Magellan Biosciences Announces Agreement with Bruker to Provide Microbiology Tools to Battle Drug Resistance

Magellan Biosciences announced an agreement with Bruker Corporation to deliver microbial identification from cultures using MALDI-TOF proteomic finger-printing, along with Magellan's TREK-brand susceptibility tests to clinical, research, and veterinary laboratory customers. The compatible product offerings are expected to improve the microbiology laboratory workflow, offering fast, reliable results that enable clinicians to make more-informed treatment decisions. Prescribing the right antimicrobial drug at the lowest possible dose to eradicate a bacterial, fungal, or yeast infection is not only important to the specific patient's health, but also critical to the global efforts to combat the burgeoning problem of drug resistance.

Under the terms of the agreement, Magellan will develop and test an integrated cross-platform software interface that will enable microbial identification information gathered on the Bruker MALDI Biotyper mass spectrometry-based proteomic finger-printing system to be combined with Magellan's Sensititre® susceptibility results. The software will allow laboratories to generate custom expert rules, which can guide laboratory and clinical action upon receipt of results from both systems. Magellan's U.S. microbiology sales force will then promote the complementary product offerings.

"We are pleased to offer these enhanced microbiology tools that will deliver complete, actionable information to improve patient care and fight deadly drug resistance," said Magellan President and Chief Executive Officer Hiroshi Uchida, Ph.D. "We can soon combine the MALDI Biotyper's rapid identification of more than 2,000 species of bacteria, as well as yeast and fungi, with Sensititre's true MIC results for an expansive list of antimicrobial drugs and dilution ranges, enabling physicians to make more-precise dosing decisions. In fact, Sensititre is the standard used by the National Antibiotic Resistance Monitoring System (NARMS) in the U.S. and Canada," Dr. Uchida added.

The MALDI Biotyper is available in a clinical version with an IVD-CE mark in the European community, and is labeled research-use-only in the United States. Bruker plans to seek U.S. FDA clearance, and regulatory clearance is underway in several other countries. The Sensititre product line features both EU and U.S. clearances, while Japan clearance for the Sensititre system is in process.

"This arrangement leverages both companies' products and experience, while providing significant improvements in ease of use and time-to-results using the MALDI Biotyper for cost-effective, proteomic fingerprint based identification," commented Bruker Daltonics Vice President for Business Development, Gary Kruppa, Ph.D. "Bruker is committed to the Open Microbiology Consortium concepts of open interfaces, and of making its systems compatible with other microbiology products in order to provide the most advanced and cost-effective solutions to microbiology customers worldwide."

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Lonza and Roche Enter into MycoTOOL® Distribution Agreement for Rapid Mycoplasma Testing Solutions

Lonza and Roche announced today that they have entered into a co-exclusive distribution agreement for the commercialization of Roche’s MycoTOOL® mycoplasma Polymerase Chain Reaction (PCR) assays. PCR is a commonly used molecular biology technique that amplifies a single copy of nucleic acid to generate millions of copies of a particular DNA sequence. MycoTOOL® utilizes PCR methodology for DNA target amplification and gel electrophoresis for same day detection, compared to standard methods that can take up to 28 days to achieve results.

MycoTOOL® detection kits are now available through Lonza for final release testing of pharmaceutical products, upon validation. Additionally, Lonza offers contract testing services using the MycoTOOL® test. The MycoTOOL® test is the first commercial NAT-based detection system that is used for mycoplasma biosafety testing of approved biological products.

Release testing with the MycoTOOL® PCR-test from Roche Custom Biotech, a part of Roche Applied Science, has been approved by the European Medicines Agency (EMA) for several pharmaceutical products. It is the first commercially available mycoplasma PCR test that is used to replace traditional mycoplasma tests (cell-dependent and cell-independent methods) during pharmaceutical production. Developed and manufactured within a regulated environment, the product design, production process, change control notification procedure, premium quality products, logistics, and fulfilment systems help ensure that the products retain their proven high quality.

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A New Screening Platform for Rapid, Same-Day Detection of Bacteria in Food and Beverage Samples

Luxcel Biosciences® in association with their partner, Mocon® Inc. have developed the GreenLight™ 900 series, a cost-effective screening platform for rapid, same-day detection of bacteria in food and beverage samples. Food processors will now have a faster, less labour intensive screening method compared to traditional agar methods. Currently, GreenLight™ can detect a TVC level in raw meats of ~1x106 CFU/g in under 5 hours, including sample preparation time.

The technology is fluorescence based using oxygen sensing probes that detects bacteria by monitoring bacterial respiration. The technology measures bacterial oxygen consumption and equates that to viable microbial load. As microbes grow, they consume oxygen, resulting in an increase in probe signal. The time taken to reach this increase in reagent signal (threshold point) is used to calculate initial microbial load. The greater the initial microbial load, the faster the time to threshold.

The GreenLight™ systems are simple to operate, less labour intensive with results recorded automatically within the software removing the need for tedious counting and subjective observation of colony numbers. It has shown excellent correlation to the traditional agar methods (ISO:4833:2003).

Two models of the GreenLight™ 900 series are currently available. Model 960 (AOAC-RI-PTM certified) is a 96 well micro-titre plate based assay that is suitable for high through-put screening for bacterial load but also highly suited for more R&D based studies for example anti-microbial analysis and food additive analysis such as spices etc. and study of the effect of the additive on microbial growth. Model 910 is a vial based system for facilities with lower through-put requirements.

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Bruker’s IVD MALDI Biotyper Now Available to Clinical Microbiology Sites in Canada for Proteomic Identification of Microorganisms

At the 2011 Annual Meeting of the Canadian Association for Clinical Microbiology and Infectious Diseases (CACMID), the companies i2A Canada and Bruker Ltd. announced together that they have met the relevant Health Products and Food Branch (HPFB) of Health Canada regulations for the Bruker IVD MALDI Biotyper, and that this product is now available for sale as a Class 1 Medical Device to all clinical microbiology sites in Canada.

The Bruker MALDI Biotyper is a MALDI-TOF mass spectrometry based bench-top platform for rapidly identifying bacteria and yeasts. Its carefully curated database includes quality-controlled entries of over 3,900 strains from over 2,000 well-characterized microbial species. Starting from a cultured colony, identification is performed by matching the measured protein fingerprint against the proprietary MALDI Biotyper database, followed by a final review by a trained microbiologist. Including the database search, identification can be performed in minutes. Multiple colonies can be spotted on a single target, and about 30-60 identifications can be performed every hour with no pre-testing required. The MALDI Biotyper offers considerably faster time-to-result (TTR), high specificity, very low false positive rates, low operational costs, and low technical barriers for new operators.

The MALDI Biotyper is available in a research-use-only version, as well as in the IVD MALDI Biotyper IVD-CE version according to EU directive EC/98/79 in certain European countries. Bruker has installed over 250 MALDI Biotyper systems worldwide in routine clinical and other laboratories for microbial identifications. Over 50 peer-reviewed papers have examined the capabilities of the MALDI Biotyper with excellent results reported to date. The Bruker MALDI Biotyper is rapidly becoming a new standard for robust, rapid microbial identification. Further applications are under development, including the research-use-only MALDI Sepsityper™ consumables kit for identification from blood cultures using the BD (Becton, Dickinson and Company) Bactec system and associated BD consumables. This rapid method for processing positive blood culture bottles is intended to reduce time to result for this critical specimen with results available in as little as 30 minutes.

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RapidChek® SELECT™ Enables Compliance with NPIP Testing Requirements

The RapidChek® SELECT™ Salmonella Enteritidis (SE) test system has been granted interim National Poultry Improvement Plan (NPIP) approval by the Secretary's Advisory Committee on Poultry Health, for use in detecting the presence of SE in poultry environments. The interim approval is in effect until the 2012 Biennial Conference of the NPIP where it will be considered for ratification by the full NPIP technical committee.

The NPIP is a cooperative Federal-State-Industry program developed to prevent or control certain egg-transmitted, hatchery-disseminated poultry diseases, including Salmonella Enteritidis. SDIX offers U.S. egg and poultry producers an easier, faster and more cost effective way to comply with the new FDA regulation that requires SE monitoring of the layer house environment. With this NPIP approval, producers now can also apply these SDIX SE testing advantages to comply with NPIP testing guidelines.

Tim Lawruk, Food Safety Market Manager at SDIX, said, “The NPIP´s approval provides hatcheries, egg layers and the broiler industry with confidence to use the SDIX RapidChek SELECT SE for the accurate detection and control of SE in the production environment. The RapidChek SELECT SE method´s improved sensitivity, reduced time to result and ease-of-use provide a highly effective testing solution for meeting NPIP environmental testing requirements.”

“In addition, the RapidChek SELECT SE method is the only rapid SE test available that uses patented enrichment media for faster detection and improved sensitivity, compared to other NPIP-approved methods. The addition of the RapidChek® CONFIRM™ immuno-magnetic separation method allows for improved recovery of SE from high background environmental swabs, for improved sensitivity and confirmation that is consistent with the NPIP and FDA procedures.”

The new testing system is comprised of the RapidChek® SELECT™ Salmonella Enteritidis detection system for screening environmental drag swabs or pooled eggs and the RapidChek® CONFIRM™ Salmonella Enteritidis immunomagnetic separation system for confirmation of environmental presumptive positive samples.

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Collaborative Project to Protect Consumers from E. coli Food Contamination

The University of Arkansas Division of Agriculture's Center for Food Safety (CFS) has entered into a public-private collaboration with Litmus Rapid-B, LLC (LRB), a Little Rock-based biotechnology company, to develop research that will lead the fight against consumer sickness and death attributed to food contamination.

Each year roughly 3,000 Americans die from food borne illnesses. Forty-eight million get sick. More than 100,000 are hospitalized. The Centers for Disease Control estimates that one out of six people is affected by this growing issue. The collaborative research is intended to improve identification of foodborne bacteria such as E.coli and Salmonella throughout processing and distribution points to create value for the food processing industry and consumers. LRB recently placed its system at the Center for Food Safety, which is the first LRB system deployed to any university in the United States.

'The LRB system allows us to pinpoint specific bacteria faster than any other current methods,' said Litmus Rapid-B president Ted Moskal. 'Ultimately, this allows for earlier detection and management of food contamination inside the processing plant.'

Steven C. Ricke, Center for Food Safety director, said, 'Developing collaborative relationships with commercial partners such as Litmus Rapid-B really enhances the Center's ability to more closely interface with the food industry to solve not only current food safety issues but develop solutions for potential issues before they become a major problem.'

LRB developed the system in conjunction with scientists at the National Center for Toxicological Research, an agency of the Food and Drug Administration in Jefferson, Ark.

The goal of the collaborative research effort is to provide the quickest and most accurate data to develop bacterial controls that protect consumers from sickness and death.

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bioMérieux and the SIBS Partner to Develop Innovative Tests for Food Safety

bioMérieux have announced a long-term strategic partnership with the Shanghai Institutes for Biological Sciences (SIBS) to develop innovative tests to better address the needs for the microbiological quality control of food products produced in China and other countries.

Under the partnership, French and Chinese R&D teams from bioMérieux will work with scientists from the Institute for Nutritional Sciences (INS), part of the SIBS, on research projects in the area of food safety. They will focus on different food-borne pathogens as well as contaminants, such as hormones, which are a growing concern.

The INS will provide its unique competencies and research facilities in Shanghai, under the direction of Dr. Hui Wang, Principal Investigator and Head of the Food Safety Research Center. bioMérieux will support the research and contribute its expertise in food quality and safety control as the world leader in industrial microbiology.

“We are very pleased to reinforce our scientific collaborations in China and to have the opportunity to work with one of the world's leading research institutions to address the important public health issue of ensuring food safety,” stated Alexandre Mérieux, Corporate Vice President, Industrial Microbiology, bioMérieux.

The SIBS and bioMérieux will also collaborate on the development of new requirements and high-quality food safety standards in China. This will help to establish a reference center for these standards that will provide education and build a network of centers throughout China and Asia.

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The foodproof® RoboPrep+ Series - First Automated Food Pathogen Detection System

For a laboratory performing high-throughput routine testing of food samples, automation of analyses is key for greater efficiency. The new foodproof® RoboPrep+ Series, offered by BIOTECON Diagnostics, is the first commercially available system for automated food sample preparation and subsequent PCR setup. It has been developed as a cost-effective tool for food pathogen testing, drastically reducing hands-on time and increasing lab efficiency. Several different instrument versions and sizes are available to match laboratory throughput demands. The largest platform, the foodproof® RoboPrep+ 150-8, allows the simultaneous preparation of 96 samples in just 2 hours and 20 minutes (2 hours 40 minutes including PCR setup). No manual handling steps are necessary other than the loading of samples and consumables.

With only a few mouse clicks, each automated run is easily started using a validated, predefined protocol. Each foodproof® RoboPrep+ workstation meets the regulatory requirements in regard to CE and 21 CFR part 11. Full data traceability is achieved through barcode reading of samples. To prevent contamination, a hood and UV air filter are available. BIOTECON Diagnostics offers complete pathogen detection solutions, including the robotic workstation, sample preparation and real-time PCR kits, consumables, as well as world-wide support, maintenance and service.

Automated sample preparation on the foodproof® RoboPrep+ workstation is performed using the foodproof® Magnetic Preparation Kit I. The kit's magnetic bead technology isolates highly purified DNA from liquid sample enrichments, while minimizing inhibiting matrix influences.

The foodproof® Magnetic Preparation Kit I has been developed in cooperation with a leading international confectionary manufacturer, who has begun implementing the foodproof® RoboPrep+ system for automated Salmonella detection in its sites globally.

For the rapid and reliable detection of Salmonella, BIOTECON Diagnostics offers the AOAC and NordVal validated foodproof® Salmonella Detection Kit. The kit detects down to 1-10 cells per 25 g sample and provides an unmatched inclusivity, showing no false-negative results when tested with more than 700 different Salmonella strains. The validation of the foodproof® RoboPrep+ Series for other parameters, e.g. Listeria, is in process.

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Automated Multiplex Real-Time PCR Test Simultaneously Screens for Bacteria and Fungi and Antibiotic Resistances within Three Hours

Seegene and Molzym today announced a partnership on the automated Magicplex™ Sepsis, a new multi-pathogen screening test capable of quick and accurate identification of over 90 leading sepsis-causing pathogens. Magicplex Sepsis provides a novel and fast-acting diagnostic technique for hospitals to simultaneously verify a complex range of targets that indicate sepsis, the leading cause of death in non-coronary intensive care units worldwide. Seegene’s automated Magicplex Sepsis will be introduced at the 2011 Congress of the European Society of Clinical Microbiology and Infectious Diseases (ECCMID, 7 -10 May 2011) in Milan, Italy.

Sepsis is a deadly disease that leaves no clear track back to initial indications, which could include gram-positive bacteria, gram-negative bacteria or fungi. The results are devastating: the annual incidence rate of sepsis has increased 91.3 percent over the last 10 years, and every hour 25 people in the United States die from severe sepsis. One of every three patients who develop severe sepsis will die within a month. Severe sepsis, the leading cause of death in the non-coronary intensive care unit, takes more lives than breast, colorectal, pancreatic, and prostate cancers combined.

The Magicplex Sepsis Test simultaneously screens for over 90 sepsis-causing pathogens: 73 Gram (+), 12 Gram (-), 6 fungi, and 3 antibiotic resistant genes can also be discriminated. The Magicplex Sepsis Test requires 1ml of patient’s whole blood and provides test results within three hours (after extraction). The microbial DNA enrichment is based on Molzym”s MolYsis technology enabling up to 40,000-fold DNA enrichment over conventional technologies. Automated DNA isolation is performed with Seegene”s Seeprep12 instrument based on Nordiag”s “Arrow” system.

“The Magicplex Sepsis Test will be the new gold standard for performing accurate, rapid and cost-effective sepsis diagnosis,” said Dr. Jong-Yoon Chun, chief executive officer of Seegene. “In treating sepsis, time and accuracy are demanded. Every hour of delay in giving patients the correct antibiotics results in an 8% increase in the mortality rate.” “The automation reduces the total process costs significantly and makes Magicplex Sepsis Test the first true routine sepsis test worldwide” says Prof. Dr. Michael Lorenz, Chief Scientific Officer at Molzym.

Magicplex Sepsis Test is based on Seegene’s proprietary READ™ technology, which combines the advantages of multiplex Real-Time PCR system. The result is a molecular diagnostic test system that provides higher specificity and sensitivity over currently available PCR systems.

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Collaboration to Improve Speed, Accuracy and Efficiency in the Microbiology Laboratory

BD Diagnostics and Bruker Daltonics, Inc have an international co-development and co-marketing collaboration that will promote an emerging, integrated approach to bacterial and fungal identification and antimicrobial susceptibility testing. This new approach has the potential to transform how traditional microbiology has been performed for decades.

Through this collaboration, identification of microorganisms will be performed with the Bruker MALDI Biotyper, a mass spectrometry-based proteomic ‘fingerprinting’ system specifically configured for rapid identification of bacteria, yeast and fungi.

BD and Bruker intend to combine the MALDI Biotyper microbial ID system with automated antimicrobial susceptibility testing on the BD Phoenix™ Microbiology System. The BD EpiCenter™ Microbiology Data Management System, which will manage patient data from both the identification and the susceptibility test systems, will facilitate this industry-first integrated approach.

The MALDI Biotyper – BD EpiCenter software integration will be further developed to optimise workflows for rapid MALDI Biotyper pathogen identification directly on positive blood cultures from the leading BD BACTECTM blood culture system. This rapid blood culture-to-ID workflow is supported by Bruker’s new MALDI Sepsityper™ consumables kit, which today is for RUO. It is expected to become clinically important in the future, as time-to-result for pathogen identification is critical to management of patients having potentially serious bloodstream infections or sepsis.

The Bruker MALDI Biotyper allows highly accurate, rapid and cost-effective identification through a process in which organisms are identified by the unique spectrum of the major proteins and peptides that constitute their makeup. The accuracy and benefits of the MALDI Biotyper have been well documented in over 30 peer-reviewed articles. Antimicrobial susceptibility testing is conducted via traditional automated systems such as the BD Phoenix System.

The combination of the two leading technologies, the BD Phoenix System and the MALDI Biotyper, and the data management through the BD EpiCenter System, will provide laboratorians with a groundbreaking new approach to identification and susceptibility testing, which will reduce the turnaround time for critical diagnostic results, while also improving laboratory efficiency and costs.

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