NanoLogix Announces Expansion of EPA Work on Rapid Tests for Drinking Water Quality and Provides Update on Publication of Group B Streptococcus Trial

NanoLogix, a biotechnology innovator in the rapid detection and identification of live-cell bacteria and microorganisms, announced today the U.S. Environmental Protection Agency (EPA) intends to expand its Cooperative Research And Development Agreement (CRADA) with NanoLogix to include additional water-borne pathogens. To accommodate the additional research, the company will add two scientists to its staff at its Cincinnati laboratory. More information on the NanoLogix CRADA can be found at the EPA MCEARD News Archive where an article on the company's work can be found two-thirds down the page.

University of Texas Health Science Center - Houston Group B Streptococcus Update

NanoLogix is pleased to announce Phase I of the Group B Strep research utilizing NanoLogix technology is expected to be published by the end of August, 2011 in a major peer-reviewed American medical journal. In addition, lead researcher on the UTHSC-Houston clinical trial, Dr. Jonathan Faro M.D., Ph.D., assistant professor in General Obstetrics & Gynecology at UTHSC-Houston, will present these Phase I findings at the Central Association of Obstetricians and Gynecologists Annual Meeting on October 26-29, 2011. Results of the completed UTHSC Phase II trial are currently being prepared for publication. Meanwhile, the final phase of the 300-patient clinical trial (constituting Phase III of the Group B Strep trial) is on-going and nearing completion.

NanoLogix is a biotechnology company focused primarily on rapid diagnostics. Its products offer accelerated detection and identification of microorganisms. In addition to medical and homeland security applications, NanoLogix technology is applicable in pharmaceutical, industrial, veterinary and environmental testing. Patents granted to NanoLogix can be used in the areas of applied microbiology, soil microbiology and bioremediation, microbial physiology, molecular biology, pharmacology, pharmaco-kinetics, and antibiotic sensitivity.

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nanoMR Announces $13 Million Series B Financing

nanoMR, Inc., today announced that the company has raised $13 million in equity financing. Excel Venture Management led the round, joined by Healthcare Ventures, and existing investors vSpring Capital, The Dow Chemical Company, and Sun Mountain Capital. Dr. Steven Gullans of Excel and Gus Lawlor of Healthcare Ventures will join the board. The financing will enable nanoMR to develop commercial instruments for the clinical microbiology market, perform clinical studies and prepare for product launch.

"We are extremely excited to partner with Excel and Healthcare Ventures to advance our development of diagnostic products for the clinical microbiology market," said Victor Esch, nanoMR's CEO. "Our new investors have great expertise in helping to transform new technology advances into leading edge health care companies."

The inability to isolate pathogens directly from blood has been for many years the key issue hindering early, appropriate treatment of bloodstream infections - to prevent sepsis - and nanoMR has solved this problem. The company's immunomagnetic technology rapidly isolates pathogens directly from blood in under 30 minutes, enabling identification of infectious organisms using existing molecular diagnostic devices in under two hours. The current time-frame, based on blood culture, takes at least 48 hours. Delay in detection and treatment of bloodstream infections causes more than 250,000 deaths each year in the USA and costs the average hospital over $7.7 million annually.

"Currently, clinical microbiology laboratories depend on culturing microorganisms from clinical samples prior to analysis," said Steve Gullans. "The time required for culturing -- one to two days - means that results are rarely timely enough to influence choice of therapy and can often result in use of inappropriate antibiotics, jeopardizing a patient's survival. nanoMR's new system will identify pathogens in fewer than two hours, enabling rapid administration of the most appropriate antibiotic, resulting in better clinical outcomes and substantially reduced medical costs."

"nanoMR is today demonstrating to the market that it is capable of detecting bacteremia in minutes instead of days, with the potential of saving hundreds of thousands of lives in the process," added Dinesh Patel, Ph.D, managing director, vSpring Capital. "With the added financial and strategic support of Excel and Healthcare Ventures, we believe this is just the beginning."

nanoMR is an early stage life sciences company developing novel diagnostic systems for rapid and sensitive identification of pathogens in whole blood and other samples. nanoMR's system couples immunochemistry with analytical methods such as PCR or DNA hybridization to identify bacterial and fungal infections at clinically-relevant levels. The company's first product addresses the blood culture market, identifying organisms causing blood-stream infections in under 2 hours, compared with days for the existing blood culture-based systems. Potential future diagnostic products include rapid antibiotic sensitivity testing of blood stream infections, pathogen capture from different sample types, including industrial and food microbiology applications, and capture of rare circulating cells.

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Luminex Corporation Receives U.S. FDA Clearance for New, Front Line Respiratory Viral Panel Test

Luminex Corporation announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its xTAG Respiratory Viral Panel FAST (RVP FAST). This front line test has the potential to significantly change the way respiratory viral testing is performed and complements the company's existing respiratory portfolio.

Laboratories and healthcare providers are looking for ways to improve efficiency while managing increasingly complex disease states. The value of multiplexed testing for respiratory viruses is well established with Luminex as the market leader in providing comprehensive multiplexed testing for respiratory viruses. The addition of xTAG RVP FAST assay to Luminex's RVP growing product portfolio brings additional testing options to diagnostic laboratories looking for a front line assay targeting eight essential respiratory pathogens and delivering up to 96 patient results in a few hours.

"Providing faster results from a broad panel makes it easier for physicians to quickly identify appropriate treatment. Better patient outcomes have the potential to reduce hospitalizations and the associated burden on the healthcare system," said Rodney Arcenas, Ph.D., Clinical Scientist, Molecular Microbiology and Immunology for Memorial Healthcare System in Hollywood, Florida. "A streamlined and scalable assay that produces results in shorter time is important in effectively managing fluctuating patient volumes and seasonal spikes typically associated with respiratory viral illnesses."

xTAG RVP FAST panel includes: Respiratory Syncytial Virus (RSV), Influenza A, Non-specific influenza A, H1 subtype, H3 subtype, Influenza B, Metapneumovirus (hMPV), Adenovirus and Entero-Rhinovirus.

With minimal hands-on-time from laboratory staff, xTAG RVP FAST offers clinical and diagnostic laboratories the ability to rapidly provide actionable patient results to physicians. In addition to cost and time savings for the laboratory, earlier detection and differentiation between viral and bacterial infections facilitate appropriate physician treatment decisions, improving patient care and helping to reduce healthcare costs.

"Clearance of xTAG RVP Fast allows us to provide clinical laboratories with a new diagnostic tool to help manage their patients with influenza-like illness," said Patrick Balthrop president and CEO of Luminex. "Luminex is recognized for its leadership in the area of infectious disease multiplexing assays, and particularly in respiratory viral testing and we are pleased to provide a range of testing options that meet our customers' needs and ultimately improve healthcare for patients worldwide."

In addition to xTAG RVP FAST, Luminex's growing family of molecular diagnostic products for infectious diseases include:

xTAG RVP which received FDA approval in January 2008 as the first respiratory viral panel testing for 12 viruses including H1N1 and was awarded the 2010 Prix Galien Award for Best Medical Technology.

xTAG Gastrointestinal Pathogen Panel (GPP) which received CE mark approval in May 2011 and was recently used as a first-line screen in the management of the E. coli outbreak in Europe.

MultiCode-RTx Herpes Simplex Virus (HSV) 1&2, the first FDA approved PCR-based qualitative test for detection and typing of HSV-1 or HSV-2.

The xTAG RVP FAST panel is built on the versatile Luminex® 100/200(TM) platform that makes available a broad menu of applications and will be commercially available from Abbott Molecular Diagnostics and Fisher Healthcare.

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Thermo Fisher Scientific Acquires TREK Diagnostic Systems

Thermo Fisher Scientific Inc. today announced that it has acquired TREK Diagnostic Systems, a global provider of microbiology solutions, including blood culture, microorganism identification and antibiotic susceptibility testing (AST) products, from Magellan Biosciences. Based near Cleveland, Ohio, the company had full year revenue in 2010 of $34 million and has 150 employees.

“The range of products manufactured by TREK ideally complements our existing portfolio of microbiological testing technologies,” said Marc N. Casper, president and chief executive officer of Thermo Fisher Scientific. “Advances in automation and the development of more rapid and reliable tests enable us to provide our customers with improvements in productivity and efficiency that are critical when responding to increasingly complex microbiological threats to human health.”

TREK Diagnostic Systems currently serves pharmaceutical and clinical laboratory markets and will be integrated into Thermo Fisher’s Analytical Technologies Segment.

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Accelr8 to Receive Award for ICAAC Presentation

Accelr8 Technology Corporation announced that the company received notice of an ICAAC Program Committee Award in the area of Clinical Microbiology and Diagnosis. The award recognizes the "outstanding presentation of an abstract accepted by ICAAC" for the 51st ICAAC to be held in Chicago on September 17-20, 2011. The award will be presented at the meeting. The presentation title is "Same-Shift ID Directly from Respiratory Specimens by Automated Microscopy." It will report results from a study using Accelr8's BACcel(TM) rapid diagnostic system in collaboration with investigators at the Barnes-Jewish Hospital in St. Louis.

Accelr8 will announce the study results at the time of the presentation.

ICAAC ( www.icaac.org ) is the annual Interscience Conference on Antimicrobial Agents and Chemotherapy. Organized by the American Society for Microbiology ( www.asm.org ), ICAAC is a major global congress for Clinical Microbiology and Infectious Diseases Medicine.

In additional news, Accelr8 received notice of issuance for a Japanese patent on the BACcel(TM) system. The new patent joins previously issued US and international patents to broaden Accelr8's global patent coverage for the BACcel(TM) system.

According to David Howson, Accelr8's president, "We are honored by the recognition from ICAAC's review committee. It reflects the BACcel(TM) system's potential importance in Clinical Microbiology. Our culture-free methods have repeatedly demonstrated the unprecedented ability to quantitatively identify multiple pathogens directly from patient specimens in less than 2 hours. Our pilot clinical studies pass the 'real specimen' hurdle that continues to stymie new attempts to replace multi-day culturing. The BACcel(TM) system continues to widen its lead in helping to fight the worsening global antibiotic resistance pandemic."

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Particle Measuring Systems

5475 Airport Blvd.

Boulder, Colorado 80301

phone: +[1] 303-443-7100

fax: +[1] 303-546-7380

email: info@pmeasuring.com

website: http://www.pmeasuring.com

Particle Measuring Systems Offers Their Innovative Instrument, the BioLaz™ Real-Time Microbial Monitor for Rapid Detection of Airborne Biological Organisms in Controlled Environments.

The BioLaz™ Real-Time Microbial Monitor provides immediate notification when biological particles are present and real-time verification of biological activity levels during aseptic manufacturing or other operations. This significantly improves the ability to demonstrate control over clean environments.

BioLaz Technology

The BioLaz uses a proven solid state laser-based optical technology for the detection of biological organisms. Air is drawn into the system and if biological particles are present, they fluoresce and are counted in real-time. The BioLaz Real-Time Microbial Monitor’s benefits include:

• Validated to USP <1223> Validation of Alternative Microbiological Methods and of EP 5.1.6 Alternative Methods for Control of Microbiological Quality
• Continuous monitoring with real-time reporting of biological counts
• Easy to integrate data via RS-232 or Ethernet communications
• Internal pump, eliminating the need for external vacuum systems
• Small footprint, 316L stainless steel enclosure

Environmental Monitoring Integration

The BioLaz integrated with traditional methods, Agar plates and particle counters, can lead to improved compliance and potential cost reductions. Particle Measuring Systems provides turn-key systems with traditional particle and microbial monitoring, combined with rapid microbial detection into one complete environmental monitoring solution.

Please visit our web site at www.pmeasuring.com to view an introductory video detailing the BioLaz™ Real-Time Microbial Monitor’s operations and capabilities.

Particle Measuring Systems is the global leader in environmental monitoring technology, with 40 years of experience providing solutions for particle and microbial monitoring for companies with cleanroom manufacturing environments. As the inventor of laser-based particle counters, Particle Measuring Systems sets the standard for particle monitors in pharmaceutical, nanomaterial, aerospace, integrated circuit and electronics manufacturing.

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Life Technologies Introduces First and Only USDA-Approved Real-Time PCR Test to Detect Swine Influenza Virus

Life Technologies Corporation, a provider of innovative life science solutions, today introduced the first USDA-approved, real-time PCR test to detect a broad range of Swine Influenza Virus (SIV), a common debilitating condition that causes fever, lethargy, breathing problems and significant weight loss resulting in economic loss to producers.

The Applied Biosystems VetMAXTM-Gold SIV Detection Kit from Life Technologies provides veterinary diagnostic laboratories around the world with a highly accurate tool to test production swine for SIV strains, including H1N1. The kit is the market's first USDA-licensed, polymerase chain reaction-based (PCR) solution for rapid detection of SIV. Designed to zero in on the pathogen's RNA, it also targets multiple genomic regions to decrease the likelihood of false negatives.

The approval of the VetMAXTM-Gold SIV Detection Kit is based on the successful completion of the USDA's stringent review process to ensure safety and effectiveness of the real-time PCR test and evaluate production and quality systems compliance at the manufacturing site. Veterinary diagnosticians have historically relied on Life Technologies' molecular reagents and instrumentation to detect and control disease. However, the USDA-validated product now provides them with a federally approved test containing instructions, reagents and controls in a single kit.

"Life Technologies is committed to providing the most reliable and accurate animal health diagnostics," said Nir Nimrodi, head of Animal Health and Food Safety for Life Technologies. "Our newest kit complements our growing number of federally approved, molecular solutions developed to help test for diseases that threaten food producers' valuable herds and, ultimately, their business."

The VetMAXTM-Gold SIV Detection Kit is for animal diagnostic use only.

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Molecular Detection Inc. Receives Notice of Allowance for US Patent Application Broadly Covering Detection of Antibiotic-Resistant Bacteria

Molecular Detection Inc. (MDI), a company developing Detect-Ready® assays designed to increase the speed and accuracy of infectious disease diagnosis, today announced that it has received a notice of allowance from the US Patent and Trademark Office (USPTO) for a patent application titled "Methods, Compositions and Kits for Detection and Analysis of Antibiotic Resistant Bacteria." The allowed claims cover a key aspect of MDI's PCR-based technology platform, which accurately distinguishes between samples containing MRSA (methicillin resistant Staphylococcus aureus), MSSA (methicillin sensitive S. aureus) and mixed populations of bacteria by amplifying and evaluating multiple gene targets.

"Allowance of these claims confirms that MDI's approach is indeed state-of-the-art," said Todd Wallach, CEO and chairman of MDI. "They add legal backing to a growing body of independent data confirming that our Detect-Ready panel is the most technically advanced MRSA screening test available today, and effectively raise the bar for other screening products. The allowance includes broad method and kit claims, and we expect that the issued patent will serve as a powerful resource in our drive to achieve leadership in the molecular detection of resistant pathogens, a large and growing healthcare problem worldwide."

MDI's first product, the Detect-Ready MRSA Panel, is a qualitative real-time PCR in vitro diagnostic test that is marketed in the European Union and Australia and is in late-stage development in the US. Its CE-mark label was recently expanded to include the detection of colonization with MSSA and other bacteria, in addition to MRSA. Detect-Ready is the only marketed PCR-based MRSA screening test with the proven ability to accurately discriminate between these pathogens, thereby minimizing the false positive results experienced with other MRSA screening tests and ensuring that clinicians and healthcare facilities have the timely and reliable information they need to assess and minimize patient risk.

Mr. Wallach added, "We are especially pleased with the allowed claims in view of the fact that the FDA has issued draft guidelines for MRSA screening tests that require the discrimination and accuracy enabled by our proprietary technology. Plans for our US validation trial are progressing well, with US launch targeted for 2012."

Infections by MRSA and other antibiotic-resistant pathogens pose a growing problem to hospitals and healthcare facilities worldwide. The highly contagious bacteria that cause MRSA infections are resistant to all but the most powerful antibiotics. The Centers for Disease Control (CDC) estimates that in 2005, there were approximately 90,000 persons in the US diagnosed with severe MRSA infection and an estimated 19,000 died. The incidence of MRSA infections has been rising, and some experts estimate that over 60% of hospital-acquired bacterial infections are now antibiotic-resistant.

The allowed patent application (Application No. 12/106,137) is expected to issue in the next few months.

Detect-Ready kits are compatible with a number of the real time-PCR platforms currently found in most hospitals. They offer healthcare providers a high-performance sample-to-answer MRSA screening panel with an unmatched combination of accuracy, speed, flexibility and cost-effectiveness.

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MicroKit Simplifies Infectious-Disease Detection

Infectious diseases, such as the H1N1 influenza strain, have wrought havoc not only on human populations in recent years but increasingly on critical bits of economic infrastructure such as transport systems and hospitals. Efforts to contain the spread of the viruses are often hampered by the time and complicated processes involved in the diagnosis, isolation and treatment of patients showing symptoms of such viruses.

A Singapore outfit has developed a device that could dramatically slash the amount of time, costs and human resources needed to diagnose infectious diseases during critical outbreaks. At first glance, the Institute of Bioengineering and Nanotechnology's MicroKit looks like a souped-up breadmaker. But its insides reveal the convergence of technologies from a number of different research fields, including electrical, biomedical and chemical engineering. The invention is a finalist in the Asian Innovation Awards. The kit brings together a number of traditionally complicated and hazardous processes involved in disease detection into one small unit.

"The main challenge is to basically miniaturize the whole system so it's very fast and requires a very small amount of samples," IBN Executive Director Jackie Ying said. "The whole set-up is very small so that you can put it on a benchtop and be able to use it not just in the hospital but in the clinics as well as in checkpoints such as airports," she said. Using samples of bodily tissue or fluids, the kit marries the RNA/DNA extraction and the molecular diagnosis processes and reduces the time taken for the total detection process to two hours from six.

An operator using the MicroKit need only place a very small sample into a cartridge that slots into the device for analysis. At present, the sample-preparation process involves several steps between different pieces of equipment, often located in different facilities. The numerous steps also increase the chance of sample contamination as well as exposure of the virus to those collecting and analyzing the sample. However, the portability of the MicroKit means disease detection can be carried out at decentralized locations where human traffic is concentrated. Additionally, people operating the kit in the field don't need to be medical professionals.

IBN has licensed the MicroKit technology to SG Molecular Diagnostics, a spinoff of Singapore-based Dynamed Biotech Pte. Ltd., which plans to develop a range of diagnostic devices. It's also currently engaged in clinical trials for bacterial detection with Singapore General Hospital and National University Hospital, also in Singapore. Another important advance the kit makes is through its sub-typing capabilities, which remove the historically troublesome degree of uncertainty about which strain of influenza a person may be carrying.

This means people who are carrying only seasonal variants of the flu as opposed to the more virulent strains of influenza A H1N1 need not be isolated, helping reduce congestion in the hospital system. Over the past decade, pandemics of highly infectious diseases have created large problems for governments, not just in terms of human lives claimed but also in terms of their ability to cripple health and transport systems. The increased connectivity of the global economy means the economic impact of such outbreaks can extend well beyond those parts of the world immediately affected by the infections.

While the development of this device has its genesis in the various influenza strains that have made headlines in recent years, Professor Ying says the kit, with minor modifications, could also be used to identify a host of other diseases and infections such as HIV; hand, foot and mouth disease; hepatitis; dengue fever; SARS and cancer. It could also be useful in helping pick up traces of bacteria in the food industry.

"We are always looking at being able to upgrade our system so we can not only look at one sample at a time but 20 samples at a time, which is really what's needed when you have an outbreak of disease," Professor Ying said.

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Pacific Biosciences Contributes Whole Genome Sequence Data For German E. Coli Outbreak Strain And 11 Related Strains For Comparative Analysis

Pacific Biosciences of California, Inc. announced that it has completed a de novo sequence assembly of the Escherichia coli O104:H4 strain responsible for the recent outbreak in Germany using its Single Molecule Real Time (SMRT™) technology, and sequenced 11 related bacterial strains (including six previously unsequenced strains of the same serotype) for comparative analyses. An international team of scientific experts on E. coli collaborated on the rapid sequencing project to provide more comprehensive information about the origins of the strain that gave rise to the deadly outbreak. The data were generated using an early version of chemistry and software in development at Pacific Biosciences for the next major PacBio RS product upgrade, planned for the fourth quarter of 2011.

The data provided to the public domain includes a complete assembly of the German outbreak strain, alignment to assemblies from other outbreak isolates, and sequences for 11 related Enteroaggregative E. coli strains. The project demonstrates the ability to produce a PacBio-only de novo assembly for a complex microbial pathogen, and the power of rapid sequencing of multiple genomes with the PacBio RS to elucidate the evolutionary history of a pathogenic microbe. A summary of the project appears on the company’s website at http://blog.pacificbiosciences.com.

“Using samples provided by our collaborators, we rapidly sequenced each strain using a standard PacBio RS protocol that took on average less than eight hours from sample preparation to sequencing results,” said Dr. Schadt. “The ability to sequence the outbreak strain with reads averaging 2,900 base pairs and our longest reads at over 7,800 bases, combined with our circular consensus sequencing to achieve high single molecule accuracy with a mode accuracy distribution of 99.9%, enabled us to complete a PacBio-only assembly without having to construct specialized fosmid libraries, perform PCR off the ends of contigs, or other such techniques that are required to get to similar assemblies with second generation DNA sequencing technologies.”

Dr. Krogfelt commented: “These high quality data will provide scientists with more information about the genomic features of this strain that could provide new markers for predicting the higher degree of pathogenicity we are seeing with this outbreak. A more comprehensive evolutionary view of this pathogen may also help identify markers for antibiotic drug resistance that could be used in the future should other related strains emerge. The complexity of this case proves that international collaborations and communications are important in the achievement of detailed scientific information.”

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Bruker and the Institute of Medical Microbiology at the University of Zurich Announce a Collaboration for Mass Spectrometry-based Microbial Identification with Focus on Coryneform Bacteria, Actinomycetes, Fastidious Gram-negative Rods and Moulds

At the 4th Congress of European Microbiologists (Federation of European Microbiological Societies, or FEMS) meeting in Geneva, Bruker announces a collaboration with the Institute of Medical Microbiology (IMM) at the University of Zurich. The IMM is using Bruker´s MALDI Biotyper system as their next-generation, rapid microbial identification system. The Institute of Medical Microbiology is the Swiss national reference centre for mycobacteria and its strain collections of coryneform bacteria, actinomycetes and fastidious gram negative bacteria and moulds are acknowledged worldwide. The IMM is faced with the characterization and identification of challenging microorganisms on a daily base. Therefore, the IMM has developed their own algorithms and workflows for identification and antibiotics susceptibility testing (AST). Their AST approaches are mainly based on Kirby-Bauer testing methods, which are now applied in combination with MALDI-TOF based identification technology.

The focus of the collaboration between the Institute of Medical Microbiology and Bruker is the field of coryneform bacteria, actinomycetes, fastidious gram negative bacteria and moulds. The identification of these microorganisms is one of the most challenging tasks of many microbiological laboratories. The MALDI Biotyper provides a substantial contribution to a more thorough characterization of this group of microorganisms. Furthermore, the IMM microbiologists designed a study to validate the analytical performance of the MALDI Biotyper against their own molecular-characterized strain collection. Based on the results, the MALDI Biotyper reference library will be further extended. This will further improve its proven outstanding identification performance.

Dr. Michael Hombach, the Associate Head of Bacteriology at the Institute of Medical Microbiology, stated: “We have started the collaboration with Bruker to further develop the MALDI-TOF based microorganisms identification system, because the MALDI Biotyper has the potential to improve and support our microbiology identification strategy due to its quick and accurate performance in identifying difficult bacteria, yeasts and fungi samples. During our daily routine we increasingly face the problem of a broadening spectrum of infections and of complex resistance patterns. In order to keep up with fast modifications of microbial species characteristics, the open and flexible concept of the MALDI Biotyper is a promising solution to further improve the performance of our diagnostic lab.”

Dr. Guido Mix, Director of Microbiology Sales at Bruker Daltonics, commented further: “The collaboration with the Institute of Medical Microbiology support our efforts to provide novel and advanced tools to the microbiologists that make daily identifications faster and easier. The comprehensive and worldwide acknowledged expertise of the IMM in the field of coryneform bacteria, actinomycetes, fastidious Gram-negative rods and moulds will also be adopted in our developments. Thus, MALDI Biotyper based confident identification even of these challenging microorganisms will become more established in microbiologists’ daily work.”

Bruker’s dedicated MALDI Biotyper solution enables molecular identification, taxonomical classification or dereplication of microorganisms like bacteria, yeasts and fungi. Classification and identification of microorganisms is achieved reliably and fast using proteomic fingerprinting with high-throughput MALDI-TOF mass spectrometry. Applications include clinical routine microbial identification, environmental and pharmaceutical analysis, taxonomical research, food and consumer product processing and quality control, as well as in marine microbiology. Bruker’s robust MALDI Biotyper method requires minimal sample preparation efforts and offers low cost per sample. The MALDI Biotyper is available in a research-use-only version, as well as in an IVD version according to the EU directive EC/98/79 in certain EU countries.

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Real-Time PCR Assay and Rapid Diagnostic Tests for the Diagnosis of Clinically Suspected Malaria Patients in Bangladesh

More than 95% of total malaria cases in Bangladesh are reported from the 13 high endemic districts. Plasmodium falciparum and Plasmodium vivax are the two most abundant malaria parasites in the country. To improve the detection and management of malaria patients, the National Malaria Control Programme (NMCP) has been using rapid diagnostic test (RDT) in the endemic areas. A study was conducted to establish a SYBR Green-based modified real-time PCR assay as a gold standard to evaluate the performance of four commercially-available malaria RDTs, along with the classical gold standard- microscopy.

Methods: Blood samples were collected from 338 febrile patients referred for the diagnosis of malaria by the attending physician at MatirangaUpazila Health Complex (UHC) from May 2009 to August 2010. Paracheck RDT and microscopy were performed at the UHC. The blood samples were preserved in EDTA tubes. A SYBR Green-based real-time PCR assay was performed and evaluated. The performances of the remaining three RDTs (Falcivax, Onsite Pf and Onsite Pf/Pv) were also evaluated against microscopy and real-time PCR using the stored blood samples.ResultIn total, 338 febrile patients were enrolled in the study.

Malaria parasites were detected in 189 (55.9%) and 188 (55.6%) patients by microscopy and real-time PCR respectively. Among the RDTs, the highest sensitivity for the detection of P. falciparum (including mixed infection) was obtained by Paracheck [98.8%, 95% confidence interval (CI) 95.8-99.9] and Falcivax (97.6%, 95% CI 94.1-99.4) compared to microscopy and real-time PCR respectively. Paracheck and Onsite Pf/Pv gave the highest specificity (98.8%, 95% CI 95.7-99.9) compared to microscopy and Onsite Pf/Pv (98.8, 95% CI 95.8-99.9) compared to real-time PCR respectively for the detection of P. falciparum. On the other hand Falcivax and Onsite Pf/Pv had equal sensitivity (90.5%, 95% CI 69.6-98.8) and almost 100% specificity compared to microscopy for the detection of P. vivax. However, compared to real-time PCR assay RDTs and microscopy gave low sensitivity (76.9%, 95% CI 56.4-91) in detecting of P. vivax although a very high specificity was obtained (99- 100%).

Conclusion: The results of this study suggest that the SYBR Green-based real-time PCR assay could be used as an alternative gold standard method in a reference setting. Commercially-available RDTs used in the study are quite sensitive and specific in detecting P. falciparum, although their sensitivity in detecting P. vivax was not satisfactory compared to the real-time PCR assay.

Author: Mohammad Shafiul AlamAbu Naser MohonShariar MustafaWasif Ali KhanNazrul IslamMohammad Jahirul KarimHamida KhanumDavid SullivanRashidul Haque Credits/Source: Malaria Journal 2011, 10:175.

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Gaiker-IK4 Evaluates Rapid Diagnosis Techniques Guaranteeing Safety of Foodstuffs During Their Life Cycle

Gaiker-IK4 researchers are participating jointly with more than 500 experts from 40 countries in the MoniQA (Monitoring and Quality Assurance in the Food Supply Chain) network of excellence. This is a network which has a budget of over 12 million euros, the aim of which is to harmonise, at an international level, rapid analytical methods which, integrated with information and communication technologies (ITC), enable ensuring and controlling the quality of foodstuffs throughout the whole food chain, from the primary production stage to the dinner table.

In recent years new demands from consumers, increasingly aware of the implications of food and eating habits for health, have given special relevance to the levels of food safety and traceability offered to the consumer, improving, even more if it is possible, the control techniques for raw materials, processes and end-product. Recent events, such as the current food scare in Germany, have only served to intensify this growing social sensitivity to food safety and traceability.

The European Union, aware for some time now of the need to provide a coherent answer to this matter, laid down a decade ago the corresponding mechanisms for standards, defining la traceability as “the possibility of finding and following the traces of a foodstuff, animal fodder, an animal destined for food or for fodder, or with a probability of being so, throughout all their stages of production, transformation and distribution” (ISO 8402). The MoniQA network of excellence falls within this remit.

The main task of Gaiker-IK4 in the MoniQA network is focused on the coordination of tasks related to the identification of food risks, drawing up references, materials for the harmonisation of analytical methods, validation of methods and the generation of a data base containing information regarding food safety at an international level (legislation, food alerts, existing analytical methods for food control).

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