The Wellcome-funded diagnostic – developed by researchers at University College London (UCL) and the Western Eye Hospital – allows doctors to see individual nerve cell death in the back of the eye. Early detection means doctors can start treatment before sight loss begins. The test also has potential for early diagnosis of other degenerative neurological conditions, including Parkinson’s, Alzheimer’s and multiple sclerosis. Professor Francesca Cordeiro, at UCL Institute of Opthamology, who led the research, said: "Although detection has been improving, most patients have lost a third of vision by the time they are diagnosed. "Now, for the first time, we have been able to show individual cell death and detect the earliest signs of glaucoma. While we cannot cure the disease, our test means treatment can start before symptoms begin." Glaucoma affects 60 million people worldwide and one in ten go blind. The new technique means patients could be diagnosed up to ten years earlier than is currently possible. Bethan Hughes, Wellcome’s Strategic Development Lead for Innovation, said: "This innovation has the potential to transform lives for those who suffer loss of sight through glaucoma, and offers hope of a breakthrough in early diagnosis of other neurodegenerative diseases." Loss of sight in patients with glaucoma is caused by the death of cells in the retina at the back of the eye – apoptosis. The new technique is called DARC, which stands for detection of apoptosing retinal cells. It uses a specially developed fluorescent marker which attaches to cell proteins when it’s injected into patients. Damaged retinal cells appear as white fluorescent spots during eye examination. Initial clinical trials were carried out on a small number of glaucoma patients and compared with tests on healthy people to establish the test’s safety. DARC uses equipment that is already part of routine hospital eye examinations. The researchers hope that eventually it may be possible for opticians to do the tests. This would mean even earlier detection of the disease. Treatment for glaucoma is much more successful when it is begun in the early stages of the disease. Further studies will now be carried out into DARC and how it could be used to detect other neurodegenerative conditions where increasing numbers of nerve cells are lost as the disease progresses.
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Mellitus, LLC reported the publication of results from a prospective, investigator-initiated study conducted at Brigham and Women’s Hospital (BWH) demonstrating the potential clinical utility of glycated CD59 (GCD59) as a novel biomarker for the screening and diagnosis of gestational diabetes mellitus (GDM). The data from this study showed that a single blood test that measures plasma GCD59 at week 24-28 of gestation identified women with GDM with high sensitivity and specificity. The study was completed by a team of investigators at BWH led by Jose A. Halperin, M.D., in collaboration with researchers from Harvard T.H. Chan School of Public Health. Dr. Halperin, scientific Co-founder of Mellitus, is a physician and researcher at BWH and Associate Professor of Medicine at Harvard Medical School (HMS). Gestational Diabetes Mellitus (GDM), also known as diabetes in pregnancy, is a major cause of adverse pregnancy outcomes for both babies and mothers. Babies born from mothers with GDM tend to be large for their gestational age (LGA). Delivery of LGA babies is the main cause of the many complications associated with GDM, including pre-term birth, foetal injury, perinatal mortality and required caesarean delivery. GDM also increases the mother’s risk of preeclampsia and gestational hypertension. Because treatment of GDM mitigates the risk of complications, practice guidelines from professional organizations such as the American College of Obstetrics and Gynaecology and the American Diabetes Association recommend screening of all non-diabetic pregnant women for GDM. Approximately four million pregnant women are screened for GDM each year in the United States in accordance with these practice guidelines. Currently, the standard of care predominantly uses a two-step approach. The first step is administration of the Glucose Challenge Test (GCT); in this test, blood sugar is measured one-hour after drinking a glucose solution. If a woman has a positive GCT test, she is reflexed to having a second test, an Oral Glucose Tolerance Test (OGTT). The OGTT serves to diagnose GDM. The OGTT requires women to fast overnight prior to having a blood draw, followed by drinking a glucose solution and additional blood tests every hour for three hours. These tests are time consuming, uncomfortable for the patients and are reported to have poor reproducibility. Other tests that measure HbA1c or fructosamine are not sensitive and therefore not routinely used during prenatal care to screen and diagnose GDM. Issues associated with screening and diagnosing GDM highlight the need for an accurate, simpler and more patient-friendly test for GDM. The protein known as CD59 is an inhibitor of the complement system that is inactivated by high glucose in diabetes to form glycated CD59 (GCD59). Inactivation of CD59 decreases its protective effect and promotes complement-mediated damage that reportedly plays a role in the processes leading to complications of diabetes such as nephropathy, neuropathy and retinopathy. The study published evaluated levels of GCD59 in plasma samples from 1,000 women undergoing routine screening and diagnosis of GDM at week 24-28 of gestation at Brigham and Women’s Hospital in Boston. 500 of the samples were from women who had a normal GCT (controls) and another 500 were from women who had failed the GCT and completed a subsequent OGTT (cases). Of the cases, 127 were diagnosed with GDM. The primary objective of the study was to assess the accuracy of plasma GCD59 to predict the results of the GCT. Secondary aims were to assess the accuracy of plasma GCD59 in predicting the diagnosis of GDM by OGTT and the association of plasma GCD59 with the prevalence of LGA newborns. The study found that, compared to controls, median levels of plasma GCD59 were 8.5-fold higher in women who failed the GCT and 10-fold higher in women diagnosed with GDM. Results also demonstrated that measurement of plasma GCD59 independently discriminated cases from controls with high sensitivity and specificity, even after adjustment for covariates such as maternal age, BMI, race/ethnicity, multiplicity, gestational age and previous history of diabetes. More detailed results can be found in the Diabetes Care paper. "This is the first study to demonstrate that a single measurement of plasma GCD59 can be used as a simplified method to identify women who would have failed a GCT and are at higher risk of GDM," said Dr. Halperin. "These results indicate that measurement of this novel disease-associated biomarker may be a convenient and effective alternative to the cumbersome methods currently used to screen and diagnose GDM; the study opens the door to future multi-center studies to confirm the clinical utility of plasma GCD59 as a biomarker for detection and diagnosis of GDM."
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A highly sensitive method that can detect even the earlier stages of colorectal cancer has been developed by researchers in Japan. Shimadzu Corporation, the Kobe University Graduate School of Medicine, and the National Cancer Center in Japan have collaborated to develop a new screening method that comprehensively analyses the metabolites in our blood. Colorectal cancer is one of the most common causes of cancer death, and cases of this cancer are increasing in developed countries. In 2012, a group headed by Associate Professor YOSHIDA Masaru at Kobe University used gas chromatography-mass spectrometry (GC/MS) and clinical metabolomic analysis methods to analyse serum samples from colorectal cancer patients and healthy subjects. The group succeeded in identifying four metabolite markers that can be used to diagnose colorectal cancer and developed a highly reliable diagnostic prediction model using those markers. This model was considered to be more practical in comparison with existing tumour markers, but it lacked sensitivity and specificity when actually used as a screening method. Following this, a research team combining members from Shimadzu Corporation and Kobe University developed an analytical approach that enabled much more accurate measurement of metabolites in blood plasma. To achieve this, they used high-speed and high-sensitivity GC-MS/MS, which relies on Shimadzu’s Advanced Scanning Speed Protocol (ASSP) and Smart MRM technologies. By using this approach to analyse a large number of samples (at least 600) with known clinical data stored at the National Cancer Center, they were able to develop a high-performance screening method. After reviewing the results of comprehensive analyses of the metabolites contained in blood plasma from colorectal cancer patients and healthy subjects, they discovered eight multi-biomarkers that can be used to diagnose colorectal cancer. Based on the data for these eight metabolites, they were able to create a diagnostic prediction model for colorectal cancer that exceeded 96% for both sensitivity and specificity. They also confirmed that the sensitivity of this new model remained at high levels even with early-stage colorectal cancer patients (stage 0 and stage I).
Kobe University www.kobe-u.ac.jp/research_at_kobe_en/NEWS/news/2017_04_26_01.html
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Think of life as a house: if DNA molecules are blueprints, then messenger RNAs (mRNAs) are orders, describing the required parts (proteins) and when they should arrive. But putting in many orders doesn’t always mean you’ll get all of the parts on time — maybe there’s a delay with your vendor or delivery service. Similarly, mRNA levels alone do not dictate protein levels. Today in ACS Central Science, researchers report a method to address that issue.
David Tirrell, Kelly Burke and Katie Antilla note that in order to better understand how genes are regulated, one needs to see the mRNA when it is at the site of protein synthesis. Using fluorescence probes, the researchers designed a technique that shows mRNA when it comes in contact with giant protein synthesizing machines called ribosomes. They used this method to record the synthesis of proteins and to measure cellular responses to iron. Unlike previous methods, their tool works without the need to engineer an mRNA of interest. Tirrell notes that the method is applicable to essentially any type of RNA, and could be modified to visualize other types of interactions in the cell.
American Chemical Societywww.acs.org/content/acs/en/pressroom/newsreleases/2017/may/imaging-mrna-right-where-it-is-made-at-the-site-of-translation.html
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Cancer of the oropharynx has become increasingly common: In the United States alone, the number of newly diagnosed cases has tripled over the past three decades. About 70 percent of these tumours are caused by infection with human papillomavirus (HPV) type 16.
Tim Waterboer and his colleagues at the German Cancer Research Center (Deutsches Krebsforschungszentrum, DKFZ) in Heidelberg have now revealed that an antibody test that they developed can detect early if a person has a very high risk of developing an HPV-associated cancer of the oropharynx. The DKFZ researchers collaborated in this project with colleagues from the International Agency for Research on Cancer (IARC) and the U.S. National Cancer Institute.
The immune system responds to an infection with HPV by producing antibodies against components of the virus. HPV protein E6 is produced by chronically infected cells and plays an important role in the development of cancer. Therefore, antibodies against E6 are regarded as very valuable indicators.
In the new study, the scientists investigated blood samples from the U.S. PLCO study. For this early cancer detection study, approximately 150 000 healthy participants were recruited between 1993 and 2001 and cancers that they developed in the period under investigation were documented. The DKFZ researchers studied 198 blood samples from patients with tumours of the oropharynx. The samples had been taken when the participants entered the study, i.e., long before the onset of the disease. The control samples were from 924 PLCO participants without cancer diagnosis.
In 42.3 percent of the patients with oropharyngeal cancer, the DKFZ researchers were able to detect antibodies against HPV16 E6 in their blood samples. "This pretty much corresponds to the percentage of HPV-related cases of oropharyngeal cancer that we expected to find for that time in the American population," Tim Waterboer said. By comparison, only 0.5 percent of individuals in the control group tested positive to HPV16 E6.
Tumour tissue of some study patients was also available for study besides the blood samples. Based on the activity of viral genes in the tissue, the researchers were able to identify the tumours that had been caused by HPV. They found that only those patients tested positive to the antibodies whose cancer was in fact associated with HPV16.
If the test result for HPV16 E6 antibodies is positive once, it remains stable over many years, discovered the researchers in study participants from whom blood samples had been obtained repeatedly over a long time. In some cases, the blood samples had been taken up to 13 years prior to cancer diagnosis. "This means that a single blood sample test taken at any point of time might be sufficient for assessing a person’s risk for developing cancer of the oropharynx within the next 10 years," said Waterboer.
Nevertheless, detection of HPV16-E6 antibodies is –at least for now – not a suitable method for early cancer detection in larger population groups. "The occurrence of new cases of oropharyngeal cancer is rather low at about five cases per 100 000 inhabitants," said Waterboer, who is the study head. "That means that although the test is highly specific, very many healthy people would receive false positive results. However, in certain high-risk groups, up to ten times more people can develop the disease. HPV16 E6 antibody detection is the first ever easy-to-analyze biomarker that enables us to narrow down the circle of individuals who are at an extremely high risk of developing the cancer." The DKFZ virologists are currently examining possibilities of making the biomarker applicable in the clinic.
However, the test for antibodies against HPV16 E6 is not suitable for assessing the risk for cervical cancer and other HPV-associated cancers in genital areas. As opposed to cancer of the oropharynx, the revealing antibodies do not occur here before the cancer becomes clinically detectable.
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Scientists have discovered the genetic mutation that causes the rare skin disease, keratolytic winter erythema (KWE), or ‘Oudtshoorn skin’, in Afrikaners.
KWE causes a redness of the palms and soles with consecutive cycles of peeling of large sections of thick skin, often exacerbated during winter months. Oudtshoorn is a town in the Western Cape province of South Africa where the disorder was present in large families.
Afrikaners are Afrikaans-language speakers descended from predominantly Dutch, German and French settlers, who arrived in South Africa in the 17th and 18th centuries. Afrikaners have a high risk for several genetic disorders, the best known being familial hypercholesterolaemia (inherited high cholesterol leading to heart attacks early in life) and porphyria (sensitivity of the skin to ultra-violet exposure and adverse reactions to specific drugs).
These disorders are common because of founder mutations brought to South Africa by small groups of immigrants who settled in the Cape of Good Hope and whose descendants are now spread throughout the country. KWE is one of these less well-known founder genetic disorders.
KWE was first described as a unique and discrete skin disorder in 1977 by Wits dermatologist, Professor George Findlay. He noticed that it occurred in families and had a dominant mode of inheritance – i.e., on average, if a parent has the condition about half the children inherit it in every generation.
In addition to identifying the genetic mutation for scientific purposes, this research now enables dermatologists to make a definitive diagnosis of KWE in patients. It further enables researchers to understand similar skin disorders and is a starting point for developing possible treatments.
Researchers at the University of Notre Dame have discovered a way to make influenza visible to the naked eye, according to a new study. By engineering dye molecules to target a specific enzyme of the virus, the team was able to develop a test kit that emitted fluorescent light when illuminated with a hand-held lamp or blue laser pointer.
Scientists used test samples that mimicked that of an infected patient, and spiked the samples with the enzyme, called neuraminidase, which had been purified from flu virus. The samples emit red fluorescent light as a positive indication of the influenza virus. Blue fluorescent light signals a negative result. The same process also allowed scientists to determine which of two approved antiviral drugs would be a better treatment option for the individual patient.
While still a prototype, researchers believe that with optimization the diagnostic could be developed to be used in point of care clinics or the home environment for a rapid, easy to interpret test for the presence of influenza.
“Viral cultures are the gold standard for diagnosis of influenza but take several days to develop. By targeting an enzyme inherent to the virus and identifying its presence in a sample, we can make a rapid determination of the influenza in a patient for an efficient and immediate diagnostic that would improve patient treatment and reduce overuse of antivirals,” said Bradley Smith, Emil T. Hofman Professor of Chemistry and Biochemistry in the Department of Chemistry and Biochemistry, director of the Notre Dame Integrated Imaging Facility and co-author of the study.
Smith and his team created a new method to detect neuraminidase, which is located on the surface of the virus. Researchers began by designing a dye molecule to emit red fluorescent light when it interacts with the neuraminidase. Following validation of enzyme recognition, researchers then tested the dye with two antiviral drugs used to treat influenza — Zanamivir, also known as Relenza, and Oseltamivir, known widely as Tamiflu. The antivirals are neuraminidase inhibitors. Samples containing dye and neuraminidase were combined with each of the antivirals and illuminated. Red fluorescence indicated the enzyme was still active, meaning the antiviral failed to inhibit the virus in that patient. Blue light indicated the enzyme had been blocked, presenting an effective treatment option.
University of Notre Damenews.nd.edu/news/researchers-shed-new-light-on-influenza-detection/
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Researchers investigating a form of adult-onset diabetes that shares features with the two better-known types of diabetes have discovered genetic influences that may offer clues to more accurate diagnosis and treatment.
Latent autoimmune diabetes in adults (LADA) is informally called "type 1.5 diabetes" because like type 1 diabetes (T1D), LADA is marked by circulating autoantibodies, an indicator that an overactive immune system is damaging the body’s insulin-producing beta cells. But LADA also shares clinical features with type 2 diabetes (T2D), which tends to appear in adulthood. Also, as in T2D, LADA patients do not require insulin treatments when first diagnosed.
A study uses genetic analysis to show that LADA is closer to T1D than to T2D. "Correctly diagnosing subtypes of diabetes is important, because it affects how physicians manage a patient’s disease," said co-study leader Struan F.A. Grant, PhD, a genomics researcher at Children’s Hospital of Philadelphia (CHOP). "If patients are misdiagnosed with the wrong type of diabetes, they may not receive the most effective medication."
Grant collaborated with European scientists, led by Richard David Leslie of the University of London, U.K.; and Bernhard O. Boehm, of Ulm University Medical Center, Germany and the Lee Kong Chian School of Medicine, a joint medical school of Imperial College London and Nanyang Technological University, Singapore.
Occurring when patients cannot produce their own insulin or are unable to properly process the insulin they do produce, diabetes is usually classified into two major types. T1D, formerly called juvenile diabetes, generally presents in childhood, but may also appear first in adults. T2D, formerly called non-insulin-dependent diabetes, typically appears in adults, but has been increasing over the past several decades in children and teens. Some 90 percent or more of all patients with diabetes are diagnosed with T2D.
Grant and many other researchers have discovered dozens of genetic regions that increase diabetes risk, usually with different sets of variants associated with T1D compared to T2D. The current study, the largest-ever genetic study of LADA, sought to determine how established T1D- or T2D-associated variants operate in the context of LADA.
The study team compared DNA from 978 LADA patients, all adults from the U.K. and Germany, to a control group of 1,057 children without diabetes. Another set of control samples came from 2,820 healthy adults in the U.K. All samples were from individuals of European ancestry.
The researchers calculated genetic risk scores to measure whether LADA patients had genetic profiles more similar to those of T1D or T2D patients. They found several T1D genetic regions associated with LADA, while relatively few T2D gene regions added to the risk of LADA. The genetic risk in LADA from T1D risk alleles was lower than in childhood-onset T1D, possibly accounting for the fact that LADA appears later in life.
One variant, located in TCF7L2, which Grant and colleagues showed in 2006 to be among the strongest genetic risk factors for T2D reported to date, had no role in LADA. "Our finding that LADA is genetically closer to T1D than to T2D suggests that some proportion of patients diagnosed as adults with type 2 diabetes may actually have late-onset type 1 diabetes," said Grant.
Grant said that larger studies are needed to further uncover genetic influences in the complex biology of diabetes, adding, "As we continue to integrate genetic findings with clinical characteristics, we may be able to more accurately classify diabetes subtypes to match patients with more effective treatments."
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Siemens Healthineers has recently been commissioned to take over the clinical laboratory service operations for two new hospitals in Turkey built and operated as Public Private Partnership (PPP) of DiA Holding and Turkish Ministry of Health. The five-year contract grants a minimum of close to 30 million Euros in revenues. The amount is based on a guaranteed annual test volume, and is expected to reach up to over 100 million Euros revenue based on the anticipated test volumes. Siemens Healthineers will assume the laboratory services for all medical laboratory disciplines (Biochemistry, Microbiology, Hematology, Immunology, Emergency, Genetics, Pathology and Point of Care testing) within these hospitals. Siemens Healthineers also will provide the design, medical and technical equipment, appliances, consumables, service and maintenance, in addition to laboratory technical staff. “This project combines our expertise in equipping laboratories with our service portfolio. It is a proof point for how we enable our customers to meet their current challenges and to excel in their respective environments. The new business model is designed to support our customers in increasing efficiency and containing costs right from the beginning,” said Bernd Montag, Chief Executive Officer, Siemens Healthineers. This order will strengthen our portfolio and is consistent with our strategy.” Siemens Healthineers will operate the laboratories at the hospitals in Bilkent, Ankara, and in Mersin in partnership with lab doctors from Turkey’s Ministry of Health. Both hospitals are being built by DiA Construction, a subsidiary of DiA, for the Turkish Ministry of Health as a public-private partnership. The new hospitals are intended to improve healthcare as part of a Turkish government programme to restructure the country’s healthcare system, which was initiated in 2003. It is expected that around 92 million patients will benefit from the partnership over the next five years”. According to the Turkish government, the Bilkent health campus — with almost 3,800 beds and an affiliated hotel, congress centre and commercial area — is the largest project in the healthcare sector ever constructed from scratch in the country. Beginning in mid-2018, more than 10,000 medical staff will be responsible for nearly 25,000 patients there on a daily basis. The new hospital in Mersin will hold about 1,300 beds and has become operational at the end of January 2017.
www.siemens.com/healthineers
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EKF Diagnostics, the global in vitro diagnostics company, announces that it is expanding the distribution of its Procalcitonin LiquiColor Test into Eastern Europe, Middle East and APAC regions. Procalcitonin (PCT) is a marker for bacterial infection and sepsis, a condition that has grown in awareness in recent years. PCT is now widely recognized as an important adjunct marker in sepsis diagnosis which aids in the differentiation between viral and bacterial infections. Sepsis can quickly develop into severe sepsis and septic shock – conditions associated with signs of end-stage organ damage and hypotension. At this stage, risk of death is high and increases drastically the longer the initiation of treatment is delayed. However, if a patient receives antimicrobial therapy within the first hour of diagnosis, their chances of survival are close to 80%. This short window is therefore often referred to as ’the golden hour.’ EKF’s Stanbio Chemistry PCT assay can be used in conjunction with other tests, to rapidly assess initial severity of sepsis within the golden hour. As it provides quantitative results within ten minutes, it helps physicians to monitor treatment and track improvements over time. The test is CE-marked and will shortly receive FDA approval. It is an open-channel immunoturbidimetric assay that can run with multiple sample types, providing a cost effective solution for many hospital laboratories. “We have started to see significant interest in Asia Pacific for PCT. Here we are working closely with three major distributors covering the Philippines, Indonesia and Vietnam to introduce PCT into hospitals,” said Trevor McCarthy, EKF’s Sales Manager. “As awareness about the severity of sepsis and the importance of early detection grows, we anticipate more and more interest globally in this product. FDA approval will help us build our brand, both in the Asian market and further afield.”
www.ekfdiagnostics.com
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New eye test detects earliest signs of glaucoma
, /in E-News /by 3wmediaThe Wellcome-funded diagnostic – developed by researchers at University College London (UCL) and the Western Eye Hospital – allows doctors to see individual nerve cell death in the back of the eye.
Early detection means doctors can start treatment before sight loss begins. The test also has potential for early diagnosis of other degenerative neurological conditions, including Parkinson’s, Alzheimer’s and multiple sclerosis.
Professor Francesca Cordeiro, at UCL Institute of Opthamology, who led the research, said: "Although detection has been improving, most patients have lost a third of vision by the time they are diagnosed.
"Now, for the first time, we have been able to show individual cell death and detect the earliest signs of glaucoma. While we cannot cure the disease, our test means treatment can start before symptoms begin."
Glaucoma affects 60 million people worldwide and one in ten go blind.
The new technique means patients could be diagnosed up to ten years earlier than is currently possible.
Bethan Hughes, Wellcome’s Strategic Development Lead for Innovation, said: "This innovation has the potential to transform lives for those who suffer loss of sight through glaucoma, and offers hope of a breakthrough in early diagnosis of other neurodegenerative diseases."
Loss of sight in patients with glaucoma is caused by the death of cells in the retina at the back of the eye – apoptosis.
The new technique is called DARC, which stands for detection of apoptosing retinal cells.
It uses a specially developed fluorescent marker which attaches to cell proteins when it’s injected into patients. Damaged retinal cells appear as white fluorescent spots during eye examination.
Initial clinical trials were carried out on a small number of glaucoma patients and compared with tests on healthy people to establish the test’s safety.
DARC uses equipment that is already part of routine hospital eye examinations.
The researchers hope that eventually it may be possible for opticians to do the tests. This would mean even earlier detection of the disease.
Treatment for glaucoma is much more successful when it is begun in the early stages of the disease.
Further studies will now be carried out into DARC and how it could be used to detect other neurodegenerative conditions where increasing numbers of nerve cells are lost as the disease progresses.
Wellcome Trust
wellcome.ac.uk/news/new-eye-test-detects-earliest-signs-glaucoma
Study supporting glycated CD59 as a novel alternative for gestational diabetes screening
, /in E-News /by 3wmediaMellitus, LLC reported the publication of results from a prospective, investigator-initiated study conducted at Brigham and Women’s Hospital (BWH) demonstrating the potential clinical utility of glycated CD59 (GCD59) as a novel biomarker for the screening and diagnosis of gestational diabetes mellitus (GDM). The data from this study showed that a single blood test that measures plasma GCD59 at week 24-28 of gestation identified women with GDM with high sensitivity and specificity. The study was completed by a team of investigators at BWH led by Jose A. Halperin, M.D., in collaboration with researchers from Harvard T.H. Chan School of Public Health. Dr. Halperin, scientific Co-founder of Mellitus, is a physician and researcher at BWH and Associate Professor of Medicine at Harvard Medical School (HMS).
Gestational Diabetes Mellitus (GDM), also known as diabetes in pregnancy, is a major cause of adverse pregnancy outcomes for both babies and mothers. Babies born from mothers with GDM tend to be large for their gestational age (LGA). Delivery of LGA babies is the main cause of the many complications associated with GDM, including pre-term birth, foetal injury, perinatal mortality and required caesarean delivery. GDM also increases the mother’s risk of preeclampsia and gestational hypertension.
Because treatment of GDM mitigates the risk of complications, practice guidelines from professional organizations such as the American College of Obstetrics and Gynaecology and the American Diabetes Association recommend screening of all non-diabetic pregnant women for GDM. Approximately four million pregnant women are screened for GDM each year in the United States in accordance with these practice guidelines. Currently, the standard of care predominantly uses a two-step approach. The first step is administration of the Glucose Challenge Test (GCT); in this test, blood sugar is measured one-hour after drinking a glucose solution. If a woman has a positive GCT test, she is reflexed to having a second test, an Oral Glucose Tolerance Test (OGTT). The OGTT serves to diagnose GDM. The OGTT requires women to fast overnight prior to having a blood draw, followed by drinking a glucose solution and additional blood tests every hour for three hours. These tests are time consuming, uncomfortable for the patients and are reported to have poor reproducibility. Other tests that measure HbA1c or fructosamine are not sensitive and therefore not routinely used during prenatal care to screen and diagnose GDM. Issues associated with screening and diagnosing GDM highlight the need for an accurate, simpler and more patient-friendly test for GDM.
The protein known as CD59 is an inhibitor of the complement system that is inactivated by high glucose in diabetes to form glycated CD59 (GCD59). Inactivation of CD59 decreases its protective effect and promotes complement-mediated damage that reportedly plays a role in the processes leading to complications of diabetes such as nephropathy, neuropathy and retinopathy.
The study published evaluated levels of GCD59 in plasma samples from 1,000 women undergoing routine screening and diagnosis of GDM at week 24-28 of gestation at Brigham and Women’s Hospital in Boston. 500 of the samples were from women who had a normal GCT (controls) and another 500 were from women who had failed the GCT and completed a subsequent OGTT (cases). Of the cases, 127 were diagnosed with GDM. The primary objective of the study was to assess the accuracy of plasma GCD59 to predict the results of the GCT. Secondary aims were to assess the accuracy of plasma GCD59 in predicting the diagnosis of GDM by OGTT and the association of plasma GCD59 with the prevalence of LGA newborns.
The study found that, compared to controls, median levels of plasma GCD59 were 8.5-fold higher in women who failed the GCT and 10-fold higher in women diagnosed with GDM. Results also demonstrated that measurement of plasma GCD59 independently discriminated cases from controls with high sensitivity and specificity, even after adjustment for covariates such as maternal age, BMI, race/ethnicity, multiplicity, gestational age and previous history of diabetes. More detailed results can be found in the Diabetes Care paper.
"This is the first study to demonstrate that a single measurement of plasma GCD59 can be used as a simplified method to identify women who would have failed a GCT and are at higher risk of GDM," said Dr. Halperin. "These results indicate that measurement of this novel disease-associated biomarker may be a convenient and effective alternative to the cumbersome methods currently used to screen and diagnose GDM; the study opens the door to future multi-center studies to confirm the clinical utility of plasma GCD59 as a biomarker for detection and diagnosis of GDM."
EurekAlert
www.eurekalert.org/pub_releases/2017-04/mbci-ssg042517.php
New method for early screening of colorectal cancer
, /in E-News /by 3wmediaA highly sensitive method that can detect even the earlier stages of colorectal cancer has been developed by researchers in Japan. Shimadzu Corporation, the Kobe University Graduate School of Medicine, and the National Cancer Center in Japan have collaborated to develop a new screening method that comprehensively analyses the metabolites in our blood.
Colorectal cancer is one of the most common causes of cancer death, and cases of this cancer are increasing in developed countries. In 2012, a group headed by Associate Professor YOSHIDA Masaru at Kobe University used gas chromatography-mass spectrometry (GC/MS) and clinical metabolomic analysis methods to analyse serum samples from colorectal cancer patients and healthy subjects. The group succeeded in identifying four metabolite markers that can be used to diagnose colorectal cancer and developed a highly reliable diagnostic prediction model using those markers. This model was considered to be more practical in comparison with existing tumour markers, but it lacked sensitivity and specificity when actually used as a screening method.
Following this, a research team combining members from Shimadzu Corporation and Kobe University developed an analytical approach that enabled much more accurate measurement of metabolites in blood plasma. To achieve this, they used high-speed and high-sensitivity GC-MS/MS, which relies on Shimadzu’s Advanced Scanning Speed Protocol (ASSP) and Smart MRM technologies.
By using this approach to analyse a large number of samples (at least 600) with known clinical data stored at the National Cancer Center, they were able to develop a high-performance screening method. After reviewing the results of comprehensive analyses of the metabolites contained in blood plasma from colorectal cancer patients and healthy subjects, they discovered eight multi-biomarkers that can be used to diagnose colorectal cancer.
Based on the data for these eight metabolites, they were able to create a diagnostic prediction model for colorectal cancer that exceeded 96% for both sensitivity and specificity. They also confirmed that the sensitivity of this new model remained at high levels even with early-stage colorectal cancer patients (stage 0 and stage I).
Kobe University
www.kobe-u.ac.jp/research_at_kobe_en/NEWS/news/2017_04_26_01.html
Imaging mRNA right where it is made — at the site of translation
, /in E-News /by 3wmediaThink of life as a house: if DNA molecules are blueprints, then messenger RNAs (mRNAs) are orders, describing the required parts (proteins) and when they should arrive. But putting in many orders doesn’t always mean you’ll get all of the parts on time — maybe there’s a delay with your vendor or delivery service. Similarly, mRNA levels alone do not dictate protein levels. Today in ACS Central Science, researchers report a method to address that issue.
David Tirrell, Kelly Burke and Katie Antilla note that in order to better understand how genes are regulated, one needs to see the mRNA when it is at the site of protein synthesis. Using fluorescence probes, the researchers designed a technique that shows mRNA when it comes in contact with giant protein synthesizing machines called ribosomes. They used this method to record the synthesis of proteins and to measure cellular responses to iron. Unlike previous methods, their tool works without the need to engineer an mRNA of interest. Tirrell notes that the method is applicable to essentially any type of RNA, and could be modified to visualize other types of interactions in the cell.
American Chemical Societywww.acs.org/content/acs/en/pressroom/newsreleases/2017/may/imaging-mrna-right-where-it-is-made-at-the-site-of-translation.html
A biomarker for cancer of the oropharynx
, /in E-News /by 3wmediaCancer of the oropharynx has become increasingly common: In the United States alone, the number of newly diagnosed cases has tripled over the past three decades. About 70 percent of these tumours are caused by infection with human papillomavirus (HPV) type 16.
Tim Waterboer and his colleagues at the German Cancer Research Center (Deutsches Krebsforschungszentrum, DKFZ) in Heidelberg have now revealed that an antibody test that they developed can detect early if a person has a very high risk of developing an HPV-associated cancer of the oropharynx. The DKFZ researchers collaborated in this project with colleagues from the International Agency for Research on Cancer (IARC) and the U.S. National Cancer Institute.
The immune system responds to an infection with HPV by producing antibodies against components of the virus. HPV protein E6 is produced by chronically infected cells and plays an important role in the development of cancer. Therefore, antibodies against E6 are regarded as very valuable indicators.
In the new study, the scientists investigated blood samples from the U.S. PLCO study. For this early cancer detection study, approximately 150 000 healthy participants were recruited between 1993 and 2001 and cancers that they developed in the period under investigation were documented. The DKFZ researchers studied 198 blood samples from patients with tumours of the oropharynx. The samples had been taken when the participants entered the study, i.e., long before the onset of the disease. The control samples were from 924 PLCO participants without cancer diagnosis.
In 42.3 percent of the patients with oropharyngeal cancer, the DKFZ researchers were able to detect antibodies against HPV16 E6 in their blood samples. "This pretty much corresponds to the percentage of HPV-related cases of oropharyngeal cancer that we expected to find for that time in the American population," Tim Waterboer said. By comparison, only 0.5 percent of individuals in the control group tested positive to HPV16 E6.
Tumour tissue of some study patients was also available for study besides the blood samples. Based on the activity of viral genes in the tissue, the researchers were able to identify the tumours that had been caused by HPV. They found that only those patients tested positive to the antibodies whose cancer was in fact associated with HPV16.
If the test result for HPV16 E6 antibodies is positive once, it remains stable over many years, discovered the researchers in study participants from whom blood samples had been obtained repeatedly over a long time. In some cases, the blood samples had been taken up to 13 years prior to cancer diagnosis. "This means that a single blood sample test taken at any point of time might be sufficient for assessing a person’s risk for developing cancer of the oropharynx within the next 10 years," said Waterboer.
Nevertheless, detection of HPV16-E6 antibodies is –at least for now – not a suitable method for early cancer detection in larger population groups. "The occurrence of new cases of oropharyngeal cancer is rather low at about five cases per 100 000 inhabitants," said Waterboer, who is the study head. "That means that although the test is highly specific, very many healthy people would receive false positive results. However, in certain high-risk groups, up to ten times more people can develop the disease. HPV16 E6 antibody detection is the first ever easy-to-analyze biomarker that enables us to narrow down the circle of individuals who are at an extremely high risk of developing the cancer." The DKFZ virologists are currently examining possibilities of making the biomarker applicable in the clinic.
However, the test for antibodies against HPV16 E6 is not suitable for assessing the risk for cervical cancer and other HPV-associated cancers in genital areas. As opposed to cancer of the oropharynx, the revealing antibodies do not occur here before the cancer becomes clinically detectable.
DKFZwww.dkfz.de/en/presse/pressemitteilungen/2017/dkfz-pm-17-19-A-biomarker-for-cancer-of-the-oropharynx.php
Genetic mutation responsible for rare skin disease in Afrikaners
, /in E-News /by 3wmediaScientists have discovered the genetic mutation that causes the rare skin disease, keratolytic winter erythema (KWE), or ‘Oudtshoorn skin’, in Afrikaners.
KWE causes a redness of the palms and soles with consecutive cycles of peeling of large sections of thick skin, often exacerbated during winter months. Oudtshoorn is a town in the Western Cape province of South Africa where the disorder was present in large families.
Afrikaners are Afrikaans-language speakers descended from predominantly Dutch, German and French settlers, who arrived in South Africa in the 17th and 18th centuries. Afrikaners have a high risk for several genetic disorders, the best known being familial hypercholesterolaemia (inherited high cholesterol leading to heart attacks early in life) and porphyria (sensitivity of the skin to ultra-violet exposure and adverse reactions to specific drugs).
These disorders are common because of founder mutations brought to South Africa by small groups of immigrants who settled in the Cape of Good Hope and whose descendants are now spread throughout the country. KWE is one of these less well-known founder genetic disorders.
KWE was first described as a unique and discrete skin disorder in 1977 by Wits dermatologist, Professor George Findlay. He noticed that it occurred in families and had a dominant mode of inheritance – i.e., on average, if a parent has the condition about half the children inherit it in every generation.
In addition to identifying the genetic mutation for scientific purposes, this research now enables dermatologists to make a definitive diagnosis of KWE in patients. It further enables researchers to understand similar skin disorders and is a starting point for developing possible treatments.
Wits Universitywww.wits.ac.za/news/latest-news/research-news/2017/2017-05/scientists-find-genetic-mutation-responsible-for-rare-skin-disease-in-afrikaners.html
Researchers shed new light on influenza detection
, /in E-News /by 3wmediaResearchers at the University of Notre Dame have discovered a way to make influenza visible to the naked eye, according to a new study. By engineering dye molecules to target a specific enzyme of the virus, the team was able to develop a test kit that emitted fluorescent light when illuminated with a hand-held lamp or blue laser pointer.
Scientists used test samples that mimicked that of an infected patient, and spiked the samples with the enzyme, called neuraminidase, which had been purified from flu virus. The samples emit red fluorescent light as a positive indication of the influenza virus. Blue fluorescent light signals a negative result. The same process also allowed scientists to determine which of two approved antiviral drugs would be a better treatment option for the individual patient.
While still a prototype, researchers believe that with optimization the diagnostic could be developed to be used in point of care clinics or the home environment for a rapid, easy to interpret test for the presence of influenza.
“Viral cultures are the gold standard for diagnosis of influenza but take several days to develop. By targeting an enzyme inherent to the virus and identifying its presence in a sample, we can make a rapid determination of the influenza in a patient for an efficient and immediate diagnostic that would improve patient treatment and reduce overuse of antivirals,” said Bradley Smith, Emil T. Hofman Professor of Chemistry and Biochemistry in the Department of Chemistry and Biochemistry, director of the Notre Dame Integrated Imaging Facility and co-author of the study.
Smith and his team created a new method to detect neuraminidase, which is located on the surface of the virus. Researchers began by designing a dye molecule to emit red fluorescent light when it interacts with the neuraminidase. Following validation of enzyme recognition, researchers then tested the dye with two antiviral drugs used to treat influenza — Zanamivir, also known as Relenza, and Oseltamivir, known widely as Tamiflu. The antivirals are neuraminidase inhibitors. Samples containing dye and neuraminidase were combined with each of the antivirals and illuminated. Red fluorescence indicated the enzyme was still active, meaning the antiviral failed to inhibit the virus in that patient. Blue light indicated the enzyme had been blocked, presenting an effective treatment option.
University of Notre Damenews.nd.edu/news/researchers-shed-new-light-on-influenza-detection/
Genetic findings in ‘type 1.5’ diabetes may shed light on better diagnosis, treatment
, /in E-News /by 3wmediaResearchers investigating a form of adult-onset diabetes that shares features with the two better-known types of diabetes have discovered genetic influences that may offer clues to more accurate diagnosis and treatment.
Latent autoimmune diabetes in adults (LADA) is informally called "type 1.5 diabetes" because like type 1 diabetes (T1D), LADA is marked by circulating autoantibodies, an indicator that an overactive immune system is damaging the body’s insulin-producing beta cells. But LADA also shares clinical features with type 2 diabetes (T2D), which tends to appear in adulthood. Also, as in T2D, LADA patients do not require insulin treatments when first diagnosed.
A study uses genetic analysis to show that LADA is closer to T1D than to T2D. "Correctly diagnosing subtypes of diabetes is important, because it affects how physicians manage a patient’s disease," said co-study leader Struan F.A. Grant, PhD, a genomics researcher at Children’s Hospital of Philadelphia (CHOP). "If patients are misdiagnosed with the wrong type of diabetes, they may not receive the most effective medication."
Grant collaborated with European scientists, led by Richard David Leslie of the University of London, U.K.; and Bernhard O. Boehm, of Ulm University Medical Center, Germany and the Lee Kong Chian School of Medicine, a joint medical school of Imperial College London and Nanyang Technological University, Singapore.
Occurring when patients cannot produce their own insulin or are unable to properly process the insulin they do produce, diabetes is usually classified into two major types. T1D, formerly called juvenile diabetes, generally presents in childhood, but may also appear first in adults. T2D, formerly called non-insulin-dependent diabetes, typically appears in adults, but has been increasing over the past several decades in children and teens. Some 90 percent or more of all patients with diabetes are diagnosed with T2D.
Grant and many other researchers have discovered dozens of genetic regions that increase diabetes risk, usually with different sets of variants associated with T1D compared to T2D. The current study, the largest-ever genetic study of LADA, sought to determine how established T1D- or T2D-associated variants operate in the context of LADA.
The study team compared DNA from 978 LADA patients, all adults from the U.K. and Germany, to a control group of 1,057 children without diabetes. Another set of control samples came from 2,820 healthy adults in the U.K. All samples were from individuals of European ancestry.
The researchers calculated genetic risk scores to measure whether LADA patients had genetic profiles more similar to those of T1D or T2D patients. They found several T1D genetic regions associated with LADA, while relatively few T2D gene regions added to the risk of LADA. The genetic risk in LADA from T1D risk alleles was lower than in childhood-onset T1D, possibly accounting for the fact that LADA appears later in life.
One variant, located in TCF7L2, which Grant and colleagues showed in 2006 to be among the strongest genetic risk factors for T2D reported to date, had no role in LADA. "Our finding that LADA is genetically closer to T1D than to T2D suggests that some proportion of patients diagnosed as adults with type 2 diabetes may actually have late-onset type 1 diabetes," said Grant.
Grant said that larger studies are needed to further uncover genetic influences in the complex biology of diabetes, adding, "As we continue to integrate genetic findings with clinical characteristics, we may be able to more accurately classify diabetes subtypes to match patients with more effective treatments."
EurekAlertwww.eurekalert.org/pub_releases/2017-05/chop-gfi050417.php
Laboratory services worth up to 100 million Euros for hospitals in Turkey
, /in E-News /by 3wmediaSiemens Healthineers has recently been commissioned to take over the clinical laboratory service operations for two new hospitals in Turkey built and operated as Public Private Partnership (PPP) of DiA Holding and Turkish Ministry of Health. The five-year contract grants a minimum of close to 30 million Euros in revenues. The amount is based on a guaranteed annual test volume, and is expected to reach up to over 100 million Euros revenue based on the anticipated test volumes. Siemens Healthineers will assume the laboratory services for all medical laboratory disciplines (Biochemistry, Microbiology, Hematology, Immunology, Emergency, Genetics, Pathology and Point of Care testing) within these hospitals. Siemens Healthineers also will provide the design, medical and technical equipment, appliances, consumables, service and maintenance, in addition to laboratory technical staff. “This project combines our expertise in equipping laboratories with our service portfolio. It is a proof point for how we enable our customers to meet their current challenges and to excel in their respective environments. The new business model is designed to support our customers in increasing efficiency and containing costs right from the beginning,” said Bernd Montag, Chief Executive Officer, Siemens Healthineers. This order will strengthen our portfolio and is consistent with our strategy.”
Siemens Healthineers will operate the laboratories at the hospitals in Bilkent, Ankara, and in Mersin in partnership with lab doctors from Turkey’s Ministry of Health. Both hospitals are being built by DiA Construction, a subsidiary of DiA, for the Turkish Ministry of Health as a public-private partnership. The new hospitals are intended to improve healthcare as part of a Turkish government programme to restructure the country’s healthcare system, which was initiated in 2003. It is expected that around 92 million patients will benefit from the partnership over the next five years”.
According to the Turkish government, the Bilkent health campus — with almost 3,800 beds and an affiliated hotel, congress centre and commercial area — is the largest project in the healthcare sector ever constructed from scratch in the country. Beginning in mid-2018, more than 10,000 medical staff will be responsible for nearly 25,000 patients there on a daily basis. The new hospital in Mersin will hold about 1,300 beds and has become operational at the end of January 2017.
www.siemens.com/healthineers
EKF expands geographical reach of PCT test for early sepsis detection
, /in E-News /by 3wmediaEKF Diagnostics, the global in vitro diagnostics company, announces that it is expanding the distribution of its Procalcitonin LiquiColor Test into Eastern Europe, Middle East and APAC regions. Procalcitonin (PCT) is a marker for bacterial infection and sepsis, a condition that has grown in awareness in recent years. PCT is now widely recognized as an important adjunct marker in sepsis diagnosis which aids in the differentiation between viral and bacterial infections. Sepsis can quickly develop into severe sepsis and septic shock – conditions associated with signs of end-stage organ damage and hypotension. At this stage, risk of death is high and increases drastically the longer the initiation of treatment is delayed. However, if a patient receives antimicrobial therapy within the first hour of diagnosis, their chances of survival are close to 80%. This short window is therefore often referred to as ’the golden hour.’ EKF’s Stanbio Chemistry PCT assay can be used in conjunction with other tests, to rapidly assess initial severity of sepsis within the golden hour. As it provides quantitative results within ten minutes, it helps physicians to monitor treatment and track improvements over time. The test is CE-marked and will shortly receive FDA approval. It is an open-channel immunoturbidimetric assay that can run with multiple sample types, providing a cost effective solution for many hospital laboratories. “We have started to see significant interest in Asia Pacific for PCT. Here we are working closely with three major distributors covering the Philippines, Indonesia and Vietnam to introduce PCT into hospitals,” said Trevor McCarthy, EKF’s Sales Manager. “As awareness about the severity of sepsis and the importance of early detection grows, we anticipate more and more interest globally in this product. FDA approval will help us build our brand, both in the Asian market and further afield.”
www.ekfdiagnostics.com