Texas A&M University has New Rapid Foodborne Pathogen State-Of-The Art Laboratory

A new state-of-the-art laboratory equipped with instrumentation to allow rapid foodborne pathogen testing and characterization was showcased recently at The Science Park in College Station.

The new facility is designed to support the efforts of faculty who are members of the Center for Food Safety, a collaborative effort by Texas A&M AgriLife Research, Texas A&M AgriLife Extension Service and Texas A&M University.

“We have never had access to a shared facility like this before,” said Dr. Gary Acuff, director. “Imagine being able to use all of this technology and space without being required to purchase the equipment, pay for maintenance contracts or provide support for experienced technical research staff.”

Acuff said the center provides comprehensive access to food safety expertise through faculty members who can offer “the appropriate science to address a vast range of food safety issues supporting the food industry, regulatory agencies, small businesses and consumers.”

“The new multi-user facility offers unprecedented training opportunities through access to new laboratory and pilot plant facilities that allow for hands-on training,” he said. “In addition, the unique design of the facility permits observation of all laboratory activities from outside the Biosafety Level 2 environment to provide training and demonstration opportunities to attendees who lack certification to enter a BL2 environment.”

The new laboratory is equipped with instrumentation from leaders in the food testing industry, such as bioMerieux, BioControl, Neogen and Roka Bioscience, Acuff said.

“This equipment provides automated sample analyses that include enumeration of bacterial indicators, immunoassays, bacterial isolate identification, antimicrobial susceptibility and multiple technologies for DNA detection. Our new Roka Atlas system will allow detection of salmonella or listeria from as many as 500 samples in one day.”

Acuff said members of the center are provided access to the facility and experienced staff as a benefit of membership. “Membership in the center is free for Texas A&M University faculty members and fees for use of the facility are extremely affordable since they are based on simply maintaining operations,” he said.

Acuff said the center’s goal is to facilitate the recognition of Texas A&M University as a “national and international leader in food safety research.”

“This vision will be fulfilled by cultivating a collaborative, integrated group of research and Extension faculty members and staff,” he said. “This will foster relationships with the food industry and develop a sophisticated portal that attracts external interest and provides outreach and Extension opportunities for center members.”

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Rapid Micro Biosystems Announces the 2013 Availability of Growth Direct™ System for Multiple Applications

Rapid Micro Biosystems, the provider of rapid, automated, non-destructive detection and enumeration technologies in microbiology, today announced the 2013 availability of the next generation of Growth Direct™ applications. The new system will support environmental monitoring testing, sterility testing, water testing and bioburden testing within the same instrument using the proven detection technology.

With the introduction of the Growth Direct™ system for multiple applications, the Rapid Micro Biosystems product portfolio expands to include 3 instrument systems and 4 specific applications:

The Growth Direct™ System for Environmental Monitoring which automates the high volume testing typically found in the combination of air, surface and personnel monitoring.
The Growth Direct™ System for Sterility which revolutionizes pharmaceutical microbial quality control testing while adhering to the stringent regulatory requirements of sterility testing.
The Growth Direct™ System for multiple applications which supports all the tests above plus product bioburden and water testing on a single device.

These new systems and applications build on the existing Growth Direct™ technology platform currently used in FDA regulated manufacturing facilities. Sample preparation mimics the existing method. Once samples are loaded, the system uses the natural auto-fluorescence of the living cells to automatically detect, analyze and enumerate growing colonies. The test is non-destructive and uses no reagents, ensuring the availability of the sample for identification. User configurable software allows for the creation of alerts on out-of-specification samples, with reporting in colony forming units (CFUs.) The system software is easy to use in modes ranging from totally manual to paperless via the laboratory information system (LIMS.)

"The ability to provide all key microbial tests using a non-destructive, rapid method on a single, automated system will revolutionize quality control in pharmaceutical manufacturing. Businesses will be able to react quickly to contamination events while increasing productivity and standardizing their QC processes," said Steve Delity, President and CEO of Rapid Micro Biosystems.

The new systems and applications will be available in the first half of 2013.

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Nanosphere Test Accurately Detects a Broad Panel of Bacterial Targets and Resistance Determinants Directly From Blood Culture

Nanosphere's Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) (IUO), based on the company's proprietary array-based nanoparticle technology, demonstrated overall sensitivity and specificity of 99%, respectively, for the detection of a broad panel of gram-positive bacteria from positive blood cultures, according to a recent study. The BC-GP Test also correctly detected the presence or absence of genes encoding vancomycin resistance in Enterococcus spp. and methicillin resistance in Staphylococcus aureus or S. epidermidis. Researchers concluded that the test, which required less than 5 minutes of user hands-on time, provided accurate organism identification and detection of resistance genes compared to routine laboratory methods.

The investigator-initiated study, showcased in an oral presentation Saturday, October 20 at the inaugural IDWeek(TM) in San Diego, California, was conducted by Dr. Sandra Richter and colleagues at the Cleveland Clinic in Cleveland, Ohio. Nanosphere funded the research.

Rapid identification of pathogenic bacteria from blood cultures can greatly reduce length of hospital stay and improve patient outcomes. Benefits of rapid diagnosis are widely recognized and include increased survival rates, decreased costs of patient care, and reduced dosage of unnecessary antibiotics. Current microbiological culture techniques take 24-48 hours to identify bacterial pathogens and determine their resistance or susceptibility to common antibiotics.

Recently FDA-cleared, the BC-GP Test (IVD) notably expands Nanosphere's automated sample-to-result Verigene® platform to include an infectious disease test capable of rapid detection of bacteria that can cause deadly bloodstream infections. The automated BC-GP Test detects 12 bacterial targets and 3 antibiotic resistance targets in less than two and a half hours with less than 5 minutes hands-on time. The Respiratory Virus Plus Nucleic Acid Test (RV+) is an FDA-cleared in vitro diagnostic test for the detection of multiple respiratory viruses and virus subtypes. A sample-to-result test for C. difficile is currently pending FDA review, while tests for gram-negative blood cultures and enteric bacteria and viruses are currently in development and in clinical trials, respectively.

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Rapid and Point-of-Care Tests Accurate, Convenient for Hepatitis C Screening

Rapid and point-of-care screening tests for hepatitis C have a high accuracy and quick turnaround time, suggest results of a systematic review and meta-analysis.

The researchers say that these tests "could play a substantial role in expanded global screening initiatives, which would eventually impact the control of hepatitis C virus (HCV) infection at the population level."

Writing in the Annals of Internal Medicine, Nitika Pant Pai (McGill University Health Centre, Montreal, Quebec, Canada) and colleagues explain that many people infected with hepatitis C remain undiagnosed. It has been suggested that rapid diagnostic tests (RDTs) and point-of-care tests (POCTs) are a time- and cost-saving alternative to conventional laboratory tests. However, their global uptake depends on their performance.

To investigate further, Pant Pai and team performed a meta-analysis of 19 studies assessing the diagnostic accuracy of POCTs and RDTs to screen for hepatitis C in adults.

They found that POCTs of blood (serum, plasma, or whole) had the highest accuracy, followed by RDTs of serum or plasma and POCTs of oral fluids. Indeed, the sensitivity of POCTs of blood was around 99%, followed by 98% for RDTs of serum or plasma, and 98% for POCTs of oral fluid.

Specificity of POCTs of blood was also high, at more than 99%, followed by 98.6% for RDTs of serum or plasma and 98.2% for POCTs of oral fluid.

"First generation point-of-care tests are convenient, effective and informative for clinical decision making," say Pant Pai et al. "These tests don't usually require specialized equipment, they can provide results within 30 minutes, or maximally within one patient visit or one working day, and many do not require electricity."

They add that, in light of the tests' accuracy and an "urgent need to increase hepatitis C screening in marginalized and at-risk populations and in endemic HCV settings," these tests may be useful in expanding first-line screening for hepatitis C.

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Micro Imaging Technology to Present the MIT 1000 at the International Conference for Food Safety and Quality

Micro Imaging Technology, Inc. announced that it will attend the 7th Annual International Conference for Food Safety and Quality on November 13-14, 2012 in Chicago, Illinois. We will have the privilege of making a brief presentation of our Rapid Microbial Identification System, the MIT 1000, to food safety professionals throughout the government, academia and food supply industries.

Each year, the Food Safety Institute of America hosts a conference which provides attendees with information on current and emerging food safety issues, the latest science, innovative solutions to new and recurring problems, and the opportunity to network with thousands of food safety professionals from around the globe. "This conference will be another excellent opportunity to bring the MIT 1000 to the direct attention of the food safety community and those professionals who will embrace the value of our technology and its diagnostic capabilities," stated Jeff Nunez, MIT's Chairman and CEO. "As we expand on our marketing strategy and increase attention on the MIT brand, we anticipate that our product will continue to generate a great deal of interest."

The MIT 1000 is a stand-alone, optically-based, software driven system that can detect pathogenic bacteria and complete an identifying test in less than five (5) minutes for pennies per test. According to MIT's Chief Scientist, David Haavig, PhD, "In the U.S. alone, around 76 million cases of food-borne illnesses, resulting in 325,000 hospitalizations and 5,000 deaths, are estimated to occur each year. The leading cause of these illnesses and deaths are three main strains of bacteria: E. coli, Salmonella, and Listeria. Rapid identification of these disease-causing pathogens in food is critical to the health and safety of all consumers."

The AOAC Research Institute (AOAC RI) awarded the Company in June 2009, Performance Tested Methods SM (PTM) certification for the rapid identification of Listeria. The AOAC RI provides an independent third party evaluation and expert reviews of methods and will award PTM certification to methods that demonstrate performance levels equivalent or better than other certified bacteria identifying methods. The MIT System underwent hundreds of individual tests, including ruggedness and accuracy, to earn AOAC RI's certification for the identification of Listeria.

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Mass Spectrometry Allows for Rapid Bacterial ID at Le Bonheur Children's

New mass spectrometry technology is helping Le Bonheur Children's physicians analyze microbiology samples quickly – identifying specific bacteria present in a sample within minutes.

Le Bonheur is one of a handful of children's hospitals using the technology to analyze samples.

"We can cut hours out of our analysis with mass spectrometry," said Royce Joyner, MD, medical director of Laboratories at Le Bonheur. The alternative method for bacterial identification is Gram stain technique, which can only determine broad groupings of microorganisms.

Because false positive results can be ruled out more quickly with mass spectrometry, families can be saved the stress of a possible septicemia, says Le Bonheur Infectious Disease Lab Manager Tekita McKinney. True positives can be confirmed in minutes, speeding up the treatment process.

"This equipment has the potential to help improve patient care, by substantially decreasing the time it takes to identify bacteria in clinical specimens. This, in turn, will enable clinicians to more rapidly decide which antibiotics (if any) are best suited for their patients," said Le Bonheur Infectious Disease Specialist Steve Buckingham, MD. "We are excited about implementing this cutting-edge technology, which is only the latest step in our ongoing effort to optimize patient care."

Mass spectrometry works by using laser beam to disrupt and ionize proteins in the bacteria – a process called matrix-assisted laser desorption/ionization. Proteins are then measured for mass and charge – the ratio of which determines a culture's peaks or spectra. The mass spectrometer's library of peak signatures identifies the type of bacteria in the sample.

Mass spectrometry has, for a long time, been used in chemistry and toxicology and is a common tool in forensics. The technique is relatively new to the field of microbiology and will have a positive impact on health care, says Joyner.

New Genome Sequence Scanning Technology To Speed Food Testing
Tuesday October 16, 2012
PathoGenetix, Inc., developer of Genome Sequence Scanning™ (GSS™) technology for rapid microorganism strain typing, announced today that it will deliver the first commercial application of its proprietary technology in food safety testing, for availability in 2013. The automated benchtop GSS system will identify food pathogens to strain level, directly from complex mixtures such as food samples, in just four hours.

Genome Sequence Scanning is a breakthrough in microbial identification technology with significant advantages for food pathogen testing and outbreak tracking. GSS works directly from complex samples and provides results in just four hours—days faster than current identification methods. The strain-level information provided is comparable to pulsed field gel electrophoresis (PFGE), the current gold standard for food pathogen outbreak investigation. Yet GSS’s automated platform and simplified protocol required minimal training and ensure consistent, accurate results.

“PathoGenetix’s Genome Sequence Scanning is a breakthrough technology for food companies and government agencies working to ensure safe food,” says PathoGenetix CEO, John Canepa. “Rapid, accurate and cost-effective strain typing of food pathogens allows more informed decisions, better source tracking and faster outbreak investigations, and that means safer food and saved lives.”

Food Safety Testing and Outbreak Tracking

New regulations and increasing food recalls and public concern are heightening the need for faster identification of dangerous pathogens in food. Food companies, government agencies and public health labs conduct regular food safety testing on raw materials, production facilities and finished products to ensure food quality and detect potentially dangerous organisms like Salmonella, Listeria or E. coli in food imports and food products.

If a pathogen is detected in food or in a production facility, additional testing is required to identify the pathogen strain and track it back to its source. Current identification systems, however, require time-consuming sample preparation and complex test methods that add numerous days to a process where every minute can make a difference.

PathoGenetix’s novel Genome Sequence Scanning technology extracts microbial DNA directly from complex samples, without the need for cultured isolates or primer design. A restriction enzyme cuts the DNA into large fragments and fluorescent tags are added based on the organism’s genome sequence. GSS uses the DNA fragment length and spacing of tags to create a fingerprint, similar to a genomic barcode, which is recorded and compared to a database for strain identification.

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Rapid Kits to Diagnose Malaria

The launch of rapid diagnostic test (RDT) kits for malaria in Kenya - where only 30 percent of people treated for suspected malaria are tested to confirm infection - is expected to improve the reach, speed and accuracy of diagnosis and treatment, says a senior health official.

“Those found positive [for malaria] will be treated with recommended anti-malarial medicine,” said Shahnaaz Sharif, director of public health and sanitation. “The policy decision is also in line with the global recommendation on diagnosis of all suspected malaria cases.”

Self-diagnosis based on flu-like symptoms and treatment using over-the-counter anti-malarial drugs is common, Sharif said. Malaria is endemic in Kenya and is among the leading causes of outpatient hospital attendance in some regions.

The Global Malaria Programme’s new initiative, T3: Test. Treat. Track, urges malaria-endemic countries to aim for universal access to diagnostic testing and anti-malarial treatment. It also promotes the building of stronger malaria surveillance systems. Key interventions include prompt treatment with artemisinin-based combination therapies, the UN World Health Organization says.

According to the Ministry of Public Health and Sanitation, medical officers at the district and provincial levels are expected to ensure malaria treatment is diagnosis-based; they are also expected to make timely and accurate reports of all test kits’ results at the national level.

“This will ensure continued support for strengthening of malaria services in the country,” said Sharif.

Millions to be Distributed

At least eight million RDTs have been procured for distribution in 2012, with another 11 million targeted for distribution in 2013, Sharif said, adding that there are appropriate validation systems in place to ensure that high quality is maintained at all levels of use.

“The RDTs will be distributed to all public and faith-based health facilities across the country,” he said. Priority will be given to health facilities, which currently do not provide diagnostic services for malaria - mainly health centres and dispensaries.

Training on the use of the RDT kits and on the reporting of test results will be provided alongside the kits’ distribution. The kits will be channelled through provincial medical directors on to the district, division and lower administration levels.

According to Sharif, the 2007 malaria indicator survey showed that the disease’s prevalence had dropped from 40 percent to less than 20. However, the population around western Kenya’s Lake Victoria Region has a higher prevalence.

To address this, the health ministry is planning to raise awareness of the need for malaria testing and treatment.

“It is impossible to arrest and prosecute each pharmacist who sells malaria drugs without prescription from a doctor, so we will enlighten the public through the media,” John Kinuthia, public relations officer in the Ministry of Public Health and Sanitation, told IRIN.

Malaria testing in Kenya had previously been through microscopy, which, unlike RDTs, requires electricity and the use of expensive reagents.

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Joint Commission Offers Course on Rapid Influenza Testing in Ambulatory Settings

The Joint Commission announces the launch of Strategies for Improving Rapid Influenza Testing in Ambulatory Settings (SIRAS), a free continuing education (CE) course designed for physicians, physician assistants and registered nurses who provide care in ambulatory settings. SIRAS was developed under a cooperative agreement between the Centers for Disease Control and Prevention (CDC) and the Joint Commission.

The purpose of this course is to provide guidance to help clinicians appropriately use rapid influenza diagnostic tests (RIDTS) in the diagnosis and treatment of influenza in the ambulatory setting. The correct diagnosis of influenza relies heavily on the practitioner’s ability to understand performance implications of RIDT and the impact of circulating influenza strains. RIDTs, if correctly interpreted, provide quick results and can play a key role in guiding clinical decisions in the ambulatory setting. The module contains videos that demonstrate proper techniques for collecting respiratory specimens, as well as a review of information pertinent to performing point of care testing in the ambulatory setting.

“As the 2012-2013 influenza season begins, we are offering this continuing education course with the hope that it will educate clinical workers who are on the front lines of preventing and treating the flu, and reinforce leading practices for rapid influenza testing,” says Jerod M. Loeb, PhD, executive vice president, Division of Healthcare Quality Evaluation, the Joint Commission. “Our goal is to provide assistance to healthcare workers, so that they in-turn can provide the highest-quality care to their patients.”

SIRAS provides 2.0 hours of CE credits (ACCME, ANCC) issued by Joint Commission Resources, a not-for-profit affiliate of The Joint Commission. In addition to the CE for ambulatory care providers, the Joint Commission is offering a free, no-credit SIRAS training module for medical office staff who collect respiratory specimens for influenza testing. The course will provide a demonstration of proper techniques for performing point-of-care testing on respiratory specimens in the ambulatory setting, an important issue given that surveys have indicated that specimen collection is often performed by staff with little or no training in specimen collection technique.

To register for the course, visit www.sirastraining.com. For more information about the SIRAS modules, contact Jill Chmielewski at jchmielewski@jointcommission.org.

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bioMérieux Industry Announces AOAC Approval for the VIDAS® Campylobacter (CAM) Assay and Campy Food Agar Enumeration Method

bioMérieux, a world leader in the field of in vitro diagnostics, today announced AOAC Research institute Performance Tested MethodSM (PTM) approvals for the automated VIDAS® Campylobacter (CAM) detection assay and the Campy Food Agar (CFA) enumeration and detection methods.

Campylobacter is one of the most common causes of diarrheal illness in the United States. Active surveillance through FoodNet indicates that about 13 cases are diagnosed each year for each 100,000 persons in the population1. Campylobacteriosis is estimated to affect over 2.4 million persons every year, or 0.8% of the population1. Most cases of campylobacteriosis are associated with eating raw or undercooked poultry meat or from cross-contamination of other foods by these items in addition to unpasteurized milk or contaminated water.

The VIDAS® CAM (PTM # 051201) and CFA (PTM # 071201) methods have been validated and certified as effective methods for the detection of chicken carcass rinsate and turkey carcass sampled sponges when compared to USDA/FSIS MLG 41.00 reference method; and as effective detection methods for fresh pork, raw chicken breast and processed chicken nuggets when compared to ISO 10272-1 and 2:2006 reference methods. CFA was also approved for the enumeration of carcass rinsate, turkey carcass sampled sponges, raw pork, raw chicken breast and processed chicken nuggets when compared to the USDA/FSIS MLG 41.00 reference method and ISO 10272-1 and 2:2006 reference methods, respectively.

"Food laboratories today are striving to improve productivity and shorten their time-to-results," said Jean-Marc Durano, Corporate Vice President, Industrial Microbiology Unit. "Providing a fully integrated and AOAC validated solution for Campylobacter is a significant milestone in minimizing foodborne pathogens in the meat and prepared foods industry."

(1) United States Department of Agriculture, Food Safety Inspection Services

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Azbil BioVigilant Announces Decision to Deploy IMD-A Rapid Microbial Monitoring System by Compounding Pharmacy Innovator

Azbil BioVigilant, Inc., inventors of Instantaneous Microbial Detection™, announced today that Leiter Rx, one of the country’s foremost compounding pharmacies, will utilize Azbil BioVigilant’s IMD-A® 300-series systems for select cleanroom applications benefiting from real-time microbial air monitoring.

Leiter Rx, established in 1926, has built a reputation in quality process innovation fundamental to reducing risk of product contamination. Charles Leiter, recognized as one of the leading ophthalmic pharmacists in the country, said, “We have never been afraid to invest in technology that will improve our operations. Azbil BioVigilant’s IMD-A system will be used to continuously monitor our cleanroom during syringe filling operations which will reduce the potential risk of product contamination. We also will utilize the system to promote the best aseptic techniques among our staff. It is a very versatile piece of equipment that keeps us on the cutting edge of quality process advancements.”

When told of the decision, Aric Meares, CEO of Azbil BioVigilant, stated that this was another important milestone for the company. “Pharmaceutical compounding is an area of need where instantaneous microbial detection delivers great benefit. It is gratifying to see Leiter Rx among the first in compounding to utilize our technology platform across their cleanroom area.” He added, “The Food and Drug Administration is actively encouraging drug makers to deploy advanced technologies such as the IMD-A system to realize both quality and drug delivery benefits.”

Azbil BioVigilant’s IMD-A 300 and IMD-A 350 systems can detect immediately the presence of bacteria in the aseptic manufacturing process, and as a result, greatly accelerate the quality assurance processes for drug batch release.

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Qualcomm Funds Study of Bloodstream Sensors

The Qualcomm Foundation announced this week that it had awarded the Scripps Translational Science Institute (STSI) $3.75 million to fund clinical trials focused on wireless biosensor systems, rapid pharmacogenomic diagnostic tests, and apps and embedded sensors for tracking and predicting heart attacks, Type 1 diabetes and some types of cancer. The monies will help fund three years of research focused on wireless health.

According to the companies, one of the first projects that the STSI will take on as a result of the grant will be a research study of AirStrip Technologies’ mobile-enabled remote patient monitoring offering. STSI Director Dr. Eric Topol will lead the study, which aims to determine how mobile monitoring of patients by physicians may improve clinical workflow, patient recovery rates and more.

In addition to the AirStrip study, the grant will enable STSI to focus on three projects:

Clinical trial validation of biosensor systems: Tiny sensors floating in the blood stream can serve as round-the-clock scouts for signs of health problems, such as heart disease, Type 1 diabetes and cancer. Clear evidence of the benefit and value of these technologies is critical for regulatory clearance, reimbursement approval and adoption by healthcare providers.

Development of mobile apps for embedded sensors: These devices look for particular gene expressions, gene mutations, proteins or antibodies that provide the molecular signatures of medical conditions. Once trouble is detected, the sensor can send the data wirelessly to an app on a patient’s smartphone, triggering a message to seek treatment. STSI is collaborating with Dr. Axel Scherer and his team at the California Institute of Technology Nanofabrication Group to build the embedded nanosensors.

Handheld genotyping for precisely prescribing medications: In collaboration with DNA Electronics and Dr. Chris Toumazou at the Imperial College London, STSI is testing a point-of-care chip genotyping platform that can determine within 20 minutes a patient’s DNA compatibility with certain drugs such as Plavix, Metformin and Interferon. The project could help lead to a radical change in the way prescriptions are filled at pharmacies and help to eliminate the costly use of ineffective drugs.

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T2 Biosystems Named a “Fierce 15” Medical Device and Diagnostic Company of 2012

T2 Biosystems, a company developing direct detection products enabling superior diagnostics, today announced that it has been named to the FierceMedicalDevices “Fierce 15” list, designating it as one of the leading medical device and diagnostic companies of 2012. FierceMedicalDevices Editors Mark Hollmer and Damian Garde, in conjunction with Editor-in-Chief John Carroll and Executive Editor Ryan McBride, chose this year's winners based on their promising technologies and market opportunities, top management teams and notable financial backing. T2 Biosystems was chosen as one of the Fierce 15 based, in part, on its creativity and innovations in the industry.

“We will watch this company closely as it gears up for human clinical trials in 2013 for its T2Candida rapid diagnostic assay and a de novo regulatory submission later in that year. The test is a game-changer,” said Hollmer.

“We are honored to be selected as a member of the ‘Fierce 15’, an award that highlights T2 Biosystems’ potential to make a fundamental change in the diagnosis of diseases with our proprietary T2MR detector,” said John McDonough, CEO, T2 Biosystems. “Our dedicated scientists and engineers have created a technology that enables rapid, direct detection from any clinical sample, including blood, sputum and urine. Our initial assay panel, T2Candida, will aid in the reduction of the estimated 40% mortality rate associated with Candida infection through its ability to identify species-specific Candida directly from whole blood in about two hours, compared with current detection methods that take from two to five days.”

T2 Biosystems is developing the first-ever diagnostic system capable of direct detection in any clinical sample for accurate detection of molecular and immunological targets. T2 Biosystems has presented preclinical data on its assays currently in development: T2Candida will aid in the reduction of the mortality rate associated with Candida infection through rapid, sensitive, and specific Candida species detection; T2Hemostasis, which is capable of rapidly characterizing key coagulation, platelet and other hematologic factors directly from whole blood on a single, compact instrument; and T2Endotoxin, a novel method to screen injectable drugs and medical devices for the presence of endotoxins that are produced by gram negative bacteria or fungi.

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Pathogenica and Life Technologies EMEA Partner to Control Hospital Acquired Infections

Life Technologies have announced an exclusive agreement with Pathogenica, Boston, Massachusetts, to co-market and distribute for research use, the Pathogenica HAI (Hospital Acquired Infection) BioDetection Kit on the Ion Torrent PGM™ in Europe, the Middle East and Africa (EMEA).

Based on Pathogenica's DxSeq™ technology and the Ion Torrent™ sequencing platform, the kit enables identification of pathogens with high accuracy, at high specific strain resolution and at a scale that could make hospital-wide testing practical.

'Hospital acquired infections are becoming an increasingly serious health risk for patients and present significant economic issues for hospitals,' said Peter Silvester, President, Life Technologies EMEA. 'The combination of Pathogenica's technology with the Ion Torrent PGM™ will provide a solution that can help address this problem by enabling hospitals to quickly detect these types of infections with extreme accuracy.'

Pathogenica's analysis software provides simple, concise output reports that indicate which species and strains are present and at what levels. These kits are not for use in the diagnosis of hospital patients.

Current methods for detecting causative organisms can take days for results or are limited to a few pathogens. The Pathogenica/Life Technologies HAI solution quickly and cost-effectively identifies not only what species are present in a sample, but also provides high-resolution sequence data that includes strain identity and resistance genes, which is critical information for understanding and containing or preventing HAI outbreaks. Pathogenica's kit can detect more than 12 pathogenic bacteria and 15 resistance gene families in a single assay and up to 12 samples can be tested per sequencing run. Dozens of samples can simultaneously be tested in one day with results in an impressive timeframe of less than 12 hours.

The companies are evaluating an opportunity to pursue CE marking together for use of the kit as an in-vitro diagnostic assay.

"As we enter yet another market with Life Technologies as our partner, it is gratifying that together we are helping to make hospitals safer around the world," said Yemi Adesokan, co-founder and CEO of Pathogenica. "The Ion Torrent™ PGM has continued to expand its installed base and is an excellent complement to our technology and our mission of making next-generation sequencing relevant and accessible to clinicians."

Each Pathogenica kit provides reagents for identification of the following pathogens and drug resistance markers per sample: Acinetobacter baumannii, Clostridium difficile, Escherichia coli, Enterococcus faecalis, Enterococcus faecium, Enterobacter aerogenes, Enterobacter cloacae, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Coagulase negative Staph (S.epidermidis, S.saprophyticus), Staphylococcus aureus, common beta-lactamase resistance genes, mecA, and the vanA gene family. The technology allows for fast modification to incorporate the detection of emerging pathogenic fungi, viruses and resistances.

All products referenced are for Research Use Only. Not intended for diagnostic uses.

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Alverix Technology Powers Rapid Detection of Flu A + B

Alverix, Inc., a world leader in the design and manufacture of next-generation platforms for diagnostic Point-of-Care (POC) testing, announced that BD Diagnostics, a segment of Becton Dickinson and Company, a leading global medical technology company, received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for nasopharyngeal wash, aspirate and swab in transport media specimens on the BD VeritorTM System for Rapid Detection of Flu A + B. This new product is cleared for use in clinical settings.

BD selected Alverix to design, develop and supply the digital reader component of BD’s new POC diagnostic system, which offers users advanced performance with reliable, easy-to-read results. The new BD Veritor System for Rapid Detection of Flu A + B laboratory kit is specifically configured for testing liquid specimens obtained via nasopharyngeal wash, aspirate or swab in transport media. The system, with proprietary technologies, eliminates the subjective result interpretation of visually read assays and helps deliver an accurate read by providing reliable, objective results on a hand-held digital reader designed, developed and manufactured by Alverix, Inc. The BD Veritor System for Rapid Detection of Flu A + B demonstrated proven performance versus polymerase chain reaction (PCR) tests. This is the first rapid diagnostic flu test that has been referenced and FDA-cleared against this high-sensitivity standard.

“The clearance of the new BD Veritor System kit specifically for samples in transport media in clinical settings is a significant addition to the Flu A + B product line,” said Ric Tarbox, CEO of Alverix. “The BD Veritor System can now provide accuracy, consistency and convenience to all near patient testing environments allowing integrated delivery networks to realize all of the cost saving synergies normally associated with standardization of product and testing procedures. Alverix is truly excited to be associated with BD in delivering rapid results that physicians and laboratory professionals can trust.”

The BD Veritor System utilizes Advanced Particle and Adaptive Read technologies that are integrated into a proprietary hand-held digital reader from Alverix, Inc. The Advanced Particle Technology, along with improved chemistries, greatly increases the sensitivity of the test. The Adaptive Read technology reduces false-positive results through analyzing and compensating for many of the effects of non-specific binding resulting in improved specificity.

The clinical lab version joins the previously FDA-cleared and CLIA-waived BD Veritor System for rapid detection of Flu A + B and represents the first of many assays on the roadmap for this proprietary platform.

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Nanotechnology Device Aims to Prevent Malaria Deaths Through Rapid Diagnosis

Around 800,000 people die from malaria each year after being bitten by mosquitoes infected with malaria parasites. Signs that the parasite is developing resistance to the most powerful anti-malarial drugs in south-east Asia and sub-Saharan Africa mean scientists are working to prevent the drugs becoming ineffective.

The €5.2million (£4million) Nanomal project - launched on September 24 - is planning to provide an affordable hand-held diagnostic device to swiftly detect malaria infection and parasites' drug resistance. It will allow healthcare workers in remote rural areas to deliver effective drug treatments to counter resistance more quickly, potentially saving lives.

The device - the size and shape of a mobile phone - will use a range of latest proven nanotechnologies to rapidly analyse the parasite DNA from a blood sample. It will then provide a malaria diagnosis and comprehensive screening for drug susceptibility in less than 20 minutes, while the patient waits. With immediately available information about the species of parasite and its potential for drug resistance, a course of treatment personally tailored to counter resistance can be given.

Currently for malaria diagnosis, blood samples are sent to a central referral laboratory for drug resistance analysis, requiring time as well as specialised and expensive tests by skilled scientists. Additionally, confirmation of malaria is often not available where patients present with fever. Very often, drug treatments are prescribed before the diagnosis and drug resistance are confirmed, and may not be effective. Being able to treat effectively and immediately will prevent severe illness and save lives.

The Nanomal consortium is being led by St George's, University of London, which is working with UK handheld diagnostics and DNA sequencing specialist QuantuMDx Group and teams at the University of Tuebingen in Germany and the Karolinska Institute in Sweden. It was set up in response to increasing signs that the malaria parasite is mutating to resist the most powerful class of anti-malaria drugs, artemisinins. The European Commission has awarded €4million (£3.1million) to the project.

Nanomal lead Professor Sanjeev Krishna, from St George's, said: "Recent research suggests there's a real danger that artemisinins could eventually become obsolete, in the same way as other anti-malarials. New drug treatments take many years to develop, so the quickest and cheapest alternative is to optimise the use of current drugs. The huge advances in technology are now giving us a tremendous opportunity to do that and to avoid people falling seriously ill or dying unnecessarily."

QuantuMDx's CEO Elaine Warburton said: "Placing a full malaria screen with drug resistance status in the palm of a health professional's hand will allow instant prescribing of the most effective anti-malaria medication for that patient. Nanomal's rapid, low-cost test will further support the global health challenge to eradicate malaria."

The handheld device will take a finger prick of blood, extract the malarial DNA and then detect and sequence the specific mutations linked to drug resistance, using a nanowire biosensor. The chip electrically detects the DNA sequences and converts them directly into binary code, the universal language of computers. The binary code can then be readily analysed and even shared, via wireless or mobile networks, with scientists for real-time monitoring of disease patterns.

The device should provide the same quality of result as a referral laboratory, at a fraction of the time and cost. Each device could cost about the price of a smart phone initially, but may be issued for free in developing countries. A single-test cartridge will be around €13 (£10) initially, but the aim is to reduce this cost to ensure affordability in resource-limited settings.

In addition to improving immediate patient outcomes, the project will allow the researchers to build a better picture of levels of drug resistance in stricken areas. It will also give them information on population impacts of anti-malarial interventions.

Clinical trials of the device are expected to begin within three years, after which it will be brought to market. The technology could be adapted afterwards for use with other infectious diseases.

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Diagnostic Chip Based on Vibrating Beads

Scientists have developed a lab-on-a-chip technology based on superparamagnetic microbeads that they suggest could form the basis of a rapid diagnostic platform. The technology hinges on the principle that if two balls of different sizes are submerged in water (or another fluid) and subjected to a kinetic force, the smaller ball will move further because it has a smaller cross section and thus isn’t affected as much by the fluid’s resistance.

Massachusetts Institute of Technology (MIT) researchers have exploited this phenomenon to develop a technology in which superparamagnetic beads (the balls) are coated with capture probes for the analytes being tested, and subjected to a magnetic field that sets them oscillating. The test fluid is then added, and if any target molecules are present they bind to the beads, increasing the bead size, which changes the resonant frequency by a detectable amount.

In order to make the platform workable for chip-based biomedical applications, Elizabeth Rapoport, Ph.D., Geoffrey Beach, Ph.D., and Daniel Montana combined the bead concept with a technology they developed earlier this year for creating magnetic tracks on a microchip surface, along which the beads can be transported rapidly and positioned. Controlling the magnetic field directions in closely spaced adjacent regions enables the creation of minute areas with very strong magnetic fields, known as magnetic domain walls that can be moved along the track, to transport and capture the beads. These domain walls also act as the sensors.

The final device would thus consist of the microchip itself, overlaid with reservoirs that contain the magnetic beads and biological samples. However, rather than pumping the fluid and particles through the channels, the beads in the MIT team’s device would be directed through the chip by changing the applied magnetic fields.

The team says their device could feasibly offer much faster assays than existing chip-based platforms, and require much smaller volumes of biological sample. And while most biochips are designed to detect just one analyte, the magnetic bead-based system could be a true multitasker. After completing one test, the chip could be flushed through and magnetic beads for a different analyte added. “You’d just use it, wash it off, and use it again,” Dr. Rapoport suggests.

The MIT investigators haven’t yet tested the system on biological samples, but have provided proof of principle that it will work, by using magnetic beads of differing sizes to represent the increases in bead size caused by bound biomolecules. “We now have all the elements required to make a sensing device,” professor Beach says. “The next step is to combine the pieces in an operational device and demonstrate its performance.”

The team describes its technology in Lab on a Chip, in a paper titled “Integrated capture, transport, and magneto-mechanical resonant sensing of superparamagnetic microbeads using magnetic domain walls.”

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New Molecular Assay Detects Rapidly Emerging Multidrug-Resistant Superbug

BD Diagnostics, a segment of BD (Becton, Dickinson and Company), announced the release of a research use only (RUO) molecular test designed to rapidly detect antibiotic resistance genes found in the superbug known as carbapenem-resistant Enterobacteriaceae (CRE). These deadly organisms are associated with high mortality rates, are easily spread from patient-to-patient and are resistant to nearly all antibiotics. In some cases there are no treatments that are effective against infections caused by CRE.

Rapid identification is critical to allow proper treatment and isolation of patients to prevent its spread. The assay, performed on the fully-automated BD MAX™ System, is designed to detect carbapenem resistance genes and produces results in just two hours. Conventional culture methods take several days to report results. BD is making the assay available, for research use only, to a limited number of infectious disease experts and researchers to gather feedback on its performance.

"BD has a strong scientific commitment to developing innovative diagnostics in response to the challenge of emerging pathogens," said Patrick Murray, Ph.D., Worldwide Director of Scientific Affairs, BD Diagnostics – Diagnostic Systems. "We are offering this assay initially as a research tool to help BD and infectious disease researchers explore its clinical utility while we pursue development of an in vitro diagnostic solution." The RUO assay is not for in vitro diagnostic (IVD) use.

Incidence of carbapenem-resistant organisms has increased dramatically over the past decade. The most concerning are CRE that have acquired carbapenemase genes including KPC, NDM, and OXA-48. The BD MAX assay is the first fully-automated assay to detect all three of these genes directly from specimens. In 2011, KPC strains were reported in 37 U.S. states. NDM strains, first discovered in 2008, have spread worldwide, while OXA-48 is now found throughout Europe, Northern Africa and India.

"Multiple antibiotic-resistant bacteria, including carbapenemase-producing strains, have emerged worldwide at an alarming rate and now routinely cause both community- and hospital-acquired infections," said Dr. Brian Currie, Vice President and Medical Director for Research at Montefiore Medical Center and Assistant Dean for Clinical Research at the Albert Einstein College of Medicine. "The medical community urgently needs more rapid and accurate methods to detect carbapenemase-producing bacteria in order to prevent the further spread of these deadly organisms."

Assays already available on the BD MAX System to address healthcare-associated infections include methicillin-resistant Staphylococcus aureus (MRSA) and toxigenic Clostridium difficile, both CE-marked for IVD use in Europe. The BD MAX MRSA assay was FDA-cleared with CLIA Moderate Complexity categorization earlier this year. The toxigenic Clostridium difficile assay has been submitted to the FDA for 510(k) review and clearance.

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Disposable Microchip Could Simplify Disease Diagnosis

Doctors could soon be able to test patients for 100 different conditions at once using a disposable microchip under development in the UK.

The ‘e-Gnosis’ chip could allow doctors to easily check samples of blood or saliva for different types of diseases, such as cancers, sexually transmitted infections or even allergies, using a rapid pregnancy-test-style reader connected to a smartphone or computer.

Like many new diagnosis technologies, the chip works by detecting molecules in the body that act as markers for a specific condition. But because it can also determine their concentration, it can check instantly for diseases that would otherwise need laboratory tests.

‘Although such systems exist to some degree, the fact that almost all of them rely on optical readers makes the setup cost, or the upfront cost, quite expensive,’ said the chip’s designer Dr Peter Kollensperger, a researcher at Imperial College London and recipient of a Royal Academy of Engineering enterprise fellowship.

‘That’s fine if you are a hospital running the same tests over and over again, but if you are a GP, or an outreach nurse, that may not be feasible. The chip could also be used in home monitoring, where patients take readings themselves instead of going to their GP or hospital.’

The e-Gnosis chip could also be used to detect other substances, such as drugs or pesticides in water, and Kollensperger believes targeting the sports market might be the easiest way to commercialise the technology before developing it for medical use.

The technology is based around a semiconductor sensor comprising an insulating layer covered in millions of nanometre-sized wells, which separates two sets of electrodes.

As the sample fluid is delivered to the chip, the molecular biomarkers get trapped in the wells, constricting their size and altering the current that passes between the electrodes.

The points where the electrodes intersect are known as pixels, each of which are around 100µm² in size and contain more than 100,000 nanowells filled with a specific type of antibody.

These antibodies each correspond to and bind with a specific biomarker and so different pixels can be used to detect different diseases on a single chip. The number of tests depends on the size of the pixel but a 3mm² chip could run 100 tests.

Using biomarkers and antibodies has become a common way of developing rapid tests but the technology is usually designed to produce a colour change, which only indicates whether or not a biomarker is present.

The e-Gnosis technology can use the current reading to calculate the concentration of the biomarkers, which is necessary for diagnosing some diseases such as prostate cancer but could also indicate how much medication is needed.

Kollensperger is hoping to produce a prototype chip running one or two tests over around 12 pixels by March next year.

‘In order to keep the chips as cheap as possible you want them as small as possible, which means you want to have the electrodes as close together as possible,’ he said. ‘And at some point, it becomes quite difficult to do larger readings of these in parallel to modify them chemically.

‘But the smaller you make the pixel, the fewer molecules you’d need to get a larger signal. These things are all interconnected and it depends what you’re looking for. Some tests might not be achievable for us.’

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