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Xpert MTB/RIF diagnostic test rollout could reduce TB incidence in India

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A new study suggests that the Xpert MTB/RIF, a recently implemented tuberculosis (TB) test, would be effective in helping control the TB epidemic in India. However, the mathematical model described in the study of tuberculosis transmission, care-seeking behaviour, and diagnostic/treatment practices shows that such improvements would depend on a major overhaul of the implementation strategy currently in place for TB diagnosis and treatment, involving both the public and private sectors. The study is published today in the journal PLoS Medicine, from researchers in the USA, India and Canada, led by Dr David Dowdy of Johns Hopkins University.

Tuberculosis (TB) remains a significant health problem internationally, causing 1.4 million deaths per year. Over one quarter of these occur in India, prompting the country to announce a goal of universal access to quality TB diagnosis and treatment. This goal is complicated by the complex health care system in India, with many people depending on private providers with no formal medical training or with some training in allopathic or non-allopathic training. While a Revised National Tuberculosis Control Programme (RNTCP) has made progress over the last 15 years in improving TB control in the public sector, many people turn to the public sector only as a last resort. There is a need to extend the current narrow implementation strategy to include the private sector and improve referral networks between the private and public sectors. In this context, combined with improved funding, the Xpert MTB/RIF, a recently implemented tuberculosis (TB) test, has the potential to control the TB epidemic in India.

Xpert MTB/RIF is a new TB diagnostic test with improved sensitivity compared to other currently used diagnostic tests, including the sputum smear microscopy test commonly used in the public sector in India and the even lower-performing tests used in the private sector, such as antibody or interferon-gamma release assays. It is a molecular test that uses semi-automated PCR to detect mycobacterial DNA. It has the added advantage of being able to detect resistance to the most effective TB antibiotic rifampicin, due to inclusion of specific primers. However, the cost of Xpert MTB/RIF is substantial and resource constraints currently dictate that the RNTCP is implementing this test chiefly as a rapid drug susceptibility testing method in vulnerable adults and children with HIV or at high risk of multi-drug resistant TB, rather than as a rapid and sensitive diagnostic test for TB.

In the current study, the research team constructed a mathematical model of tuberculosis transmission, care-seeking behaviour and diagnostic/treatment practices in India to predict the impact on TB incidence if six different rollout strategies were to be implemented. The most effective predicted scenario envisaged adding Xpert MTB/RIF access for 20% of all individuals with TB symptoms seeking diagnosis in the public sector and 20% of individuals seeking care from qualified private practitioners. Compared to the current implementation strategy, this scenario would be predicted to reduce TB incidence by 14.1%. However, it would entail substantial cost as it would require more than 2,200 Xpert machines and reliable treatment referral. It is worth noting that a scenario envisaging encouragement of informal private providers to refer suspected TB cases to the public sector for diagnosis using currently available tests predicted a greater impact on TB incidence than if the Xpert system were scaled up only within the public sector.

While the authors acknowledge that their findings must be interpreted in the light of uncertainties in the assumptions made in the model, they are confident that: “Xpert [MTB/RIF] ... could substantially reduce the burden of TB disease due to poor diagnosis in India; however, this impact depends not only on the accuracy of the test, but also on the behavior of both patients and providers, their level of access to new tools, and quality TB treatment following diagnosis.”
The authors conclude: “any Xpert [MTB/RIF] rollout strategy must also consider the complex health-care infrastructure into which the test is being rolled out. To achieve maximum impact of novel diagnostics, India should engage the private sector, improve quality of care across all sectors, and dramatically increase resources.”

Sources

Salje H, Andrews JR, Deo S, Satyanarayana S, Sun AY, et al. (2014) The Importance of Implementation Strategy in Scaling Up Xpert MTB/RIF for Diagnosis of Tuberculosis in the Indian Health-Care System: A Transmission Model. PLoS Med 11(7): e1001674. doi:10.1371/journal.pmed.1001674;
http://www.plosmedicine.org/article/info...ed.1001674

News source: PLoS Medicine

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Genetic basis of schizophrenia: new insights

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A new study sheds new light on the genetic underpinnings of schizophrenia. The study, from the international, multi-institution Schizophrenia Working Group of the Psychiatric Genomics Consortium (PGC) is published today in the journal Nature. It involved a genome-wide association study (GWAS) on 36,989 schizophrenia cases and 113,075 controls. This represents the largest GWAS to date in any psychiatric illness. 128 independent associations were identified over 108 specific locations of the human genome associated with schizophrenia risk; 83 of these had not been previously reported in schizophrenia risk.

Schizophrenia is a heritable disorder present in about 1:100 of the population. It features hallucinations, delusions, and disordered thinking and exacts an enormous human and financial cost. Current therapies mainly tackle the psychosis element; there are no effective treatments for the cognitive elements of the disease. Recent research suggests that the genetic basis of schizophrenia is highly complex, involving interaction of many genes. The current study, using a total of 55 datasets from more than 40 different contributors, confirmed and built on this knowledge as a result of years of work from the Schizophrenia Working Group of the Psychiatric Genomics Consortium. One of the contributors, Dr Jo Knight of Canada's Centre for Addiction and Mental Health (CAMH) explains: "Large collaborative efforts such as this one are needed to identify genes that influence complex disorders…The result is a major advance in understanding the genetic basis of brain functioning in schizophrenia."

The study identified the importance of genes expressed in brain tissue, particularly those related to neuron functioning and of signalling via synapses. They included genes implicated in control of synaptic plasticity, which is crucial in learning and memory, and pathways in the cells receiving the signal. A smaller number of immune system genes were also identified, supporting hypotheses concerning links between schizophrenia and immunity. While many of these findings point to new insights into the aetiology of schizophrenia, associations at the dopamine receptor DRD2 and many genes associated with glutamatergic neurotransmission point to molecules already known to have potential therapeutic relevance to schizophrenia.

Senior author Dr Michael O’Donovan of the MRC Centre for Neuropsychiatric Genetics and Genomics at Cardiff University School of Medicine concludes: "The fact that we were able to detect genetic risk factors on this massive scale shows that schizophrenia can be tackled by the same approaches that have already transformed our understanding of other diseases…The wealth of new findings has the potential to kick-start the development of new treatments in schizophrenia, a process which has stalled for the last 60 years."

Sources

Schizophrenia Working Group of the Psychiatric Genomics Consortium. Biological insights from 108 schizophrenia-associated genetic loci. Nature (2014)doi:10.1038/nature13595

Press release: CAMH; available at http://www.eurekalert.org/pub_releases/2...072114.php [Accessed 22 July 2014]

International Bioprinting Congress: DeCoster presentation on 3D and 2D advances

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The International Bioprinting Congress taking place between July 24-25 at the Biopolis Research and Development Center in Singapore will feature leading international scientists who will share insights into the latest developments and techniques in 3D bioprinting. Advances that will be featured will include additive manufacturing of tissues and biofabrication, scaffolds and biomaterials for tissue engineering, biological laser printing, biological inkjet printing, and research into achieving synergy by fusion of bio-additive and micro manufacturing.

Among the invited speakers will be Dr. Mark DeCoster, the James E. Wyche III Endowed Professor in Biomedical Engineering at Louisiana Tech University. Dr DeCoster is an eminent scientist who has published 60 peer-reviewed papers, generating over 1,750 citations. He will present a lecture titled, “Bioprinting interfaces for 2D and 3D cell and tissue models.” This will highlight the work of Dr DeCoster’s lab in developing a novel, matrix-free method for generating 3D cell spheroids. This combines knowledge from bioprinting methods on 2D surfaces to link 3D cellular structures.

Dr DeCoster explains the potential for 3D bioprinting techniques in biology and medicine: “The cells of our bodies exist in both a three dimensional (3D) environment, which is rounder, as well as places that are more two dimensional (2D) or flattened…What is so new and exciting about 3D printers in the biomedical sciences and engineering is that we can now enable our imagination to convert a good idea into something that is printable and testable in 3D, and could have significant impacts on human health…3D printers are now replicating materials that are compatible with biology and medicine such as delivery of drugs to fight off cancer or growth-promoting materials that can be used for tissue engineering to heal a wound or repair a damaged part of the body.”

Dr DeCoster’s lab uses 3D printers to generate cell-compatible building blocks which they then use to study cell groups in both 3D and 2D. Dr DeCoster clarifies the relevance of this: “We feel this is important because we need to understand how to put cells together to grow better tissues or repair them, and also to understand how damaged or diseased cells behave…We need to understand both the 2D and 3D environments since different parts of the body use different materials to function, and this complexity of materials will most likely also be needed in bioprinting…In my presentation at the International Bioprinting Congress, I look forward to sharing the research we’re doing at Louisiana Tech on how normal cells of the brain as well as cancer cells (such as in brain tumors), can be studied using materials from 3D printers and how we combine those materials with cells.”

Source:

Press release: Louisiana Tech University; available at http://news.latech.edu/2014/07/21/biomed...singapore/ [Accessed 22 July 2014]

High fat diet can damage your sense of smell

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A high-fat diet can impact on the sense of smell, which during obesity could perpetuate poor dietary decision making. This is suggested by a recent study on a mouse model in the Journal of Neuroscience led by researchers in Florida State University.

Obesity has reached epidemic proportions in western nations, with for example 65% of Americans considered to be overweight or obese and perhaps even more disturbingly, about one third of children and adolescents. Obesity has serious health implications, for example in terms of increased risk of cancer, cardiovascular disease, diabetes and cognitive decline. However, there is little understanding of how obesity impacts on sensory systems such as the olfactory system or sense of smell. Olfaction is important in that it has an input into food choice, which directly links to development of obesity if poor choices are consistently made.

In the current study, the researchers used a mouse model in order to induce long-term, diet-induced obesity by feeding both obesity-prone (C57BL/6J) and obesity-resistant (Kv1.3−/−) mice with high-fat diets. They compared these mice models to another type of mouse, MC4R−/−, which features late-onset, genetic-induced obesity. Over a six-month study period, the mice were taught to associate between a particular odour and a reward (water).

The results indicated that the mice fed on a fatty diet were comparatively slower to learn reward-reinforced behaviours and also could not rapidly adapt when a new odour was introduced to monitor their adjustment. Furthermore, the changes were long-lasting as when the obese mice were taken off the high-fat diet and changed to a chow diet on which they regained normal weight and resting glucose, the olfactory dysfunction remained. The changes in olfactory perception and reduced reward association responses corresponded to loss of olfactory sensory neurons and their axonal projections with a high fat diet.

First author Dr Nicolas Thiebaud says: "This opens up a lot of possibilities for obesity research." Current plans include examining whether exercise can impact on the effects of the high-fat diet on smell and whether a high-sugar diet has similar effects to a high-fat diet. For now, the research contributes another layer of understanding on the negative effects of poor dietary choices over time.

Sources

Thiebaud N. et al. (2014) Hyperlipidemic Diet Causes Loss of Olfactory Sensory Neurons, Reduces Olfactory Discrimination, and Disrupts Odor-Reversal Learning. Journal of Neuroscience 34(20): 6970-6984; doi: 10.1523/JNEUROSCI.3366-13.2014

Press release: Florida State University; available at http://www.eurekalert.org/pub_releases/2...072114.php [Accessed 22 July 2014]

R&D staff cuts likely as Allergan fights Valeant hostile takeover

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As Allergan attempts to evade a hostile takeover attempt value at $53 billion from Canadian company Valeant, Fierce Biotech reports that its R&D division is likely to be hard hit. This is despite optimism at the beginning of the year from CEO David Pyott that the R&D wing would be further enhanced in the company. The newly announced Allergan plans include letting 1500 workers go and removing 250 vacant positions. In this way Allergan claims it can reduce its 2015 budget by $475 million. While all elements of the company would be affected by such major cost-cutting, including commercial, general, administrative and manufacturing staff, R&D is likely to be particularly impacted. Emphasis would be in maintenance of ‘customer-facing’ staff and protection of current key development programmes rather than in new discoveries.

Valeant has a reputation for taking over drug companies, as with Medicis in 2012, and then laying off R&D staff and severely cutting ongoing development projects. While Valeant attempts to raise the resources for a 25% stake in Allergan, David Pyott has been emphasising that Allergan are themselves looking to make new acquisitions, indicating that they would be most interested in companies with a profile that is “specialist in nature" and a with new therapeutic "pillar" that could be used in new product development. However, Allergan has suffered the loss of one of its major investors, Capital Research & Management, and has also faced the blow of a third time rejection of its migraine drug Semprana by the US Food and Drug Administration (FDA).

The announced proposed cutbacks from Allergan may make the acquisition more difficult for Valeant to effect. Sterne Agee analyst Shibani Malhotra noted: “Today's announcement by Allergan makes it more difficult for Valeant to demonstrate how a merger can add incremental value and AGN shareholders may now require Valeant to pay a greater premium for Allergan, we believe."

Sources

Fierce Biotech: http://www.fiercebiotech.com/story/aller...2014-07-21 [Accessed 22 July 2014]

Fierce Biotech: http://www.fiercebiotech.com/story/hosti...2014-06-11 [Accessed 22 July 2014]

Eye canal insights and importance for glaucoma

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New insights into a specialised eye structure called the Schlemm’s canal may be critical in advancing research on the blinding eye disease glaucoma, which affects over 70 million people globally. The insights are presented in a new study from a research team based in Jackson Laboratory and in Tufts University School of Medicine in Boston, published today in the journal PLoS Biology.

Schlemm’s canal, essentially a tube lined with endothelial cells, is vital for control of eye fluid flow and of intraocular pressure. It is directly implicated in glaucoma. However, its role is poorly understood. In the current study, the researchers used mouse models engineered to express fluorescent proteins and developed a ‘whole mount’, three-dimensional approach to the study of these animals. Using this novel methodology, they were able to observe how the Schlemm’s canal forms and both in regard to the eye and to adjacent tissues.

As a result of the study, the researchers identified a unique vascular development process they called ‘canalogenesis’ which combines elements of angiogenesis, vasculogenesis and lymphangiogenesis but also novel features that distinguishes it from all of them. They also identified a vascular endothelial growth factor receptor, a receptor tyrosine kinase called kinase insert domain receptor, as functionally important in early Schlemm’s canal development.

Another important finding was that the endothelial cells (SECs) lining the Schlemm’s canal were shown to have properties of blood and lymphatic endothelial cells. First author Dr Krishnakumar Kizhatil, an associate research scientist in the laboratory of JAX Professor and Howard Hughes Medical Investigator Dr Simon John explains the significance of this finding “Thus, Schlemm’s canal is a unique vessel with endothelial cells that are highly specialized for its complex functions…This resolves a long-standing controversy about the cellular phenotype of SECs.”

Co-author Dr Jeffrey Marchant of Tufts concludes: “This study lays a critical new foundation for determining the functions of Schlemm’s canal both in maintaining ocular health and when things go wrong in glaucoma.”

News source: PLOS Biology

News reference: Kizhatil K, Ryan M, Marchant JK, Henrich S, John SWM (2014) Schlemm’s Canal Is a Unique Vessel with a Combination of Blood Vascular and Lymphatic Phenotypes that Forms by a Novel Developmental Process. PLoS Biol 12(7): e1001912. doi:10.1371/journal.pbio.1001912; available at: http://www.plosbiology.org/article/info:...io.1001912

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