Bruker Receives FDA Clearance for the MALDI Biotyper Microbial Identification System

Bruker Corporation announced that it has been granted U.S. FDA clearance under Section 510(k) to market its MALDI Biotyper CA System in the United States for the identification of Gram negative bacterial colonies cultured from human specimens.

The MALDI Biotyper CA System includes the bench-top microflex™ MALDI-TOF (matrix-assisted laser desorption ionization time-of-flight) mass spectrometer, software, IVD labeled reagents, a 48-spot MALDI target and a library of microorganism reference spectra. Bruker has conducted a multi-site clinical trial comparing performance of the MALDI Biotyper CA System to 16S ribosomal RNA gene sequencing. The overall accuracy of the MALDI Biotyper CA System was comparable to that of nucleic acid sequencing. FDA clearance of the MALDI Biotyper CA System is the latest achievement in Bruker’s continuous efforts to develop MALDI-TOF mass spectrometry into the most advanced platform for clinical microbiology identification.

In 2009, Bruker launched a MALDI Biotyper system in compliance with the European in vitro diagnostic directive EC/98/79, making the CE-IVD labelled IVD-MALDI Biotyper the first MALDI-TOF based product registered for use in European clinical microbiology laboratories. Since then, Bruker has continued its effort to expand into routine clinical microbiology and other markets throughout the world. Currently the CE-IVD labelled IVD-MALDI Biotyper is available for clinical microbiology routine usage in Europe, as well as in many countries around the world, including Canada, Argentina, Mexico, Colombia and Ecuador in the Americas and in Japan, Hong Kong, Singapore, Malaysia and Taiwan in Asia/Pacific.

Frank Laukien, President and Chief Executive Officer of Bruker Corporation, commented: “We are very excited about this major milestone in our effort to introduce MALDI-TOF mass spectrometry into clinical diagnostics. For the last seven years Bruker has been working on continuous innovation in the field of MALDI-TOF-based microbial identification, bringing the MALDI Biotyper platform into clinical routine laboratories. The MALDI Biotyper has been a success with more than 1,000 systems sold or leased worldwide, which has positively affected the health of many patients. Bruker has initiated a continuing revolution in clinical microbiology towards the MALDI Biotyper as a next-generation identification technique. With clearance by the US FDA to market the MALDI Biotyper CA System, we expand our market reach into the largest clinical market in the world, with expected significant improvements in outcomes and reductions in the cost of healthcare.”

Dr. Robert Jerris, PhD, D (ABMM), the Director of Clinical Microbiology at the Children´s Healthcare of Atlanta pediatric hospital, added: “MALDI-TOF has had a dramatic impact on patient care at Children’s Healthcare of Atlanta. The ability to identify organisms directly from plates - saving at minimum a day over conventional phenotypic tests for many organisms - has impacted therapy, timely infection control and contributed to decrease in healthcare expenditures. Outcome studies have shown such significant positive results that it is predictable to say that this technology will eventually be a staple in clinical microbiology.”

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European LabOnFoil Detects Pathogens

Led by the Basque R&D Alliance IK4, 13 organisations in 8 different countries have been conducting research for three years under the European LabOnFoil project to develop new rapid diagnostic devices.

A patch for detecting cocaine consumption from skin perspiration, a chip to identify pathogens in foods, a device for monitoring colon cancer via a patient's blood, and a sensor to detect environmental contamination via the analysis of marine algae. All four applications have something in common: they all arose from the same European research project, entitled LabOnFoil. This initiative, which ended recently, was set-up to develop rapid and low-cost diagnostics devices that could be adapted to different situations and, in short, offer society new advances to improve quality of life.

The collaboration between the 13 entities from eight European countries who participated in the project has borne fruit in the form of the aforementioned four applications, which have generated new business opportunities in sectors with high added value. As underlined by the project coordinator, Jesús M. Ruano-López, "the consortium's efficient use of resources and good management in general have enabled LabOnFoil to have a significant economic impact".

No wonder some of the applications are now being commercially exploited by different consortium partners. The Spanish company POC Microsolutions, for example, is industrialising one of the prototypes for launch on the market in 2015. For its part, the Irish company Biosensia is launching patches onto the market to detect the presence of drugs, whilst DTU Nanotech (Denmark) is opening a new line of business based on one of these developments.

The LabOnFoil project, which commenced in 2008 and ended in February 2013, had a budget of 7.1 million Euro, and was co-financed by the VII European Framework Programme (EU).

Ruano-López explained that "the goal for all LabOnFoil project partners was none other than the development of devices with a positive social and economic impact. Results have been achieved thanks to our determination to develop compact, reliable devices with added value compared to existing competitors, that is, that could be commercially exploited".

"Teamwork has enabled us to combine consortium members' different specialisations, such as microtechnology, molecular biology, materials, and electronics, to develop much more compact, economical and easier to use diagnostic systems than exist at present. Which ultimately enables drugs, illnesses, contamination, etc. to be identified in very different scenarios, with a very significant commercial impact", stated Ruano-López.

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Rapid Pathogen Identification System Evaluated for Food Industry Testing

PathoGenetix, Inc., a developer of an automated system for bacterial strain typing, and Marshfield Food Safety, LLC, a full service microbiology and chemistry contract testing laboratory, have signed an agreement to evaluate PathoGenetix’s RESOLUTION™ Microbial Genotyping System. Under the agreement, Marshfield will conduct independent testing of the RESOLUTION instrument, assays and database in their corporate laboratory, and provide feedback to PathoGenetix on the speed, utility and ease-of-use of the RESOLUTION System for food industry applications.

The RESOLUTION System provides confirmation for presumptive positive screening tests and identifies molecular serotype and strain type information of foodborne pathogens in five hours. Based on PathoGenetix’s breakthrough Genome Sequence Scanning™ (GSS™) technology, the System isolates and analyzes microbial DNA directly from enriched food samples, without a cultured isolate, to type target bacteria in just five hours, even when multiple serovars are present.

The strain type information provided by GSS is comparable to pulsed field gel electrophoresis (PFGE), the current gold standard for pathogen identification. Unlike PFGE, however, GSS is culture independent, and fully automated from sample preparation to final report. As a result, the RESOLUTION System has the potential to greatly reduce the time, complexity and skill-level required to identify foodborne pathogens in both food industry testing and public health outbreak investigations.

Marshfield Food Safety, LLC, participated in PathoGenetix’s RESOLUTION Customer Experience Program in November to get an initial in-depth and hands-on review of the GSS technology. “We are very excited to evaluate the RESOLUTION System further, and believe that it has the potential to be a very powerful new tool for our customers,” said Marshfield CEO, Roy Radcliff, PhD. “We believe the System can simplify pathogen confirmation and reduce the time required to identify microbial contamination and trace it back to the original source in the production facility.”

Marshfield provides full service microbiology and chemistry testing and food safety risk management services to clients along the food chain from farm to table. In addition to conducting laboratory services for national food producers in its Wisconsin-based corporate laboratory, Marshfield also designs and staffs onsite quality and safety testing laboratories for food producers around the U.S.

“We are extremely excited to begin placing Systems for external evaluations,” said John Czajka, PhD, PathoGenetix’s Vice President of Business Development. “These evaluations will demonstrate the simplicity and utility of the RESOLUTION System, while providing key end-user feedback on how the workflow and user-interface might be improved as the System moves into full commercial production.”

As a part of the collaboration, Marshfield will provide feedback to PathoGenetix that will assist in commercializing the RESOLUTION instrument, database and assays. PathoGenetix also has signed a collaborative agreement with the U.S. Food and Drug Administration (FDA) to evaluate the System for use in public health foodborne illness outbreak investigation and response.

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Urine-Based Assay Diagnoses Chlamydia in 20 Minutes

A rapid and sensitive assay requiring no special equipment can detect Chlamydia trachomatis directly from urine samples with high accuracy, according to a study published in the January issue of the Journal of Molecular Diagnostics.

Katrin Krõlov, from the University of Tartu in Estonia, and colleagues describe an assay to detect C. trachomatis in urine samples using recombinase polymerase amplification of a highly conserved target within the CDS2 gene. The assay was tested on urine samples from 70 patients attending a sexual health clinic and compared with the Roche Cobas Amplicor C. trachomatis assay.

The researchers found that the test had a minimum detection limit of five to 12 pathogens and could detect pathogen directly in urine within 20 minutes. Initial analysis of the assay showed specificity of 100 percent and a sensitivity of 83 percent.

"The whole procedure is fairly simple and does not require specific machinery, making it potentially applicable in point-of-care settings," Krolov and colleagues conclude.

The abstract and full text may be accessed here.

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EMSL Implements the bioMérieux VITEK®MS

bioMérieux,Inc a world leader in the field of in vitro diagnostics, is pleased to announce that EMSL Analytical, a leader in microbiology testing specializing in rapid pathogen detection is adopting the company’s VITEK® MS technology for rapid identification of potentially harmful microorganisms.

VITEK MS, uses MALDI-TOF mass spectrometry technology to identify bacteria, yeast, and mold, offering significant time savings with respect to traditional identification methods, the system was the first to receive de novo FDA clearance for IVD August 21, 2013. It is also extremely sensitive, providing a standard of accuracy above many of the current state-of-the-art techniques.

“We are excited to bring this state of the art technology to EMSL. The VITEK MS gives us the ability to provide microbial identification with unprecedented speed and accuracy for our clients. VITEK MS also aligns with the needs of EMSL’s cGMP Microbiology lab as well as environmental and forensic microbiological capabilities. We look forward to providing our clients with the benefits that the VITEK MS brings,” said Dr. Frasca, President of EMSL LABS.

Bacterial and mold identification are crucial to confirm contaminations and to guide corrective actions in the production of consumable products made by pharmaceutical, cosmetic, and food manufacturers. With 50 years of experience in microbial identification, bioMérieux brings to the customer the benefits of a robust data collection model suited for industry needs. VITEK MS provides fast, flexible, and robust results, and can provide an identification of a microorganism’s genus and species in just a few minutes. As the world leader in microbiology, bioMérieux pairs VITEK MS system with the most comprehensive microbial database specific for industry in the business.

“Reference laboratories today are striving to improve productivity and shorten their time-to-results needed by their customers,” said Pierre-Louis Thiney, Executive Director US Industry for bioMérieux. “Providing a fully integrated, rapid solution for microbial identification is a significant step in providing timely and accurate results to the customer.”

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New Biotechnology Offers Rapid Diagnostics

The revelation of a new optical dimension in nanophotonics offers untapped clinical potential in non-invasive cancer diagnostic kits, rapid pathogen screening for acute infection, and invisible coding for identification of authentic pharmaceuticals.

Lead researchers Yiqing Lu and Dayong Jin from Macquarie University have invented a new generation of nanocrystals, called "τ-Dots".

τ-Dots can be coded in the time dimension in addition to colours, that is, their luminescence lifetimes (τ) can be engineered and assigned to a single nanoparticle.

"This extra dimension offers an exponential boost in the total number of potential combinations, which can be used for multiple medical tasks or diagnoses simultaneously," said Lu.

"These nanocrystals can form combination codes, like barcodes, to form a vast library of distinguishable molecular probes, which can be used for complex diagnostics. Screening tests can more quickly and accurately identify the cause of infection, residue cancers at an early stage, and locate the specific molecular targets for targeted drug therapies. " said ARC Future Fellow Dr Jin.

Co-author, Professor J Paul Robinson from Purdue University said "This toolset is really a paradigm shift for identifying rare events in high-noise environments typical in biological systems such as cancer detection, high throughput screening and also in the biodetection domain."
The τ-Dots also have application in improving the storage capacity and security of data, and can invisibly mark genuine drug products as an anti-counterfeit measure, says Lu.

"Our ability to layer the τ-Dots' lifetimes enables higher density storage than was previously possible. We can also protect the data by codifying the τ-Dots until they are essentially impossible to crack.

"By applying τ-Dots to any surface, we can leave a secret message or mark on any product, which will only be revealed by a specially designed scanner. This has huge potential in confirming the authenticity of any product, from pharmaceutical drugs to medical courier supplies."

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Microchip Aids Rapid Microorganism Identification

Researchers have developed a glass/silicon polymer chip with a microscopically small channel that enables clinicians to rapidly sort microbes using dielectrophoresis, according to findings in a new study.

The goal is to develop a battery-operated, hand-held device using the technology to reduce from days to minutes the amount of time needed to identify and characterize microorganisms, Mark A. Hayes, PhD, associate professor in the department of chemistry and biochemistry at Arizona State University in Tempe, and colleagues reported in Analytical and Bioanalytical Chemistry.

Traditional methods of identifying microorganisms require the time-consuming process of growing cultures from food or infected patients and then sending them out to a laboratory. The novel microchip technology relies on dielectrophoresis, a process that involves applying voltage to bacteria causing them to become trapped at different points along the microchip’s channel based on its molecular and electrical properties.

The technology has successfully distinguished between extremely similar pathogenic and nonpathogenic strains of Escherichia coli serotypes, Hayes and colleagues said.

They injected three E. coli strains into a single microchannel and applied voltage to drive the cells downstream. Geometric features of the channel created an electrical field with different intensity levels at different regions, creating a gradient insular dielectrophoretic force that allowed some cells to pass and trapped others based on phenotype.

“The fact that we can distinguish such similar bacteria has significant implications for doctors and health officials,” Hayes said.

So far, the researchers have only tested pure cultures, but aim to test complex mixtures of particles similar to those found in nature or the human body in the near future.

The next step will be to create cheap, portable devices that could enable point-of-care or field-based analysis, potentially yielding more rapid responses to disease and contamination.

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Rapid TB test Could Be Ready in 18 Months

A new rapid tuberculosis test shortens diagnosis time on one of the world’s deadliest diseases from several weeks to a few hours.

The disease, caused by various strains of mycobacteria, attacks the lungs or other organs and is spread through the air when an individual with active form of TB coughs or sneezes. As much as one-third of the world’s population may be infected with TB and another one percent becomes infected every year. One in ten cases progress to the active disease, which presents symptoms such as a chronic cough, coughing up bloody sputum (mucus), fever, night sweats and weight loss.

If left untreated—a common scenario in developing countries lacking the infrastructure or resources to efficiently screen and follow up with infected patients—a person with active TB has only a 50 percent chance of survival.

Jeffrey Cirillo, professor in the Department of Microbial Pathogenesis and Immunology at Texas A&M Health Science Center (TAMHSC) College of Medicine, and his team have discovered a new method to spot the bacteria that causes TB, a profound advance in point-of-care diagnosis of the disease.

“We’ve identified a fluorescence substrate that reacts with the bacteria,” Cirillo says. “This gives us a very sensitive signal that wouldn’t be possible otherwise.”

Once sputum samples are combined with the reactive substance, a battery-powered, handheld reader is then used to detect any fluorescence and deliver the diagnosis.

“There isn’t a diagnostic tool comparable to this in terms of allowing patients to rapidly determine whether or not they are infected.”

While other TB tests exist, they take several days to produce results. Cirillo’s breakthrough involves using the new substrate to targeting a specific enzyme the bacteria produces as an indicator of the bacteria’s presence. It has not been previously possible to target a specific TB enzyme as a diagnostic for this disease.

The lab is working on developing alternative methods that would enable testing using urine or other types of human tissue, as well as taking a first look at additional bacteria that may be susceptible to this florescent reaction.

“We would like to apply it in all respiratory diseases,” Cirillo says. “The first applications in the next few years will be TB.”

The research team includes GBDbio, a Texas A&M spinout company, and Jianghong Rao at Stanford University. The project, published in Nature: Chemistry, has letters of support from the World Health Organization, Doctors Without Borders, and the Clinton Health Access Initiative. Cirillo is now seeking late-stage funding for the additional testing required to replicate his findings in independent labs, a crucial final step before production and distribution of the test kits can begin.

“We’ve done smaller scale testing in hundreds of samples,” Cirillo says. “To validate for worldwide use, it will require thousands of tests and validation in multiple labs outside our own. Right now, we’re at maybe an 18-month window for this device to be out serving patients.”

The Bill and Melinda Gates Foundation and the Wellcome Trust funded the project.

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Researchers Have Identified a Biomarker for Sepsis in Blood

Researchers at King’s College London have identified a biomarker – a biological ‘fingerprint’ – for sepsis in the blood, and showed it could be possible to diagnose the condition within two hours by screening for this biomarker at a patient’s bedside.

Sepsis (sometimes referred to as ‘blood poisoning’) is a life-threatening condition that arises when the body’s inflammatory response to a bacterial infection injures its own tissues and organs. Costing the NHS over £2billion annually, the condition kills more people than breast and bowel cancer combined (approximately 37,000 a year). Rapid diagnosis and treatment with antibiotics saves lives, but as there are currently no biomarkers in clinical use to enable fast diagnosis, it can take up to two days to analyse samples in the laboratory.

Published in the journal PLOS ONE and funded by both Guy’s and St Thomas’ Charity and the National Institute for Health Research (NIHR) Biomedical Research Centre at Guy’s and St Thomas’ NHS Foundation Trust and King’s College London, this study highlights a possible biomarker for the rapid diagnosis of sepsis. The work was performed in collaboration with Cepheid, developer of the GeneXpert, which is capable of performing rapid molecular detection.

RNA helps decode and regulate DNA. This paper investigated microRNAs, which come in many varieties and influence disease processes. Researchers at King’s and Cepheid, a molecular diagnostics company, took samples of blood from three groups of patients; those with sepsis, patients with other Systemic Inflammatory Response Syndrome (that does not respond to antibiotics), and healthy patients. From the blood samples they were able to amplify small amounts of RNA into large quantities to see which particular microRNAs were increased. By using this method, the team found that a certain group of microRNAs were more active in the sepsis patients than in the other groups, highlighting a potential biomarker for the condition.

The study was replicated with a large group of Swedish patients with severe sepsis, which validated the results. By using this method of screening and analysing the blood in both studies, the researchers were able to diagnose sepsis within two hours, with 86 per cent accuracy.

Professor Graham Lord, Director of the NIHR Biomedical Research Centre at Guy’s and St Thomas’ NHS Foundation Trust and King’s College London, said: “Sepsis is a hidden killer, causing nearly a third of all hospital deaths. Rapid antibiotic treatment for the condition is vital – every minute counts. Yet current diagnostic methods can take up to two days, so an accurate diagnostic test that can be carried out at the patient’s bedside is urgently needed.

“We have for the first time identified a group of biomarkers in the blood that are good indicators of sepsis. We have shown that it is possible to detect these markers by screening a patient’s blood in the ward, a process which can deliver results within two hours. This is an extremely exciting development which has the potential to completely transform the management of this severe disease and save thousands of lives worldwide every year. These are promising early findings, and now we need to test this approach in a large clinical trial.”

Symptoms of sepsis are similar to other types of Systemic Inflammatory Response Syndrome (SIRS), yet only sepsis responds to antibiotics. It is therefore important for clinicians to be able to distinguish sepsis from other types of SIRS as administering antibiotics in non-sepsis cases can add pressure to the development of antibiotic resistance. Professor Lord continued: “Not only would an accurate diagnostic test improve outcomes for patients, but it would contribute to tackling the ongoing problem of antibiotic resistance by allowing clinicians to distinguish between SIRS and sepsis and diagnose these severe conditions more accurately.”

Plans for a randomised clinical trial are underway at King’s College London and Guy’s and St Thomas’ NHS Foundation Trust, part of King’s Health Partners Academic Health Sciences Centre.

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New Diagnostic Test Detects Chlamydia trachomatis in Less Than 20 Minutes

Researchers have developed a new assay for rapid and sensitive detection of Chlamydia trachomatis, the most common sexually transmitted infection (STI) in humans. This procedure takes less than 20 minutes and can be easily performed at the point of care (POC) during the patient's visit, reports The Journal of Molecular Diagnostics.

C. trachomatis affects 5% to 10% of the population and is particularly common in young adults under 25 years. It is a major public health concern due to its prevalence and potential severe long-term consequences. One of the main reasons it is so prevalent is that in the majority of cases (75% of women and 50% of men) there are minimal to no symptoms, and it therefore often goes undiagnosed. Infection is associated with non-gonococcal urethritis in men and several inflammatory reproductive tract syndromes in women such as inflammation of the uterine cervix and pelvic inflammatory disease. Untreated, the infection increases the risk of ectopic pregnancy and is one of the leading causes of female infertility worldwide.

The assay uses recombinase polymerase amplification (RPA), a nucleic acid amplification technique (NAAT), to detect C. trachomatis directly from urine samples. Because the assay's novel approach does not require the purification of total DNA from the urine sample, the need for specialized equipment is eliminated. The procedure is significantly less laborious, less time-consuming, and consequently less expensive. It is relatively simple to perform and could therefore be applied in numerous POC settings.

"The assay enables highly specific C. trachomatis detection with sensitivity levels significantly improved compared to currently available C. trachomatis POC assays," says Ülo Langel, PhD, Professor of Molecular Biotechnology, University of Tartu, Estonia, and Professor of Neurochemistry, Stockholm University, Sweden.

Existing polymerase chain reaction (PCR)-based techniques for testing C. trachomatis are widely applied but are only suitable for use in hospitals with trained staff and expensive machinery. Studies have shown that up to 50% of patients never return to get the diagnostic result or required treatment.

Although several rapid-diagnosis POC tests have already been developed, none offer a comparable sensitivity to hospital-based techniques. Recent independent studies have shown that currently available POC tests have a sensitivity of just 10% to 40%. Initial analysis of the new assay's performance indicated a specificity of 100% and a sensitivity of 83%, evidence of its potential reliability.

"The alarmingly poor performance of the available POC tests for C. trachomatis has limited their wider use, and there is a clear requirement for more sensitive and cost-effective diagnostic platforms. Hence, the need for an applicable on-site test that offers reasonably sensitive detection," concludes Prof. Langel.

TECHNICAL DETAILS OF THE STUDY

Recombinase polymerase amplification (RPA) is a nucleic acid amplification technique (NAAT) – a laboratory technique that involves the in vitro synthesis of many copies of DNA or RNA from one original template. These techniques have revolutionized diagnostic technology. Current technologies that allow the detection of amplification in real time are fast becoming diagnostic industry standards.

C. trachomatis cells contain plasmids (small DNA molecules that are separate from chromosomal DNA) that have a number of coding sequences. For identification and amplification by RPA, researchers selected a gene fragment within a gene (CDS2) that was conserved across sexually transmitted C. trachomatis strains. The assay does not require the purification of total DNA from the urine sample. Heating the sample for five minutes at 90°C is enough to release a sufficient amount of the amplification target to determine whether the pathogen is present. Urine contains polymerase chain reaction (PCR) inhibitors, but up to 5 μl of urine can be added without affecting sensitivity of the RPA, whereas the addition of 10 μl affects amplification efficiency significantly.

The C. trachomatis assay developed here was able to detect at least 50 copies of the CDS2 target. C. trachomatis harbors, on average, between four and ten copies of the plasmid per elementary body depending on the strain and development stage. The lowest detectable amount of the C. trachomatis RPA assay can therefore be translated to 5 to 12 pathogens per reaction and is in the same range as other nucleic acid amplification-based techniques.

The assay was tested on urine samples from 70 patients (51 females and 19 males) attending a sexual health clinic in Estonia. The samples were tested in parallel using RPA and Roche Cobas Amplicor C. trachomatis assays.

Fifty-eight samples tested negative in both assays. As no false negatives were detected, the clinical specificity of the C. trachomatis RPA assay can be estimated at 100%.

Twelve of the samples tested as positive using the Roche assay. Of these, 10 tested positive and two tested negative in the RPA reaction. Based on these results, the clinical sensitivity of the RPA assay can be estimated at 83%.

Of the 12 patients who tested positive, three complained of symptoms. The other nine patients were asymptomatic. Of the 58 C. trachomatis-negative patients, 15 (26%) complained of symptoms that could be associated with C. trachomatis infection. One of these tested positive for N. gonorrhoeae and M. genitalium. Others were diagnosed with bladder inflammation (two patients), bacterial vaginosis (five patients), yeast infection (four patients), or abdominal pain of non-gynecological origins (three patients).

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Whole-Genome Sequencing Accurately identifies Bacteria in Clinical Specimens

Researchers in Denmark have found that using whole-genome sequencing directly on clinical samples identified the bacteria causing urinary tract infections in 18 hours.

“Using conventional methodologies, this would have taken several days to weeks, and even using whole-genome sequencing on cultured bacteria would have taken an extra day,” Frank M. Aarestrup, DVM, PhD, of the Technical University of Denmark, said in a press release.

In the study, the researchers examined 35 random urine samples from patients with suspected UTIs using conventional microbiology, whole-genome sequencing of isolated bacteria and directly sequencing the clinical samples. Using conventional identification, they found 19 different isolates for species identification and antimicrobial susceptibility testing.

When they performed whole-genome sequencing on the 17 isolates made in pure culture, the results confirmed the conventional identification in the cases. In addition, there was agreement between the predicted antimicrobial susceptibility. The researchers also performed whole-genome sequencing on 23 of the urine samples, including the 19 positive samples. In the 17 isolates made in pure culture, the sequencing on the urine samples yielded the same species identification.

“Rapid identification of the causative agent, and of any antibiotic resistance, is crucial to choosing the correct treatment for individual patients,” Aarestrup said. “Choosing the wrong antibiotic will lead to longer infections and, in the worst case, deaths.

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Rapid Identification of the Salmonella Serovars S. enteritidis and S. typhimurium

The U.S. Food and Drug Administration (FDA) has issued the Final Rule “Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation”, that requires “shell egg producers to implement measures to prevent SE from contaminating eggs” (74 FR 33030). SE can infect the reproductive tract of chickens and enter shell eggs before the shell is formed. An accurate and sensitive test system is required, because levels of SE in eggs from infected hens are often low. The proposed FDA BAM method to test environmental and egg samples is time-consumptive and takes up to seven days for a negative result. BIOTECON Diagnostics now offers a fast, sensitive and convenient assay for the detection and identification of the Salmonella serovars SE and ST: The foodproof® Salmonella Enteritidis & Typhimurium Detection LyoKit, a lyophilized, pre-aliquoted rapid test for the identification of SE and ST in one assay.

The foodproof® Salmonella Enteritidis & Typhimurium Detection LyoKit is the first multiplex real-time PCR rapid test on the market, which detects SE and ST simultaneously in one single test in less than 24 hours. In combination with the foodproof® StarPrep One Kit for sample preparation, BIOTECON Diagnostics offers a safe, easy-to-use and time-saving solution. Get the accuracy, the ease-of-use and a faster time-to-result with reduced overall testing costs, even with challenging samples.

The rapid assay has been validated with more than 110 SE and ST strains, including the monophasic variant 1,4,[5],12:i:-, in combination with all relevant matrices, e.g. egg shells, chocolate and cheese. For exclusivity more than 550 non-Enteritidis, non-Typhimurium Salmonella strains were successfully tested. With this kit BIOTECON Diagnostics introduces the foodproof® LyoKits Product Series, designed to raise the convenience, sensitivity and safety of the foodproof® kits. The pre-filled reaction mix is lyophilized, and the DNA sample preparation can be added directly to each reaction tube. With less pipetting steps, the risk of cross-contamination has been further reduced. The LyoKits are easy to store at 2 - 8 °C and can be shipped at room temperature. Every LyoKit includes an internal amplification control and the proven Uracil-N-Glycosylase system, which prevents carry-over contamination by prior PCR amplificates. The LyoKits are compatible with nearly all open real-time PCR cyclers based on Hydrolysis Probes.

The foodproof® LyoKits Product Series will be expanded by further parameters; Salmonella, STEC and Listeria monocytogenes are already in the process to be launched. Get the accuracy, the ease-of-use and a faster time-to-result with reduced overall testing costs, even with challenging samples.

About 80% of all Salmonella infections in humans are due to Salmonella enterica subspecies enterica serovar Enteritidis (SE) and Salmonella enterica subspecies enterica serovar Typhimurium (ST), according to the European Food Safety Authority. Salmonellosis in humans is often associated with consumption of poultry, eggs and egg-derived products. Additionally, infections in chickens, turkeys and ducks cause economic loss worldwide with morbidity of up to 85% and a low to moderate mortality. Usually, infected birds are culled or rejected at slaughter.

Because SE and ST are the predominant serovars associated with human disease in most countries and because of the differences in the epidemiology as compared to other Salmonellae, these are often specifically cited in zoonosis control legislation. For example, the EU Regulation 1086/2011 claims, that fresh poultry meat has to be free of SE and ST, including the monophasic Salmonella Typhimurium strain.

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NanoLogix and Saudi Company To Work Together for Distribution of NanoLogix Products in the Arabian Gulf Region

NanoLogix, Inc., an innovator in the rapid detection, identification of live bacteria, and determination of their antibiotic resistance and sensitivity, announces that they are working with Nasaem-Aljazira, a Saudi Arabian company headquartered in Riyadh, to establish exclusive distribution and/or manufacturing of NanoLogix products in Saudi Arabia and the Arabian Gulf region, also known as the Gulf Cooperation Council (GCC) area.

This area offers a large market potential to Nasaem-Aljazira and NanoLogix, with Saudi Arabia being a leader in advanced health care initiatives for its people.

NanoLogix is also in negotiations with groups and companies in Europe, Asia and Africa on additional distribution outlets and manufacturing options.

The Company currently sells and ships its products in the US and to the UK.

In keeping with NanoLogix' policy of continual product improvement, the Company has begun electron beam (e-Beam) processing of the majority of its filled Petri plate and BNP detection kit FlatPacks through the facilities at Synergy HealthAST.

This process was initiated to ensure that our FlatPack preserved Petri plates and BNP kits remain viable throughout their extended shelf life, which in some cases for common agars have now exceeded one year at room temperature and two years in cold storage. These times are in sharp contrast with the 3-4 months of shelf life available with competitor's products and offer a significant economic advantage to customers with limited or no cold storage capacity, or those with dynamic testing and project schedules.

NanoLogix recently added 13 additional product variants that have been in demand by its customers and has improved its ordering procedure, enabling a "mix and match" capability for ordering that allows customers to order up to ten different Flatpack detection products in one single carton.

NanoLogix and researchers at UTHSC Houston are working to finalize development of the Company's new N-Assay detection and identification assay. The original concept for use with one bacteria has expanded to one in which as many as five different pathogens can be rapidly detected, identified, and analyzed for antibiotic sensitivity or resistance on one N-Assay multiwell microplate.

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Molecular Assay for Patient Screening Detects S. aureus and Newly Emerging MRSA Strains Now Available in the US

BD Diagnostics, a segment of BD (Becton, Dickinson and Company), a leading global medical technology company, today announced it has received FDA clearance to market the BD MAX(TM) StaphSR Assay for use on the fully-automated BD MAX(TM) System. The assay, with eXTended Detection Technology, accurately detects Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) DNA directly from nasal swabs, including mecA dropout mutants and new strains of MRSA that may not be detected by other assays.

The BD MAX StaphSR Assay is the first and currently the only commercially-available molecular assay in the United States that detects recently discovered MRSA strains with the mecC gene. Rapid, accurate detection of colonized patients enables effective strategies that can help reduce the risk of surgical-site infections (SSIs), improve patient safety and save healthcare costs.(i,ii)

"Increased accuracy in determining patient colonization with either S. aureus or MRSA can enable clinicians to implement appropriate pre-surgical prophylaxis and direct appropriate utilization of isolation and decolonization," said Dr. Tobi Karchmer, Worldwide Vice President, Medical Affairs, BD Diagnostics. "With results available in approximately two hours compared to two or more days for culture methods, the BD MAX StaphSR Assay provides accurate and timely information to help physicians ensure safe and appropriate management of surgical patients."

SSIs are the most frequent healthcare-associated infection (HAI) in the United States, occurring in about one out of every 50 operations, and constitute the greatest portion of HAI-related costs nationally. SSIs due to MRSA increase hospital length of stay for patients by an average of 23 days and cost more than $40,000 per case to treat.(iii) Nasal carriage of S. aureus, including MRSA, is a well-defined risk factor for subsequent infection in surgical patients. Rapid screening and targeted decolonization decreases SSIs by nearly 60 percent and improves clinical and economic outcomes for surgical patients.(iv,v)

With many commercial assays, SA strains carrying SCCmec where the mecA gene is absent (commonly called "dropout mutants") may be incorrectly detected as MRSA. These false positive results can lead to inappropriate use of vancomycin for surgical prophylaxis and unnecessary, expensive isolation of patients.(vi) MRSA strains with the recently discovered mecC gene account for nearly three percent of all new MRSA cases(vii) but cannot be detected by assays that do not detect that gene.(viii) These false negative results can lead to inappropriate surgical prophylaxis in patients who should receive vancomycin to cover for MRSA and lack of appropriate isolation precautions to prevent transmission in the operating room and during hospitalization.

The BD MAX StaphSR Assay represents an important milestone in BD's commitment to provide healthcare institutions with cutting edge assays to detect and prevent HAIs. Other HAI assays available on the BD MAX System include BD MAX(TM) MRSA for the detection of MRSA DNA and BD MAX(TM) Cdiff for the detection of toxigenic Clostridium difficile DNA. These BD MAX(TM) HAI Solutions combine efficiency with the flexibility to perform multiple HAI assays in the same run, allowing hospital laboratories to customize testing in response to current and future challenges in the fight against HAIs.

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