is time to face the fact that increasing the HDL cholesterol level in isolation seems unlikely” to confer the same protections as innately high HDL-C levels. Professor and chair of preventive medicine at the Northwestern University Feinberg School of Medicine in Chicago, Lloyd-Jones served on committees of the American Heart Association and American College of Cardiology that released new guidelines on assessing CVD risk and on treating blood cholesterol to lower CVD risk.
Source: https://www.aacc.org/
Researchers Find New Way to Prevent Dangerous Blood Clots
For the first time, scientists at the UNC School of Medicine have shown that eliminating the enzyme factor XIII reduces the number of red blood cells trapped in a clot, resulting in a 50 percent reduction in the size of the clot. The finding, featured in last month's Journal of Clinical Investigation, has major implications for people at high risk of deep vein thrombosis (DVT), a condition that - together with its deadly cousin pulmonary embolism - affects 300,000 to 600,000 people in the United States every year. Between 60,000 and 100,000 people die from these conditions every year in the U.S., according to the CDC.
For the first time, scientists at the UNC School of Medicine have shown that eliminating the enzyme factor XIII reduces the number of red blood cells trapped in a clot, resulting in a 50 percent reduction in the size of the clot. The finding, featured in last month's Journal of Clinical Investigation, has major implications for people at high risk of deep vein thrombosis (DVT), a condition that - together with its deadly cousin pulmonary embolism - affects 300,000 to 600,000 people in the United States every year. Between 60,000 and 100,000 people die from these conditions every year in the U.S., according to the CDC.
New Type of Cell Movement Discovered
For decades, researchers have used petri dishes to study cell movement. These classic tissue culture tools, however, only permit two-dimensional movement, very different from the three-dimensional movements that cells make in a human body. In a new study from the University of Pennsylvania and National Institute of Dental and Craniofacial Research, scientists used an innovative technique to study how cells move in a three-dimensional matrix, similar to the structure of certain tissues, such as the skin. They discovered an entirely new type of cell movement whereby the nucleus helps propel cells through the matrix like a piston in an engine, generating pressure that thrusts the cell's plasma membrane forward. "Our work elucidated a highly intriguing question: how cells move when they are in the complex and physiologically relevant environment of a 3-D extracellular matrix," said Hyun (Michel) Koo, a professor in the Department of Orthodontics at Penn's School of Dental Medicine.
For decades, researchers have used petri dishes to study cell movement. These classic tissue culture tools, however, only permit two-dimensional movement, very different from the three-dimensional movements that cells make in a human body. In a new study from the University of Pennsylvania and National Institute of Dental and Craniofacial Research, scientists used an innovative technique to study how cells move in a three-dimensional matrix, similar to the structure of certain tissues, such as the skin. They discovered an entirely new type of cell movement whereby the nucleus helps propel cells through the matrix like a piston in an engine, generating pressure that thrusts the cell's plasma membrane forward. "Our work elucidated a highly intriguing question: how cells move when they are in the complex and physiologically relevant environment of a 3-D extracellular matrix," said Hyun (Michel) Koo, a professor in the Department of Orthodontics at Penn's School of Dental Medicine.
Source: http://www.medicalnewstoday.com/
Metastasis More Likely to Occur With Clusters of Circulating Tumor Cells Rather Than Single Cells
Circulating tumor cell (CTC) clusters - clumps of from 2 to 50 tumor cells that break off a primary tumor and are carried through the bloodstream - appear to be much more likely to cause metastasis than are single CTCs, according to a study from investigators at the Massachusetts General Hospital (MGH) Cancer Center. Their report in the journal Cell also suggests that a cell adhesion protein binding CTC clusters together is a potential therapeutic target.
Circulating tumor cell (CTC) clusters - clumps of from 2 to 50 tumor cells that break off a primary tumor and are carried through the bloodstream - appear to be much more likely to cause metastasis than are single CTCs, according to a study from investigators at the Massachusetts General Hospital (MGH) Cancer Center. Their report in the journal Cell also suggests that a cell adhesion protein binding CTC clusters together is a potential therapeutic target.
Source: http://www.medicalnewstoday.com/
War Between Bacteria and Phages Benefits Humans
In the battle between our immune systems and cholera bacteria, humans may have an unknown ally in bacteria-killing viruses known as phages. In a new study, researchers from Tufts University, Massachusetts General Hospital, Partners in Health, Haiti’s National Public Health Laboratory, and elsewhere, report that phages can force cholera bacteria to give up their virulence in order to survive. Importantly, the study — published in eLife — found that cholera’s mutational escape from phage predation occurs during human infection.
“This is the first time we have seen cholera bacteria defend themselves from phages while infecting humans. This suggests that these phages are actively working in our favor, first by killing cholera bacteria within the patient, and second, by genetically weakening the bacteria that are shed by the infected patient such that they are less fit to survive in the environment or less able to cause infection in other people,” said senior author Andrew Camilli, a Howard Hughes Medical Institute investigator, professor of molecular biology & microbiology at Tufts University School of Medicine, and member of the Molecular Microbiology program faculty at the Sackler School of Graduate Biomedical Sciences at Tufts University.
Source: http://www.newswise.com/In the battle between our immune systems and cholera bacteria, humans may have an unknown ally in bacteria-killing viruses known as phages. In a new study, researchers from Tufts University, Massachusetts General Hospital, Partners in Health, Haiti’s National Public Health Laboratory, and elsewhere, report that phages can force cholera bacteria to give up their virulence in order to survive. Importantly, the study — published in eLife — found that cholera’s mutational escape from phage predation occurs during human infection.
“This is the first time we have seen cholera bacteria defend themselves from phages while infecting humans. This suggests that these phages are actively working in our favor, first by killing cholera bacteria within the patient, and second, by genetically weakening the bacteria that are shed by the infected patient such that they are less fit to survive in the environment or less able to cause infection in other people,” said senior author Andrew Camilli, a Howard Hughes Medical Institute investigator, professor of molecular biology & microbiology at Tufts University School of Medicine, and member of the Molecular Microbiology program faculty at the Sackler School of Graduate Biomedical Sciences at Tufts University.
Public Health and Patient Safety
CDC: Toddlers' Vaccine Coverage Holds Steady
Most childhood vaccination rates appeared stable in 2013, with two vaccines showing small but significant increases in use, the CDC is reporting. For children 19 through 35 months, estimated coverage for the 10 recommended vaccines ranged from 54.7% for at least two doses of hepatitis A vaccine to 92.7% for at least three doses of polio vaccine, the agency reported in the Aug. 29 issue ofMorbidity and Mortality Weekly Report. There were important variations from state to state as well as disparities based on poverty and race or ethnicity, the CDC report said, but only seven children in 1,000 nationwide got no vaccines at all.
Most childhood vaccination rates appeared stable in 2013, with two vaccines showing small but significant increases in use, the CDC is reporting. For children 19 through 35 months, estimated coverage for the 10 recommended vaccines ranged from 54.7% for at least two doses of hepatitis A vaccine to 92.7% for at least three doses of polio vaccine, the agency reported in the Aug. 29 issue ofMorbidity and Mortality Weekly Report. There were important variations from state to state as well as disparities based on poverty and race or ethnicity, the CDC report said, but only seven children in 1,000 nationwide got no vaccines at all.
Source: http://www.medpagetoday.com/
Experimental Ebola Drug Halts Virus in Monkeys Five Days After They Were Infected
The experimental drug pressed into emergency use in the West African Ebola epidemic cured a group of 18 monkeys of the deadly disease, including some who didn't receive the treatment until five days after they were injected with the virus, researchers reported. The finding, published online in the journal Nature, raises new hope for use of the cocktail of monoclonal antibodies, called ZMapp, against Ebola, which has no known cure or vaccine. It has been fatal to more than half the people who have contracted the virus in Liberia, Guinea, Sierra Leone and Nigeria.
The experimental drug pressed into emergency use in the West African Ebola epidemic cured a group of 18 monkeys of the deadly disease, including some who didn't receive the treatment until five days after they were injected with the virus, researchers reported. The finding, published online in the journal Nature, raises new hope for use of the cocktail of monoclonal antibodies, called ZMapp, against Ebola, which has no known cure or vaccine. It has been fatal to more than half the people who have contracted the virus in Liberia, Guinea, Sierra Leone and Nigeria.
Source: http://www.washingtonpost.com/
Alarms Raised Again on Drug-resistant Gonorrhea
Public health officials are sounding the alarm — again — about the looming problem of drug-resistant gonorrhea in the wake of a Swedish study about four cases that didn’t immediately respond to treatment. The new “treatment failures” from Europe show the need for new anti-gonorrhea drugs, William Smith, executive director of the National Coalition of STD Directors, said.
Public health officials are sounding the alarm — again — about the looming problem of drug-resistant gonorrhea in the wake of a Swedish study about four cases that didn’t immediately respond to treatment. The new “treatment failures” from Europe show the need for new anti-gonorrhea drugs, William Smith, executive director of the National Coalition of STD Directors, said.
Source: http://www.washingtontimes.com/
HPV Vaccinated Women Neglecting Regular Cervical Cancer Checks in Australia
Women who have been vaccinated against the human papillomavirus (HPV) are neglecting their 2-yearly Pap smears at higher rates than unvaccinated women, jeopardizing benefits of the vaccine, according to research published in the Medical Journal of Australia. In an editorial in the same issue of the MJA, Dr Annabelle Farnsworth, from Douglass Hanly Moir Pathology, wrote that this trend is concerning given recent evidence from England. "In April this year, the Medical Services Advisory Committee announced recommendations to significantly alter cervical screening in Australia. The recommendations include: replacing cytological testing for primary screening with HPV testing [...and] increasing the age of commencement to 25 years.
Source: http://www.medicalnewstoday.com/Women who have been vaccinated against the human papillomavirus (HPV) are neglecting their 2-yearly Pap smears at higher rates than unvaccinated women, jeopardizing benefits of the vaccine, according to research published in the Medical Journal of Australia. In an editorial in the same issue of the MJA, Dr Annabelle Farnsworth, from Douglass Hanly Moir Pathology, wrote that this trend is concerning given recent evidence from England. "In April this year, the Medical Services Advisory Committee announced recommendations to significantly alter cervical screening in Australia. The recommendations include: replacing cytological testing for primary screening with HPV testing [...and] increasing the age of commencement to 25 years.
Health IT
EHRs Boost Routine HIV Screening Rates
In New York, HIV testing rates rose from 8 percent to 56 percent after implementing the EHR documentation program, according to the report. A hospital in New Orleans implemented alerts in the EHR to prompt clinicians to offer HIV tests to urgent care and emergency department patients who had not been tested in the past six months. In the urgent care center, testing rates increased from 3 percent to 17 percent. In the ED, testing rates increased from 17 percent to 26 percent, according to the report.
In New York, HIV testing rates rose from 8 percent to 56 percent after implementing the EHR documentation program, according to the report. A hospital in New Orleans implemented alerts in the EHR to prompt clinicians to offer HIV tests to urgent care and emergency department patients who had not been tested in the past six months. In the urgent care center, testing rates increased from 3 percent to 17 percent. In the ED, testing rates increased from 17 percent to 26 percent, according to the report.
CMS Finalizes EHR Meaningful-Use Rule, Adds Some Flexibility
The CMS late Friday finalized a rule allowing hospitals and eligible professionals more flexibility in how they meet meaningful-use requirements for the electronic health-record incentive program. The agency had first proposed the idea in a May draft rule. Friday's final rule left the May proposal unchanged. The American Hospital Association's Chantal Worzala, director of policy, said in a statement: “The American Hospital Association appreciates the flexibility offered by CMS. Unfortunately, this rule offers little relief because CMS did not grant a shorter reporting period for FY 2015, which begins on Oct. 1.” Marilyn Tavenner, CMS administrator, said in a release: “We listened to stakeholder feedback and provided” flexibility for 2014.
The CMS late Friday finalized a rule allowing hospitals and eligible professionals more flexibility in how they meet meaningful-use requirements for the electronic health-record incentive program. The agency had first proposed the idea in a May draft rule. Friday's final rule left the May proposal unchanged. The American Hospital Association's Chantal Worzala, director of policy, said in a statement: “The American Hospital Association appreciates the flexibility offered by CMS. Unfortunately, this rule offers little relief because CMS did not grant a shorter reporting period for FY 2015, which begins on Oct. 1.” Marilyn Tavenner, CMS administrator, said in a release: “We listened to stakeholder feedback and provided” flexibility for 2014.
Source: http://www.modernhealthcare.com/
Firm Date for ICD-10 Switch Still Not Raising Urgency
The new ICD-10 coding system was originally set to take effect this October, but was then pushed back at least a year in a bill -- the Protecting Access to Medicare Act of 2014 (H.R. 4302) -- which was signed into law in April. Then, on July 31, the Centers for Medicare and Medicaid Services (CMS) announced that Oct. 1, 2015, was the definitive date for the change. CMS also in July announced a "four-pronged approach" to helping physicians get ready for ICD-10. It includes:
The new ICD-10 coding system was originally set to take effect this October, but was then pushed back at least a year in a bill -- the Protecting Access to Medicare Act of 2014 (H.R. 4302) -- which was signed into law in April. Then, on July 31, the Centers for Medicare and Medicaid Services (CMS) announced that Oct. 1, 2015, was the definitive date for the change. CMS also in July announced a "four-pronged approach" to helping physicians get ready for ICD-10. It includes:
- CMS internal testing of its claims processing systems:
- Provider-initiated beta testing tools:
- Acknowledgement testing:
- End-to-end testing:
Source: http://www.medpagetoday.com/
EHR Use in Hospitals Rises, but Health IT Still a Challenge
Nearly 26 percent of hospitals have a comprehensive EHR system, more than quintuple the figure from 2010, according to the AHA report. While most hospitals utilize a basic electronic health record (EHR) system, more advanced use of health care IT is still a challenge, according to data from the American Hospital Association’s 2013 Annual Survey IT Supplement. According to the data, 59 percent of hospitals have a basic or comprehensive EHR system (quadruple the figure from 2010), but while the majority of hospitals can meet many of the Stage 2 Meaningful Use requirements, only 5.8 percent of hospitals are able to meet all of those criteria. Stage 2 Meaningful Use requirements stem from the Health Information Technology for Economic and Clinical Health Act, which was passed in 2009.
Source: http://www.eweek.com/Nearly 26 percent of hospitals have a comprehensive EHR system, more than quintuple the figure from 2010, according to the AHA report. While most hospitals utilize a basic electronic health record (EHR) system, more advanced use of health care IT is still a challenge, according to data from the American Hospital Association’s 2013 Annual Survey IT Supplement. According to the data, 59 percent of hospitals have a basic or comprehensive EHR system (quadruple the figure from 2010), but while the majority of hospitals can meet many of the Stage 2 Meaningful Use requirements, only 5.8 percent of hospitals are able to meet all of those criteria. Stage 2 Meaningful Use requirements stem from the Health Information Technology for Economic and Clinical Health Act, which was passed in 2009.
Other News
Supercomputers Make Discoveries That Scientists Can't
No researcher could read all the papers in their field – but machines are making discoveries in their own right by mining the scientific literature
IN MAY last year, a supercomputer in San Jose, California, read 100,000 research papers in 2 hours. It found completely new biology hidden in the data. Called KnIT, the computer is one of a handful of systems pushing back the frontiers of knowledge without human help. KnIT didn't read the papers like a scientist – that would have taken a lifetime. Instead, it scanned for information on a protein called p53, and a class of enzymes that can interact with it, called kinases. Also known as "the guardian of the genome", p53 suppresses tumours in humans. KnIT trawled the literature searching for links that imply undiscovered p53 kinases, which could provide routes to new cancer drugs. Having analysed papers up until 2003, KnIT identified seven of the nine kinases discovered over the subsequent 10 years. More importantly, it also found what appeared to be two p53 kinases unknown to science. Initial lab tests confirmed the findings, although the team wants to repeat the experiment to be sure. KnIT is a collaboration between IBM and Baylor College of Medicine in Houston, Texas.
No researcher could read all the papers in their field – but machines are making discoveries in their own right by mining the scientific literature
IN MAY last year, a supercomputer in San Jose, California, read 100,000 research papers in 2 hours. It found completely new biology hidden in the data. Called KnIT, the computer is one of a handful of systems pushing back the frontiers of knowledge without human help. KnIT didn't read the papers like a scientist – that would have taken a lifetime. Instead, it scanned for information on a protein called p53
, and a class of enzymes that can interact with it, called kinases. Also known as "the guardian of the genome", p53 suppresses tumours in humans. KnIT trawled the literature searching for links that imply undiscovered p53 kinases, which could provide routes to new cancer drugs. Having analysed papers up until 2003, KnIT identified seven of the nine kinases discovered over the subsequent 10 years. More importantly, it also found what appeared to be two p53 kinases unknown to science. Initial lab tests confirmed the findings, although the team wants to repeat the experiment to be sure. KnIT is a collaboration between IBM and Baylor College of Medicine in Houston, Texas.
Source: http://www.newscientist.com/
Wrong Diagnosis Leading Cause for Catastrophic Malpractice Payouts
Many huge malpractice awards can be prevented by targeted interventions by health care provider organizations to reduce patient safety risks, such as reducing diagnosis errors. The authors noted that errors in diagnosis have twice the odds for a catastrophic payout and that health systems should focus more attention on ensuring diagnostic accuracy. A study published in the Journal for Healthcare Quality reports that many huge malpractice awards can be prevented by targeted interventions by health care provider organizations to reduce patient safety risks, such as reducing diagnosis errors.
Many huge malpractice awards can be prevented by targeted interventions by health care provider organizations to reduce patient safety risks, such as reducing diagnosis errors. The authors noted that errors in diagnosis have twice the odds for a catastrophic payout and that health systems should focus more attention on ensuring diagnostic accuracy. A study published in the Journal for Healthcare Quality reports that many huge malpractice awards can be prevented by targeted interventions by health care provider organizations to reduce patient safety risks, such as reducing diagnosis errors.
Source: http://www.sciencedaily.com/
Disease Biomarkers Reflect Genetics and Lifestyle, Too
While biomarkers may be used to diagnose disease, the ups and downs of biological molecules may not depend entirely on whether a particular disease is present. Protein levels in the blood stream, for example, may vary with individual genetic, clinical, and lifestyle factors. This observation isn’t exactly novel. Biomarkers for specific diseases have been linked with lifestyle and demographic factors. For example, in a study of diabetes that considered how well the disease could be predicted by assessing levels of a protein called sex hormone binding globulin (SHBG), relevant factors were found to include age, reproductive history, usage of exogenous estrogen, body mass index, physical activity, alcohol consumption, coffee intake, smoking, and various dietary factors.
Source: http://www.genengnews.com/While biomarkers may be used to diagnose disease, the ups and downs of biological molecules may not depend entirely on whether a particular disease is present. Protein levels in the blood stream, for example, may vary with individual genetic, clinical, and lifestyle factors. This observation isn’t exactly novel. Biomarkers for specific diseases have been linked with lifestyle and demographic factors. For example, in a study of diabetes that considered how well the disease could be predicted by assessing levels of a protein called sex hormone binding globulin (SHBG), relevant factors were found to include age, reproductive history, usage of exogenous estrogen, body mass index, physical activity, alcohol consumption, coffee intake, smoking, and various dietary factors.
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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