Healthcare News
A Weekly Compilation of Clinical Laboratory and Related Information
from The Division Of Laboratory Programs, Standards And Services
August 21, 2014
- Researchers Unlock Clues to How Ebola Disarms Immune System
- Wide Variation in Hospital Charges for Blood Tests Called ‘Irrational’
- Point-of-Care Reaches a Crossroads
- Routine Serum Folate Testing Unnecessary
- Blood Test Identifies People With Resistant Malaria
- Dog Study Suggests Bacteria as Cancer Fighter
- Newly Discovered Heart Molecule Could Lead to Effective Treatment for Heart Failure
- Artificial Anti-cancer Molecules Self-assemble in Minutes
- HPV Vaccine Safe, Effective Over Eight Years
- U.S. Speeds up Human Clinical Trials for Promising Ebola Vaccine
- Developing a Shared, Nationwide Roadmap for Interoperability
- FDA Employing High-Performance IT to Ready for NGS Submissions
View Previous Issues - Healthcare News Archive
Leading News
Researchers Unlock Clues to How Ebola Disarms Immune System
Researchers say they've discovered how the deadly Ebola virus disables the immune system. They hope the findings will prove valuable in efforts to find treatments for the disease taking hundreds of lives in Africa. American researchers found that the Ebola protein VP24 disrupts a cell's natural immune response. They said this action is an important first step on Ebola's path to causing fatal disease, according to the study published Aug. 13 in the journal Cell Host & Microbe. "We've known for a long time that infection with Ebola obstructs an important immune compound called interferon. Now we know how Ebola does this, and that can guide the development of new treatments," Dr. Gaya Amarasinghe, of Washington University School of Medicine, said in a journal news release.
Researchers say they've discovered how the deadly Ebola virus disables the immune system. They hope the findings will prove valuable in efforts to find treatments for the disease taking hundreds of lives in Africa. American researchers found that the Ebola protein VP24 disrupts a cell's natural immune response. They said this action is an important first step on Ebola's path to causing fatal disease, according to the study published Aug. 13 in the journal Cell Host & Microbe. "We've known for a long time that infection with Ebola obstructs an important immune compound called interferon. Now we know how Ebola does this, and that can guide the development of new treatments," Dr. Gaya Amarasinghe, of Washington University School of Medicine, said in a journal news release.
Source: http://consumer.healthday.com/
Wide Variation in Hospital Charges for Blood Tests Called ‘Irrational’
One California hospital charged $10 for a blood cholesterol test, while another hospital that ran the same test charged $10,169 — over 1,000 times more. For another common blood test called a basic metabolic panel, the average hospital charge was $371, but prices ranged from a low of $35 to a high of $7,303, more than 200 times more. The wide disparity in hospitals’ listed charges for routine blood tests at California hospitals was revealed in a study published in the August issue ofBMJ Open. The study examined the listed charges for routine blood tests performed in 2011. Researchers said their analysis found no rational explanation for the stark variation in listed prices, though teaching hospitals and government hospitals generally set lower charges than other facilities. Officials with the California Hospital Association dismissed the report as irrelevant, saying that the vast majority of patients pay discounted rates that have been negotiated by their insurance plans. “Charges are meaningless data — virtually no one pays charges,” said Jan Emerson-Shea, the association’s vice president for external affairs. “It is true that an uninsured person will receive a hospital bill based on charges,” she said, but California law requires the bill to “include text referencing the availability of free or discounted care to persons who meet income guidelines.” Those discounted fees must be based on what government programs pay for services, under California law, she said. But researchers say the list prices are a starting point for negotiations with insurers and patients, so they play a role in driving up health-care costs. Some uninsured patients, as well those with insurance who have gone out of network, may also be billed for the full charges.
One California hospital charged $10 for a blood cholesterol test, while another hospital that ran the same test charged $10,169 — over 1,000 times more. For another common blood test called a basic metabolic panel, the average hospital charge was $371, but prices ranged from a low of $35 to a high of $7,303, more than 200 times more. The wide disparity in hospitals’ listed charges for routine blood tests at California hospitals was revealed in a study published in the August issue ofBMJ Open. The study examined the listed charges for routine blood tests performed in 2011. Researchers said their analysis found no rational explanation for the stark variation in listed prices, though teaching hospitals and government hospitals generally set lower charges than other facilities. Officials with the California Hospital Association dismissed the report as irrelevant, saying that the vast majority of patients pay discounted rates that have been negotiated by their insurance plans. “Charges are meaningless data — virtually no one pays charges,” said Jan Emerson-Shea, the association’s vice president for external affairs. “It is true that an uninsured person will receive a hospital bill based on charges,” she said, but California law requires the bill to “include text referencing the availability of free or discounted care to persons who meet income guidelines.” Those discounted fees must be based on what government programs pay for services, under California law, she said. But researchers say the list prices are a starting point for negotiations with insurers and patients, so they play a role in driving up health-care costs. Some uninsured patients, as well those with insurance who have gone out of network, may also be billed for the full charges.
Point-of-Care Reaches a Crossroads
As diagnostic variety expands, so too do the challenges.
Point-of-care testing (POCT) is among the fastest-growing areas of laboratory medicine, driven by clinicians’ increased need for technologies that are faster, cheaper, and provide more robust, clinically useful results than ever—a need fueled more recently by the ongoing restructuring of U.S. healthcare. The POCT market is projected to grow to $27.5 billion by 2018 based on a compound annual growth rate of 9.3% since 2013 (MarketsandMarkets), which would peg the current market size at a little over $16 billion. Glucose tests remain the majority of the POCT market—53.7% in 2013 (Reportlinker.com)—but have fallen from 70% in 2011 (RnR Market Research), reflecting expanded use of POCT.
Several factors have driven POCT growth; Harry Glorikian, a life sciences and healthcare industry consultant, told Clinical OMICs that in addition to continued demand for more rapid results, clinical practices have been drawn to point-of-care testing by:
As diagnostic variety expands, so too do the challenges.
Point-of-care testing (POCT) is among the fastest-growing areas of laboratory medicine, driven by clinicians’ increased need for technologies that are faster, cheaper, and provide more robust, clinically useful results than ever—a need fueled more recently by the ongoing restructuring of U.S. healthcare. The POCT market is projected to grow to $27.5 billion by 2018 based on a compound annual growth rate of 9.3% since 2013 (MarketsandMarkets), which would peg the current market size at a little over $16 billion. Glucose tests remain the majority of the POCT market—53.7% in 2013 (Reportlinker.com)—but have fallen from 70% in 2011 (RnR Market Research), reflecting expanded use of POCT.
Several factors have driven POCT growth; Harry Glorikian, a life sciences and healthcare industry consultant, told Clinical OMICs that in addition to continued demand for more rapid results, clinical practices have been drawn to point-of-care testing by:
- Its increasing ability to satisfy the need for analyzing more patient data
- New technologies that allow small POCT devices to yield quality of results previously only available in large, centralized devices
- New outcomes-based guidelines that offer incentives for enhanced patient care through POCT
Source: http://genengnews.com/
Residents Discuss Determining the “One Best Test”
An estimated one-third of health care costs—about $750 billion—don’t actually improve health, according to the Institute of Medicine (IOM). Residents’ exams often ask them to choose the “one best test” for diagnosis to avoid health care waste, but what if the real-world choice is “all of the above”? “Trainees watch role models take a ‘do-everything-at-once’ approach, often just because they can,” said Sharon Rikin, MD, a member of the AMA Resident and Fellow Section (RFS) Committee on Science and Public Health. “Often we are too far removed from the actual money exchanging hands to see the necessity of practicing cost-effective medicine.” “Initially, the cost of a basic metabolic panel is shocking, but eventually it fades and the ordering of ‘daily labs’ reoccurs,” Dr. Rikin said. “As a senior resident myself, I hope to role model appropriate stewardship of finite health care resources. As I discuss my expectations with my team, I ask my interns to question what labs we order on a daily basis, and I task my medical students to identify potentially wasteful tests.”
An estimated one-third of health care costs—about $750 billion—don’t actually improve health, according to the Institute of Medicine (IOM). Residents’ exams often ask them to choose the “one best test” for diagnosis to avoid health care waste, but what if the real-world choice is “all of the above”? “Trainees watch role models take a ‘do-everything-at-once’ approach, often just because they can,” said Sharon Rikin, MD, a member of the AMA Resident and Fellow Section (RFS) Committee on Science and Public Health. “Often we are too far removed from the actual money exchanging hands to see the necessity of practicing cost-effective medicine.” “Initially, the cost of a basic metabolic panel is shocking, but eventually it fades and the ordering of ‘daily labs’ reoccurs,” Dr. Rikin said. “As a senior resident myself, I hope to role model appropriate stewardship of finite health care resources. As I discuss my expectations with my team, I ask my interns to question what labs we order on a daily basis, and I task my medical students to identify potentially wasteful tests.”
Source: http://www.ama-assn.org/
Talking to Men About PSA Testing
My patient looked back at me with a blank stare. I had just finished my take on the pros and cons of having a PSA test, and he looked lost. “What would you do if you were me, Doc?” he said. I had just finished explaining the decision every man faces when he turns 50: whether to be screened for prostate cancer with a prostate-specific antigen (PSA) test. The decision is still unsettled despite the results of a giant, long-term study published earlier this month in the journal The Lancet. The study did not support the use of widespread screening. What makes the decision so tricky? It’s partly that prostate cancer is a weird cancer. Unlike cancer of the breast or the lung or the colon, which tends to kill people within five or 10 years, prostate cancer is usually slow growing. Men tend to die with it rather than of it. In fact, many live with it for 30 years or more and never even know they have it. That said, 3 percent of men do die of prostate cancer. So if we had an easy, safe treatment for prostate cancer, it would make sense to screen everyone and treat all the cancers we found. But the main treatments for prostate cancer carry a high risk of causing urinary incontinence and erectile dysfunction. As a result, when a man decides to be screened for prostate cancer, there’s a high risk he will sustain permanent harms from treating a cancer that he never would have known he had. And that risk is probably much higher than the chance that he will live longer because he was screened.
My patient looked back at me with a blank stare. I had just finished my take on the pros and cons of having a PSA test, and he looked lost. “What would you do if you were me, Doc?” he said. I had just finished explaining the decision every man faces when he turns 50: whether to be screened for prostate cancer with a prostate-specific antigen (PSA) test. The decision is still unsettled despite the results of a giant, long-term study published earlier this month in the journal The Lancet. The study did not support the use of widespread screening. What makes the decision so tricky? It’s partly that prostate cancer is a weird cancer. Unlike cancer of the breast or the lung or the colon, which tends to kill people within five or 10 years, prostate cancer is usually slow growing. Men tend to die with it rather than of it. In fact, many live with it for 30 years or more and never even know they have it. That said, 3 percent of men do die of prostate cancer. So if we had an easy, safe treatment for prostate cancer, it would make sense to screen everyone and treat all the cancers we found. But the main treatments for prostate cancer carry a high risk of causing urinary incontinence and erectile dysfunction. As a result, when a man decides to be screened for prostate cancer, there’s a high risk he will sustain permanent harms from treating a cancer that he never would have known he had. And that risk is probably much higher than the chance that he will live longer because he was screened.
Source: http://well.blogs.nytimes.com/
CMS to Release a Comparative Billing Report on Immunohistochemistry and Special Stains in August
CMS will be issuing a national provider Comparative Billing Report (CBR) on immunohistochemistry and special stains in August 2014. The CBR, produced by CMS contractor eGlobalTech, will contain data-driven tables and graphs with an explanation of findings that compare providers’ billing and payment patterns to those of their peers in the state and across the nation. The goal of these reports is to offer a tool that helps providers better understand applicable Medicare billing rules. These reports are only available to the providers who receive them.
Source: http://www.cms.gov/CMS will be issuing a national provider Comparative Billing Report (CBR) on immunohistochemistry and special stains in August 2014. The CBR, produced by CMS contractor eGlobalTech, will contain data-driven tables and graphs with an explanation of findings that compare providers’ billing and payment patterns to those of their peers in the state and across the nation. The goal of these reports is to offer a tool that helps providers better understand applicable Medicare billing rules. These reports are only available to the providers who receive them.
Laboratory Testing / Diagnostics
Routine Serum Folate Testing Unnecessary
Serum folate testing should be significantly curtailed in the United States or eliminated, say the authors of a report published this week. "In the post-fortification era, folate deficiency is extremely rare in the United States. Serum folate testing is very unlikely to reveal low levels," Dr. Jesse Theisen-Toupal, of the Hospital Medicine Program at Beth Israel Deaconess Medical Center in Boston, Massachusetts, told Reuters Health by email. "Serum folate levels should not be ordered. In patients who are at risk for folate deficiency (e.g. those who have emigrated from countries that do not fortify folic acid), supplements costing as little as a penny a day may be a better use of resources," Dr. Theisen-Toupal added. Since the US initiated folic acid fortification in 1998, the prevalence of folate deficiency in the general population has decreased, the researchers point out in a Research Letter online August 11 in JAMA.
Serum folate testing should be significantly curtailed in the United States or eliminated, say the authors of a report published this week. "In the post-fortification era, folate deficiency is extremely rare in the United States. Serum folate testing is very unlikely to reveal low levels," Dr. Jesse Theisen-Toupal, of the Hospital Medicine Program at Beth Israel Deaconess Medical Center in Boston, Massachusetts, told Reuters Health by email. "Serum folate levels should not be ordered. In patients who are at risk for folate deficiency (e.g. those who have emigrated from countries that do not fortify folic acid), supplements costing as little as a penny a day may be a better use of resources," Dr. Theisen-Toupal added. Since the US initiated folic acid fortification in 1998, the prevalence of folate deficiency in the general population has decreased, the researchers point out in a Research Letter online August 11 in JAMA.
Source: http://www.medscape.com/
Blood Test Identifies People With Resistant Malaria
Until now, the only way to identify whether people with malaria carried a resistant strain was to closely monitor them over several days of treatment, taking regular blood samples to see how fast the therapy cleared Plasmodium from their system. But White and his colleagues wondered whether a blood test that detects the presence of parasites with the kelch13 mutation in infected people could offer a less labour-intensive way to identify drug-resistant malaria. They examined 1240 people being treated for malaria in South-East Asia and Africa, and showed that the blood test can be used successfully: mutations in kelch13 were found in almost all cases of resistance.
Until now, the only way to identify whether people with malaria carried a resistant strain was to closely monitor them over several days of treatment, taking regular blood samples to see how fast the therapy cleared Plasmodium from their system. But White and his colleagues wondered whether a blood test that detects the presence of parasites with the kelch13 mutation in infected people could offer a less labour-intensive way to identify drug-resistant malaria. They examined 1240 people being treated for malaria in South-East Asia and Africa, and showed that the blood test can be used successfully: mutations in kelch13 were found in almost all cases of resistance.
Source: http://www.newscientist.com/
New Genetic Test Helps Identify Some Mystery Illnesses
The test, called whole exome sequencing, stems from the decades-long push to map all the genes in the human body and translate that knowledge into diagnostic tools and therapies. The test has been commercially available for less than three years and doctors say it still doesn't offer definitive information for most patients with genetic disorders. The largest published study, by scientists at Baylor College of Medicine in Houston, found diagnoses a quarter of the time, though the success rate appears to be rising. Data analysis takes three to four months, and the test is so new there is no insurance billing code and often no coverage for the average $7,000 cost -- even though insurers may pay more for a series of smaller genetic tests and potentially ineffective therapies. Unlike tests that look for one or a small number of genetic mutations, such as the BRCA test for breast cancer, exome sequencing allows analysis of thousands of genes at once. The exome is composed of about 22,000 genes, about 1 percent of the human genome. But it is believed to be where functionally important DNA is housed, and where 85 percent of harmful mutations are found.
The test, called whole exome sequencing, stems from the decades-long push to map all the genes in the human body and translate that knowledge into diagnostic tools and therapies. The test has been commercially available for less than three years and doctors say it still doesn't offer definitive information for most patients with genetic disorders. The largest published study, by scientists at Baylor College of Medicine in Houston, found diagnoses a quarter of the time, though the success rate appears to be rising. Data analysis takes three to four months, and the test is so new there is no insurance billing code and often no coverage for the average $7,000 cost -- even though insurers may pay more for a series of smaller genetic tests and potentially ineffective therapies. Unlike tests that look for one or a small number of genetic mutations, such as the BRCA test for breast cancer, exome sequencing allows analysis of thousands of genes at once. The exome is composed of about 22,000 genes, about 1 percent of the human genome. But it is believed to be where functionally important DNA is housed, and where 85 percent of harmful mutations are found.
Source: http://insurancenewsnet.com/
Biomarker Panel Could Improve Detection of Esophageal Cancer
A 4-protein biomarker panel could improve the diagnosis of esophageal cancer, according to research published online August 5 in Cancer. The panel might also help guide treatment for those with the disease. "We have [developed] a biomarker panel that is very inexpensive, highly accurate, and easy to use with just a blood test. We know from testing in independent samples that the test can determine the difference between those who have cancer and those who do not," said lead investigator Blair A. Jobe, MD, director of the Esophageal and Thoracic Institute at the Allegheny Health Network in Pittsburgh. "We would like to see if we can use this biomarker panel to identify patients at an earlier stage. We haven't proven that yet, but that's our next step," Dr. Jobe told Medscape Medical News. "Our hope is that we'd be able to detect endoscopic changes in people who normally wouldn't have been endoscoped."
A 4-protein biomarker panel could improve the diagnosis of esophageal cancer, according to research published online August 5 in Cancer. The panel might also help guide treatment for those with the disease. "We have [developed] a biomarker panel that is very inexpensive, highly accurate, and easy to use with just a blood test. We know from testing in independent samples that the test can determine the difference between those who have cancer and those who do not," said lead investigator Blair A. Jobe, MD, director of the Esophageal and Thoracic Institute at the Allegheny Health Network in Pittsburgh. "We would like to see if we can use this biomarker panel to identify patients at an earlier stage. We haven't proven that yet, but that's our next step," Dr. Jobe told Medscape Medical News. "Our hope is that we'd be able to detect endoscopic changes in people who normally wouldn't have been endoscoped."
Source: http://www.medscape.com/
Lyme Disease Testing Challenges: Evaluating the Shortcomings of Current Lyme Disease Testing Methods.
Lyme disease may be much more common than previously thought, according to the Centers for Disease Control and Prevention (CDC). The agency released study results at the 2013 International Congress on Lyme Borreliosis and Other Tick-borne Diseases that suggest the disease occurs at a rate 10 times greater than previously reported. Whether current laboratory tests for Lyme disease are sufficient is one major point of contention. “While many activists claim insensitivity of serologic tests, medical professionals, including laboratorians, are concerned about over-diagnosis and over-treatment based on an excessive number of false-positive tests forBorrelia burgdorferi antibodies, the main laboratory diagnostic test for Lyme disease,”
Lyme disease may be much more common than previously thought, according to the Centers for Disease Control and Prevention (CDC). The agency released study results at the 2013 International Congress on Lyme Borreliosis and Other Tick-borne Diseases that suggest the disease occurs at a rate 10 times greater than previously reported. Whether current laboratory tests for Lyme disease are sufficient is one major point of contention. “While many activists claim insensitivity of serologic tests, medical professionals, including laboratorians, are concerned about over-diagnosis and over-treatment based on an excessive number of false-positive tests forBorrelia burgdorferi antibodies, the main laboratory diagnostic test for Lyme disease,”
Source: http://www.aacc.org/
Cardiac Troponin Elevations Indicate Worse Prognosis for Kidney Disease Patients
A research review from AHRQ finds that among patients with chronic kidney disease (CKD), higher levels of the protein cardiac troponin are associated with a worse prognosis for patients with and without suspected acute coronary syndrome (ACS). In particular, for dialysis patients without suspected ACS, increased troponin T or I, which measure heart enzymes, is a strong predictor of death, according to the review, “Cardiac Troponins Used as Diagnostic and Prognostic Tests in Patients With Kidney Disease.” However, there is insufficient evidence to conclude whether elevated troponin provides strong incremental predictive value over and above carefully assessed clinical risk factors for coronary artery disease and mortality. For this research to be effective, troponin assays and cutpoints need to be standardized and harmonized so that results can be pooled, compared and applied in practice, the review indicated.
A research review from AHRQ finds that among patients with chronic kidney disease (CKD), higher levels of the protein cardiac troponin are associated with a worse prognosis for patients with and without suspected acute coronary syndrome (ACS). In particular, for dialysis patients without suspected ACS, increased troponin T or I, which measure heart enzymes, is a strong predictor of death, according to the review, “Cardiac Troponins Used as Diagnostic and Prognostic Tests in Patients With Kidney Disease.”
However, there is insufficient evidence to conclude whether elevated troponin provides strong incremental predictive value over and above carefully assessed clinical risk factors for coronary artery disease and mortality. For this research to be effective, troponin assays and cutpoints need to be standardized and harmonized so that results can be pooled, compared and applied in practice, the review indicated.High CRP Predicts Poor RCC-Specific Survival in Hemodialysis Patients
High preoperative C-reactive protein (CRP) levels are associated with poor survival in hemodialysis patients undergoing nephrectomy for renal cell carcinoma (RCC), new study findings suggest. Kenji Omae, MD, and colleagues at Tokyo Women's Medical University examined cancer-specific survival in a group of 315 patients with end-stage renal disease requiring hemodialysis and who had nephrectomy for RCC. Of these patients, 75 (23.8%) had elevated CRP levels prior to surgery, defined as a level above 0.5 mg/dL. The median follow-up was 51 months.
High preoperative C-reactive protein (CRP) levels are associated with poor survival in hemodialysis patients undergoing nephrectomy for renal cell carcinoma (RCC), new study findings suggest. Kenji Omae, MD, and colleagues at Tokyo Women's Medical University examined cancer-specific survival in a group of 315 patients with end-stage renal disease requiring hemodialysis and who had nephrectomy for RCC. Of these patients, 75 (23.8%) had elevated CRP levels prior to surgery, defined as a level above 0.5 mg/dL. The median follow-up was 51 months.
Mix of Kudos and Caution for Fecal DNA Test
Approval and imminent Medicare coverage of a DNA screening test for colorectal cancer generally received props from clinicians and researchers, who nonetheless cited continued patient aversion as the biggest obstacle to screening. FDA approved the Cologuard test and, at the same time, the Centers for Medicare and Medicaid Services (CMS) announced proposed Medicare coverage of the test. The unprecedented parallel review by the two agencies represented the first step in a pilot program to expedite approval and coverage of selected devices. "Although screening by colonoscopy is still widely considered the gold standard and the best test for prevention of colorectal cancer, this DNA test provides an appropriate and reasonable alternative for those patients who prefer a less invasive screening option," Chan told MedPage Today in an email.
Source: http://www.medpagetoday.com/Approval and imminent Medicare coverage of a DNA screening test for colorectal cancer generally received props from clinicians and researchers, who nonetheless cited continued patient aversion as the biggest obstacle to screening. FDA approved the Cologuard test and, at the same time, the Centers for Medicare and Medicaid Services (CMS) announced proposed Medicare coverage of the test. The unprecedented parallel review by the two agencies represented the first step in a pilot program to expedite approval and coverage of selected devices. "Although screening by colonoscopy is still widely considered the gold standard and the best test for prevention of colorectal cancer, this DNA test provides an appropriate and reasonable alternative for those patients who prefer a less invasive screening option," Chan told MedPage Today in an email.
Research and Development
Dog Study Suggests Bacteria as Cancer Fighter
Pet dogs have helped researchers show that a special bacterium can seemingly fight cancer, causing tumors to shrink. A modified version of Clostridium novyi bacteria, when injected into solid soft tissue tumors, will eat away at the cancerous cells without harming surrounding healthy tissue, researchers report Aug. 13 in the latest Science Translational Medicine. "When we treated those tumors, we found that C. novyi was able to germinate inside the tumor while sparing the normal brain tissue," said co-author Dr. Verena Staedtke, a fellow at the Johns Hopkins Kimmel Cancer Center in Baltimore.
Pet dogs have helped researchers show that a special bacterium can seemingly fight cancer, causing tumors to shrink. A modified version of Clostridium novyi bacteria, when injected into solid soft tissue tumors, will eat away at the cancerous cells without harming surrounding healthy tissue, researchers report Aug. 13 in the latest Science Translational Medicine. "When we treated those tumors, we found that C. novyi was able to germinate inside the tumor while sparing the normal brain tissue," said co-author Dr. Verena Staedtke, a fellow at the Johns Hopkins Kimmel Cancer Center in Baltimore.
Source: http://consumer.healthday.com/
Newly Discovered Heart Molecule Could Lead to Effective Treatment for Heart Failure
Researchers have discovered a previously unknown cardiac molecule that could provide a key to treating, and preventing, heart failure. The newly discovered molecule provides the heart with a tool to block a protein that orchestrates genetic disruptions when the heart is subjected to stress, such as high blood pressure. When the research team, led by Ching-Pin Chang, M.D., Ph.D., associate professor of medicine at the Indiana University School of Medicine, restored levels of the newly discovered molecule in mice experiencing heart failure, the progression to heart failure was stopped. The research was published in the online edition of the journal Nature.
Researchers have discovered a previously unknown cardiac molecule that could provide a key to treating, and preventing, heart failure. The newly discovered molecule provides the heart with a tool to block a protein that orchestrates genetic disruptions when the heart is subjected to stress, such as high blood pressure. When the research team, led by Ching-Pin Chang, M.D., Ph.D., associate professor of medicine at the Indiana University School of Medicine, restored levels of the newly discovered molecule in mice experiencing heart failure, the progression to heart failure was stopped. The research was published in the online edition of the journal Nature.
Source: http://news.medicine.iu.edu/
Artificial Anti-cancer Molecules Self-assemble in Minutes
Researchers have developed a simple and versatile method for making artificial anti-cancer molecules that mimic the properties of one of the body's natural defence systems. The chemists, led by Professor Peter Scott at the Univ. of Warwick, UK, have been able to produce molecules that have a similar structure to peptides that are naturally produced in the body to fight cancer and infection. Published in Nature Chemistry, the molecules produced in the research have proved effective against colon cancer cells in laboratory tests, in collaboration with Roger Phillips at the Institute for Cancer Therapeutics, Bradford, UK.
Source: http://www.laboratoryequipment.com/
Researchers have developed a simple and versatile method for making artificial anti-cancer molecules that mimic the properties of one of the body's natural defence systems. The chemists, led by Professor Peter Scott at the Univ. of Warwick, UK, have been able to produce molecules that have a similar structure to peptides that are naturally produced in the body to fight cancer and infection. Published in Nature Chemistry, the molecules produced in the research have proved effective against colon cancer cells in laboratory tests, in collaboration with Roger Phillips at the Institute for Cancer Therapeutics, Bradford, UK.
Source: http://www.laboratoryequipment.com/
DNA-based Suicide Risk Test
Sundance Diagnostics plans to offer its saliva-based test, which is based on research out of the Max Planck Institute of Psychiatry, to doctors beginning next month for patients taking anti-depressants like Prozac or Zoloft. People just beginning anti-depressant treatment are sometimes at increased risk of suicide. Johns Hopkins University researchers have also identified a gene that appears to be methylated in people who have committed suicide or have suicidal thoughts. However, critics say life history and environmental factors play a role in suicide risk. And Tech Review notes that connecting to dots between someone's DNA and suicidal thoughts is difficult and not straightforward. "I don't think there are any credible genomic tests for suicide risk or prevention," says Muin Khoury, head of the Office of Public Health Genomics at the US Centers for Disease Control and Prevention.
Sundance Diagnostics plans to offer its saliva-based test, which is based on research out of the Max Planck Institute of Psychiatry, to doctors beginning next month for patients taking anti-depressants like Prozac or Zoloft. People just beginning anti-depressant treatment are sometimes at increased risk of suicide. Johns Hopkins University researchers have also identified a gene that appears to be methylated in people who have committed suicide or have suicidal thoughts. However, critics say life history and environmental factors play a role in suicide risk. And Tech Review notes that connecting to dots between someone's DNA and suicidal thoughts is difficult and not straightforward. "I don't think there are any credible genomic tests for suicide risk or prevention," says Muin Khoury, head of the Office of Public Health Genomics at the US Centers for Disease Control and Prevention.
Source: http://www.genomeweb.com/
Male Infertility Linked to Low Peptide Levels
Low levels of human β-defensin 1 (DEFB1) in sperm may explain some of the common causes of male infertility, according to research published in Science Translational Medicine. Ruiying Diao, of the First Affiliated Hospital of Shenzhen University in China, and colleagues studied sperm and DEFB1 levels in men diagnosed with infertility caused by asthenozoospermia or leukocytospermia. The researchers found low levels of DEFB1 in sperm from men with infertility caused by either asthenozoospermia or leukocytospermia, both of which are associated with reduced motility and reduced bactericidal activity in sperm. The same defects in sperm were observed when there was interference with DEFB1 function.
Source: http://www.renalandurologynews.com/Low levels of human β-defensin 1 (DEFB1) in sperm may explain some of the common causes of male infertility, according to research published in Science Translational Medicine. Ruiying Diao, of the First Affiliated Hospital of Shenzhen University in China, and colleagues studied sperm and DEFB1 levels in men diagnosed with infertility caused by asthenozoospermia or leukocytospermia. The researchers found low levels of DEFB1 in sperm from men with infertility caused by either asthenozoospermia or leukocytospermia, both of which are associated with reduced motility and reduced bactericidal activity in sperm. The same defects in sperm were observed when there was interference with DEFB1 function.
Public Health and Patient Safety
HPV Vaccine Safe, Effective Over Eight Years
A new long-term study shows that the human papillomavirus (HPV) vaccine appears to protect against the sexually transmitted virus for at least eight years. Among the vaccinated preteens in the new study, none developed any of the diseases or conditions associated with HPV during the study period, the researchers reported. After eight years, those who received the vaccine still had antibodies against HPV, they found.
A survey published in the same journal issue examined the reasons more girls aren't getting vaccinated. "Almost everybody [parents and doctors] we talked to thought getting the vaccine was a good idea," said survey author Dr. Rebecca Perkins, an assistant professor of obstetrics and gynecology at Boston University School of Medicine. The CDC recommends that all kids aged 11 to 12 should get the three doses of HPV vaccine. The report was published online Aug. 18 in the journal Pediatrics.
A new long-term study shows that the human papillomavirus (HPV) vaccine appears to protect against the sexually transmitted virus for at least eight years. Among the vaccinated preteens in the new study, none developed any of the diseases or conditions associated with HPV during the study period, the researchers reported. After eight years, those who received the vaccine still had antibodies against HPV, they found.
A survey published in the same journal issue examined the reasons more girls aren't getting vaccinated. "Almost everybody [parents and doctors] we talked to thought getting the vaccine was a good idea," said survey author Dr. Rebecca Perkins, an assistant professor of obstetrics and gynecology at Boston University School of Medicine. The CDC recommends that all kids aged 11 to 12 should get the three doses of HPV vaccine. The report was published online Aug. 18 in the journal Pediatrics.
Source: http://health.usnews.com/
U.S. Speeds up Human Clinical Trials for Promising Ebola Vaccine
Researchers at the National Institutes of Health are accelerating human clinical trials for what scientists hope is a promising new vaccine to combat the deadly Ebola virus. Phase 1 of the clinical trials, which were previously not expected to begin until the end of September, will start early next month in response to the Ebola outbreak in West Africa, said Dr. Anthony Fauci, director of the NIH’s National Institute of Allergy and Infectious Diseases. Fauci said researchers hoped to finish Phase 1 by the end of November rather than January 2015, as originally planned. “We’re dealing with an urgent situation,” Fauci said. “We want to respond as safely as we can but also as quickly as we can.” The NIH’s Vaccine Research Center has been working on the vaccine for years with Okairos, a Swiss-Italian biopharmaceutical company now owned by British drug maker GlaxoSmithKline. The experimental vaccine has shown promising results in nonhuman primates, Fauci said. The vaccine will be tested on 20 healthy adults at the NIH Clinical Center in Bethesda, Md.
Researchers at the National Institutes of Health are accelerating human clinical trials for what scientists hope is a promising new vaccine to combat the deadly Ebola virus. Phase 1 of the clinical trials, which were previously not expected to begin until the end of September, will start early next month in response to the Ebola outbreak in West Africa, said Dr. Anthony Fauci, director of the NIH’s National Institute of Allergy and Infectious Diseases. Fauci said researchers hoped to finish Phase 1 by the end of November rather than January 2015, as originally planned. “We’re dealing with an urgent situation,” Fauci said. “We want to respond as safely as we can but also as quickly as we can.” The NIH’s Vaccine Research Center has been working on the vaccine for years with Okairos, a Swiss-Italian biopharmaceutical company now owned by British drug maker GlaxoSmithKline. The experimental vaccine has shown promising results in nonhuman primates, Fauci said. The vaccine will be tested on 20 healthy adults at the NIH Clinical Center in Bethesda, Md.
Source: http://www.latimes.com/
US Fast-Tracking Process Toward Human Testing of Ebola Vaccine
A biopharmaceutical company in Ames, Iowa has been given the go-ahead and funding from a branch of the U.S. Department of Defense to work toward human testing of an Ebola vaccine. NewLink Genetics and their subsidiary, BioProtection Systems, were recently given a government contract from the U.S. Defense Threat Reduction Agency (DTRA), for $1 million to research and speed up the process to begin human clinical testing of their existing Ebola vaccine. As of now, the vaccine has only been tested on animals, like rodents and monkeys, and scientists have seen positive results. However, before a vaccine can be tested on humans, there are many time-consuming precautionary steps that have to be taken. With the deadly Ebola outbreak in West Africa, these processes are speeding up. NewLink Genetics has been working on an Ebola vaccine for years, but the government contract will help speed up their research. The $1 million is only the first part of funding that is available should the vaccine be successful and make it to human clinical trials.
A biopharmaceutical company in Ames, Iowa has been given the go-ahead and funding from a branch of the U.S. Department of Defense to work toward human testing of an Ebola vaccine. NewLink Genetics and their subsidiary, BioProtection Systems, were recently given a government contract from the U.S. Defense Threat Reduction Agency (DTRA), for $1 million to research and speed up the process to begin human clinical testing of their existing Ebola vaccine. As of now, the vaccine has only been tested on animals, like rodents and monkeys, and scientists have seen positive results. However, before a vaccine can be tested on humans, there are many time-consuming precautionary steps that have to be taken. With the deadly Ebola outbreak in West Africa, these processes are speeding up. NewLink Genetics has been working on an Ebola vaccine for years, but the government contract will help speed up their research. The $1 million is only the first part of funding that is available should the vaccine be successful and make it to human clinical trials.
Source: http://www.foxnews.com/
How a Canadian Prairie City Made an Ebola Vaccine
An experimental Ebola vaccine that is offering some hope for West Africa was invented in a small Canadian Prairie city and had its roots in the Cold War, the German town of Marburg and a disease scare that panicked Toronto in the 1970s. The Canadian government said this week that the Ebola vaccine, developed at its National Microbiology Laboratory in Winnipeg, Manitoba, though untested on humans, would be offered to the World Health Organization for use in Africa. The WHO ruled that it would be ethical, given the extraordinary circumstances of the Ebola outbreak, to give untested treatments to infected patients. Canada is one of only two countries in the world, along with the United States, to have developed an Ebola vaccine. The Winnipeg lab where the vaccine, called VSV-EBOV, was developed also produced some of the components of the ZMapp treatment given to two American aid workers who were stricken with Ebola.
An experimental Ebola vaccine that is offering some hope for West Africa was invented in a small Canadian Prairie city and had its roots in the Cold War, the German town of Marburg and a disease scare that panicked Toronto in the 1970s. The Canadian government said this week that the Ebola vaccine, developed at its National Microbiology Laboratory in Winnipeg, Manitoba, though untested on humans, would be offered to the World Health Organization for use in Africa. The WHO ruled that it would be ethical, given the extraordinary circumstances of the Ebola outbreak, to give untested treatments to infected patients. Canada is one of only two countries in the world, along with the United States, to have developed an Ebola vaccine. The Winnipeg lab where the vaccine, called VSV-EBOV, was developed also produced some of the components of the ZMapp treatment given to two American aid workers who were stricken with Ebola.
Source: http://www.reuters.com/
Ebola Tracking: Health and Human Services
The speed of and wide access to social media has also enhanced the ability of public safety agencies to respond to rapidly emerging threats. HHS has recognized the potential public social posts to allow for faster detection of disease outbreaks: two years ago the agency established a contest for web developers to create an app that would analyze public Twitter feeds and hashtags to identify infection outbreaks. The end result is an open resource that medical providers, health researchers, and the general public can access to learn more about current diseases trends. And, given the pervasiveness of Twitter use worldwide even in developing countries, the site can track diseases like Ebola as they spread across international borders. (Nigeria’s government has itself taken note and begun deploying Facebook and Twitter Ebola alerts to its own citizens.) In many ways, this HHS program perhaps represents a key success in government social media. Not only was the agency able to derive value by crowdsourcing information provided by individual users, but it was able to blend both engagement and service delivery together by soliciting private citizens’ technical expertise through a contest that then guided the creation of a final product. Looking forward, efforts like these can help revolutionize the way agencies interact with their customers and ultimately further their mission.
The speed of and wide access to social media has also enhanced the ability of public safety agencies to respond to rapidly emerging threats. HHS has recognized the potential public social posts to allow for faster detection of disease outbreaks: two years ago the agency established a contest for web developers to create an app that would analyze public Twitter feeds and hashtags to identify infection outbreaks. The end result is an open resource that medical providers, health researchers, and the general public can access to learn more about current diseases trends. And, given the pervasiveness of Twitter use worldwide even in developing countries, the site can track diseases like Ebola as they spread across international borders. (Nigeria’s government has itself taken note and begun deploying Facebook and Twitter Ebola alerts to its own citizens.) In many ways, this HHS program perhaps represents a key success in government social media. Not only was the agency able to derive value by crowdsourcing information provided by individual users, but it was able to blend both engagement and service delivery together by soliciting private citizens’ technical expertise through a contest that then guided the creation of a final product. Looking forward, efforts like these can help revolutionize the way agencies interact with their customers and ultimately further their mission.
Source: http://www.govexec.com/
DARPA Seeks Model to Forecast Fast-moving Virus
The Defense Advanced Research Projects Agency (DARPA) issued a $150,000 challenge to build a model that accurately charts the path of the chikungunya virus through the Americas. Participants will submit a description of their model and data sources by Sept. 1 of this year, along with an initial forecast. The forecast will be augmented by monthly submissions updating predictions for the spread of the virus, with a final report including a complete methodology due Feb. 1, 2015. Progress on the model will be tracked via an online leaderboard.
Source: http://fcw.com/The Defense Advanced Research Projects Agency (DARPA) issued a $150,000 challenge to build a model that accurately charts the path of the chikungunya virus through the Americas. Participants will submit a description of their model and data sources by Sept. 1 of this year, along with an initial forecast. The forecast will be augmented by monthly submissions updating predictions for the spread of the virus, with a final report including a complete methodology due Feb. 1, 2015. Progress on the model will be tracked via an online leaderboard.
Health IT
Developing a Shared, Nationwide Roadmap for Interoperability
When we issued our interoperability vision paper, Connecting Health and Care for the Nation: A 10-Year Vision to Achieve an Interoperable Health IT Infrastructure, in June, and the HHS Principles and Strategy for Accelerating Health Information Exchange last year, we promised that the journey would be collaborative. I am pleased to say we are delivering on this promise and launching a new, interactive community on www.healthit.gov/interoperability-community. Over the course of the coming months we will be drafting a document, with input from you – stakeholders who may be interested in contributing. The goal is to develop version 1.0 of a nationwide interoperability roadmap. The roadmap will be a companion to our vision paper and dive deeper on how we can collectively achieve the 3, 6, and 10 year interoperability milestones described in the paper. Our ultimate goal is to have a learning health system where accurate and evidence-based information helps ensure the right individual receives the right care at the right time to increase health care quality, lower health care costs and improve population health.
When we issued our interoperability vision paper, Connecting Health and Care for the Nation: A 10-Year Vision to Achieve an Interoperable Health IT Infrastructure, in June, and the HHS Principles and Strategy for Accelerating Health Information Exchange last year, we promised that the journey would be collaborative. I am pleased to say we are delivering on this promise and launching a new, interactive community on www.healthit.gov/interoperability-community
. Over the course of the coming months we will be drafting a document, with input from you – stakeholders who may be interested in contributing. The goal is to develop version 1.0 of a nationwide interoperability roadmap. The roadmap will be a companion to our vision paper and dive deeper on how we can collectively achieve the 3, 6, and 10 year interoperability milestones described in the paper. Our ultimate goal is to have a learning health system where accurate and evidence-based information helps ensure the right individual receives the right care at the right time to increase health care quality, lower health care costs and improve population health.Source: http://www.healthit.gov/
FDA Employing High-Performance IT to Ready for NGS Submissions
The U.S. Food and Drug Administration (FDA) is preparing for anticipated massive amounts of data from submissions employing next-generation sequencing (NGS). In order to handle this "flood of information" the FDA is readying a new cloud-based computing tool referred to as HIVE (High-Performance Integrated Virtual Environment). HIVE will enable the agency to appropriately review and understand the interpretation of NGS data in regulatory submissions. The challenge, the FDA says, is that NGS produces vast quantities of data that can "overwhelm" most computer systems, hampering the ability to store, search, analyze, or transfer NGS-generated data. The agency is anticipating a rise in NGS submissions related to diagnostic tests, new treatments, and as a means to track the quality of certain products, including biologics.
Source: http://www.g2intelligence.com/
The U.S. Food and Drug Administration (FDA) is preparing for anticipated massive amounts of data from submissions employing next-generation sequencing (NGS). In order to handle this "flood of information" the FDA is readying a new cloud-based computing tool referred to as HIVE (High-Performance Integrated Virtual Environment). HIVE will enable the agency to appropriately review and understand the interpretation of NGS data in regulatory submissions. The challenge, the FDA says, is that NGS produces vast quantities of data that can "overwhelm" most computer systems, hampering the ability to store, search, analyze, or transfer NGS-generated data. The agency is anticipating a rise in NGS submissions related to diagnostic tests, new treatments, and as a means to track the quality of certain products, including biologics.
Source: http://www.g2intelligence.com/
Unique Device Identification System Small Entity Compliance Guide
The UDI Rule establishes a UDI system. It requires the labels and device packages of medical devices distributed in the United States include a unique device identifier (UDI), unless we grant an exception or alternative to UDI label requirements. As will be explained later, this UDI will be in both easily readable plain-text and Automatic Identification and Data Capture (AIDC) technology—usually a bar code. The UDI Rule also requires specified product information be submitted to FDA’s Global Unique Device Identification Database (GUDID). Most of this information in GUDID will be made available to the public. When fully implemented, the UDI system will serve several important public health objectives:
• It will facilitate the healthcare community, industry, and the public’s rapid and accurate identification of a device using the UDI that appears on the device’s label and device package.
• Medical providers, patients and others will be able to more easily access important information concerning the device, thereby reducing medical errors.
• It will allow more accurate reporting, reviewing, and analyzing of adverse event reports so that problems can be identified and corrected more quickly.
• It will provide a standard and clear way to document device use in electronic health records, clinical information systems, claims data sources and registries, leading to a more robust postmarket surveillance system which can be leveraged to support premarket approval or clearance of new devices and new uses of currently marketed devices.
• It will enable manufacturers, distributors and healthcare facilities to more effectively manage medical device recalls.
Source: http://www.fda.gov/The UDI Rule establishes a UDI system. It requires the labels and device packages of medical devices distributed in the United States include a unique device identifier (UDI), unless we grant an exception or alternative to UDI label requirements. As will be explained later, this UDI will be in both easily readable plain-text and Automatic Identification and Data Capture (AIDC) technology—usually a bar code. The UDI Rule also requires specified product information be submitted to FDA’s Global Unique Device Identification Database (GUDID). Most of this information in GUDID will be made available to the public. When fully implemented, the UDI system will serve several important public health objectives:
• It will facilitate the healthcare community, industry, and the public’s rapid and accurate identification of a device using the UDI that appears on the device’s label and device package.
• Medical providers, patients and others will be able to more easily access important information concerning the device, thereby reducing medical errors.
• It will allow more accurate reporting, reviewing, and analyzing of adverse event reports so that problems can be identified and corrected more quickly.
• It will provide a standard and clear way to document device use in electronic health records, clinical information systems, claims data sources and registries, leading to a more robust postmarket surveillance system which can be leveraged to support premarket approval or clearance of new devices and new uses of currently marketed devices.
• It will enable manufacturers, distributors and healthcare facilities to more effectively manage medical device recalls.
Other News
Stem Cell Therapy: FDA Regulatory Science Aims to Facilitate Development of Safe and Effective Regenerative Medicine Products
One of FDA’s primary missions is to make sure that the products we approve are safe and effective. There is tremendous interest in the development of regenerative medicine, including numerous proposed products that rely on stem cells. Stem cells have the ability to generate more stem cells or to turn into more mature cell types such as nerve- or bone-producing cells. These properties make stem cells potentially well suited for use in regenerative medicine. They might be used in repairing heart, nerve, and brain damage or in treating diabetes and other diseases by repairing or replacing cells and tissues. Because stem cells can change based on their surroundings, whether during growth outside of the body or following injection into the body, ensuring the safety of effective regenerative medicine products can be challenging.
One of FDA’s primary missions is to make sure that the products we approve are safe and effective. There is tremendous interest in the development of regenerative medicine, including numerous proposed products that rely on stem cells. Stem cells have the ability to generate more stem cells or to turn into more mature cell types such as nerve- or bone-producing cells. These properties make stem cells potentially well suited for use in regenerative medicine. They might be used in repairing heart, nerve, and brain damage or in treating diabetes and other diseases by repairing or replacing cells and tissues. Because stem cells can change based on their surroundings, whether during growth outside of the body or following injection into the body, ensuring the safety of effective regenerative medicine products can be challenging.
Source: http://blogs.fda.gov/
DoD Releases List of Genetic Tests Covered by Tricare
The Defense Health Agency has announced which genetic tests Tricare will cover starting in September. The Pentagon’s health arm published a list of 35 laboratory-developed tests covered under a new pilot program, from the better-known BRCA1 and BRCA2 tests for breast cancer and in-utero cystic fibrosis to tests for rare inherited disorders like Lynch syndrome and Von Hippel-Lindau disease. The demonstration project starts Sept. 1. But if beneficiaries paid for a test on the list since Jan. 1, 2013, they may be eligible for reimbursement. They will have to file a claim to receive payment, according to a Tricare news release. DHA created the pilot project as a way to cover the tests, which, until recently, have not been regulated by the Food and Drug Administration. By law, Tricare is restricted from paying for medications or equipment not approved by the FDA — even those not subject to FDA approval. Tricare drafted the pilot as a way to cover the tests while the FDA debated how to proceed on regulating laboratory-developed tests.
The Defense Health Agency has announced which genetic tests Tricare will cover starting in September. The Pentagon’s health arm published a list of 35 laboratory-developed tests covered under a new pilot program, from the better-known BRCA1 and BRCA2 tests for breast cancer and in-utero cystic fibrosis to tests for rare inherited disorders like Lynch syndrome and Von Hippel-Lindau disease. The demonstration project starts Sept. 1. But if beneficiaries paid for a test on the list since Jan. 1, 2013, they may be eligible for reimbursement. They will have to file a claim to receive payment, according to a Tricare news release. DHA created the pilot project as a way to cover the tests, which, until recently, have not been regulated by the Food and Drug Administration. By law, Tricare is restricted from paying for medications or equipment not approved by the FDA — even those not subject to FDA approval. Tricare drafted the pilot as a way to cover the tests while the FDA debated how to proceed on regulating laboratory-developed tests.
Source: http://www.militarytimes.com/
NPs and PAs Perform Office Procedures Beyond Their Medical Training, Study Finds
Amidst the primary care shortage, mid-level providers like nurse practitioners (NPs) and physician assistants (PAs) perform procedures for which they may not have formal training across primary care offices around the country, a new study published in JAMA Dermatology revealed. Researchers analyzed the 2012 Medicare Physician/Supplier Procedure Summary Master file, which reflects claims paid by Medicare for procedures independently billed by mid-level providers in outpatient health provider offices.
Source: http://www.fiercepracticemanagement.com/Amidst the primary care shortage, mid-level providers like nurse practitioners (NPs) and physician assistants (PAs) perform procedures for which they may not have formal training across primary care offices around the country, a new study published in JAMA Dermatology revealed. Researchers analyzed the 2012 Medicare Physician/Supplier Procedure Summary Master file, which reflects claims paid by Medicare for procedures independently billed by mid-level providers in outpatient health provider offices.
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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