Accelr8 4-Hour Test Identifies New Drug-Resistant "Staph" (hVISA) Undetectable By Hospital Labs

Accelr8 Technology Corporation announced results from two studies presented at ASM 2011 (American Society for Microbiology) held in New Orleans. Authors included principal investigators from Denver Health and from the Barnes-Jewish Hospital in St. Louis. The annual ASM General Meeting is a major international congress for microbiologists and Infectious Diseases physicians.

One study screened 281 randomly collected clinical specimens and identified 62 for complete detailed analysis of pathogen content. The purpose was to test the accuracy and timing for BACcel™ rapid diagnostic assays intended for use with critically ill patients who acquire serious infections. The BACcel™ system eliminates culturing and analyzes individual live microbial cells directly from a patient specimen. All specimens came from the lower respiratory tract, used to diagnose pneumonia and other severe lung or bronchial infections. Hospital acquired pneumonia is the leading infectious cause of death in ICUs.

The study targeted three major pathogenic bacterial species responsible for infections multi-drug resistance (MDR). Together, these three species account for more than half of hospital acquired MDR infections. They include Staphylococcus aureus ("Staph," including MRSA), Pseudomonas aeruginosa, and Acinetobacter species. The latter two organisms already have high MDR propensity. But investigators are now finding new strains that recently acquired novel, rapidly-spreading "superbug" KPC genes from entirely unrelated species.

The new ASM study reported that the total time from specimen to results only required 4 hours, instead of the typical 3-day time for cultures using the same specimens. Results included organism counts, identification, and expression of two major resistance types for each one, including MRSA. Identification was correct in 182 of 186 tests, and antibiotic resistance classification in 31 of 32 tests.

The second study characterized Accelr8's new test for a hidden type of resistance in "Staph." Not only MRSA, but also the more common type of Staph can effectively resist the standard anti-MRSA antibiotic, vancomycin. With a new type of strain known as hVISA, culturing tests indicate susceptibility to vancomycin, but fails to detect subtle indications of low-level resistance that can lead to treatment failure. Microbiologists refer to this type of cryptic behavior as "heteroresistance." The investigators screened Staph clinical isolates (laboratory strains) and found 15 hVISA using complex culturing methods. The new BACcel™ assay correctly classified 14 of the 15 as hVISA, and 14 of 14 Staph clinical isolates negative for cryptic resistance.

Culturing methods to detect hVISA take 3 days or longer, depending on the methods. The BACcel™ system produced results in 4 hours. The test can be used directly from patient specimens, which would add no more than 1 hour to the total processing time.

According to David Howson, Accelr8's president, "the specimen study used types of specimen that may be the most difficult specimens for a lab to analyze. They are highly variable, and contain large amounts of sticky and bulky interfering materials. In the past, new diagnostic tests that have worked well with cultured strains often failed when challenged directly with respiratory specimens. We believe this study demonstrates that we've overcome this major hurdle. The study also set a new speed record for counting, identifying, and analyzing multiple targets with multiple resistance tests-only four hours after starting with a specimen. If we consider these results and the results presented a week ago at ATS, the combined data show that the BACcel™ rapid diagnostic system is accurate and very fast."

"The hVISA study also follows a presentation three weeks ago at the European ECCMID meeting that used the BACcel™ hVISA test, along with others. The new results add details that more fully characterize the test performance with this difficult new strain. The ASM study demonstrates the BACcel™ system's potential for revealing fundamental modes of resistance expression that were neither predicted nor detected using standard culturing methods," Howson continued. "These and other tests for multiple organisms and multiple resistance expression modes provide the platform for expanded studies and integration into the next BACcel™ generation. We are now widening our key opinion leader network to prepare for these important studies," Howson concluded.

Read more

bioMérieux Receives FDA Clearance for NucliSENS EasyQ® MRSA, Automated, Rapid Molecular Screening Test

bioMérieux announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its NucliSENS EasyQ® MRSA, an automated molecular test for Methicillin Resistant Staphylococcus aureus (MRSA).

The test detects seven MRSA types, covering the most prevalent strains. The test also simultaneously detects two targets, which provides added confidence to the screening results. The EasyQ system will support efficient batch processing of up to 46 MRSA screening tests in a compact space with a rapid turn-around time of only three hours. Real-time actionable results enable more informed clinical decisions, which play an essential role in the management of antimicrobial resistance. Helping clinicians to take faster action to isolate patients and limit transmission is a critical issue, since MRSA is one of the leading causes of healthcare-associated infections (HAI). MRSA is also on the rise and has spread into the community. In the United States, MRSA infections alone kill nearly 19,000 people a year. Studies have shown that the frequency of MRSA transmission is reduced 38-fold if patients are identified and isolated. Systematic infection control measures, including MRSA screening, reduce the MRSA rate by 50%.

NucliSENS EasyQ MRSA complements chromID™ MRSA, bioMérieux’s chromogenic media, which enables direct, color-specific visual observation of the bacterial colonies in patient samples. bioMérieux can now offer hospitals and healthcare providers cost-effective alternatives for both culture-based and molecular-based MRSA screening. The complete suite of bioMérieux MRSA solutions also includes VITEK® 2 for rapid identification and antibiotic susceptibility testing, Etest® for extended dilution MICs (minimum inhibitory concentration), and DiversiLab® for strain typing.

The NucliSENS EasyQ MRSA test was cleared with a clinical sensitivity of 94.7% and a clinical specificity of 96.5% when testing nasal samples from adult patients. Additionally, the assay also received clearance with a clinical sensitivity of 100% and a clinical specificity of 97.3% when testing nasal samples from pediatric patients.

Read more

Nanologix introduces new "Petri Flat Pack"

NanoLogix, a biotechnology innovator in the rapid detection and identification of live-cell bacteria and microorganisms, announced today its latest innovation for the microbial diagnostic industry, the Flat Pack. The company has applied for a patent for this new packaging method to improve on conventional Petri packaging practices. The Flat Pack method more effectively protects the quality and integrity of NanoLogix BioNanoPore (BNP) and BioNanoFilter (BNF) Rapid Test Kits during both shipment and long-term storage, for all types of laboratory settings and locations.

The NanoLogix Flat Pack is a practical solution to the common challenges of traditional packaging, which expose plates to cracking and contamination by wrapping stacks of dishes in thin-film plastic. By contrast, the NanoLogix Flat Pack method vacuum seals a single layer of BNP/BNF Test Kits between two sheets of thick plastic. The process of vacuum-packaging protects the kits from damage and creates a sterile environment to prevent contamination from the outside air. In addition, the flat surface of the Flat Pack, allows for easy storage and visibility of product quality.

“We are pleased with the innovation of our Flat Pack packaging,” said Bret Barnhizer, NanoLogix CEO. “The sterile environment of the vacuum seal demonstrates our commitment to high-quality rapid diagnostics, no matter what type of use or laboratory location. From the hospital and the manufacturing floor, to biodefense operations and developing regions the Flat Pack ensures our products arrive intact and are ready for use at a moment’s notice.”

Read more

T2 Biosystems Announces Presentation of Data at ASM 2011 Demonstrating Rapid Detection of Candida with Single-Process Magnetic Biosensor Test

T2 Biosystems, Inc., a company developing next generation diagnostic products, today announced that data from studies performed on the company’s novel magnetic resonance diagnostic platform will be presented at the 2011 General Meeting of the American Society for Microbiology (ASM 2011), May 21- 24, 2011, in New Orleans, LA. The data to be presented highlight the efficacy, sensitivity, and utility of the company’s magnetic biosensor test in detecting the fungal pathogen Candida directly in whole blood from patients with the fungal infection, candidemia.

The data presented at ASM 2011 demonstrate how T2 Biosystems’ technology enables detection of multiple pathogens and species in a single-process test with rapid diagnostic results within minutes to under two hours. In comparison, today’s conventional diagnostic technologies use optical signals, require pre-processed biologic samples, and can take days to yield useful results. In addition, the data show that T2 Biosystems’ Candida test yields high sensitivity results through direct detection in whole blood, in contrast to the extraction and purification step required by conventional techniques which often lead to low yield of the analytical target and reduced overall sensitivity. By delivering results faster than these methods, T2 Biosystems’ technology can improve health outcomes while reducing healthcare costs.

Unlike current diagnostic tools, including culture-based diagnostic methods, which utilize optical signals and require preparation of a clean biologic sample, T2’s magnetic biosensor technology combines nanotechnology with the power of magnetic resonance detection. A “dirty sample” of a patient’s blood, saliva, urine or other biofluid is loaded directly into a desktop instrument via a disposable cartridge. The sample is then mixed with magnetic nanoparticles and analyzed for the presence of specific fungal, bacterial or viral pathogens or biomarkers using a technique similar to magnetic resonance imaging (MRI). The system is able to detect low concentrations of target agents or specific pathogens and present a result to the user within minutes to under two hours.

T2 Biosystems is disrupting the landscape of clinical diagnostics with its proprietary magnetic biosensor detection platform. The T2Dx platform enables healthcare professionals to save lives and reduce costs by providing sensitive, accurate, and rapid diagnostics results. The company’s products can detect any molecular or immunoassay target directly from unpurified clinical samples in hospitals, labs, and physicians’ offices. T2 Biosystems is located in Lexington, Massachusetts.

Read more

bioMérieux Becomes the World Leader in Food Testing with AES Laboratoire Acquisition

bioMérieux, a world leader in the field of in vitro diagnostics, has signed an agreement to acquire AES Laboratoire, a leading French group, specialized in industrial microbiological control, for 183 million euros. This will be bioMérieux’s ninth acquisition in five years and its third in the area of industrial applications.

Founded 30 years ago, the AES Laboratoire group, AES CHEMUNEX’s parent company, ranks fifth among industrial microbiology companies worldwide, with annual sales of 76 million euros. The company has close to 400 employees, with R&D and manufacturing sites located in France and Canada, in addition to four commercial subsidiaries. Commercial and administrative headquarters are based near Rennes (France).

“This acquisition fits perfectly with bioMérieux’s strategy. The quality of AES Laboratoire’s product offering will enable us to reinforce our leadership position in industrial applications,” declared Jean-Luc Bélingard, Président Directeur Général of bioMérieux. “We are convinced that AES Laboratoire’s outstanding entrepreneurial spirit, imparted by its founder and chairman, Mr. Le Roch, and deep understanding of market dynamics, provide a solid foundation for our future development. We feel very fortunate to have such an experienced and talented team join our company,” he added.

Alain Le Roch, Chairman of the AES Laboratoire group, added: “Over the past 30 years, AES Laboratoire has gained unique expertise and innovative technologies, including ultra rapid and sensitive microorganism detection solutions. Choosing an alliance with bioMérieux offers the best perspectives for growth, especially on a global scale.”

bioMérieux’s and AES Laboratoire’s product lines are highly complementary. An expert in all steps of microbiological analysis, AES Laboratoire has products spanning applications for the food, pharmaceutical, and cosmetic industries. The company’s offer includes a complete portfolio of conventional and novel culture media, rapid microbiology testing methods, and laboratory instruments. AES Laboratoire has a leadership position in cytometry for the detection of microorganisms, with an innovative range of flow cytometers and a unique solid-phase cytometer, ChemScan® RDI. The company also provides a range of services, as well as software for laboratory monitoring and metrology.

“AES Laboratoire’s innovative solutions, especially in lab automation and rapid microbiology, are aligned with our 2015 strategic goals. We will be leveraging bioMérieux’s extensive global commercial network to make AES Laboratoire’s technologies more broadly available, providing bioMérieux and AES Laboratoire customers with the most comprehensive product offering worldwide,” said Stéphane Bancel, Chief Executive Officer of bioMérieux.

AES CHEMUNEX’s unique expertise in the agri-food and cosmetic sectors will support bioMérieux’s growth strategy. bioMérieux intends to further develop and invest in AES Laboratoire’s cytometry solutions and other promising platforms, reinforcing the company’s strong competitive position.

Read more

vermicon AG Develops the World's Fastest Identification and Quantification Method for E. coli and Coliform Bacteria

Microbiology specialist vermicon AG from Munich, Germany, developed an innovative detection system for efficient and cutting-edge water monitoring outlined for industrial clients. Within only 12 hours the most relevant drinking water bacteria Escherichia coli and coliform bacteria can be identified and absolutely quantified.

Drinking water has to be thoroughly tested due to legal regulations. The main focus lies on the indicator bacteria E. coli and other coliforms. Conventional methods take up to 48 hours for producing results. Not in time for quickly detecting contamination or quickly releasing locked down pipe lines. With vermicon's VIT gene probe technology analysis time is reduced drastically and safety is maximised instantly: Gene probes penetrate the bacteria and make them shine highly specifically. This not only allows for specific identification but also provides exact quantification of the microorganisms within the investigated sample.

vermicon has developed a detection system for coliform bacteria and particularly E. coli which allows the highly specific identification and simultaneous quantification of bacteria contained in water samples: ScanVIT-E. coli/Coliforms. The system is based on the innovative and reliable ScanVIT technology which is already applied for the detection of Legionella. With this system in one sample all E. coli cells and in parallel all coliform bacteria are detected. Thus, you get two conclusions in one test.

After filtration the water sample is cultivated shortly. After 9 hours at most the grown micro-colonies are identified precisely and quantified absolutely by using the gene probe technology. Absolute quantification means that every grown colony of E. coli or other coliform bacteria is identified specifically and counted subsequently.

With this testing system vermicon offers the world's most rapid detection system for identification and absolute quantification of E. coli/coliforms. Within only 12 hours the test presents highly specific quantitative and qualitative results. It provides users with entirely innovative testing options – and forms the basis of a highly efficient and cutting-edge water monitoring system.

Read more

Rapid Micro Biosystems Announces New Chief Financial Officer

Rapid Micro Biosystems
One Oak Park Drive
2nd Floor
Bedford, MA 01730
Contact Mark Severns
phone: +1 781-271-1444 x267
email: mseverns@rapidmicrobio.com
website: www.rapidmicrobio.com

Rapid Micro Biosystems, a leading provider of non-destructive, rapid microbial detection, today named Michael J. Mullen Chief Financial Officer. Mullen will lead the financial planning, accounting, human resources, supply chain and IT functions for the business. He will report directly to the CEO, Steve Delity.

Mr. Mullen brings more than 30 years experience managing the financial endeavors in biotechnology and pharmaceutical instrument businesses. Prior to his role as Chief Financial Officer for Rapid Micro Biosystems, Mullen was an interim CFO with Valeritas, Inc. and CFO with Magellan Biosciences. While serving as CFO at Magellan Biosciences he implemented a comprehensive program of strategic acquisitions and divestitures which drove significant improvements in revenue and EBITDA.

Mullen was a co-founder and partner at JMH Capital, and has also held senior financial management roles with PerkinElmer, Inc, and Thermo Optek. Mullen graduated from James Madison University in Harrisonburg, VA, with a BBA in accountancy.

“We are excited to have Michael join our executive team,” said CEO Steve Delity. “His experience and knowledge in the pharmaceutical and biotech industry combined with his expertise in growing businesses will be integral to Rapid Micro Biosystems long-term objectives.”

Mullen commented: “I am privileged to join Rapid Micro Biosystems at an inflection point in the company’s history. I am impressed with the business’ performance thus far and am eager to play a role in the company’s plans forward.”

Rapid Micro Biosystems, headquartered in Bedford, Massachusetts, provides innovative products for faster detection of microbial contamination in the manufacture of pharmaceutical, biotechnology, and personal care products. The Company’s Growth Direct™ System detects contamination earlier, delivering compelling economic benefits to manufacturers while improving their quality process. The Growth Direct™ System is the first and only automated system that accelerates testing, fits with current regulatory practices, and addresses all key applications. For more information, visit, visit www.rapidmicrobio.com.

Read more

Magellan Biosciences and Miacom Diagnostics Team Up to Enable Faster, Easier Identification of Pathogens

Magellan Biosciences is partnering with Germany-based miacom diagnostics GmbH to bring miacom’s unique, cost-effective family of molecular tests to the U.S. and Canadian markets. The 30-minute tests identify sepsis-related pathogens directly from blood-culture bottles, enhancing Magellan’s suite of blood culture, microbial identification, and susceptibility test products for microbiology laboratories. The combined offering is designed to provide fast, reliable results for laboratories of all sizes, enabling clinicians to make more-informed treatment decisions that improve patient care and help in the global fight against drug resistance.

The product suite will include Magellan’s TREK-brand VersaTREK® microbial-detection system, miacom’s lucesco®IVD (in vitro diagnostic) kits for affordable, rapid identification of bacteria and fungi/yeast from blood cultures, and Magellan’s TREK-brand Sensititre® susceptibility-testing system. Pathogens from a positive blood culture on the VersaTREKsystem can be identified quickly using a lucesco IVD kit, with microbial susceptibility determined using the Sensititre system. Under the terms of the agreement, Magellan will be the exclusive U.S. and Canada provider of Bacteremia and Fungimia panels using the miacom platform. Four miacom diagnostics tests have already been approved for use in Europe; this year, Magellan expects to market a family of miacom sepsis tests available for research use only in the U.S. while beginning the clinical trials toward FDA clearance.

Commenting on the agreement, miacom’s Chief Executive Officer, Mirko Stange, Ph.D., said, “We are pleased to partner with Magellan to improve patient care across the globe. Unlike most other molecular technologies, miacom assays can be performed in virtually any microbiology laboratory. Doctors no longer have to rely on an empirical approach to therapy – the combination of our rapid lucesco IVD results and Sensititre susceptibility testing eliminates guess work, enabling clinicians to prescribe the best, most-targeted therapy to their patients as quickly as possible.”

The miacom assays, which incorporate a next-generation fluorescence in situ hybridization, streamline and greatly simplify molecular testing – yielding multiplex pathogen identification in just 30 minutes. Further, handling and performance limitations from error-prone washing steps common to traditional techniques are completely eliminated in miacom’s proprietary method. The workflow is as simple as performing a Gram stain and results are available one- to five-days earlier than traditional culture methods.

“Getting patients on the correct antibiotic, in the right dosage, in the least amount of time is crucial to both patient health, and to countering the emerging problem of drug resistance,” said Magellan President and Chief Executive Officer Hiroshi Uchida, Ph.D. “By combining rapid miacom identification technology with the flexibility and accuracy of the VersaTREK and Sensititre systems, laboratories of all sizes can battle drug resistance with a cost-effective solution for blood culture, identification, and susceptibility testing.”

Read more

Sandia Labs Developing Automated Sample Prep for Sequencing Unknown Pathogens

To enable the rapid sequencing of unknown pathogens, researchers at Sandia National Laboratories are creating an automated, microfluidic-based sample preparation process for next-generation sequencing from unascertained biological samples. The single-step sample prep system is part of Sandia's Rapid Threat Organism Recognition, or RapTOR, project, which is geared toward developing a rapid sequencing method for bioterrorism applications under a Sandia internal laboratory research directive that provides seed money for projects of interest to other government agency customers. The sample prep component of the project consists of a microfluidic hub that connects a group of modular microscale sample processing components that normalize, ligate, separate, and otherwise prepare DNA samples from unknown pathogens.

"With [RapTOR] we want to be able to detect unknown pathogens or new, emerging pathogens — things we've never seen before — using sequencing technology," said Kamlesh Patel, one of RapTOR's team leaders. While sequencing has become faster and easier with next-gen systems, the pre-sequencing steps can still slow down things down by days or even weeks — too long a wait where the discovery of unknown pathogens is concerned, Patel said. The goal of RapTOR is to scale down and automate the traditional steps of sample prep in order to more quickly identify novel or modified pathogens in the event of a bioterrorism attack. "The idea is that you can sequence everything that you have, and when you find a sequence you know is real but doesn’t belong to any taxonomy, you can go in and investigate very quickly that this is a new species or that this was an E. coli that’s been modified, [and] here are some… events where someone has gone in and tinkered with the genetic code," Patel said. "Hopefully someday … [someone] could just put in a DNA sample and press a button … and then come back when he's ready to look at the data," Patel added. "Our goal is to have a platform that we can deliver to say, the [US Centers for Disease Control and Prevention], where somebody with minimal training can operate this."

Though the RapTOR project as a whole involves several areas, including the development of protocols for sequencing and post-sequencing bioinformatics, the automated sample prep system has been a central achievement, especially the design of the digital microfluidic hub, which routes sample from one step to another in the form of droplets. "Rather than put it all on one microfluidic chip, or one fluidic channel, we are developing this interface that takes modules and connects them together... It's a PCR machine, a normalization module, a separations module all connected together via a droplet," Patel said. A finished sample would come out of this modular system and go right into a sequencer, he explained. "We can do PCR at the micro scale [as well as] separation, cleanup, and fragmentation," he said. "So what we're working on now is [doing] all of these in concert. For the most part, we are adapting proven biological protocols at the bench top, but there are some modifications we have to do to go to the sub-microliter scale."

Normalization is a particularly important aspect of RapTOR's prep system, because DNA samples from people sickened by an unknown pathogen are predominantly host DNA, which must be suppressed for pathogen DNA to stand out, Patel said. "When you think about a clinical sample, let's say a blood sample or a nasal swab from a clinically sick patient, 99.99 percent of the DNA you're going to sequence is really human. And maybe that .01 percent is going to be the pathogen. You may just get lucky and find it and that does happen, but it's kind of a poor use of the awesome power and the bandwidth a sequencer can provide," he said. In the RapTOR system, two techniques are used to suppress human DNA, according to Patel: normalization with hydroxyapatite chromatography and a "bead-based capture technique where we capture the human exome and remove it from the sample." To normalize, "basically [we] take the entire DNA population and actually melt it at 95 degrees so everything turns into single strands," Patel said. A droplet moves the sample from a heating area to another region where it is cooled to 65 degrees. As the DNA cools, "you get a partial re-hybridized population where the high-abundance components have a higher statistical chance of finding [their] complementary pair and will hybridize, and the rare fractions will not find [their complement] and will remain a single strand," Patel said.

In tests with known samples, this aspect of RapTOR's prep process has been shown to can increase the proportion of pathogen DNA recovered, at least as well as benchtop enzymatic methods, Patel said. The hub also connects with components that perform other preparation steps. Patel noted that sequencers such as the Illumina Genome Analyzer require DNA to be fragmented into lengths of about 200 to 300 base pairs. RapTOR's sample prep uses enzyme-based technology to do this fragmentation, he said. Ligation and barcoding for multiplexing are also connected to the hub, as are cleanup steps and a PCR module. The small scale offers benefits, Patel said, for example smaller sample sizes, lower volume amounts, and speed. Benchtop PCR takes well over an hour, but "at the micro scale you can do PCR in less than ten or fifteen minutes," and the process requires less sample manipulation than at the macro scale, he said. "You can combine a lot of the cleanup steps together whereas on the bench top you have to do those separately."

Patel said that the team has been testing the systems by running one half of the modules and then the other. The remaining challenge is to get the whole group working together. "We haven't fully integrated the entire system, but I anticipate it [will] take up space no larger than the size of a desktop computer, at best," Patel said. According to Patel, the group has applied for several patents on the droplet manipulation aspect of the platform and its interface, but they are still pending. He said the group is looking for commercial partners who might want to take the technology to the next step. In addition, the researchers have received funding from the US Army Criminal Investigations Lab to spin off the tech in another direction: genotyping instead of genome sequencing. "The idea is that we could build a portable system that could [enable] DNA fingerprinting in the field," Patel said.

Patel mentioned the recent DNA fingerprinting of Osama Bin Laden, saying that while this would now require sending samples to a lab, a compact automated system would mean future missions could "take a DNA sample and put it into this portable genotyping system and get the results then and there on the helicopter ride back." "As you look into the crystal ball, look down the road, you can imagine a desktop-like sequencer in all kinds of places, like a doctor's office," Patel added. "And attached to that is an automated microfluidic version of sample prep."

Read more

Bruker Introduces New Consumable MALDI Biotarget™ For The MALDI Biotyper™ Workflow Using Proteomic Microbial Identification

At the 21st Annual Meeting of the European Society of Clinical Microbiology and Infectious Diseases, Bruker introduces single-use MALDI Biotarget™ sample plates for the mass spectrometry-based MALDI Biotyper workflow for microbial identification of a wide range of microbial species by means of specific proteomic fingerprints.

Due to its very fast result generation and superior analytical performance, in recent years MALDI Biotyper-based molecular identification has increasingly replaced classical biochemical identification in clinical microbiology laboratories. The MALDI Biotyper allows for microbial identification from pure cultures within a few minutes. It enables a broad and unbiased identification of more than 2,000 species of gram-negative and gram-positive bacteria, as well as yeasts. Currently, more than 250 MALDI Biotyper systems have been installed, mostly in clinical routine laboratories.

The MALDI Biotargets are a further addition to Bruker´s product range for fast and cost-effective microbial identification. They complement Bruker´s reusable steel target plates, and can, for example, be used in laboratory networks that have a central core facility equipped with a Bruker MALDI-TOF mass spectrometer. In this use case, the samples can be prepared in satellite microbiology laboratories and can be sent to the central core laboratory for species analysis. The results can then be reviewed via a local MALDI Biotyper software client for the final approval of the identification by the microbiologist.

Conveniently, the MALDI Biotargets make target cleaning procedures unnecessary, and they reduce the need for chemical handling in laboratories. Via their barcode-label, the MALDI Biotargets enable sample tracking of the microbial isolates. The MALDI Biotargets are suitable for the preparation of up to 48 microbial isolates, and MALDI Biotargets are currently for research-use-only.

An additional, proprietary reusable steel BigAnchorChip™ target plate is the best choice for workflows coming from liquid phase, like in the rapid detection of salmonella after pre-enrichment from stool samples.

Dr. Ulrich Weller of Laboratory Boogen in Cologne, Germany, stated: “Our laboratory has done most of our microbial routine identification work with the MALDI Biotyper in the last few years. Now we have extensively studied and validated the new consumable MALDI Biotargets in comparison to Bruker´s reusable steel targets. The MALDI Biotargets have shown the same excellent performance, and make handling even more convenient. Moreover, they allow us to send prepared samples for measurements in partner laboratories.”

Dr. Wolfgang Pusch, Vice President for Clinical Research Solutions & IVD at Bruker Daltonics, added: “We are very pleased to introduce the MALDI Biotargets for our customers in microbiology to ensure high quality sample preparation to achieve the best results for new workflows in microbiology. Our reusable steel targets are the basic sample preparation plates for standard workflows. The new MALDI Biotargets now allow for a further reduction in workload and chemical handling by our customers.”

Read more

Bruker Develops Integrated Microbiology Workflow for MALDI Biotyper Microbial Identification and BD Phoenix Antibiotic Susceptibility Testing System

Bruker announced the completion of an integrated workflow using the Bruker MALDI Biotyper for microbial identification (ID) from cultures, and the BD Phoenix system for antibiotic susceptibility testing (AST) at the 21st Annual Meeting of the European Society of Clinical Microbiology and Infectious Diseases.

The ID and AST systems are integrated via the BD EpiCenter data management system. The workflow integration has been validated at a number of pilot sites in Europe and in the U.S., including public and private laboratories such as Dynacare (Milwaukee, Wisconsin), Klinikum Bayreuth (Germany), Synlab Weiden (Germany), Synlab Augsburg (Germany) and the Vatican Hospital (Rome, Italy).

The integrated workflow begins with ordering the MALDI Biotyper ID and BD Phoenix AST using the customer's Laboratory Information System (LIS). The order is automatically transferred to the BD EpiCenter middleware and can be used for worklist management. Barcode labels containing the laboratory accession and isolate number can be automatically printed for the BD Phoenix and MALDI Biotyper samples. The sample location on the MALDI Biotyper plate is mapped using a pre-printed template and BD EpiCenter barcode labels. The barcodes are scanned into the MALDI Biotyper software for accurate specimen tracking. The AST and ID samples are then each processed according to their respective protocols.

Upon completion of the microbial ID, the MALDI Biotyper results and confidence values are automatically transferred to BD EpiCenter over a network interface, and the ID is matched to the AST results produced by BD Phoenix. All results are analyzed by the BD Xpert system for quality assurance and alerting. Completed results are reviewed and released for review by the clinicians and subsequently to the LIS.

Bruker further noted it is also working with BD Diagnostics on an integrated blood culture workflow, using the BD BACTEC blood culture system, the Bruker MALDI SepsiTyper Kit for sample preparation directly from positive BD blood culture bottles prior to rapid MALDI Biotyper ID.

Bruker's proprietary MALDI Biotyper solution enables molecular identification, taxonomical classification or dereplication of microorganisms like bacteria, yeasts and fungi. Classification and identification of microorganisms is achieved using proteomic fingerprinting by 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 marine microbiology.

Bruker's MALDI Biotyper method requires minimal sample preparation efforts and offers low consumables cost per sample. The MALDI Biotyper is available in a research-use-only version, as well as in an IVD-CE version according to EU directive EC/98/79 in certain European countries. The MALDI SepsiTyper Kit is presently for research use only.

Read more

The Increasing Application of Rapid Testing in Global Food Safety

New research has reported that there is an increasing demand for rapid microbiological testing in the food industry. One possible cause for this development is the food manufacturers’ discontent and disappointment over the current quality control methods that are being implemented. These food companies are turning to automated tests that produce fast results to determine the level of food safety of their products. Another driving force for this development is the increasing demand for food consumption, as well as the increasing demand to prioritize food safety and regulations.

Currently, there are more than 60 types of rapid tests that are used to check the safety of food, and most companies all over the world accept these testing methods. It has also been indicated that rapid tests will increase in usage even more in the next five years. Despite these tests being more expensive than the traditional ones, rapid testing methods will still have a significant gain in the market.

Contributing to the growth of rapid testing methods in the food safety industry is the consumers’ growing awareness of microbiological hazards that can be found in food. This increasing awareness will also lead to the demand to give more priority to food safety. Also, the development of new biotechnological tools in rapid testing will be adopted by the food industry, further spurring the growth of the rapid food testing market around the world.

Currently, what is being utilized the most are tests for determining the presence of pathogens in food. However, in years to come, rapid testing will also cover Genetically Modified Organisms (GMO) testing, as well as other tests for processed food products.

Read more

BD Launches BD MAX™ Open System in Europe and Reveals Strategy to Build Broad Menu of Assays that Provide Timely, Accurate Information to Laboratories and Clinicians

BD Diagnostics, a segment of Becton, Dickinson and Company, announced the European launch of the BD MAX™ Open System for molecular testing, which will enable laboratories to run both laboratory and BD-developed assays and offer enhanced testing services that elevate the standards of care at their institutions. BD made the launch announcement on the opening day of the 21st European Congress of Clinical Microbiology and Infectious Diseases and the 27th International Congress of Chemotherapy (ECCMID/ICC) in Milan, Italy.

“In a world with ever-evolving pathogens, laboratories need to provide clinicians with fast, accurate and actionable diagnostic information that will save patient lives,” said Tom Polen, President of BD Diagnostics - Diagnostic Systems. “The new completely open, state-of-the-art BD MAX System empowers laboratories to automate their unique internally developed molecular assays, while accessing a rich and growing menu of world-class assays from BD and our leading assay development partners.”

BD MAX is the first and only fully automated, open, bench-top molecular testing workstation able to perform both IVD/CE and laboratory-developed tests. The BD MAX System gives clinical laboratory professionals new ability to help their institutions respond to emerging threats, such as new strains of deadly drug-resistant bacteria or respiratory illnesses.

“BD’s strategy is to make BD MAX the laboratory equivalent of a smartphone,” said Polen. “We are working with leading assay development companies from around the world to develop a constantly growing, content-rich menu of tests that deliver critical information to caregivers faster and more accurately than current methods. Our plan is to make the BD MAX System an indispensable tool that no laboratory professional will want to live without.”

According to Polen, BD intends a steady stream of announcements regarding agreements with best-in-class IVD assay developers to bring new assays to the BD MAX System for a broad range of disease categories. The BD MAX System’s content-rich menu, open capability, full automation and standardized workflow will enable laboratories to consolidate and standardize a broad range of molecular tests to build programs that meet both their current and future clinical needs. The system will give European laboratories the ability to run their current laboratory developed assays as well as the ability to develop new ones.

Read more

FDA Clears First One-Day Susceptibility Test for Diagnosis of Deadly Bacteria

MicroPhage, Inc., announced it has received 510(k) clearance from the U.S. Food and Drug Administration to market its KeyPath™ MRSA/MSSA Blood Culture Test - BT, which returns same-day antibiotic susceptibility results for deadly S. aureus infections. The test is unique because it not only enables doctors to identify a S. aureus infection; it also determines whether the strain is methicillin resistant (MRSA) or methicillin susceptible (MSSA), thus providing the physician with the means to determine an effective course of treatment.

"MRSA and other antibiotic-resistant 'superbugs' represent one of the greatest public health challenges of our century, and identifying those dangerous bacteria early is crucial in both treating patients and limiting the spread of the infection to others," said Don Mooney, President and Chief Executive Officer at MicroPhage. "This test is a timely and a much-needed improvement to an important area of hospital and laboratory medicine."

As many as half of all patients with S. aureus infections are initially prescribed inappropriate or sub-optimal antibiotics before traditional test methods return information about the bacteria's antibiotic susceptibility. The KeyPath™ MRSA/MSSA Blood Culture Test - BT provides key diagnostic information that enables doctors to prescribe the most appropriate antibiotics for a patient's infection up to two days sooner than is possible with current test methods.

The test is the first product developed using MicroPhage's proprietary Bacteriophage Amplification Technology (BAT™) platform and meets stringent CLSI and FDA criteria. Unlike current test methods, which rely on lengthy culture procedures to isolate and characterize bacteria, BAT™ accelerates the process while exposing the bacteria to antibiotics, delivering true phenotypic antibiotic susceptibility results. The test requires only a few minutes of hands-on time and can be integrated into any laboratory immediately as no special instrumentation is required.

"The mortality rate for S. aureus bloodstream infections is in the range of 30 to 40 percent and patients are typically placed on a combination of antibiotics to fight the infection prior to obtaining the culture results. The information provided by this test will allow physicians to more rapidly optimize therapy, which is strongly correlated with better patient outcomes," said Richard Proctor MD, Professor Emeritus at the University of Wisconsin Medical School. "Increasing rates of antibiotic resistance in most bacterial pathogens makes antibiotic selection difficult. This test provides significant advantage over existing alternatives."

The KeyPath™ MRSA/MSSA Blood Culture Test - BT was evaluated in a clinical study of 1,116 blood samples at four major U.S. hospital centers, including Duke University Medical Center, UMDNJ-Robert Wood Johnson Medical School, Northwestern University and Denver Health. The test was 98.9 percent accurate (178/180) for MRSA identification and 99.4 percent accurate (153/154) in determining MSSA within the organisms identified as S. aureus.

"Other methods, such as PCR, mass spectrometry and immunoassays have been introduced but only provide bacterial identification and, in some cases, markers for antibiotic resistance," said Drew Smith, Ph.D., Chief Science Officer at MicroPhage. "However, these methods are affected by genetic mutations and other biological variables that can impact their accuracy. In contrast, the MicroPhage BAT™ platform provides a phenotypic result that directly assesses the organism's response to an antibiotic. The platform can be extended to a broad range of bacterial pathogens and sample types thus enabling development of a long pipeline of clinically useful susceptibility tests and test panels."

The MicroPhage product pipeline includes rapid single-pathogen and multi-pathogen diagnostic tests for simultaneous detection and determination of antibiotic susceptibility. The KeyPath™ MRSA/MSSA Blood Culture Test - BT has already achieved CE marking and commercialization efforts are under way in Europe.

Read more

BAX® System Real-Time Assay for E. coli O157:H7 Approved by Health Canada

Beef processors in Canada can now use a real-time BAX® System assay from DuPont Qualicon to test ground beef and beef trim for E. coli O157:H7. This rapid method delivers same-day results, providing reduced hold times and increased confidence in release decisions.

Health Canada, the federal department responsible for helping Canadians maintain their health, is publishing the approved method as MFLP-76: The BAX® System real-time assay for the detection of Escherichia coli O157:H7 in foods in volume three of the Compendium of Analytical Methods.

This real-time assay has already been certified by the AOAC Research Institute as a performance-tested method for detecting E. coli O157:H7 on real-world samples sizes with shortened enrichment times. Developed in collaboration with the Agricultural Research Services of the U.S. Department of Agriculture, the assay quickly detects all known E. coli O157:H7, even atypical strains.

According to Shannon McCoy, Canada business manager for DuPont Qualicon, “This latest government approval allows meat producers in Canada to better compete in world markets by using technology that reduces total test time while maintaining the highest levels of food safety.”

Read more

Supply & Demand Chain Executive Honors Celsis' Significant Impact on Manufacturing Process

Celsis International today announced that the company has been selected for inclusion in the 2011 Supply & Demand Chain Executive (SDCE) 100 – “100 Great Supply Chain Projects”. This year’s awards focus on projects that transformed supply chains and had a significant impact on a company’s manufacturing process.

Celsis was selected for its success in improving and streamlining the final product release process for Kao Worldwide, formerly the Andrew Jergens Company, a leading manufacturer of personal care products. As reporter Willliam Atkinson explained in SDCE’s August/September 2010 issue, “If there is a way to help the Quality department get its job done faster, then, by definition, the operations process can move along faster, thus reducing time in the supply chain.”

Kao Worldwide was looking for a solution that would help them speed up product quality testing in the lab without sacrificing consumer safety. Kao selected the Celsis Advance system, a technology that delivers rapid microbiology results, for quality control and final product release of its hair care, skin care and soap products. “Since the [Celsis] technology allows us to get micro results in half the time, we are able to release products and ship products pretty much as needed,” said Mark Entrup, USA corporate microbiologist for Kao. “This has also reduced our warehouse space significantly,” he added. “Instead of having to produce and then stockpile, the technology allows us to produce as orders require.”

“Manufacturers are looking for cost efficient ways to streamline operations and reduce inventory requirements. Celsis takes great pride in being able to deliver a unique, innovative solution to help customers save money while getting their products to market quickly and safely,” said Celsis CEO Jay LeCoque. “We are pleased to share this award with Kao. It is further proof that a lean Quality department can make important, bottom-line contributions.”

By identifying contaminated products faster, companies using Celsis are able to respond faster, preventing more contaminated batches from being manufactured and often preventing contaminated products from being shipped to market in the first place. The system delivers the fastest time to confirm the absence of microbial contamination – the essential information needed to release the vast majority of products quickly -- detecting even slow-growing moulds within 24 hours.

Final recipients will be featured in the June 2011 issue of Supply & Demand Chain Executive, as well as online at www.SDCExec.com.

Read more