Wednesday, July 23, 2014

bioMérieux VIRTUO™, the New Generation of Blood Culture System, Is CE-Marked

bioMérieux, a world leader in the field of in vitro diagnostics, announces that VIRTUO(TM), the new generation of BacT/ALERT(R) , has been CE-marked. This uniquely innovative automated blood culture microbial detection system further enriches the offering of the BacT/ALERT(R) product range and is now commercially available in targeted countries that recognize CE marking. The enhanced performance of the system will help laboratories provide rapid results to clinicians to help maximize laboratory efficiency and facilitate better patient outcomes.

VIRTUO(TM) is the first continuously monitoring blood culture microbial detection system to offer "set and forget" loading, allowing personnel with any skill level to load the instrument any time throughout the day and night, thus enabling even more rapid results and improved patient care. With VIRTUO(TM), laboratories minimize hands-on time and maximize laboratory efficiency: when bottles are placed on the conveyor belt of the motion-activated loading bay, the conveyor belt feeds bottles via a carousel into a smart scanning station where the bottle barcodes are read and an image of the labels is captured. The system uses precision robotics to load all bottles into available cells for incubation and determination of a blood stream infection. Following a five-day protocol, negative bottles are automatically discarded into a waste bin.

VIRTUO(TM) offers a faster time to detection versus the current BacT/ALERT(R) due to the inclusion of high fidelity optics and a new detection algorithm which has shown faster detection times on average four hours earlier compared to the BacT/ALERT(R) 3D. This reduction in time to detection facilitates the ability to positively impact patient care.

In line with ever increasing accreditation standards, the new target VIRTUO(TM) system, along with new reagent labeling, enables features to automatically track lot numbers, check for expired bottles and measure the sample volume to help ensure compliance with the collection of the recommended blood volume of 10ml per bottle.

This next generation BacT/ALERT(R) system utilizes proven blood culture reagent bottles for increased recovery of organisms associated with blood stream infections. Currently included in the BacT/ALERT(R) media portfolio are the standard, charcoal based FAN and the new FAN Plus bottles, which use proprietary Adsorbent Polymeric Beads (APB).

"True to bioMérieux's pioneer spirit, VIRTUO(TM) is a highly differentiated solution. It seamlessly integrates the blood culture workflow in order to help laboratories provide efficient and actionable results to the clinicians thus enabling the early introduction of an appropriate antibiotic therapy for achieving a better clinical outcome of septic patients", said Alexandre Mérieux, bioMérieux CEO. "For over 50 years, bioMérieux has developed world-renowned expertise in the fields of infectious diseases and microbiology thanks to major innovations in the areas of pathogen detection, identification, antibiotic susceptibility testing and blood culture, which have led to more rapid and more accurate diagnostics. Rapid detection and identification of microorganisms by clinical microbiology laboratories is of crucial importance for optimal patient treatment, especially in serious infections such as blood stream infections which may progress to severe sepsis."

BacT/ALERT(R) has a large installed base of automated blood culture systems in every region in the world. The BacT/ALERT(R) range of systems makes it possible to meet the needs of all sizes of laboratories due to the flexibility and scalability of the instrument portfolio. The VIRTUO(TM) launch will initially be focused on current customers as bioMérieux's number one priority until the Company comes back to a satisfactory level of bottle media supply.

The combination of substantial operational and capital investments in the Durham (N.C., United States) facility for bottle media production and the launch of this new VIRTUO(TM) instrument demonstrates bioMérieux's commitment to blood culture and the rapid reliable diagnosis of sepsis.

Tuesday, July 22, 2014

Vivione Biosciences Inc. Receives AOAC Certification, Positions Brand for Fast Growth in Food Industry

Vivione Biosciences Inc. (“Vivione”), through its wholly owned subsidiary Vivione Biosciences, LLC, is proud to announce that it has received AOAC (Association of Analytical Communities) certification for its E. coli O157 and Non O157 STEC diagnostic tests for the RAPID-B platform. This is Vivione’s first AOAC certification for its RAPID-B platform, whose technology has the ability to accurately detect a contamination issue in seven hours or less.

“We are extremely pleased to have been awarded this globally recognized certification,” said Kevin Kuykendall, CEO of Vivione. “Our technology is one of the fastest diagnostic tests on the market for E-coli O157 and Non O157 STEC. We believe it represents a new generation of tests for producers looking for increased sensitivity, accuracy and speed, with the added benefit of enumerating the bacterial load. Although we’ve had great interest in our technology over the past two years, now that we have AOAC certification, producers are able to purchase the RAPID-B platform to be used for a variety of applications, from incoming inventory analysis to end product testing.”

The RAPID-B platform offers results in seven hours or less, which is of great significance when comparing it to other diagnostic testing platforms that take 24 hours or more to produce results. These benefits are both economically significant and potentially life-saving. After almost eight years in development with National Center for Toxicological Research, Vivione is excited to finally bring these tests to market with AOAC certification. The AOAC certification is the premiere standard for the food industry, particularly the beef industry. Food producers look for the AOAC standard when selecting new platforms and bacterial contamination tests.

Achieving this milestone, Vivione’s RAPID-B E. coli O157 and Non O157 STEC tests are positioned to become one of the “go-to” tests used within the food industry. More importantly, these tests provide producers with something that they have not had access to prior to today: a test that can deliver increased sensitivity, while also significantly reducing the time needed to receive clear test results. The ability to undertake and report upon a test, beginning with the receipt and preparation of the sample through to the final analysis, in seven hours or less instead of the customary 24, stands to allow food producers to get their products to market faster while reducing potential recall risk.

Azbil BioVigilant and TSI End Patent Dispute

Azbil BioVigilant, Inc., inventors of Instantaneous Microbial Detection™, recently announced that the Company has successfully resolved its dispute with TSI concerning TSI’s U.S. patent number 6,831,279.

Last week, TSI filed a notice with the U.S. Patent and Trademark Office, which in effect, will result in the termination of the patent. In addition, TSI and Azbil BioVigilant jointly filed a request to dismiss TSI’s appeal of the U.S. District Court’s ruling where the underlying claims of TSI’s patent were found to be invalid.

“We are pleased to bring this patent litigation to a conclusion. This ends, once and for all, the threat the suit presented to our customers,” said Aric Meares president and CEO of Azbil BioVigilant.

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

Friday, July 18, 2014

Cornell and NYS Public Health Scientists Speed Up Detection of Foodborne Pathogens

New York is on the front lines of detecting foodborne pathogen outbreaks, thanks to a partnership between public health scientists and Cornell researchers.

Members of the Cornell Food Safety Lab, led by food science professor Martin Wiedmann and research associate Henk den Bakker, are helping the New York State Department of Health (NYSDOH) harness the capabilities and cost efficiencies of next-generation DNA sequencing techniques to rapidly identify strains of salmonella and read the results in a way that could quicken responses to potential outbreaks.

Traditional methods of assessing bacteria samples submitted to public health laboratories, based on pulsed-field gel electrophoresis (PFGE), often do not deliver the level of precision needed to pinpoint specific strains of pathogens, their relationships to each other and whether they share a common origin – vital information when trying to trace the source of illness outbreaks.

For Salmonella enterica serovar Enteritidis, for instance, 85 percent of isolates can be classified into just five PFGE types, and 40 percent belong to one subtype in particular.

“There’s so little variation in the genome, and when there’s an outbreak, it’s almost impossible to differentiate using that method,” den Bakker said.

By sequencing all 4.5 million base pairs of the bacteria’s DNA using single nucleotide polymorphisms (SNPS) in a technique known as rapid whole-genome sequencing, scientists are able to get much more nuanced information.

“This kind of detailed information improves our ability to tell whether outbreaks are isolated, sporadic or part of a cluster, which allows for more thorough epidemiologic investigations,” said NYSDOH collaborator William J. Wolfgang.

The introduction of small, affordable, bench-top, whole-genome sequencing equipment has made it possible for clinical and public health labs to consider adding the technology to their arsenal. The NYSDOH’s Wadsworth Center in Albany, New York, was one of the first public health labs to make the investment – Cornell was able to provide the bioinformatics expertise to enable the lab to make sense of the data it would be collecting and to analyze it quickly.

Their proof of concept was published July 16 in the Centers of Disease Control journal Emerging Infectious Diseases in a paper that uses a case study of a salmonella outbreak in a long-term care facility to demonstrate how the technique could benefit public health labs.

In a regional collaboration, samples collected by the Connecticut Department of Public Health were sequenced by NYSDOH and analyzed by Cornell, and researchers discovered the outbreak was even larger than suspected. In addition to the seven residents identified in 2010 as being sickened in the outbreak, nine additional samples from patients in surrounding communities matched the main strain.

“This suggests a common contaminated source outside the long-term care facility. Knowledge of these cases at the time of the outbreak might have improved the chances of finding the outbreak source, which was never identified,” the researchers wrote in the paper.

The technique is already gaining traction in several other states through the GenomeTrakr initiative sponsored by the U.S. Food and Drug Administration (FDA), which is providing sequencing equipment, reagents, funds for personnel, and training on the equipment to seven State Public Health Laboratories including New York. In return, the public health labs upload raw sequence data to a centralized site for analysis. Any clusters that appear are reported back to local labs and epidemiologists, allowing for a quick, coordinated response.

The study was partly funded by a grant from the USDA Agriculture and Food Research Initiative, the Center for Food Safety and Applied Nutrition at the FDA and the NYSDOH Wadsworth Center).

Lawrence Livermore Array Could Screen for Emerging Viral Diseases

A microbe detection array technology developed by Lawrence Livermore National Laboratory scientists could provide a new rapid method for public health authorities to conduct surveillance for emerging viral diseases.

This possible use of the Lawrence Livermore Microbial Detection Array (LLMDA) was studied by an international team of researchers from eight nations in a paper published late last month in the PLOS ONE scientific journal.

Among the viruses detected in the clinical samples were: Dengue fever, West Nile, Crimean-Congo hemorrhagic fever, Chikungunya, polyomaviruses, herpes simplex, hepatitis GB virus C, and Coxsackie.

The only sample in the study that was not identified was a Dengue fever virus, in which the viral concentration was determined to be below the detection limit. However, seven other clinical samples tested with Dengue fever virus were detected.

“The disease symptoms for emerging viruses are often similar to those of other more common viruses, posing a diagnostic challenge to clinicians unfamiliar with the novel organism,” the authors wrote. “In the case of emerging viruses, it is crucial for patient treatment and for containment of a potential epidemic to quickly identify the correct virus.”

With the use of the LLMDA, combined with a DNA amplification technique developed by researchers from Denmark, the team was able to correctly identify 29 different emerging viruses in both clinical and non-clinical samples.

One of LLMDA’s most important advantages is that the tool can perform thousands of tests in parallel within 24 hours, while another method, polymerase chain reaction (PCR) – though faster – can only run dozens of tests at a time.

The paper’s lead author is a researcher from the Copenhagen-based Statens Serum Institut, Denmark’s equivalent of the United States’ Centers for Disease Control and Prevention (CDC). Two LLNL scientists – bioinformaticist Shea Gardner, who designed the array, and biostatistician Kevin McLoughlin, who designed the analysis algorithm – were members of the team.

“The study shows that we are moving closer to having a robust technology that can be used for surveillance of emerging diseases,” McLoughlin said. “It could be used in public health laboratories to screen samples for viruses that are unexpected in the population.”

Emerging viruses are normally endemic to tropical and sub-tropical regions of the world, but increased global travel and other factors are believed to contribute to the spread of these viruses into new regions.

In the view of the paper’s authors, the risk of importing rare, exotic and emerging diseases to Europe has increased.

“Some areas in Europe already maintain environmental conditions favorable to these pathogens, such as hantavirus, Crimean-Congo hemorrhagic fever virus and West Nile virus. Travelers visiting endemic areas are a potential source for spreading these diseases,” the authors said.

“There is a demand,” they noted, “for rapid and accurate identification of the virus to initiate specific treatment, if available, as well as appropriate case management, such as isolation and contact tracking.”

In the study, the team used an earlier version of the LLMDA that contained some 388,000 probes that could detect 2,195 viruses and 924 bacteria.

The current version of the array, with 180,000 probes, can identify 4,377 viruses and 5,457 bacteria, as well as a combined total of more than 775 protozoa, fungi and archaea species.

Developed in 2008, the LLMDA detects microbes with the use of probes that fit in a checkerboard pattern in the middle of a one-inch wide, three-inch long glass slide. The instrument is seen as occupying a niche role between PCR and sequencing.

Other institutions that participated in the research included: Aristotle University of Thessaloniki (Greece), Spiez Laboratory (Spiez, Switzerland), the French Army Forces Biomedical Institute (Marseille, France), the Swedish Institute for Communicable Disease Control (Solna, Sweden), the National Veterinary Institute (Uppsala, Sweden), Linkoping University (Linkoping, Sweden); the University of Stirling (the United Kingdom), Robert Koch Institute (Berlin, Germany) and the University of Southern Denmark (Odense, Denmark).

The PLOS ONE paper, entitled, “The Microbial Detection Array for Detection of Emerging Viruses in Clinical Samples - A Useful Panmicrobial Diagnostic Tool,” can be reviewed by clicking on the title link.

Wednesday, July 16, 2014

Miacom Diagnostics Partners with Fosun Diagnostics to Market Molecular Pathogen Detection Assays

miacom diagnostics GmbH announced that Fosun Diagnostics, the diagnostic division of Shanghai Fosun Pharmaceutical, teams up with miacom Diagnostics to bring its molecular beacon based diagnostic assays to the Chinese and Asian markets. Miacom´s proprietary multiplex assays used for the detection of Sepsis- and Pneumonia-related pathogens are easy to use and will further complement Fosun´s diagnostic portfolio.

“Providing a tool for a reliable and rapid diagnostic of pathogens from positive blood cultures and respiratory samples will remarkably improve the patients’ outcome,” said Ted Zhu, General Manager of Fosun Diagnostics, “Combining miacom´s assay with Fosun´s experience in the Asian markets will have a great impact in the diagnosis of infectious diseases.”

The miacom assay combines a new way of sample handling with a specific optical marking of the pathogenic agents aiming for an identification and differentiation of various bacteria in 30 minutes. The assay can be easily implemented in nearly every laboratory since it does not require complicated hardware or special environment conditions.

“We are very proud to have a strong partner with Fosun Diagnostics which have a tremendous presence and experience in the in-vitro diagnostics marketplace”, said Dr. Mirko Stange, CEO of miacom diagnostics GmbH, “Having such partners in Asia makes a wide-spread distribution of our products in the Asian market feasible. We believe that this partnership will further strengthen our position in other markets as well.” Currently, Fosun Diagnostics is planning to build an FDA compliant, large-scale production facility. This will dramatically reduce the production costs of miacom’s products and drive the competitive advantage for the company also in the European and American markets.

At the upcoming annual meeting of the American Association for Clinical Chemistry (AACC) in Chicago both companies will share a booth so that interested parties can learn more how this partnership will facilitate the work of laboratory managers and ICU doctors.

About miacom diagnostics

Miacom diagnostics specializes in in vitro diagnostic tests for pathogens causing acute systemic diseases. All kits enable a simultaneous detection of clinically relevant pathogens directly from specimens, and deliver results within 30 minutes. In Europe, Miacom has already commercialized several rapid tests, including diagnostic tools for important systemic infectious diseases such as sepsis and pneumonia. All kits are designed as affordable multiplex tests that detect and differentiate up to 14 bacterial targets on a single microscope slide.

About Fosun Diagnostics

Fosun Diagnostics is one of the largest IVD manufacturers and distributors in China with products covering the four segments of In-Vitro Diagnostics: Biochemistry, Molecular Diagnostics,Microbiology and Immunology. With 28 local sales offices around China and in excess of 150 sales engineers, Fosun Diagnostics has successfully expanded its business national wide with as high profile presence in the domestic market.

Tuesday, July 15, 2014

Vivione Signs Strategic Alliance Agreement with IEH and Launches New Oil and Gas Rapid Microbial Contamination Detection Opportunities

Vivione Biosciences Inc. (the “Corporation”), through its wholly owned subsidiary, Vivione Biosciences, LLC, announced today that it has signed a strategic alliance agreement with Institute for Environmental Health, Inc (“IEH”), a Washington-based lab service provider, to handle all laboratory testing for the Corporation’s new oil and gas service offerings.

IEH is an internationally renowned microbiological laboratory network of 119 locations with experience in the food, agriculture and analytical chemistry industries. The strategic alliance with IEH will provide Vivione with access to IEH’s 119 locations, technology, personnel and infrastructure. When coupled with Vivione’s RAPID-B system, the new strategic alliance provides the companies with a new service opportunity in the oil and gas sector that is unrivaled.

The new product offerings are especially significant in the oil and gas sector, where the economic and environmental impact of microbial contamination is an ever-present concern. The new diagnostic tests co-developed by IEH and Vivione can reduce producers’ costs by accurately and rapidly diagnosing the bacteria issues that could potentially cost producers hundreds of thousands to millions of dollars.

“The strategic alliance with IEH agreement is a big win for us,” said Vivione’s Chief Executive Officer Kevin Kuykendall. “IEH has over 13 years of experience operating 119 labs around the world, which gives us access to facilities and necessary personnel to support our new product offerings. As part of the strategic alliance, we will market the new oil and gas products under the name of Petro Chemical Bio-Diagnostics.”

Mansour Samadpour, Chief Executive Officer of IEH, said, “We are excited to be working with Vivione on these new product offerings. Both companies have had success in the microbiology field and have worked in food service. We believe our new suite of product offerings will provide customers with the necessary diagnostic information to reduce their exposure to microbial contaminations that are costing the industry millions annually. Petro Chemical Bio-Diagnostics is the first suite of offerings we’ve seen that provides valuable information, specifically identifying the type of bacteria that are in wells and which biocides will have the greatest efficacy. We believe this solution will meet the growing needs of microbial detection within the oil and gas industry.”

Vivione’s RAPID-B system provides a universal platform that allows companies to rapidly detect and evaluate solutions for microbial contamination within the food, bio-therapeutics, clinical and, now, oil and gas industries. This system provides companies with real-time diagnostics which quickly and accurately identify and enumerate pathogens in different products and environments. Through the launch of the Corporation’s three new products, the Well Characterization Test (WCT), Bio-Treatment Efficacy Test (BET) and Total Bacteria Count (TBC), producers will be able to make more informed decisions regarding types and quantities of biocides to use in their specific oil and gas wells.

Monday, July 14, 2014

Rapid Pathogen Screening, Inc. Restructures Nicox Licensing Agreement

Rapid Pathogen Screening, Inc. (RPS®) announced the restructuring of the North American licensing rights to the AdenoPlus® test as well as two diagnostic tests in development. Effective August 1st, 2014, RPS will resume responsibility for marketing these tests to eye care professionals in the United States (U.S.) and all medical professionals in Canada. RPS already manufactures and markets the AdenoPlus test to aid in the rapid diagnosis of Adenoviral conjunctivitis (pink eye) to primary and urgent care professionals in the U.S. Nicox will continue to commercialize AdenoPlus and the previously licensed development products in all markets outside North America.

In 2012, RPS and Nicox entered into a licensing agreement giving Nicox access to RPS’s innovative diagnostic tests. These tests are based on RPS’s proprietary technology and enable the rapid and accurate in-office diagnosis of specific ocular diseases and conditions. Now, AdenoPlus and the future development products will be marketed to eye care professionals through RPS’s dedicated eye care team, which has extensive industry experience and currently markets InflammaDry®, a novel test for dry eye disease. The team will leverage and support this expanded product portfolio, accelerating access for both existing and new customers.

“RPS built out a robust commercial sales organization targeting eye care professionals for the successful launch of InflammaDry. We view the AdenoPlus and InflammaDry tests as synergistic products that both aid in the in-office diagnosis of common diseases affecting the ocular surface,” said Robert Sambursky, MD, chief executive officer and president of RPS. “Reacquiring the rights to AdenoPlus and future diagnostics in North America expands our eye care team’s product offerings, while maintaining a strong continued collaboration with Nicox outside North America.”

Nicox has paid a total of $3 million to RPS in license and option fees and has contributed to half of the costs of the two products in development. Under the amended agreement, Nicox will no longer contribute to development costs but may pay additional development milestones, up to a potential maximum of $525,000, related to approval of products outside North America. Nicox will continue to purchase manufactured products from RPS at a discounted price and will pay single digit royalties to RPS on sales of all products licensed outside North America. Nicox will no longer market these products in the U.S. or Canada but retains a co-promotional option in these markets, with complementary therapeutics that Nicox may obtain in the future. No additional rights to other RPS products have been transferred. RPS will pay Nicox single digit royalties on sales of the relicensed products in the defined markets within the U.S. and Canada.

AdenoPlus – a rapid, in-office test that can help detect Adenoviral conjunctivitis using a small tear sample – was created to aid in the diagnosis of pink eye. Adenoviral conjunctivitis is highly contagious and can result in prolonged morbidities even after the primary infection has resolved. Due to the overlap in signs and symptoms with other causes of acute conjunctivitis, healthcare providers often treat all conjunctivitis cases with topical antibiotics, which are ineffective against the viral form of the infection. As a result, this course of treatment can lead many patients to return to school, work, or daycare while still contagious. The AdenoPlus test can be performed by a nurse or technician and provides a result in only ten minutes, making the correct diagnosis available at the time of the office visit rather than relying only on overlapping signs and symptoms or waiting for results from a laboratory. The speed and accuracy of the test results help clinicians make an accurate diagnosis and provide the appropriate treatment before the patient leaves the office.

Sunday, July 13, 2014

Micro Imaging Technology Adds Salmonella Choleraesuis to Its Catalog of Identifiers

Micro Imaging Technology, Inc. announced that its MIT 1000 System can now identify Salmonella enterica serotype Choleraesuis. S. Choleraesuis is a non-typhoid strain that is a serious cause of foodborne infection. It also shows a higher predilection for causing bacteremia (bacteria in the blood) in humans by entering blood vessels through the stomach wall.

"This is significant step forward for MIT 1000 technology," said Dr. David Haavig, Micro Imaging Technology's Chief Scientist. "The completion of this Identifier demonstrates the sensitivity of this non-biological bacterial identification technology. This new Identifier gives our MIT 1000 the ability to identify a serotype of the species Salmonella enterica. A serotype is a distinct variation within a species that has cell surface antigens that differ from other serotypes of the same species; that is a very small difference. Our other Identifiers give the MIT 1000 the ability to identify Listeria genus and Staphylococcus genus where each genus consists of multiple species, some of which can be pathogenic."

Identifiers give the MIT 1000 System the ability to identify bacteria. All Identifiers, including this new S. Choleraesuis Identifier as well as all future Identifiers, use the same simple chemical-free, very low-cost, one-minute sample preparation procedure and two-minute average hands-off test with no modification or addition to the MIT 1000 System.

The S. Choleraesuis Identifier is available now and will soon undergo AOAC Certification. The MIT 1000 is a rapid, bacterial cell-based detection and identification system that can identify pathogenic bacteria, now including Salmonella Choleraesuis, in three minutes (average). At a cost of $4.00 per test, the MIT 1000 is less than half the industries average cost of a pathogen test.

Meanwhile, MIT is working on a series of Salmonella Identifiers including the common food pathogens S. Heidelberg, S. Enteritidis and S. Typhimurium.

New Technology Increases Accuracy and Rapid Detection Time of Molecular Biomarkers for Disease Diagnosis and Treatment

Cellgen Diagnostics announced the availability of a free whitepaper on a molecular diagnostics platform that can rapidly detect genetic material to identify various illnesses and diseases in humans. It also provides absolute quantification for the purpose of gene expression analysis for research and discovery. Gene Expression analysis helps researchers understand disease pathways, which in turn helps them to identify means to interfere with those disease pathways (e.g. pharmacological) to develop treatments.

Although qPCR (Polymerase Chain Reaction) is the "Gold Standard" for today's $3B gene expression analysis industry, research professionals have long desired a departmentally affordable, gene expression analysis platform that provides near real-time turnaround times, quantitative digital outputs and automation to remove the currently extensive labor required to perform each test.

The whitepaper, Oil-Encapsulated Nanodroplet Array for Bio-molecular Detection, is available for download at

In this publication, Cellgen Scientists along with collaborators from the University of California, San Diego describe an ultra-sensitive, on-chip sample concentrating-detection technology for the purpose of biomolecular quantification. This technology is the foundation of Cellgen's proprietary platform that has demonstrated the ability to enrich and concentrate DNA samples up to a million times to allow for low-abundance (femto-molar range) detection of targeted analytes without biochemical amplification within 30 minutes.

"The result is a patent pending, molecular diagnostic platform that will provide greater accuracy and rapid gene quantification at a deeper threshold than any existing molecular device on the market," said Lavance Northington, CEO of Cellgen Diagnostics.

Blood and biofluids contain many biomolecules, namely proteins, DNAs, and RNAs that can be used as diagnostic biomarkers, but their low concentration levels often make accurate and rapid detection challenging.

"Cellgen's technology would allow us to look at genetic material - the basis of all illness and disease - and make diagnoses in near real time that, right now, are not possible at the bedside," said Dr. Alexander Khalessi, Director of Endovascular Neurosurgery at the University of California, San Diego Medical Center. "More importantly, we would be able to tailor our treatment to a specific genetic profile. For me as a clinician, this is going to make the real difference going forward and change the way medicine is practiced."

Specifically, the technology does not require the thermal cycling component, costly enzymes, or sequence specific labeling procedure like PCR/Amplification technologies, and presents as an innovative solution to provide near real time, quantitative results in a number of markets. These include disease diagnosis, veterinary diagnostics, companion diagnostics, food and safety testing, agriculture improvements, environmental testing, GMO testing and biological research testing.

"Beyond providing health care providers with tools to better attain personalized medicine, our technology will have an immediate impact on the $3B gene expression analysis market. We are highly anticipating the release of our prototype to the biological research markets in Q2/Q3 of 2015," said Northington.

Faster analysis time, automation and affordability will be the key drivers in the adoption of Cellgen technology in the research and discovery industry.

Monday, July 07, 2014

CDNA Microarray On A Chip For Rapid Detection Of Dengue Fever

Researchers at the Center for Research and Advanced Studies (Cinvestav) in Mexico have developed a cDNA microarray chip that allows detection of the RNA strand of the dengue fever virus.

The genetic information pinpoints the exact serotype of malaria that an infected person or mosquito is carrying  and allows analysis of the complementary strand of DNA (cDNA) obtained from the dengue fever virus being carried by the infected patient. The cDNA is covalently linked to a slide (substrate) that can be a glass or paper.

Through probes marked with fluorescent elements, called fluorochromes, they can perceive in the chip different colors according to the serotype of dengue fever the patient is bearing. Additionally, the cDNA microarray can display more than one color if the patient carries two serotypes.

According to Maria de Lourdes Muñoz Moreno, researcher at the Department of Genetics and Molecular Biology at Cinvestav, the problem is that sometimes dengue fever cases are diagnosed improperly. "A simple flu could be mistaken for dengue fever; or on the contrary, the latter could be diagnosed as a cold."

Muñoz Moreno added that a mis-diagnosis of dengue fever could trigger the progression of the disease. "If a painkiller or an antihistamine are prescribed to the patient infected by the virus, such drugs could cause a thinning of the blood vessels walls, thus triggering hemorrhagic fever" the researcher said.

Knowing the precise serotype of dengue fever virus the patient is carrying, the progression of the disease would stop and an optimal follow up of the treatment would be held. "When it comes to a second infection with another serotype, the antibodies that protect the body from dengue fever in the first infection, could now adhere to the virus of a new serotype, causing the cells to be more easily infected," explained Muñoz Moreno.

Currently, the research group at Cinvestav is working to achieve a microarray that differentiates dengue fever from Chikungubya, a viral disease recently reported in Latin America that is transmitted in a dengue-like manner, causing an acute febrile phase lasting two to five days.

Corgenix, Research Group Announce NIH Grant to Develop Rapid Ebola Diagnostic Test Kit

Corgenix Medical Corporation, a worldwide developer and marketer of diagnostic test kits, has been awarded a three-year, $2.9 million National Institutes of Health (NIH) grant to advance the development of an Ebola rapid diagnostic test kit. Collaborating with Corgenix on the program will be members of the Viral Hemorrhagic Fever Consortium (VHFC), a collaboration of academic and industry members headed by Tulane University and partially funded with support from the NIH.

The NIH phase II, R44 grant is a continuation of a previous two-year grant to develop special proteins for use in testing. It is the fifth major grant or contract awarded to Corgenix and its VHFC collaborative partners to combat dangerous viral hemorrhagic fevers, including Ebola, Lassa and Marburg viruses. Development of the Ebola test would enable rapid response to public health and bioterrorism threats posed by the deadly virus.

"This grant comes at a critical time for Ebola and related virus research," said Douglass Simpson, Corgenix President and CEO. "Ebola virus outbreaks are relatively uncommon, but when they do occur, they are deadly and can spread rapidly. This latest outbreak demonstrates that point-of-care testing will be needed on a routine basis to diagnose or rule out both Ebola and Lassa in West Africa, now that Ebola is present in a Lassa endemic region."

The grant enables researchers to further develop efforts for a point-of-care test kit that can be used in any clinical or field lab to determine in a matter of minutes if a patient is infected with Ebola. Corgenix and the VHFC have already developed and CE marked the ReLASV(R) rapid test for the Lassa fever virus.

"Ebola is clearly a problem that's not going away," said Robert Garry, Ph.D., Professor of Microbiology and Immunology at the Tulane University School of Medicine. "This grant allows us to build on our previous Ebola testing research, ultimately putting local and regional governments and healthcare workers in a much better position to identify and contain outbreaks with rapid diagnostic testing."

Current testing for the Ebola virus requires special biohazard handling and sending test samples long distances to special labs -- a process that takes several days. This results in a critical loss of time to diagnose, treat and help prevent the spread of the virus.

Ebola is indigenous to Africa and is one of the deadliest viruses on the planet, with mortality rates of between 50 and 90 percent. Ebola infection is characterized by bleeding and coagulation abnormalities and can kill within 10 days to two weeks. Ebola and other viral hemorrhagic fevers are difficult to diagnose because many of the early signs and symptoms resemble those of other infectious diseases such as typhoid and malaria.

The most recent outbreak of Ebola in West Africa started in Guinea and then spread into Liberia and now into Sierra Leone.

New Rapid Diagnostic Test for Multi-Resistance to Broad-Spectrum Antibiotics

A rapid diagnostic test for multi-resistance to broad-spectrum antibiotics has just been developed at the University of Fribourg. Prof Patrice Nordmann and Dr Laurent Poirel of the Medical and Molecular Microbiology Unit have been collaborating with Unit 914 of the National Institute of Health and Medical Research (INSERM) in Paris, of which Patrice Nordmann is also Director. This new test allows the identification, in less than two hours, of multidrug-resistant strains of Acinetobacter baumannii, an important hospital pathogen. The large-scale application of this test will mean better control of the spread of certain traits of antibiotic resistance.

Bacterial resistance to antibiotics has increased considerably over recent years. The situation is particularly dramatic in regard to gram-negative bacilli (Escherichia coli and Klebsiella pneumoniae, Pseudomonas aeruginosa and Acinetobacter baumannii), in, for example, septicemic and abdominal infections and infections of the urinary tract and the lungs, considered to be the most frequent human infections in 2014. There are already signs of a real therapeutic impasse. Extremely broad-spectrum antibiotics, such as the broad-spectrum cephalosporins and the carbapenems, antibiotics of last resort, are already proving totally ineffective against certain strains of bacteria. It is estimated that in Europe the total number of deaths associated with multi-resistance to antibiotics is 25,000 annually. The rapid development of this resistance risks compromising whole areas of 21st century medicine which require effective preventative or curative antibiotics for transplants and major surgery as well as resuscitation.

Rapid diagnosis: a crucial factor

When a bacterium hydrolyses an antibiotic, it deactivates the way it works in some way. It is this phenomenon which had already been targeted by two rapid diagnosis tests developed by Patrice Nordmann and Laurent Poirel. These tests detected the presence of extended spectrum Beta lactamase enzymes and of carbapenemases (which hydrolyse wide-spectrum cephalosporins and carbapenems in Enterobacteriaceae and Pseudomonas aeruginosa, respectively). Now the two researchers have developed the CarbAcineto NP test which allows the detection of carbapenemase activity in A. baumannii; and it is this carbapenemase activity which is systematically associated with multi-resistance to antibiotics in this type of bacterium (click figure to enlarge).

The test is based on the acidification properties generated by the enzymatic hydrolysis of a carbapenem, Imipenem, when it is cleaved by a carbapenemase. The medium acidifies and the acidity (pH) indicator then turns from red to yellow. The detection of this carbapenemase activity can be realised by testing already isolated bacteria or any site infections. The result is obtained in less than 2 hours, while other techniques currently available require a minimum of 24 hours, most frequently 72 hours. The sensitivity and specificity of the CarbAcineto NP test is close to 100%, a value rarely achieved by a diagnostic test in medicine.

The development of the CarbAcineto test is an important contribution to the struggle against the emergence of antibiotic resistance. It is simple, cost-effective and, by detecting multidrug-resistant strains, it can prevent them spreading via outbreaks of hospital infections caused by multidrug-resistant bacteria, particularly among the most seriously ill patients - those undergoing resuscitation. This new test also provides a guide in the choice between the very few remaining treatment options for infected patients.

Reference: Laurent Dortet, Laurent Poirel, Caroline Errera, Patrice Nordmann, CarbAcineto NP test for rapid detection of carbapenemase producers, Acinetobacter sp. J. Clin Microbiol, May 2014.

Source: University of Freiburg