Archive for ‘Tuberculosis’

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UPC teams conduct research in biomedical engineering to improve people’s health

UPC teams conduct research in biomedical engineering to improve people’s health

Systems to improve patient rehabilitation, methods that help detect diseases, and smart biomaterials for optimising treatments—scientific advances in the field of biomedical engineering are unstoppable. A number of leading UPC teams are carrying out research aimed at harnessing technology to improve people’s health.

Parkinson’s disease is the second most common neurodegenerative disease after Alzheimer’s. Optimising treatment and rehabilitation of the people it affects and improving their quality of life is the goal of Joan Cabestany and Andreu Català, researchers at the Technical Research Centre for Dependency Care and Autonomous Living (CETpD) of the Universitat Politècnica de Catalunya · BarcelonaTech (UPC).

The two engineers are heading up a European project known as REMPARK (Personal Health Device for the Remote and Autonomous Management of Parkinson’s Disease), which has a budget of €4.73 million. The objective is to develop a pioneering wearable monitoring system that can be used to identify and quantify, in real time and with high reliability, the motor status of Parkinson’s patients during their everyday lives. The system will act automatically—though always under medical supervision—in response to the situations that are most incapacitating for patients, intervening in the least invasive and most effective way possible. Other participants in this ambitious project coordinated by the UPC include the Teknon Medical Centre, Telefónica R&D, the European Parkinson’s Disease Association, and a number of research centres and companies based in Germany, Portugal, Italy, Israel, Ireland, Sweden and Belgium.

The system being developed consists of two elements: a bracelet equipped with a sensor for measuring tremor in patients and a smart device the size of a mobile phone, which is worn at the waist on a belt made of biocompatible material. The device is equipped with a set of sensors and has the capacity to process and wirelessly transmit all the information collected and processed.

When a gait-freezing episode occurs, the REMPARK system will act to synchronise the patient’s movements. This will be achieved by means of auditory, visual or haptic (touch-related) cueing devices, a pump for regulated subcutaneous drug delivery, and a functional electrical stimulation (FES) system. “The device will make it possible to quantify the effects of a drug in a particular patient and adjust the dose accordingly,” says Joan Cabestany, stressing that REMPARK is “a personalised system that adapts to each person’s needs.”

For the first time in Europe, REMPARK will be tested on a hundred patients in their homes. “We want to use the technology to give Parkinson’s patients back their confidence, which is gradually eroded by the disease,” says Andreu Català. The project “will reduce the number of hospitalisations and improve patient treatment and rehabilitation,” adds the researcher, who works at the Vilanova i la Geltrú Campus.

Stress-free cells

The REMPARK project is set to run until 2015, but others are yielding results that are about to hit the market. This was clear at the BIO International Convention, the world’s largest biotechnology exhibition, which was held in Boston (Massachusetts, United States) last June.

The UPC presented a number of patents at the event, including an automatic method for introducing substances such as drugs and DNA into cells (transfection). The method, known as in vitro electroporation, is more efficient and economical than existing approaches.

The technique, which is applied manually, is commonly used in gene therapy, cell-based therapies, and tumour treatment by electrochemotherapy. Cells are detached from the bottom of the plates where they are grown and put into suspension, i.e. into a mixture. They are then placed in a special cuvette with aluminium electrodes on its sides. The cuvette is loaded into a device (an electroporator) that creates a high-intensity electric field across the cells, causing the pores in the cell membrane to open. Substances can then be introduced through these pores.

The new system simplifies and automates this process. A microelectrode assembly is introduced directly into the culture plate and placed at a distance of 10 ìm (10 millionths of a metre) from the cells. A 20 V electric field is then applied (in the conventional process a 500 V field is used). The lower voltage reduces the cost of the devices used to carry out these biotechnological processes and subjects the cells to less stress. The low cost of the microelectrodes also makes it possible to produce single-use electroporators. This patent was developed by researcher Ramon Bragós and doctoral student Tomàs Garcia, who are attached to the Biomedical Engineering Research Centre (CREB), in collaboration with a team at the University of Barcelona (UB).

The UPC is also contributing to major advances in the development of medical devices and diagnostic imaging. The UPC’s Institute of Industrial and Control Engineering (IOC) and the Pulmonology Research Group of Bellvitge Hospital’s Institute for Biomedical Research have developed a virtual bronchoscopy system that improves the diagnosis of lung cancer. The technology provides doctors with information that enables them to decide with more confidence whether an actual bronchoscopy is necessary or not. This helps minimise risk and discomfort for patients.

The system is based on images provided by a virtual bronchoscopy using 2D computed tomography images. The novel feature of the system is that it takes into account the geometry and kinematic constraints of the bronchoscope.

The device is designed so that a pulmonologist can virtually navigate through a patient’s airways and simulate the movements that will later be executed when a flexible bronchoscope is used to perform the examination. It is a useful tool that facilitates “very realistic planning of the most feasible path from the trachea to peripheral pulmonary lesions,” says Jan Rosell, the researcher who carried out the project together with Paolo Cabras and Alexander Pérez, who also work with the IOC. “Doctors can also use the device to determine whether the end of the bronchoscope will reach a lesion, or, if not, how close it can be manoeuvred and what technique will need to be used to obtain a biopsy sample,” Rosell adds.

In addition to pursuing advances in diagnostic imaging, molecular biology and telemedicine, UPC researchers are also doing innovative work in another area of interest: metabolomics, the scientific study of chemical processes involving metabolites. It is in this field that another CREB team has patented an innovative software tool. The advanced program, based on a new algorithm, helps medical professionals make more accurate, automated predictions in disease diagnosis and drug screening.

Developed by Àlex Perera and Francesc Fernández in collaboration with researchers with the University of Barcelona’s Department of Nutrition and Food Science, the tool improves detection of biomarkers, the biological markers used to detect diseases.

Another advantage of the software is that it reduces prediction error in metabolomic analysis and testing (used to examine the small organic molecules in biological systems). Metabolomic analyses are based on biological samples of urine or blood, nuclear magnetic resonance (NMR) techniques, and mass spectrometry (LC/MS). Making predictions in this area is complex because it requires analysis of extensive data obtained from individual samples, but it is of vital importance in evaluating the effectiveness of new drugs, for example.

New test for tuberculosis

Tuberculosis is one of the diseases that accounts for the most morbidity and mortality worldwide. Despite this, there are still a lot of unanswered questions about the disease and many scientific challenges remain to be tackled. Daniel López Codina and Clara Prats of the UPC’s Discrete Modelling and Simulation of Biological Systems group have carried out research in this field in collaboration with a team at the Experimental Tuberculosis Unit of the Germans Trias i Pujol Health Sciences Research Institute Foundation.

The two teams have patented a new method that offers a fast, easy and reliable way to determine the virulence (ability to produce disease) of Koch’s bacillus. The technique allows specialists to make more accurate diagnoses.

López Codina’s team observed the tuberculosis bacillus (Mycobacterium tuberculosis) in an in vitro culture and looked at the way it grows by forming clumps. Given the difficulty of applying conventional microbiological methods with this type of culture, the researchers used an alternative approach: microscopy and analysis with image processing techniques. “This is the first time we’ve been able to use a culture to observe two different strains of the bacterial parasite and the existence of a correlation between the characteristic clumping pattern and the virulence of the disease,” said the researcher.

The results have created a new business opportunity for companies involved in biomedical imaging and diagnostic testing.

Projects like these highlight the huge potential of engineering and medicine to continue delivering solutions that improve people’s quality of life.

Source : http://www.news-medical.net/news/20121123/UPC-teams-conduct-research-in-biomedical-engineering-to-improve-peoples-health.aspx

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USC Develops Robot With Tactile Sensors That Can Outperform Humans

USC Develops Robot With Tactile Sensors That Can Outperform Humans

USC Develops Robot With Tactile Sensors That Can Outperform Humans

What does a robot feel when it touches something? Little or nothing until now. But with the right sensors, actuators and software, robots can be given the sense of feel – or at least the ability to identify materials by touch.

Researchers at the University of Southern California’s Viterbi School of Engineering published a study today in Frontiers in

A robot hand equipped with SynTouch’s BioTac sensors.

Neurorobotics showing that a specially designed robot can outperform humans in identifying a wide range of natural materials according to their textures, paving the way for advancements in prostheses, personal assistive robots and consumer product testing.

The robot was equipped with a new type of tactile sensor built to mimic the human fingertip. It also used a newly designed algorithm to make decisions about how to explore the outside world by imitating human strategies. Capable of other human sensations, the sensor can also tell where and in which direction forces are applied to the fingertip and even the thermal properties of an object being touched.

Like the human finger, the group’s BioTac® sensor has a soft, flexible skin over a liquid filling. The skin even has fingerprints on its surface, greatly enhancing its sensitivity to vibration. As the finger slides over a textured surface, the skin vibrates in characteristic ways. These vibrations are detected by a hydrophone inside the bone-like core of the finger. The human finger uses similar vibrations to identify textures, but the BioTac is even more sensitive.

When humans try to identify an object by touch, they use a wide range of exploratory movements based on their prior experience with similar objects. A famous theorem by 18th century mathematician Thomas Bayes describes how decisions might be made from the information obtained during these movements. Until now, however, there was no way to decide which exploratory movement to make next. The article, authored by Professor of Biomedical Engineering Gerald Loeb and recently graduated doctoral student Jeremy Fishel, describes their new theorem for this general problem as “Bayesian Exploration.”

Built by Fishel, the specialized robot was trained on 117 common materials gathered from fabric, stationery and hardware stores. When confronted with one material at random, the robot could correctly identify the material 95% of the time, after intelligently selecting and making an average of five exploratory movements. It was only rarely confused by a pair of similar textures that human subjects making their own exploratory movements could not distinguish at all.

So, is touch another task that humans will outsource to robots? Fishel and Loeb point out that while their robot is very good at identifying which textures are similar to each other, it has no way to tell what textures people will prefer. Instead, they say this robot touch technology could be used in human prostheses or to assist companies who employ experts to judge the feel of consumer products and even human skin.

Robots Get A Feel For The World from USC Viterbi on Vimeo.

Loeb and Fishel are partners in SynTouch LLC, which develops and manufactures tactile sensors for mechatronic systems that mimic the human hand. Founded in 2008 by researchers from USC’s Medical Device Development Facility, the start-up is now selling their BioTac sensors to other researchers and manufacturers of industrial robots and prosthetic hands.

Another paper from this research group in the same issue of Frontiers in Neurorobotics describes the use of their BioTac sensor to identify the hardness of materials like rubber.

Original funding for development of the sensor was provided by the Keck Futures Initiative of the National Academy of Sciences to develop a better prosthetic hand for amputees. SynTouch also received a grant from the National Institutes of Health to integrate BioTac sensors with such prostheses. The texture discrimination project was funded by the U.S. Defense Advanced Research Projects Agency (DARPA) and the material hardness study by the National Science Foundation.

Fishel just completed his doctoral dissertation in biomedical engineering based on the texture research. Loeb, also Director of the USC Medical Device Development Facility, holds 54 U.S. Patents and has published over 200 journal articles on topics ranging from cochlear implants for the deaf to fundamental studies of muscles and nerves.

The technology developed by SynTouch enables a robot equipped with BioTacs to discriminate between 117 different textures with greater than 95% accuracy. The system was even shown to outperform human subjects in discriminating between difficult pairs of textures.

In order to endow robots with human-like abilities to characterize and identify objects, they must be provided with tactile sensors and intelligent algorithms to select, control, and interpret data from useful exploratory movements. Humans make informed decisions on the sequence of exploratory movements that would yield the most information for the task, depending on what the object may be and prior knowledge of what to expect from possible exploratory movements. This study is focused on texture discrimination, a subset of a much larger group of exploratory movements and percepts that humans use to discriminate, characterize, and identify objects. Using a testbed equipped with a biologically inspired tactile sensor (the BioTac), we produced sliding movements similar to those that humans make when exploring textures. Measurement of tactile vibrations and reaction forces when exploring textures were used to extract measures of textural properties inspired from psychophysical literature (traction, roughness, and fineness). Different combinations of normal force and velocity were identified to be useful for each of these three properties. A total of 117 textures were explored with these three movements to create a database of prior experience to use for identifying these same textures in future encounters. When exploring a texture, the discrimination algorithm adaptively selects the optimal movement to make and property to measure based on previous experience to differentiate the texture from a set of plausible candidates, a process we call Bayesian exploration. Performance of 99.6% in correctly discriminating pairs of similar textures was found to exceed human capabilities. Absolute classification from the entire set of 117 textures generally required a small number of well-chosen exploratory movements (median = 5) and yielded a 95.4% success rate. The method of Bayesian exploration developed and tested in this paper may generalize well to other cognitive problems.

Source : http://viterbi.usc.edu/news/news/2012/robots-get-a.htm

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Veredus VereMTB Chip for Fast Diagnosis of TB

Veredus VereMTB Chip for Fast Diagnosis of TB

Veredus VereMTB Chip for Fast Diagnosis of TB

Tuberculosis (TB) is a common, and in many cases lethal infectious diseases caused by various strains of mycobacterium, usually Mycobacterium tuberculosis complex. It is spread through the air when people who have an active MTB infection cough, sneeze, or otherwise transmit their saliva through the air. Most infections in humans result in an asymptomatic, latent infection, and about one in ten latent infections eventually progress to active disease, which, if left untreated, kills more than 50% of those infected.

Global prospects for TB control are challenged by the emergence of drug-resistant strains, especially those that are multidrug resistant (MDR) and extensively drug resistant (XDR). Soon after anti-TB drugs became available in the 1940s came reports of drug resistance among patients undergoing treatment. The prevalence of TB resistance to a single drug was continuously on the rise in several parts of the world, and eventually in the early 1990s, multiple converging factors led to an explosive emergence of MDR-TB, defined as resistance to the two most effective first-line anti-TB agents, Isoniazid and Rifampicin. In 2010, there were an estimated 650 000 cases of MDR-TB.

The threat of tuberculosis has propelled the need of a new tuberculosis diagnostic test system that should be able to do fast and reliable detection and identification of Mycobacterium tuberculosis complex, with the capability to differentiate it from clinically relevant non-tuberculous mycobacterium species as well as detecting drug resistance especially multidrug resistance.

The threat of tuberculosis has propelled the need of a new tuberculosis diagnostic test system that should be able to do fast and reliable detection and identification of Mycobacterium tuberculosis complex, with the capability to differentiate it from clinically relevant non-tuberculous mycobacterium species as well as detecting drug resistance especially multidrug resistance.

Product Description:

VereMTB™ is a fast, multiplexed PCR-microarray based test using the VereID™ Biosystem Lab-on-Chip technology to identify 10 different mycobacterium strains with special emphasis on Mycobacterium tuberculosis Complex (MTBC) and its Resistance to Rifampicin and/or Isoniazid from Smear-Positive Pulmonary Clinical Specimens or Cultivated Samples (MDR-TB).

VereMTB™ enables a rapid result from smear-positive pulmonary patient specimen and from culture material (liquid or solid cultures). Also for diagnosing patients after treatment failure and relapse, with unknown anamnesis and originating from high prevalence areas of MDR-TB as well as for diagnosing patients in high prevalence TB countries and high burden MDR-TB regions the use of VereMTB™is reasonable. Finally the test can also be applied for screening purposes to develop country-specific TB action plans.

The VereMTB™ is a nucleic acid-based, Lab-On-Chip (LOC) device which combines multiplex PCR and microarray hybridization assay to detect, differentiate and identify:10 different mycobacterium strains with special emphasis on Mycobacterium tuberculosis Complex (MTBC) and its Resistance to Rifampicin and/or Isoniazid from Pulmonary Clinical Specimens or Cultivated Samples (MDR-TB)

Singapore based Veredus Laboratories announced the launch of its VereMTB multiplexed lab-on-a-chip for the detection of various mutations of mycobacterium responsible for causing tuberculosis as well as nine other similar clinically interesting mycobacterium. The chip identifies the specific mycobacterium within three hours after being presented with a sample of coughed up direct sputum.

The technology doesn’t require culturing the bacteria, a slow process that can extend into days when rapid detection is key.

VereChip Veredus VereMTB Chip for Fast Diagnosis of TB

From the announcement:

Based on STMicroelectronics’ industry-proven Lab-on-Chip technology, the VereMTB chip is currently undergoing evaluations by the Chinese Center for Disease Control and Prevention in Beijing, China as part of their ongoing program to assess new technologies for TB diagnostics. According to the 2012 World Health Organization report on TB, India and China combined have almost 40 percent of the world’s TB cases, and nearly 60% of multi-drug resistant cases in 2011 were in India, China, and the Russian Federation.

“At the main CDC National TB Reference Lab in Beijing, we have been evaluating VereMTB using samples, collected from across China with a special interest in detecting challenging multi-drug resistant strains that are difficult to detect using other methods,” said Professor Zhao Yanlin Director of National TB Reference Laboratory and Vice Director of the National Center for Tuberculosis Control and Prevention at the Chinese Center for Disease Control and Prevention. “The speed, accuracy and comprehensiveness of the results have been

very promising. We look forward to continuing our collaboration with Veredus for new breakthroughs in diagnosing TB.”

source : http://www.vereduslabs.com/index.php?option=com_content&view=article&id=29&Itemid=64

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New tool can particularly sort tumor-causing cancer cells

New tool can particularly sort tumor-causing cancer cells

A new tool developed by scientists at The Methodist Hospital separates tumor-causing cancer cells from more benign cells by subjecting the cells to a microscopic game of Plinko — except only the squishiest cells make it through.

As reported in this week’s Proceedings of the National Academy of Sciences (early edition online), the more flexible, tumor-causing cells navigated a gamut of tiny barriers, whereas the more rigid, more benign cells had trouble squeezing through 7 micrometer holes. Methodist scientists worked with University of Texas MD Anderson Cancer Center researchers to test the device with different kinds of cancer cells.

The work supports the hypothesis that cell squishiness indicates tumor potential. Most normal cells contain a developed cytoskeleton — a network of tiny but strong rod-shaped proteins that give cells their shape and structure. In their feverish drive to divide, cancer cells may be diverting resources away from developing a cytoskeleton in favor of division, hence the squishiness.

“We have created many pathways for cells to cross barriers,” said Methodist nanomedical faculty Lidong Qin, Ph.D., the project’s principal investigator. “The throughput of a MS-Chip is at the level of one million cells. When a stiff cell blocks one particular barrier, many other bypasses will allow flexible cells to flow through.”

Cancer stem cells are known to be squishier than other cancer cells. The team of scientists showed that flexible cells separated by the MS-Chip exhibited gene expression patterns consistent with cancer stem cells.

“Many papers indicate the presence of cancer stem cells means a worse prognosis for patients,” said cancer scientist Jenny Chang, M.D., co-principal investigator and director of Methodist’s Cancer Center. “Yet they are not typically quantified by doctors.”

Subsequent analysis of separated cells by the Methodist and MD Anderson team showed the flexible cells were less likely to express cell cytoskeleton genes and more likely to express the motility genes that could contribute to metastasis.

By testing for the presence of metastatic cells, doctors may be able to tell whether cancer treatment was successful, or an as-yet untreated cancer’s likelihood of metastasizing to another part of the body.

A growing awareness of cancer stem cells’ role in cancer metastasis and recurrence and has been frustrated by the absence of technology that makes this knowledge useful to doctors and their patients. Up to now, there has been no way of quickly and reliably separating and identifying the more dangerous tumor-causing cells from a biopsy.

The new device, which was developed at Methodist, successfully enriched tumor-causing cells from a mixture of cancer cells. It is called the Mechanical Separation Chip, or MS-Chip. Cells separated by the device can be easily collected and studied. The current standard for cell separation, flow cytometry, is relatively slow and relies on cell surface biomarkers.

“Our microfluidics cell separation via MS-Chip provides a high throughput method that can particularly sort cells to different levels of stiffness, which opens a new avenue to study stiffness related cellular and molecular biology,” Qin said. “Downstream molecular analysis, including genomic and proteomic profiling of the cell subtypes, provides an approach to identifying new biomarkers relevant to cancer stem cells and cancer metastasis.”

Right now, each MS-Chip costs about $10 to produce.

“If massively produced, MS-Chip cost could be at the level of one dollar per chip,” Qin said. “Running a mechanical cell separation will be even less expensive than flow cytometry cell sorting.”

Source : http://www.news-medical.net/news/20121103/New-tool-can-particularly-sort-tumor-causing-cancer-cells.aspx

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Mass spectrometry can help visualize how drugs work inside living cells to kill infectious microbes

Mass spectrometry can help visualize how drugs work inside living cells to kill infectious microbes

Weill Cornell Medical College researchers report that mass spectrometry, a tool currently used to detect and measure proteins and lipids, can also now allow biologists to “see” for the first time exactly how drugs work inside living cells to kill infectious microbes. As a result, scientists may be able to improve existing antibiotics and design new, smarter ones to fight deadly infections, such as tuberculosis. The new study was published in today’s early online edition of Science.

“The development of antibiotics has been stalled for several decades and many infectious microbes have become drug-resistant,” says the study’s senior investigator, Dr. Kyu Y. Rhee, an infectious disease expert who is an associate professor of medicine in the Division of Infectious Diseases and associate professor of microbiology and immunology at Weill Cornell Medical College. “We must restock the antibiotic pipeline and our study findings provide a powerful new approach for doing just that.”

The need to develop new antibiotics is perhaps nowhere more pressing than for the treatment of tuberculosis, TB, which is the single leading bacterial cause of death worldwide, and with the emergence of now total drug resistance, an unchecked global public health emergency.

“Current TB treatments are long and complex, lasting a minimum of six months, and often resulting in treatment failures and the paradoxical emergence of multi-drug resistance,” says Dr. Rhee, who is also an associate attending physician at NewYork-Presbyterian Hospital/Weill Cornell Medical Center. “We are still using the antibiotics that were first developed for TB about 50 years ago.”

Most TB drugs — as well as antibiotics for other infections — were developed through a combination of empirical approaches, Dr. Rhee explains. “However, it had been impossible to know what the drug was doing inside the bacteria.”

That situation has now changed. Dr. Rhee and his colleagues, who include investigators from the National Institutes of Health, applied modern technologies that stem from use of mass spectrometry to directly visualize what happens when these drugs infiltrate TB cells. They can “watch,” at a basic biochemical level, what happens to both the antibiotic agent and infecting bacteria over time after the drug is administered.

Mass spectrometry, simply stated, is a tool that weighs individual molecules as a way to identify them. It was first used in physics, but has expanded to many disciplines to help scientists identify molecules and determine the quantity of each kind in gases, liquids, as well as solids. Advances in mass spectrometry have made it possible for biologists to leverage the tool in the last few years, and, with this study, evaluate the intracellular fates and actions of small drug molecules.

This study is the first to show mass spectrometry can also be adapted to understand the action of antibiotics on living, intact bacterial cells.

In the study, Dr. Rhee’s research team exposed TB to para-aminosalicylic acid (PAS), which was developed more than 50 years ago, and is still part of the multi-drug regimen used to treat resistant TB. It is the second oldest TB drug on the market.

The drug was thought to work by inhibiting an enzyme used by bacteria to synthesize folates, an essential class of nutrients that humans acquire by eating, but bacteria must make on their own. “Many thus believed that the drug interfered with folate synthesis in the TB bacterium by functioning as an occlusive plug that blocked this pathway,” says Dr. Rhee.

However, researchers actually found, while it is true PAS prevents the utilization of the natural precursors used to synthesize folates, once inside TB, PAS itself also turns toxic. “PAS is an agent that uses the TB cell’s machinery to turn it into a poison. Thus, it doesn’t simply kill the cell by stopping its food supply, it also morphs into a lethal drug,” Dr. Rhee says.

The researchers also tested a different drug, sulfonamide (sulfa), which is an 80-year-old class of antibacterial agents known to defeat many infections, but not TB successfully.

“Scientists thought sulfa didn’t penetrate TB cells, but we witnessed, using mass spectrometry, that it did, in fact, enter the bacteria. But that once inside, TB bacteria were able to degrade the drug,” Dr. Rhee says. This finding suggests to researchers that it might be possible to modify the sulfa molecule so that it can withstand degradation by TB bacteria.

“Both of these findings were completely unexpected,” says Dr. Rhee. “The study findings show us that sometimes there is a profound disconnect between what we think a drug is doing and how it actually works inside cells.”

“The power of mass spectrometry is now evident, and we can’t wait to use it to test all of the current cocktail of drugs used to treat TB to find ways to improve them,” Dr. Rhee says. “Best of all will be the use of this tool to design and test the much-needed next generation of effective anti-TB agents.”

Source : http://www.news-medical.net/news/20121103/Mass-spectrometry-can-help-visualize-how-drugs-work-inside-living-cells-to-kill-infectious-microbes.aspx

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OncoSec Medical System for Opening Pores in Tumors Gets EU OK (VIDEO)

OncoSec Medical System for Opening Pores in Tumors Gets EU OK (VIDEO)

OncoSec Medical System for Opening Pores in Tumors Gets EU OK (VIDEO)

SAN DIEGO – October 17, 2012 – OncoSec Medical Inc. (OTCBB: ONCS), a company developing its advanced-stage ImmunoPulse DNA-based immunotherapy and NeoPulse drug-based chemotherapy to treat solid tumor cancers, announced it has received authorization to CE mark its proprietary gene and drug delivery platform, the OncoSec Medical System (OMS) electroporation device, for use in the European Economic Area (EEA). SGS Group, an industry-leading inspection, verification, testing and certification company, supervised the assessment and certification process.

A CE mark verifies the OMS electroporation device has met all applicable directives of the European Commission (EC) and subsequently the laws and regulations of the European Union (EU) member states and therefore can be commercialized within the 30-nation EEA and Switzerland. The electroporation device applies short electric impulses to a tumor, causing pores to open in the membrane of cancer cells, significantly increasing the uptake of anti-cancer agents into these cells. The granting of this CE mark involved a comprehensive audit of the company’s quality system as well as thorough evaluation and testing of the OMS electroporation device to assure it performs safely and as designed. The CE mark affirms OncoSec’s commitment to product quality and development, and augments the notified body certification to the International Organization for Standardization’s (ISO) 13485 standard for the “design, development, manufacture, and distribution of electroporation devices,” which the company received in July.

Punit Dhillon, President and CEO of OncoSec, commented,

“The approval marks an essential regulatory milestone on the road to commercialization and further approval of the OncoSec Medical System. The CE mark shows that OncoSec has the capability to manufacture and develop a device that meets commercial regulatory requirements.”

It’s a potentially disfiguring, debilitating, and life-threatening disease facing one in five Americans, yet the reality is that skin cancer has limited options for treatment.

With the development of the OncoSec Medical System™ (OMS), we are changing that reality.

The electroporation technology powering OMS has the potential to extend lifespans and enhance the quality of life for people whose cancers are resistant to conventional treatment approaches. Our impact is greatest among skin cancers that are typically hardest to treat such as metastatic melanoma, Merkel cell and cutaneous t-cell lymphoma. In particular, conventional treatments for melanoma are usually highly toxic, with severe side effects that compromise the patient’s health even further.

OncoSec is ready to bring hope, a better level of care, and proven results to an underserved market, with the ultimate goal of delivering this remarkable new technology to patients worldwide.

San Diego based OncoSec received the CE mark for its OncoSec Medical System (OMS) electroporation device. The OMS is used during chemotherapy and immunotherapy to open pores within the membranes of target cancer cells, making them more susceptible to injected compounds.

The system delivers short electric pulses via a stylus held by a physician, making it most practical for use in treating aggressive skin cancer. The company hopes that its technology will significantly improve the effectiveness of chemo and immunotherapies, reduce systemic toxicity, and lead to faster recovery for the patient.

Here’s a video describing OncoSec’s electroporation technology:

Source : http://oncosec.com/index.php/oncosec-receives-ce-mark-for-its-electroporation-device

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OncoSec Medical System for Opening Pores in Tumors Gets EU OK

OncoSec Medical System for Opening Pores in Tumors Gets EU OK

OncoSec Medical System for Opening Pores in Tumors Gets EU OK

CE Certification Enables Commercialization of OncoSec Medical System (OMS) Electroporation Device in European Economic Area

SAN DIEGO – October 17, 2012 – OncoSec Medical Inc. (OTCBB: ONCS), a company developing its advanced-stage ImmunoPulse DNA-based immunotherapy and NeoPulse drug-based chemotherapy to treat solid tumor cancers, announced it has received authorization to CE mark its proprietary gene and drug delivery platform, the OncoSec Medical System (OMS) electroporation device, for use in the European Economic Area (EEA). SGS Group, an industry-leading inspection, verification, testing and certification company, supervised the assessment and certification process.

A CE mark verifies the OMS electroporation device has met all applicable directives of the European Commission (EC) and subsequently the laws and regulations of the European Union (EU) member states and therefore can be commercialized within the 30-nation EEA and Switzerland. The electroporation device applies short electric impulses to a tumor, causing pores to open in the membrane of cancer cells, significantly increasing the uptake of anti-cancer agents into these cells. The granting of this CE mark involved a comprehensive audit of the company’s quality system as well as thorough evaluation and testing of the OMS electroporation device to assure it performs safely and as designed. The CE mark affirms OncoSec’s commitment to product quality and development, and augments the notified body certification to the International Organization for Standardization’s (ISO) 13485 standard for the “design, development, manufacture, and distribution of electroporation devices,” which the company received in July.

Punit Dhillon, President and CEO of OncoSec, commented,

“The approval marks an essential regulatory milestone on the road to commercialization and further approval of the OncoSec Medical System. The CE mark shows that OncoSec has the capability to manufacture and develop a device that meets commercial regulatory requirements.”

It’s a potentially disfiguring, debilitating, and life-threatening disease facing one in five Americans, yet the reality is that skin cancer has limited options for treatment.

With the development of the OncoSec Medical System™ (OMS), we are changing that reality.

The electroporation technology powering OMS has the potential to extend lifespans and enhance the quality of life for people whose cancers are resistant to conventional treatment approaches. Our impact is greatest among skin cancers that are typically hardest to treat such as metastatic melanoma, Merkel cell and cutaneous t-cell lymphoma. In particular, conventional treatments for melanoma are usually highly toxic, with severe side effects that compromise the patient’s health even further.

OncoSec is ready to bring hope, a better level of care, and proven results to an underserved market, with the ultimate goal of delivering this remarkable new technology to patients worldwide.

San Diego based OncoSec received the CE mark for its OncoSec Medical System (OMS) electroporation device. The OMS is used during chemotherapy and immunotherapy to open pores within the membranes of target cancer cells, making them more susceptible to injected compounds.

The system delivers short electric pulses via a stylus held by a physician, making it most practical for use in treating aggressive skin cancer. The company hopes that its technology will significantly improve the effectiveness of chemo and immunotherapies, reduce systemic toxicity, and lead to faster recovery for the patient.

Here’s a video describing OncoSec’s electroporation technology:

Source : http://oncosec.com/index.php/oncosec-receives-ce-mark-for-its-electroporation-device

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New Coating Tech to Help Make Tracheal Stents Safer

New Coating Tech to Help Make Tracheal Stents Safer

New Coating Tech to Help Make Tracheal Stents Safer

If a person‘s windpipe is constricted, an operation in which the surgeon inserts a stent to enlarge the trachea is often the only way to relieve their respiratory distress. But this grid-like implant can slip out of position, closing off the windpipe altogether. Researchers are working on a special surface coating for the stents to keep them in place.

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When coronary blood vessels are constricted, cardiologists try to prevent a heart attack by widening them with small grid-like implants called stents, which stabilize the veins and arteries, improve the flow of blood and prevent vascular obliteration. A lesser known fact is that stents can be used to treat pathological constriction of the windpipe. This kind of respiratory stenosis, which may be caused by tumors, chronic infections or congenital deformities, can be life-threatening. The metal or plastic stents are designed to enlarge the trachea and prevent it from closing up altogether.

But complications can arise when the implants are inserted. Firstly, there is the danger that the stents will shift, thus partially or completely obstructing the respiratory tract. Secondly, bacteria can colonize the stents and trigger pneumonia. The reason for this is that the stents have no barrier-forming cells of the kind usually present in the respiratory system, whose task is to fend off bacteria and inhaled substances such as particulate. “The windpipe has an important barrier function, with goblet and cilia cells purifying the inhaled air. It is very important that cells like these can adhere to the stents so as to maintain the air-purifying effect of the damaged section of the windpipe and to promote incorporation of the stents in the surrounding tracheal tissue,” says Dr. Martina Hampel, a scientist at the Fraunhofer Institute for Interfacial Engineering and Biotechnology IGB in Stuttgart. Together with Prof. Dr. Thorsten Walles, head of the department of thoracic surgery at the University Hospital of Würzburg and a visiting scientist at the IGB, Dr. Hampel and her team took part in the “REGiNA” project, the goal of which was to develop surface coatings that enable the stents to be incorporated in the surrounding tissue, thus reducing the risk that they will move. REGiNA, a German acronym for Regenerative Medicine in the Neckar-Alb and Stuttgart Region, is funded by the German Federal Ministry of Education and Research BMBF.

Bioactive coatings lower the risk for patients

The scientists used stents lined with a polyurethane (PU) film, which were produced by Aachen-based Leufen Medical GmbH. In the ensuing tests, a wide variety of different coatings were applied to the PU film: In addition to synthetic polymers composed of organic acids, the researchers also tried out biological proteins such as fibronectin and type-I collagen. The coating was modified again using plasma technology, with vacuum-ionized gas being used to treat the surface. The experts used an untreated PU film for control purposes. “In order to find out which of the surface coatings was the most suitable, we brought both lab-cultivated cell lines and human primary tracheal epithelial cells into contact with the films in cell culture vessels. What we wanted, of course, was for the primary respiratory cells from human tissue to attach themselves to the film,” explains Hampel. The researchers achieved their best results with the protein-coated film, on which the primary tracheal epithelial cells grew particularly well and multiplied. “The respiratory cells proved to be more vital on bioactive films rather than on ones treated with plasma. By contrast, polymer-coated film turned out to be completely useless,” says Hampel.

The laboratory tests have since been completed, and animal tests are in preparation. If the good lab results are confirmed in these tests, the next step will be to conduct clinical trials of the modified stents at the Schillerhöhe specialist lung clinic, part of the Robert Bosch Hospital. “We hope that, within just a few years, our well-tolerated, cell-compatible surface coatings will be used for other biomedical prostheses such as pacemaker leads, tooth implants and replacement joints,” says Hampel.

Tracheal stents can be lifesavers for people who have trouble breathing because of a constriction due to a tumor, congenital defect, or some other reason. These types of stents have been known to slip out of place as well as help develop pneumonia because they typically lack any anti-bacterial properties.

Researchers from the Fraunhofer Institute for Interfacial Engineering and Biotechnology in Stuttgart and University Hospital of Würzburg are working on stent coatings that will both help in securing the stents in place as well as help goblet and cilia cells settle on the stent to prevent the spread of infections.

The scientists used stents lined with a polyurethane (PU) film, which were produced by Aachen-based Leufen Medical GmbH. In the ensuing tests, a wide variety of different coatings were applied to the PU film: In addition to synthetic polymers composed of organic acids, the researchers also tried out biological proteins such as fibronectin and type-I collagen. The coating was modified again using plasma technology, with vacuum-ionized gas being used to treat the surface. The experts used an untreated PU film for control purposes. “In order to find out which of the surface coatings was the most suitable, we brought both lab-cultivated cell lines and human primary tracheal epithelial cells into contact with the films in cell culture vessels. What we wanted, of course, was for the primary respiratory cells from human tissue to attach themselves to the film,” explains Hampel [Dr. Martina Hampel, scientist at Fraunhofer Institute for Interfacial Engineering and Biotechnology]. The researchers achieved their best results with the protein-coated film, on which the primary tracheal epithelial cells grew particularly well and multiplied. “The respiratory cells proved to be more vital on bioactive films rather than on ones treated with plasma. By contrast, polymer-coated film turned out to be completely useless,” says Hampel.

The laboratory tests have since been completed, and animal tests are in preparation. If the good lab results are confirmed in these tests, the next step will be to conduct clinical trials of the modified stents at the Schillerhöhe specialist lung clinic, part of the Robert Bosch Hospital.

Source : http://www.fraunhofer.de/en/press/research-news/2012/july/non-slip-tracheal-implants.html

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Bruker launches BioPharmaCompass 1.1 software

Bruker launches BioPharmaCompass 1.1 software

At the 2012 CASSS 9th Symposium on the Practical Applications of Mass Spectrometry in the Biotechnology Industry, Bruker today launches the first software solution to encompass the complete biopharmaceutical characterization challenge, including glycoforms, impurities and modifications. The unique BioPharmaCompass 1.1 software allows biotech customers to leverage Bruker’s leadership in cutting-edge mass spectrometry for intact protein and post-translational modification analysis in a routine industrial biologics environment.

BioPharmaCompass 1.1 introduces several major enabling innovations in the quest for a complete picture of biological products for regulatory approval and compliance:

Intact precise-mass product confirmation and impurity identification in a single run

Handling of multiple-point time-course studies including impurity analysis and stress studies

Antibody determination by top-down sequencing, including antibody-drug conjugate analysis with instant visualization of N and C terminal modification analysis against expected batch standard

Glycan profiling, PTM and artifact determination, localization and quantification including novel ETD (electron transfer dissociation) strategy for determination of deamidation sites

Rapid identity testing by peptide mass fingerprinting using digest match chromatogram search, as well as full software enablement of combined CID and ETD strategies for 100% sequence coverage even including formerly difficult-to-sequence domains

Automatic combination of data from multiple enzymatic approaches

The industry’s first automated glycan profiling and identification workflow, expandable using Bruker’s recently launched Glycoquesttm complete glycoprotein analysis solution and integrated library, making sophisticated glycoprotein identification and assignment as simple as a standard protein database search, combining protein sequence and glyco-structure sequencing data into a single 360 degree report

Bruker has pioneered the field of novel mass spectrometry techniques for the direct measurement and sequencing of intact proteins. The industry-leading highest resolution maXis ESI-QqTOF spectra available at maximum sensitivity for trace impurities, patented top-down ISD-T3 sequencing on Flex series MALDI TOF/TOF and best-in-class amazon ETD ion-trap technology for PTM analysis are all critical steps in a complete understanding of the composition of a biotherapeutic. Now, BioPharmaCompass 1.1 enables biotech and pharmaceutical customers to manage information from any or all of these unique capabilities, dramatically speeding the licensing and production of biological drugs.

Explaining the urgent need for the new solution, Dr. Ian Sanders, President of the Bruker Daltonics Life Science Mass Spectrometry division, commented: “The speed and completeness of the analytical picture is vital to our customers securing regulatory approval in this rapidly growing market. There is continual pressure to stay one step ahead of regulatory requirements and we aim to deliver the insight from the most sophisticated new MS approaches with the minimum of expert intervention required by the customer.”

Bruker’s launch follows successful trials by some of the leading organizations in biotherapeutics. Dr. Alain Beck, Senior Director, Antibody Physico-Chemistry, Center of Immunology at Pierre Fabre commented: “We had a chance to work with Bruker’s scientists on antibody characterization by Mass Spectrometry including the use of BioPharmaCompass. We were really impressed by the performance of different complementary mass spectrometers as well as the ability of the software to identify minor modifications in the sequence.”

The new development also delivers significant value in increased productivity in the industrial environment. Dr. Malcolm Saxton, Senior Scientist at Novozymes Biopharma, explained: “BioPharmaCompass has allowed our laboratory to significantly increase throughput. More samples are now analysed while scientists are able to spend a higher proportion of their time on complex problems and new method development. The automated data analysis carried out through BioPharmaCompass ensures high quality and, importantly, fully reproducible data is obtained, reported and traceably stored ensuring that trained staff only spend their time interrogating the samples that need further inspection.”

Source : http://www.news-medical.net/news/20120912/Bruker-launches-BioPharmaCompass-11-software.aspx

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Akonni receives NSF’s Phase 2 SBIR Grant to develop Lab-on-a-Film microarray

Akonni receives NSF’s Phase 2 SBIR Grant to develop Lab-on-a-Film microarray

Akonni Biosystems, a life science tools / molecular diagnostics company that develops, manufactures, and plans to market molecular testing devices for diagnosing infectious diseases and human genetic disorders, announced today the receipt of a $498,780 Phase 2 SBIR Grant from the National Science Foundation (NSF). This second round of funding from NSF will enable Akonni to further develop its Lab-on-a-Film microarray consumable that can be manufactured on ultra-low-cost film using a highly automated, reel-to-reel production process.

“Reel-to-reel assembly is a method of high volume manufacturing used predominantly for the assembly of lateral flow strips and flexible film electronics,” said Dr. Christopher Cooney, Principal Investigator on the grant and Director of Engineering at Akonni Biosystems. “The benefit of this manufacturing approach is that Lab-on-a-Film microarray production and assembly can be automated at very high speeds, resulting in ten- to one hundred-fold savings in consumable costs.”

Lab-on-a-Film manufacturing has the potential to produce mid-multiplexed microarray consumables for just a few dollars. Combining low-cost production with the multiplexing power of Akonni’s gel-drop microarrays, to simultaneously interrogate tens to hundreds of disease markers in a single clinical sample, offers the potential to change the economics of patient wellness monitoring and disease diagnosis. This is especially true in global health settings, where end user adoption of a technology depends critically on cost.

Among projected applications for the Lab-on-a-Film consumable is its integration into the Akonni hands-free, end-to-end genetic testing system. This system is currently being designed for use in moderate-complexity lab settings. It primarily uses Akonni-developed intellectual property, which includes technology that covers cell lysis, rapid nucleic acid extraction (TruTip®), thermocycling, amplification (On-Chip PCR™), and microarray imaging and analysis. Eventual use of Lab-on-a-Film consumables is anticipated in systems designed for CLIA-waved settings.

Source : http://www.news-medical.net/news/20120906/Akonni-receives-NSFs-Phase-2-SBIR-Grant-to-develop-Lab-on-a-Film-microarray.aspx

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