Meridian Bioscience Receives FDA Clearance For ImmunoCard® C. difficile GDH Test

Meridian Bioscience, Inc. today announced it has received FDA clearance for a new Clostridium difficile assay, ImmunoCard® C. difficile GDH. This test detects the C. difficile common antigen glutamate dehydrogenase (or GDH). This assay has already been successfully launched and accepted in global markets as an excellent screening option for C. difficile. The GDH common antigen is present in both toxigenic and nontoxigenic strains of C. difficile.

Toxigenic strains of C. difficile are frequently associated with hospital and community-acquired diarrhea and can lead to life-threatening complications or death. Therefore, laboratories can use this highly sensitive screening test to identify patients with a suspected C. difficile infection and then reflex positives to a sensitive and more specific molecular assay like illumigene(R) C. difficile, which can confirm infection with the toxin-producing strains. Meridian Bioscience is the only manufacturer that can provide a complete portfolio of C. difficile testing solutions that meets the needs of its global customers. ImmunoCard C. difficile GDH, used in conjunction with illumigeneC. difficile, empowers cost-sensitive laboratories with an economical algorithmic option for C. difficile diagnostic testing.

Jack Kraeutler, Chief Executive Officer stated, "C. difficile continues to be both a dangerous and costly infection for patients and the healthcare institutions that care for them. For a screening test to be most effective, it must be very sensitive so as not to miss any true positives. In rigorous clinical studies, ImmunoCard C. difficile had the highest negative predictive value when compared against competing screening tests. The introduction of ImmunoCardC. difficile GDH in the US market continues Meridian's legacy of leadership in the detection and identification of C. difficile. This new product, along with the Meridian illumigeneC. difficile molecular assay, allows laboratories to identify C. difficile infected patients with a rapid screening test and molecular confirmation in less than two hours."

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Researchers Strike Gold with Nanoparticle Virus Test

An Egyptian research team has won a prize for developing a hepatitis C test using gold nanoparticles. The test could become a cheap and rapid way to screen people and blood banks for the virus. Hassan Azzazy, chair of the chemistry department at The American University in Cairo (AUC), and his team, won third place at the Intel Global Challenge held at the University of California, Berkeley, in the United States, last month (7–10 November) winning US$10,000.

"Nanoparticles are promising tools for developing the next generation of diagnostic assays because of their unique properties," Azzazy told SciDev.Net. He said gold nanoparticles exhibit a phenomenon known as surface plasmon resonance, which causes them to change colour from an intense red to blue when they aggregate. The test works by adding a target agent that binds to viral genetic material, forcing the nanoparticles to aggregate and turning the solution blue.

Azzazy said that "conventional detection of active hepatitis C generally requires two tests that take from three to four days and cost about US$78 per sample, while the nanogold test can generate similar results in less than one hour and for one-tenth of the cost. One gram of gold tetrachloride costs US$260 and is enough for 10,000 samples."

According to the WHO, hepatitis C infects 200 million people worldwide, but is especially prevalent in the Middle East and North Africa (MENA) with about 9.2 million individuals infected. For most MENA countries, the prevalence is between one and two per cent; the exception is Egypt where estimated prevalence is 14 per cent for adults aged 15–60.

"Early identification and treatment of infected patients is critical to reducing transmission of the disease, and a fast and relatively cheap new assay will be of great help," said Hala Gabr, professor of haematology at Cairo University.

Amr Abul-Fotouh, lecturer in tropical medicine and hepatology at Cairo University, added: "Although the nanogold test is a good one, it is not quantitative so it cannot be used to treat and follow up patients, as this needs the quantity of the virus to be detected by a PCR [polymerase chain reaction] test".

He pointed out that the new assay could be used in blood banks to check for hepatitis C. "We have seen that about 20 per cent of Egyptian blood donors test positive for the virus," he said.

Sherif Shawky, a doctoral fellow at AUC, and a member of the research team, told SciDev.Net that the technology can be adapted for detecting other infectious agents such as tuberculosis, and for use as cancer biomarkers. A spin-off company, NanoDiagX, has been set up to develop these bio-nanotechnology platforms.

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Nanosphere Receives FDA Clearance of Gram-Positive Blood Culture Test for Staphylococcus

Nanosphere, Inc., a leader in the development and commercialization of advanced molecular diagnostics systems, announced today it has received 510(k) clearance from the FDA for the Verigene(R) Staphylococcus Blood Culture Nucleic Acid Test (BC-S). The BC-S test expands Nanosphere's infectious disease test capabilities to include the rapid detection of bacteria that cause deadly bloodstream infections.

The Verigene BC-S test was submitted to the FDA as the first phase of a stepwise process to obtain clearance for a larger test panel which will be marketed as the Verigene BC-GP test. The test will be comprised of up to 16 bacterial/resistance marker targets, all on a single test cartridge. A second 510(k), needed to obtain clearance for the full BC-GP test panel, is currently under FDA review.* Last week, Nanosphere obtained CE-IVD Mark for regulatory approval of the full BC-GP test as an in vitro diagnostic in Europe.

"With the BC-S test, clinicians diagnosing patients suspected of deadly infections have a rapid, accurate molecular diagnostic tool which can differentiate two important disease-causing Staphylococcus bacteria, while simultaneously determining antibiotic resistance within the critical timeframe for making and adjusting initial treatment decisions," said Nanosphere CEO Bill Moffitt. "With this clearance we continue expansion of our product offering, enabling microbiologists to replace century-old methods with rapid, accurate molecular diagnostic tests," he added

In a single automated test, the Verigene BC-S test provides detection of Staphylococcus aureus, Staphylococcus epidermidis, and the mecA gene. The mecA gene confers resistance to the antibiotic methicillin/oxacillin. Methicillin-resistant Staphylococcus aureus (MRSA) bacteremia is associated with a significantly higher mortality rate than methicillin-susceptible Staphylococcus aureus bacteremia, posing a substantial healthcare burden.

The BC-S test provides species and resistance detection from two types of gram-positive blood culture bottles within two and a half hours, as compared with current microbiological culture methods, which can take up to 3 days. Identification of bacteria and resistance markers is critical in guiding appropriate antibiotic treatment. Studies have shown that delayed administration of appropriate antibiotics is associated with a 7.6% decrease in survival rate for each hour that therapy is delayed. Rapid molecular testing of blood cultures has been shown to reduce this time, and is associated with hospital cost savings of up to $21,000 per patient.

The sample-to-result BC-S test automates the steps of bacterial nucleic acid extraction and target detection on the Verigene System. The ease-of-use and rapid turnaround time of the BC-S test allow hospitals of any size to benefit from the speed and accuracy of automated molecular testing.

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Taiwanese Researchers find Way to Quickly Detect Bacteria in Blood

Taiwanese researchers have developed a bio-nanotechnology platform that makes it possible to rapidly capture and detect bacteria in human blood samples without the need for time-consuming culture processes.

"Detecting bacteria in clinical blood samples without using time-consuming culture processes will allow more rapid diagnoses," said Wang Yuh-lin, a distinguished research fellow at Academia Sinica and National Taiwan University (NTU) professor, who led the research team.

According to Wang, conventional methods commonly require a sample preparation time ranging from days for fast growing bacteria to weeks for slow growing bacteria.

The result was reported in the Nov. 15 issue of the journal Nature Communications.

Liu Ting-yu, an assistant professor at NTU and a member of the team, said that "like every instrument that has its own distinct sound, every molecule has its specific spectrum, and scientists have used the feature to differentiate bacteria."

He said that coating silver-nanoparticle arrays with the antibiotic vancomycin using a technology called surface-enhanced Raman spectroscopy (SERS) can lead to a 1,000-fold increase in bacteria capture compared with conventional approaches.

Vancomycin was chosen because it is one of the strongest antibiotics available and captures nearly all forms of bacteria.

Liu said the captured bacteria can then be concentrated in a special vancomycin coated module, while blood cells are excluded, making identification easier.

The development could have wide-ranging benefits, with the top priority at present the detection of sepsis, a potentially deadly condition that is characterized by a whole-body inflammatory state and the presence of known or suspected infection.

Doctor Han Yin-yi of NTU Hospital said the technology would help obtain a much faster and more precise initial test result of the infection, reducing patient fatalities and the incidence of complications.

Han said that once the technology becomes available, doctors will no longer have to engage in guesswork when prescribing drugs to patients, and antibiotic abuse will also be reduced.

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Particle Measuring Systems Offers the The BioLaz™ Real-Time Microbial Monitor for the Rapid Detection of Airborne Organisms

Particle Measuring Systems

5475 Airport Blvd.

Boulder, Colorado 80301

phone: +[1] 303-443-7100

fax: +[1] 303-546-7380

email: info@pmeasuring.com

website: http://www.pmeasuring.com

Particle Measuring Systems Offers Their Innovative Instrument, the BioLaz™ Real-Time Microbial Monitor for Rapid Detection of Airborne Biological Organisms in Controlled Environments.

The BioLaz™ Real-Time Microbial Monitor provides immediate notification when biological particles are present and real-time verification of biological activity levels during aseptic manufacturing or other operations. This significantly improves the ability to demonstrate control over clean environments.

BioLaz Technology

The BioLaz uses a proven solid state laser-based optical technology for the detection of biological organisms. Air is drawn into the system and if biological particles are present, they fluoresce and are counted in real-time. The BioLaz Real-Time Microbial Monitor’s benefits include:

• Validated to USP <1223> Validation of Alternative Microbiological Methods and of EP 5.1.6 Alternative Methods for Control of Microbiological Quality
• Continuous monitoring with real-time reporting of biological counts
• Easy to integrate data via RS-232 or Ethernet communications
• Internal pump, eliminating the need for external vacuum systems
• Small footprint, 316L stainless steel enclosure

Environmental Monitoring Integration

The BioLaz integrated with traditional methods, Agar plates and particle counters, can lead to improved compliance and potential cost reductions. Particle Measuring Systems provides turn-key systems with traditional particle and microbial monitoring, combined with rapid microbial detection into one complete environmental monitoring solution.

Please visit our web site at www.pmeasuring.com to view an introductory video detailing the BioLaz™ Real-Time Microbial Monitor’s operations and capabilities.

Particle Measuring Systems is the global leader in environmental monitoring technology, with 40 years of experience providing solutions for particle and microbial monitoring for companies with cleanroom manufacturing environments. As the inventor of laser-based particle counters, Particle Measuring Systems sets the standard for particle monitors in pharmaceutical, nanomaterial, aerospace, integrated circuit and electronics manufacturing.

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New BD Veritor™ System for Rapid Detection of Flu A+B Receives 510(k) Clearance and CLIA Waiver

BD (Becton, Dickinson and Company), a leading global medical technology company, announced today that it received 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver from the U.S. Food and Drug Administration (FDA) for the BD Veritor™ System for rapid detection of Flu A+B. This is the first rapid influenza test system that incorporates a digital read out of results to receive CLIA waiver.

The BD Veritor System delivers very good analytical sensitivity and specificity, offering healthcare professionals a new and different option in rapid influenza testing versus current visually read CLIA-waived assays. The BD Veritor System provides objective results on an easy to read digital display, unlike current CLIA-waived rapid influenza tests, which require a subjective visual test interpretation to determine a positive or a negative test result.

"The new BD Veritor System provides a new approach for CLIA-waived rapid tests for influenza A+B by offering a combination of speed, accuracy and convenience with an objective read that physicians can trust," said Tom Polen, President, BD Diagnostics – Diagnostic Systems. "We believe the BD Veritor System has the potential to change the way doctors view in-office rapid flu testing."

The BD Veritor System rapid flu immunoassay reports performance measured against polymerase chain reaction (PCR) results, the highest sensitivity standard currently available. This newly designed system incorporates BD's novel Nano Detection Particle and Adaptive Read Technology. With this unique combination of technologies in a CLIA-waived Flu assay, the BD Veritor System offers users:

• A convenient workflow
• Few, easy steps requiring very little sample preparation
• No sample incubation required prior to running the test
• Ten-minute period for the test to run and ten seconds of instrument read for final results.

The assay for rapid detection of Flu A+B on the BD Veritor System represents the first of many different assays that are planned on this new platform.

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BAX® System Receives FDA Equivalence for Detecting Salmonella Enteritidis in Eggs

The U.S. Food and Drug Administration has awarded test method equivalency to the BAX® System from DuPont Qualicon for detecting Salmonella enteritidis in eggs.

Accuracy, precision and sensitivity of two BAX® System PCR assays – Salmonella and Salmonella 2 -- were determined equivalent to the reference culture method published in the FDA’s Bacteriological Analytical Manual. Moreover, results for both assays were available just 55 hours after sampling, instead of 7 or more days required by the culture method.

S. enteritidis, a foodborne pathogen most commonly associated with eggs, has been identified as the most frequent cause of Salmonella infection in Europe. In the United States, it’s responsible for 79,000 illnesses and 30 deaths each year. FDA regulations introduced in 2010 require egg producers to implement preventive measures and monitor for S. enteritidis with frequent testing.

“This FDA equivalence is welcome news for egg producers who prefer the BAX® System’s speed, accuracy and ease of use,” said Doris Engesser, global leader, DuPont Qualicon. “Significantly shorter enrichment with this method means that eggs can be released days faster, reducing inventory and refrigerated storage costs while helping to prevent contaminated products from reaching the food supply.”

Food processing companies around the world rely on the BAX® system to detect pathogens or other organisms in raw ingredients, finished products and environmental samples. The automated system uses leading-edge technology, including polymerase chain reaction (PCR) assays, tableted reagents and optimized media to detect Salmonella, Listeria, E. coli, Campylobacter, Vibrio and more. With certifications and regulatory approvals in the Americas, Asia and Europe, the BAX® system is recognized globally as one of the most advanced pathogen testing systems available to food companies. DuPont Qualicon science-based systems for pathogen detection and microbial monitoring, together with Danisco Care4U™ range of natural food protection solutions, help companies protect their products, productivity and brands.

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3M Food Safety Unveils Innovative Molecular Detection System for Dangerous Foodborne Pathogens

After decades of transforming the food processing industry with 3M™ Petrifilm™ Plates, 3M is once again revolutionizing the industry -- this time in the area of pathogen detection. Today, 3M Food Safety introduces the 3M™ Molecular Detection System: a fast, accurate and easy-to-use method of detecting dangerous pathogens, like Salmonella, E. coli O157 and Listeria, that can shut down businesses and threaten public health.

Available worldwide, the 3M Molecular Detection System is based on an innovative combination of unique technologies involving isothermal DNA amplification and bioluminescence detection. The system was designed with 3M's customer testing needs in mind, which translates into a compact, simple, robust system that offers easy implementation and low maintenance without compromising accuracy and reliability.

"Leveraging 3M's record of innovation, including close collaboration with our customers, we believe we've found a transformational solution that makes for a faster and simpler way of accurately detecting pathogens," said Francine Savage, vice president and general manager, 3M Food Safety. "Just as 3M Petrifilm Plates succeeded by melding sophistication with simplicity, the 3M Molecular Detection System optimizes technicians' time and productivity, improving bottom lines, protecting brands and ensuring public health."

The 3M Molecular Detection System delivers highly sensitive results by targeting and amplifying nucleic acid in enriched samples. The automated technology has been evaluated with a variety of food types, including produce, meats, processed foods, pet food and food processing-related environmental samples. The instrument is sleek and compact -- taking up less counter space than a laptop computer, making it portable and adaptable to various lab environments.

"Pathogen testing has now been made simple and affordable," said Niki Montgomery, 3M Food Safety global marketing development manager. "Food processors will benefit greatly from the system's affordable accuracy and fast time to results, minimizing downtime in the lab. Numerous organisms can be tested in a single run and it was designed to help our customers perform fewer repeat tests and make critical decisions faster."

As part of the 3M Molecular Detection System platform, individual, pathogen-specific assays, or procedural tests, will be sold as a test kits. Each assay test kit uses the same software interface and same DNA extraction protocol for testing between one and 96 samples per run. Assays for Salmonella, E. coli O157 (including H7) and Listeria are available immediately; a test for Listeria monocytogenes is expected in early 2012. 3M will continue to invest in developing a full portfolio of pathogen testing solutions to address customer needs.

Independent laboratory studies with the 3M Molecular Detection System are currently underway to pursue global method recognitions.

"In our evaluation of the Listeria species assay, we liked the small footprint of the system as well as the quick delivery of results after sample enrichment," said Dr. Martin Wiedmann, a professor in Cornell University's Department of Food Science who studied the system's analyses of samples taken from meat-packing, seafood processing and retail locations. "This system definitely illustrates the potential of isothermal methods for rapid detection of foodborne pathogens."

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Market Report - Second-Generation Microbiological Tests Detect Pathogens Within One Day

Automated and rapid microbiological tests are rapidly adopting new technologies and automated techniques reducing the time required to detect pathogens from five to ten days to only one day in most cases. These second-generation microbiological tests are moving away from the first-generation technologies such as immunoassays, chromatography and polymerase chain reactions whilst adopting new advanced concepts of biotechnology and molecular diagnostics.

By the end of 2017, the automated and rapid microbiological tests market is forecast to be valued at US$4.5 billion. The increasing number of cases of infectious diseases and sexually transmitted diseases combined with the increased expenditure into developing quicker and more accurate methods of testing is driving growth in this market sector.

The United States is forecast to remain the largest regional market for automated and rapid microbiological testing. The market place is highly saturated and lowering costs of testing services is expected to spawn an era of vertical and horizontal integration across the market. Advancements in molecular diagnose such as genetic probe tests hold the key to dominating this market place, taking market share from players adopting the more traditional rapid microbiology tests approach.

In Europe, the microbiological testing market is forecast to increase by 5.6% with the other markets in Asia and Latin America also expected to report strong growth as the new technologies are implemented.

The largest end-use market sector is automated identification with GC / Chlamydia Rapid Tests representing the fastest expanding sector, growing at a strong rate of 5.3% CAGR. The main players in the automated and microbiological testing market are Abbott Laboratories, Alere Inc., Becton Dickinson and Company, bioMerieux SA, Bio-Rad Laboratories Inc., Cellabs Pty Ltd, Celsis International Plc, Coris BioConcept, F. Hoffmann-La Roche Ltd., Gen-Probe Inc., Sekisui Diagnostics LLC, MedMira Inc., Meridian Biosciences Inc., Orasure Technologies Inc., Orion Diagnostica Oy, Quidel Corp., Siemens Healthcare Diagnostics Inc., and Thermo Fisher Scientific Inc.

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Leading Product Development Company Sagentia Selected by PathoGenetix to Develop Commercial-Scale, Rapid Microbial Detection System

Sagentia, an international technology and product development company, announced today that it has been selected by PathoGenetix to develop a commercial scale system for rapid microbial detection and strain typing based on PathoGenetix's Genome Sequence Scanning Technology (GSS). The system is being designed to capitalize on the broad range of potential GSS applications that span microbial genomics research, food and product safety, and clinical infectious disease testing.

PathoGenetix's proprietary GSS technology combines automated sample preparation and single molecule detection making it possible to detect and characterize microbes from complex biological samples in as little as three hours. Specifically, the technology extracts genomic barcodes from microbial DNA as it flows through a microfluidic chip at 150 million base pairs per second. A universal reagent set decorates the DNA enabling specific pathogens to be identified by comparing their unique DNA 'barcode' with PathoGenetix's own library of templates. With this approach, it is possible to identify thousands of different microbial strains through a single test, days faster and at far lower cost than current techniques. The GSS technology was developed with more than $50 million in support from the United States Departments of Defense and Homeland Security under advanced biosensor programs.

Sagentia, an experienced leader in the development of new technologies and breakthrough products, including complex diagnostics, was brought in to the project to take the current laboratory prototype and help turn it into a technically and commercially successful platform. Sagentia's work will include further integration of state-of-the-art optics and microfluidics, making the technology more robust, enhancing the usability of the system, driving cost reduction, and increasing manufacturing efficiency.

"Sagentia's commitment to PathoGenetix directly reflects our mission to help clients develop and deliver innovative technologies through all the stages of device development," said Brent Hudson, chief executive officer of Sagentia. "Working across the complete product development continuum - from market needs analysis to transfer to volume manufacturing - we make it possible for companies to take complex ideas and develop them into products that are robust and usable in many settings. We are excited to work with PathoGenetix and look forward to helping them bring this groundbreaking new technology to market."

"We are very excited to be working with Sagentia on this critical initiative," said John Canepa, chief executive officer of PathoGenetix. "At PathoGenetix, we are focused on revolutionizing microbial identification and diagnostics. We chose Sagentia because of the company's extensive technical knowledge and the team's understanding of our core objectives. We believe that Sagentia's team will add tremendous value to this project and we look forward to working with them to bring to market an instrument platform that will improve the speed and efficacy in a range of diagnostics applications." He added that PathoGenetix expects to launch the system's initial commercial application, for the research market, in late 2012.

This is another important client project for Sagentia as the company continues to grow its US footprint. In November of 2010, Sagentia expanded its presence in the U.S. by opening an office at One Broadway Street in Cambridge, Massachusetts where the company was selected to be a member of Governor Deval Patrick's U.S.-U.K. trade partnership.

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Celsis Rapid Detection Launches Enhanced Software

Celsis, which provides rapid microbial testing systems for industry, released a new and enhanced version of Innovate.im software for the Celsis Innovate system that is used worldwide by dairy, food and beverage manufacturers to screen products for microbial contamination. The Celsis Rapid Detection system shortens product and ingredient testing times from 4-14 days to as few as 24-48 hours.

“Faster testing cycles help manufacturers be more responsive to customers, prevent contamination from spreading and reduce costs for inventory and warehousing,” said Scott Scdoris, Director of Food & Beverage for Celsis. “The new Innovate.im software also provides secure, remote and real-time access to testing data, so company executives are better prepared to monitor and respond to potential consumer health risks.”

Mary Kamm, director of research and quality at Byrne Dairy, said, “The new Celsis Innovate.im software allows us to more efficiently manage test results from our complex operations; thereby allowing us to ensure the highest standards of product quality for our customers. In particular we benefit from the new Celsis software being compatible with the new Windows operating systems, allowing us to upgrade our laboratory computers. It is also compatible with our LIMS system, allowing for efficient data transfer to our quality assurance testing database.”

Manufacturers of packaged dairy, food and beverage products that are expected to be free of microbial contamination can benefit from the rapid, absence/presence results offered by the Celsis system. The new software update provides additional support for high-volume packagers, allowing multiple instruments to write data to a single, searchable database.

Additional features of the new software include updated graphical user interface; improved database querying capabilities; new plate preparation features; beverage/juice protocols; new user-definable data fields; and an updated on-screen menu.

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PositiveID Corp. Granted Patent for Portable Pathogen Detection from U.S. Patent and Trademark Office

Located in Delray Beach, Florida, PositiveID Corp. (OTCBB: PSID) develops unique medical devices and molecular diagnostic systems with their focus primarily on diabetes management, rapid medical testing and airborne bio-threat detection. Yesterday, the young company took a major step towards prominence with the announcement they have been granted Company Patent No. 8,053,214 from the U.S. Patent and Trademark Office.

The patent was awarded to PositiveID’s MicroFluidic Systems (“MFS”), which is a subsidiary of PositiveID. MFS has a growing patent portfolio where the targeted applications of which are biological sample collection processing and detection from environmental samples and clinical samples. The patent will allow PositiveID to make a substantial impression within the sector and to take advantage of DHS’ $3 billion “Bio Watch Program.”

Leading the way at PositiveID is William J. Caragol whom serves as the company’s CEO. In reference to this press release, Caragol stated, “This latest U.S. Patent demonstrates the vast array of derivative technology stemming from M-BAND, a system developed under a decade of funding received from DHS exceeding $35 million. We believe M-BAND continues to be well positioned as a proven technology to compete for DHS’ Third Generation BioWatch program, a $3 billion program to identify pathogens in the air as part of an early warning system designed to thwart a potential terrorist attack.”

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Thermo Fisher Scientific makes it Easier to Test Food for Shiga Toxin-producing E. coli

The new BAX® System STEC Assay Suite includes a screening assay and two panel assays. The screening assay detects STEC virulence genes (stx1, stx2 and eae), quickly and conveniently ruling out negative samples. The panel assays determine which of the six clinically most significant STEC serogroups identified over the past 20 years (O26, O111, O121, O45, O103 and O14) a positive sample contains.

The BAX® System STEC Assay Suite is simple to use. Single-stage enrichment is complete in as little as nine hours. Dual tests for STEC and O157:H7 can be run from the same prepared sample (also used for the panel assays). With no need for additional sample prep between tests, hands-on time and the risk of cross-contamination are reduced. Rapid real-time processing delivers results in less than one hour, allowing food processors to make product-release decisions quickly and with confidence.

The BAX® System allows food laboratories to easily, quickly and accurately detect organisms in raw ingredients, finished products and environmental samples. The cycler/detector allows samples to be loaded and left to run. Interpreted results are clearly displayed on-screen, with raw data easily accessible.

The BAX® system decreases false positives and minimizes re-testing, it helps reduce employee training and increases product time to market. The speed and accuracy of DNA-based detection; the simplicity of the load-it and leave-it operation; the familiarity of the Microsoft™ Windows™ interface: The BAX® system combines all this, for smooth testing procedures at any stage in the processing pipeline.

Assays for the BAX® System Q7 include: Salmonella, Genus Listeria, Listeria monocytogenes, Escherichia coli O157:H7, Staphylococcus aureus, Campylobacter coli/jejuni/lari, E. sakazakii (Cronobacter), Vibrio cholerae/parahaemolyticus/vulnificus, yeast and mould and now the new, BAX® Real-Time STEC Assay Suite.

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Contractors Selling Faster Way to Run DNA Tests

As DNA identification technology advances and becomes easier and quicker to use, contractors are finding sales opportunities at the Pentagon and other security agencies. Falls Church-based Northrop Grumman said last month that, partnered with IntegenX, it won a contract to supply a rapid human DNA identification system to the Army’s Biometrics Identity Management Agency.

Alan Leckenby, vice president of identity and business solutions for Northrop Grumman’s information systems business, said the award moves the company into a new area of biometrics. “Numerous local, state and national ... security agencies use DNA-based human identification to assist in decision-making,” he said. But “in the laboratory, it takes a long time to process DNA samples. ... Shortening up the timeline is critically important” on the battlefield.

Bethesda-based Lockheed Martin, too, is focused on more-rapid DNA testing. The company has been partnering with Zygem Microlab in Charlottesville for about four years to develop small plastic chips and an associated instrument that together allow for DNA testing. The chip uses microfluidic chemical processing — which refers to using very small samples and chemicals to conduct the analysis — to allow quick, portable and relatively inexpensive DNA testing.

Conventional DNA testing requires six pieces of pricey lab equipment and processing time of about eight to 10 hours, if there’s no backlog, said John Mears, director of biometrics and identity management solutions within Lockheed’s information systems and global solutions civil unit.

“We’re talking about being able to take something as simple as a cheek swab ... stick it in the machine and have a DNA identification in about an hour,” said Mears, noting that it does not require trained laboratory technicians. The technology is only designed at this point to analyze the DNA that allows for identifying an individual, but Mears said future applications could include verifying family relationships for immigrant petitions or identifying food pathogens. “We’ve gone through several revisions of the prototype,” Mears said of Lockheed’s product. “I expect we’ll have something that’s marketable by the middle of next year.”

Mears said the company sees the military, the Department of Homeland Security and the Justice Department as potential buyers.

Leckenby too said Northrop is seeing promise in the technology, particularly as the cost goes down as units are produced in larger quantities.

“I think the high degree of accuracy is going to be very appealing,” he said. “It is expensive upfront when you’re at this stage of development, but the prices have come way down and will continue to go down.”

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China Health Labs & Diagnostics Ltd. Announces $10.1 Million Sales Order for its Food Safety Business

China Health Labs & Diagnostics Ltd. announced that it has secured a sales order of RMB 61.5 million ($10.1 million) for food safety testing equipment, lab management system ("LMS") software and hardware, and installation services from the Beijing municipal government, through a bidding agent, Oriental Scientific Instruments Import and Export Corporation. The sales order is for delivery in 2011, and includes a LMS software developed by the Company to connect all the Beijing food safety labs, enabling more efficient communications and operations.

This sales order represents growth of 100% for the food safety business compared to 2010, when the Company had revenues of $33.7 million of which 15% or $5.5 million was from the food safety business.

"Improving food safety is a high priority for the Chinese government at the central and municipal levels. The Chinese government established the State Council Food Safety Commission last year and this year, the SCFSC announced a five-year program for food safety education," said Wilson Yao, CEO of China Health. "We have used our expertise in lab management and design to assist the Beijing municipal government to establish an effective network of food testing labs that operate with our proprietary lab management system. In the future, we plan to use our track record in Beijing as a reference to expand our food safety sales to other cities in China."

In 2008, China Health entered the food safety market by installing food-testing labs mandated and paid for by the Beijing municipal government in response to concerns due to the growing number of high profile food safety incidents and the need to improve safety for the Beijing Olympics. In 2009 and 2010, the Company developed and provided food safety lab solutions, including the Company's proprietary LMS software, for major food distribution centres in Beijing and a mobile lab solution based on the need for on-site rapid testing, which generated increasing revenues in each year.

Currently, the Company's food safety lab solutions test for, among other things: (1) heavy metal residue, such as mercury, cadmium and lead; (2) pesticide residue, such as alpha-BHC, formothion, oryzalin, pyraflufen-ethyl, DDT and nitenpyram; (3) veterinary drug residue, such as ampicillin, amoxicillin, altrenogest and bacitracin; (4) pathogenic micro-organisms, such as salmonella, shigella, vibrio parahaemolyticus and clostridium botulinum; and (5) poisonous food additives, such as lean meat powder, melamine, plasticizer and malachite green. The food safety lab solutions include equipment assembled at the Company's Beijing manufacturing facility and sourced from other manufacturers. To date, China Health has installed 17 major labs, 250 mini-labs (in food distribution and manufacturing facilities) and supplied 17 mobile labs to the Beijing municipal government to improve food safety.

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OraSure Technologies Receives CLIA Waiver for OraQuick(R) HCV Rapid Test

OraSure Technologies, Inc. announced that the U.S. Food and Drug Administration ("FDA") has granted a waiver under the Clinical Laboratory Improvement Amendments of 1988 ("CLIA") for its OraQuick(R) HCV Rapid Antibody Test for use with fingerstick whole blood and venous whole blood specimens.

The OraQuick(R) HCV Rapid Antibody Test is the first and only FDA-approved rapid test for the detection of antibodies to the hepatitis C virus ("HCV"). The test, which utilizes the OraQuick(R) technology platform, provides results in 20 minutes. With this waiver, the OraQuick(R) HCV test now can be used by more than 180,000 sites in the United States to test persons who are at risk for hepatitis C or have signs or symptoms of hepatitis. These sites now extend to facilities that can perform CLIA-waived tests, such as outreach clinics, community-based organizations and physician offices.

"Today, more than 4 million Americans are infected with hepatitis C and the vast majority do not know it," said Dr. Willis C. Maddrey, President of the Chronic Liver Disease Foundation. "Hepatitis C is a leading cause of chronic liver disease, cirrhosis and liver cancer. However, new therapies are now available that can effectively treat a high percentage of people with HCV infection, making expanded and accessible testing for HCV a critical step in fighting this epidemic."

"A CLIA waiver for our OraQuick(R) HCV test represents a critical milestone in our quest to make the test available to the widest possible range of at risk individuals in the U.S.," said Douglas A. Michels, President and Chief Executive Officer of OraSure Technologies. "The CLIA waiver will enable healthcare providers, those on the front lines of fighting this devastating disease, to use this simple and accurate test in physician offices and outreach settings so more individuals infected with hepatitis C can be diagnosed and treated."

As previously announced, OraSure has entered into agreements with Merck & Co. to collaborate on the development and promotion of the OraQuick(R) HCV test. Under these agreements, Merck will provide detailing and other promotional support for the test in the physicians' office markets in the United States and internationally. The approval of the CLIA waiver will now enable physicians to utilize the test in their office settings.

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P&G Implementing Celsis ReACT Assay at Detergent Plants Worldwide

The Procter & Gamble Company is implementing the Celsis ReACT molecular assay at its liquid detergent manufacturing sites worldwide. The two-hour ReACT test is being used as a follow-up to Celsis' AKuScreen test, which P&G currently uses as a primary screen for the release of their products. AKuScreen is an adenylate kinase (AK)-based assay, which generates definitive microbiological test results in under 24 hours.

"P&G's reputation is founded on quality. We want to assure that the consumer gets a safe, reliable product," said Neil Lewis, Global Microbiology Delivery Organization Technical Leader, P&G. On the rare occasion when a product sample tests positive and further analysis is required, the Celsis ReACT RNA-based secondary assay is used to determine the possible source of an organism.

"In our validation of ReACT, we have found it to be more accurate than a standard Gram stain test which is what we use it for," said Lewis. "We've not only got a faster test, but we've got a better test. ReACT has a huge potential that I don't think we've started to fully understand yet, given we've only been using it for 6-9 months now," he added.

The ReACT product grew out of earlier collaborative discussions on how Celsis could help P&G's quality teams respond to potential problems faster while maintaining customer safety as a top priority.

"The global supply leadership team at P&G have been more than proponents and users of our rapid screening systems. They have been true collaborative partners with Celsis in helping to define our industry's next generation market needs," said Jay LeCoque, CEO of Celsis International Ltd.

Celsis ReACT is an easy-to-use molecular assay for detecting objectionable organisms quickly and definitively without the need for expensive equipment or specialized training. It is based on molecular technology that targets 16S or 18S rRNA to match a microbial classification or species using an integrated probe set.

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Quidel Receives CE Mark for Its Sofia™ Strep A Fluorescent Immunoassay (FIA) Test

Quidel Corporation, a leading provider of diagnostic testing solutions, announced today that it has received the CE Mark for its Sofia Strep A FIA for use with its Sofia Analyzer.

Sofia is the brand name for Quidel's next generation, immunoassay system. The Sofia Analyzer and Sofia Strep A FIA combine unique fluorescent chemistry, advanced lateral flow technology, and failure alert and fail-safe systems to ensure a reliable, objective, rapid and highly accurate diagnostic result. This press release follows closely on the recent announcement of the FDA clearance of the Sofia Analyzer and Sofia Influenza A+B FIA.

The Strep A FIA is the second assay to incorporate Sofia-related immunochemistry. The CE Mark allows Quidel to launch the Sofia Strep A FIA just before the respiratory disease season in Europe as well as in other locations outside of the United States. The product is currently not for sale in the U.S.

"We are very pleased to receive the CE Mark for Strep A on Sofia ahead of schedule. In combination with our Sofia Influenza A+B FIA, this product will provide healthcare workers with added testing versatility during this respiratory disease season," said Douglas Bryant, president and chief executive officer of Quidel Corporation.

The Sofia Strep A and Influenza A+B FIAs use the Sofia Analyzer, an instrument that is designed to quickly incorporate software upgrades for new analyte-specific algorithms as the Sofia menu of products expands. The development of several additional FIAs for application to the Sofia Analyzer is well underway.

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MicroVal Certifies GreenLight TVC Method for Raw Meat, Poultry

The GreenLight™ total viable count (TVC) method, which automatically detects microbial contamination in food and beverage samples, was recently validated and certified by MicroVal for raw meats and poultry. Based in The Netherlands, MicroVal validates and certifies alternative microbiological analysis methods according to EN-ISO 16140.

“After a successful launch in the United States, the MicroVal certification will now enhance our ability to market GreenLight™ series instrumentation across Europe. The rigorous independent testing that this methodology has gone through over the past two years, gives European food processors the confidence to convert to faster, more efficient technology,” says Dr. Richard Fernandes, chief executive officer, Luxcel Biosciences Ltd.

GreenLight™ sensor technology was developed by Luxcel Biosciences and has been marketed in the United States by MOCON, Inc. (NASDAQ: MOCO) since 2010. The methodology has been previously qualified by AOAC International, Gaithersburg, MD, which provides validation and conformity assessment of commercial and analytical methods.

As part of the MicroVal certification process, the microbial contamination methodology was tested at eight independent laboratories in five different European countries.

The GreenLight™ series was developed to provide precise, same-day results in a cost-effective manner. Depending on the bacterial load, results can be obtained between minutes and 12 hours. This is more than ten times faster than the traditional agar plate or film methods, which typically require 48 to 72 hours to achieve a meaningful microbial count. Shorter testing cycles provide packers and processors with the potential of getting their perishable food items to the consumer in less time.

“The rigorous independent testing of the GreenLight™ microbial test methodology provides further validation of its ability to perform precise tests for bacterial loads in raw meat and poultry. Additionally, GreenLight™’s outstanding time-to-result when compared to traditional methods enables us to play a key role in creating a safer world market for food,” Dr. Fernandes says.

Three different units, the GreenLight™ 910, 930 and 960 are available to handle a variety of throughput requirements. The series also targets company and laboratory microbial contamination testing requirements for seafood, dairy, produce, etc.

MicroVal certificate number RQA2008LR15 was issued to Luxcel Biosciences, Ltd. on October 11, 2011. The certification is valid for four years.

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