Thursday, January 26, 2012

MSU Technology Spin-Out Company to Market Portable Biohazard Detection

A new company formed around Michigan State University nanotechnology promises to move speedy detection of deadly pathogens and toxins from the laboratory directly to the field.

Food contamination and other biohazards present a growing public health concern, but laboratory analysis consumes precious time. The company, nanoRETE, will develop and commercialize an inexpensive test for handheld biosensors to detect a broad range of threats such as E.coli, Salmonella, anthrax and tuberculosis.

A significant leap forward in detection and diagnostic technology, it utilizes novel nanoparticles with magnetic, polymeric and electrical properties developed by Evangelyn Alocilja, MSU professor of biosystems and agricultural engineering and chief scientific officer of nanoRETE.

“Our unique preparation, extraction and detection protocol enables the entire process to be conducted in the field, without significant training,” Alocilja said. “Results are generated in about an hour from receipt of sample to final readout, quickly identifying contaminants so that proper and prompt actions can be taken.”

The mobile technology comes at only a fraction of the cost of the closest currently available competing technology, company officials said.

“Although the technology originates from research for biodefense applications, its potential reaches far beyond the initial scope,” said Fred Beyerlein, CEO of nanoRETE. “Our X-MARK platform-based technology has the ability to detect multiple pathogens or toxins at one time, in a rapid, point-of-use, cost-effective manner. Imagine the potential applications for food growers, packagers or sellers. Contaminated food or water could be quickly identified, isolated and resolved before reaching the ultimate consumer – you or me.”

nanoRETE is backed by Michigan Accelerator Fund I, a Grand Rapids, Mich., investment partnership focused on Michigan-based early stage life science and technology companies.

“Our task was to find promising technologies, identify strong management and support with investment dollars,” MAF-1 managing director Dale Grogan said. “We reviewed literally hundreds of technologies developed within MSU and determined that this particular technology best fit our investment model. We are excited about nanoRETE’s future and hope this is the first of many companies we help develop with MSU.”

MSU Technologies, the office that manages technology transfer at MSU, was actively involved in licensing the technologies to nanoRETE. In addition to other grants, the technologies earned funding from the MSU Foundation to continue development across the financial “valley of death” between research and commercialization.

“We have had great faith that Dr. Alocilja’s work in nano-scale detection would be a very successful platform on which to start a new company,” said Charles Hasemann, executive director of MSU Technologies. “MAF-1 has been a great partner in building nanoRETE. With its partnership and investment, we expect to move rapidly to a marketable product.”

Wednesday, January 25, 2012

Idaho Technology Inc. Delivers 10 Target BioThreat Detection Kit for US Military

Idaho Technology, Inc. (ITI) announced that it has delivered its first shipment of the RAZOR™ CRP BioThreat-X Kits to the Critical Reagents Program (CRP) which supplies test reagents to the US military. The RAZOR CRP BioThreat-X Kit represents the first US Department of Defense (DoD) system capable of testing for 10 biothreat agents at one time in the field with results available in 30 minutes. The RAZOR CRP BioThreat-X Kit contains polymerase chain reaction (PCR) assays developed in US DoD laboratories. These assays are packaged and freeze-dried in ITI’s patented pouch system that is designed specifically to run on the RAZOR™ BioThreat Detection System platform. In addition to testing for 10 biothreat targets, the RAZOR CRP BioThreat-X Kit includes a PCR inhibition control and amplification control that confirms proper system operation. ITI’s RAZOR™ and RAZOR™ EX instruments provide reliable and sensitive field biothreat detection capabilities that are easy to use.

The detection kit was developed at the direction of the CRP, the principal resource of biological detection assays and reagents for the US DoD. The 18-month joint effort involved evaluating existing US Government assays, optimizing them for the RAZOR System and transitioning for manufacture. “Idaho Technology is fully committed to collaborating with the US Military to enhance its biological threat detection capabilities in support of the warfighter, and this project is a good example of the many joint efforts between Idaho Technology and the US Government,” says Kirk Ririe, Idaho Technology’s CEO. The RAZOR CRP BioThreat-X will be available for purchase to cleared agencies through the CRP catalog.

Life Technologies Acquires UK-Based Matrix MicroScience; Cuts Food Pathogen Testing Workflow and Cost Per Sample by 50 Percent

Life Technologies Corporation announced that it has acquired Matrix MicroScience, a British manufacturer of large-volume, automated sample preparation systems and consumables for the food safety testing industry.

Matrix MicroScience’s technology will be added to Life Technologies’ existing foodborne pathogen detection workflow. The complementary technologies will ultimately help reduce the cost of testing by more than 50 percent and speed up time to results by hours or days in some cases, resulting in lower inventory holding costs for food producers.

Among the key complementary technologies from the British firm is the PATHATRIX AUTO, a benchtop, sample-prep instrument that isolates and concentrates target bacteria in food samples at high volumes with walk-away convenience. The system is designed to work in conjunction with reagent kits that isolate a variety of pathogens, including Salmonella, E. coli O157:H7, Listeria, Cronobacter and Campylobacter. Life Technologies is the leading manufacturer of real-time PCR instruments for the food safety testing market. Its portfolio includes real-time PCR-based detection kits for these same pathogens.

“This acquisition provides all the benefits we were looking for to address our customers’ needs: a solution that dramatically decreases the wait time for results, lowers their price per sample, and makes the technology even more accessible and easy to use for our growing customer base,” said Nir Nimrodi, Vice President and General Manager, Food Safety and Animal Health.

“Matrix MicroScience’s sample-prep technology is ideally suited for Life Technologies’ broad portfolio of PCR-based pathogen detection kits for the food testing industry,” said Dr. Adrian Parton MBE, CEO of Matrix MicroScience. “It’s a good fit for both organizations and ultimately benefits our customers.”

Not for use in human diagnostic procedures.

Monday, January 23, 2012

USDA Awards Grant to the University of Nebraska-Lincoln for E. coli Research to Help Reduce Public Health Risks

The U.S. Department of Agriculture (USDA) announced today that it has awarded a research grant to the University of Nebraska-Lincoln (UNL) to help reduce the occurrence and public health risks from Shiga toxin-producing E. coli (STEC) along the entire beef production pathway. Dr. Chavonda Jacobs-Young, acting director of USDA's National Institute of Food and Agriculture (NIFA), is scheduled to award the $25 million grant to the UNL-lead research team today at the university in Lincoln.

"Shiga toxin-producing E. coli are a serious threat to our food supply and public health, causing more than 265,000 infections each year," said Chavonda Jacobs-Young, acting NIFA director. "As non-O157 STEC bacteria have emerged and evolved, so too must our regulatory policies to protect the public health and ensure the safety of our food supply. This research will help us to understand how these pathogens travel throughout the beef production process and how outbreaks occur, enabling us to find ways to prevent illness and improve the safety of our nation's food supply."

Dr. James Keen at UNL, along with a multi-institutional and multi-disciplinary team of researchers, educators and extension specialists, will use the $25 million grant to improve risk management and assessment of eight strains of STEC in beef. This work will include the O104 strain that caused the recent outbreak in Germany. The project will focus on identifying hazards and assessing exposures that lead to STEC infections in cattle and on developing strategies to detect, characterize and control these pathogens along the beef chain. This knowledge will then be used to find practical and effective STEC risk mitigation strategies. The five main objectives of the project include:

  • Detection: develop and implement rapid detection technologies for pre-harvest, post-harvest and consumer environments.
  • Biology: characterize the biological and epidemiological factors that drive outbreaks of STEC in pre-harvest, post-harvest, retail and consumer settings.
  • Interventions: develop effective and economical interventions to lessen STEC risk from cattle, hides, carcasses, and ground and non-intact beef and compare the feasibility of implementing these interventions for large, small and very small beef producers.
  • Risk analysis and assessment: develop a risk assessment model for STEC from live cattle to consumption to evaluate mitigation strategies and their expected public health impacts.
  • Risk management and communication: translate research findings into user-friendly food-safety deliverables for stakeholders, food safety professionals, regulators, educators and consumers.

Most STEC outbreaks are caused by ingestion of contaminated food and contact with fecal material from cattle and other ruminant animals. Most of what is known about STEC comes from outbreak investigations and studies of E. coli O157. The non-O157 STEC strains are not nearly as well understood, partly because outbreaks due to them are rarely identified. This project will help improve our understanding of these strains in addition to O157 strains.

Keen's team includes researchers from the University of Arkansas, University of California-Davis, University of California-Tulare, University of Delaware, Kansas State University, New Mexico State University, North Carolina State University, Texas A&M, Virginia Tech, USDA's Agricultural Research Service and a research consortium comprised of government, academic and industry scientists and food safety professionals. The team will also work collaboratively with several consumer groups, cattlemen groups and meat processor associations, along with numerous industry partners and technology providers, to improve the safety of the beef supply.

Through the President's Food Safety Working Group, USDA and its federal partners have been working on a new, public health-focused approach to food safety based on the principles of prevention, strengthening surveillance and enforcement, and improving response. In September 2011, USDA's Food Safety and Inspection Service announced a proposal to declare six additional serogroups of pathogenic E. coli as adulterants in non-intact raw beef. Under the proposal, if the serogroups O26, O103, O45, O111, O121 and O145 are found in raw ground beef or its precursors, those products will be prohibited from entering commerce. USDA will launch a testing program to detect these dangerous pathogens and prevent them from reaching consumers.

The coordinated agricultural project grant announced today is through USDA's Agriculture and Food Research Initiative (AFRI) and administered through NIFA. AFRI food safety grants promote and enhance the scientific discipline of food safety, with an overall aim of protecting consumers from microbial, chemical, and physical hazards that may occur during all stages of the food chain, from production to consumption.

AFRI is NIFA's flagship competitive grant program and was established under the 2008 Farm Bill. AFRI supports work in six priority areas: plant health and production and plant products; animal health and production and animal products; food safety, nutrition and health; renewable energy, natural resources and environment; agriculture systems and technology; and agriculture economics and rural communities.

Alere™ Rapid Flu Test Receives CLIA Waiver from FDA

Alere Inc. received confirmation that The U.S. Food and Drug Administration (FDA) has cleared the Alere™ Influenza A&B Test for the U.S. market, categorizing it as CLIA-waived. This highly sensitive rapid test is intended for use in the physician's office and will help healthcare practitioners manage patients with influenza-like illness more effectively.

The U.S. Congress passed the Clinical Laboratory Improvement Amendments (CLIA) in 1988 to set quality standards for all laboratory testing and ensure that tests, no matter where they are performed, deliver accurate, reliable and timely patient results. In 2008, the FDA, which determines what tests are eligible for waiver, established more stringent guidelines for in-vitro diagnostics to make certain that only accurate and easy-to-use tests reach the physician's office. In order for a device to be considered for waiver, manufacturers must demonstrate that it is accurate and simple to use in a CLIA-waived environment. Testing, moreover, must be performed by the intended user--for instance, a nurse, medical assistant, or doctor--as opposed to a specially trained laboratory technologist.

After multiple studies to validate the test and considerable collaboration with the FDA, the Alere™ Influenza Test has been granted waived status. "We are very pleased to receive the CLIA waiver for the new Alere™ Influenza Test," said Avi Pelossof, Vice President Infectious Disease at Alere Inc. "By getting this product into the waived segment of the marketplace, we are giving healthcare providers a new tool that will enable them to make better decisions about flu diagnosis and treatment while patients are still in the office."

The Alere™ Influenza A&B Test uses highly sensitive antibodies to detect influenza types A and B antigen. When compared to viral culture, the new Alere test showed performance with sensitivity / specificity of 93.8% / 95.8% for flu A and 77.4% / 98% for flu B. Sample collection for the Alere™ Influenza A&B Test, which makes use of a nasal swab, is minimally invasive. The test also provides results in 10 minutes, making it possible for physicians to administer treatment while patients are still in their care.

The Alere™ Influenza A&B Test adds a dipstick format test to Alere's existing portfolio of influenza diagnostics, which includes the card format BinaxNOW(R) Influenza A&B Test, enabling Alere to provide primary care physicians with a full range of easy-to-use, effective tools for identifying influenza A & B at the point of care.

"Alere is dedicated to ensuring that only the highest quality products reach the hands of healthcare providers," stated Pelossof. "And the Alere™ Influenza A&B Test is one of them."

Saturday, January 21, 2012

Astra Biotech to Offer High Specificity Tests for Infectious Diseases

Astra Biotech GmbH is preparing to launch a range of test kits for the diagnosis and monitoring of infectious diseases with the potential for significant pathogenesis. Based on the ELISA principle and characterised by high specificity, these kits detect the presence of IgG antibodies to Herpes simplex virus (HSV), Toxoplasma gondii, Hepatitis B virus and HIV. Additionally, IgG avidity is determined using an Astra Biotech Toxoplasma Test Kit.

The Herpes Simplex Type 1 kit provides quantitative detection of HSV 1 specific IgG, allowing monitoring of antibody concentration and estimation of therapy effectiveness. Whereas IgM tests may give misleading results and cannot distinguish between HSV 1 and HSV 2, this kit is both highly sensitive and highly specific.

Diagnosis of a recently acquired primary Toxoplasma infection is not easy, in that the IgM antibodies (a typical marker for recent infections) developed during toxoplasmosis may persist for many months and even for years. However, recent infections can be identified with Astra Biotech’s Toxoplasma-IgG-Avidity kit which measures the avidity of specific IgG. This is possible as the initial IgG antibody response to infection is characterised by antibodies with low avidity. Also available is a Toxoplasma IgG kit which enables diagnosis of the acute phase of the disease and monitoring of the recovery process.The Astra Biotech range includes two kits which detect and confirm the presence of Hepatitis B surface antigen, and two kits which detect antibodies to HIV-1 and HIV-2. The HIV-HIV-Ag/At product also detects the p24 antigen, a marker appearing as early as 1–3 weeks after contamination and therefore enabling very early diagnosis of HIV infection.

Astra Biotech ELISA test kits are manufactured by incorporating only certified high purity reagents and in accordance with stringent internal quality control procedures. All the assays are IVD-compliant and therefore suitable for direct diagnostic purposes. The standard 96-well plate format fits into all work flows and the assays’ high specificity and sensitivity parameters allow consistently accurate results and guarantee high reproducibility.

Biótica's Legipid® Bioalarm Legionella Test for Detection of Legionella pneumophila receives prestigious AOAC Approval

The Spanish company based at Espaitec, the Scientific, Technological and Business Park of Universitat Jaume I, has earned Performance Tested Method approval from the AOAC Research Institute for its Legipid® Bioalarm Legionella for the detection of Legionella pneumophila in waters. The approval was granted after extensive independent evaluation. Biótica's newly-approved test for Legionella pneumophila (AOAC-RI 111101) is a fast, economic and simple immuno-magnetic analysis that revolutionizes the risk assessment of this pathogenic bacterium in water bodies.

Biótica, Bioquímica Analítica, S.L., is an innovating technology-based company (ITBC), which develops fast techniques for the microbiological detection and quantification, based on the combination of molecules recognition, like antibodies, with advanced nanomaterials, like paramagnetic particles.

Guillermo Rodríguez, Biotica's Chief Scientist, has stood out the importance of the international certification from AOAC, since it is obtained after an intense technical evaluation on a third independent party. "Legionella pneumophila is one of the main agents causing a serious kind of pneumonia called Legionnaires’ Disease, with elderly and immuno-compromised people most at risk. L. pneumophila is the major cause of sporadic and outbreak of legionellosis (91.5%). About 5-15% of cases prove fatal".

Rodríguez has explained that "The AOAC Research Institute (AOAC RI) awarded the Company Performance Tested MethodsSM (PTM) certification for the rapid detection of L. pneumophila. The AOAC provides an independent third-party evaluation of methods and will award PTM certification to methods that demonstrate performance levels equivalent or better than other bacteria determining methods. The Legipid® Bioalarm Legionella underwent hundreds of individual tests over several months to earn AOAC RI's certification for the detection of Legionella; including evaluations of sensitivity, specificity, ease of use, documentation, ruggedness and efficiency. This extensive evaluation by the AOAC RI included rigorous independent testing and thorough reviews by its expert examiners. This evaluation process resulted in Biótica being awarded the prestigious AOAC RI Certificate of Performance Testing".

The test detects this bacterium in minutes, not days, and at a significant per test cost savings when compared to any other conventional method. The World Health Organisation (WHO) says that the incidence of Legionellosis is increasing. Thus, rapid and simple detection of these disease causing pathogens in water is critical to the health and safety prevention.

Tuesday, January 17, 2012

Life Technologies Partners With DaAn Gene to Develop and Commercialize Molecular Diagnostic Assays in China

Life Technologies Corporation today announced that it has signed an agreement with DaAn Gene, a leading Chinese company in molecular in-vitro diagnostics (IVD), to form Life Technologies DaAn Diagnostics, a joint venture diagnostics business in China. The move is expected to contribute to the early diagnosis of oncology, infectious diseases and genetic diseases. Financial terms of the deal were not disclosed.

Life Technologies DaAn Diagnostics with its headquarters in Guangzhou, will develop and commercialize a portfolio of molecular diagnostic assays using Life Technologies' 3500Dx Capillary Electrophoresis instrument and the Big Dye® Cycle Sequencing technologies, focused on IVD assays for oncology, infectious and genetic diseases. The joint venture allows both companies to expand the use of Capillary Electrophoresis technology into the Chinese clinical diagnostics market.

"This joint venture strengthens the foundation of our clinical diagnostics business and represents a big leap forward for our business in China," said Gregory Lucier, Chairman and CEO of Life Technologies. "As a leading biotechnology company, we are at the forefront of a rapidly evolving healthcare landscape. This joint venture and its products will play a key role in disease prevention and therapy selection and is complementary to the Chinese government's 12th five-year plan to promote national economic and social development."

"The joint venture will help us offer leading medical diagnostic technologies with cost-effective solutions to Chinese healthcare professionals," said Dr. Siddhartha Kadia, President of Life Technologies, Greater China. "This approach leverages our expertise in platform development and DaAn's expertise in regulated markets with kit development and commercialization."

"Twenty years ago, the cooperation between DaAn and Applied Biosystems brought PCR technology into China's molecular diagnostic field, positioning China with the most potential to become the world's largest PCR market for clinical diagnostics. Today, the cooperation with Life Technologies introduces DaAn's products to the global marketplace, while bringing Life's superior technologies into China's IVD market. Together, we are working toward becoming a premium IVD product supplier that has global impact," said Zhou Xinyu, CEO of DaAn Gene.

Life Technologies' 3500Dx instrument is a capillary-based Sanger Sequencer intended for use in the analysis of human DNA for the detection of genetic changes that may lead to disease presence or improved response to various therapies. Life Technologies' Sanger Sequencers supplied the technology that powered the Human Genome Project. Sanger instruments remain the sequencing gold-standard for accuracy, reliability and ease of use. The 3500Dx Genetic Analyzer was approved by China State Food and Drug Administration (SFDA) for IVD diagnostic use in China in October 2011.

Roka Bioscience Awarded AOAC-RI Certification for Roka Listeria Detection Assay

Roka Bioscience announced today that their Roka Listeria Detection Assay has received AOAC Performance Tested Method(SM) certification from the AOAC Research Institute (AOAC-RI). The independent laboratory study testing was conducted by Silliker, Inc., as part of the AOAC-RI independent third-party evaluation and validation processes.

The Roka Listeria Detection Assay runs on the Atlas(TM) System, an innovative fully automated molecular instrument for the detection of food pathogens in food and environmental samples. This instrument utilizes a simple three-step procedure--Enrich, Transfer, Automate--and is capable of processing over 300 samples in 8 hours. The instrument's dynamic scalability and high throughput provides greater efficiency, flexibility, and freedom to meet the ever-increasing demands placed on food safety laboratories.

The initial menu for the Atlas System will be the Roka Listeria and Salmonella Detection Assays. Internal and external AOAC studies for the Roka Salmonella Detection Assay has been completed and submitted for AOAC Performance Tested Method Certification. Additional assays are currently in development.

"AOAC-RI certification of the Roka Listeria Detection Assay was a critical step for us," stated Paul Thomas, CEO and President of Roka Bioscience. "This certification is recognized worldwide as the ultimate performance-based validation in our industry. We can now say with even more certainty that this assay, together with the Atlas System, gives food safety laboratories an ideal testing solution. Accuracy, speed, ease of use, flexibility--with this system, laboratories can truly have it all."

Thursday, January 12, 2012

New Test Uses Mass Spectrometry to Rapidly Detect Staph Infections

Researchers from the Georgia Institute of Technology and the Centers for Disease Control and Prevention (CDC) have developed a new laboratory test that can rapidly identify the bacterium responsible for staph infections. This new test takes advantage of unique isotopic labeling combined with specific bacteriophage amplification to rapidly identify Staphylococcus aureus.

Quickly and accurately detecting infections caused by S. aureus is critical because the pathogenic bacterium causes a broad spectrum of infections, ranging from acute to chronic disease, which need to be treated in a prompt manner with the correct antibiotic.

The test uses mass spectrometry to quantify the number of S. aureus organisms in a large number of samples in just a few hours, compared to a day or two for culturing techniques typically used to detect this bacterium.

“Our method for detecting staph infections using mass spectrometry will be valuable in a variety of situations, but will be crucial when a large number of people need to be tested very quickly, which will ultimately improve treatment,” said Facundo Fernández, an associate professor in the Georgia Tech School of Chemistry and Biochemistry.

Details of the new staph infection detection method were published in the January issue of the journal Molecular and Cellular Proteomics. Partial funding for this research was provided by 3M and the CDC/Georgia Tech seed award program.

Fernández together with Carrie Pierce, Jon Rees and John Barr from the CDC’s Division of Laboratory Sciences created this test.

“The simplicity of sample preparation, the low cost of required reagents and the increased availability of mass spectrometers in clinical laboratories make this new method a cost-effective way to rapidly and effectively detect staph infections, which must be treated quickly to prevent spread of the disease,” explained Pierce, a research chemist at the CDC who also worked on the project as a graduate student at Georgia Tech.

To run their test, the researchers first inject a known amount of bacteriophage labeled with nitrogen-15 into a sample. The phages -- which are viruses that infect bacteria -- infect only live S. aureus cells, which then multiply and amplify the phage signal. Following a two-hour incubation, the researchers break up proteins from the phage shell into component peptides using a trypsin digest technique.

Then they analyze the sample using liquid chromatography with tandem mass spectrometric detection. By detecting peptides from the protein shell of the phage, the researchers can measure the concentration of S. aureus in the sample.

“The strength of this technique is coupling a well-characterized method for identifying bacteria with a modern detection device, such as a mass spectrometer,” said Barr, biological mass spectrometry lead in the CDC’s Division of Laboratory Sciences. “By labeling input phage with heavy nitrogen isotopes, we were able to use mass spectrometry to effectively distinguish between the parent and progeny phage, thus enhancing the selectivity of the method.”

This prototype mass spectrometry-based technique has been optimized to detect low concentrations of bacteria that should allow clinicians to diagnose staph infections without the need for a significant culture period. Coupled with standard laboratory robotics, the test will reduce manual labor and subjective interpretation of results inherent in traditional techniques.

“An exciting aspect of this phage method is that with small modifications to the procedures, resistance and susceptibility to a number of different antibiotics can be determined in addition to bacterial identification,” said Rees. “This additional piece of information may be the key to wide acceptance of the method.”

Tuesday, January 10, 2012

NanoLogix Instructs Third-Party to Prepare US FDA Submittals and is Granted US and Chinese Patents

NanoLogix Inc., an innovator in the accelerated detection, identification and antibiotic sensitivity determination of live bacteria announces that has instructed a third-party to prepare a total of six applications for submittal to the US FDA. The applications are to include:

Results of third-party TB tests for approval for use as a BSL-3 test process for Tuberculosis using NanoLogix BNP technology.

Results of the University of Texas Health Science Center-Houston Group B Streptococcus tests (currently ongoing) for use as a recognized test kit using NanoLogix BNF technology.

Results of multiple third-party tests on gram-positive bacteria with BNP and BNF technologies for approval as recognized tests for the gram-positive family of bacteria.

Results of multiple third-party tests on gram-negative bacteria with BNP and BNF technologies for approval as recognized tests for the gram-negative family of bacteria.

"We are excited to have the process of preparation for FDA submittal moving forward with a third-party," said NanoLogix CEO Bret Barnhizer. "The accuracy of the data and the expertise of the third-party in FDA submittals provides us with confidence that the submittal process will run smoothly and successfully. While it takes the timeline out of our hands, it frees NanoLogix staff and resources to focus on further research and development of our technologies."

Entry Into Food Testing

NanoLogix is currently working with a third-party to develop a unique antibody for Listeria for use in pre-screening food packaging, food processing equipment and preparation surfaces and work areas. Tests of the efficacy of the antibody will occur at client facilities.

Patents Granted and Newly Filed

NanoLogix is pleased to announce it has received two additional patents for its BNC technology. The first is a foundational patent by China. The second (Patent No. US 8,067,154 B2) details how the NanoLogix BNC technology changes the shape of micro-colonies, thus allowing for more rapid detection and counting of cells. The company has multiple patent applications pending in China, India, Brazil, Japan, Russia and Europe for their BNC, BNP and BNF (BioNanoFilter) detection technologies.

In addition, the company this week filed a patent application under the International Patent Cooperation Treaty for a significant addition to its detection technology library.

American Journal of Perinatology Prints Group B Streptococcus Research Using NanoLogix Biotechnology

The peer-reviewed Group B Strep research from the University of Texas Health Science Center - Houston, previously available online, appeared in the November print issue of the American Journal of Perinatology. The research shows NanoLogix BNF test results for viable Group B Strep (GBS) in a total of 4 to 6 Hours. Established in 1983, the journal is the definitive forum for specialists in obstetrics, neonatology, perinatology, and maternal/fetal medicine, with emphasis on bridging the different fields.

Life Technologies Receives AFNOR Validation For Tests Designed To Detect Listeria Contamination In Food Samples

Life Technologies Corporation has received validation from the certification body of Association Francaise de Normalisation (AFNOR) for its MicroSEQ® Listeria spp. and MicroSEQ® Listeria monocytogenes assays, molecular tests that are designed to quickly and accurately detect the presence or absence of this food-borne pathogen that most recently has been associated with an outbreak in cantaloupes.

AFNOR certification, which validates alternative methods according to the ISO standard EN/ISO 16140 and applicable throughout Europe, enables customers there to adopt rapid testing methods with proven performance equivalency standards. The polymerase chain reaction (PCR)-based tests, along with Life Technologies’ full suite of sample preparation solutions and instruments, decreases the time to results (for negative samples) to 24 hours instead of 4-5 days when using the reference method.

The method equivalency findings for both Listeria species and Listeria monocytogenes products, which previously also received AOAC Research Institute validation for use in the United States, mark an important milestone for Life Technologies. The company now has both AOAC and AFNOR validation for its top four testing kits, including MicroSEQ Salmonella spp. and MicroSEQ® E.coli O157:H7. All four validated assays cover 90 percent of pathogens tested for by the food industry.

“Considering the rise of high-profile pathogen outbreaks in the last year alone, it’s clear that rapid and accurate molecular tests that have been validated by internationally recognized certification bodies is paramount to keep widespread contamination at bay,” said Nir Nimrodi, Vice President and General Manager, Food Safety and Animal Health. ”Life Technologies is creating partnerships with a growing number of customers in order to customize for them the most reliable suite of sample-to-answer detection solutions in support of their unique needs.”

Life Technologies has developed highly accurate and rapid testing solutions for a broad range of food products and environmental samples since 2008. The company has done so by leveraging its whole genome sequencing capabilities to design its assays. AFNOR and AOAC certification for its top four products – MicroSEQ® Listeria spp., Listeria monocytogenes, MicroSEQ® Salmonella spp. and E.coli O157:H7 – applies to the assays, the sample preparation workflow, the real-time PCR instrumentation and the data interpreting software.

Not for use in human diagnostic procedures.

Hygiene Assessment Tester Given All Clear for Breweries

The EnSURE hygiene quality monitoring system manufactured by Hygiena International has been assessed as suitable for use in breweries by The Campden BRI Instrument Assessment Service.

The EnSURE system comprises a hand held luminometer, together with surface swabs and liquid testing dippers, used to measure the Adenosine Triphosphate levels on working surfaces or other contamination-sensitive areas, as well as in water or other liquids. ATP is found in all living organisms, foods and beverages and its presence on surfaces or in liquids is used as a measure of cleanliness and contamination.

The EnSURE system can be used to test hygiene levels, the efficacy of surface cleaning procedures, as well as the quality of potable liquids, thus reducing the potential for microbial proliferation thereby safeguarding product safety and the brand. The equipment is easy to use, with results available within 15 seconds of the test procedure, and with a sensitivity of detection down to a level of 0.1 femtomole. The ease of operation, combined with the speed and accuracy of the results makes the system an ideal tool for monitoring all areas of production, handling and preparation for food and drink products, right through to the point of sale to the consuming public.

The Hygiena EnSURE system comprises a high quality single instrument that provides the platform for a variety of specific tests and a range of devices used to collect, analyse and provide data from multiple quality indicators. This hand-held luminometer is light-weight, robust, simple to use and flexible, providing high quality accurate monitoring for a wide range of applications. The seven button keypad is sealed and splash-proof, while being easy to both use and navigate for the operator.

Multiple tests can be undertaken with a single instrument, such as high sensitive hygiene monitoring (SuperSnap and AquaSnap), rapid detection of specific bacteria (MicroSnap) and enzymes used as process indicator (ZymoSnap). The instrument has twenty programmable test plans and 251 programmable locations per test plan, together with storage capacity for 2000 test results. The instrument runs off 2 x AA batteries (suitable for>6000 tests) and utilises an advanced solid-state technology.

The SuperSnap swab is a highly sensitive ATP test device suitable for surfaces requiring the highest standards of cleanliness, eg in support of allergen control programs. This is complemented by Hygiena AquaSnap liquid testing devices which provide a consistent sample collection size of 100µl. All the devices use liquid-stable reagents for superior reproducibility and sensitivity, covering a wide range of application requirements. Both these pen-sized testing devices are economical, easy to use and give real time results.

Monday, January 09, 2012

QIAGEN and Max Planck Institute for Infection Biology Collaborate to Develop Assay for Active TB Risk in Individuals With Latent Infection

QIAGEN N.V. and the Max Planck Institute for Infection Biology (MPIIB), Department of Immunology have announced a new collaboration to develop a molecular diagnostic test to assess the risk of an individual with latent tuberculosis (TB) developing active TB disease during their lifetime. Financial terms were not disclosed.

Approximately one-third of the world's population is estimated to be infected with Mycobacterium tuberculosis, but do not have active tuberculosis. The identification and treatment of these individuals is critical to controlling this disease since approximately 5-10% of latent TB patients are at risk for developing active TB during their lifetime, particularly those with weakened immune systems. As a follow-up to those who test positive for latent TB, this new test will be designed to enable early treatment before reactivation of the TB disease, when it becomes contagious and causes life-threatening respiratory illnesses and other diseases.

This new molecular reflex assay, which is based on significant research conducted at the MPIIB in Berlin, is expected to be a PCR-based test targeting multiple biomarkers. It will be designed to run on the QIAsymphony modular automation platform and to serve as a reflex test following QIAGEN's QuantiFERON-TB Gold test, the modern gold standard for detection of latent TB. The kits are not expected to be available before 2013 and will be commercialized by QIAGEN.

During TB infection, changes occur in the transcriptional profiles of immune cells circulating through blood - alterations in gene expression that reflect the body's immune response and help to distinguish between latent and active disease. The goal of QIAGEN's collaboration with the MPIIB is to format the most suitable markers from the sets of biomarkers identified by the institute into a molecular assay that can predict susceptibility or resistance to active TB disease in individuals with latent TB.

"We are excited to collaborate with the MPIIB to jointly create an innovative and advanced prevention tool against the global TB threat," said Dr. James Rothel, Vice President, Head of Scientific Affairs, at QIAGEN. "These assays are highly complementary to our QuantiFERON technology. We believe that the combination of 'pre-molecular' and DNA-/RNA-based molecular testing technologies is the next-generation solution for screening and identifying infected individuals before they develop active TB disease. This initiative has the potential to reduce the spread of infectious diseases significantly and also to generate cost savings by treating individuals before development of active TB. The collaboration with the MPIIB underpins QIAGEN's strategy to further expand its portfolio with new innovative assay technologies for profiling diseases to make improvements in life possible."

In the developed world, current screening protocols for TB typically identify individuals with positive test results (commonly up to 20% of high-risk patients screened) who need to be evaluated for active TB. A test combining TB infection markers with risk markers for the progression of latent into active TB could significantly increase the effectiveness of treatment options and disease control efforts. The market for latent TB testing is assumed to be approximately 50 million tests per year in the developed world.

"While the highest morbidity and mortality rates from TB disease occur in developing countries, global travel and immigration render TB a problem for the whole world," said Professor Stefan H.E. Kaufmann, Director of the Department of Immunology at the MPIIB in Berlin. "We believe QIAGEN, as a leader in infectious disease testing, is the right choice to help us reach new scientific achievements and jointly improve previously inadequate preventive, diagnostic and therapeutic tools for TB. Through this collaboration we will gain access to important technologies and concomitantly strengthen the further development of our vaccine program."

The Department of Immunology at the MPIIB is performing pioneering research on infectious diseases that threaten global health. One major project includes development of a vaccine against TB in combination with the definition of biomarkers to reliably distinguish between latent and active TB. "Results from this research may accelerate clinical trials of TB vaccines. Identification of biomarkers that can predict risk of active TB disease in individuals with latent TB will also be able to predict protective efficacy of a vaccine candidate early in clinical trial", explains Prof. Stefan H.E. Kaufmann.

Friday, January 06, 2012

ZyGEM and USAMRIID Sign CRADA for Development of Simplified Sample Processing Solutions for Biothreat Agents

ZyGEM Corp. Ltd., a developer and marketer of innovative products for the analysis of DNA and other nucleic acids, and the US Army Medical Research Institute of Infectious Diseases (USAMRIID), today announced the signing of a Cooperative Research and Development Agreement (CRADA) for the development of simplified sample processing solutions for biothreat agents. The two organizations will collaborate on the development, testing and validation of new solutions for the rapid and efficient extraction of DNA and other nucleic acids for the detection of biothreat agents and other pathogens from a variety of sample matrices, including buffer, serum, whole blood and swabs.

The CRADA effort will leverage ZyGEM's proprietary technology for the extraction of DNA and other nucleic acids from diverse samples using thermophilic enzymes produced by extremophile organisms. USAMRIID and ZyGEM intend to collaboratively explore the utility of a number of enzymes capable of isolating nucleic acids. ZyGEM's enzyme technologies will be evaluated and optimized to provide sample processing capabilities for the detection of a variety of biothreat agents and for use in challenging environments.

ZyGEM currently markets products based on a similar approach. The unique properties of its EA1 protease, the key ingredient in the company's prepGEM™, forensicGEM™, livestockGEM™ and RNAGEM™ families of nucleic acid extraction kits, make possible cost effective and flexible solutions for researchers performing a wide variety of studies, including human genotyping, animal testing and basic research. This enzyme has characteristics that make it well-suited for DNA and RNA extraction in a closed tube, where a simple temperature shift modulating enzyme activity rapidly provides high quality DNA and RNA that is ready for analysis by most PCR-based methods, while avoiding the contamination and low yields that can be encountered with other approaches.

"Molecular diagnostics offers the potential to increase the speed, efficiency and accuracy of pathogen detection, but its use has been limited by the fact that isolation of the nucleic acids needed for the analysis is often laborious and inefficient, yielding low quality material that is contingent on the target organism and the sample matrix," noted David Saul, Ph.D., senior scientist at ZyGEM. "We believe our enzymatic approaches have the potential to enable the rapid preparation of high quality DNA and RNA for the timely detection of biothreat pathogens from a variety of sample matrices simply and efficiently, which could be especially valuable for use in demanding conditions in the field. We are very pleased to be working with the infectious disease experts at USAMRIID to assess and develop new approaches that seek to harness our unique enzymes to help combat potential biothreats."

Roche's Novel Tests for the Management of Hepatitis C Virus Infection Receive CE Mark

Roche announced that its novel, state of the art Hepatitis C virus (HCV) qualitative and quantitative tests received CE mark. The tests detect HCV RNA, which is a crucial marker in the management of hepatitis C infection. In the new era of antiviral HCV therapies, sensitive detection and measurement of HCV RNA play an important role in determining treatment duration and predicting treatment response.

"The two tests provide a holistic solution for the management of hepatitis C infection: from the confirmation of a hepatitis C infection to the prediction and assessment of treatment response," said Paul Brown, Ph.D., Head of Roche Molecular Diagnostics. "Considering the rapidly changing hepatitis C treatment environment, we are pleased to provide two medically relevant tests on one fully automated platform. This offers clinicians the tools to manage their patients effectively and laboratories the automation and flexibility to maximize their workflow efficiency."

COBAS AmpliPrep/COBAS TaqMan HCV Qualitative Test, v2.0(1) is intended for the confirmation of HCV antibody positive specimens and COBAS AmpliPrep/COBAS TaqMan HCV Quantitative Test, v2.0 is intended for viral load monitoring and the prediction of virological response to antiviral therapy. Both tests are standardized with the World Health Organization (WHO) International Standard and have a limit of detection and lower limit of quantitation of 15 IU/mL. These characteristics make them medically relevant diagnostic tools in the management of hepatitis C infection.

Thursday, January 05, 2012

R&D Direction in 2012 for Sequencing Technologies Is Aimed at Clinical Medicine

Fast forwarding to the near future and based on the recent past, sequencing instrument companies will continue to develop more user-friendly and cheaper technology, focused on the benchtop and clinical markets. Manufacturers will also continue to form partnerships and make acquisitions that place heavy bets on completely novel, potentially disruptive sequencing technologies.

On a worldwide basis, life science research along with drug discovery and development applications currently comprise the two largest sequencing markets. They together accounted for about $920 million in 2010 and are expected to reach nearly $1.7 billion in 2015 with a compound annual growth of 13%.

By far the largest market opportunity, though, is in emerging applications of personal genomics and clinical diagnostics. These segments are expected to account for $541 million by 2015 from $15.5 million in 2010, representing a CAGR of 103.5%.

Recent advancements in the field of next-generation sequencing have resulted in the advent of so-called personal genome machines (PGMs), smaller-scale, benchtop genome sequencers marketed by Illumina (MiSeq), Life Technologies (Ion Torrent), and Roche 454 (GS Junior). PGMs bring DNA sequencing directly into individual laboratories and will impact the high-throughput sequencing (HTS) market in the process. Companies will continue to advance these machines, but those aiming at the clinical space will need to gain regulatory approval for their use in clinical laboratory diagnostics.

Life Technologies’ Investments

A key disruptive technology introduced to the market in 2010 by Life Technologies is the Ion Torrent DNA sequencer. It has set a completely new competitive bar in PGMs. This technology eliminates the need for optical readout, instead gathering sequence data by directly sensing hydrogen ions produced by template-directed DNA synthesis.

In less than a year since Life Technologies first commercially launched its PGM, the semiconductor-based instrument became the best-selling sequencing machine in the world. The technology provides low cost and scalable sequencing on a massively parallel semiconductor-sensing device, or ion chip. Reactions are performed using all natural nucleotides, and the individual ion-sensitive chips are disposable and inexpensive. The instrument combines fluidics, micromachining, and semiconductor technology, allowing direct translation of genetic information to digital information.

The firm has ambitious plans for the magic sequencing machine. Last October, the company announced that it will seek FDA 510(k)-clearance for the Ion PGM™ sequencer in 2012 in order to expand it into the clinical setting. The company’s R&D plans will also certainly focus on kits to accompany this PGM, including its AmpliSeq™ Cancer Panel. It is the first product utilizing Ion AmpliSeq technology and covering oncogenes and tumor suppressor genes.

Additionally, Life Technologies has placed a big bet on another potentially disruptive technology, privately held Genia’s biological nanopore technology. In April 2011, Genia closed a strategic investment with Life Technologies. The technology comprises an engineered pore protein embedded in a lipid bilayer membrane. Single-stranded DNA (ssDNA) with its double-stranded end inside the vestibule of the nanopore and single-stranded end threaded through the transmembrane of the nanopore travels through the central pore of the protein.

As the ssDNA travels through the pore, it attenuates the current traveling through the membrane in a sequence-dependent manner, each of the four bases interacting with the nanopore recognition site differently and partially blocking the ion current by a specific amount characteristic of that base’s unique electrochemical interactions with the nanopore recognition site. DNA sequences are computed from the residual currents flowing through the nanopore/DNA complex.

Genia co-founder and CEO, Stefan Roever, commented that the platform can actively control the DNA template, moving it back-and-forth through the nanopore multiple times if needed. "We can oversample, rewind, and read again. You change the applied voltage and the DNA goes backward. If you capture the DNA in the pore, you can ‘dental floss’ it; you can read it 10–20 times." Roever would not detail the read-out mechanism, other than to say, "our approach relies on some IT to reassemble those sequences.

"If Ion Torrent—electrical detection but requiring amplification—and Pacific Biosciences—single-molecule but optical—are third-generation sequencing technologies, then we’re fourth generation: single molecule, electrical detection," said Roever. "That’s the holy grail because it combines low-cost instruments with simple sample prep. So we’d like to think of it as last-gen!"

Illumina’s Strategy

Illumina is planning to extend the clinical reach of its MiSeq for diagnosing infectious diseases. The firm says that through its November 2011 alliance with Siemens Healthcare Diagnostics, it will also apply the technology to identify potential treatment paths for these diseases. The companies said they plan to make existing Siemens molecular HIV tests compatible with MiSeq.

Illumina, like Life Technologies, has also put a stake in the nanopore sequencing space through its deal with Oxford Nanopore Technologies. Oxford is developing its GridION system, which uses nanopores for the direct, electronic analysis of single molecules including DNA, RNA, proteins, and other molecules. The company says that its nanopore-based method obviates the need for amplification or labeling by detecting a direct electrical signal.

While the company has not disclosed key elements of the system’s operation, a 2010 paper in Nature Nanotechnology described some important aspects of the process. The paper was published by Oxford scientists and their collaborators at the University of Southern California (UCSC).

It describes the passage of ssDNA as it translocates through a protein nanopore. Movement of the ssDNA was controlled by polymerase-facilitated replication of individual DNA molecules and could be initiated under electronic control. Polymerase activity could be blocked in solution when the ssDNA was not at the nanopore opening, however, capture of the strand by the pore removes a blocking strand of nucleotides and allows the polymerase to function on the trapped strand.

Commenting on the technology, Jay Flatley, Illumina president and CEO said, "Oxford Nanopore’s technology holds tremendous promise to achieve the sub-$1,000 human genome. Making electrical measurements of unmodified DNA removes the need for complex sample prep and the high-performance optics found in today’s sequencing systems."

Agilent’s Pipeline

Agilent will continue to enhance the efficiency of its next-gen sequencing technologies and has moved to augment its SureSelect technology platform. SureSelect is the company’s front-end method for isolating complex subsets used in targeted resequencing, for example. SureSelect, the company has explained, replaces other labor-intensive methods of targeted resequencing such as PCR techniques.

Eric Endicott, Agilent’s global public relations manager, life sciences group, told GEN that the company’s November 2011 acquisition of Halo Genomics’ technology will complement Aglient’s SureSelect target-enrichment platform technology. Halo Genomics’ HaloPlex technology, Endicott said, provides a high-performance solution for small capture sizes, at a speed that specifically addresses the needs of the desktop sequencing market.

In addition to expanding Agilent’s portfolio of solutions for the rapidly growing next-generation sequencing market, Halo Genomics’ technology further pulls Agilent’s target capture solutions toward the next-generation clinical sequencing market.

New Kid on the Block

Massachusetts 2010 startup Noblegen says its nanopore-based technology usually requires complex instruments, but has the potential to deliver high speed and low costs. Noblegen says its technology’s ability to directly and rapidly read DNA sequences could make it economically feasible to bring sequencing technology into clinical labs to diagnose cancer and other diseases.

Noblegen’s technology works by first converting genomic DNA into a synthetic version that’s labeled with four different fluorescent dyes, one for each type of base. Each base in the original sequence is represented by one fluorescently labeled segment in the synthetic one.

The synthetic sequences are then directly read out by Noblegen’s relatively simple instrument based on a silicon chip with pores a few nanometers in diameter and illuminated by an inexpensive laser. The long, charged synthetic molecules are pulled through the hole by electrostatic forces. As the DNA moves through the pore one segment at a time, the labels become detached, creating a flash of light that is then imaged by a CMOS sensor similar to those used in digital cameras.

NobleGen co-founder and CEO Frank Feist has said that the company’s goal is to aggressively drive down the cost and increase the speed of sequencing whole genomes to a point where it makes economic sense for hospital labs in the next three or four years.

While the company won’t divulge details of its current instrument prototypes, Feist noted that the technology could be scaled up to arrays of 400 by 400 nanopores that sequence over 500 gigabases an hour—or about one genome, covered 30 times, in 15 minutes.

All around, sequencing equipment manufacturers run some financial risk from spending cutbacks by research labs for this year. But all are focused on staying ahead of the technology curve through smaller, faster, and less expensive instrumentation. They are also counting on the future of clinical sequencing.

BioVigilant Changes Name to Azbil BioVigilant, Inc.

BioVigilant Systems, Inc., inventors of Instantaneous Microbial Detection™, announced today that it has changed its name to Azbil BioVigilant, Inc. The name change reflects the Company's alignment with its corporate parent, Yamatake Corporation of the azbil Group, to focus its 47 subsidiaries and affiliates around a common philosophy of "human-centered automation."

"Since Yamatake's formation in 1906, the company has not wavered in its focus to create and deliver value to society. It is this longstanding view that drives the philosophy bringing together the many family members now comprising the azbil Group. Azbil BioVigilant's mission - to pioneer innovative technology that elevates the level of quality assurance and productivity achievable in controlled manufacturing environments - is a natural fit with this philosophy," said Aric Meares, President and CEO of Azbil BioVigilant. He added, "With the resources of a 105-year-old company with over 8000 employees and FY2010 revenues approaching $3 billion dollars (219.2 billion yen), our mission objectives are well supported."

In May 2009, Yamatake Corporation acquired the majority stock of BioVigilant, extending its expertise in automation which includes a growing portfolio of products and solutions organized into Building Automation, Advanced Automation and Life Automation business units. Collectively, azbil Group companies create value for customers and society in environmental preservation and energy conservation, health and safety, quality of life, and human productivity. Effective April 1, 2012, Yamatake Corporation also will transition to the new corporate name of Azbil Corporation.

Sunday, January 01, 2012

Bacterial ID In A Half-Hour

A doctor can wait for days to get laboratory results identifying the microbe behind a patient’s illness. But a new biosensing chip can do the same thing on-site in minutes. The chip both breaks apart cells and detects bacterial DNA in a novel all-in-one test.

A rapid method to identify bacteria is a “pressing unmet need,” says Shana O. Kelley at the University of Toronto. After taking a sample from a patient, doctors depend on either growing the bacteria on a culture plate, which can take days, or amplifying the bacterial DNA using polymerase chain reaction, which requires pure samples and expensive equipment.

Kelley decided to tackle the problem with a biosensor that can detect a microbe’s nucleic acids without sample preparation or complex equipment. Earlier this year, Kelley’s group developed a highly sensitive bacterial DNA-sensing chip that could spot DNA even in unpurified samples. But the researchers still had to break open the bacterial cells—a process called lysis—to release the DNA before applying the samples to the chip. To make a more useful clinical test, they now have added a lysis chamber to the chip.

Their two-step testing cartridge is not much bigger than a domino. It first applies an electrical field to the sample to break cells apart. Then biomolecule probes bind to DNA from specific disease-causing bacteria, triggering an electrochemical reaction that reports the binding.

The researchers put their system to the test by adding probes for two common microbes responsible for urinary tract infections: Staphylococcus saprophyticus and Escherichia coli. The cartridge detected both bacteria in urine at levels as low as one cell per microliter, which makes it sensitive enough to be made into a tool doctors could use. Kelley says the cartridge can be tweaked to detect up to 100 types of pathogens at once and would be easy to make in bulk.