Mass Spectrometry Accelerates Research to Identify Microbiological Sources of E. coli

Thermo Fisher Scientific Inc. has announced that its collaboration with the Health Protection Agency (HPA) in the U.K. has led to a significant development in mapping the proteome of the organism responsible for the recent E. coli outbreak in Europe. Using Thermo Scientific LTQ Orbitrap mass spectrometry technology, HPA researchers have identified the protein toxins expressed by the deadly strain, which has resulted in 37 deaths and made nearly 3,400 people ill.

The Health Protection Agency is an independent organization set up by the U.K. government in 2003 to protect the public from the threats of infectious diseases and environmental hazards. Thermo Fisher and the HPA are collaborating in a study on the use of mass spectrometry to better understand the role of microorganisms in causing illness and disease in humans.

"The significance of this study is that scientists were able to develop techniques to study microorganisms and determine how the genetic code is being translated into the protein building blocks that determine traits such as toxicity," said Dr. Ian Jardine, vice president, global research and development, Thermo Fisher Scientific. "Our leading Orbitrap mass spectrometry system is providing researchers with the ability to understand what makes this E.coli strain so devastating, and may lead to an improved understanding of how to treat patients."

Orbitrap technology specifically enabled scientists to identify and analyze the protein fingerprint of this new strain of E. coli using a proteomic method that is rapid and reliable. Understanding the organism's ability to produce toxins and other proteins present in this specific strain may significantly reduce the risk to human health and provide more effective treatment options. This ability to identify toxic proteins and other proteins of significance in a disease process may also be applicable to a range of illnesses caused by microorganisms.

The HPA was assisted in its effort by representatives from Thermo Fisher's Hemel-Hempstead, U.K., facility. The full results of the research will be published in a future issue of a noted scientific publication.

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Bruker and Francisco Soria Melguizo S.A. Expand their Exclusive Agreement for Distribution of the MALDI Biotyper to Cover Spain and Portugal

At the 4th Congress of European Microbiologists (FEMS 2011), Bruker announces the amendment of its exclusive distribution agreement for clinical microbiology for Bruker's MALDI Biotyper with Francisco Soria Melguizo S.A. to cover now also Portugal, as another territory in addition to Spain. Francisco Soria Melguizo is one of the market leaders for clinical microbiology in Spain, providing products for microbial identification and antibiotics susceptibility testing. Bruker is the global leader in MALDI-TOF mass spectrometry based identification of microorganisms.

Since the beginning of the collaboration in May 2009, Francisco Soria Melguizo has placed approximately 20 MALDI Biotyper systems in microbiology laboratories of key opinion leaders in Spain, and recently the first system in Portugal. The MALDI Biotyper system has essentially become the new de facto standard for microbial identification in Spain, just as in many in other European countries.

Rafael Rumin, General Manager at Francisco Soria Melguizo, commented: "The Spanish clinical microbiologists found that the MALDI Biotyper system could be easily integrated into their existing workflows and that it has significantly improved the turnaround time for microbial identification. Additionally, they like the open architecture of the MALDI Biotyper, which allows easy integration with already existing technologies in the laboratory. The MALDI Biotyper is for sure one of the biggest innovations in clinical microbiology, and we are very excited to be part of its success in Spain and in Portugal. The MALDI Biotyper truly enables next- generation microbial identification for the 21st century."

Dr. Wolfgang Pusch, Bruker Daltonics Vice President for the Clinical Research and IVD Business, added: "We are very pleased with the rapid adoption of the MALDI Biotyper in the Spanish microbiology market. Francisco Soria Melguizo has done an outstanding job in Spain and therefore we have expanded our exclusive MALDI Biotyper distribution agreement to cover Portugal as well, in addition to Spain."

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 reliably and quickly using proteomic fingerprinting by high-throughput. 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 robust 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.

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Rs 1.14 Billion Earmarked for Science and Technology

The Pakistani government has allocated Rs 1146.563 million under Public Service Development Programme (PSDP) for Science and Technological Research Division in Fiscal Year 2011-12. According to a budgetary document released Friday, an amount of Rs 1067.563 million has been allocated for 41 on-going projects and Rs 79 million for 10 new schemes in the PSDP 2011-12.

Several new-schemes include establishment of Pakistan Institute of Cost and Contracts, rapid methods for the detection of Pathogenic Microbes, Genetic Improvement of Rice for Abiotic stress tolerance, DNA based vaccine vecters against hepatitis C virus, technical training centre for the precision mechanics and instrument technology at Jafferabad, Boluchistan and up-gradation renovation, reconstruction and moderniszation of animal house for R & D activities drugs development and evaluation, PCSIR Karachi at a cost of Rs 10 million each.

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Battelle and Its Affiliated National Labs Win 19 Prestigious R&D 100 Awards

Battelle and the national laboratories it manages and co-manages for the U.S. Department of Energy (DOE) won 19 -- nearly one fifth -- of the coveted R&D Magazine's R&D 100 Awards that note the most significant scientific accomplishments of 2010.

Known as the "Oscars of Innovation," the awards are highly regarded in the research and development world. This year's awards brings the total wins for Battelle and its affiliate labs to 260, tallied during the time Battelle has managed or co-managed those labs.

Battelle was recognized for the Resource Effective Biodentification System, also known as REBS, a system that provides a rapid and flexible microbial detection, identification and enumeration capability. The laser-based system monitors pharmaceutical factories, food processing plants, hospitals and the environment for microbial contamination risks that may jeopardize personal or product safety. It can also be used for national security purposes to detect dangerous biological agents in the air.

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Veredus Laboratories Develops Lab-on-Chip Solution to Detect and Differentiate Several Food-Borne Pathogens, Including E. coli

Veredus Laboratories and its technology partner, STMicroelectronics, announced the successful development and deployment of VereFoodborne™, a Lab-on-Chip application that is able to detect 10 to 12 food-borne pathogens in one test, including the Shiga toxin-producing Escherichia coli (E. coli) responsible for the recent severe food poisoning outbreak in Europe.

VereFoodborne, based on STMicroelectronics' Lab-on-Chip platform, is a portable Lab-on-Chip application that can detect and differentiate food-borne pathogens including E. coli, Shiga toxin-producing E. coli (including E. coli 0157 and E.coli 0104), Salmonella, Listeria and Campylobacter. The ability of the VereFoodborne chip to simultaneously lock on multiple segments of the genes of food-borne pathogens enables it to identify bacteria and viruses with a much higher degree of confidence compared to other tests. This capability is made possible with a microarray on the chip that allows it to detect multiple pathogens in one test, saving time and resources over existing approaches.

"We started the design and development of VereFoodborne about two years ago, and this solution has come at an opportune time given the current outbreak. VereFoodborne is ideal for use in the testing and surveillance of food," said Dr Rosemary Tan, Chief Executive Officer of Veredus Laboratories. "VereFoodborne is already being deployed to several pilot users in Asia and we are anxious to have it protect consumers from food-borne pathogens."

"In the face of mutations and changes in the profile of the pathogens we need to detect, the combination of ST's Lab-on-Chip platform with Veredus' molecular diagnostics expertise stands out as a powerful tool in the ability to provide rapid and accurate identification of pathogens and adaptation to new challenges," said Anton Hofmeister, Group Vice-President and General Manager for ST's Microfluidic Division. VereFoodborne will be a very powerful tool for health authorities and the food industry to carry out food safety surveillance as well as poisoning-outbreak investigation.

With this tool, health authorities can speed up their investigations of food-borne poisoning outbreaks. VereFoodborne's faster testing means the health authorities can eliminate 'suspects' faster and zero in on their 'culprit' pathogen more accurately. This would lead to faster containment and stop the spread of infection early on. Wrong 'suspects' in a poisoning outbreak investigation, which could be a shipment of farm produce, for example, can be released from quarantine faster, avoiding unnecessary costs and spoilage of goods.

Major food companies, on the other hand, vigorously test all their ingredients pre and post processing. The traditional method, which takes much longer to complete, means that perishable ingredients need to be held-up longer in storage while their shelf-life clock is ticking away. Smaller companies, which normally would depend on central labs, can also now carry out their own testing at a lower cost and shorter time if they use the VereFoodborne.

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bioMérieux Launches Groundbreaking Salmonella Detection Technology to Improve Food Safety

bioMérieux today announced the launch of a new, innovative food safety testing method, VIDAS® UP Salmonella (SPT). This new food safety solution utilizes recombinant bacteriophage (phage) proteins, which offer best-in-class specificity and sensitivity for the targeted capture and detection of Salmonella bacteria in food and environmental samples. The technology complements the company’s VIDAS E. coli O157 (including H7) phage technology for the detection of Escherichia coli O157:H7.

Salmonella is a bacterium that causes one of the most common intestinal infections worldwide (Salmonellosis). In the United States alone it is implicated in more than one million cases of foodborne illness annually, according to a 2011 report from the Centers for Disease Control and Prevention. Of these cases, approximately 20,000 result in hospitalization and 378 result in death.

“The issue of food safety is a significant public health concern globally, and food producers and manufacturers are in need of more advanced, comprehensive and science-based approaches to ensuring the safety of their products,” said Jean-Marc Durano, corporate vice president, Industrial Microbiology, bioMérieux. “VIDAS SPT, the latest addition to the VIDAS UP range, provides optimum performance to help simplify agri-food laboratories’ workflow and deliver rapid information to maximize the overall efficiency of food production. We, at bioMérieux are pleased to provide yet another innovative solution to combat one of the most important food safety challenges today.”

The new VIDAS SPT assay, utilizing phage protein technology, is able to detect low levels of contamination by Salmonella and is one of the most rapid and easy-to-use diagnostic tools available for the screening of Salmonella in environmental samples, standard and large-size food samples. The technology provides an extremely simple, one-step sample preparation which reduces laboratory hands-on time, and delivers results in as little as 19 hours as compared to reference methods which require up to three days.

“Because phages are extremely host-specific, they can offer unrivaled specificity and sensitivity for the targeted capture, detection and differentiation of bacteria from a given sample,” said Dr. Lawrence Goodridge, associate professor of food microbiology, Colorado State University. “Food pathogen detection methods utilizing bacteriophage technology can provide food producers with the ability to detect bacterial pathogens present in their products with unprecedented speed and reliability. This is critical to reducing the magnitude and severity of foodborne illness caused by the consumption of foods contaminated with dangerous bacteria.”

Bacteriophages, some of the most abundant life forms on earth, are highly specific viruses programmed exclusively to identify and infect host bacteria. Phages have co-evolved with bacteria for more than a billion years and are able to survive in the most extreme environments including soil, animal waste and intestinal tracts. Research shows that bacteriophages offer a number of advantages, such as superior specificity and superior binding, when used in microbiological test systems. Phage proteins have been proven to provide robust performance in many different applications, even when challenged with the most demanding and complex food matrices.

Licensed exclusively to bioMérieux, the recombinant phage technology was developed by the German biotech company Hyglos GmbH.

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It’s in the Sprouts!

The head of Germany’s national disease control centre, Reinhard Burger, has stated that after the epidemiological investigation there is enough evidence to conclude that the E. Coli outbreak started from sprouts (bean). What effect this will have on the farmers and consumer confidence worldwide only time will tell. There is a need for greater vigilance in food hygiene, particularly for those who are responsible for production and delivery of food. Challenges can come not only from know pathogens, but recent years have seen the sudden emergence of previously unknown strains with tragic lethal outcomes for consumers, while for producers and suppliers the consequences can be legally and economically disastrous.

Andrew Broggio, Managing Director from Medical Wire (a UK-based firm that has a number of products which can be utilised to detect foodborne pathogens) says “it is therefore imperative that rigorous and validated cleaning procedures are maintained to prevent contamination in all aspects of food handling and processing environments. Andrew goes on to explain this is “to ensure cleaning continues to be effective all cleaned surfaces must be regularly sampled and tested to ensure microbial levels are within acceptable limits and that no dangerous pathogens are present.”

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Little Rock Firm Develops Rapid Test for E. coli

Preliminary tests by scientists at the University of Arkansas Division of Agriculture’s Center for Food Safety and a federal agency have confirmed that a technology developed by the center’s industry collaborator, Litmus Rapid-B LLC (LRB), will provide a significant improvement over current conventional methods for detecting pathogenic E. coli bacteria.

LRB’s detection technology was validated by a lab of the federal Food and Drug Administration’s (FDA) Food Emergency Response Network (FERN). The tests by the university scientists confirmed the performance claims by LRB, and also mirrored the FDA FERN lab’s data that previously supported LRB’s claims of speed and accuracy.

“The significant improvement in speed and accuracy by LRB could improve detection and allow protocols to shift to more proactive testing for E. coli,” said Steven Ricke, director of the Center for Food Safety.”Accurate results are provided in five hours rather than eight to 24 hours for other rapid methods,” he said.

LRB, a Little Rock-based biotechnology company, developed its technology in a collaboration with the National Center for Toxicological Research (NCTR), an agency of the FDA based in Jefferson, Ark. “The Center for Food Safety is excited about the possibility of nurturing an Arkansas-based and derived technology that will lead to the employment of University of Arkansas graduates,” Ricke said.

Based on the confirmation of LRB’s performance claims for testing E. coli, the center will also begin work to confirm the company’s performance claims and protocols for Salmonella and a total plate count (TPC) assay for environmental samples.

The center is also seeking resources to add LRB to research on a previously unknown strain of E. coli found recently in Germany that has sickened thousands and killed dozens. The new strain, known as E. coli O104:H4, may be more potent than longer known strains of the bacterium. Outbreaks of illness from the strain have been limited to Europe to date.

Ricke said the center will seek resources to add LRB’s system to its research into shiga toxin-producing E. coli (STEC) strains other than the well-known pathogenic E. coli O157:H7. The STEC bacteria can cause illness ranging from mild intestinal disease to severe kidney complications. The center will also study the use of the LRB system as a rapid screening tool for Non 0157 STEC E. coli strains and to process the results by other methods to determine their typing for pathogenicity.

“The collaboration with LRB will allow the Center for Food Safety to continue its tradition of introducing novel technologies and protocols to the food processing industry,” Ricke said. In addition to improving prospects for food safety, Ricke said, the collaboration with LRB helps the Division of Agriculture in its long-standing drive to improve economic development in Arkansas.

Students in the food science undergraduate and graduate degree programs in the university’s Dale Bumpers College of Agricultural, Food and Life Sciences participate in Center for Food Safety research, which has been enhanced by LRB system equipment.

Recently, LITMUS RAPID-B LLC entered into a collaboration with the Center for Food Safety to improve identification of foodborne bacteria such as E. coli and Salmonella throughout processing and distribution points.

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InstantLabs® Expands Middle East Presence of Hunter Accelerated-PCR® Systems for Detection of E. coli and Other Pathogens

InstantLabs®, a provider of new generation portable PCR testing systems to users at points-of-need, today announced the placement of eight of its Hunter Accelerated-PCR® systems in Middle Eastern countries. InstantLabs has globally launched its Hunter system in the product verification and food safety markets, while concurrently advancing clinical development of human diagnostics tests. The capabilities and unique advantages of the system were featured at a Food Safety and Health Seminar held on May 24, 2011 in Doha, Qatar and hosted by the state's Supreme Council of Health (SCH). Qatar imports over 90% of its food and has a large guest worker population, making foodborne pathogen and infectious disease testing a high priority.

The Hunter system provides the accuracy of RT-PCR in a compact, portable, affordable and fully-integrated system that makes possible gold-standard molecular diagnostic testing at points-of-need such as border control points, airports and import facilities. InstantLabs designed this revolutionary system with advanced networking capabilities that allow for central monitoring of Hunter units in use at multiple locations; an advantage for organizations like the SCH. Additional users in the Middle East include food and beverage companies, ministries of health, and prestigious reference labs in countries including Iraq, Jordan (the Jordanian FDA and the Jordanian Army Lab), Lebanon (the Lebanese Agricultural Research Institute and the AZM Bio Research Lab in Tripoli), and Kuwait (the Kuwaiti Institute for Scientific Research).

"We are pleased by the reception of our technology in Middle Eastern countries for both food safety and medical diagnostic needs. These geographies are extremely dependent on food imports and unfortunately experience high rates of tuberculosis. With the Hunter system, we are now able to bring point-of-need, top quality real-time PCR system to geographies and organizations who can most benefit from rapid detection, accuracy and affordability," said W. Ross Newland, Vice President International for InstantLabs. "A large and growing selection of our patented chemistry-ready disposable assay cartridges are available to screen for Salmonella, E. coli, Listeria and other common and problematic foodborne pathogens."

In addition to screening for foodborne pathogens, other potential applications for the Hunter system include disease screening (e.g. for tuberculosis) at ports of entry, and measuring toxins and bacteria levels in water. Municipal authorities, health entities and food companies can utilize the Hunter system to rapidly and accurately conduct pathogen testing and reporting, without typical waiting times associated with central reference laboratories. Mr. Newland also noted that InstantLabs has interest in partnership agreements with local scientific institutions and reference laboratories, based on specific RT-PCR tests for the food and human pathogens that constitute the biggest challenges in the region.

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Meridian Tests Detect Deadly Toxins Produced by E. coli O104 Outbreak Strain

Meridian Bioscience, Inc. today announced that its tests detect the deadly toxins produced by the recent outbreak strain E. coli O104:H4. E. coli O104:H4 is the novel shiga toxin-producing strain associated with a number of deaths in Europe. It has also caused hemolytic uremic syndrome (HUS) (a type of kidney failure) in hundreds of others. In the United States, one confirmed and three suspected cases of E. coli O104:H4 infections have been identified in persons who recently traveled to Germany. One case of HUS in Massachusetts has been confirmed as matching the German outbreak strain. Among the three suspected cases, two are cases of HUS, one case each in Michigan and Wisconsin. The third suspected case, a person with shiga toxin-positive diarrheal illness, is still under investigation. (See information posted to the CDC website.) Meridian has been able to conduct testing on clinical isolates from one of these clinical samples utilizing its two distinct tests for shiga toxin-producing E. coli (STEC) and confirmed that its tests have correctly identified the samples as shiga toxin-producing and, more specifically, that it produces shiga toxin-2.

Shiga toxin-producing E. coli, or STEC, are common foodborne contaminants. It is the shiga toxins that the organisms produce, either shiga toxin 1 or shiga toxin 2, that cause serious complications in the infected person. The most commonly detected STEC strain in North America is O157:H7. Mike Loeffelholz, PhD, ABMM, Associate Professor in the Department of Pathology and Director of the Clinical Microbiology Laboratory at University of Texas Medical Branch in Galveston, TX states,, “Detection of E. coli O157:H7 alone will under-detect shiga toxin-producing strains of E. coli (STEC). A U.S. study showed that roughly half of STEC isolates from routine stool samples were non-O157 strains (Hedican et al. 2009. CID). It is estimated that approximately one third of all illnesses caused by STEC, including hemolytic uremic syndrome (HUS), is due to non-O157 strains (Mead et al. 1999. EID; Mellmann et al. 2008. EID). As the distribution of gene targets for shiga toxins 1 and 2 varies among O157 and non-O157 STEC (Hedican et al. 2009. CID; Kappeli et al. 2011. EID), it is important that diagnostic assays detect both toxins. Some studies indicate that shiga toxin 2 has a higher association with HUS (Friedrich et al. 2002. JID), so the ability of assays to differentiate between the two toxins may also be clinically relevant.”

Meridian’s Premier™ EHEC (cleared by the FDA in April of 1995) and ImmunoCard STAT!® EHEC (cleared by the FDA in February of 2007) assays detect both toxin types. ImmunoCard STAT!® EHEC provides an additional advantage in that the test differentiates between shiga toxin 1 and shiga toxin 2. Rapid identification of the toxin 2 type will enable physicians to immediately isolate and appropriately treat infected patients to reduce the likelihood for the development of HUS.

As expected, the toxin produced by the deadly E. coli strain from Europe is detected by Meridian’s shiga toxin-detecting assays, Premier™ EHEC and ImmunoCard STAT!® EHEC. Richard Eberly, Chief Commercial Officer, stated, “Meridian will continue to support global demands by ensuring these kits are available in all regions where they are needed to detect and control infection.”

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NanoLogix Eyes FDA Clearance of Rapid Diagnostic Bacteria Tests

The Youngstown, Ohio-area company, which develops diagnostics kits for bacteria and other microorganisms that it says are several times faster than traditional methods of detection, currently has no products cleared for commercial sales by the U.S. Food and Drug Administration.

With no 510(k) product clearances from the FDA in hand, NanoLogix sells only to the research market, but that could soon change. CEO Bret Barnhizer is eyeing sales to the food and veterinary industries after — and if — the company passes the appropriate regulatory hurdles.

NanoLogix develops diagnostic kits for a wide variety of bacteria and microorganisms, which includes salmonella, E. coli, listeria, staph, anthrax, spores and mold. Barnhizer expects to receive FDA clearance for diagnostic tests for several families of bacteria within the next few months.

The company’s BioNanoPore and BioNanoFilter technologies involve a proprietary water-permeable cellulose membrane that’s surrounded by a nutrient mix and lays in a petri dish. Bacteria grows on the membrane, which is then transferred to a staining plate, and allows bacterial micro colonies to become visible after about five minutes, according to the company.

“We don’t make anything grow any faster,” Barnhizer said. “The membrane provides the ability for people to see what’s growing much faster.” NanoLogix’s technology is capable of producing visible results in six hours, which Barnhizer says is several times faster than a petri dish alone.

The technology is involved in two ongoing clinical trials — one in the U.S. and one in Europe. In a 300-patient trial, researchers from the University of Texas Health Science Center in Houston are evaluating the technology’s ability to detect and identify Group B Streptococcus (GBS) in pregnant women. GBS is a bacterial infection that can be passed to a woman’s baby during delivery. Initial results from the trial have shown that NanoLogix’s technology detects and identifies GBS within two to six hours, which the company says is eight to 24 times faster than conventional methods. The second 300-patient trial is also evaluating the technology’s ability to detect GBS and is being led by an Italian researcher. The trial is aimed at helping NanoLogix obtain European regulatory clearance to begin selling its products on the continent.

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BioLumix DMF Submission for Rapid Microbiological System Accepted by FDA

BioLumix announced today that the US Food and Drug Administration (FDA) have accepted a BioLumix Drug Master File (DMF) entitled “Microbiological Rapid Method for the Detection and Enumeration of Microorganisms in Pharmaceutical Products”. The DMF provides specific technical and regulatory information to the FDA which allows companies planning to use the BioLumix Rapid Microbiological System to obtain regulatory approvals for prescription drugs.

Dr. Ruth Eden, President of BioLumix said that “The DMF can be referenced by drug manufacturers, reducing the FDA review times and accelerates the regulatory approval process for use the BioLumix System. In addition Over the Counter (OTC) products can be tested in conjunction with BioLumix validation Package. The BioLumix DMF includes the information that the FDA requires to assess alternative microbiological detection systems. It includes information about the technology, its accuracy, specificity, limit of detection, robustness, ruggedness, and equivalence to USP methodology.”

“FDA actively encourages use of new technologies including rapid microbiology methods (RMM)” stated Dr. David Hussong, FDA’s Associate Director for New Drug Microbiology, Office of Pharmaceutical Science, CDER. Newer microbiological methods can improve company’s quality of testing and result in significant financial savings. Such methods can reduce cycle times resulting in a leaner and more responsive supply chain.

“The BioLumix System is extremely easy to operate, it offering straightforward, streamlined testing design and rapid, accurate results lead to reduced material-holding time for faster product release. “ said Kevin LaBrecque, Director of sales and Marketing at BioLumix. “It offers a simplified single-platform testing for all assays with a 48-hour Automated Certificate of Analysis, while avoiding any product interference.”

In the DMF BioLumix share specific technical and regulatory information with the FDA, including details about reagent composition, mode of action of reagents and growth media, and performance characteristics of its system. The FDA will be able to evaluate the use of the BioLumix system in pharmaceutical applications for rapid detection of microorganisms, when referenced by the customer.

BioLumix provides products for rapid detection of microorganisms for the Pharmaceutical, Nutraceutical, dietary supplements, cosmetics, toiletry and the food industries, using an internally developed proprietary advanced technology. A wide variety of test kits are available covering all required microbiological assays. By reducing the testing time and time for product release BioLumix system increases manufacturing productivity and improves supply chain management.

Further information can be found on the BioLumix website at www.mybiolumix.com.

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Pall GeneDisc® Technology a Key Detection Tool in E. coli Outbreak

Pall Corporation
25 Harbor Park Drive
Port Washington, New York 11050
toll free phone: 1-800-521-1520
fax: 516-801-9754
email: genedisc@pall.com
website: http://www.pall.com/biopharm_53215.asp

Pall Corporation’s GeneDisc® System is helping German authorities screen for a deadly strain of E. coli that has sickened nearly 3000 people and disrupted that nation’s food industry.

Pall’s GeneDisc technology is being used by Germany’s national reference laboratory to expedite testing of food samples for the toxic strain of the pathogen known as E. coli O104:H4 (STEC).

“We are using Pall’s GeneDisc test kit for investigative screening of potential E. coli O104:H4 samples as well as for confirmation of presumptive positive samples. The GeneDisc system has proven highly effective in rapidly identifying STEC and helping us manage this public health crisis,” said Dr. Lothar Beutin of Germany’s Federal Institute for Risk Assessment (BfR). 2700 cases of serious illness, including 25 fatalities, have been reported in 12 countries to date as a result of the outbreak. Dr. Beutin has studied the use of Pall GeneDisc technology in identifying STECs associated with human illness.

The Pall GeneDisc System is a rapid, simple and reliable testing solution for the detection of multiple food-borne contaminants. Based on real-time Polymerase Chain Reaction (qPCR) technology, the system features an exceptionally robust platform utilizing ready-to-use consumables. The system and test procedure yields consistent results and virtually eliminates operator error. Data on the presence or absence of multiple pathogens are produced in as little as one hour after enrichment, as opposed to the days required by traditional methods.

“The Pall GeneDisc System is an ideal tool for reference laboratories and food manufacturers needing fast and specific detection of potential health risks,” said Jonathan Pratt, President Pall Food & Beverage.

The Pall GeneDisc System recently became the first technology to receive multiparametric validation from the AOAC Research Institute for the detection of non-O157 STEC in meat. The system enables producers to test simultaneously for the pathogenic E. coli O157 and four of the top six non-O157 STECs targeted by the U.S. Department of Agriculture. GeneDisc is also validated for Salmonella and E. coli O157:H7 testing. The Pathogenic E. coli O104:H4 test kit is the newest commercial assay in the GeneDisc product line.

The effectiveness of the GeneDisc platform in identifying STECs associated with hemorrhagic colitis and hemolytic uremic syndrome – the two catastrophic illnesses presenting in the German E. coli outbreak – was reported in the International Journal of Food Microbiology in April 2010. The study conducted jointly by Health Canada, the French Food Safety Agency (ANSES), and the German Federal Institute for Risk Assessment (BfR) stated: “In conclusion, this report demonstrates that the GeneDisc array can be used for the fast and simultaneous detection of several serotypes and virulence factors of STEC. Simultaneous detection of these markers provides data suitable for molecular risk assessment of the potential virulence of STEC isolates.” [Marie Bugarel, et. al. Volume 142 (2010), page 318-329]

An overview of the technology platform and sample workflow can be found by CLICKING HERE.

Further information can be found on the Pall website at www.pall.com/biopharm_53215.asp.

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FDA Approves Test for Diagnosing Leishmaniasis Caused by Sand Flies

The U.S. Food and Drug Administration cleared the way for the SMART Leish PCR assay, a test to aid in the diagnosis of individuals with cutaneous leishmaniasis caused by certain species of sand flies. The Army Medical Research and Materiel Command worked for several years to develop the diagnostic test to address the global health issue of cutaneous leishmaniasis, which has occurred in thousands of U.S. troops serving in Iraq and Afghanistan.

The SMART Leish PCR assay was developed in partnership among Walter Reed Army Institute of Research, or WRAIR, Army Medical Materiel Development Activity and the commercial partner, Cepheid USA, Inc.

Endemic throughout Africa, Asia, Europe as well as the Americas, leishmaniasis is a protozoan parasitic disease caused by single-cell organisms transmitted through the bite of a sand fly. Cutaneous leishmaniasis is the most common form of the disease. Though not considered life threatening, the disease can cause disfiguring skin ulcers that take months to heal and cause scarring. Up to this point there were no FDA cleared devices for the diagnosis of the disease. Traditional testing methods require a small tissue sample of the skin ulcer lesion. The samples are examined under microscope and culture to determine the presence of the intracellular form of the leishmania parasites called amastigotes. These traditional testing methods can require anywhere from 30 minutes to four weeks to produce results. In contrast, the SMART Leish PCR is a qualitative test that uses real-time Polymerase Chain Reaction to amplify DNA sequences unique to the organism that causes cutaneous leishmaniasis. Samples are acquired from skin lesions in the same way they are acquired for traditional methods.

“The Smart Leish Real-Time PCR assay can provide consistent results within hours of sample receipt, even when the numbers of parasites in the skin are so low that microscopy and culture results will be negative at day 30. This allows for timely treatment of the disease,” said Lisa Hochberg from WRAIR's division of entomology. “Servicemembers will immediately benefit from this new assay since the Smart Leish Real-Time PCR will be part of the battery of tests run at the Leishmania Diagnostic Laboratory, Division of Experimental Therapeutics at WRAIR,” said Col. Max Grogl, the director there. “In the near future, this assay may be utilized at additional strategically located DoD medical facilities, enhancing our capability to provide rapid diagnosis to servicemembers and improve patient management,” said Grogl.

According to Hochberg, this assay represents the first FDA-cleared real time PCR diagnostic device for infectious diseases developed and cleared by the Army.

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TessArae, LLC Taps L. Thomas Richards, M.D. as President

TessArae®, LLC, a privately held company, today announced that it has appointed Tom Richards as its new President. Dr. Richards has held faculty positions at Stanford University Medical Center and UCSF Medical Center, where he currently practices as an Assistant Clinical Professor in the Department of Emergency Medicine. Richards is a graduate of Harvard Medical School and Yale College.

"I am excited to be joining the team at TessArae," says Dr. Richards. "TessArae's technology makes it one of the most exciting molecular diagnostic companies today. In a single assay, it simultaneously detects and identifies hundreds of pathogens, confronting some of the most confounding problems in healthcare: nosocomial infections, antibiotic resistance, blood safety, food safety and pharmaceutical manufacturing quality assurance. That same technology allows it to analyze hundreds of human genetic mutations in a single assay, providing researchers and clinicians alike the chance to help patients understand their own genetic risks and inform their reproductive decisions. TessArae is positioned at an inflection point of very rapid growth."

Klaus Schafer, CEO of TessArae adds, "Tom brings a unique combination of skills to TessArae: he is a practicing academic physician with an investment banking background, public board experience and a deep grounding in Wall Street transactional finance. His medical and financial acumen will be a great contribution to our team and to our rapidly expanding customer base, which now includes the US, Canada, Mexico, China and the Middle East."

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Rapid Molecular Diagnosis Deemed a Game Changer for UTI Management

Rapid molecular diagnosis of urinary tract infection will soon enable individualized, evidence-based selection of antibiotics "right at the point of care," according to Dr. Joseph C. Liao. "Currently we rely on urine culture, which takes 2-3 days at a central microbiology laboratory," he said. "What if in the future [you] could obtain molecular diagnosis in less than 1 hour right there in your office? And what if we could tailor the choice of antibiotics for the patient sitting in your office [rather than start broad-spectrum antibiotics empirically]?"

Personalized, evidence-based selection of antibiotics has become an increasingly important goal – for both individual and public health – as the problem of antibiotic resistance has intensified, said Dr. Liao and other speakers at the annual meeting of the American Urological Association.

Over the past several years, Dr. Liao and his colleagues in the urology department at Stanford (Calif.) University have used biosensor technology to develop an assay for rapid pathogen identification, as well as a biosensor-based antimicrobial susceptibility test for urinary tract infection (UTI). "We’ve been able to achieve pathogen identification within an hour, and antimicrobial susceptibility testing within 3 hours," Dr. Liao reported.

The biosensor (a molecular sensing device that generates a measurable signal in the presence of a target analyte) is already part of everyday clinical practice, he noted. The glucose sensor and the i-STAT portable clinical analyzer, for example, are commonly used biosensor-based devices. The biosensor being utilized in the "next generation" of UTI diagnostic tools is comprised of a chip about the size of a microscope slide with 16 individual sensors. "Like computer technology, it can be mass produced at a relatively low cost," said Dr. Liao, who is also chief urologist at the Veterans Affairs Palo Alto (Calif.) Health Care System.

The overall strategy for pathogen identification involves lysis of the bacteria present in a urine sample, followed by a hybridization process that enables the sensor to detect bacterial 16S rRNA, a kind of "bacterial molecular fingerprint." This results in a signal output. "Essentially, we’re converting a molecular hybridization event into an electrical signal," Dr. Liao explained. "And the higher the bacterial concentration, the higher the signal."

Bacterial 16S rRNA is also a marker of bacterial growth, a property that Dr. Liao’s research group has exploited to develop a biosensor-based antimicrobial susceptibility test (AST). By incubating a urine sample in the presence or absence of commonly used antibiotics, and quantifying the 16S rRNA level, "we can follow the differential growth and derive the AST," he said. Dr. Liao and his colleagues recently completed a clinical validation study in which they compared results from their biosensor platform with results from standard microbiological analysis in more than 200 urine samples collected from patients at the Spinal Cord Injury Service at the Veterans Affairs Palo Alto system. Pathogen detection sensitivity and specificity were 92% and 97%, respectively, and "in corresponding AST, we found an overall agreement of 94%," said Dr. Liao, whose study was published early this year (J. Urol. 2011;185:148-53).

In the future, Dr. Liao hopes to use biosensor technology to also detect biomarkers that are shown to be indicative of infection in the presence of pathogens, he said. Such an integrated assay would detect both biomarkers and pathogens, and thus address the host immunity response as well as identify the pathogen. This could further improve the now-challenging task of differentiating colonization, simple UTI, and early complicated UTI, "and [could] help us better differentiate and stratify the severity of infection," he said.

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Akonni Biosystems Announces the Appointment of CFO

Akonni Biosystems, Inc., announced that it has appointed Jan Smilek as its Chief Financial Officer, effective immediately. Akonni, founded in 2003, is developing and commercializing novel nucleic acid extraction and microarray-based testing systems designed to rapidly and economically analyze biological samples. These systems will be used in clinical laboratory and research settings, and also have industrial manufacturing, biothreat detection, and forensics applications.

The Company’s core technology is based on work developed at Argonne National Laboratory and the Engelhardt Institute of Molecular Biology and utilizes gel-drop array technologies optimized for medical applications. Supported by a series of government grants and contracts from NIH, CDC, DOE, DOD, NIJ, and NSF, the Company has significantly advanced the original technology by improving the system’s capabilities from sample preparation to final result. Commercial products and products in its near-term pipeline include rapid sample preparation methodologies for nucleic acid extraction (TruTip) and multiplex panel assays for detecting multidrug-resistant tuberculosis (MDR-TB), upper respiratory infections, viral encephalitis, and hospital-acquired infections (MRSA).

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NanoLogix Announces European Clinical Trial of Its Rapid Detection Kits

NanoLogix, a biotechnology innovator in the rapid detection and identification of live-cell bacteria and microorganisms, announced today its BioNanoFilter (BNF) technology will undergo a clinical trial, led by Dr. Gian Carlo Di Renzo of the University of Perugia in Italy. The 300 patient trial will study the speed and accuracy of NanoLogix technology compared to current methods in the detection and identification of Group B Streptococcus (GBS) in pregnant women. Initial BNF results on GBS from the University of Texas Health Science Center-Houston show detection and identification within two to six hours. This is eight to twenty-four times faster than conventional methods. The trial will be the second clinical trial conducted on the NanoLogix BNF technology for Group B Strep. Results from this clinical trial will accelerate the approval of the BNF kits for use in Europe, North Africa and the Middle East.

Conventional technology can take at least 48-72 hours to return results for Group B Strep. Often during this waiting period it is recommended that physicians treat patients empirically with antibiotics if they fall into specified "at risk" categories for being colonized with GBS. This practice protects the mother from health risks and the unborn child from life threatening illnesses related to Group B Strep. However, it can also lead to the development of antibiotic resistance in GBS strains.

About 30 percent of reproductive age women carry GBS, which can cause life-threatening infections such as sepsis, meningitis and pneumonia in newborns, if their mothers are not treated prior to delivery. In the U.S., delivery without treatment results in around 8,000 newborns being infected each year. The Centers for Disease Control guidelines for the prevention of neonatal GBS call for testing all pregnant women for GBS between 35 and 37 weeks. In 2009, just over 4 million women gave birth in the U.S. alone.

"We are excited to have our BioNanoFilter technology undergo a clinical trial in Europe," said NanoLogix CEO Bret Barnhizer. "We expect this European clinical trial to pave the way for certification and validation of our rapid detection technologies there, as well as in North Africa and the Middle East. We thank Dr. Di Renzo and the other physicians and technicians who are involved in the trial."

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Abaxis Launches Two New Rapid Diagnostic Tests in Veterinary Market

Abaxis, Inc., a medical products company manufacturing point-of-care blood analysis systems, today announced the Company's Animal Health group has added two new rapid diagnostic tests, the VetScan Canine Parvovirus Rapid Test and the VetScan Giardia Rapid Test. The VetScan Canine Parvovirus Rapid Test was launched in March 2011 and the VetScan Giardia Rapid Test began selling in May 2011 and both rapid tests have been well received by the veterinary community. The Parvo and Giardia rapid tests are the latest addition to the VetScan rapid diagnostic test product line that already includes the successful Canine Heartworm Rapid Test, which was launched in January of 2009.

Canine Parvovirus is a highly contagious and potentially life threatening disease that usually attacks the gastrointestinal tract causing vomiting, diarrhea, and dehydration. Canine Parvovirus is most common in puppies 6-20 weeks old. Giardiasis is also a gastrointestinal infection caused by the protozoan parasite Giardia. Symptoms of Giardia infection include diarrhea and weight loss and infection is also more common in younger pets.

Michael Solomon, director of business development for Abaxis Animal Health commented, "The launch of these two new products demonstrates Abaxis' commitment to the veterinary market. The Company will continue to add high quality and cost-effective diagnostic tests to its product portfolio in order to best serve the veterinarians, their clients and their patients."

Martin Mulroy, vice president of sales and marketing for Abaxis Animal Health commented, "The addition of these two rapid tests strengthens Abaxis' overall presence in the marketplace by providing the veterinarian with more in-house testing options from a trusted partner. The VetScan Parvo and Giardia rapid tests are just two more additions to the continually growing VetScan family of products. We will continue to provide animal health providers innovative, reliable, and low-cost solutions to enhance their practices."

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ENDETEC Presents Innovative Rapid Microbial Detector for Water Systems

ENDETEC will present their innovative solutions at ACE11, the American Water Works Association’s 130th Annual Conference & Exposition, June 12 - 16, 2011, in Washington, D.C. ENDETEC’s focus is to ensure water quality by providing continuous in-pipe monitoring of chemical pollutants and early warning detection of microbiological contamination. ENDETEC represents another milestone in VWS’ continued pledge to ensure Safe Water Integrity with its KAPTA™ line of multi-parameter water sensor probes and the state-of-the-art TECTA™ B16 rapid microbial detection instrument for E. coli and Total Coliforms, as well as its “All-In- One” TECTA™ CCA test cartridge, the most rapid detection method available on the market. ENDETEC will exhibit their products at booth #2264 and present the TECTA™ B16 rapid microbial detection instrument in the New Product Technology Showcase.

Globalization and the increasingly competitive world we live in forces people to manage their time more effectively. Our customers are asking for more rapid tests, more automation, and less subjective interpretation in their microbial detection program. With real-time monitoring capabilities, our systems provide early warning detection in case of an adverse event, providing drinking water operators all over the world with management optimization of the distribution network, peace of mind and time to react.

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3M™ Announces Infection Prevention Solution to Monitor and Manage Hygiene of Hospital Surfaces

As part of its effort to offer a wide range of environmental hygiene solutions for healthcare facilities, 3M Infection Prevention today announced its 3M™ Clean-Trace™ Hygiene Management System. This solution is designed to help hospitals assess the cleanliness of a surface and validate the efficacy of cleaning protocols and worker performance in less than one minute.

The Clean-Trace System detects adenosine triphosphate (ATP), a substance found in all living cells and present on any contaminated surface. Samples from high-touch surfaces in a hospital, such as bed rails, light switches or nurse call buttons, are collected using the 3M™ Clean-Trace™ ATP Surface Test. If the test picks up any organic material (ATP), it will emit light in direct proportion to the contamination level which can be read and quantified by the hand-held 3M™ Clean-Trace™ NGi Luminometer. Data collected can be uploaded to the 3M™ Clean-Trace™ Online Software which provides the users advanced data analysis with tracking and full trending capabilities including automatic report generation.

Until now, hospitals and healthcare facilities have relied primarily on visual inspections to determine the hygienic status of a surface. However, more and more facilities are finding that visual inspections alone cannot reliably determine the presence of surface contamination when many soils such as bacteria, biofilm and organic residues are not visible to the naked eye. The Clean-Trace System does detect the presence of any organic contamination you cannot see. This technology is transforming the practice of environmental hygiene and provides healthcare facilities with a real-time assessment tool.

John Boyce, MD, chief of Infectious Diseases Section at Hospital of Saint Raphael in New Haven, Conn., has studied the effectiveness of hospital cleaning practices. His studies were published in the July 2009 and January 2010 issues of Infection Control and Hospital Epidemiology. “During the last 5 to 10 years, there has been increasing appreciation for the fact that contaminated surfaces in the hospital can contribute to the transmission of healthcare-associated pathogens,” said Dr. Boyce. “While hand hygiene has long been recognized as one of the most important infection prevention practices, organizations such as the CDC recognize the need to also pay attention to surfaces.”

“There is now evidence showing that by cleaning the environment more effectively, there is a reduction in the patients’ risk of acquiring resistant bacteria such as vancomycin-resistant Enterococcus (VRE), Clostridium difficile (C. diff), and methicillin-resistant Staphylococcus aureus (MRSA), in the hospital,” said Dr. Boyce.

According to the Agency for Healthcare Research and Quality of the U.S. Department of Health and Human Services report, healthcare-associated infections (HAIs) are the most common complication of hospital care and one of the top 10 leading causes of death in the United States. In 2002, HAIs accounted for an estimated 1.7 million infections and 99,000 associated deaths.

Government and industry organizations also have called for better monitoring techniques. In its Management of Multidrug-Resistant Organisms in Healthcare Settings, 2006 guideline, the Healthcare Infection Control Practices Advisory Committee of the Centers for Disease Control (CDC) recommends that healthcare facilities should “monitor cleaning performance to ensure consistent cleaning and disinfection of surfaces.” Both the Society for Healthcare Epidemiology of America (SHEA) and the Infectious Diseases Society of America (IDSA) indicate that having systems for monitoring adherence to environmental cleaning and disinfection protocols is desirable. In the most recent CDC Toolkit document, “Options for Evaluating Environmental Cleaning,” the CDC recognized ATP Bioluminescence as “an objective method for the evaluation of environmental hygiene.”

“The Clean-Trace System is a game changer for our healthcare facility partners, who share our mission of reducing HAIs,” said Debra Rectenwald, 3M Infection Prevention Division president and general manager. “This ATP Hygiene Management System is a frontline tool that will revolutionize environmental hygiene and is a key part of our mission is to put together all the elements of a superior hygiene monitoring solution. In addition, 3M offers education, protocols, service, compliance tools and a cleaning portfolio, all of which round out our full range of unique Environmental Hygiene Solutions for our customers’ infection prevention arsenals.”

Currently, an approximate 150 hospitals and healthcare facilities across the U.S. are using Clean-Trace. One of those facilities is Tampa General Hospital, which houses the area’s only level 1 trauma center and one of four burn centers in the state. John Scolaro, Certified Healthcare Environmental Service Professional and director of environmental/textile services, is responsible for overseeing environmental cleaning at the West Central Florida medical facility. Like many hospitals, Tampa General used careful visual inspection and periodic, random culture sampling and laboratory testing, but Scolaro sought a more intensive, real-time method to help monitor and confirm cleaning effectiveness. Since 2009, Tampa General has been using the 3M Clean-Trace Hygiene Management System and already has seen positive results.

According to Scolaro, the ability to confirm cleaning performance by individual touch point and cleaning staff member has led to improved results and has helped change the infection prevention dynamic in the facility.

“The significant improvement from 85 percent to 96 percent in compliance scores can be attributed to the provision of immediate performance feedback and the consequent ability to assess and refine our procedures,” Scolaro said. “It is now possible to demonstrate performance differences between proper and improper cleaning, on the spot. This system is, in effect, making the invisible visible and has quickly become a very important tool for us.”

In addition, the Clean-Trace System has become an effective cleaning tool and positive motivator for the cleaning staff. “Our staff can see first-hand what works and are able to change their practices to consistently meet the standard,” Scolaro said.

The 3M Clean-Trace Hygiene Management System currently is available for environmental hygiene use. 3M expects to introduce Clean-Trace applications for surgical instruments and endoscopes later in 2011.

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Roche Applied Science and TIB Molbiol offer Assay Solution for Rapid EHEC Identification

With the recent outbreak in Europe of Enterohaemorrhagic Escherichia coli (EHEC), Roche Applied Science and TIB Molbiol are providing scientists with complementary technologies that can be used for the rapid identification and detection of EHEC.

As of the second week of May 2011, there has been a significant increase in the number of cases of bloody diarrhea associated with hemolytic-uremic syndrome (HUS). Currently, 329 laboratory confirmed cases have been reported, three of them with fatal outcome (Robert Koch Institute’s report May 29th). The majority of cases are in northern Germany, but recently emerging cases from southern Germany and other European countries have also been reported. The German Consiliary Center for EHEC has identified EHEC producing Shiga toxin 2 (Stx2), as the causative agents. Possible sources are reported to be contaminated vegetables.

Fast, reliable detection of the EHEC bacterium is essential for monitoring and controlling EHEC infections. The most appropriate targets for the rapid, sensitive identification of the EHEC bacterium are unique genetic sequences, which can be amplified and detected using the polymerase chain reaction (PCR) method. Roche Applied Science provides complete systems for PCR, including LightCycler® Instruments, software, reagents and consumables. These detection systems are designed for life science research to enable the rapid development and adaptation of PCR assays, accelerating the progress of appropriate diagnostic tools.

The detection of EHEC by real-time PCR using the LightCycler® platform was already developed in 2002, and published jointly (J. Clin. Microbiol. (2002) 40, 2555-2565) by scientists from the universities of Regensburg (Prof. Dr. U. Reischl), Muenster (Prof. Dr. H. Karch), and the CDC in Atlanta (Dr. N. Strockbine). Since 2002, this real-time PCR test has been widely adopted by laboratories worldwide.

The new LightMix® Kit EHEC from TIB Molbiol contains pre-mixed primers and probes and an appropriate positive control for use with the LightCycler® Instruments. The test detects and differentiates both Shiga toxin genes and can be performed in less than one hour. The kit is based on the previously published assay from Grys et al., (J. Clin. Microbiol. (2009) 47, 2008-2012).

The standard analytical procedure for EHEC detection requires an overnight bacterial culture from patient stool samples prior to performing the PCR assay. To expedite time-to-result, such as for the EHEC outbreaks and samples with bloody diarrhea, it is possible to isolate the bacterial nucleic acids directly from stool samples using automated isolation methods of the Roche Applied Science MagNA Pure Sample Preparation Systems. This automated workflow followed by direct real-time PCR is currently under evaluation by a number of laboratories.

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Immunetics Receives $500,000 from Massachusetts Life Sciences Center to Commercialize BacTx® Test for Bacterial Contamination in Platelet Transfusions

Immunetics, Inc. announced it has been awarded a $500,000 Massachusetts Life Sciences Center Small Business Matching Grant (SBMG) to commercialize its BacTx® rapid test for detecting bacterial contamination in platelets.

Platelets are a vital blood product enabling clotting, and patients suffering from trauma, surgical procedures, cancer, or chemotherapy must receive platelet transfusions to survive. Bacterial contamination of platelets is the leading cause of infection during transfusion, with patients facing the risk of severe or fatal transfusion-associated sepsis from the roughly 1 in 2,000 platelet units that are contaminated.

"Rapidly detecting bacteria in platelet units presents a major challenge. Some current testing methods are ineffective because of low sensitivity. Others are overly difficult or time-consuming to perform close to transfusion," said Dr. Andrew Levin, president and scientific director, Immunetics. "According to the American Association of Blood Banks (AABB), a rapid test with high sensitivity performed close to the time of transfusion would represent a breakthrough in transfusion safety. The Massachusetts Life Sciences Center grant will help us transition the critical juncture from R&D to manufacturing scale-up and regulatory approval — and commercially launch BacTx," Levin said.

Immunetics has concluded clinical trials for BacTx® and plans to submit an application for approval to the U.S. Food and Drug Administration (FDA) this summer. With FDA approval, BacTx® could be launched as early as this year.

Immunetics was one of four life sciences firms named by the Massachusetts Life Sciences Center’s Board of Directors ("the Center") to share in $2 million in new SBMGs. The four recipients were chosen through a competitive process after extensive review by the Center’s peer review panel, Scientific Advisory Board, and Board of Directors. The grants foster job growth and technology commercialization in the Massachusetts Life Sciences Supercluster.

"Helping our life sciences companies grow is all about creating jobs," said Governor Deval Patrick. "As we continue to strengthen our global leadership in the life sciences, the Center’s Small Business Matching Grant Program is meeting an important need and making Massachusetts an even more attractive place for life sciences companies to locate and grow."

"The SBMG program is another example of the Center’s leveraging strategy," said Dr. Susan Windham-Bannister, President and CEO of the Massachusetts Life Sciences Center. "Federal SBIR/STTR grants provide Massachusetts companies with funds for their research and development; our SBMG program then provides the funds that companies need to bridge to commercialization. These four promising companies will bring cost-effective new treatments to the market and expand employment opportunities in Massachusetts. We are especially pleased that some of our grantees will contribute directly to the creation of biomanufacturing jobs in the Commonwealth."

"As an author of the legislation creating the Life Sciences Center several years ago, I am excited about the wonderful opportunity to grow the Life Sciences industry on the South Boston Waterfront," said State Senator Jack Hart (D-South Boston).

"Immunetics is doing important work to prevent infectious disease and improve public health in our state and around the world," said State Representative Nick Collins (D-South Boston), a member of the Joint Committee on Economic Development and Emerging Technologies. "This award by the Massachusetts Life Sciences Center is an example of the Commonwealth’s commitment to investing in our state’s economic future. It is also another sign of the continued emergence of the South Boston Waterfront as a center for innovation and job creation in the life sciences industry."

"I am extremely grateful for the continuing support by the Commonwealth and the Massachusetts Life Sciences Center of our mission to introduce innovations in the diagnosis of infectious diseases, as we grow our company in South Boston and become a stronger part of — and employer in — the very exciting Massachusetts Life Sciences community," Levin said.

Immunetics received two SBIR Phase II grants totaling approximately $4 million from the National Heart, Lung, and Blood Institute (NHLBI), an agency of the National Institutes of Health (NIH), which supported the research and development of the test. The technology underlying the test is protected by a recently issued U.S. patent, and foreign patents with approved claims are in process of issue.

With FDA approval, the BacTx® test will be marketed to blood centers and hospitals throughout the U.S. and around the world. In total, about 5 million platelet units are collected annually in the U.S. and an equal number outside the U.S.

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BioVigilant Introduces Next-Generation Rapid Biologic Detection System to Safeguard Pharmaceutical Manufacturing Areas

BioVigilant Systems, Inc. today announced the introduction of its next-generation IMD-A® family of rapid biologic detection systems for real-time environmental air monitoring in pharmaceutical manufacturing environments.

BioVigilant’s IMD-A 300 and IMD-A 350 systems can detect immediately the presence of bacteria in the drug manufacturing process, in contrast to traditional growth methods, which can take as long as one week while cultures are being grown. As a result, IMD-A systems can greatly accelerate the quality assurance processes for drug batch release.

Based on the principles of Mie Scattering and the intrinsic fluorescence of microorganisms, the IMD-A 300/350 systems utilize laser light to simultaneously distinguish inert from biologic particles, on a single particle basis. This single particle analysis capability offers greater sensitivity in the detection of bacteria, in contrast to the limited operational ranges displayed by common types of traditional equipment, making them less sensitive in detecting low levels of bacteria. In addition, IMD-A systems can be used to continuously monitor the environment as opposed to traditional methods that are used periodically for spot checks.

The IMD-A 300 samples 1.15 liters of air per minute while IMD-A 350 samples 28.3 liters per minute. Inert and biologic particles are grouped into one of six bins from 0.5 microns to greater than 10 microns as displayed in PharmaMaster®, the systems’ 21CFR Part-11 compliant software. The software offers different levels of functionality based on user need and authority, and allows for a library of profiles to be created, each with discrete alert and action levels to address a range of applications and manufacturing process environments. Both visual and audible prompts warn the operator when an alert or action limit has been reached, with a video feed from an optional Webcam available to assist with root-cause analysis when needed.

BioVigilant CEO Aric Meares said, “The US FDA continues to be very supportive of industry’s move to adopt modern technology and reap its benefits. BioVigilant’s IMD-A systems offer a ready tool for the advancement of Quality by Design principles and Process Analytical Technology inside pharmaceutical manufacturing.”

He added, “BioVigilant and the IMD Consortium, a group of renowned pharmaceutical drug companies from around the globe, share a common purpose: to advance the course of healthcare everywhere. For BioVigilant’s part, our aim is to deliver real-time information about the microbial risks present in an environment, empowering our customers to act. We are fortunate to have cultivated strong relationships with these industry leaders over the past several years and have tailored our products to meet their needs.”

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