Ensuring a Safer Egg

In August 2010, an outbreak of Salmonella Enteritidis (SE) was responsible for illness in almost 2,000 people in at least 25 states. More than 550 million eggs were recalled from the market. While methods have been in place to test for the presence of SE in eggs, the traditional methodology is time consuming, requiring up to 10 days to determine the presence or absence of SE in egg samples.

Recognizing that this timeframe wasn’t acceptable, the microbiology laboratory at Penn Vet’s New Bolton Center has played a significant role in the development of rapid SE-specific molecular diagnostic methods. The polymerase chain reaction (PCR) test developed at Penn Vet allows quick determination of the presence or absence of SE in egg samples, and provides accurate results in approximately 27 hours – a tenfold reduction in waiting time for results.

This methodology came in handy for the Federal Egg Safety Program, which requires all large-scale producers in the US to test for SE before products reach consumers.

As a result, the Salmonella Enteritidis Detection Kit was developed by Shelley Rankin, PhD, associate professor of microbiology at Penn Vet and chief of NBC’s microbiology, in collaboration with The Life Technologies Corporation, which allows producers to quickly test their eggs for SE. FDA-approved for use in the Federal Egg Safety Program in early 2011, the kit was validated by Dr. Rankin’s lab.

“Penn Vet has been collaborating with the Commonwealth of Pennsylvania to ensure food safety for decades,” said Dr. Joan C. Hendricks, the Gilbert S. Kahn Dean of Penn Vet. “The adoption of our egg-testing protocols by the FDA illustrates our researchers’ success in their field and the importance that veterinary researchers play in ensuring public health and food safety. I am thrilled that Penn Vet is continuing to lead the way in setting the standard in food safety and public health.”

“The FDA equivalence determination for this test marks a milestone for the egg industry in this country,” said Dr. Rankin. “The Commonwealth was the first state in the nation to initiate a voluntary egg quality assurance program and the Pennsylvania Animal Diagnostic Laboratory System will be the first to implement this new level of testing. It's very exciting that the FDA has adopted this test for the Federal Egg Safety Program. This action demonstrates their commitment to delivering the safest quality food to the consumer and I'm proud to be a part of that trend.”

Penn Vet has been active in the development and implementation of the state’s PEQAP (Pennsylvania Egg Quality Assurance Program), and much of what has been learned and shared by PEQAP forms the basis for the national Egg Safety Program. Dr. Rankin has more than 20 years experience in the detection and characterization of Salmonella from human and animal sources.

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Accelr8 Announces Development Expansion for Blood-Based Diagnostic Tests

Accelr8 Technology Corporation announced that it successfully completed two technical feasibility studies for test methods that expand its BACcel™ rapid diagnostic test library and automation capabilities. The first is a same-day multi-pathogen, multiple drug resistance diagnostic panel for positive blood cultures. Blood-borne infections produce extremely low bacterial or fungal counts in blood, so all blood tests require an overnight culture before testing. As with other specimen types, standard culture tests require colony isolation and then additional tests to identify pathogens and specific drug resistance expression. These require 2-3 additional days after obtaining a positive culture. Some of the new molecular diagnostic methods, such as mass spectrometry ("MALDI-TOF"), also require isolates and some require further sample extraction for best accuracy.

Accelr8 adapted its respiratory infection test methods to provide same-day results for positive blood cultures. The blood test panel includes multiple pathogens and multiple drug resistance types for each pathogen. The BACcel™ tests can report results by the end of the second day after obtaining a blood specimen, rather than 3-4 days.

The second project developed an innovative method for automating specimen preparation. Patient specimens typically contain a large proportion of materials that interfere with organism extraction or analysis. Reducing this content can markedly improve test accuracy for most test methods, including the BACcel™ system. Accelr8's new technology reduces the total preparation time from about 45 minutes with the existing respiratory specimen cleanup to less than 10 minutes. Development uses Accelr8's latest BACcel™ lab prototype fluidics robot to automate most of the operation.

The company believes that the new BAC-Xtrax™ device will completely integrate a "specimen-to-answer" automated BACcel™ system. It can also stand alone as a lab product, or integrate into other companies' automated systems for processing patient specimens.

"In addition to our own development plan, we've received requests from medical opinion leaders and from other companies for these new capabilities. We will submit presentations to major medical congresses where these advances will have the greatest impact," said David Howson, the company's president. "We continue to expand our network of medical and commercial collaborators as we enhance the BACcel's performance for long-term leadership in clinical diagnostic and pharmaceutical development markets. We are in dialogue with potential US, European, and Chinese collaborators," he concluded.

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Kiestra Lab Automation: New Advanced Technologies in Microbiology Diagnostics

In the good old days, the microbiology laboratory used to be a labor intensive place equipped with incubators and microscopes. Microbiologists were patient scientists waiting at least 24 hours before their isolated cultures were grown enough for identification. Today, laboratory medicine is developing at a rapid pace and the microbiology lab is having its own evolution going on. Lab automation is emerging and processes are done faster than ever with more standardized and comparable tests. Samples are barcoded before they enter a string of analyzers measuring mass spectra, fluorescence and specific DNA sequences. Almost all serology tests run in multiplex (simultaneously measure multiple analytes) and high throughput machines that can produce about 1000 results in an hour. These are intelligent machines that can automatically expand tests depending on earlier results, for example repeat, reflex or add-on extra tests.

One of the companies involved in this laboratory revolution is Kiestra lab automation BV based in the Netherlands. They created a system to cover the whole process from inoculation to identification automatically.

Their slogan “It’s the sample that moves!” involves many features. The system starts with the ‘InoqulA,’ a full automatic inoculation machine, in which any fluid specimen will automatically be opened-inoculated-spread-sorted and transported to the incubators. This can be done at a high through-put rate of up to 400 inoculations per hour. It uses a new technology with magnetic rolling beads to streak the plates, this creates enough single colonies in various specified directions.

Your preferred identification and susceptibility methodology ( e.g. biochemical, Malditof, disc diffusion, etc. ) can be integrated within the system. A monitor dashboard can be installed in the laboratory in order to optimize workload management. In a blink of the eye each supervisor can see how many digital reads have to be done at which hour.

In order to create a 24/7 non stop laboratory, incubation, processing and digital imaging is performed non-stop day and night. Having digital images of each culture makes it possible to view them remotely. The use of smart-phones within bacteriology comes within reach: the ReadA Browser on the iPhone makes it possible to check your cultures from just about anywhere.

The company has developed a very informative video on the system, which includes a demonstration of automated sampling and spreading of the inoculum using the magnetic beads. You can view the video by CLICKING HERE.

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3M Forced to Pay for Breach of Obligations Over MRSA - High Court

Investment fund manager Porton Group and the Ministry of Defence subsidiary Ploughshare Innovations* today won a court battle with 3M over the multi-national company's failure to promote a test for the "superbug" MRSA. The High Court in London found 3M was "in material breach of its obligation" under an agreement to actively market the product, BacLite.

Porton Group CEO Harvey Boulter said:- "I am delighted that we have been vindicated in our attempt to force 3M to face up to their responsibilities. "But the victims here are those infected with MRSA. A weapon in that fight was wrongfully abandoned by 3M. "This is a question of trust and honour which in my opinion seems to have been sadly lacking in 3M's behaviour. "The Judge has made it quite clear that 3M did not live up to its promises."

BacLite detects MRSA within 5-6 hours, a rapid detection time that could save lives around the world.

Judge Mr Justice Hamblen awarded Porton Capital Technology Funds, Porton Capital Inc and the Ministry of Defence's technology development arm, Ploughshare Innovations Ltd (hereafter "MoD"), damages of approximately $1.3 million ($1,299,808) in compensation. The Judge also said that Porton and the MoD had not been unreasonable when they objected to 3M's decision to shut down the project on December 31 2008, just a day before a 12-month earn-out period, under which the sellers would be paid part of the profits, began. The issue dates back to February 2007 when 3M agreed to buy a company called Acolyte Biomedica - part-owned by Porton and MoD - set up to exploit the BacLite technology.

3M convinced Acolyte that 3M had the medical device expertise and the global sales and marketing expertise to take over successful sales of BacLite worldwide and specifically in four major markets - the EU, including the UK, the US, Canada and Australia. But the Judge said that 3M was not only in breach of its obligation to "actively market" BacLite but also failed to gain regulatory approval in the US. "I find that from the end of March 2008 3M was in breach of its obligation diligently to seek regulatory approval for BacLite in the US and that had it complied with its obligation such approval would have been obtained by the beginning of February 2009," the Judge said.

The test was originally developed by the British Government's Defence Science and Technology Laboratory at Porton Down, Wiltshire, to detect biological weapons.

In the course of the trial, the Judge heard that 3M's original estimate of the earn-out payment under the Share Purchase Agreement in January 2007, a month before the purchase, was $33 million. While the companies and the MoD were not unreasonable to reject 3M's decision to close down the project, he added: "It was also reasonable for them to suspect that the failure of the business had been contributed to by 3M's own breaches of the SPA."

Referring to 3M's compensation offer before the trial, the Judge went on: "The reasonableness of the vendors' refusal is borne out by the fact that there were a number of 3M estimates at the time which exceeded the figure offered and that the figure was meant to be conservative." The failure by 3M "diligently" to pursue approval for BacLite by the US regulator - the Food and Drug Administration ("FDA") - after March 2008 was an important element in the project's termination, the Judge said. [166]. The judge found that 3M could have achieved US FDA regulatory approval by February 2009 "at the earliest" if they had corrected their own errors. Despite having identified problems with the methodology of the pre-approval testing, which had been changed by 3M from that carried out originally in the UK, and with 3M scientists suggesting solutions, there were concerns at the highest level in the company that the project was not making money fast enough. In an internal email of 7 March 2008, the Judge said, 3M's chairman and Chief Executive Officer, George Buckley, since awarded a knighthood, suggested "pulling the plug." A day later he said in another email he stated "tell them to deliver or tell them that we are likely pulling the plug" and warned "its time to fish or cut bait."

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Micro Imaging Technology Updates the Status of the MIT 1000A Accompanying Family of Bacteria Identifying Software

Micro Imaging Technology, Inc. today provided an update on the family of bacteria identifying software that accompanies the MIT 1000A. The System, manufactured exclusively for MIT by Hawthorne, CA-based OSI Optoelectronics, Inc., is a stand-alone optically-based bacteria identification system that uses proven principles of physics in conjunction with proprietary PC-based software and is USB compliant. The MIT 1000A can complete an identifying test in less than five (5) minutes and with a material cost of pennies -- adding further credence to MIT's claims of being able to annually save thousands of lives and tens of millions of dollars in health care costs with their unique technologies.

As explained by MIT's Chief Scientist, David Haavig, PhD: "In the US, 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."

Dr. Haavig further explained: "The AOAC Research Institute (AOAC RI) awarded the Company, in June 2009, Performance Tested MethodsSM (PTM) certification for the rapid identification of Listeria. The AOAC RI provides an independent third-party evaluation of methods and will award PTM certification to methods that demonstrate performance levels equivalent or better than other bacteria identifying methods. The MIT System underwent hundreds of individual tests over an eighteen-month period to earn AOAC RI's certification for the identification of Listeria; including evaluations of hardware, software, ease of use, documentation, ruggedness and accuracy."

Michael Brennan, MIT's Chairman, expanded on the Certification status: "MIT will begin the process of earning Performance Tested Methods Certification from the AOAC RI for the identification of E. coli and Salmonella in December, 2011. This certification process is far less difficult than the original Listeria certification. All hardware, software, documentation, and test procedures are identical to the Listeria certification process. The only items to prepare are the E. coli and Salmonella Identifiers, or database component, that should be concluded by early December."

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Pall Corp. Showcases New Beverage Production Technologies at Brau Beviale

Pall Corporation will introduce new developments for beer and beverage production at Brau Beviale, November 9-11, 2011 in Nuremberg, Germany. The company also will hold a panel discussion on the subject of kieselguhr-free beer filtration on November 9th. During the discussion, users of PROFi technology will have the chance to share experiences with beer filtration experts.

Innovations being spotlighted by Pall during the show include the Pall GeneDisc(R) Rapid Microbiology System.

Pall's GeneDisc system is a new easy-to-use instrument for quick and reliable detection of beer-spoiling microorganisms. Based on real-time PCR technology, the flexible, modular GeneDisc system helps optimize work flow and offers the capability to process different applications simultaneously. Its intuitive touch-screen interface and built-in, user-friendly software and barcode reader allow for easy adoption of the technology. A clear, straightforward display of results enables minimally trained personnel to routinely perform sophisticated biological sample testing for rapid decision-making.

The Pall GeneDisc system recently helped German authorities screen for a deadly strain of E.coli that disrupted the nation's food industry. The technology was 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).

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Contaminated Food Leads To About 2ΜΝ Deaths Annually Driving Increased Demand For Agricultural And Environmental Diagnostics

The WHO estimates that approximately 2 billion illnesses and 1.8 million deaths on an annual basis are a direct result of contaminated food. The pathogens such as E. Coli, listeria, salmonella and others are linked to food borne illnesses and the increased prevalence of these pathogens are driving the necessity or improved scientific and technological solutions to test agriculture and environmental hygiene in the human food chain.

By 2017, the agriculture and environmental diagnostics market is forecast to be valued at US$3.8 billion. Strong growth in the agricultural and environmental diagnostics market is due to rising concerns over food and water safety and increasingly stringent controls and regulations on food safety and agricultural practices. The technological advances in testing equipment is also expected to drive increases in market value for the agricultural and environmental diagnostics market.

Food testing laboratories are benefiting from the increased food production and more intense agricultural practices which subsequently placing more importance on controlling and monitoring food safety worldwide. The increased connectivity of food distribution and centralised nature of food production results in the need for more control over food safety and diagnostic testing. One small issue on a single food source could have implications on a national or even worldwide scale due to the complex distribution networks currently in operation.

The agricultural and environmental diagnostics market deals with food product examination for the presence of disease-causing organisms, chemical residues, and other hazardous materials in food. Testing of food products is gaining prominence worldwide, owing to increasing consumer awareness on health concerns, growing demand for specialist diets in developed markets, and an increasing demand for cheaper, convenience food.

Europe represents the largest market for agricultural and environmental diagnostics, with the United States in second place. Asia-Pacific region is forecast to report an annual growth rate of 11 percent during the period 2011 to 2016. In terms of a particular testing segment, Microbiology represents the fastest expanding sector.

The requirement for more rapid testing in microbiology, is expected to drive a faster growth in revenues within the diagnostic industry, purely because the technology required to turnaround results in a timely manner are more expensive than the more traditional methodologies. Rapid testing diagnostic methods are forecast to increase their market share of the total diagnostic market.

The major players in the agricultural and environmental diagnostics market are 3M Company, Agdia Inc., Biocontrol Systems Inc., Biomerieux SA, Charm Sciences, C-Qentec Diagnostics, Eurofins Scientific Inc., IDEXX Laboratories Inc., Neogen Corp., R-Biopharm, Strategic Diagnostics Inc., Vicam.

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Neogen Develops Quicker Test for Yeast and Mold

Neogen Corporation has developed an even quicker method to rapidly and accurately detect yeast and mold in food products. Neogen's new Soleris® test detects yeast and mold in 48 hours or less -- conventional methods take up to 5 days.

Tests for yeast and mold comprise approximately 15% of all microbiological tests performed worldwide. While it does not present the acute health threats of foodborne pathogens, spoilage caused by yeast and mold is one of the leading causes of food loss. Yeast and molds are a large and diverse group of microorganisms that can cause various degrees of deterioration and decomposition of foods.

"With the recent marking of global population at 7 billion, reducing food loss is becoming more critical than ever," said James Herbert, Neogen's chairman and CEO. "The United Nations estimates that approximately one-third of all the food produced annually is lost or wasted before it is consumed. The use of our new Soleris test can help reduce that loss, and ensure the quality and shelf-life of a wide variety of food products."

The new test is a Soleris direct vial system that can detect one colony forming unit (CFU) of yeast or mold per sample vial in 48 hours or less -- 24 hours faster than the previous rapid yeast and mold assay, and days faster than most tests. Neogen's new test also requires less technician time.

The Soleris system is a rapid optical method for the detection of microbial contamination based on an innovative application of classic microbiology. Soleris enables operators to release products quicker, saving the organization inventory costs, and allows operators to easily identify, monitor, and map problematic spots in their facilities.

In addition to the yeast and mold test, Neogen's Soleris system provides the quickest automated quality indicator tests for:

• E. coli results in 7-10 hours; conventional methods can take up to 4 days
• Total viable count (TVC) results in as little as 6-8 hours; conventional methods take 24-48 hours
• Coliform results in 9-10 hours; conventional methods take 24 hours
• Lactic bacteria results in 30-35 hours; conventional methods take 3-5 days

The independent testing laboratory AOAC-Research Institute has recently validated the performance of another of Neogen's test kits, its Soleris test that detects E. coli in as little as 7 hours (Performance Tested Method(SM) No. 101101). Most food companies and testing laboratories regard AOAC approval as a requirement for their use.

"Each time we receive a validation from an influential third party on any of our tests, it provides further assurance to our many customers that our tests perform as expected. We expect no less, and neither should our customers," said Herbert.

The results of a rigorous AOAC-RI validation study clearly indicate the Soleris E. coli method can be used for rapid and accurate detection of E. coli in a variety of food commodities. The Soleris test offers significant time savings of up to 3 days over the conventional reference procedure, while also reducing the amount of technician labor required. Neogen has also received AOAC-RI validation on its Soleris test for coliforms.

Neogen Corporation develops and markets products dedicated to food and animal safety. The company's Food Safety Division markets dehydrated culture media, and diagnostic test kits to detect foodborne bacteria, natural toxins, genetic modifications, food allergens, drug residues, plant diseases and sanitation concerns. Neogen's Animal Safety Division manufactures and distributes a variety of animal healthcare products, including diagnostics, pharmaceuticals, veterinary instruments, wound care and disinfectants.

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GenturaDx Latest Patents Cover Innovations in the Automation of Sample Preparation

Molecular diagnostics company GenturaDx today announces that it has been awarded two additional patents from the United States Patent Office related to the company's IDbox™, it's fully-integrated molecular diagnostics platform. These two new patents (U.S. Patent Nos. 7,910,062 and 8,029,746) relate to GenturaDx's proprietary method of manipulating paramagnetic particles inside a closed cartridge for the purpose of purifying nucleic acids, and expand the company's total number of issued U.S. patents to four. The company's proprietary method of purifying nucleic acids is fully integrated with amplification and detection capabilities within the IDbox™ instrument and consumable cartridge and enable the platform to detect a broad range of pathogens from a wide variety of starting sample types.

"Our focus on nucleic acid purification is the cornerstone of our highly flexible system," said GenturaDx Chief Scientific Officer Jesus Ching, Ph.D. "These latest two patents are part of our long term strategy of targeting and acquiring key patents and licenses to support our proprietary cassette and fully integrated platform."

GenturaDx's fully automated molecular diagnostics platform, the IDbox™ System and its initial HSV 1&2 assay, are currently in beta testing, with clinical trials beginning in 2012. The IDbox™ System's integrated and automated design brings rapid, cost-effective, high performance molecular testing capabilities to hospital labs seeking to further automate existing molecular testing or bring testing in house.

"The addition of these two patents support our goal of developing a more effective, flexible and practical system that is protected by strong IP," said GenturaDx CEO Mark Bagnall. "GenturaDx has already benefitted from a license to proprietary PCR technology and continues to pursue additional patents. Our success at obtaining the initial four patents provides exciting momentum as we build our long-term portfolio."

GenturaDx is a molecular diagnostic company focused on making high-performance molecular diagnostics both affordable and practical for any laboratory to perform. The company is developing a fully integrated, automated instrument that conducts testing using a single-use cassette. This platform will make rapid, high-quality molecular diagnostics accessible to hospitals and patients worldwide - circumventing long-standing barriers of costs, automation and performance. GenturaDx's compact, self-contained platform incorporates sample preparation with proprietary, real-time PCR amplification and detection, reducing the risk of contamination and saving time. The platform's unique engineering design and intuitive interface relies on semi-batch processing capability while improving clinical value by offering multiple molecular targets in a single test.

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The Institute of Bioengineering and Nanotechnology's MicroKit Wins Asian Innovation Award

The Institute of Bioengineering and Nanotechnology (IBN), is pleased to announce that its disease diagnostics technology, the MicroKit, has won the Silver Award at the Asian Innovation Awards 2011 organized by The Wall Street Journal Asia. The result was announced yesterday evening at the awards ceremony held at the Four Seasons Hotel in Hong Kong, which was officiated by Sir John Major, former Prime Minister of the United Kingdom.

The Asian Innovation Awards recognize innovations that break with conventional processes in creative ways. Developed in Singapore by IBN Executive Director, Professor Jackie Y. Ying and her team members, Guolin Xu and James Tseng-Ming Hsieh, the MicroKit is an automated diagnostic device that can detect viruses rapidly and accurately within two hours. Current efforts to contain infectious diseases are often hampered by the time it takes to diagnose and isolate those carrying the virus. Conventional diagnostic tests can take up to half a day and can only be conducted in dedicated biosafety laboratories by clinical personnel, who might risk accidental exposure to the virus.

Designed to enable diagnosis outside the laboratory, the MicroKit is portable and easy to use for non-clinical personnel. The MicroKit simplifies disease detection by integrating the sample preparation, amplification and detection processes in a disposable polymer cartridge. As everything takes place within the completely sealed cartridge, the risk of potential virus exposure is minimized. This portable device can be used at airports, borders, checkpoints and clinics to help contain the rapid spread of infectious diseases and prevent pandemics.

"We are delighted to receive the Silver award for the MicroKit. Our device aims to diagnose infectious diseases safely and quickly. Such diagnostic kits really help towards curbing the spread of diseases such as H1N1. This invention is the result of multidisciplinary research and reflects IBN's mission to develop innovative biomedical devices that will improve healthcare and benefit society," said Professor Jackie Y. Ying.

Now in its 12th year, The Wall Street Journal's Asian Innovation Awards attracted 256 entries from 18 countries and territories in the Asia Pacific region this year. The Asian Innovation Awards is committed to finding the next big technological ideas in Asia. This year's entries have been shortlisted based on three criteria: level of creativity or degree of innovation, quality of execution, and potential impact on quality of life or productivity. The awards were open to individuals, small businesses, large corporations or academia in Asia Pacific. IBN's MicroKit was one of the 12 finalists selected, and one of 5 finalists from Singapore. Please refer to the Annex for information on the judging panel for the awards.

IBN licensed the MicroKit technology to SG Molecular Diagnostics Pte Ltd in January 2009 to develop a range of diagnostic devices. The Institute is also working on the nextgeneration MicroKit, which will process 20 samples for 25 different diseases simultaneously.

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PathoGenetix Inc. Raises $7.5 Million in Second Closing of Series B Financing for Rapid Bacterial Identification System

PathoGenetix Inc., today announced that the Company received $7.5 million in the second closing of its Series B financing to support the development and commercialization of its Genome Sequence Scanning technology for bacterial strain identification. Along with the $4 million raised in the first closing, announced August 1, 2011, the Series B round totals $11.5 million. New investor Ascension Health Ventures (AHV) participated in the financing through its second fund, CHV II, L.P., along with the existing investor group, which includes Excel Venture Management, CB Health Ventures, and HealthCare Ventures.

The Company's Genome Sequence Scanning (GSS) technology provides a broad platform for the rapid identification of bacterial strains in a wide range of settings. The technology enables simultaneous identification and characterization of thousands of bacterial strains in a single test in three hours. Applications include microbiome research, clinical diagnostics, antibiotic development, detection of bacterial contamination in food and pharmaceutical products, and biothreat detection.

"PathoGenetix's technology has demonstrated great potential to fill enormous needs in healthcare and public health to accelerate decision making, improve outcomes, and reduce unnecessary costs," said Dr. Tara Butler of AHV. "Delayed or incorrect diagnosis results in more than 100,000 deaths in the U.S. annually from hospital acquired infections and billions of dollars in costs. Food borne pathogens present a large and growing problem that result in more than 325,000 hospitalizations every year and 5,000 deaths."

"The funds will allow us to complete development and begin commercializing GSS in the rapidly emerging research market for analysis of microbial populations," said John J. Canepa, PathoGenetix CEO. "The addition of Ascension Health Ventures to our strong investor group will also enable us to leverage expertise from the more than 200 acute care hospitals within its limited partner base."

The GSS technology was initially developed with more than $50 million in support from the United States Departments of Defense and Homeland Security under their advanced biosensor programs. The technology extracts genomic barcodes from microbial DNA as it flows through a microfluidic chip at 150 million base pairs per second. Complex clinical specimens can be scanned to identify pathogenic strains days faster and at lower cost than current diagnostic techniques.

PathoGenetix is developing an automated system for the rapid identification of bacterial strains using proprietary Genome Sequence Scanning Technology. The company's approach, which employs a single reagent set to generate genomic bar codes based on bacterial DNA, can cost-effectively identify thousands of strains in a single test from complex samples in three hours. PathoGenetix is developing its GSS platform for use in genomics research, food and product safety testing, and clinical infectious disease diagnostics, with initial commercial introduction into the research market planned for late 2012.

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Experts Report That Abbott’s New PLEX-ID Assay Offers Important Testing Capabilities For Biothreat Defense

Abbott’s PLEX-ID system provides reliable and rapid results for key microbial biothreat agents and should be considered as a first line analytical tool for biodefense, biosecurity and microbial forensics programs, according to research presented at the 13th Medical Biodefense Conference in Munich. The meeting is a global congress for civilian and military researchers covering the latest developments in the diagnosis, therapy and prevention of diseases caused by dangerous pathogens.

“An essential component for robust defense against bioterrorism is to develop rapid microbial forensic diagnostic capabilities so threats can be identified with prompt and appropriate actions taken in response,” said Bruce Budowle, Ph.D., professor, forensic and investigative genetics, University of North Texas Health Sciences Center, speaking at a symposium sponsored by the German Society for Military Medicine and Pharmacy. ”The PLEX-ID is a versatile instrument system and when coupled with the Biothreat Assay showed broad detection capability for a wide range of deadly and crippling microbes that could be used in a bioterrorism attack.”

The PLEX-ID Biothreat Assay rapidly identifies 17 different biothreat pathogens without the need for time consuming culture testing. A variety of specimens including blood, food, water, and air filter samples can be analyzed, and definitive results can be generated in less than eight hours.

Carson D. Baldwin, Ph.D., research chemist, U.S. Army Medical Research Institute for Infectious Diseases (USAMRIID), presented results of an evaluation of the PLEX-ID Biothreat Assay in which several different panels of specimens were analyzed utilizing the Biothreat Assay. The specimens contained pathogenic bacteria and viruses that could be used by terrorists to cause anthrax, cholera, and other diseases. In the evaluation, PLEX-ID correctly detected and identified all the targeted bacteria and viruses including several important subspecies.

Rapid identification and characterization of potential biothreat agents is critical and was cited by speakers at the Medical Biodefense Conference as an attribute of the PLEX-ID system.

The PLEX-ID system combines the sensitivity of nucleic acid amplification with the accuracy of high-performance electrospray ionization mass spectrometry followed by base-composition analysis to identify a broad array of microorganisms, including bacteria, viruses, fungi, and parasites. Certain PLEX-ID assays also provide information about drug resistance, virulence, and strain type. Anticipated public health and biodefense applications include epidemiologic research and identification of emerging or previously unknown agents. In addition, the system is being used for forensic characterization of human samples. In 2009, PLEX-ID was recognized by both The Scientist and the Wall Street Journal as a top scientific innovation of the year. Since its development in 2005, PLEX-ID technology has been deployed in sites around the United States, including the Centers for Disease Control and Prevention and the U.S. Food and Drug Administration.

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Local Researchers Cook Up Qay to Reduce Food-Borne Illnesses

Crystal Diagnostics is trying to beef up the nation’s food safety with a locally developed technology. The company unveiled a new system on Wednesday that uses liquid crystals to help quickly detect potentially deadly food-borne pathogens in meats, produce and other products.

Researchers at Kent State University and the Northeast Ohio Medical University (Neomed) invented the biosensor technology used in the testing system, known as the Crystal Diagnostics MultiPath System. Unlike other rapid tests on the market, the MultiPath System can be used to detect multiple pathogens at the same time, said Paul Repetto, chief executive of Crystal Diagnostics. Results are available within 30 minutes, compared to 24 to 48 hours for traditional testing methods that rely on growing cultures of contaminating bacteria, Repetto said.

“It promises to save lives, and what could be more important than that?” Kent State University President Lester A. Lefton said on Wednesday during an event at Crystal Diagnostics’ manufacturing facility in the Kent State University Centennial Research Park. The goal is to have the food-safety system on the market next year after a round of beta-testing with national food producers and processors is complete. The company is trying to capture a piece of the growing food testing market, which Repetto estimates at $3 billion to $4 billion annually.

Deadly outbreaks of food-borne illness threaten customers’ health, as well as the financial health of food producers and processors. According to the U.S. Centers for Disease Control and Prevention (CDC), food-borne pathogens cause about 48 million illnesses, 128,00 hospitalizations and 3,000 deaths nationwide each year. Most recently, a multistate outbreak this fall from tainted cantaloupe from Colorado sickened 133 people and killed 28, according to information released this week by the CDC.

The Crystal Diagnostics Multi-Path System works by using a five-cell, disposable test cassette that contains liquid crystals inside a laminate casing. Liquid crystals are commonly used in such items as television screens and computer monitors.

Before testing, a food sample is smashed into a thick slurry, said Dan Minardi, Crystal Diagnostics’ president and chief technology officer. Antibodies for the bacteria being tested, such as E. coli or listeria, are added before the liquefied mixture is placed in three of the test cells (the two remaining cells serve as controls). The test cassette then is placed in a reader, which can display results on an iPad, computer screen or smart phone.

“This is groundbreaking technology in food-safety testing,” Minardi said. “It’s reliable, it’s cost-effective and it’s easy to use.” If the bacteria are present, the antibodies will clump and distort the liquid crystal matrix, explained Gary D. Niehaus, Crystal Diagnostics’ chief scientist and a professor of physiology at Neomed. As a result, the reader will detect light passing through and give a positive result.

Initially, at least, the Crystal Diagnostics MultiPath System is being marketed to food producers and processors for optional testing, Niehaus said. But the technology also could have future applications for everything from water safety testing to rapid-result testing in physicians’ and veterinarians’ offices. A price for the one-time use test cassette and reader hasn’t been set, Repetto said. However, he added, the cassettes likely will be more cost effective than currently available rapid tests, which can only be used to detect one pathogen at a time.

Kent State and Neomed (formerly NEOUCOM) have a licensing deal with Crystal Diagnostics that includes royalties from sales, said Maria Schimer, general counsel for Neomed and board chair for Crystal Diagnostics. “Then we’ll be able to plow that back into the research enterprise.” The universities also each have a 3 percent ownership stake in the company, officials said. Crystal Diagnostics has offices in Broomfield, Colo., a bioscience laboratory at Neomed in Rootstown Township and the manufacturing facility in Kent. The $3 million Kent facility has the capacity to eventually make 1 million testing cassettes annually, Minardi said. Local employment is expected to grow from the current six to at least 20 as production increases. So far, Crystal Diagnostics has secured $8.5 million in private-venture funding and $3.5 million in state grant funding, Schimer said.

The project is a good example of ongoing efforts to translate laboratory findings into products that can create jobs and generate alternative funding for universities at a time when state support is shrinking, Neomed President Dr. Jay A. Gershen said. “We try to take the great ideas of faculty and bring them to the mainstream of commerce,” he said.

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FDA Approves Gen-Probe's APTIMA® HPV Assay, New Molecular Test to Detect Virus that Causes Cervical Cancer

Gen-Probe, a global leader in the development, manufacture and marketing of rapid, accurate and cost-effective molecular diagnostic products and services that are used primarily to diagnose human diseases, screen donated human blood, and ensure transplant compatibility, has announced that the US Food and Drug Administration (FDA) has approved its APTIMA HPV assay, an amplified nucleic acid test that detects high-risk strains of human papillomavirus (HPV) that are associated with cervical cancer and precancerous lesions. The test has been approved to run on Gen-Probe's fully automated, high-throughput TIGRIS instrument system.

Gen-Probe's TIGRIS system is the first fully automated, high-throughput molecular testing system, and the only one approved for use with an HPV test. More than 200 TIGRIS systems are being used by US clinical laboratories. The system has been cleared by the FDA to test for: Chlamydia and gonorrhea, two common bacterial sexually transmitted diseases (STDs), with the APTIMA Combo 2, APTIMA CT and APTIMA GC assays; Trichomonas vaginalis, the cause of a common parasitic STD, with the APTIMA Trichomonas assay; Human papillomavirus, with the APTIMA HPV assay.

"We believe our APTIMA HPV assay will offer physicians and patients a more accurate screening test for cervical cancer, and significantly improve testing efficiency for our laboratory customers," said Carl Hull, Gen-Probe's president and chief executive officer. "FDA approval represents a major milestone for the Company, since developing the APTIMA HPV assay was the largest and most complex diagnostic R&D programme we have ever completed."

The APTIMA HPV assay detects 14 high-risk HPV types associated with cervical cancer and precancerous lesions. Testing is performed from ThinPrep liquid cytology specimens routinely used for Pap testing. Unlike other FDA-approved, DNA-based HPV tests, the APTIMA HPV assay detects messenger RNA over-expressed from two viral oncogenes that are integral to the development of cervical cancer.

"Most HPV infections clear up on their own, so it's important to identify those persistent, high-risk infections that are most likely to lead to cervical cancer," said Tom Wright, MD, professor of pathology and cell biology at the Columbia University Medical Center. "In numerous clinical studies involving approximately 45,000 women, the APTIMA HPV assay has consistently shown similar sensitivity and better specificity than the most frequently used DNA-based test. This means the APTIMA HPV assay is highly accurate in detecting cervical disease, but is less likely to raise false alarms that can result in unnecessary medical procedures."

The APTIMA HPV assay is approved to test women age 21 and older whose Pap tests showed atypical squamous cells of undetermined significance (ASC-US), meaning they were neither normal nor clearly indicative of pre-cancerous changes, and to screen women age 30 and older as an adjunct to Pap testing. This means the assay can be used to meet consensus guidelines for cervical cancer screening recommended by leading US medical organizations. "Physicians can use the APTIMA HPV test to make early, more accurate decisions about patient care, which in turn may prevent many women from developing a potentially deadly disease," Dr. Wright said.

FDA approval was based on data from the CLEAR (CLinical Evaluation of APTIMA HPV RNA) trial, which analyzed approximately 11,000 women undergoing routine Pap testing at 18 US clinics. In the study, the APTIMA HPV assay showed similar sensitivity for the detection of cervical disease as an FDA-approved, DNA-based test. However, the specificity of the APTIMA HPV assay was higher than that of the DNA-based test, and this advantage was statistically significant.

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NanoLogix Technology Delivers Live Tuberculosis (TB) Detection Results in a Revolutionary 4 Days versus Traditional 21 Days

NanoLogix, an innovator in the rapid detection, identification and antibiotic sensitivity determination of live bacteria announced today third-party results for detecting live Mycobacterium tuberculosis (TB) in a revolutionary time of 4 days with its BNP (BioNanoPore) technology. The advanced culture test results with the NanoLogix BNP technology are at least 500% faster than the 21-day standard for live TB culture detection. Additionally, other test methods for tuberculosis are expensive, labor intensive and cannot determine if a microbe found in a sample is living or dead. The NanoLogix technology provides a significant advantage over conventional methods for detecting TB in developing regions where medical resources are scarce and TB infections are rampant.

The 4-day TB results are a part of a lab research study conducted by a well-respected third party laboratory. The organization maintains anonymity until research data is published in a leading scientific journal.

"We are ecstatic over the third-party 4-day TB test results," said Bret Barnhizer, CEO of NanoLogix. "Typically, physicians must wait at least 21 days to determine if a patient should be put on antibiotics for TB. With an annual death toll of well over one million from this devastating disease, providing definitive, viable determination of TB in 4 days is a true game-changer."

The World Health Organization estimates that roughly one third of the world's population is infected with TB, either in an active or latent form. Highly contagious, active tuberculosis infections commonly attack the lungs and have a 50% mortality rate. In recent decades, the misdiagnosis and mismanagement of TB infections have led to a number of antibiotic-resistant strains, such as Mutli-Drug Resistant Tuberculosis and Extensively Drug Resistant TB.

Because of its slow growing nature, speeding up the definitive diagnosis of live-cell TB detection has been a consistent challenge for the medical industry. While techniques such as X-ray examinations, smear tests and DNA sequencing have provided alternatives to 21 day culture results, their inability to differentiate between the simple presence of a bacteria and a true active infection have left them unable to provide a comprehensive tool for fighting TB.

"By making the 'gold standard' method of culturing a faster process, our technology has the potential of providing the medical community with an extremely rapid, accurate, affordable and definitive culture-based TB test," continued Barnhizer. "With NanoLogix, physicians will soon have the opportunity to detect live TB faster, administer antibiotics properly, and monitor the efficacy of antibiotics in a close to real-time mode. This will provide the opportunity to reduce the prevalence of TB infections around the world."

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