GeneSeek Now Offers Rapid PEDV Test

Neogen Corporation has announced the immediate availability of a new test to rapidly and accurately detect Porcine Epidemic Diarrhoea Virus (PEDV).

Early detection of the virus is critical to stop its spread from farm to farm, and between facilities within a pig farm or pig production site.

Neogen’s new PEDV test is offered through the veterinary diagnostics laboratory of its GeneSeek subsidiary, which is based in Lincoln, Neb. Each test is $25, and depending on testing volumes, GeneSeek anticipates most test results should be available on the next business day after sample receipt. Sample types accepted for testing include environmental sample pads or swabs, fecal swabs and oral fluids.

“Porcine epidemic diarrhea virus can devastate a population of nursing pigs, with mortality approaching 100 per cent, and can significantly impact the performance of adult pigs,” said GeneSeek’s Dr Stewart Bauck. “Especially now, it is important to determine the causative agent of a diarrheal disease, as the clinical signs of porcine epidemic diarrhea can mimic other similar but less pathogenic diseases, such as transmissible gastroenteritis.

“Livestock biosecurity experts we have worked with believe the most efficient testing protocol for PEDV is to perform environmental testing in farm facilities and on vehicles that move between farms, and within the different operations of a single farm,” Dr Bauck continued.

“One very easy environmental sample collection method is the use of moist, unscented disposable mop pads, such as those sold under the Swiffer brand. All we need is that sample mop pad in a sealed plastic bag, and we can quickly determine if the sample contains PEDV.”

The new test utilises real-time polymerase chain reaction (PCR) methodology and is one of many rapid animal health tests available through GeneSeek. Other tests for swine include those for porcine reproductive and respiratory syndrome virus (PRRSV), swine influenza virus (SIV), Mycoplasma hyopneumoniae, and porcine circovirus type 2 (PCV2).

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Rapid Assay Classifies Meningitis Bacteria

Researchers in the UK have developed a new method that uses surface enhanced Raman scattering (SERS) to quickly identify which meningitis causing bacteria is responsible for an infection.
Onset of meningitis is often rapid and severe, particularly when a bacterial infection is the cause. Several types of bacteria cause meningitis and each is sensitive to different antibiotics.

The faster the type of bacteria can be identified by DNA analysis, the faster patients can receive the most effective antibiotic for their condition. This also reduces the need for broadband antibiotics, overuse of which is increasing bacterial resistance.

Karen Faulds’ group at the University of Strathclyde, Glasgow, used SERS, a spectroscopic imaging technique, to identify which of Haemophilus influenzae, Streptococcus pneumoniae and Neisseria meningitidisis were present in a single sample, with a view to analysing cerebral spinal fluid from patients suspected to have meningitis. A series of DNA probes containing dyes detectable by SERS make it possible to single out the different pathogens.

‘The great advantage of SERS is this multiplexing capability,’ says Faulds. ‘This technique gives sharp, recognisable signals, like finger printing, so we can more easily discriminate what analytes are present in a mixture.’

Combining the SERS technique with chemometrics means the amount of bacteria in a sample can be measured whilst simultaneously identifying the bacteria. This would be particularly useful where co-infection of multiple species is common. Identifying the dominant pathogen present would allow targeted treatment.

‘Each individual pathogen in a mixture can be consistently identified and quantified much faster than conventional culture based methods,’ says Yiping Cui, director of the Advanced Photonic Center at Southeast University in Nanjing, China. ‘This facilitates the determination of a more effective course of treatment.’

Marc Porter, whose group at the University of Utah in the US uses SERS to examine biomarkers, says the ability to identify and concurrently quantify three common meningitis bacterial pathogens is impressive. ‘The work takes an important step in moving SERS and nanoparticle-based signalling much closer to meeting a critical need in pathogen detection,’ he adds.

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bioMérieux Acquires BioFire And Strengthens Infectious Disease Capability

bioMérieux, a world leader in the field of in vitro diagnostics, announces that it has finalized its acquisition of 100% ownership in BioFire Diagnostics Inc., a privately held U.S.-based company specialized in molecular biology. The agreement to purchase BioFire was first announced on September 4.

Created over 20 years ago, BioFire has developed, produced and marketed a number of automated PCR molecular biology systems. More recently, BioFire developed FilmArray(R) , a unique CE-marked and FDA-cleared multiplex PCR system that integrates all molecular diagnostics steps - sample preparation, amplification, detection and analysis - into one system. FilmArray(R) which has introduced the syndromic approach(*) to infectious disease molecular diagnostics creates a new standard in this market with its essential combination of speed, accuracy, ease-of-use and comprehensiveness in one single assay. This allows hospitals to perform the molecular biology tests available on its menu in the hospital laboratory, thereby enabling faster and more efficient medical decision making. FilmArray(R) as of today has two CE-marked and FDA-cleared panels - the Respiratory Panel and the Blood Culture Identification Panel.

The two companies present strong strategic synergies, especially in marketing, manufacturing and innovation. FilmArray(R) is a key differentiating asset in the development of bioMérieux's franchise in infectious disease diagnostics, its primary area of expertise. FilmArray(R) will benefit from the global and dynamic bioMérieux commercial network. Additionally, bioMérieux will contribute its capabilities to the automation of reagent production, thereby optimizing manufacturing costs. The BioFire's site in Salt Lake City (Utah - United States) will become bioMérieux's hub for its expansion in molecular biology and R&D teams from the two companies will contribute to the development of new panels, creating very attractive prospects for the future.

Jean-Luc Belingard, Chairman and Chief Executive Officer of bioMérieux, commented: "The acquisition of BioFire creates strong growth opportunities. FilmArray(R) meets perfectly the growing hospital laboratory demand for high medical value solutions in infectious disease diagnostics, thus ideally complementing our current product offering, especially for emergency situations and critical care. We welcome our new employees and look forward to providing our worldwide customer base with our complete range of diagnostic solutions dedicated to infectious diseases."

Kirk Ririe, Chief Executive Officer and Founder of BioFire, said: "We are pleased to see both companies join forces to enrich FilmArray(R) 's menu and to reach new customers with a global sales and marketing force. The legacy of what we have built at BioFire is the result of the contributions of so many talented individuals and we are tremendously excited about our prospects under the stewardship of bioMérieux, a company similarly committed to improving patient care worldwide."

bioMérieux and BioFire will start integration process, focusing on leveraging the positive synergies between both companies, to drive FilmArray(R) sales and menu expansion. In order to meet the expectations of BioFire's biodefense customers in the United States, a wholly owned subsidiary dedicated to the biodefense activities will be established. All the BioFire personnel, activities and equipment associated with the defense business are physically transferred to a protected and separate site in Salt Lake City.

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WHO Calls for Interested Parties for Rapid Malaria Testing Programme

The World Health Organization, the Foundation for Innovative New Diagnostics and other partners on January 8 called for expressions of interest in Round 6 of the WHO Malaria Rapid Diagnostic Test Product Testing Programme.

The testing will look at the comparative performance of an antigen-detecting malaria rapid diagnostic test that is already available on the market. The WHO test will be based on testing against a range of cyro-preserved malaria parasite samples derived from an international malaria specimen bank. The testing will be undertaken at the U.S. Centers for Disease Control and Prevention’s Division of Parasitic Disease’s Malaria Branch.

Since 2008, the WHO and its partners have completed five rounds of testing. The tests add to the understanding of the possible performance of malaria rapid diagnostic tests to improve comprehensive testing recommendations in national malaria control programs performed by a range of organizations. Results from the most recent round, Round 5, are expected to be released and published this April.

The WHO and its partners ask that all interested parties submit expressions of interest to the WHO by February 7. Round 6 of the Malaria Rapid Diagnostic Test Product Testing Programme is set to begin in May.

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Atlas Develops io™ Reader, a Point-of-Care Device for Rapid Detection of Infectious Diseases

Atlas Genetics Ltd (“Atlas” or the “Company”), the diagnostic company developing ultra-rapid point-of-care (POC) tests for a range of infectious diseases, today announces that it has completed development of the Atlas io™ Reader, a POC device that can deliver laboratory quality results for molecular assays in under thirty minutes.

The Atlas io™ Reader, developed with The Technology Partnership plc (“TTP”), operates with a disposable cartridge, to which an unprocessed clinical specimen is added. The instrument fully automates the three-stage process of sample preparation, DNA amplification, and electrochemical detection to analyse the patient’s sample for the target infection.

The current clinical practice usually involves sending test samples to the central laboratory for analysis with a turn-around time of up to ten days.  The Atlas io™ Reader allows rapid diagnosis of infectious diseases, providing clinicians with the opportunity to treat the patient immediately, eliminating the need for a return visit and greatly improving patient outcomes.

The Atlas io™ Reader is now entering pilot manufacture ahead of the company conducting clinical studies to support its application for regulatory clearance in Europe later this year.

John Clarkson, CEO of Atlas, said: “Our focus is on diseases including sexually transmitted, and hospital acquired infections, where rapid diagnosis is essential for effective treatment and control. The Atlas io™ Reader is an accurate, low cost, diagnostic instrument that has the potential to revolutionise infectious disease diagnosis by allowing clinicians to test and treat their patients in the same visit.“

Piers Harding, project leader at TTP, comments: “The outstanding results that we are seeing from initial production instruments are testament to the close working relationship that Atlas Genetics and TTP have formed over the past year.“

The Atlas io™ Platform

POC diagnostics offer health professionals the ability to test for medical conditions at the site of patient care.  Atlas has developed a flexible POC technology platform, which has been designed to accurately and quickly diagnose a wide range of medical conditions within 30 minutes.  The Atlas io™ instrument consists of an inexpensive test machine into which a disposable cartridge containing a patient sample is inserted.  The Atlas io™ Reader is scheduled for clinical trials in 2014, followed by rollout in Europe and the United States, pending regulatory approvals.

Atlas is developing tests for a range of infectious diseases including sexually transmitted diseases and hospital acquired infections.  The Atlas io™ system will initially be launched for the testing of Chlamydia and Gonorrhoea, allowing clinicians to test and treat patients in a single visit.  Over 50 million tests are carried out for these diseases in Europe and the US every year.  According to the European Centre for Disease Prevention and Control, Chlamydia is the most frequently reported Sexually Transmitted Disease (STD), with prevalence rates in young people between 5-10%, whilst Gonorrhoea is the second most commonly reported STD. The worldwide in vitro diagnostic market for infectious disease testing is estimated to be worth around US$9 billion.

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New Rapid Test for Detecting Lactic Acid Bacteria

Neogen has developed a quicker and easier method to rapidly and accurately detect lactic acid-producing microorganisms in food products.

Neogen’s new Soleris® DLA-109 vial detects lactic acid microorganisms in as little as 48 hours, depending on the commodity. Alternative methods take up to five days. Neogen’s new test also requires about half the technician preparation time of the older methodology.

“The development of our new direct Soleris test for lactic acid bacteria continues our initiative to upgrade more of our Soleris product line to the quicker, easier, and more consistent direct vial format,” said Neogen’s Dr Janice McGregor. “If you’re using our vial-in-vial format for lactic acid bacteria that detects changing carbon dioxide levels, I would suggest that you convert to the new direct test. If your lab is using our red or green lactic acid bacteria tests that detect shifts in pH, you should consider evaluating the new test for faster detection, depending on the product matrix and organisms of concern. If your lab is not using Soleris at all, I suggest you give it a try to see just how fast and easy microbial testing can be.”

The new test is a Soleris direct vial system that consists of a detection chamber containing carbon dioxide indicators separated by a barrier layer from a chamber containing a growth medium and the sample.

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 organisation inventory costs, and allows operators to easily identify, monitor, and map problematic spots in their facilities.

Lactic acid bacteria are a major concern in the dressings and sauces industry as these organisms can reduce shelf life and contribute to poor quality. Traditional methods for detection require long holding times and are labour-intensive, often requiring a trained microbiologist. In addition, plating and counting methods can be difficult to interpret when dealing with heavily coloured products, or those containing food particulates.

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Nanosphere Receives FDA Clearance for Gram-Negative Blood Culture Test and Submits New Enteric Pathogen Test

Nanosphere, Inc., a company enhancing medicine through targeted molecular diagnostics, today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for its Verigene® Gram-Negative Blood Culture (BC-GN) Test and has submitted its Verigene Enteric Pathogens Test for gastrointestinal infections to the FDA.

Verigene BC-GN, which received clearance from the FDA, is a rapid in vitro diagnostic test that identifies a broad spectrum of gram-negative bacteria that cause bloodstream infections and determines resistance to commonly used antibiotics up to two to three days faster than conventional identification methods.

Bloodstream infections can lead to sepsis, a primary cause of death resulting in over $20 billion in healthcare costs in the U.S. annually. Infections complicated by antibiotic resistance are especially difficult to treat and are associated with greater mortality. Among the critical genetic markers of antibiotic resistance identified by Verigene BC-GN are five genes which can identify Carbapenem-resistant Enterobacteriaceae (CRE), so-called "superbugs" that are resistant to nearly all available antibiotics. In a recent landmark report, the Centers for Disease Control and Prevention (CDC) assigned an urgent hazard level to CRE, indicating they pose an immediate public health threat and require urgent and aggressive action.

The 14-target Verigene BC-GN test joins Nanosphere's currently marketed Verigene BC-GP Test, which detects a broad spectrum of gram-positive bacteria and the antimicrobial resistance genes associated with methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococci (VRE).

"Antimicrobial resistance poses a significant threat and significantly affects how we practice medicine, as the availability of viable antibiotics to treat these life-threatening infections is decreasing," said Richard Thomson, Ph.D., director of clinical microbiology at NorthShore University HealthSystem. "Knowing what bacterium is responsible for the infection and which antibiotics it's resistant to is an important step toward ensuring that our patients are receiving targeted therapy and that we are not using any unnecessary antibiotics."

Verigene Enteric Pathogens Test, which was recently submitted by Nanosphere to the FDA, is designed to help hospitals more efficiently and cost-effectively diagnose patients with community-acquired diarrhea, typically caused by consumption of contaminated food or water containing bacterial, viral or parasitic gastrointestinal pathogens.

Most cases of community-acquired diarrhea are self-resolving and not life-threatening, yet gastrointestinal infections are associated with 3.7 million emergency department visits, 1.3 million inpatient hospitalizations and more than $6 billion in healthcare costs per year in the U.S.

Since symptoms alone are often not sufficient to make treatment decisions, rapid identification of the cause of community-acquired diarrhea is critical for optimal patient management and can lead to fewer hospital admissions, reduced use of inappropriate or unnecessary antibiotics and workflow benefits to laboratories.

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Meridian Bioscience Granted Special 510(k) Clearance for Avian H7N9 Influenza A Virus Sensitivity Claim

Meridian Bioscience, Inc. today announced that the company's TRU FLU(R) assay received FDA clearance for an analytical sensitivity claim for the novel avian Influenza H7N9 strain, A/Anhui/1/2013. TRU FLU(R) is a rapid immunoassay that detects influenza A and influenza B viruses in 15 minutes in human respiratory specimens.

New strains of Influenza viruses are continuously emerging to replace the more contemporary or common strains. The novel avian Influenza A strain H7N9 was first reported in China in March 2013. Since then, there have been 147 confirmed human cases of avian influenza A H7N9, with 47 deaths reported in China. It is important that rapid assays are able to detect novel strains as they emerge to enable physicians to deliver prophylaxis to and manage infected patients in a timely manner.

Meridian's TRU FLU and TRU RSV(R) products provide closed systems that limit the exposure of laboratory personnel to infectious agents in test samples during incubation and disposal.

John A. Kraeutler, Chief Executive Officer, stated, "Meridian is committed to providing accurate and rapid diagnostic solutions as novel flu strains emerge globally. During the 2009 H1N1 pandemic, Meridian received special 510(k) FDA clearance to add H1N1 analytical sensitivity claim for TRU FLU. Once again, Meridian knew that it was critically important to be prepared for a potential pandemic with the novel avian H7N9 strain to provide the best patient care."

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Patent Issued for Array for Rapid Detection of a Microorganism

By a News Reporter-Staff News Editor at Journal of Engineering -- From Alexandria, Virginia, VerticalNews journalists report that a patent by the inventors Martin, Stephanie Michelle (Woodstock, GA); MacDonald, John Gavin (Decatur, GA); Lye, Jason (Atlanta, GA); Sayre, Curt (Atlanta, GA); Thompson, Kimberlee (Chattanooga, TN), filed on May 12, 2009, was published online on December 31, 2013.

The patent's assignee for patent number 8617874 is Kimberly-Clark Worldwide, Inc. (Neenah, WI).

News editors obtained the following quote from the background information supplied by the inventors: "The ability to rapidly detect microorganisms is becoming an increasing problem in a wide variety of industries, includes the medical and food industries. For instance, rapid detection of a microorganism in the medical field may be crucial for proper diagnosis and treatment of an illness. Unfortunately, multiple etiologic agents may be responsible for a particular condition, thereby making it difficult to rapidly identify the cause of the condition. The need for selective identification of the type of microorganism is important for a variety of reasons. For example, the knowledge of which type of microorganism is present may lead one to identify the particular source of contamination and to choose an appropriate treatment. Most of the current diagnostic procedures involve culturing the microorganism for identification, a process that usually requires several days and often gives negative results. Not only is culturing a lengthy process, but certain pathogens (e.g., mycobacteria) are notoriously difficult to grow outside the host. Although 'non-culturing' techniques have been developed, they are typically designed for only a specific pathogen. Thus, several assays are required to obtain a diagnosis, which are expensive and time-consuming.

"As such, a need currently exists for a technique of rapidly and simply detecting the presence of microorganisms, and identifying the particular type of detected microorganism."

As a supplement to the background information on this patent, VerticalNews correspondents also obtained the inventors' summary information for this patent: "In accordance with one embodiment of the present invention, a method for detecting a microorganism in a sample is disclosed. The method comprises contacting the sample with an array, the array comprising a plurality of individual array addresses spaced apart in a predetermined pattern on a solid support. The addresses each contain a colorant so that the array produces a visually observable spectral response. The spectral response is detected (e.g., visually) and correlated to the presence of one or more microorganisms.

"In accordance with another embodiment of the present invention, an array for detecting a microorganism in a sample is disclosed. The array comprises a plurality of individual array addresses spaced apart in a predetermined pattern on a solid support. The addresses each contain a colorant so that the array produces a visually observable spectral response that is distinct for one or more microorganisms.

"Other features and aspects of the present invention are discussed in greater detail below."

For additional information on this patent, see: Martin, Stephanie Michelle; MacDonald, John Gavin; Lye, Jason; Sayre, Curt; Thompson, Kimberlee. Array for Rapid Detection of a Microorganism. U.S. Patent Number 8617874, filed May 12, 2009, and published online on December 31, 2013.

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Rapid HIV Testing Rolled Out In Hastings

Rapid testing for human immunodeficiency virus (HIV) could be available in the Hastings soon, NSW Health said this week.

The comment comes as health staff from the Mid-North Coast spend this week in Lismore, working alongside their Northern Rivers colleagues at Australia's first pop-up rapid HIV testing site.

Personnel from the Mid-North Coast and Northern NSW health districts are operating the service from a specially designed Airstream bus at Tropical Fruits Festival. The regional pop-up follows the success of a similar initiative in Sydney's Taylor Square in December, and is a partnership between NSW Ministry of Health, the aforementioned local health districts, ACON and St Vincent's Pathology.

A spokeswoman for NSW Health said the van is an example of how NSW Health is adapting its policies and services to take advantage of new advances in HIV testing and treatment. She said the initiative signals the department's intention to "roll out rapid testing statewide" to community health centres, including Port Macquarie, as soon as possible.

Northern NSW's manager of manager HIV & Related Programs (HARP), Jenny Heslop, said trained clinical staff from the Mid-North Coast were busy helping thousands of people at Lismore's annual festival of lesbian, gay, bisexual and transsexual culture.

"The beauty of rapid access testing is that it works for a lot of people in rural and regional areas who aren't desperate for medical attention, but do want to manage their health without the whole town knowing," Ms Heslop said.

"A lot of the stigma is removed because someone knows they can get (the test) done quickly, and everyone won't know."

The testing is a simple process which involves a finger prick of blood, with results available within 30 minutes. Those tested can choose to wait at the site or go away and wait for a text message notifying them their results are ready. Those who test positive are accompanied to a nearby health centre for further blood tests and support.

"We encourage people at risk - especially men who have sex with men, people who inject drugs and people who work in the sex industry - to take advantage of the site," Ms Heslop said.

There are 18 established rapid testing centres in NSW, and Ms Heslop said she hopes major regional communities including Port Macquarie will soon be able to provide the service.

"We've had quite a few people come through today (in Lismore) and they're very grateful that's it so accessible, easy and fast," she said. "We're hoping these successful test-runs mean the testing will be able to expand to more areas in 2014."

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3M Petrifilm Rapid Yeast and Mold Plate Receives AOAC-PTM Approval

3M Food Safety announced today that its new 3M(TM) Petrifilm™ Rapid Yeast and Mold Count Plate has received certification (#121301) from the AOAC Research Institute's Performance Tested Methods(SM) (PTM) Program.

The 3M™ Petrifilm™ Rapid Yeast and Mold Plate was first introduced in September 2013 as an indicator test that enables the detection of yeasts and molds in as little as 48 hours, faster than conventional agar methods. The AOAC-PTM certification validates 3M's innovative test as equivalent to or better than standard reference methods for enumerating yeast and mold within food products including yogurt, sour cream, almonds, sliced apples, frozen bread dough, ready-made pie, sandwiches, dehydrated soup, fermented salami, and frozen ground beef patties.

The AOAC Research Institute bases certification of methods on independent study results demonstrating that a given method meets the claims expressed in package inserts. Specific studies performed as part of this certification involved robustness, inclusivity/exclusivity, and lot-to-lot/stability as well as comparison tests with FDA BAM and ISO reference methods.

"Easier colony interpretation and faster time to results are benefits that our food processing customers have quickly appreciated and been able to see before their very eyes since we introduced this new product in the fall," said Eric Amann, global marketing manager with 3M Food Safety. "That said, having the affirmation that comes from AOAC Research Institute's rigorous testing program provides another level of meaning and is exceptionally reassuring."

3M Food Safety developed the new plate to expand the 3M Petrifilm technology that has become a worldwide standard due to its reliability and simplicity since being introduced 30 years ago. The technology has been rigorously tested to perform well on both low and high water activity foods, and will be especially useful for processors of grain, fruit and dairy products where yeast and mold control is particularly important. This new plate offers food processors a simplified solution for inoculation along with an easy, consistent way to interpret and enumerate colonies.

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Research Team Releases PCR-based Method to Detect Vibrio in Shrimp

A PCR-based method to detect early mortality syndrome (EMS) of shrimp, developed by a Tainan-based research team led by Dr Chu-Fang Lo, Dean of the College of Life Sciences at National Cheng Kung University (NCKU), in cooperation with Dr Tim Flegel from Thailand, has been announced by the university.

Dr Lo also announced that the primers and protocol were being put into the public domain, which is definitely thrilling news for shrimp researchers around the world, as it will help to control outbreaks of this disease.

Dr Lo’s team cooperated with Dr Flegel from Mahidol University for the last few months and developed a Polymerase Chain Reaction (PCR) method to detect EMS, also called acute hepatopancreatic necrosis disease (AHPND), a disease of cultured shrimp.

“We decided to release, free for public access, detailed information on the sequences and protocols from our research for a PCR-based detection method for bacteria causing AHPND, since there are currently severe, widespread outbreaks of this disease,” Dr Lo said.

She also noted that the bacteria causing AHPND belong to Vibrio parahaemolyticus (VP), but they have unique plasmids not present in non-pathogenic VP.

Dr Lo’s team used a whole-genome sequencing strategy to identify the plasmids as targets for detection and they designed two pairs of primers (AP1 and AP2) for the PCR method, a rapid test to detect virulent VP.

“If shrimp has virulent VP, the AP1 and AP2 primers will identify the VP and give a positive reaction,” explained Dr Lo.

AHPND is causing high mortality in farm-raised shrimp in China, Viet Nam, Thailand and Malaysia, according to Dr Lo, who noted that the disease, first reported in 2009, now causes annual losses exceeding $1 billion.

These outbreaks were characterised as AHPND, in the absence of any accompanying sign of an infectious agent, during the early cultivation period of approximately 35 days.

The rapid PCR method to determine if shrimp is infected with the bacterium that causes AHPND will be highly beneficial to the shrimp-producing industry, Dr Lo said.

Also, quick detection of AHPND could be very valuable for the aquaculture/seafood market, according to Dr Lo.

She noted that release of this critical information will assist interested stakeholders to develop measures to reduce the risk of AHPND outbreaks.

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US Patent and Trademark Office’s Examiner Issues Final Decision in Favor of Azbil BioVigilant

Azbil BioVigilant, Inc., inventors of Instantaneous Microbial Detection™, announced today that, for a third and final time, the Examiner for the US Patent and Trademark Office (USPTO) has issued a decision rejecting TSI’s latest arguments in the reexamination of U.S. Patent No. 6,831,279.

Specifically, on December 19, 2013, the USPTO found that all claims of TSI’s patent are unpatentable. As is customary, the Office has issued a Right of Appeal Notice (RAN) allowing 30 days in which TSI may appeal the Examiner’s final decision to the Patent Trial and Appeal Board.

Axbil BioVigilant holds 19 patents with an additional 37 applications pending.

Representing Azbil BioVigilant in its patent litigation is Amster, Rothstein & Ebenstein LLP.

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Rapid Method Will Help Make Better Wine

Invisible Sentinel is getting into the wine business.

The Philadelphian life sciences company, which specializes in rapid molecular diagnostic test kits for the food industry, has formed a partnership with Jackson Family Wines, a family-­owned winery in California’s Sonoma County.

The two organizations plan to work together using Invisible Sentinel’s existing technology to develop Veriflow Brett — a diagnostic assay to detect Brettanomyces, a wine-­spoiling yeast. Their plan is to market the product across the wine industry.

Financial terms of the collaboration were not disclosed.

The company’s Veriflow technology is already used to detect food pathogens such as listeria and salmonella in meat products

Brettanomyces produces compounds that, in excess, can foul the taste of wine and give it a “barn-yardy” odor. Current methods of on-site testing for Brettanomyces, according to the companies, are time-consuming — which means the yeast can continue to accumulate before corrective measures are initiated and more product is subject to spoilage.

Hugh Reimers, chief operating officer of Jackson Family Wines, said he expects the new application of Invisible Sentinel’s detection technology will enhance the winery’s “already rigorous quality control” processes.

The partnership with Jackson Family Wines was established through Invisible Sentinel’s contract service that helps clients develop customized assays using the company’s Veriflow technology platform.

“We’re excited to be working with such a well-recognized thought leader in the global wine industry,” said Ben Pascal, chief business officer for Invisible Sentinel. “Importantly, the partnership with Jackson Family Wines showcases our custom solution program and the ability to deliver a first-in-class rapid diagnostic to meet the unique demands of our clients.”

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Micro Imaging Technology Adds Staph Bacteria to Its Catalog of Identifiers

Micro Imaging Technology, Inc. announced that its MIT 1000 System can now identify the potentially life-threatening bacteria Staphylococcus. Staph is one of the five most common causes of infections after injury or surgery and can lead to very serious complications with the lung (pneumonia), brain (meningitis), bone (osteopmyelitis), heart (endorcarditis), and blood (bacteremia and septicemia). It is also an important food pathogen. "This is a tremendous step forward for both our technology and our Company," stated Jeff Nunez, MIT's President and CEO. "We have not only added another Identifier to our catalog, but this opens the door for the MIT 1000 Technology to enter the clinical pathogen detection and identification arena. The Identifier is available now and will soon undergo AOAC certification," he continued. Staph can also be contracted through food contamination, as recently reminded by the USDA's announcement involving the recall of dried sausage products in San Jose, California(1). The MIT 1000 is a rapid, bacterial cell-based detection and identification system that can identify pathogenic bacteria, now including Staph, in three minutes (average) at half the cost of the industry average for pathogen tests.

In October 2013, the Company announced that it is collaborating with the Northern Michigan University (NMU) Department of Biology to identify and differentiate Staphylococcus aureus (S. aureus) and the "superbug," Methicillin Resistant S. aureus (MRSA). The goal of this strategic research with NMU is to rapidly and cost-effectively identify these two particular healthcare threats using the MIT 1000 System. Staph infections can range from mild skin problems to potentially fatal conditions if the bacteria invade deeper into the body. Most can be easily treated, however, some Staphs are drug-resistant. The faster the responsible disease causing bacteria is identified, the faster the appropriate treatment can begin. This is the driving goal behind the NMU/MIT collaboration using the MIT 1000 to differentiate between the common S. aureus and MRSA. At this stage, the collaboration involves scientists from MIT and NMU gathering preliminary data and developing collaborative research proposals seeking funding in support of continued research.

Dr. Josh S. Sharp, assistant professor at NMU's Department of Biology, is directing the NMU research on clinical applications of the MIT 1000. "Being able to quickly identify if a patient has an S. aureus infection, and whether or not that S. aureus is MRSA, a strain of S. aureus resistant to certain antibiotics, would be extremely useful in dictating the proper course of treatment for that patient, and ultimately, increase the likelihood of a successful patient outcome," Sharp said.

Micro Imaging Technology's Chief Scientist, Dr. David Haavig, was instrumental in developing the MIT 1000 and is the program director of the effort and will lead MIT's team in the collaboration. "This Staph Identifier is a key addition," he said. "This Staphylococcus Identifier will simplify and speed the creation of our upcoming S. aureus, Staphylococcus epidermidis (S. epidermidis) and MRSA Identifiers." The Staphylococcus Identifier and candidate S. aureus and S. epidermidis Identifiers and an MIT 1000 System will be delivered to Professor Sharp within the next few weeks, then he with his graduate and undergraduate students and we at MIT will begin the preliminary stage of our MRSA collaboration. Meanwhile, MIT is working on a series of Salmonella Identifiers including the common food pathogens S. Enteritidis and S. Typhimurium.

(1) December 19, 2013 - Lee Bros. Foodservice Inc., a San Jose, Calif. establishment, is recalling 740 pounds of sausage products that may be contaminated with Staphylococcus aureus enterotoxin, the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) announced today.

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Quidel Receives FDA Clearance for Its Hand-Held Group B Strep Molecular Diagnostic Test

Quidel Corporation, a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for the sale of its AmpliVue Group B Strep Assay. AmpliVue is Quidel's non-instrumented molecular diagnostic test that employs a novel amplification technology with an easy-to-use, hand-held device. The AmpliVue Group B Strep Assay combines isothermal Helicase Dependent Amplification (HDA) with Quidel's well-established expertise in lateral flow technology to detect Group B Streptococcus (GBS) from enriched broth cultures of specimens from antepartum women.

GBS is responsible for illness in people of all ages, but it is a particularly serious pathogen for newborns in whom it can cause life-threatening sepsis, pneumonia and sometimes meningitis with a risk for long lasting effects, including deafness and developmental disabilities.(1) According to the Centers for Disease Control and Prevention (CDC), roughly 10% to 30% of pregnant women carry GBS that can be transmitted to the newborn at delivery. CDC guidelines recommend that all pregnant women should be tested for GBS infection between 35 and 37 weeks of pregnancy.(2)

Although more rare, serious GBS infections can also occur in adults, leading to bloodstream infections, pneumonia, and other infections that can be fatal.(3)

"We are pleased to receive 510(k) clearance for our AmpliVue Group B Strep assay," said Douglas Bryant, president and chief executive officer of Quidel Corporation. "We can now provide the hospital laboratories with another AmpliVue assay for fast, accurate infectious disease testing without the need for additional investments in expensive equipment."

The AmpliVue Group B Strep assay now enables laboratories of all sizes to perform highly sensitive and specific molecular tests and is Quidel's second assay to launch in the hand-held, disposable AmpliVue format. The AmpliVue C. difficile assay was launched earlier this year for the detection of toxigenic Clostridium difficile bacterial DNA. Both assays are now available for sale throughout the U.S. and Europe. Diagnostic tests for other analytes of interest that will use the novel AmpliVue platform are in development.

(1) http://www.cdc.gov/groupbstrep/about/index.html
(2) http://www.cdc.gov/groupbstrep/about/fast-facts.html
(3) http://www.cdc.gov/groupbstrep/about/adults.html

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New PCR Assay Accurately Identifies Burkholderia Bacteria

A newly developed assay could provide increased accuracy, with reduced cost when attempting to identify Burkholderia bacteria, which some varieties are deadly.

DTRA CB/JSTO-funded research at Northern Arizona University collects genetic information on all types of Burkholderia that will be used to improve identification tools for developing better assays for more accurate disease diagnosis. One product spun off from this effort was the development of a polymerase chain reaction (PCR) based assay, Bu550, that allowed for the easier and more accurate differentiation of B. ubonensis, the nonfatal infective organism, from its near-neighbor, B. pseudomallei, the highly lethal bacterium.

In the article “Accurate and Rapid Identification of the Burkholderia pseudomallei Near-Neighbour, Burkholderia ubonensis, Using Real-Time PCR,” that was recently published in the journal PLoS ONE, Dr. David Wagner of Northern Arizona University detailed the development of the new assay. Both species share an environmental niche and are frequently confused when cultured on Ashdown’s medium, the selective for Burkholderia spp. Until now, characterization of B. ubonensis and differentiation from its near neighbors has relied on laborious, time‐consuming and costly methodologies. It is anticipated the Bu550 assay will catalyze research on B. ubonensis by enabling rapid identification of this organism and distinguishing it from other Ashdown‐positive Burkholderia colonies.

The ability to distinguish infections and non-infectious, Burkholderia can impact planning risk assessments in estimating the risk of warfighters contracting diseases when deployed into a new region. This assay allows planners to minimize exposure to deployed warfighters by avoiding areas of known elevated risk of infection.

Continued genetic characterization of B. ubonensis and other Burkholderia near-neighbors will aid in the improvement of current sequence-based assay specificity, thereby reducing misidentification events. Misidentification of Burkholderia spp. has implications for all decision-makers in the fields of environmental studies, clinical diagnosis and biosecurity response.

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