Tuesday, October 29, 2013

Study Shows Specific Technologies Rapid Method is Faster than bioMérieux BacT/ALERT at Detecting Pathogenic Yeasts

During IDWeek, the Cleveland Clinic presented results of a study demonstrating identification of pathogenic yeasts with Specific Technologies blood culture system with 97% accuracy 4 times faster (2 days sooner) than current standard practice.

Multiple yeast species were tested in blood to determine the speed and accuracy of identification. Detection of microorganisms in blood specimens using the Specific Technologies system was compared with the bioMérieux BacT/ALERT® system.  The Cleveland Clinic study found that the metabolic sensor array detected yeasts 15% faster than the BacT/ALERT® system, and simultaneously provided species identification with 97.5% sensitivity.  The BacT/ALERT system simply detects the presence of microorganisms, and requires 2 additional days to identify the yeast by current standard practice.

Specific Technologies system is a rapid, low cost method to detect and identify microorganisms during culture.  The system combines incubation, detection, and identification into a single step, cutting the time to identification while lowering lab labor and equipment cost compared to current practice.

Without requiring any additional instrument or processing steps, the metabolic sensor system can deliver culture results before molecular and mass spectrometry (MALDI) methods even start.

Sepsis is the 10th leading cause of death, responsible for 11% of ICU admissions, with a mortality rate estimated at 28% to 50%, adding up to $50K costs per patient. To diagnose sepsis, more than 150 million blood cultures are performed globally each year.  Time is of the essence, survival rates decrease every hour without effective antibiotic treatment.  Current clinical practice typically takes 2 to 3 days to identify an effective antibiotic treatment.

Ray Martino COO of Specific Technologies commented, "During growth in culture, yeast produce small metabolic volatiles unique to each species and strain.  The Specific Technologies system for identifying the microorganism from its metabolomic signature is an exciting new technology that can save precious hours critical in sepsis diagnosis and treatment."

IDWeek offers healthcare professionals in infectious diseases and related disciplines unparalleled access to credible research and innovative practitioners; more than 5,500 professionals from more than 80 countries attend. IDWeek was held earlier in the month in the Moscone Convention Center San Francisco.

About Specific Technologies

Specific Technologies has developed in vitro diagnostic systems for rapid identification of microorganisms to diagnose infections that lead to serious medical conditions including sepsis. The company's unique, patented, metabolomic signature technology identifies microorganisms during culture growth before existing technologies based on molecular or chemical tests can be deployed resulting in faster diagnosis with less labor and no additional instruments. Specific Technologies is located in Mountain View, CA.

Gambia: Health Workers Trained On Rapid Diagnostic Test

The Central River Regional Health Management Team recently concluded a three-day training workshop for village health workers on the use of the Rapid Diagnostic Test (RDT), which closing ceremony was held at the Regional Health Resource Centre in Bansang, Upper Fulladu West district. The Global Fund, through the National Malaria Control Program (NMCP), funded the training.

Speaking at the closing ceremony, the regional health director, Jankoba Jabbie, while underscoring the importance of the training, emphasized that the village health workers are the first point of contacts; hence, he maintained, exposing them to such training would further equip them with effective ways of diagnosing and reading test results.

He revealed that the purpose of training was to educate the trainees on why RDTs are important for malaria control. He therefore urged the participants to take up the training seriously as it would help them with the skills and knowledge on Rapid Diagnostic Test (RDT).

The regional principal nursing officer, Ebba Secka, said the training would also give an insight into ways and means of improving on access to services and treatment of malaria; as one of the indicators of Global Fund. He noted that the training would not only introduce the participants to rapid diagnostic test but also how to use a finger prick blood sample.

Secka disclosed that a lot of achievements have been registered in preventing and controlling malaria in The Gambia but however pointed out that still a lot more need to be done in many areas such as access to effective anti-malaria drugs. Malaria prevention and control, the regional principal nursing officer went on, requires collaborative efforts from all.

The topics discussed include introduction to Rapid Diagnostic Test (RDT), importance of RDP in malaria control, materials needed in making an RDT test, how to use RDT, malaria rapid diagnostic test, how to record test results and how to read test results among others.

Monday, October 28, 2013

Abaxis and LamdaGen Collaborate on Infectious Disease/Clinical Biosensor

Abaxis, Inc., a medical products company manufacturing point-of-care blood instrumentation and consumables to the medical, research and veterinary markets, and privately-held LamdaGen Corporation, an optical biosensor company, announced today an R&D agreement to integrate LamdaGen's high-sensitivity Plasmonic ELISA technology on the Abaxis Piccolo and VetScan rotors.  System feasibility testing is currently underway.

LamdaGen's patented biosensor platform is based upon LSPR (Localized Surface Plasmon Resonance) and provides rapid, quantitative diagnostic results with broad dynamic range and detection levels in the femtomolar range.

"We believe that LamdaGen's technology will provide a unique opportunity for Abaxis to integrate a high sensitivity immuno-based system onto our existing rotor-based platforms. This would allow us to provide both our existing clinical chemistry menu together with a wide range of high-sensitivity immunoassays, all within the scope of our present designs. If proven viable, both medical and veterinary customers will be able to simultaneously analyze for chemistry parameters as well as for infectious disease, hormones and a wide range of other markers on the same rotor," commented Clint Severson, Chief Executive Officer of Abaxis.  "The ability to unify both diagnostic systems onto our existing rotor will greatly expand Abaxis' global diagnostic offerings."

"Abaxis is a leader in the POC industry, and we are very excited to collaborate with them in shaping the future of diagnostic testing," added Randy Storer, Chief Executive Officer of LamdaGen.

Northern Michigan University and Micro Imaging Technology to Collaborate on Rapid Detection of Staph and MRSA Pathogens

Micro Imaging Technology, Inc. announced that it will collaborate with the Northern Michigan University (NMU) Department of Biology to expand MIT’s technology to identify and differentiate Staphylococcus aureus (S. aureus) and Methicillin Resistant Staphylococcus aureus (MRSA). The goal of the strategic research with NMU is to rapidly and cost-effectively identify these two particular healthcare threats using the MIT 1000 System, a bacterial cell based identification system that can identify pathogenic bacteria in three minutes (average) at significant cost savings per test.

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, Ph.D., assistant professor at the Northern Michigan University Department of Biology, will direct the NMU portion of the research at his laboratory in Marquette, MI. Sharp received a B.S. at Western Michigan University in 1998 and his Ph.D. in Biological Sciences at the Mount Sinai School of Medicine of New York University in 2006. His initial research in this collaboration will focus 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, is the program director of the effort and will lead MIT’s team in the collaboration. He received his Ph.D. in Physics from Purdue University in 1983. Haavig was instrumental in developing the MIT 1000, a stand-alone, rapid laser based bacteria detection and identification technology that can detect pathogenic bacteria and complete an identifying test in less than three minutes (average) at significant cost savings per test.

“We are extremely pleased to be working with Dr. Sharp and his staff on this project,” Haavig said. ”We are confident that this collaborative effort will be highly successful and the result of our teamwork and the clinical implications for this technology may very well prove to be immeasurable.”

PassPork - A New EU Food Safety Project for the Rapid Detection of Pathogens

Foodborne pathogens in fresh and processed meat products pose a serious threat to the health of consumers, as well as an additional burden on healthcare systems. In today’s meat supply chain, products may reach consumers in geographically dispersed markets within two to three days, thus making rapid and accurate pathogen detection technologies key to protecting public health and ensuring “business as usual” in the meat industry.

Within the European meat sector the pork industry is crucial both in terms of consumption and in terms of its commercial importance; pork is the most produced and consumed meat in Europe (51%), as well as the most exported. According to FaoStat, pigmeat supply in the EU in 2007 was estimated at over 21 Million tonnes, with pigmeat export reaching a total value of over 10 billion Euros in 2009. Despite these positive figures, pork is also responsible for a higher number of verified outbreaks per year, comparing to beef or bovine meat. These outbreaks are due to certain specific pathogens or serotypes, the most important of which are Salmonella, Yersina, Listeria and Campylobacter which represent practically all verified pork-associated infections reported in 2007.

The purpose of the PassPork project is to develop a device for identifying particular key pathogens in pork meat. The nominated solution will be an analyzer that will utilise a combination of recent advances in immunochromatography and optical scanner technologies, together with specific monoclonal antibodies with high affinity to the target pathogens (Salmonella, Yersina, Listeria and Campylobacter), to allow the simultaneous, rapid and accurate detection of the key pathogens in the pork industry. This combination of technologies will improve limit of detection. This will allow meat producers, such as abattoirs and meat-processors, to immediately take appropriate remedial action, significantly reducing risk of cross contamination and the possibility of pathogens entering the food chain.

Within the European meat sector the pork industry is crucial in terms of consumption and commercial importance; pork is the most produced and consumed meat in Europe (51%), as well as the most exported. However, pork is also responsible for a high number of verified outbreaks per year, with Salmonella, Yersinia, Listeria and Campylobacter representing practically all verified pork-associated infections in the EU in recent years. While large enterprises in the pork industry may be able to afford the regular application of expensive tests; for SMEs, which account for 94% of businesses in the European meat industry, these methods are mostly beyond economic reach, thus impeding their capability to comply with strict regulations. Consequently, Small producers in the pork industry are losing competitive advantages to larger and foreign competitors with the total number of businesses in the industry dropping by 1% a year. There is a clear need for an affordable solution for reliable pathogen detection which can be applied in Critical Control Points in small businesses in the pork industry.

The main objective of PassPork is to develop, validate and test an affordable, robust, rapid and reliable multi-pathogen detector for use by non-technical staff in the pork industry. The device will build upon a combination of immuno-chromatography, fluorescence labelling and optical scanner technologies, together with specific monoclonal antibodies, which will reach detection limit in the range of 10-100cfu/ml. The final product, a rapid pre-screening device for identifying Salmonella, Yersina, Listeria and Campylobacter in pork meat, will be manufactured and distributed by the projects SMEs to businesses throughout the pork supply chain. With expected market price of 500/device and 3/test, the consortium estimated sales of approx. 10M after 5 years in the market.

The specific objectives of the project are as follows:

1. Identification, screening and production of specific antibodies for Salmonella, Yersina, Listeria and Campylobacter.
2. Design of a compatible meat sampling method and treatment protocol adapted to field conditions.
3. Development of a reliable detection system.
4. Development of a rapid and robust fluorescence optical reader, corresponding to lateral flow assays for the detection of four pathogens of importance in the porcine industry.
5. Development of simple and fully-integrated device.
6. Lab validation and field testing of the final prototype.

Wednesday, October 23, 2013

LIGHTNING MVP ICON™ Rapid Solution for Environmental Monitoring

With the recent introduction of the Food Safety Modernization Act (FSMA), regulatory guidelines for controlling food hazards have become increasingly more stringent. For food manufacturers, ensuring products are free from potentially hazardous elements such as pathogenic bacteria often starts with ensuring these organisms are not present in the manufacturing environment or equipment. In fact, FSMA requires that manufacturers diligently establish, evaluate and document preventative controls and their efficacy to ensure a safe production environment. This can best be accomplished through the implementation of a comprehensive environmental monitoring program, including elements of all of the following methods.

Targeted Pathogen Detection: The most specific method is direct pathogen detection. Product contamination with pathogens frequently occurs after processing through contact with environmental surfaces. As such, a primary concern for most food manufacturers is preventing the establishment of these organisms anywhere in the plant. While highly targeted to detect specific organisms such as Listeria or Salmonella that present a public health risk, these methods require one to five days after sampling to provide results.

Quantifying Microbial Levels: Plate count methods, either traditional agar or rapid methods, provide a quantitative estimate of key indicator organisms, such as total aerobic bacteria, yeasts and molds or coliforms. Tracking these counts provides a view into a sanitation program’s ability to control the microbiological population of the manufacturing environment. While impossible to eliminate, keeping the population relatively low reduces the likelihood of pathogens becoming established. Similar to pathogen detection methods, these results are available in one to five days after sampling.

ATP Detection: Ensuring proper cleaning and sanitation of the environment and equipment upfront is a critical step in controlling the microbiological population in the plant and preventing the establishment of pathogens in the environment. Adenosine triphosphate (ATP) is present in all living organisms and most foods, making it an ideal candidate for environmental testing methods targeting both microorganisms and food residues. ATP is easily detected and, while the source of the ATP cannot be determined, the level of ATP present on a surface is a direct indicator of the cleanliness of the surface. Additionally, ATP test results are available instantly, allowing problem areas to be addressed immediately. Trending ATP levels over time can help improve the effectiveness of any sanitation program.

An innovative new tool from BioControl Systems that monitors ATP levels and helps manage a company’s sanitation program is the LIGHTNING MVP ICON™ and Dashboard software. The MVP ICON and Dashboard software was developed to help food manufacturers manage their sanitation programs and comply with Hazard Analysis and Critical Control Points (HACCP) and FSMA requirements, as well as their own internal Sanitation Standard Operating Procedures (SSOPs). Quality teams can utilize the software’s program management capabilities to proactively monitor key performance indicators and perform trending analysis to evaluate whether cleaning and sanitation efforts are effective. The innovative dashboard interface provides insight into vital criteria for HACCP and hygiene monitoring programs, such as automatic identification of problem areas within the facility, whether failed results have been re-cleaned and re-tested and if the appropriate number of samples have been tested. In-depth analysis and reporting capabilities reveal if a sanitation program has improved over time or where vulnerabilities lie to proactively improve cleaning procedures. These enhanced reporting capabilities, along with the advanced design of the new MVP ICON instrument, have made it the go-to system for many food manufacturers.

When asked to describe their experiences with the MVP ICON, a quality control professional from a leading U.S. ingredient manufacturer states, “The MVP ICON has been a huge asset to our facilities. When we incorporated the MVP ICON into our program, our employees had a first-hand view of how it works and how quickly the results become available. It has also made them even more aware of our cleaning processes and why it is important to follow them.” This newly designed piece of equipment utilizes the latest advancements in technology to provide a simplified user interface and smaller, lightweight instrument. Featuring the ability to randomize test points, create customized sample plans and track the re-cleaning and re-testing of failed test points, it is the ideal tool for ensuring clean surfaces before beginning production.

    A successful environmental monitoring program incorporates a comprehensive, multi-tiered approach to maintaining a low-risk manufacturing environment. Targeted pathogen detection, quantification of key groups of indicator organisms and rapid ATP detection to determine surface cleanliness combine to reduce the potential risk of product contamination in a manufacturing facility.

Tuesday, October 22, 2013

Microbiologics Announces New Molecular Products Division

Microbiologics, a leading global manufacturer of prepared quality control microorganism products, has formed a new molecular products division with the acquisition of the assets of Phthisis Diagnostics, including their patented process for designing and manufacturing molecular standards. These molecular standards are specifically designed to be used as performance controls for a wide variety of molecular instruments and assays in pharmaceutical, food safety and clinical testing.

Brad Goskowicz, Microbiologics Chief Executive Officers, commented, “These innovative molecular standards will lay the foundation for Microbiologics to design and launch a broad collection of molecular products and custom services. It will expand our range of biomaterials to include viruses and other hard to grow microorganisms.” Microbiologics is currently the global leader in producing an array of lyophilized microorganism products in convenient, ready-to-use formats for quality control of microbiological testing.

Joining the Microbiologics senior management team is Brian Beck, PhD, Vice President of Molecular Products and Services. Doctor Beck earned his PhD in Bacteriology from the University of Wisconsin-Madison and has spent the last ten years at ATCC in Manassas, Virginia where he managed the Microbiology Collection. “I’m quite excited to extend what Microbiologics has done with their culture business and bring that same practical, user-friendly type of format to the molecular diagnostic business,” Beck said.

To commence their new initiative in molecular sciences, Microbiologics will be exhibiting at the upcoming Association for Molecular Pathology (AMP) 2013 Annual Meeting from November 14-16, 2013 in Phoenix, Arizona. Visit them at booth #231 to learn more.

About Microbiologics:

Microbiologics manufactures cost‐effective, reliable, and easy-to-use microorganism preparations for quality control testing in microbiology laboratories across multiple disciplines including clinical, food, pharmaceutical and cosmetic, medical device, water and environmental. Microbiologics is an FDA-registered establishment and has received ISO 9001 and ISO 13485 certifications, as well as ISO 17025 and ISO Guide 34 accreditations. Currently, Microbiologics has an international distribution network of over 140 companies throughout the world.

For additional information, please contact Microbiologics or visit their website:

Microbiologics, Inc.
Customer Service
Phone: 320.253.1640
Email: info@microbiologics.com

Wednesday, October 09, 2013

PathoGenetix Research Shows Rapid Identification of Multiple Salmonella Serovars in Food Samples

New research presented at the 4th American Society for Microbiology (ASM) Conference on Salmonella today demonstrates culture-independent identification and strain typing of multiple Salmonella serotypes directly from enriched food samples using PathoGenetix’s Genome Sequence Scanning (GSS) technology.

PathoGenetix, Inc., a commercial-stage developer of an automated system for rapid bacterial identification, will present new research today demonstrating the use of Genome Sequence Scanning™ (GSS™) technology to confirm and identify multiple serovars of Salmonella in enriched food samples in less than five hours. The data, included in a poster presentation at the 4th American Society for Microbiology (ASM) Conference on Salmonella in Boston, add to a growing body of research demonstrating the use of PathoGenetix’s proprietary genotyping technology to reliably identify pathogens of public health and food safety significance, including Salmonella and Shiga toxin-producing E. coli (STECs).

The study evaluated the use of GSS in molecular serotyping and sub-typing of Salmonella, and as a tool for simultaneous detection of multiple serovars of Salmonella in complex mixtures. The study results show that GSS can be used to infer the serotype of an unknown Salmonella strain, based on the location of the strain on the GSS tree and the identity of its neighbors. The results also demonstrate the ability of GSS to shorten the time to just five hours for pathogen subtyping and serotype determination from an enriched food sample, including those containing multiple serovars.

Because Genome Sequence Scanning is culture independent, and fully automated from sample preparation to final report, the technology greatly reduces the time, complexity and skill required when compared to other molecular and next generation sequencing (NGS) identification approaches. The strain-type information provided by GSS is comparable to pulsed field gel electrophoresis (PFGE), the current standard for pathogen typing in foodborne outbreak investigation and response. As a result, GSS offers a powerful new tool for epidemiological investigations and outbreak monitoring that can enable quicker decisions affecting food safety and public health. The GSS technology will be commercially available in 2014 in the RESOLUTION™ Microbial Genotyping System.

According to the American Society of Microbiology, Salmonella infections continue to be a major public health problem in many parts of the world. In the U.S., Salmonella is the leading cause of foodborne illnesses leading to hospitalization and death. The Salmonella genus has more than 2,500 serotypes or serovars, based on the antigens that the organism presents on its surface. In the U.S., Salmonella Enteritidis and Salmonella Typhimurium are the most common serotypes, accounting for half of all Salmonella infections in people.

The 4th ASM Conference on Salmonella brings together scientists from a variety of backgrounds to present the most recent research and discoveries in the field, including new approaches in diagnosis, treatment and prevention of infections. PathoGenetix’s research, entitled “Evaluation of Genome Sequence Scanning technology for molecular (sub)-serotyping of Salmonella and simultaneous detection of multiple Salmonella serovars in complex mixtures” is being presented in a poster session on October 9.

The research tested the strain typing capability of GSS using more than 400 strains and genome sequences representing the most frequently encountered Salmonella serovars from food products associated with human illness. The results show that Genome Sequence Scanning clustered Salmonella strains into serovar-specific branches on the GSS tree, clearly demarcating the major serovars from each other. Polyphyletic lineage serovars like S. Newport and S. Saintpaul formed more than one distinctly separated branch on the tree, reflecting the genetic heterogeneity within these serovars. GSS assigned correct serovar designations to strains untypeable by conventional serotyping and to antigenic variants of serovars based on genetic similarity. Genome Sequence Scanning also reliably detected the presence of up to three different serovars of Salmonella in the presence of complex background flora, demonstrating the technology’s ability to provide strain information directly from complex mixtures.

About PathoGenetix™, Inc.

PathoGenetix, Inc. is a commercial-stage developer of an automated system for rapid bacterial identification from complex samples. PathoGenetix is a venture-backed company that has received more than $50 million in technology development funding from the Department of Homeland Security. The core Genome Sequence Scanning™ (GSS™) technology analyzes DNA from an enriched biological sample—without the need for a cultured isolate—and provides results in five hours. GSS has broad applicability in food safety, industrial microbiology, and clinical diagnostics and research. The GSS technology will be available in the RESOLUTION™ Microbial Genotyping System in 2014 for use in food safety testing and foodborne illness outbreak investigations.

Sunday, October 06, 2013

Specific Technologies’ Metabolic Sensor-Based Blood Culture System Rapidly Identifies Bacterial Strains

Today at IDWeek, Dr. Paul Rhodes, CEO of Specific Technologies, presented results of a study performed at Stanford University Medical Center, demonstrating rapid detection and simultaneous identification of bacterial species and strains during blood and plate culture.
The Specific Technologies' rapid, low cost, blood culture system based upon its groundbreaking metabolic sensor system promises a new, powerful diagnostic tool for hospital epidemiologists in the identification and disruption of outbreaks in near real-time, which is not presently possible.

The U.S. Department of Health and Human Services (HHS) has identified the reduction of healthcare associated infections (HAIs) as an agency priority goal. According to the HHS at any given time, about 1 in every 20 inpatients has an infection related to hospital care. These infections cost the U.S. health care system billions of dollars each year and lead to the loss of tens of thousands of lives.

In the study reported at IDWeek, over 1600 individual experiments were performed with a minimum of 12 technical replicates per strain. 17 different species of bacteria tested were identified with overall 95% accuracy over 1631 trials. Strain identification accuracy varied by species, but generally exceeded 90% accuracy.

The study showed remarkable correspondence with genetic classification. The Specific Technologies system grouped genetically related strains together, further supporting the studies conclusion that the metabolomic fingerprint of bacteria is strain-specific.

Specific Technologies has developed a system to identify microorganisms by their metabolomic signature as they grow in culture before molecular methods can even begin. Most molecular methods start after culture and require expensive instruments, additional process and labor. The Specific Technologies system is inexpensive, and can be integrated into existing lab procedures, providing identification of species and strain while lowering lab labor and equipment cost.

IDWeek offers healthcare professionals in infectious diseases and related disciplines unparalleled access to credible research and innovative practitioners; more than 5,500 professionals from more than 80 countries attend. IDWeek is being held October 2-6, 2013 in the Moscone Convention Center San Francisco.

A Rapid, Paper-Based Diagnostic Test for Tuberculosis

In a study published in the journal Science and Technology of Advanced Materials (STAM), researchers in Taiwan describe a simple, color-based diagnostic approach with the potential to detect target DNA sequences found in TB-causing mycobacteria – in just a fraction of the time required for established diagnostic tests.

More than a century after the identification of organisms that cause tuberculosis (TB), this disease remains a global public health challenge. According to World Health Organization estimates, there were 8.7 million new cases in 2011 and 1.4 million deaths. Most new cases occur in developing countries that lack the facilities and trained personnel required for early detection of TB.

In a new study, published in the journal Science and Technology of Advanced Materials (STAM), researchers in Taiwan describe a simple, color-based diagnostic approach with the potential to detect target DNA sequences found in TB-causing mycobacteria – in just a fraction of the time required for established diagnostic tests.

The standard method for TB detection in a clinical setting involves culturing the Mycobacterium tuberculosis bacillus, which requires 3-6 weeks to grow on solid culture media or 9-16 days in rapid liquid culture media. A faster alternative is the polymerase chain reaction (PCR) technology. However, it is still too slow (turnaround time 2-5 hours) and requires sophisticated infrastructure and trained personnel that might be unavailable in developing countries.

In their STAM paper, Tsung-Ting Tsai and colleagues employed gold nanoparticles and microfluidic paper-based analytical devices to achieve rapid diagnosis without the need for complex and time-consuming laboratory processes. They easily detected TB mycobacterium target sequences, and the turnaround time was approximately 1 hour after the human DNA was extracted from patients.

Although the authors are still optimizing their technology, they already believe that it will result in "affordable, sensitive, specific, user-friendly, rapid and robust, equipment-free, and highly end-user-deliverable diagnostic applications".

The paper is titled "Paper-based tuberculosis diagnostic devices with colorimetric gold nanoparticles."

Friday, October 04, 2013

Argos Therapeutics Earns Global Regulatory Approval with Eurofins Lancaster Laboratories’ Rapid Mycoplasma MilliPROBE® Assay

Argos Therapeutics, a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer and infectious diseases using its ArcelisTM technology platform, and Eurofins Lancaster Laboratories, a global bio/pharmaceutical GMP product testing laboratory, today announced regulatory approval from authorities in the US, UK, Canada, Czech Republic and Israel for rapid mycoplasma testing of an autologous cell-based therapy produced by Argos Therapeutics.

Eurofins Lancaster Laboratories validated the use of the MilliPROBE® system, marketed by EMD Millipore, to test samples of the autologous immunotherapy currently in clinical trials for renal cell carcinoma. The assay can deliver same- day preliminary results compared to 28 days required for the standard compendial method, thereby eliminating the need to conditionally release cell- based products that require rapid turnaround time.

“Mycoplasma contamination of cell lines used to produce biopharmaceutical products can disrupt cellular growth and metabolism and alter gene expression, leading to decreased product quantity and quality,” says Jeri Ann Boose, Ph.D., Director of Biopharmaceutical Services at Eurofins Lancaster Laboratories. “World-wide regulatory agencies require that products produced in cell substrates be tested to ensure the absence of mycoplasma contamination. The compendial
method requires 28 days and is therefore not suitable for obtaining the rapid lot release testing results needed for biopharmaceutical products that have short half-lives or for which there is high market demand.”

For the FDA submission, Argos Therapeutics described how the test would be used, listed the validation standards for the test (USP <1223> and USP<1127>, EP 2.6.7, EP 2.6.21 and EP 5.1.6), summarized the Eurofins Lancaster Laboratories validation results for the MilliPROBE® system as well as the matrix interference testing performed at Eurofins Lancaster Laboratories for the Argos product. A summary of work performed was submitted to regulatory authorities in Canada, Israel, Spain, Czech Republic, Italy and the UK, along with the Eurofins Lancaster Laboratories interference testing summary.

The MilliPROBE® system uses Real-Time Transcription-Mediated Amplification (TMA) technology to detect targeted microbial contamination within hours compared to the weeks usually required to generate results using traditional culture-based technology. Faster detection allows biopharmaceutical manufacturers to take corrective action earlier in the production process, which reduces downstream processing risks, optimizes product yields and improves final product quality. The MilliPROBE® assay probe system was designed by sequence analysis to detect Mycoplasma, Spiroplasma and Acholeplasma using a multiplex of conserved rRNA sequences in non-clinical applications. EMD Millipore has validated the non-clinical specificity and sensitivity of the system using 13 key mycoplasma species, which include the eight species specified in EP 2.6.7.

“In addition to accelerating time to results, the MilliPROBE® system validated by Eurofins Lancaster Laboratories offers other important benefits,” described Fran Hutson, head of BioMonitoring North America sales and marketing, EMD Millipore. “The system can process up to 20 mL of a sample, making it preferable to PCR and RT-PCR methods typically limited to testing sample volumes that are 1-2 mL. The membrane-based sample preparation device effectively removes inhibitory substances that can interfere with nucleic acid amplification technologies.”

Tuesday, October 01, 2013

Study Demonstrates Significant Clinical and Economic Impact of Nanosphere's Verigene Blood Culture Test

Nanosphere, Inc., a company enhancing medicine through targeted molecular diagnostics, today announced publication of a study in the Journal of Clinical Microbiology that evaluated the clinical and economic impact of rapid bacterial identification and antibiotic resistance determination by the Verigene® Gram-Positive Blood Culture (BC-GP) Test for patients with enterococcal bacteremia, which can lead to sepsis.

The manuscript reports that following implementation of Verigene BC-GP for the detection of bloodstream infections caused by Enterococcus, there was an average per patient reduction in hospital length of stay of 21.7 days, and an average savings of $60,729 in hospital costs.

In addition, there was a significant decrease in the average time it took for patients to receive appropriate treatment (23.4 hours), and an even greater reduction in time (31.1 hours) for patients with vancomycin-resistant Enterococcus (VRE) bacteremia -- an especially deadly cause of bloodstream infection and sepsis. Importantly, Verigene results enabled clinicians to immediately select appropriate therapy for 100 percent of patients with vancomycin-susceptible Enterococcus (VSE) bacteremia, potentially resulting in further cost savings.

Finally, there was complete agreement between BC-GP test results and those derived from conventional culture and susceptibility methods, along with a significant reduction in time to reporting of test results (47.5 hours).

"Minimizing time to appropriate antimicrobial therapy permits more effective targeting of the causative pathogens, decreases antimicrobial exposure, and can result in cost avoidance," said Yvette McCarter, PhD, D(ABMM), Director of Clinical Microbiology, University of Florida Health Jacksonville. "Utilization of assays such as the BC-GP test, supported by collaboration between microbiology and pharmacy, can optimize antimicrobial use, decrease unnecessary length of stay and costs, and improve time to appropriate therapy."

"We are very pleased with the study results as they demonstrate the significant clinical and economic value of Verigene in equipping antimicrobial stewardship teams with the information they need to recommend the best course of treatment for their patients," said Michael McGarrity, Nanosphere's president and chief executive officer. "A recent CDC landmark report highlighted the importance of improved antibiotic stewardship and the implementation of new diagnostic tests to aid in addressing the problem of antibiotic-resistant infections. As demonstrated in this study, Verigene has the ability to help hospitals meet this critical need, and the potential to improve patient outcomes, optimize antibiotic therapy, reduce costs and save lives."

Published ahead of print under the title "A Stewardship Approach to Optimize Antimicrobial Therapy Through Use of a Rapid Microarray Assay on Blood Cultures Positive with Enterococcus species," the study was performed at University of Florida Health Jacksonville. It is the first study to evaluate the clinical and economic impact of using rapid microarray technology on optimizing therapy for enterococcal bacteria.

About Verigene® Gram-Positive Blood Culture Nucleic Acid Test
The Verigene® Gram-Positive Blood Culture Nucleic Acid (BC-GP) Test performed using the sample-to-result Verigene System is a qualitative, multiplexed in vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria which may cause bloodstream infection. These include the following organisms and antibiotic resistance markers:

Staphylococcus spp.
Streptococcus spp.
Listeria spp.
Enterococcus faecalis
Enterococcus faecium
Staphylococcus aureus
Staphylococcus epidermidis
Staphylococcus lugdunensis
Streptococcus pneumoniae
Streptococcus anginosus group
Streptococcus agalactiae
Streptococcus pyogenes


mecA gene (methicillin resistance)
vanA and vanB genes (vancomycin resistance)

The Verigene BC-GP Test is performed directly on blood culture bottles identified as positive by a continuous monitoring blood culture system and which contain gram-positive bacteria. The Verigene BC-GP Test is indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial bloodstream infections; however, it is not to be used to monitor these infections. Sub-culturing of positive blood cultures is necessary to recover organisms for susceptibility testing, identify organisms not detected by the Verigene BC-GP Test, differentiate mixed growth, associate antimicrobial resistance marker genes to a specific organism, or for epidemiological typing.

About the Verigene® System

The Verigene System uses core proprietary gold nanoparticle chemistry to offer highly sensitive, highly specific molecular diagnostic results through low-cost multiplexing. The Verigene System rapidly and accurately detects infectious pathogens and drug resistance markers by mapping the genome of a particular bacterium. Currently, Verigene assays target infections of the bloodstream, respiratory tract and gastrointestinal tract. The System also offers additional capabilities in cancer, cardiovascular disease and autoimmune disease. The information gathered from Verigene enables clinicians to identify diseases earlier and make informed patient treatment decisions more quickly, which may result in improved patient outcomes, reduced costs, optimized antibiotic therapy, reduced spread of antibiotic resistance and potentially, saved lives.

T2 Biosystems to Exhibit Rapid and Sensitive Assay for Sepsis Pathogens

T2 Biosystems, a company developing direct detection products enabling superior diagnostics, today announced that it will provide demonstrations of its flagship test, T2Candida®, for the rapid and sensitive identification of species-specific Candida directly from whole blood, on its T2Dx® instrument at Booth #922 at IDWeek 2013, October 2-6, 2013, in San Francisco, CA. Without the need for blood culture, T2Candida directly detects five species of Candida in a whole blood specimen in approximately 3 hours with a limit of detection as low as 1 CFU/mL. The T2Candida test is currently being evaluated in a pivotal clinical trial, and results will be available in the first half of 2014.

T2Candida has the potential to address a significant health threat as described in the recently published report on Antimicrobial Resistant Threats in the United States, 2013 by the U.S. Department of Health and Human Services through the Centers for Disease Control and Prevention, which places Candida in the Serious Hazard Level category. As a Serious Threat, the CDC warns that ongoing monitoring and prevention is necessary to prevent Candida from becoming an Urgent Hazard.

The T2Candida assay is run on the T2Dx instrument, which utilizes the Company’s T2MR® technology. T2MR uses miniaturized magnetic resonance to directly detect any immunodiagnostic, molecular or hemostasis target from complex clinical samples, such as whole blood, plasma, serum, sputum and urine.

About Candidemia/Sepsis

Sepsis is a potentially life-threatening illness caused by the body’s severe reaction to infection by bacteria, fungi, viruses or parasites. It is one of the top 10 leading causes of death in the United States, and each hour of delayed treatment increases the mortality of these patients by 8%. Candida is a fungal pathogen known to cause sepsis, and it is associated with approximately 100,000 cases of candidemia in the U.S. annually, making it the fourth-leading cause of hospital-acquired infections. Currently, candidemia has a greater than 40% mortality rate, which can be reduced to 11% with appropriate treatment within 12 hours of presentation. Current detection methods rely on blood culture, a process that can take two to five days before identifying a Candida infection. The T2Candida® test is able to detect species-specific Candida directly from whole blood without the limits experienced with optical detection technology, even at low copy numbers, and provide results in approximately three hours.

About T2 Biosystems

T2 Biosystems is disrupting the landscape of clinical diagnostics with T2MR®, the Company’s proprietary magnetic biosensor detector which provides sensitive, accurate and rapid assay results. The Company’s products are capable of detecting molecular or immunoassay targets as well as hemostasis biomarkers directly from unpurified clinical samples in hospitals, labs and physicians’ offices.

USDA and PathoGenetix to Evaluate Strain Typing System on Salmonella and E. coli

PathoGenetix™ and the U.S. Department of Agriculture’s Agricultural Research Service (USDA-ARS) have agreed to collaborate on an evaluation of PathoGenetix’s Genome Sequence Scanning technology for use in identifying strains of Shigatoxin-producing E. coli (STECs) and Salmonella enterica, two types of pathogens frequently implicated in foodborne illness outbreaks. The ability to quickly and accurately identify these pathogens, particularly in their most virulent forms, can have significant public health and financial impact for consumers, farmers and ranchers, and the agricultural and food industries.

Under the agreement, USDA-ARS will provide PathoGenetix with genetic information and bacterial strains of E. coli and Salmonella. USDA-ARS and PathoGenetix researchers will analyze the strains, both as isolates and in mixed cultures, using PathoGenetix’s Genome Sequence Scanning™ (GSS™) technology, currently in development for commercial use as the RESOLUTION™ Microbial Genotyping System. Results of the joint analysis will assist USDA-ARS in evaluation of the RESOLUTION System as a platform for rapidly identifying pathogenic Salmonella and E. coli in food samples.

“As we work to deliver a fully automated RESOLUTION System for rapid and effective pathogen strain typing next year, we are pleased to partner with USDA-ARS to demonstrate the speed and effectiveness of the GSS technology, particularly in differentiating the most virulent pathogens that pose the greatest challenges to food safety and public health investigations,” said Ann Merrifield, CEO of PathoGenetix.

Shiga-toxigenic Escherichia coli (STEC) and Salmonella enterica are an important U.S. public health concern, causing an estimated 1.2 million cases of foodborne illness each year. E. coli O157:H7, the most common of the virulent STECs, has been implicated in multiple foodborne illness outbreaks, and six additional STEC serogroups are now considered adulterants in certain beef products. Unlike STEC O157:H7, however, the “Big 6” virulent strains are not easily distinguished using available molecular testing methods. Of the more than 2500 identified strains of Salmonella enterica, 1700 of them are classified as human pathogens belonging to subspecies S. enterica I. Just 20 of these serotypes are responsible for greater than 70% of the illnesses caused by S. enterica subspecies I. Clearly there is a need to be able to rapidly and cost-effectively identify these more virulent strains when present in food products.

PathoGenetix’s GSS technology identifies microbial DNA from complex mixtures or from isolates, and automates the process from sample preparation through data analysis to provide actionable information in five hours. Because GSS scans microbial DNA directly from a mixed culture and does not require a pure culture, it can reduce the time, complexity, skill and cost required for molecular identification and strain typing. The strain type information provided by GSS is comparable to pulsed field gel electrophoresis (PFGE), the current standard for pathogen typing in foodborne outbreak investigation and response. As a result, GSS may enable quicker decisions affecting food safety and public health.

In addition to demonstrating use of GSS to identify pathogens such as Salmonella in enriched food samples in five hours, PathoGenetix research also has shown the use of the technology to differentiate virulent Shiga toxin-producing E. coli (STEC). As a result, the RESOLUTION System also could be used as a confirmatory method for “Big 6” STEC screening assays, and potentially reduce the loss of product associated with false positive results from current STEC screening tests.

Purdue University and Micro Imaging Technology Collaborate on Rapid Detection of Pathogens

Micro Imaging Technology, Inc. announced today a strategic research collaboration with Purdue University to prove the concept of faster, cheaper, and easier pathogen testing for Listeria and Listeria monocytogenes in foods using laser light scattering. The partnership pairs similar laser light scattering technologies developed independently by each contributor to demonstrate the speed and accuracy of using non-biological methods to provide a simple, rapid, and cost-effective solution to food pathogen testing.

Dr. Arun Bhunia, BVSc, PhD, Professor of Food Microbiology at the Purdue University Department of Food Science, will direct the Purdue portion of the research together with Dr. Euiwon Bae, a mechanical engineer, at his facilities in West Lafayette, IN. Prof. Bhunia received his Ph.D. in Food Microbiology at the University of Wyoming. A recent recipient of Purdue's Outstanding Graduate Educator (College of Agriculture), Dr. Bhunia's research has focused on the development of novel detection and diagnostic tools for food borne pathogens employing optical and electrical biosensors, including light scattering based sensors. Dr. Bhunia's group developed Purdue's BARDOT (Bacterial Rapid Detection using Optical scattering Technology,) a colony-based bacterial screening system that very rapidly scans and detects pathogens on culture plates.

Micro Imaging Technology's Chief Scientist, Dr. David Haavig, is the Program Director of the effort and also will lead MIT's efforts in the collaboration. Coincidentally, he received his Ph.D. in Physics from Purdue University in 1983. Dr. Haavig was instrumental in developing the MIT 1000, a bacterial cell based identification system that can identify pathogenic bacteria in three (3) minutes (average) at significant cost savings per test. "The synergy of these two systems for independent detection (BARDOT) and confirmation (MIT 1000) of the presence of pathogens in food is fantastic. This is a win-win program," Dr. Haavig remarked. "It benefits MIT, Purdue and its students, as well as the entirety of the food industry and consumers worldwide. We cannot be more pleased to be working with Dr. Bhunia and his staff."