Thursday, August 15, 2013

Charm Sciences Announces Charm(r) FAST PHAGE Method Accepted by EPA for Detection of Coliphage in Ground Water

Charm Sciences, Inc. announces Charm® FAST PHAGE Method is EPA approved effective May 31, 2013. Refer to Federal Register notice

FAST PHAGE is a less than 24 hour, ready to use, EPA approved method for the detection of coliphage in compliance with Ground Water Rule regulations. With FAST PHAGE approval, EPA has added a more rapid, by 24 to 48 hour, easier ready-to-use method to the available coliphage methods. Coliphage testing adds additional water safety integrity to municipal testing programs.

Coliphage are virus particles, bacteriophage, specific to the coliform bacteria. EPA lists coliphage as an alternative to E. coli in fecal detection in ground water safety testing. Coliphage, because they are robust small viruses, last longer than bacteria in water and diffuse greater distances through soil and create greater filtration challenges. FAST PHAGE approval allows water municipalities to more easily enhance their bacterial water safety testing programs with coliphage monitoring of water sources and water production processes.

Fast Phage approval was based on published performances detailed in Applied Environmental Microbiology and the Journal of the American Water Works Association

Pathogenica Achieves CE Marking for HAI BioDetection Kit

Pathogenica, Inc. announced today that the company has achieved the CE mark under the European Directive on In Vitro Diagnostic Medical Devices for its HAI BioDetection kit that runs on the Ion PGM™ benchtop sequencer.  This milestone marks the HAI BioDetection CE-IVD kit as the first sequence-based infectious disease diagnostic kit on the market.

"The kit and interpretation software system provides clinicians with a revolutionary diagnostic tool for the identification of disease-causing bacteria and accompanying antibiotic resistance markers in a clinically actionable timeframe," said Yemi Adesokan, Pathogenica's CEO.  "Our team is proud to be supporting the evolving way healthcare providers will routinely manage patient care and treatment options."

Healthcare associated infections (HAIs) are recognized as a severe health threat associated with increases in cost, morbidity, and mortality.  Although screening has enabled reductions in some facilities' MRSA infection rates, recent lethal outbreaks of antibiotic resistant Acinetobacter, Enterococcus, Klebsiella, and Pseudomonas emphasize the diversity of organisms that threaten patient health.  Intensive care units (ICUs) and other hospital wards with patients particularly susceptible to infection may benefit from advanced screening measures.

The HAI BioDetection CE-IVD kit enables identification of the causative agents of 95% of nosocomial infections in a single assay, enabling clinicians to rapidly take appropriate precautions for specific patients.  The assay not only identifies the pathogen but also includes a broad panel of 10 resistance genes (including mecA, vanA, KPC and TEM), enhancing a clinician's ability to choose the appropriate antimicrobial therapy and practice proper antibiotic stewardship.  Studies have shown active surveillance to be a valuable component of a quality infection control program that enhances treatment decisions, improves patient care, and reduces costs due to extended length of stay, unnecessary isolation, and nursing time.

The HAI BioDetection CE-IVD kit prepares samples for sequencing from DNA extracted from isolates, colonies, positive blood culture, urine, rectal swabs, and stool.  This broad array of sample types makes Pathogenica's assay a strong fit for identifying pathogens associated with enteric diseases, bloodstream infections and respiratory disorders – the key profile for HAIs in the US and EU.  Furthermore, the assay requires no pre-culturing for urine, rectal swabs, and stool, enabling a streamlined lab workflow and clinically actionable turnaround (12 hours from DNA extraction to results) for patients affected by urinary tract infections or enteric disorders.
"Culture independent sequencing is a great step forward for clinical applications," said Pathogenica co-founder George Church, Prof. of Genetics at Harvard Medical School.  "Pathogenica has delivered a next-generation sequencing diagnostic tool that provides identification and antibiotic resistance information for improved infection control and therapeutic decision making."

"Thought leaders in infection control departments have been enthusiastic about our rapid high resolution test," said Adesokan. "Pathogenica produces clinically superior and actionable results more rapidly after sample collection than other technologies such as MALDI-TOF and PFGE, which require pre-cultured samples."

In validation testing, the HAI BioDetection CE-IVD kit demonstrated a 100% correct identification rate for 771 bacterial samples.  From specific clinical specimens, the kit identified 100% of Enterococcus positive rectal swabs, with an 89% detection rate of vanA, and achieved 92% concordance with microbial culture from stool for a broad set of bacterial targets.

FDA Approves Apheresis Platelet Claims for Immunetics’ BacTx Rapid Test for Bacterial Contamination

Immunetics, Inc., a leading clinical test provider, has received U.S. Food and Drug Administration (FDA) clearance for its BacTx® rapid test for bacteria in apheresis platelets. The BacTx system is a colorimetric assay that can detect aerobic, anaerobic, gram-negative and gram-positive bacteria in a single test.

“The FDA clearance of BacTx as a point-of-issue assay, initially for whole-blood derived and now for apheresis platelets, represents an additional tool for transfusion services to further reduce the risk of transfusion of bacterially contaminated platelets,” said Dr. Michael Jacobs, director of clinical microbiology, University Hospitals Case Medical Center.

The BacTx assay combines high sensitivity with simple, easy workflow integration. It utilizes a patented, highly specific, universal bacterial detection reagent that has been shown to detect wild and cultured bacterial strains. BacTx is intended for use as a point-of-issue test performed at the transfusion site on the day of issue.

“Bacterial contamination of platelets represents the greatest infectious risk to patients in transfusion medicine. It is a worldwide problem that has not been satisfactorily solved and puts transfusion patients — particularly those most vulnerable to disease — at greater risk of serious illness or death from a contaminated platelet transfusion,” said John Yonkin, CEO of Immunetics. “We are proud to have developed a novel technology that brings a more sensitive and effective test to the market to help reduce patient risk.”

The BacTx assay can be used for quality control testing of leukocyte-reduced apheresis platelets (LRAP) within 24 hours of transfusion, following testing with an FDA-cleared growth-based bacterial detection device. Pools of up to six units of leukocyte-reduced whole-blood derived platelets that are pooled within 4 hours of transfusion.

Immunetics has an established record of developing unique diagnostic tests and products to solve complex problems in infectious disease. "FDA clearance is a major step in bringing BacTx technology to the marketplace,” said Yonkin. “We are now fully committed to rapid commercial development of BacTx for the improvement of transfusion safety both in the U.S. and in markets around the world, and will be shipping our new product by year-end.”

MALDI-TOF Enhances Rapid Diagnostics, Antimicrobial Stewardship Intervention

The use of rapid diagnostic testing along with intervention by antimicrobial stewardship teams decreased the time to identify organisms, as well as time to receipt of effective antimicrobial therapy, according to a report in Clinical Infectious Diseases.

The two-step intervention included the identification of organisms using matrix-assisted laser-desorption/ionization time-of-flight (MALDI-TOF), followed by an intervention by a member of the antimicrobial stewardship team, who provided prescribers with real-time evidence-based antibiotic recommendations immediately following culture results.

“At most hospitals, prescribers are notified in real time of positive Gram’s stain results from the microbiology lab, but not organism identification or susceptibilities results,” Jerod Nagel, PharmD, clinical specialist in infectious diseases at the University of Michigan Hospitals and Health System, told Infectious Disease News. “Data on resistance could be available for up to 24 hours before antibiotic modifications are made. This laboratory-stewardship team interface improved time to optimal antibiotic therapy, leading to improved mortality, decreased length of stay and dramatic reduction in costs.”

Nagel and colleagues conducted the study that included 501 patients. A group of 256 patients who had a bloodstream infection identified with MALDI-TOF and the antimicrobial stewardship team intervention from Sept. 1 to Nov. 30, 2012, were compared with a group of 245 historical controls.

They found that the use of MALDI-TOF decreased time to organism identification by more than 30 hours: 84 vs. 55.9 hours (P<.001). Integrating real-time review and intervention by antimicrobial stewardship teams also improved the time to effective therapy by almost 10 hours (30.1 vs. 20.4 hours; P=.021) and time to effective therapy by more than 40 hours (90.3 vs. 47.3 hours; P<.001).

The use of MALDI-TOF and antimicrobial stewardship team intervention also led to a reduction in 30-day all-cause mortality (20.3% vs. 12.7%; P=.021) and improved overall survival, as well as a significant reduction in ICU length of stay.

“There are numerous studies with different technologies and different intervention methods, which have almost unanimously demonstrated improved outcomes and reduced costs with rapid organism identification and real-time intervention,” Nagel said. “Given the growing number of studies demonstrating significant improvements in outcomes and reduction in costs, hospitals should consider implementing an antimicrobial stewardship team to receive real-time notifications following positive blood cultures.”

Source: Healio

Tuesday, August 13, 2013

Vivione and Kirkegaard & Perry Laboratories Announce Collaboration

Vivione Biosciences Inc. ("Vivione") is pleased to announce a new development relationship with Kirkegaard & Perry Laboratories, Inc. ("KPL"). This relationship is expected to allow Vivione to accelerate commercialization of the detection kits used in Vivione's RAPID-B food-borne pathogen detection platform. The detection kits will be powered by KPL's well-characterized BacTrace(R) affinity-purified primary antibodies. Vivione and KPL plan immediate initiation of manufacturing and commercialization of the detection kits, with the first commercial detection kit (E. coli O157:H7) already submitted for independent certification by the Association of Analytical Communities.

Vivione's RAPID-B system combines flow cytometry with proprietary reagents (contained in detection kits which are designed to target a particular pathogen) and has the potential to provide food pathogen detection down to a single cell in as little as seven hours (including sample preparation) versus up to 48 hours for competing culture based methods. The resulting system offers much higher performance compared to other rapid diagnostic systems currently on the market. Unlike culture-based methods, the RAPID-B system does not require isolation of bacteria and works with background interference from complex matrices like food.

The RAPID-B system is easy to operate by lab personnel and does not require frequent calibration like most flow cytometer systems, making the RAPID-B system more capable of being used in real manufacturing environments. Bacteria detection, data collection, and analysis are seamless with results being provided after only 60 seconds in the system (which does not include sample preparation).

"Vivione collaborated with the U.S. Food and Drug Administration's National Center for Toxicological Research (NCTR) over the past 6 years to accomplish the development and testing of the RAPID-B system," said Kevin Kuykendall, Chief Executive Officer of Vivione. "The strategic relationship with KPL enables us to immediately expand our product offerings and get to market much faster by leveraging their leadership expertise in antibody-based reagent production."

For more than 20 years, KPL has been a well-recognized leader in high specificity, polyclonal, affinity-purified antibodies for food-borne pathogen detection. Although most interest today lies in KPL's offering of antibodies for Salmonella, STECs, E. coli O157:H7, Listeria, and Campylobacter, KPL has a continuous stream of new products in development to detect infectious disease and emerging food-borne pathogens that Vivione will be able to leverage going forward.

Albert Perry, Chief Executive Officer of KPL stated, "The Vivione relationship is a perfect example of what we do best. A significant portion of our business success stems from enabling our supply partners to accelerate commercialization with products that we are confident are robust and work the same way year after year. We are pleased to be part of the RAPID-B commercialization program and believe it will provide food manufacturers with the ability to reduce their time to results while providing more accurate information which can be used to reduce potential recalls and provide better consumer protection."

Friday, August 09, 2013

FDA Approves First Rapid Test to Detect Both HIV-1 Antigen and HIV-1/2 Antibodies

The U.S. Food and Drug Administration today approved the first rapid Human Immunodeficiency Virus (HIV) test for the simultaneous detection of HIV-1 p24 antigen as well as antibodies to both HIV-1 and HIV-2 in human serum, plasma, and venous or fingerstick whole blood specimens. Approved for use as an aid in the diagnosis of HIV-1 and HIV-2 infection, the Alere Determine HIV-1/2 Ag/Ab Combo test is also the first FDA-approved test that independently distinguishes results for HIV-1 p24 antigen and HIV antibodies in a single test.

The test can be used by trained professionals in outreach settings to identify HIV-infected individuals who might not be able to be tested in traditional health care settings. The test does not distinguish between antibodies to HIV-1 and HIV-2, and is not intended to be used for screening of blood donors.

Detection of HIV-1 antigen permits earlier detection of HIV-1 infection than is possible by testing for HIV-1 antibodies alone. The test, can distinguish acute HIV-1 infection from established HIV-1 infection when the blood specimen is positive for HIV-1 p24 antigen but is negative for HIV-1 and HIV-2 antibodies.

“This test helps diagnose HIV infection at an earlier time in outreach settings, allowing individuals to seek medical care sooner,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research. “Earlier diagnosis may also help to reduce additional HIV transmission.”    

HIV infection can result in the development of Acquired Immune Deficiency Syndrome, or AIDS. HIV damages the body’s defense mechanisms by destroying specific blood cells, called CD4+ T cells, which are crucial to helping the body fight diseases. Two types of HIV have been identified, HIV-1 and HIV-2. HIV-1 is responsible for most HIV infections throughout the world. HIV-2 is found primarily in West Africa; however, cases of HIV-2 infection have been reported in North America and Europe.

The Centers for Disease Control and Prevention estimates that each year approximately 50,000 people are infected with HIV in the United States. Of the more than 1 million people living with HIV in the United States, approximately 20 percent of those people have not been diagnosed.

The Alere Determine HIV-1/2 Ag/Ab Combo test is manufactured by Orgenics, Ltd. (an Alere, Inc. company) of Yavne, Israel.

Tuesday, August 06, 2013

3M Molecular Detection System Receives First AOAC Salmonella Validation

3M Food Safety announced today that its 3M(TM) Molecular Detection Assay Salmonella has been validated through AOAC INTERNATIONAL as a First Action Official Method of Analysis(SM) (OMA method number 2013.09) for the detection of Salmonella in selected foods. A complete review of the study conducted for this AOAC-OMA validation will be published by the Official Methods of Analysis of AOAC INTERNATIONAL, online and in an upcoming edition of its Journal of AOAC INTERNATIONAL.

3M's Molecular Detection Assay Salmonella was introduced in December 2011 at the same time as the 3M(TM) Molecular Detection System as a means to help food processors and other parties detect Salmonella and thereby help to prevent salmonellosis, which affects millions of people each year. It received certification from the AOAC-Research Institute as a Performance Tested Method(sm) (PTM) in April 2012.

The Official Methods of Analysis (OMA), AOAC INTERNATIONAL's premier, internationally recognized program for chemical, microbial and molecular biological testing methods, consists of a multi-laboratory validation of the method, and review by an expert panel. Methods assigned AOAC-OMA Final Action status are used throughout the world by standards organizations who rely on OMA's reputation for rigorous scientific and systematic scrutiny.

"Food safety is increasingly recognized throughout the world as a crucial to human, social and economic development," said DeAnn Benesh, 3M Food Safety regulatory affairs specialist. "Our commitment to partnering with leaders in food and science to offer accurate, effective and easily implemented testing solutions is unwavering, and we're proud to have received this OMA First Action approval from the AOAC's distinguished review committee."

The 3M Molecular Detection System offers a unique, reliable and rapid qualitative method of pathogen detection in enriched food and feed, as well as food manufacturing environment samples. Developed with insights from customers around the world and representing multiple food industries, the system integrates two innovative technologies -- isothermal DNA amplification and bioluminescence detection. Additional assay test kits are available for E. coli O157 (including H7), Listeria and Listeria monocytogenes.

Monday, August 05, 2013

DNA Detection Systems Protect Europe’s Crops and Woodland from Pathogens

In the UK, Plant Health Officials are approving a newly developed portable DNA testing device for disease diagnosis. They are checking for ash dieback, the spore-borne disease caused by the fungus Chalara fraxinea which, according to the UK Forestry Commission, has infected more than 330 sites in the UK and resulted in the destruction of tens of thousands of young trees. A sample of infected bark is taken from an ash tree and prepared in a manner which can amplify and detect DNA from the organism. The result is available within minutes rather than the days it would have taken if the sample had been sent for laboratory analysis. Since speed is of critical importance in diagnosing such disease outbreaks, this is a major step forward.

The development of the Genie II portable DNA device was one of the several advances achieved by Q-DETECT, a three-year research project from the European Commission which started in 2010 with the support of European Union (EU) funding, to pioneer simple, user-friendly methods of detecting and monitoring a wide range of plant pests and pathogens that threaten European crop and forestry output.

European rules currently list some hundreds of organisms that are subject to quarantine control. They include, for example, viruses, bacteria, fungi, insects and nematodes (roundworms) and they are estimated to cost Europe billions of Euros every year. Given a chance, these pests and pathogens spread rapidly, so speedy detection and response are vital. Bringing together 15 partner organisations - not only from Europe but also, reflecting the international significance and scope of the issue, Peru and China as well - the Q-DETECT project faced a complex challenge. Not only did it have to develop detection methods which were easy to use in situ, capable of providing reliable and quick results, but it also had to confront the reality that the sheer variety of quarantine plant pests or pathogens to be guarded against meant that no single detection method would be sufficient. A whole arsenal of weapons was required.

In addition to the portable DNA testing, one of the areas the Q-DETECT researchers focused on was using the sense of smell to ‘sniff out’ contamination by plant pests, developing devices such as electronic noses or laser-based spectroscopes to detect the volatile compounds known to be emitted by plants in response to infection.

Remote imaging provided another productive avenue of research for Q-DETECT. Seen through the near infrared part of the spectrum, for example, diseased or damaged vegetation is much less reflective than healthy crops. As Q-DETECT’s project coordinator, Dr Neil Boonham of the UK’s Food and Environment Research Agency points out, this approach has been made all the more relevant as a result of the emerging availability of unmanned high-altitude vehicles, such as one recently developed by Rutherford Appleton Laboratory, one of the Q-DETECT partners.

Acoustic detection was a third method investigated by the project, with the development of devices carefully tuned to identify the distinctive sounds made by various wood-boring insects including the Asian Longhorn Beetle. Finally, Q-DETECT also developed the use of physical traps to capture and monitor pests including ‘smart traps’ able to remotely record and transmit images of what is caught.

Some of the techniques developed by Q-DETECT are already available for use or close to being so, such as portable DNA testing. Others, such as laser spectroscopy, require further research.

The ultimate aim of Q-DETECT was not just to develop the tools, says Dr Boonham. It was also to model the inspection processes themselves in order to provide detailed guidance on how the new techniques could practically be used by inspectors in their day-to-day work. “If sniffing techniques were used, for example, how would they be used? At what point in the chain? This was an important part of the work, moving from blue-sky thought to real application,” Dr Boonham emphasizes.

Sources: Environmental Technology