Healthcare News
A Weekly Compilation of Clinical Laboratory and Related Information
from The Division Of Laboratory Programs, Standards And Services
July 31, 2014
- Outbreak of Ebola in Guinea, Liberia, and Sierra Leone | Recent Updates
- Laboratory Diagnosis of Ebola Hemorrhagic Fever
- PT Referral Rules Bring Regulatory Relief for Labs
- FDA Issues Informed Consent Guidance
- Evidence Weak on Vitamin D Screening: Draft USPSTF Recommendations Cite Lack of Test Standardization, Consistency Across Studies
- Cancer Blood Test Moves Closer After Promising Results
- Enhanced NIST Instrument Enables High-speed Chemical Imaging of Tissues
- Less Than 10% of Human DNA Has Functional Role, Claim Scientists
- Stem Cell Therapy Could Lead to HIV Cure
- Clearing Cells to Prevent Cervical Cancer
- Fist Bumps 'Cleaner Than Handshakes'
- Student Develops Filter for Clean Water Around the World
- FDA Regulation of Mobile Health Technologies
View Previous Issues - Healthcare News Archive
Leading News
Outbreak of Ebola in Guinea, Liberia, and Sierra Leone | Recent Updates
The World Health Organization, in partnership with the Ministries of Health in Guinea, Sierra Leone, and Liberia, announced a cumulative total of 1201 suspect and confirmed cases of Ebola virus disease (EVD) and 672 deaths, as of July 23, 2014. Of the 1201 clinical cases, 814 cases have been laboratory confirmed for Ebola virus infection.
In Guinea, 427 cases, including 319 fatal cases and 311 laboratory confirmations of EVD, were reported by the Ministry of Health (MoH) of Guinea and WHO as of July 23, 2014. Active surveillance continues in Conakry, Guéckédou, Boffa, Dubreka, Fria, and Siguiri Districts.
In Sierra Leone, WHO and the Ministry of Health and Sanitation of Sierra Leone reported a cumulative total of 525 suspect and confirmed cases of EVD as of July 23, 2014. Of these 525, 419 cases have been laboratory confirmed and 224 were fatal. Districts reporting clinical EVD patients include Kailahun, Kenema, Kambia, Port Loko, Western, and Bo. Reports, investigations, and testing of suspect cases continue across the country.
As of July 23, 2014, the Ministry of Health and Social Welfare of Liberia and WHO reported 249 clinical cases of EVD, including 84 laboratory confirmations and 129 fatal cases. Cases since May have been reported from Lofa, Montserado, Margibi, Bomi, Bong, and Nimba Counties. Laboratory testing is being conducted in Monrovia. CDC is in regular communication with its international partners, WHO, and MSF regarding the outbreak.
The World Health Organization, in partnership with the Ministries of Health in Guinea, Sierra Leone, and Liberia, announced a cumulative total of 1201 suspect and confirmed cases of Ebola virus disease (EVD) and 672 deaths, as of July 23, 2014. Of the 1201 clinical cases, 814 cases have been laboratory confirmed for Ebola virus infection.
In Guinea, 427 cases, including 319 fatal cases and 311 laboratory confirmations of EVD, were reported by the Ministry of Health (MoH) of Guinea and WHO as of July 23, 2014. Active surveillance continues in Conakry, Guéckédou, Boffa, Dubreka, Fria, and Siguiri Districts.
In Sierra Leone, WHO and the Ministry of Health and Sanitation of Sierra Leone reported a cumulative total of 525 suspect and confirmed cases of EVD as of July 23, 2014. Of these 525, 419 cases have been laboratory confirmed and 224 were fatal. Districts reporting clinical EVD patients include Kailahun, Kenema, Kambia, Port Loko, Western, and Bo. Reports, investigations, and testing of suspect cases continue across the country.
As of July 23, 2014, the Ministry of Health and Social Welfare of Liberia and WHO reported 249 clinical cases of EVD, including 84 laboratory confirmations and 129 fatal cases. Cases since May have been reported from Lofa, Montserado, Margibi, Bomi, Bong, and Nimba Counties. Laboratory testing is being conducted in Monrovia. CDC is in regular communication with its international partners, WHO, and MSF regarding the outbreak.
Source: http://www.cdc.gov/
Laboratory Diagnosis of Ebola Hemorrhagic Fever
Diagnosing Ebola HF in an individual who has been infected for only a few days is difficult, because the early symptoms, such as red eyes and a skin rash, are nonspecific to ebolavirus infection and are seen often in patients with more commonly occurring diseases. However, if a person has the early symptoms of Ebola HF and there is reason to believe that Ebola HF should be considered, the patient should be isolated and public health professionals notified. Samples from the patient can then be collected and tested to confirm infection. Laboratory tests used in diagnosis include:
Diagnosing Ebola HF in an individual who has been infected for only a few days is difficult, because the early symptoms, such as red eyes and a skin rash, are nonspecific to ebolavirus infection and are seen often in patients with more commonly occurring diseases. However, if a person has the early symptoms of Ebola HF and there is reason to believe that Ebola HF should be considered, the patient should be isolated and public health professionals notified. Samples from the patient can then be collected and tested to confirm infection. Laboratory tests used in diagnosis include:
| Timeline of Infection | Diagnostic tests available |
Within a few days after symptoms begin |
|
Later in disease course or after recovery |
|
Retrospectively in deceased patients |
|
Source: http://www.cdc.gov/
PT Referral Rules Bring Regulatory Relief for Labs
Laboratories now may be saved from draconian penalties, such as loss of a CLIA license and probation periods, for mistakenly sending proficiency test specimens to another facility. Under new rules published by the Centers for Medicare and Medicaid Services, laboratories have the regulatory relief the CAP advocated during the past decade. The CMS will still severely punish those attempting to cheat on proficiency testing, but laboratories that unknowingly or unintentionally refer PT specimens will face alternative sanctions, according to the regulations. “We still want to work with CMS to evaluate other scenarios that are the result of ignorance or a mistake and not with intent to cheat,” says R. Bruce Williams, MD, a CAP governor and chair of the CAP Council on Scientific Affairs. “In those instances, we need to make sure the punishment fits the crime.”
Laboratories now may be saved from draconian penalties, such as loss of a CLIA license and probation periods, for mistakenly sending proficiency test specimens to another facility. Under new rules published by the Centers for Medicare and Medicaid Services, laboratories have the regulatory relief the CAP advocated during the past decade. The CMS will still severely punish those attempting to cheat on proficiency testing, but laboratories that unknowingly or unintentionally refer PT specimens will face alternative sanctions, according to the regulations. “We still want to work with CMS to evaluate other scenarios that are the result of ignorance or a mistake and not with intent to cheat,” says R. Bruce Williams, MD, a CAP governor and chair of the CAP Council on Scientific Affairs. “In those instances, we need to make sure the punishment fits the crime.”
Source: http://www.captodayonline.com/
FDA Issues Informed Consent Guidance
The FDA recently issued an updated guidance document on obtaining informed consent for clinical trials, with increased detail about how consent should be obtained. The document, posted online, updates guidance on informed consent that was issued in 1998. It contains sections on basic elements of informed consent, including providing patients with a description of the trial, its risks, benefits, alternative treatments, confidentiality, and compensation in the event of injury. It also offers guidance on how investigators and institutional review boards (IRBs) can help ensure that informed consent is adequate and meets the FDA's requirements.
The FDA recently issued an updated guidance document on obtaining informed consent for clinical trials, with increased detail about how consent should be obtained. The document, posted online, updates guidance on informed consent that was issued in 1998. It contains sections on basic elements of informed consent, including providing patients with a description of the trial, its risks, benefits, alternative treatments, confidentiality, and compensation in the event of injury. It also offers guidance on how investigators and institutional review boards (IRBs) can help ensure that informed consent is adequate and meets the FDA's requirements.
Source: http://www.medpagetoday.com/
FDA Meeting on Biomarker Development
On September 5, 2014, the FDA is holding a public meeting at the Washington Plaza Hotel, in Washington DC, to discuss current scientific and regulatory approaches to biomarker development, acceptance, and utility in the development of therapeutic products (e.g., drugs and biologics). Specifically, FDA will focus on (1) identifying challenges for biomarker applications in early- and late- phase clinical trials, and (2) emerging best practices for successful biomarker-based programs (including codevelopment of in vitro diagnostic devices and use of biomarkers as outcome measures in clinical trials).
On September 5, 2014, the FDA is holding a public meeting at the Washington Plaza Hotel, in Washington DC, to discuss current scientific and regulatory approaches to biomarker development, acceptance, and utility in the development of therapeutic products (e.g., drugs and biologics). Specifically, FDA will focus on (1) identifying challenges for biomarker applications in early- and late- phase clinical trials, and (2) emerging best practices for successful biomarker-based programs (including codevelopment of in vitro diagnostic devices and use of biomarkers as outcome measures in clinical trials).
FDA Bans Medtech 510(k) Pathway's 'Split predicates'
Medical device regulators clamp down on the 510(k) review pathway, prohibited manufacturers from splitting their primary substantial equivalence claims between multiple devices. Federal medical device regulators finalized a new rule this week that prohibits manufacturers from using so-called "split predicates" to establish that their new products are effectively the same as devices already on the market. The rule, which is 2 years in the making, means that device makers can no longer reference separate predicate devices that have different intended uses when attempting to demonstrate "substantial equivalence." Companies must now rely on a single predicate device or devices that have the same intended purpose.
Medical device regulators clamp down on the 510(k) review pathway, prohibited manufacturers from splitting their primary substantial equivalence claims between multiple devices. Federal medical device regulators finalized a new rule this week that prohibits manufacturers from using so-called "split predicates" to establish that their new products are effectively the same as devices already on the market. The rule, which is 2 years in the making, means that device makers can no longer reference separate predicate devices that have different intended uses when attempting to demonstrate "substantial equivalence." Companies must now rely on a single predicate device or devices that have the same intended purpose.
Source: http://www.massdevice.com/
New Massachusetts Law Targets Self-Referrals of Clinical Laboratory Services
The Fiscal Year 2015 budget for the Commonwealth of Massachusetts, which was signed into law earlier, included a broad prohibition on clinical laboratory self-referrals. This legislation (the “Bill”) originally proposed by the Attorney General’s office was intended to combat self-referral arrangements between clinical laboratories and sober houses under common ownership, but it extends beyond such relationships to prohibit referrals between clinical laboratories and any person or company with a direct or indirect ownership interest in the laboratory and vice versa (with a number of notable exceptions).
Source: http://www.natlawreview.com/The Fiscal Year 2015 budget for the Commonwealth of Massachusetts, which was signed into law earlier, included a broad prohibition on clinical laboratory self-referrals. This legislation (the “Bill”) originally proposed by the Attorney General’s office was intended to combat self-referral arrangements between clinical laboratories and sober houses under common ownership, but it extends beyond such relationships to prohibit referrals between clinical laboratories and any person or company with a direct or indirect ownership interest in the laboratory and vice versa (with a number of notable exceptions).
Laboratory Testing / Diagnostics
Evidence Weak on Vitamin D Screening: Draft USPSTF Recommendations Cite Lack of Test Standardization, Consistency Across Studies
The U.S. Preventive Services Task Force (USPSTF), in a draft statement, said it found insufficient evidence to recommend routine vitamin D screening. The independent panel, funded by the U.S. Agency for Healthcare Research and Quality, based this preliminary finding on a number of factors, including a dearth of studies that point to the direct benefits of testing adults for vitamin D deficiencies, and no uniform standards for the testing. A number of testing methods exist to determine total serum 25-hydroxy vitamin D (25 (OH) D) levels. Yet, “the accuracy of these tests is difficult to determine due to the lack of studies using an internationally recognized reference standard,” according to the draft statement. Accuracy of these tests isn’t the only problem; it’s also unclear if 25(OH) D is the best way to measure vitamin D status. “The current tests measure the blood serum level of 25-hydroxy vitamin D, not its availability in the body,” Baumann says. Bioavailable 25 (OH) D, by comparison, “is a more accurate reflection of physiological availability of 25-hydroxy vitamin D,” she says.
The U.S. Preventive Services Task Force (USPSTF), in a draft statement, said it found insufficient evidence to recommend routine vitamin D screening. The independent panel, funded by the U.S. Agency for Healthcare Research and Quality, based this preliminary finding on a number of factors, including a dearth of studies that point to the direct benefits of testing adults for vitamin D deficiencies, and no uniform standards for the testing. A number of testing methods exist to determine total serum 25-hydroxy vitamin D (25 (OH) D) levels. Yet, “the accuracy of these tests is difficult to determine due to the lack of studies using an internationally recognized reference standard,” according to the draft statement. Accuracy of these tests isn’t the only problem; it’s also unclear if 25(OH) D is the best way to measure vitamin D status. “The current tests measure the blood serum level of 25-hydroxy vitamin D, not its availability in the body,” Baumann says. Bioavailable 25 (OH) D, by comparison, “is a more accurate reflection of physiological availability of 25-hydroxy vitamin D,” she says.
Source: http://www.aacc.org/
Cancer Blood Test Moves Closer After Promising Results
A British team of researchers has developed what might be a simple blood test that can detect all cancers. Scientists from the University of Bradford have so far used their technique on three types of cancer with promising results. It is hoped that in time the test could prevent costly and invasive procedures such as colonoscopies and biopsies. But researchers say it is still very early days and much more work is needed. Blood tests have been used before to detect different types of cancer, but the Bradford team hopes to develop a universal test for all cancers. The technique involves subjecting white blood cells to ultraviolet light which damages the cells' DNA.
A British team of researchers has developed what might be a simple blood test that can detect all cancers. Scientists from the University of Bradford have so far used their technique on three types of cancer with promising results. It is hoped that in time the test could prevent costly and invasive procedures such as colonoscopies and biopsies. But researchers say it is still very early days and much more work is needed. Blood tests have been used before to detect different types of cancer, but the Bradford team hopes to develop a universal test for all cancers. The technique involves subjecting white blood cells to ultraviolet light which damages the cells' DNA.
Source: http://www.bbc.com/
Enhanced NIST Instrument Enables High-speed Chemical Imaging of Tissues
A research team from the National Institute of Standards and Technology (NIST), working with the Cleveland Clinic, has demonstrated a dramatically improved technique for analyzing biological cells and tissues based on characteristic molecular vibration "signatures." The new NIST technique is an advanced form of the widely used spontaneous Raman spectroscopy, but one that delivers signals that are 10,000 times stronger than obtained from spontaneous Raman scattering, and 100 times stronger than obtained from comparable "coherent Raman" instruments, and uses a much larger portion of the vibrational spectrum of interest to cell biologists
A research team from the National Institute of Standards and Technology (NIST), working with the Cleveland Clinic, has demonstrated a dramatically improved technique for analyzing biological cells and tissues based on characteristic molecular vibration "signatures." The new NIST technique is an advanced form of the widely used spontaneous Raman spectroscopy, but one that delivers signals that are 10,000 times stronger than obtained from spontaneous Raman scattering, and 100 times stronger than obtained from comparable "coherent Raman" instruments, and uses a much larger portion of the vibrational spectrum of interest to cell biologists
Source: http://www.nist.gov/
Test Spares Men Unnecessary Biopsies for Prostate Cancer
In men with previous histopathologically negative findings, the epigenetic ConfirmMDx (MDxHealth) assay for prostate cancer can lead to a 10-fold reduction in repeat biopsies, 2 new studies show. Both confirm the utility of epigenetic profiling in helping to distinguish patients who have a true negative biopsy from those at risk for occult cancer, according to the researchers. The commercially available assay assesses methylation markers of prostate cancer (GSTP1, APC, and RASSF1) to distinguish histologically benign biopsy cores from patients diagnosed with no cancer, low-volume cancer (a Gleason score of 6), or higher-volume cancer (a Gleason score of 7). One of the studies, a clinical utility field study in which the assay was tested by practicing urologists working in community settings, was published in the May issue of American Health & Drug Benefits.
In men with previous histopathologically negative findings, the epigenetic ConfirmMDx (MDxHealth) assay for prostate cancer can lead to a 10-fold reduction in repeat biopsies, 2 new studies show. Both confirm the utility of epigenetic profiling in helping to distinguish patients who have a true negative biopsy from those at risk for occult cancer, according to the researchers. The commercially available assay assesses methylation markers of prostate cancer (GSTP1, APC, and RASSF1) to distinguish histologically benign biopsy cores from patients diagnosed with no cancer, low-volume cancer (a Gleason score of 6), or higher-volume cancer (a Gleason score of 7). One of the studies, a clinical utility field study in which the assay was tested by practicing urologists working in community settings, was published in the May issue of American Health & Drug Benefits.
Source: http://www.medscape.com/
UPMC-Developed Test Increases Odds of Correct Surgery for Thyroid Cancer Patients
The routine use of a molecular testing panel developed at UPMC greatly increases the likelihood of performing the correct initial surgery for patients with thyroid nodules and cancer, report researchers from the University of Pittsburgh Cancer Institute (UPCI), partner with UPMC CancerCenter. The test, available at the UPMC/UPCI Multidisciplinary Thyroid Center and other diagnostic testing agencies, improved the chances of patients getting the correct initial surgery by 30 percent, according to the study published this month in the Annals of Surgery. "We're currently refining the panel by adding tests for more genetic mutations, thereby making it even more accurate," said co-author Yuri Nikiforov, M.D., Ph.D., professor in the Department of Pathology at Pitt and director of thyroid molecular diagnostics at the UPMC/UPCI.
The routine use of a molecular testing panel developed at UPMC greatly increases the likelihood of performing the correct initial surgery for patients with thyroid nodules and cancer, report researchers from the University of Pittsburgh Cancer Institute (UPCI), partner with UPMC CancerCenter. The test, available at the UPMC/UPCI Multidisciplinary Thyroid Center and other diagnostic testing agencies, improved the chances of patients getting the correct initial surgery by 30 percent, according to the study published this month in the Annals of Surgery. "We're currently refining the panel by adding tests for more genetic mutations, thereby making it even more accurate," said co-author Yuri Nikiforov, M.D., Ph.D., professor in the Department of Pathology at Pitt and director of thyroid molecular diagnostics at the UPMC/UPCI.
Source: http://www.upmc.com/
Missile Detector Used to Spot Malaria Signs
Technology used to detect incoming enemy missiles has been modified to alert doctors to the signs of early-stage malaria. The Focal Plane Array detector is typically used to spot anti-tank missiles and can scan an area for heat signals within seconds. A team of researchers from Australia has now combined the technology with a microscope to analyse red blood cells for traces of the malaria parasite. It does this by looking for the infrared signature of fatty acids the parasite is made up of. The system can detect the parasite in a single blood cell within just four minutes, and does not require specialist technicians which are often hard to come by in the developing world.
Technology used to detect incoming enemy missiles has been modified to alert doctors to the signs of early-stage malaria. The Focal Plane Array detector is typically used to spot anti-tank missiles and can scan an area for heat signals within seconds. A team of researchers from Australia has now combined the technology with a microscope to analyse red blood cells for traces of the malaria parasite. It does this by looking for the infrared signature of fatty acids the parasite is made up of. The system can detect the parasite in a single blood cell within just four minutes, and does not require specialist technicians which are often hard to come by in the developing world.
Source: http://news.sky.com/
Blood Test Might Help Prevent Certain Birth Defects
A simple blood test could help prevent neural tube birth defects such as spina bifida, new research finds. The test would measure the concentration of folate (a form of vitamin B) in a pregnant women's red blood cells. The findings from this study – conducted by an international team of scientists – could help doctors predict the risk of serious birth defects known as neural tube defects because folate is vital to the proper development of a growing fetus.
A simple blood test could help prevent neural tube birth defects such as spina bifida, new research finds. The test would measure the concentration of folate (a form of vitamin B) in a pregnant women's red blood cells. The findings from this study – conducted by an international team of scientists – could help doctors predict the risk of serious birth defects known as neural tube defects because folate is vital to the proper development of a growing fetus.
Source: http://consumer.healthday.com/
QIAGEN, AstraZeneca to Develop Liquid Biopsy-based Companion Diagnostic
QIAGEN announced a collaboration agreement with AstraZeneca PLC for the co-development and commercialization of a liquid biopsy-based companion diagnostic to be paired with IRESSA, AstraZeneca’s targeted therapy for non-small cell lung cancer (NSCLC). The project builds on a master framework agreement signed by both companies in 2013 and aims to develop and market a novel QIAGEN companion diagnostic that analyzes plasma samples to assess EGFR mutation status in NSCLC patients. The assay will be designed to guide the treatment of NSCLC patients with Astra Zeneca’s oral monotherapy anti-cancer treatment when tumour tissue is not available. QIAGEN already offers the therascreen EGFR RGQ PCR Kit (therascreen EGFR test) as a tissue-based companion diagnostic for lung cancer patients, which was approved in the U.S. by the FDA in July 2013. The companies will collaborate to create a new companion diagnostic for IRESSA based on liquid biopsy samples from NSCLC patients, rather than requiring invasive surgical collection of tissue samples. IRESSA is an epidermal growth factor receptor-tyrosine kinase (EGFR-TK) inhibitor that acts to block signals for cancer cell growth and survival.
QIAGEN announced a collaboration agreement with AstraZeneca PLC for the co-development and commercialization of a liquid biopsy-based companion diagnostic to be paired with IRESSA, AstraZeneca’s targeted therapy for non-small cell lung cancer (NSCLC). The project builds on a master framework agreement signed by both companies in 2013 and aims to develop and market a novel QIAGEN companion diagnostic that analyzes plasma samples to assess EGFR mutation status in NSCLC patients. The assay will be designed to guide the treatment of NSCLC patients with Astra Zeneca’s oral monotherapy anti-cancer treatment when tumour tissue is not available. QIAGEN already offers the therascreen EGFR RGQ PCR Kit (therascreen EGFR test) as a tissue-based companion diagnostic for lung cancer patients, which was approved in the U.S. by the FDA in July 2013. The companies will collaborate to create a new companion diagnostic for IRESSA based on liquid biopsy samples from NSCLC patients, rather than requiring invasive surgical collection of tissue samples. IRESSA is an epidermal growth factor receptor-tyrosine kinase (EGFR-TK) inhibitor that acts to block signals for cancer cell growth and survival.
Research Team at University of California Santa Barbara Achieves In-vivo Monitoring of Therapeutic Drugs with Technology That Pathologists Could Adapt for Clinical Diagnostic Purposes
Researchers at the University of California Santa Barbara (UCSB) are making rapid progress in designing a biosensor that can measure therapeutic levels of a prescription drug in real time within the patient. This technology has interesting implications for anatomic pathology and clinical laboratory testing. The research team has developed a small electronic device that continuously tracks the level of medicines (doxorubicin and kanamycin) in an animal’s bloodstream. For pathologists and other physicians, this wireless tool can perhaps one day be used to help transform how drugs are chosen and monitored in patients.
Researchers at the University of California Santa Barbara (UCSB) are making rapid progress in designing a biosensor that can measure therapeutic levels of a prescription drug in real time within the patient. This technology has interesting implications for anatomic pathology and clinical laboratory testing. The research team has developed a small electronic device that continuously tracks the level of medicines (doxorubicin and kanamycin) in an animal’s bloodstream. For pathologists and other physicians, this wireless tool can perhaps one day be used to help transform how drugs are chosen and monitored in patients.
Source: http://www.darkdaily.com/
Microscopic Laser Beam Promises No-needle Blood Draws
NoNeedles Venipuncture (Altamonte Springs, FL) is working on addressing the common fear of needles (called trypanophobia) with the research backing of Dr. Rodrigo Amezcua Correa, assistant professor of optics at the University of Central Florida. Needle-phobia is one of the most common fears, and drawing blood is one of the most ubiquitous medical procedures that nearly everyone faces at some point in their lives. The NoNeedles process uses a laser beam that is fired through the skin in one quadrillionth of a second to create a microscopic channel into the vein. The bloodstream is then connected to a port to collect the blood sample before a laser is fired again to seal the channel and stop the bleeding. The result is a quick, accurate and painless procedure for collecting blood. "Our design of this instrument is intended to improve the process of performing a venipuncture--such that the quality will be better and the cost will be lower," said Calvin Wiese, president of NoNeedles Venipuncture.
Source: http://www.laserfocusworld.com/NoNeedles Venipuncture (Altamonte Springs, FL) is working on addressing the common fear of needles (called trypanophobia) with the research backing of Dr. Rodrigo Amezcua Correa, assistant professor of optics at the University of Central Florida. Needle-phobia is one of the most common fears, and drawing blood is one of the most ubiquitous medical procedures that nearly everyone faces at some point in their lives. The NoNeedles process uses a laser beam that is fired through the skin in one quadrillionth of a second to create a microscopic channel into the vein. The bloodstream is then connected to a port to collect the blood sample before a laser is fired again to seal the channel and stop the bleeding. The result is a quick, accurate and painless procedure for collecting blood. "Our design of this instrument is intended to improve the process of performing a venipuncture--such that the quality will be better and the cost will be lower," said Calvin Wiese, president of NoNeedles Venipuncture.
Research and Development
Less Than 10% of Human DNA Has Functional Role, Claim Scientists
More than 90% of human DNA is doing nothing very useful, and large stretches may be no more than biological baggage that has built up over years of evolution, Oxford researchers claim. The scientists arrived at the figure after comparing the human genome with the genetic makeup of other mammals, ranging from dogs and mice to rhinos and horses. The researchers looked for sections of DNA that humans shared with the other animals, which split from our lineage at different points in history. When DNA is shared and conserved across species, it suggests that it does something valuable. Gerton Lunter, a senior scientist on the team, said that based on the comparisons, 8.2% of human DNA was "functional", meaning that it played an important enough role to be conserved by evolution. "Scientifically speaking, we have no evidence that 92% of our genome is contributing to our biology at all," Lunter told the Guardian.
More than 90% of human DNA is doing nothing very useful, and large stretches may be no more than biological baggage that has built up over years of evolution, Oxford researchers claim. The scientists arrived at the figure after comparing the human genome with the genetic makeup of other mammals, ranging from dogs and mice to rhinos and horses. The researchers looked for sections of DNA that humans shared with the other animals, which split from our lineage at different points in history. When DNA is shared and conserved across species, it suggests that it does something valuable. Gerton Lunter, a senior scientist on the team, said that based on the comparisons, 8.2% of human DNA was "functional", meaning that it played an important enough role to be conserved by evolution. "Scientifically speaking, we have no evidence that 92% of our genome is contributing to our biology at all," Lunter told the Guardian.
Source: http://www.theguardian.com/
Stem Cell Therapy Could Lead to HIV Cure
Two teams of scientists with strong ties to the Bay Area are racing to develop a stem cell therapy that would provide a practical cure for people living with HIV infection, leaving them with an immune system capable of keeping them healthy without daily medication even as some virus remains circulating in their bloodstream. Both groups of researchers are trying to capitalize on the DNA of so-called elite controllers – people who are naturally resistant to HIV due to a genetic mutation that prevents the virus from latching on to their immune cells.
Two teams of scientists with strong ties to the Bay Area are racing to develop a stem cell therapy that would provide a practical cure for people living with HIV infection, leaving them with an immune system capable of keeping them healthy without daily medication even as some virus remains circulating in their bloodstream. Both groups of researchers are trying to capitalize on the DNA of so-called elite controllers – people who are naturally resistant to HIV due to a genetic mutation that prevents the virus from latching on to their immune cells.
Source: http://www.sfgate.com/
Clearing Cells to Prevent Cervical Cancer
A study published online in the International Journal of Cancer earlier this month describes a novel approach to preventing cervical cancer based on findings showing successful reduction in the risk of cervical cancer after removal of a discrete population of cells in the cervix. The findings come from a study that looked at squamocolumnar junction cells, or SCJ cells. These cells reside in the cervical canal and have been implicated as the origins of cervical cancer. A research team co-led by Christopher Crum, MD, director, Brigham and Women's Hospital (BWH) Women's and Perinatal Pathology, demonstrated that removal of SCJ cells resulted in a markedly lower risk of cervical intraepithelial neoplasia-a non-cancerous, abnormal growth of cells on the surface of the cervix that may progress to cervical cancer.
A study published online in the International Journal of Cancer earlier this month describes a novel approach to preventing cervical cancer based on findings showing successful reduction in the risk of cervical cancer after removal of a discrete population of cells in the cervix. The findings come from a study that looked at squamocolumnar junction cells, or SCJ cells. These cells reside in the cervical canal and have been implicated as the origins of cervical cancer. A research team co-led by Christopher Crum, MD, director, Brigham and Women's Hospital (BWH) Women's and Perinatal Pathology, demonstrated that removal of SCJ cells resulted in a markedly lower risk of cervical intraepithelial neoplasia-a non-cancerous, abnormal growth of cells on the surface of the cervix that may progress to cervical cancer.
Source: http://www.brighamandwomens.org/
New Culprit Protein Linked to Cognitive Decline, Alzheimer's
Researchers have for the first time described a pathologic role for a third protein in the Alzheimer's disease process, in addition to the well-described β-amyloid and tau proteins. In a postmortem study of 340 brains from participants identified after death as having AD, a protein called TDP-43 correlated strongly with cognitive impairment during life, as well as hippocampal and cortical atrophy, independent of amyloid deposition and at lower Braak stages of AD pathology progression.
Researchers have for the first time described a pathologic role for a third protein in the Alzheimer's disease process, in addition to the well-described β-amyloid and tau proteins. In a postmortem study of 340 brains from participants identified after death as having AD, a protein called TDP-43 correlated strongly with cognitive impairment during life, as well as hippocampal and cortical atrophy, independent of amyloid deposition and at lower Braak stages of AD pathology progression.
Source: http://www.medscape.com/
High Urate? Get Moving, Study Finds
Regular exercise significantly lessened the excess mortality risk associated with elevated serum uric acid, a large Taiwanese study found. Among individuals whose serum uric acid was above 7 mg/dL, all-cause mortality risk increased by 22% (adjusted HR 1.22, 95% CI 1.15-1.29), and for those who were physically inactive, the excess risk reached 27% (HR 1.27, 95% CI 1.17-1.37), according to Chi Pang Wen, MD, of National Health Research Institutes in Zhunan, Taiwan, and colleagues. However, for those who were "fully active," that 27% increase was not only eliminated but was decreased by a further 11%, the researchers reported online in Annals of the Rheumatic Diseases.
Regular exercise significantly lessened the excess mortality risk associated with elevated serum uric acid, a large Taiwanese study found. Among individuals whose serum uric acid was above 7 mg/dL, all-cause mortality risk increased by 22% (adjusted HR 1.22, 95% CI 1.15-1.29), and for those who were physically inactive, the excess risk reached 27% (HR 1.27, 95% CI 1.17-1.37), according to Chi Pang Wen, MD, of National Health Research Institutes in Zhunan, Taiwan, and colleagues. However, for those who were "fully active," that 27% increase was not only eliminated but was decreased by a further 11%, the researchers reported online in Annals of the Rheumatic Diseases.
Source: http://www.medpagetoday.com/
New Stem Cell Operation Could Revolutionise Treatment of Knee Injuries
Surgeons have pioneered a new knee operation that could prevent the development of arthritis and extend sporting careers. The procedure, which is being trialled at Southampton general hospital, involves coating damaged cartilage with stem cells, taken from a patient's own hip, and surgical glue. Known as Abicus (autologous bone marrow implantation of cells University Hospital Southampton), the technique, if successful, will regenerate the remaining tissue and create a permanent "like-for-like" replacement for the first time.
Surgeons have pioneered a new knee operation that could prevent the development of arthritis and extend sporting careers. The procedure, which is being trialled at Southampton general hospital, involves coating damaged cartilage with stem cells, taken from a patient's own hip, and surgical glue. Known as Abicus (autologous bone marrow implantation of cells University Hospital Southampton), the technique, if successful, will regenerate the remaining tissue and create a permanent "like-for-like" replacement for the first time.
Source: http://www.theguardian.com/
Mathematical Modelling Could Pave Way for New Chlamydia Therapies
Scientists have developed a computational model to help better understand how the sexually-transmitted infection Chlamydia spreads within a patient. It is hoped that the work led by Nottingham Trent University could in future help to shed light on potential new therapies and treatments for the condition. Chlamydia is the world's most prevalent STI, with more than 100 million new cases globally every year. Disease progression is extremely complex, however, and obtaining clinical data from patients is highly invasive and impractical. This means the need to develop mathematical and computational modelling tools to improve understanding of the infection – and identify potential new therapies - is vital.
Source: http://www.ntu.ac.uk/Scientists have developed a computational model to help better understand how the sexually-transmitted infection Chlamydia spreads within a patient. It is hoped that the work led by Nottingham Trent University could in future help to shed light on potential new therapies and treatments for the condition. Chlamydia is the world's most prevalent STI, with more than 100 million new cases globally every year. Disease progression is extremely complex, however, and obtaining clinical data from patients is highly invasive and impractical. This means the need to develop mathematical and computational modelling tools to improve understanding of the infection – and identify potential new therapies - is vital.
Public Health and Patient Safety
Fist Bumps 'Cleaner Than Handshakes'
Scientists at Aberystwyth University in Wales have shown that a shake transfers more bacteria than other forms of hand-on-hand action. They are calling for the widespread adoption of the fist bump instead, especially during flu outbreaks. Public Health England whimsically suggested a Victorian-age bow or curtsy would be even safer. The researchers took a pair of sterile rubber gloves and dipped one into a bacterial-broth so the outside was completely coated in E. coli. They then performed a range of hand manoeuvres including handshakes of varying intensities, fist bumps and high-fives. The findings, published in the American Journal of Infection Control, showed a handshake transferred 10 times as many bacteria as a meeting of fists, while a palm-to-palm high-five was somewhere in-between.
Scientists at Aberystwyth University in Wales have shown that a shake transfers more bacteria than other forms of hand-on-hand action. They are calling for the widespread adoption of the fist bump instead, especially during flu outbreaks. Public Health England whimsically suggested a Victorian-age bow or curtsy would be even safer. The researchers took a pair of sterile rubber gloves and dipped one into a bacterial-broth so the outside was completely coated in E. coli. They then performed a range of hand manoeuvres including handshakes of varying intensities, fist bumps and high-fives. The findings, published in the American Journal of Infection Control, showed a handshake transferred 10 times as many bacteria as a meeting of fists, while a palm-to-palm high-five was somewhere in-between.
Source: http://www.bbc.com/
Run for Your Life? Right!
Running for even 5 to 10 minutes a day, once or twice a week, or at slow speeds was associated with substantial mortality benefits over 15 years, a prospective study showed. Runners overall had 30% and 45% lower adjusted risks of all-cause and cardiovascular disease mortality, respectively, over that period and had 3 years longer life expectancy compared with nonrunners, Duck-chul Lee, PhD, of Iowa State University in Ames, and colleagues found.
Running for even 5 to 10 minutes a day, once or twice a week, or at slow speeds was associated with substantial mortality benefits over 15 years, a prospective study showed. Runners overall had 30% and 45% lower adjusted risks of all-cause and cardiovascular disease mortality, respectively, over that period and had 3 years longer life expectancy compared with nonrunners, Duck-chul Lee, PhD, of Iowa State University in Ames, and colleagues found.
Source: http://www.medpagetoday.com/
Student Develops Filter for Clean Water Around the World
Roughly 780 million people around the world have no access to clean drinking water. According to the World Health Organization (WHO), 3.4 million people die from water-related diseases every year. ETH student Jeremy Nussbaumer set himself the goal of making a contribution to solving this problem. Working with researchers from a group led by Wendelin Stark, head of the Functional Materials Laboratory, the 23-year-old spent a year researching a membrane filter and developing a prototype. "What makes our DrinkPure filter unique is that you can screw it on to virtually any plastic bottle. It doesn't require a pump or a reservoir, so it's very easy to use," explains the student from the canton of Aargau. "You simply screw the filter onto a bottle containing polluted water, then you can put it straight in your mouth and take a drink."
Roughly 780 million people around the world have no access to clean drinking water. According to the World Health Organization (WHO), 3.4 million people die from water-related diseases every year. ETH student Jeremy Nussbaumer set himself the goal of making a contribution to solving this problem. Working with researchers from a group led by Wendelin Stark, head of the Functional Materials Laboratory, the 23-year-old spent a year researching a membrane filter and developing a prototype. "What makes our DrinkPure filter unique is that you can screw it on to virtually any plastic bottle. It doesn't require a pump or a reservoir, so it's very easy to use," explains the student from the canton of Aargau. "You simply screw the filter onto a bottle containing polluted water, then you can put it straight in your mouth and take a drink."
Source: http://www.medicalnewstoday.com/
Potential New Flu Drugs Target Immune Response, Not Virus
The seriousness of disease often results from the strength of immune response, rather than with the virus, itself. Turning down that response, rather than attacking the virus, might be a better way to reduce that severity, says Juliet Morrison of the University of Washington, Seattle. She and her collaborators have now taken the first step in doing just that for the H7N9 influenza, and their work has already led to identification of six potential therapeutics for this highly virulent strain. The research is published ahead of print in the Journal of Virology.
The seriousness of disease often results from the strength of immune response, rather than with the virus, itself. Turning down that response, rather than attacking the virus, might be a better way to reduce that severity, says Juliet Morrison of the University of Washington, Seattle. She and her collaborators have now taken the first step in doing just that for the H7N9 influenza, and their work has already led to identification of six potential therapeutics for this highly virulent strain. The research is published ahead of print in the Journal of Virology.
Source: https://www.asm.org/
GlaxoSmithKline Seeks Approval for World's First Malaria Vaccine
GlaxoSmithKline said it is applying for regulatory approval for the world's first vaccine against malaria, designed for children in Africa. The British drugmaker said the shot, called RTS,S, is intended exclusively for use outside the European Union but will be evaluated by the European Medicines Agency (EMA) in collaboration with the World Health Organisation (WHO). Malaria, a mosquito-borne parasitic disease, kills more than 600,000 people a year, mainly babies in the poorest parts of sub-Saharan Africa. Experts have long hoped that scientists would be able to develop an effective vaccine against the disease, and scientists at GSK have been working on this one for 30 years. Yet hopes that RTS,S would be the final answer to wiping out malaria were dampened when results from a final-stage trial in babies aged six to 12 weeks showed the shot provided only modest protection, reducing episodes of the disease by 30 percent compared to immunisation with a control vaccine.
GlaxoSmithKline said it is applying for regulatory approval for the world's first vaccine against malaria, designed for children in Africa. The British drugmaker said the shot, called RTS,S, is intended exclusively for use outside the European Union but will be evaluated by the European Medicines Agency (EMA) in collaboration with the World Health Organisation (WHO). Malaria, a mosquito-borne parasitic disease, kills more than 600,000 people a year, mainly babies in the poorest parts of sub-Saharan Africa. Experts have long hoped that scientists would be able to develop an effective vaccine against the disease, and scientists at GSK have been working on this one for 30 years. Yet hopes that RTS,S would be the final answer to wiping out malaria were dampened when results from a final-stage trial in babies aged six to 12 weeks showed the shot provided only modest protection, reducing episodes of the disease by 30 percent compared to immunisation with a control vaccine.
Source: http://uk.reuters.com/
C. Diff to be Treated With 'Bacteria-Eating Viruses'
The potentially fatal Clostridium difficile bacterium is a serious problem in hospitals due to its resistance to antibiotics. However, a team of scientists from the European Molecular Biology Laboratory in Hamburg, Germany, may have found a new way to treat these difficult bacteria - by using viruses to "eat" them. Viruses called bacteriophages infect only bacteria, using the bacteria's own DNA-reading machinery to duplicate themselves and destroy the bacteria's cell walls. Breaking down these walls causes the bacteria to explode, allowing the bacteriophages to burst out and find new bacteria to attack. Rob Meijers, from the European Molecular Biology Laboratory (EMBL), led the research and believes that their study could have wide-reaching implications: "Our findings will help us to engineer effective, specific bacteriophages, not just for C. diff infections, but for a wide range of bacteria related to human health, agriculture and the food industry."
The potentially fatal Clostridium difficile bacterium is a serious problem in hospitals due to its resistance to antibiotics. However, a team of scientists from the European Molecular Biology Laboratory in Hamburg, Germany, may have found a new way to treat these difficult bacteria - by using viruses to "eat" them. Viruses called bacteriophages infect only bacteria, using the bacteria's own DNA-reading machinery to duplicate themselves and destroy the bacteria's cell walls. Breaking down these walls causes the bacteria to explode, allowing the bacteriophages to burst out and find new bacteria to attack. Rob Meijers, from the European Molecular Biology Laboratory (EMBL), led the research and believes that their study could have wide-reaching implications: "Our findings will help us to engineer effective, specific bacteriophages, not just for C. diff infections, but for a wide range of bacteria related to human health, agriculture and the food industry."
Source: http://www.medicalnewstoday.com/
Time of Day Crucial to Accurately Test for Diseases, New Research Finds
A new study published in the journal PNAS (Proceedings of the National Academy of Sciences), has found that time of day and sleep deprivation have a significant effect on our metabolism. The finding could be crucial when looking at the best time of day to test for diseases such as cancer and heart disease, and for administering medicines effectively. Researchers from the University of Surrey and The Institute of Cancer Research, London, investigated the links between sleep deprivation, body clock disruption and metabolism, and discovered a clear variation in metabolism according to the time of day.
Source: http://www.healthcanal.com/A new study published in the journal PNAS (Proceedings of the National Academy of Sciences), has found that time of day and sleep deprivation have a significant effect on our metabolism. The finding could be crucial when looking at the best time of day to test for diseases such as cancer and heart disease, and for administering medicines effectively. Researchers from the University of Surrey and The Institute of Cancer Research, London, investigated the links between sleep deprivation, body clock disruption and metabolism, and discovered a clear variation in metabolism according to the time of day.
Health IT
FDA Regulation of Mobile Health Technologies
Medicine may stand at the cusp of a mobile transformation. Mobile health, or “mHealth,” is the use of portable devices such as smartphones and tablets for medical purposes, including diagnosis, treatment, or support of general health and well-being. Users can interface with mobile devices through software applications (“apps”) that typically gather input from interactive questionnaires, separate medical devices connected to the mobile device, or functionalities of the device itself, such as its camera, motion sensor, or microphone. Apps may even process these data with the use of medical algorithms or calculators to generate customized diagnoses and treatment recommendations. Mobile devices make it possible to collect more granular patient data than can be collected from devices that are typically used in hospitals or physicians' offices. The experiences of a single patient can then be measured against large data sets to provide timely recommendations about managing both acute symptoms and chronic conditions.
Medicine may stand at the cusp of a mobile transformation. Mobile health, or “mHealth,” is the use of portable devices such as smartphones and tablets for medical purposes, including diagnosis, treatment, or support of general health and well-being. Users can interface with mobile devices through software applications (“apps”) that typically gather input from interactive questionnaires, separate medical devices connected to the mobile device, or functionalities of the device itself, such as its camera, motion sensor, or microphone. Apps may even process these data with the use of medical algorithms or calculators to generate customized diagnoses and treatment recommendations. Mobile devices make it possible to collect more granular patient data than can be collected from devices that are typically used in hospitals or physicians' offices. The experiences of a single patient can then be measured against large data sets to provide timely recommendations about managing both acute symptoms and chronic conditions.
Source: https://www.nejm.org/
Innovative Data Collection System for Cancer Patients Developed to Improve Care and Outcomes
An innovative new data collection system could revolutionize the way doctors provide treatment, helping them improve outcomes and decrease side effects for cancer patients, according to research being presented at the 56th Annual Meeting of the American Association of Physicists in Medicine (AAPM). Oncospace is a data mining system designed by medical physicists that collects comprehensive information on head and neck cancer patients to provide guidance in developing high-quality patient-specific therapy. The database contains insights on more than 500 patients and continues to grow.
An innovative new data collection system could revolutionize the way doctors provide treatment, helping them improve outcomes and decrease side effects for cancer patients, according to research being presented at the 56th Annual Meeting of the American Association of Physicists in Medicine (AAPM). Oncospace is a data mining system designed by medical physicists that collects comprehensive information on head and neck cancer patients to provide guidance in developing high-quality patient-specific therapy. The database contains insights on more than 500 patients and continues to grow.
Source: http://www.medicalnewstoday.com/
Other News
Less-educated Workers Enter Healthcare
Brookings Institution finds employees without a bachelor's degree make up 61% of healthcare workforce. The recent surge in healthcare jobs favors positions requiring less education, providing a potential pathway for lower-paid workers, according to a new report from the Brookings Institution. Between 2000 and 2011, the number of workers in 10 major healthcare occupations with a lower education level than bachelor's degree increased 46 percent, outflanking the 39 percent job growth for the entire sector, according to the report. Healthcare workers without a bachelor's make up 61 percent of the total healthcare workforce, according to the Institution. The number is slightly lower specifically in metropolitan areas, at 57 percent, suggesting the metropolitan healthcare workforce is slightly more educated.
Brookings Institution finds employees without a bachelor's degree make up 61% of healthcare workforce. The recent surge in healthcare jobs favors positions requiring less education, providing a potential pathway for lower-paid workers, according to a new report from the Brookings Institution. Between 2000 and 2011, the number of workers in 10 major healthcare occupations with a lower education level than bachelor's degree increased 46 percent, outflanking the 39 percent job growth for the entire sector, according to the report. Healthcare workers without a bachelor's make up 61 percent of the total healthcare workforce, according to the Institution. The number is slightly lower specifically in metropolitan areas, at 57 percent, suggesting the metropolitan healthcare workforce is slightly more educated.
Source: http://www.fiercehealthcare.com/
Missouri Law Allows Med School Grads to Practice Prior to Residency
A bill signed into law in Missouri allows medical school graduates to practice medicine before starting their residencies, according to a KCUR report. These clinicians will be called assistant physicians. Assistant physicians will be able to practice primary care and prescribe drugs in rural or underserved areas of Missouri with the oversight of a licensed physician. The overseeing physician must be physically present with the assistant physicians for part of their tenure, according to the report. A Missouri State Medical Association supported the bill, as it should help attract medical school graduates to the state. However, the law drew ire from the American Medical Association and the Missouri Academy of Physician Assistants.
A bill signed into law in Missouri allows medical school graduates to practice medicine before starting their residencies, according to a KCUR report. These clinicians will be called assistant physicians. Assistant physicians will be able to practice primary care and prescribe drugs in rural or underserved areas of Missouri with the oversight of a licensed physician. The overseeing physician must be physically present with the assistant physicians for part of their tenure, according to the report. A Missouri State Medical Association supported the bill, as it should help attract medical school graduates to the state. However, the law drew ire from the American Medical Association and the Missouri Academy of Physician Assistants.
HIV Self-Testing Viable in Rural South Africa
Individuals living in rural South Africa were able to perform HIV-screening tests and take the necessary follow-up steps if they received a positive test result, researchers said. Nearly all of the study participants (99.1%) – most of whom did not finish high school – successfully completed the test, and 97.8% said they understood the next step in the process, reported Krista Dong, MD, of The Ragon Institute in Cambridge, Mass., and colleagues. The institute is affiliated with Massachusetts General Hospital, the Massachusetts Institute of Technology, and Harvard University.
Individuals living in rural South Africa were able to perform HIV-screening tests and take the necessary follow-up steps if they received a positive test result, researchers said. Nearly all of the study participants (99.1%) – most of whom did not finish high school – successfully completed the test, and 97.8% said they understood the next step in the process, reported Krista Dong, MD, of The Ragon Institute in Cambridge, Mass., and colleagues. The institute is affiliated with Massachusetts General Hospital, the Massachusetts Institute of Technology, and Harvard University.
Source: http://www.medpagetoday.com/
Research Reveals Hepatitis E Risk Level for Blood Donors
One in every 3,000 blood donors in England could be infected with hepatitis E, new figures suggest. Experts said that around 1,200 “blood components” containing the virus are likely to be transfused every year in England. Hepatitis E, caused by the hepatitis E virus, is very rare in the UK and generally results in a mild and short-term infection unless the infected person has a pre-existing liver disease or is pregnant.
Source: http://www.nursingtimes.net/One in every 3,000 blood donors in England could be infected with hepatitis E, new figures suggest. Experts said that around 1,200 “blood components” containing the virus are likely to be transfused every year in England. Hepatitis E, caused by the hepatitis E virus, is very rare in the UK and generally results in a mild and short-term infection unless the infected person has a pre-existing liver disease or is pregnant.
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