Life Technologies Launches Next-Generation, High Throughput Microbial Identification System for Environmental Monitoring within Pharmaceutical Manufacturing

Life Technologies Corporation announced the launch of its next-generation, high throughput genotypic MicroSEQ® Rapid Microbial Identification System for the identification of bacteria and fungi within a pharmaceutical manufacturing environment. Powered by the new 3500 Series Genetic Analyzer, this new system offers enhanced throughput, ease-of-use features while maintaining the accuracy required by the pharmaceutical industry to rapidly identify microbial contaminations.

Contaminant analysis is important because harmful bacteria and fungi can contaminate product, raw materials and production facilities. Environmental monitoring is an important step in the detection and identification of microbial contamination in pharmaceutical manufacturing facilities, which may result in shutdowns, costly delays, or reduced productivity. Currently, regulatory guidelines include a monitoring program for bacteria and fungi in production facilities. Many microbiologists believe that genotypic methods deliver more accurate and precise results than traditional biochemical and phenotypic techniques. First introduced to the Pharma industry in 2004, the MicroSEQ Microbial Identification System is based on genotypic-based identifications, today’s gold standard in identification of bacteria and fungi. "DNA-based amplification and sequencing results are faster, more sensitive, more accurate and more reproducible than current microbiological methods," said Dr. Robert Johnson, Director of Dialogue in Switzerland.

The new MicroSEQ Rapid Microbial Identification System is designed to increase efficiency in set-up, run-time and maintenance scheduling while sustaining the high level of accuracy enjoyed by current users. Reduced sample preparation steps, plug-and-play consumables, higher capacity instrumentation and user-friendly software help enable up to a 20% reduction in process-run time. The system’s libraries include more than 3,000 fully validated bacterial and fungal species, currently the life science industry’s largest and most comprehensive collection. Additionally, the system’s accuracy can deliver a measurable financial impact through the reduction in the amount of re-testing, or outsourcing of identifications for hard-to-identify microbial contaminants.

It is this continued commitment to providing leading-edge technology that has MicroSEQ placed at many of the top pharmaceutical companies worldwide. "The MicroSEQ ID system is the standard for microbial identifications in pharma today due to its accuracy and throughput," said Tony Hunt, General Manager of Pharma Analytics at Life Technologies. "With the introduction of MicroSEQ Rapid, we continue to address the needs of microbiologists in product quality and safety testing."

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MIT Production Start-Up Is on Track and Poised to Significantly Reduce Widespread Food Contamination

Micro Identification Technologies, Inc. announces that its plans to start production of the MIT 1000 System remain on-track to begin later this year. Critical sub-system electronics were successfully tested and the remaining tasks that include the build and test of the first production System present no additional challenges for MIT and its contract manufacturer, OSI Optoelectronics. In addition, it was recently announced that 8500 pounds of beef were recalled due to E.coli contamination. The strain of E.coli causing the contamination was a shiga toxin-producing E.coli (STEC) known as E.coli O26 that many people believe should be classified as an adulterant (contaminant). Food Safety and Inspection Service (FSIS) Chief, Dr. Elisabeth Hagen stated to the New York Times, "If E. coli O157:H7 is an adulterant because it can kill your child, then other non-O157 STECs (like O26, O45, O103, O111, O121, and O145) that cause 36,700 illnesses, 1,100 hospitalizations and 30 deaths in America each year, should be adulterants as well."

The MIT 1000 has the capability to identify bacterial strains and plans have been initiated to add the non-O157 STEC's to its ID library in 2011. "MIT is poised to be an important contributor to reducing future food contamination events as witnessed by the numerous MIT 1000 inquiries from prospective customers following the recent egg recall due to Salmonella and the aforementioned beef recall," stated Michael Brennan, MIT's Chairman and Chief Executive Officer. Mr. Brennan further stated, "The MIT 1000 System's ability to conduct an ID test in under 5 minutes for less than 10 cents classifies it as both a rapid and economical ID test that may enable food processors to confirm a food contamination event before widespread distribution has occurred." MIT plans to host a webinar later this month to provide a more detailed update of the Company's status, system and plans.

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Breakthrough Method Cuts E.coli Detection Time in Ground Beef

An innovative technique that employs a unique combination of already established instrumentation can significantly reduce the time taken to detect E.coli 0157:H7 in ground beef, said a new study. The US group, lead by Lisa Mauer, said the method uses infrared spectroscopy to cut the time to identify E.coli to just hours instead of days as with current testing methods. The associate professor of food science from Purdue University, told FoodProductionDaily.com the breakthrough technique had the potential to become an industry standard and her team was already working on adapting it to detect other pathogens such as Salmonella. sing Fourier transform infrared spectroscopy FT-IR, Mauer said E.coli had been detected in ground beef in one hour compared to the 48 hours needed by conventional plating technology carried out in laboratories. She added the same labs could use the compact spectroscopy equipment to get results in a fraction of this time. The technique is also able to differentiate between strains of E. coli 0157:H7, meaning outbreaks could be tracked more effectively and quickly. Current tests are multi-step and take almost one week to get results.

"Even with all the other bacteria present in ground beef, we could still detect E. coli and recognize different strains," said Mauer. The study – Detection of E.coli 0157:H7 from Ground Beef Using Fourier Transform Infrared Spectroscopy and Chemometrics – was published in the Journal of Food Science. The research showed two methods for separating bacteria from ground beef for testing. An antibody-capture method, which binds bacteria to antibodies attached to magnetic beads, gave results in four hours, while a filtration method achieved results in about an hour. Infrared spectroscopy could detect just one E. coli cell if the bacteria were cultured for six hours. Conventional plating techniques used for E. coli detection require culturing cells for 48 hours. The faster feedback is achieved as the FT-IR is able to read the E.coli’s specific infrared spectrum by interpreting the combination of energy that has been absorbed and energy that has been reflected back when infrared light is scanned over a sample. The testing methods can also distinguish between living and dead E. coli cells, something current testing methods cannot. While dead cells are not harmful, their presence could indicate something about the quality of the product, said the study.

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Rapid Micro Biosystems Awarded Contract by Biomedical Advanced Research and Development Authority (BARDA) to Develop Rapid Sterility Testing Platform for Vaccines

Rapid Micro Biosystems announced that it has signed a contract with the Biomedical Advanced Research and Development Authority (BARDA) for the development of rapid sterility testing for vaccines as part of the Innovative Platform Technologies program of BARDA’s Strategic Science and Technology Division. Under the terms of the agreement, Rapid Micro Biosystems will receive $2.2 million in the first contract year and up to an additional $4.5 million in two option years, for a total contract value of $6.7 million.

"We are pleased to be awarded this contract by BARDA," said Steve Delity, Chief Executive Officer of Rapid Micro Biosystems. "Rapid Micro is the leader in automated rapid detection, and we look forward to working closely with BARDA to develop a solution to help with pandemic response." Reducing the time-to-release of vaccines or other biopharmaceutical countermeasures will facilitate prevention and control of epidemic diseases like influenza, other emerging infections and agents of bioterrorism. Faster microbiological quality control (QC) testing will reduce the release cycle of vaccines by as much as two to four weeks. This time decrease will save countless lives by accelerating the release of safe product to the public in the event of a pandemic or bioterrorism attack.

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Rapid Micro Biosystems Names Julie Sperry to Post of Chief Commercial Officer

Rapid Micro Biosystems, a leading provider of non-destructive, rapid microbial detection, today named Julie Sperry Chief Commercial Officer. Sperry will lead the sales and business development efforts for the company’s Growth Direct™ system. She will report directly to the CEO, Steve Delity. Sperry brings more than 30 years experience in healthcare, pharmaceutical and manufacturing operations. Sperry previously served in various general management, sales and marketing leadership roles for a number of companies in the pharmaceutical research, development and production markets. Prior to her role as Chief Commercial Officer for Rapid Micro Biosystems, Sperry was with Thermo Fisher Scientific serving in several roles including; Vice President of Corporate Marketing, Vice President of Strategic Marketing for the Laboratory Products Group and Vice President of Global Sales and Marketing for the Lab Equipment Division. Sperry has also held global sales, marketing and general management roles with Millipore Corporation, Sartorius and the former American Hospital Supply.

Sperry graduated from Bowling Green State University in Bowling Green, OH with a B.S. degree in Chemistry and Microbiology and with an MBA from Rockhurst College in Kansas City, MO. “Julie Sperry is the perfect choice for Chief Commercial Officer at Rapid Micro Biosystems. She brings significant knowledge of the pharmaceutical manufacturing industry and a proven ability to drive business growth,” ‘said CEO, Steve Delity “We are grateful to have her aboard and believe our customers and partners will be excited by her vision and proven track record of success. Sperry commented: “I am honored to have the opportunity to join Rapid Micro Biosystems at a time of accelerated growth. With our unique value proposition to the Micro QC lab, I am confident we can continue to help companies in the pharmaceutical industry save time and money, while improving their productivity.”

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Bruker Introduces the MALDI Sepsityper™ Kit for Rapid MALDI Biotyper Microbial Identification from Positive Blood Cultures

At the 50th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), Bruker Daltonics Inc. announced the introduction of the new MALDI Sepsityper(TM) kit for the rapid identification of microorganisms from positive blood culture bottles, using Bruker's industry-leading MALDI Biotyper solution. The MALDI Biotyper has obtained the IVD-CE Mark, and is currently for Research Use Only (RUO) outside of the European Union.

The MALDI Sepsityper kit is a set of consumables that enables a rapid and easy identification workflow after the blood culture bottle has tested positive. Microbial cells are harvested from an aliquot of blood culture, are processed using the MALDI Sepsityper kit, and are then identified by the MALDI Biotyper workflow. The identification assay from positive blood cultures is applicable to gram-negative bacteria, gram-positive bacteria, and importantly also to yeasts. Only a few minutes after taking an aliquot from the blood culture bottle, a sample can be ready for mass spectrometry-based molecular identification by the MALDI Biotyper. This workflow is recommended and optimized for blood culture bottles without any charcoal supplements, because such supplements would need to be removed first by additional sample preparation steps.

By using the new MALDI Sepsityper product in combination with the MALDI Biotyper, in approximately 70-90% of the tested positive blood culture samples, a high-confidence identification result is available much earlier than with conventional technology, typically saving one day (or more) in time-to-result (TTR) for the crucial identification step. The MALDI Sepsityper kit and MALDI Biotyper identification rapid blood-culture-to-ID workflow did not lead to any false positives during initial testing and validation. Bruker is planning further MALDI Sepsityper kit validation studies with an expanded number of European clinical microbiology laboratories processing blood culture samples.

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Identification of Clinically Significant Microorganisms

Thermo Fisher Scientific has announced that its range of biochemical identification kits is one of the widest available to clinical microbiologists today, providing reliable results in simple and convenient formats. The range, which includes the rapid and easy-to-use Remel RapID microbial identification systems and the Oxoid Microbact biochemical identification kits, requires no capital investment, so it allows even small laboratories to confirm the identification of clinically significant bacteria, yeasts and fungi. The RapID range is the fastest and most convenient identification system of its kind. With its simple, one-step inoculation procedure, it allows accurate identification of a comprehensive range of micro-organisms in just four hours. The RapID method detects pre-formed bacterial enzymes and, therefore, is not dependent on the growth of the organism. This allows the panels to be incubated aerobically without the need for oil overlays, which saves time and resources.

Each RapID kit has the same simple procedure, allowing it to be adopted easily in laboratory workflows, and the biochemical reactions are clearly visible as distinct color changes. These are interpreted quickly and conveniently by the Electronic RapID Compendium (ERIC), a user-friendly, Windows-based software package, to minimize misidentifications and to ensure accurate and reliable results. In trials, RapID kits demonstrated excellent performance in the identification of oxidase negative Enterobacteriaceae, anaerobic bacteria, Gram-negative glucose non-fermenters, Corynebacterium species, yeasts and related organisms and streptococci and related organisms. In addition, a new system for the identification of staphylococci and related organisms is now available. The Oxoid range of Manual Identification Systems also includes the Microbact biochemical identification kits for the identification of Gram-negative bacteria (the Enterobacteriaceae and miscellaneous Gram-negative bacteria) (Microbact 12A/E; 12B and 24E), Listeria species (Microbact 12L) and clinically important staphylococci (both coagulase-negative and coagulase-positive staphylococci) (Microbact 12S). These kits are available in convenient strip or microplate format, and organism identifications are based on pH changes and substrate utilization.

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Celsis Rapid Detection at the 2010 International Dairy Show

Celsis Rapid Detection will introduce several advances in rapid microbial detection for the dairy industry at its booth, #432, during the 2010 International Dairy Show, September 13-15 in Dallas, TX. Dairy manufacturers around the world already enjoy significant savings of time and money with Celsis Rapid Detection—including an average 5-year net present value of $500,000 or more—by shortening their product testing times from 4-7 days to only 24-48 hours allowing for reduced inventories and faster response to contamination when it occurs. The new features and options added to the Celsis Innovate system help manufacturers and packagers operate more efficiently and improve regulatory compliance. Celsis Innovate systems are used to rapidly and effectively screen a growing variety of UHT, aseptic and ESL dairy, food and beverage products, including syrups, soups and broths, brewed tea, sports and nutritional drinks, pudding, infant formula, condiments and sauces, nut milks and fruit and vegetable juices.

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ARUP Laboratories Selects Bruker's MALDI Biotyper Solution for Rapid Microbial Identification by Proteomic Fingerprinting

Bruker Daltonics today announced that ARUP Laboratories (a reference laboratory owned by the University of Utah) has selected and installed the Bruker MALDI Biotyper system as their next-generation rapid microbial identification system. The MALDI Biotyper has obtained the IVD-CE Mark, and is currently for Research Use Only (RUO) outside of the European Union. The MALDI Biotyper is a MALDI-TOF mass spectrometry based platform for rapidly identifying bacteria, yeasts and fungi. Its carefully curated database includes quality-controlled entries of over 3,700 strains from about 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. Including the database search, automatic 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. The MALDI Biotyper offers rapid time-to-result, high specificity, very low false positive rates, low operational costs, and low technical barriers for new operators. Bruker has installed over 150 MALDI Biotyper systems worldwide in routine laboratories for microbiology, and the MALDI Biotyper is rapidly becoming a new standard for robust, rapid microbial identification. ARUP plans to use the MALDI Biotyper for microbial identifications currently performed by DNA sequencing, and expects to see improvements in time to result, workflow and consumables costs. ARUP is also investigating the use of the MALDI Biotyper to replace phenotypic methods for identification, and plans to collaborate with Bruker to develop additional tests on the MALDI Biotyper.

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Microbiology Market Review 3rd Edition

Research and Markets has announced the addition of the "Industrial Microbiology Market Review 3rd Edition" report (IMMR-3). The Industrial Market is second only to the Human Clinical Market as a sizable and growing opportunity for microbiological testing. IMMR-3 is an extensively-researched overview of testing and trends worldwide, focused on the food, beverage, environmental, pharmaceutical, personal care product, and industrial process sectors. Testing volume is analyzed by type of organism, sample source, geography, and market sector. Current market values are established and projected. Complementing the analysis are detailed company profiles of 25 key test manufacturers serving the industrial diagnostics market. In addition, IMMR-3 also provides Special Situation assessments of two important market opportunities for diagnostic companies: Bioterrorism and Healthcare Infection Control. These new segments are both timely and could represent significant testing potential.

Rapid testing methods are growing at twice the rate of market growth and gaining important market share in the Industrial Market. With five-year projections of both testing volumes and market value, IMMR-3 provides critical input to strategic planning. IMMR-3 is 220 pages in length with 250 data tables, charts, and exhibits. Key topics covered include: Industrial Microbiology Market Summary; Scope; Definitions, and Methodology; Market Trends; Food Sector; Beverage Sector; Pharmaceutical Sector; Personal Care Products Sector; Environmental Sector; Industrial Process Sector; Bioterrorism; Healthcare Infection Control; 2013 Forecast Detailed Review; Rapid Microbiology Potential; Competition Business Review/Summary and Competitor Profiles. Twenty five companies are mentioned in the report.

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U.S. Department of Agriculture and DuPont Collaborate on New Test for Hard to Detect Foodborne Pathogens

DuPont and the U.S. Department of Agriculture have agreed to collaborate on the development of a new test for detecting hard-to-identify strains of toxin-producing E. coli that are not currently regulated and have been causing increased instances of food contamination and illness. The U.S. Centers for Disease Control estimate that non-O157 STEC bacteria are responsible for 36,000 illnesses, 1,000 hospitalizations and 30 deaths annually. DuPont was among the first to develop tests for E. coli O157:H7, the type of shiga toxin-producing E. coli (STEC) most frequently associated with global food contamination outbreaks.

The USDA Food Safety and Inspection Service uses the DuPont™ BAX® System to monitor for this pathogen. In recent years, other types of STEC have been identified as agents of foodborne illness, and these are a growing concern in the United States, Europe, Japan and food safety agencies worldwide. The Agriculture Research Service of the U.S. Department of Agriculture (USDA ARS) will collaborate with DuPont Qualicon to develop an effective test for the “Big 6” non-O157 STEC pathogens in food, and also will expand the diagnostic tools offered for use in the DuPont™ BAX® System. Food processing companies around the world rely on the BAX® System to detect pathogens or other organisms in raw ingredients, finished products and environmental samples.

The automated system uses leading-edge technology, including polymerase chain reaction (PCR) assays, tableted reagents and optimized media to detect Salmonella, Listeria species, Listeria monocytogenes, E. coli O157:H7, Enterobacter sakazakii, Campylobacter, Staphylococcus aureus, Vibrio, and yeast and mold.

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BIOTECON Diagnostics receives MicroVal approval for the foodproof® Enterobacteriaceae plus E. sakazakii (Cronobacter spp.) Detection Kit

BIOTECON Diagnostics has received a new approval from MicroVal for the foodproof® Enterobacteriaceae plus E. sakazakii (Cronobacter spp.) Detection Kit. The foodproof® RoboPrep+ Series 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. 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. Automated sample preparation 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. BIOTECON Diagnostics also offers the AOAC and NordVal validated 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. Other platforms include kits for the detection of Brucella, Campylobacter, E. coli, Shigella and Listeria.

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BD Announces First FDA-Cleared Assay on the BD MAX™ System to Detect Group B Streptococcus

BD Diagnostics, a segment of BD (Becton, Dickinson and Company), announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration to market the BD MAX™ GBS Assay for Group B Streptococcus (GBS) on the BD MAX™ System. The BD MAX System is a next-generation automated workstation for molecular testing designed to streamline workflow and offer full walkaway automation to accommodate varying workloads for maximum lab efficiency and flexibility. GBS remains one of the leading causes of morbidity and mortality among newborns, with maternal colonization serving as a major risk factor for early onset GBS disease. However, it is preventable with antibiotics during labor, which prevents transmission from mother to infant.

The U.S. Centers for Disease Control and Prevention (CDC) recommends universal prenatal screening for GBS colonization and intrapartum chemoprophylaxis for colonized mothers in order to prevent transmission to infants. The current standard of care for preventing neonatal GBS disease is screening pregnant women at 35 to 37 weeks of gestation using culture methods, which are limited by sensitivity, turnaround time and the need for highly trained technologists to interpret the results. “The BD MAX GBS assay on the BD MAX System is the only fully automated polymerase chain reaction method for the detection of GBS from vaginal/rectal swabs after Lim broth selective enrichment,” said Dr. Steve Young, TriCore Reference Laboratories, a clinical trial site. “As new CDC guidelines emerge to include molecular testing as an alternative to culture for detecting GBS, the BD MAX GBS assay could serve as an efficient, sensitive and specific option for laboratories desiring to utilize a molecular method.”

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AdvanDx Launches GNR Traffic Light™ PNA FISH® in Europe

AdvanDx announced the launch of its CE-IVD marked GNR Traffic Light™ PNA FISH® test in Europe. GNR Traffic Light PNA FISH is the first-ever test capable of simultaneously identifying (i)Escherichia coli, Klebsiella pneumoniae and Pseudomonas aeruginosa directly from positive blood cultures in less than 90 minutes. Every year, close to 875,000 patients in the United States contract bloodstream infections, leading to over 150,000 deaths and $12 billion in patient care costs. The infection is detected when a culture of the patient’s blood (i.e. a blood culture) turns positive with bacteria or yeast. Rapid and accurate identification of the specific infecting pathogen is crucial to ensure early and appropriate therapy and save patient lives.

PNA FISH is an easy-to-use and highly sensitive and specific fluorescence in situ hybridization (FISH) assay that uses PNA (peptide nucleic acid) probes to target species specific ribosomal RNA (rRNA) in live bacteria and yeast. The unique properties of the non-charged, peptide backbone of PNA probes enable the use of FISH assays in exceedingly complex sample matrixes, such as blood and blood cultures, and this in turn facilitates the development of very simple, yet very accurate tests that don’t require the extensive sample preparation necessary for other nucleic acid technologies. PNA FISH tests enable microbiology labs to provide rapid and accurate identification of bloodstream pathogens directly from positive blood cultures in hours instead of days. Clinical studies show that rapid identification of bloodstream pathogens using PNA FISH tests leads to more appropriate patient therapy that saves lives and reduces unnecessary antibiotic use, patient length of stay and hospital costs.

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Life Technologies Announces Agreement to Acquire Ion Torrent

Life Technologies recently announced an agreement to acquire Ion Torrent. Ion Torrent has revolutionized DNA sequencing by enabling a direct connection between chemical and digital information through the use of proven semiconductor technology. Ion Torrent's proprietary chip-based sequencing represents a new paradigm in DNA sequencing by using PostLight™ sequencing technology, the first of its kind to eliminate the cost and complexity associated with the extended optical detection currently used in all other sequencing platforms. The first product using this technology will be the Personal Genome Machine (PGM), an easy-to-use, highly-accurate benchtop instrument optimal for mid-scale sequencing projects, such as targeted and microbial sequencing. The instrument is currently available through an early access program and will be launched later this year. Subsequent products will benefit from cutting edge semiconductor fabrication technologies that can expand throughput at an accelerated pace, thereby dramatically lowering the cost to sequence a genome.

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