Sunday, March 31, 2013

bioMérieux Salmonella Test Gains Approval

bioMérieux has had its automated test for the detection of salmonella species granted Official Methods of Analysis (OMA) approval on food products and environmental samples.

The Vidas Up Salmonella (SPT) test received the backing from Association of Analytical Communities (AOAC) International, including approval for 375g samples.

AOAC, founded in 1884, is an independent, third-party, nongovernment association of international industry organisations, government agencies, research institutions, and individual scientists. The association is delivering international voluntary consensus standards, Official Methods of Analysis (OMA), Performance Tested Method (PTM) certification, laboratory proficiency testing programs, laboratory accreditation criteria, and scientific information and opportunities. The methods are used globally to promote trade and to facilitate public health and public safety.

Vidas Up Salmonella enables savings in media ancillary materials and labour time, while providing results in as little as 19 hours.

Thursday, March 28, 2013

Nanotube Sensor Test Could Lead to Accurate Lyme Disease Diagnosis

A new, more accurate Lyme disease test may result from a nanotechnology device developed by University of Pennsylvania researchers. The carbon nanotube technique was published in the Journal Biosensors and Bioelectronics.

Lyme disease, an infection spread by ticks carrying the bacterium Borrelia burgdorferi, is difficult to treat when it progresses to later stages. However, existing diagnostic tests for the disease are often unreliable in early stages- according to researchers, almost one of four Lyme disease patients is misdiagnosed. Current diagnostic tests for Lyme disease assess blood for antibodies against the bacteria, but these tests are typically not useful until an infected person's body has had enough time to build up antibodies.

"When you're initially infected with the Lyme disease bacterium, you don't develop antibodies for many days to a few weeks," said lead researcher A.T. Charlie Johnson, a professor of physics, in a press release.

"Many people see their physician before antibodies develop, leading to negative serological test results. And after an initial infection, you're still going to have these antibodies, so using these serological diagnostics won't make it clear if you're still infected or not after you've been treated with antibiotics."

The researchers created microscopic biological sensors for Lyme disease bacteria using carbon nanotubes- flexible, electrically conductive cylinders of linked carbon atoms. Instead of detecting antibodies, like existing tests, the nanotube sensors directly sensed the presence of proteins from the bacteria themselves.

According to the release from the University of Pennsylvania, the researchers connected Lyme disease antibodies to the surface of the nanotube sensors, which were charged to deliver electric signals whenever Lyme disease bacterial proteins attached to the antibodies. Then, they immersed the antibody-covered nanotube sensors in liquid solutions containing the target proteins.

The results showed that the nanotube sensors successfully detected minute concentrations of the Lyme disease bacterial protein.

"This sensitivity is more than sufficient to detect the Lyme disease bacterium in the blood of recently-infected patients, said Dustin Bresson, a study coauthor and assistant professor of biology, in the release, "and may be sufficient to detect the bacterium in fluids of patients that have received inadequate treatment."

With this success under its belt, the University of Pennsylvania team hopes to develop the nanotechnology technique into a rapid Lyme disease test. They hope that nanotube sensor test will provide more accurate diagnosis than existing antibody tests, even in early stages of the infection.

According to the Centers for Disease Control and Prevention (CDC), Lyme disease infects at least 25,000 per year in the United States. Early symptoms include fatigue, chills, fever, and joint aches, which progress to a "bull's-eye" rash and, in late stages, to arthritis and permanent neurological problems.

Source: Medical Daily

T2 Biosystems Completes $40M Financing to Support Clinical Programs and Commercialization of Sepsis Diagnostics

T2 Biosystems today announced the completion of a $40 million financing to support the clinical programs and commercialization of T2CandidaTM, the Company’s flagship molecular diagnostic test panel for the sensitive and rapid identification of species-specific Candida fungal infections directly from whole blood. The Company also intends to use the proceeds to complete development of additional sepsis diagnostic panels and to advance and expand its research and development of other molecular, immunodiagnostic and hemostasis assays. The round was led by new investor Goldman Sachs and joined by existing investors Flagship Ventures, Polaris Partners, Aisling Capital, Flybridge Capital Partners, Physic Ventures, Arcus Ventures, Partners Healthcare, Camros Capital and WS Investments.

“We believe T2 Biosystems’ breakthrough T2MR® technology has the potential to change the clinical diagnostics landscape, and we are excited to support John and his strong management team as they guide T2Candida through clinical development and commercialization,” commented T.J. Carella, Managing Director at Goldman Sachs. “This financing will enable the Company to bring to market its innovative T2Candida test and continue to advance a broad range of other products in development.”

T2 Biosystems is developing the first-ever diagnostic system capable of direct detection through the Company’s proprietary technology, T2MR. With sensitivity as low as 1 CFU/mL and diagnostic results up to 25 times faster than current methods, T2MR achieves industry- leading performance. T2MR uses miniaturized magnetic resonance to directly detect molecular, immunoassay or hemostasis targets in any clinical sample, including blood, sputum and urine.

“This financing demonstrates the enthusiastic support of our investors for our breakthrough T2MR technology that can rapidly and accurately detect virtually any target directly from complex clinical samples, such as whole blood,” said John McDonough, President and CEO, T2 Biosystems. “The new funding will support the clinical trial and launch of our innovative T2Candida test as well as fund the continued progress of our broad range of molecular, immunoassay and hemostasis products.”

About Sepsis & Candidemia

Sepsis is a potentially life-threatening illness caused by the body’s severe reaction to infection by bacteria, fungi, viruses or parasites. It is one of the top 10 leading causes of death in the United States, and each hour of delayed treatment increases the mortality of these patients by 8%. Candida is a fungal pathogen known to cause sepsis, and it is associated with approximately 100,000 cases of candidemia in the U.S. annually, making it the fourth leading cause of hospital-acquired infections.

Currently, candidemia has a 40% mortality rate, which can be reduced to 11% with early identification of the specific species. Current detection methods rely on blood culture, a process that can take two to five days before identifying a Candida infection. The T2MR platform is able to detect species-specific Candida directly from whole blood without the limits experienced with optical detection technology, even at low copy numbers, and provide results in approximately three hours.

Wednesday, March 27, 2013

Veolia and bioMérieux to Cooperate on Monitoring System for Drinking Water Quality

At Biovision, the world life sciences forum, Veolia Environnement, global leader in water services and expert in environmental services, and bioMérieux, global player in in vitro diagnostic solutions and world leader in industrial microbiology, announced today they have signed an agreement to undertake a research partnership. This partnership aims at developing an innovative technology for the continuous monitoring of the microbiological quality of drinking water. A preliminary step will be a study to assess the project's technical and economic feasibility.

This cooperation agreement between two industry leaders in their respective fields brings together complementary expertise and experience to contribute to protecting consumer safety and improving public health around the world.

Antoine Frérot, Chairman and Chief Executive Officer of Veolia Environnement, said: "Health protection is a key issue for our businesses, especially for water. Today, major efforts in innovation are needed to make further advances. This partnership illustrates, once again, our capacity to innovate, through an unprecedented combination of expertise in the fields of water and health. It is an ambitious way to meet the new public health challenges in water, with real prospects in France and other countries."

Said Alain Mérieux, founder of bioMérieux and Chairman of Institut Mérieux: "Water quality and access to safe drinking water are major public health challenges around the world, especially in developing countries. My commitment in the field, working with Fondation Mérieux, has made me acutely aware of the scale of these problems. I am very pleased with the agreement signed between bioMérieux and Veolia Environnement. Starting in France, it will enable us to develop new technologies that contribute to water quality and, more broadly, to the quality of the environment. We will thus help to prevent sanitary risks that can have major consequences for human health."

The challenge of this partnership is to adapt the microbiological control methods developed by bioMérieux for the biopharmaceutical and agri-food industries to the water industry. It involves detecting, more rapidly than with current techniques, the microorganisms in the natural environment or in water supply networks, as well as any contamination, whether accidental or due to bioterrorism. The partnership should lead to the development of an easy-to-use solution that could be implemented widely. It would be a promising scientific advance to have a precise evaluation of  the microbiological quality of drinking water at every stage of the  production chain, from the source to the consumer's tap, passing through the production plants and supply networks. In the event of a sanitary crisis, it would also enable the presence of microorganisms to be detected (bacteria, viruses and parasites, in particular).

The combined scientific expertise of the two partners, especially in infectious diseases and the modeling and control of water distribution networks, should accelerate the development of a high-value-added solution for monitoring drinking water quality.

bioMérieux is a highly specialized player in in vitro diagnostics, particularly in clinical and industrial  microbiology, two sectors where the company is world leader. Its main goal is to develop and market innovative solutions in diagnostics that meet the new health and economic challenges. With a mastery of different diagnostic techniques, bioMérieux could use flow cytometry, a technique for rapidly detecting microorganisms, in this cooperation project.

Quidel Receives CE Mark for Its Molecular Diagnostic Test for Herpes Simplex Viruses (HSV 1, HSV 2) and Varicella-Zoster Virus (VZV)

Quidel Corporation (NASDAQ: QDEL), a provider of rapid diagnostic testing solutions, cell-based virology assays and molecular diagnostic solutions, announced today that it received the CE Mark for its Quidel Molecular Direct HSV 1+2/VZV assay for the differentiation and detection of herpes simplex viruses 1 and 2 (HSV 1+2) and varicella-zoster virus (VZV) in active lesions.

Quidel's new PCR assay kit distinguishes between three infectious diseases: HSV 1, the virus responsible for most cold sores and some genital herpes transmissions; HSV 2, the virus primarily responsible for most genital herpes and some cold sores; and VZV, the virus responsible for chicken-pox in children and shingles among adults.

"The Centers for Disease Control and Prevention (CDC) estimates that there are almost 800,000 new cases of herpes in the United States each year, and about 1 in 6 Americans aged 14 to 49 have a genital HSV 2 infection,"1 said Dr. Timothy Stenzel, M.D., Ph.D., chief scientific officer of Quidel. "Although the classical signs of herpes are easy enough to recognize, the majority of patients present with atypical lesions that can be misinterpreted or confused among these three or other infections. For this reason, the introduction of a fast and accurate molecular test that distinguishes between HSV 1, HSV 2 and VZV is not only desirable, but is also consistent with recently issued European guidelines on managing genital herpes."2

The Quidel Molecular Direct HSV 1+2/VZV assay is part of Quidel's expanding line of molecular diagnostics products. The Quidel Molecular product line offers PCR reagent kits for use by molecular diagnostic laboratories with their existing thermocyclers. These reagents provide attractive features that include refrigerated storage instead of freezing, ready-to-use reagents, a short time to result, and other benefits that favorably affect diagnostic test outcome.

The Quidel Molecular Direct HSV 1+2/VZV assay kit includes an extraction-free, three-step sample preparation process that requires no heat step, no timed step, and no centrifugation as added benefits. This fast and easy direct-to-amplification procedure allows the assay to generate a result in under an hour.

"We are pleased to receive the CE Mark for our fifth Quidel Molecular assay," said Douglas Bryant, president and chief executive officer of Quidel Corporation. "Our Quidel Molecular Direct HSV 1+2/VZV assay allows us to offer a molecular complement to our best-selling ELVIS cell-based assay for herpes detection. Hospital workers will now have the ability to quickly diagnose similar herpes diseases in children and adults through the characterization of samples obtained from lesions."

Quidel offers other CE Marked and 510(k)-cleared molecular tests in the Real-Time PCR format for Influenza A+B, hMPV, RSV + hMPV and C. difficile.



Saturday, March 23, 2013

High School Student Scientist Wins Multiple Honors for Research Including Rapid Methods

This year, Fallbrook High senior Jillian Drake will compete for the fourth time at the Greater San Diego Science and Engineering Fair (GSDEF) which is in its 59th year. Drake has been the only Fallbrook High Student to ever compete at the county or state level science fairs, where she has placed first in her divisions of microbiology, environmental science and plant science for the last three years, and had been selected to compete at the California State Science Fair where she has also placed.

Drake has completed three projects researching the plant bacteria ‘candidatus liberibacater’ responsible for highly destructive diseases in huanlongbing or greening in citrus, psyllid yellows in tomatoes and zebra chip potatoes which have caused billions of dollars in lost crops worldwide. Drake conducted her research at the USDA-Agricultural Research Service National Clonal Germplasm Repository for Citrus laboratory in Riverside, under the plant pathologists Dr. Richard Lee, Dr. Manjunath Keremane and Dr. Chandrika Ramadugu.

Her first project, completed as a freshman, was "A new rapid processing method for the detection of ‘candidatus liberibacter’ bacteria in psyllid vectors" which developed and validated a new method of DNA extraction which was more significantly more efficient and less costly to perform than the current method used at the time to detect this bacterium in the field.

She has recently completed a two year project also at the USDA-ARS, "Chromosomally integrated bacteriophage in ‘candidatus liberbacter’ bacteria and its effect upon disease expression" which investigates the role of bacteriophage in disease expression for these same bacteria. Additionally, Drake completed a project at the USDA-ARS Soil and Salinity Laboratory, also in Riverside studying the effects of solarization on soil fungus and invasive weed mortality, and creating a mathematical model which predicts the effectiveness of solarization at various temperatures and heat duration intervals.

As an active member of the Fallbrook Chapter of FFA, Drake has also competed with her agriscience projects within the FFA, where she has won overall best science project in the state multiple times and has competed nationally multiple times, placing gold and silver. Also within FFA, she has won state proficiency for agriscience plant research and was a national finalist, and has also been selected to compete for the 2013 California State FFA Star Agriscience Student. Additional awards for Drake’s work include being selected as a finalist in the Junior Humanities Science Symposium Southern Region, semi-finalist (2011) and finalist (Top 5 2012) for the National Christopher Columbus Agriscience Student competitions as well as being selected to present her work to regional organizations such as the American Society of Microbiologists.

Over the last four years, Drake has worked over 2000 hours in her research efforts and has earned several thousand dollars in awards. When not in the research lab, she is active at Fallbrook High where she has been in the FFA since her freshman year. Within the FFA, she is a chapter officer and has competed on many teams including the parliamentary procedures, extemporaneous speaking and judging teams.

Additionally, Drake has been a member of the Fallbrook High tennis and track teams, a student leader in the ASB, holding multiple offices over many years, an editor for the Fallbrook High newspaper, on the yearbook staff, as well as being selected to be on the frosh, JV and senior academic teams and the academic decathlon teams. Drake is planning on pursuing a professional career in science focusing on microbiology and immunology.

Source: Fallbrook Bonsall Village News

Thursday, March 21, 2013

New EPA Rapid Water-Quality Test May Prevent Unnecessary Lake Michigan Beach Closures

A new rapid water-quality test may prevent beaches from being closed by providing accurate same day results of bacteria levels, according to a study by the U.S. Geological Survey.

With increasing outbreaks of waterborne illnesses, beaches have been at the forefront of recent research on human health risk. This new rapid water-quality test, developed by the Environmental Protection Agency, will help managers across the country determine whether beaches are safe for swimming in order to keep the public from getting sick. Previous tests could not provide same-day results, so managers had to decide whether to close a beach based on findings from the day before.

USGS scientists analyzed the accuracy of EPA’s rapid test by looking at past water quality data from five beaches along Lake Michigan to determine what the outcomes would have been if the rapid test was used. These findings were then compared to two older methods of testing which require 24 hours for results.

Scientists discovered that results from the rapid test met EPA’s safe swimming criteria more often than the older tests. If this method had been used during the study period examined, the summers of 2009 and 2010, it might have prevented hundreds of beach closure days and possibly significantly decreased incidences of waterborne illnesses.

“This study provides beach managers with a virtual “test drive” of this tool; it gives them an idea of what they can expect in terms of beach monitoring decision making,” said USGS scientist Meredith Nevers, of Chesterton.

“Our research shows that EPA’s rapid test can be an effective tool for beach managers to help keep their recreational beach goers happy and safe,” she said.

Beach closures not only impact recreational users in the summertime, but they also create huge losses for the local economy. Studies have found that the value of a beach trip is between $20-$36 per person per day — revenue which may be lost to local economies when beaches are closed.
The new rapid test, called quantitative polymerize chain reaction for enterococci, is recommended by the EPA, but is not a requirement.

The test has been included in the 2012 EPA guidelines for safe levels of indicator bacteria, including Escherichia coli (E. coli) and enterococci.

The test can be used at both freshwater and marine beaches.

Saturday, March 16, 2013

New Biosciences Company Driving Innovation to Improve Patient Care

A new company that is gearing up to “change the entire field of microbiology” officially launched its objective Thursday with a grand opening of its new headquarters and state-of-the-art laboratory space.

Accelerate Diagnostics, which moved into Pima County’s public health department building on South Country Club, is working to develop a rapid infection-detection testing system that could identify pathogens within hours, instead of what can otherwise be days using current technology. And with antibiotic-resistant bacterial infections on the rise, the company is also working toward rapid detection of drug resistance.

CEO Larry Mehren, formerly an executive with Ventana Medical Systems, said there were a number of advantages in moving the company from Denver to Tucson, including an affordable housing market and the proximity to the University of Arizona, as well as a growing sense of potential throughout the area. “This is absolutely the right place for us to be.”

He thanked the County, including County Administrator Chuck Huckelberry, for the creativity involved with the relocation, including meeting the company’s needs for a specialized wet laboratory space that uses liquids to conduct experiments on bacteria and fungi.

Relying on a low-interest loan from the Arizona Commerce Authority, the County developed the lab space, which will be able to support biotech research for years to come.

“We saw the potential of what could be,” said Board of Supervisors Chairman Ramón Valadez, applauding what he characterized as the first of many future milestones. Through the efforts of a lot of creative people, he added, “We have come up with a solution that fits and that not only fits today, but fits into the future to help this industry grow in our community.”

Mehren has already hired 30 people and is continuing to hire other scientists and engineers, with the potential to double the staff within the next year.

“These folks are just the vanguard of what is to come,” he said, adding he also anticipates his company’s success will also attract other similar companies.

Steve Eggen, the Chairman of Tucson Regional Economic Opportunities, said the company serves as an example of the bigger blueprint to grow biosciences. “This is really a great, tangible seedling of what we want to do in really getting into the biosciences,” he said. “It’s exciting to see it.”

Thursday, March 14, 2013

Lonza and Hyglos GmbH Reach Agreement for Endotoxin Detection Patents

Lonza Walkersville, Inc. and Hyglos GmbH, a German biotech company, announced today that they have reached a mutually beneficial global settlement which includes a license agreement for Hyglos under certain Lonza patents in the area of endotoxin detection. Specifically, the agreement allows Hyglos to use recombinant factor C technology protected by Lonza’s patents to produce Hyglos’ own endotoxin products. The agreement also includes the dismissal of the law suit Lonza previously filed against Hyglos.

The terms of the settlement are confidential.

“Thanks to this agreement an important door has opened for a new era in endotoxin detection. We are convinced that Hyglos’ innovative assays, entirely based on recombinant molecules, are addressing important needs of endotoxin testing laboratories worldwide” said Dr. Wolfgang Mutter, General Manager of Hyglos GmbH.

“We are very glad to have reached this agreement with Hyglos. Endotoxin detection using recombinant factor C instead of Limulus amoebocyte lysates has recently been acknowledged by the FDA as an alternative method. We believe that this sustainable animal-free alternative will be the future of endotoxin detection.” concluded Dr. Teun Van der Heide, Head Lonza Bioscience.

Wednesday, March 13, 2013

Nanosphere Obtains CE Mark for Gram-Negative Blood Culture Test

Nanosphere, Inc. announced today it has obtained the CE IVD Mark under the European Directive on In Vitro Diagnostic Medical Devices for its Gram-Negative Blood Culture test (BC-GN) on the automated sample-to-result Verigene® System.

The Gram-Negative Blood Culture test notably expands Nanosphere's infectious disease test capabilities to include rapid detection of bacteria that can cause deadly bloodstream infections, an increasingly recognized health threat. With a single automated test, the Verigene BC-GN test provides rapid genus and species level detection for a broad panel of clinically significant gram-negative bacteria. The BC-GN test also detects critical genetic markers of antimicrobial resistance, including KPC, NDM, CTX-M, OXA, VIM, and IMP. These markers include carbapenem-resistant Enterobacteriaceae (CRE) which are extremely difficult to treat bacteria that have become resistant to most antibiotics and can result in a 50% mortality rate in infected patients.  Furthermore, the prevalence of these multi drug-resistant gram-negative bacteria is increasing worldwide. Fast and accurate detection of these antimicrobial resistance markers provides clinicians vital information to manage these often difficult-to-treat gram-negative bloodstream infections.

"The Gram-Negative Blood Culture test provides clinicians a revolutionary diagnostic tool for the simultaneous detection of disease-causing gram-negative bacteria and accompanying antibiotic resistance markers in a clinically actionable timeframe," said Michael McGarrity, Nanosphere's Chief Executive Officer.

The BC-GN test provides identification of bacteria and resistance genes from gram-negative blood culture bottles in less than two hours, as compared with current microbiological methods, which can take up to 2-3 days. The sample-to-result test automates the steps of bacterial DNA extraction, hybridization and target detection on the Verigene System. The ease-of-use and rapid turnaround time of the test allow hospitals of any size to benefit from the speed and accuracy of automated molecular testing.

The Gram-Negative Blood Culture test* complements Nanosphere's broadening menu of infectious disease tests including:
  • Gram-Positive Blood Culture test (BC-GP) to detect bacteria, including antibiotic resistance markers, that may cause bloodstream infections (510(k) cleared; CE Mark)
  • Respiratory Virus Plus test (RV+) to detect multiple respiratory viruses which cause respiratory tract infections (510(k) cleared; CE Mark)
  • Clostridium difficile test (CDF) to detect potentially deadly C. difficile and identifies the 027 hypervirulent strain (510(k) cleared; CE Mark)
  • Enteric Pathogens test (EP) to detect multiple bacteria, viruses and toxin genes which cause gastrointestinal infections (In Clinical Trials). Nanosphere plans to commercialize the Enteric Pathogens test in 2013 following receipt of the necessary regulatory approvals.
*The BC-GN test in not 510(k) cleared in the United States.

Solomons Dengue Diagnoses Dependent on Rapid Testing Kits

A top health official in Solomon Islands says the authorities have ordered more testing kits for a dengue fever outbreak that has killed one person in the capital, Honiara.

A state of emergency is in place at the national referral hospital to enable staff to defer all non-emergency patients in favour of those with the mosquito-borne illness.

The ministry of health’s permanent secretary says it is the first time there has been such a large scale outbreak in Solomon Islands and there are at least 169 people known to have the illness.

Dr Lester Ross says the ability to diagnose further cases depends on the availability of rapid diagnostic testing.

“With the limited number of RDT we have we are not doing RDT on every single case of fever. There are some warning signs like people with some abnormal bleeding or severe abdominal cramp or dehydrated or vomited - these are the cases they do the rapid diagnostic test.”

Dr Lester Ross says at the moment, Solomon Islands has about 500 rapid diagnostic tests.

Tuesday, March 12, 2013

Quidel Receives FDA Clearance for Its Molecular Diagnostic Test for RSV and hMPV

Quidel Corporation announced today that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for its Quidel Molecular RSV + hMPV assay for the detection of respiratory syncytial virus (RSV) and human metapneumovirus (hMPV).

The assay distinguishes between RSV and hMPV, two different viruses that cause respiratory infections with very similar symptoms. The FDA's 510(k) clearance grants Quidel authorization to market its Quidel Molecular RSV + hMPV assay in the United States. The product launched in Europe shortly after receiving the CE Mark in March of 2012.

"RSV and hMPV infections are relatively common diseases among children, and the symptoms can be indistinguishable from each other. Often, these infections can mimic flu-like illness, and can cause ambiguity in assigning a course of treatment," said Dr. Timothy Stenzel, M.D., Ph.D., chief scientific officer of Quidel. "For these reasons, a duplex test such as the RSV + hMPV assay can prove to be very valuable."

This is one of several forthcoming assays from Quidel's expanding molecular diagnostics programs. The Quidel Molecular product line offers PCR reagent kits for use by molecular diagnostic laboratories with their existing molecular testing infrastructure, such as Life Technologies' Applied Biosystems(R) 7500 Fast DX thermocycler. These reagents provide attractive features that include simple transport and refrigerated storage (no freezer required), convenient workflow, a short time to result, and other benefits that favorably affect diagnostic test outcome. Because they share a common extraction protocol, the RSV + hMPV assay can be batched alongside other Quidel Molecular assays, such as Influenza A+B PCR assay, in the same multi-well panel for customized multiplexing capability.

"We are pleased to have received FDA clearance for another molecular diagnostic product," said Douglas Bryant, president and chief executive officer of Quidel Corporation. "We intend to broaden our menu of molecular assays over the next several quarters, and in doing so, will provide our customers with a number of easy to use infectious disease tests that can be run on their existing thermocyclers."

The RSV + hMPV assay is Quidel's third molecular PCR assay to receive 510(k) clearance. Quidel previously received FDA clearance for Quidel Molecular assays for Influenza A+B and hMPV. Quidel also received FDA clearance for its C. difficile assay in the AmpliVue(R) format in December of 2012.

Radical New Research Could Revolutionize Airborne Bacteria Detection

A new research project by scientists at the University of Ulster could revolutionize the way airborne bacteria is identified and the speed at which it is detected.

The School of Engineering at Jordanstown has received a major grant worth £600,000 from the Engineering and Physical Sciences Research Council (EPSRC) to explore the possibility of developing a portable, compact device that could immediately diagnose pathogens such as hospital superbugs.

The joint, three-year research project in collaboration with the University of Glasgow is worth £1m in total and if successful, may also transform the detection of pathogenic warfare agents such as anthrax and even extra-terrestrial life.

Professor Paul Maguire from the University’s Engineering Research Institute said: “We are looking at quite radical approaches to the serious challenge of instant or almost instant pathogen detection.

“Instead of trying to identify airborne bacteria by their microbiological properties alone, we will be looking at their precise physical structure in the hope that this will allow us to separate different strains of the target bacteria and become the basis for a rapid detection and early warning system.

“At present, standard laboratory culture techniques can require up to 48 hours delay for pathogen identification.

“Our multidisciplinary team includes physicists, microbiologists and electronic engineers who will be working on building a small proof of principle device to constantly monitor the air and issue an instant warning when it identifies the target bacteria it has been pre-programmed to detect.”

Viable, portable, immediate detection technology for pathogenic bacteria could have major impact in a hospital and public building environment, as a method of limiting airborne infection.

The development of a mobile, real-time detector would allow the source of any airborne outbreak to be traced and contained quickly.

It may also have an impact in the development of lightweight detectors for space missions searching for extra-terrestrial life and assist in the fight against international terrorism.

Added Professor Maguire: “The ongoing threat of pathogenic agent dispersal, whether chemical, nuclear or biological is a priority for governments worldwide.

“The static detection systems, set up in the USA in the wake of 9/11 can still take between six and 48 hours to identify a pathogen.

“Portable, compact, immediate, early-warning technology could limit the impact and greatly assist the management of any threat.

“Normally you don’t get physicists trying to detect bacteria, usually it is a microbiological problem, but we are coming at things from a different perspective and hopefully by sharing this challenge between physics, biology and engineering, we can make a significant advance on what is a longstanding and critical technological challenge.

“The theories that this research is based on have never been developed before and often radical scientific ideas can take up to 20 years to work, however, we will be trying to do things a bit quicker than that.

“We have three years to build a prototype and prove that identifying airborne pathogens by their physical properties will work.”

Director of the Engineering Research Institute, Professor Jim McLaughlin said: “This award from the is a reflection of the historic and strong tradition of engineering and the applied sciences at Jordanstown.

“In particular it is a reflection of the international status of our fast growing research capability with our Engineering Research Institute and the underpinning teaching of the School of Engineering.

“There will be many benefits to our wider research strands associated with Connected Health, Clean Technology, Nanotechnology and Tissue Engineering.”

UTHealth Researchers Say More Rapid Test for Group B Strep Successful

A more rapid laboratory test for pregnant women to detect potentially deadly Group B strep (GBS) has been successful at identifying GBS colonization in six and a half hours, according to the results of a study from The University of Texas Health Science Center at Houston (UTHealth).

The more rapid test could be helpful for the 13 percent of patients who experience pre-term labor before they are screened for GBS, which usually occurs between 35 and 37 weeks of gestation. The current standard test takes 48 hours. Antibiotics can be administered at the time of delivery to kill the bacteria.

"This new test could change the management of patients who present to labor and delivery with threatened preterm labor and are not expected to deliver right away," said Jonathan Faro, M.D., Ph.D., assistant professor in the Department of Obstetrics, Gynecology and Reproductive Sciences at The University of Texas Medical School at Houston, part of UTHealth. "It would likely gain use in this patient population, which is a small number, but still very significant clinically. We could target this population and this would help cut down on overuse of resources and minimize our contribution to the increased level of bacterial resistance."

The new test, developed by NanoLogix, can also detect antibiotic sensitivities for women who are allergic to penicillin, saving the additional 48 hours the standard test for antibiotic sensitivity takes, Faro said.

GBS is the most common cause of sepsis (blood infection) and meningitis and a frequent cause of pneumonia in newborns, according to the Centers for Disease Control (CDC). The CDC estimates the bacterium, which is passed from mother to child through the birth canal, is carried by 25 to 30 percent of women at any one time. Because GBS has few symptoms, many women do not know they are carriers. In 2001, 1,700 babies less than 1 week old contracted GBS, which can lead to disability and death.

In the study, 356 patients at 35 to 37 weeks of gestation at UT Physicians clinics were tested for GBS using two standard tests and the new test, which provided a high level of validity according to the study results.

Faro is studying an even faster version of the test with the hope it could detect GBS in as little as 30 minutes. That could make a difference for the up to 15 percent of pregnant women who arrive for full-term delivery and have not been screened. Right now, obstetricians must determine whether to give these women intravenous antibiotics automatically or use risk factors, which have been shown to be only half as effective as laboratory tests, to assess whether the patient has the bacteria.

"Typically, if a patient comes into the emergency room in labor and you don't know if she carries GBS, you have to treat her with antibiotics," Faro said. "Everyone is concerned that the overuse of antibiotics is leading to greater resistance to them. Some have expressed concern that by giving penicillin to everyone, we are increasing the number of babies who are getting sick from E. coli sepsis."

The study was published in a recent online edition of Infectious Diseases in Obstetrics and Gynecology and presented at the 33rd annual Society of Maternal Fetal Medicine meeting last month.

Source: University of Texas Health Science Center at Houston

Thursday, March 07, 2013

DNA Extraction from Samples in a Minute

Scientists at the Agharkar Research Institute (ARI) in Pune have developed a novel technology to extract bacterial DNA in just a minute from clinical as well as environmental (water and food) samples, which would make the process of diagnosis faster.

Currently, it takes about three to four hours to extract bacterial DNA from a sample, which can now be done in a minute. The ARI scientists have used specially designed magnetic nanoparticles for this patented technology. Significantly, the technology has now been transferred to the industry and will soon be put to commercial use.

An important aspect of this technology is that the process of extracting the DNA is done in a single step as against the traditional technology where three steps are involved, thus consuming more time. Also, the DNA extracted from the sample using ARI technology is in its purest form.

Scientists developing the technology said this 60-second DNA extraction method would revolutionise the laboratory testing system where DNA needs to be extracted in a highly pure form. Kishore Paknikar, chief investigator of this study, said, "Practically, all molecular biology work ranging from PCR to genome sequencing and analysis require highly pure DNA. We have specially designed magnetic nanoparticles that extract the purest form of DNA in a single step in the shortest period of time." Paknikar, however, refused to divulge more details about the process of this technology as it was patented and already licensed to an industry for commercial use.

ARI scientists Jyutika Rajwade and Milind Choudhari were also involved in the development of this technology. Rajwade said, "It is now possible to have an on-site method for DNA extraction from various clinical, water, food and environmental samples. This method would make microbiological testing of samples rapid, cheap and user-friendly."

Stating that the conventional method of extracting DNA is not only cost-intensive but also requires a lot of chemicals and reagents, director of the Government Institute of Forensic Science in Aurangabad, S G Gupta said, "Considering the time consumed and the process, ARI scientists have achieved a breakthrough in this field of DNA extraction. Use of nano particles will really speed up the process making the technology cost-effective." Gupta also said that the technology will be most useful in areas where DNA extraction needs to be done from a large number of samples.

Prakash Gambhir, ex-professor and head, department of genetics, immunology and biochemistry, Maharashtra University of Health Sciences said that the nature of the technology is rapid and which is its biggest plus point.

"If we can get the DNA from the sample in a matter of a minute, it is definitely going to speed up the diagnosis process. Results will come out faster." Gambhir said that, currently, there are various methods of extracting DNA for diagnosis, but, it takes a minimum of three hours and a maximum of six hours to extract it, depending on the method used.

Nano Labs Develops Diagnostic Technology to Identify Tuberculosis (TB) Through Novel Nanotechnologies

Nano Labs Corp. is pleased to present industry with promising biological diagnostics test results obtained at macro-level, on a miniaturized tuberculosis biosensor platform.

The Company successfully developed a Point-of-Care biosensor at macro-level and presents industry with proposals for miniaturization and commercialization at large scale. The joint venture proposal is for the development of miniaturized Point-of-Care (PoC) and Lab-on-Chip (LoC) biosensors.

The Company reports that four innovative solutions are proposed with the main objective to create a simple, low-cost, high-sensitivity, rapid diagnostic platform capable of being used in remote locations for PoC and LoC monitoring of critical infectious diseases, including tuberculosis (TB).

The Company's aim is to establish a commercial PoC and LoC biosensors using modern techniques by either applying common Micro-Electro-Mechanical-Systems (MEMS) batch processes, or by using simpler and more modular methods such as soft lithography or laser ablation. According to the Company report, four (4) possible innovative solutions combining biomarker-based diagnostics procedures with micro-technology have been identified:

1. Quantum-Dots Microchannels (QDμC)

2. Surface Plasmon Resonance (SPR) Spectroscopy & Plasmonic Enzyme-Linked Immuno Sorbent Assay (Plasmonic ELISA)

3. Micro Electrochemical Impedance Spectroscopy (μEIS)

4. Surface Acoustic Wave Micro-Electro-Mechanical-System (SAW-MEMS).

"It is important to note that innovative, comprehensive strategies for obtaining a functional prototype will need to be carefully addressed for all projects, at any development stage," adds Dr. Victor Castano, Chief Research and Innovation Officer at Nano Labs. "This includes packaging, interconnect with outside world, and modular integration on circuits or with some sort of display."

The Company is in discussions with industry leaders to assess product development strategies and additional research required over the next twelve months to advance the commercialization of the product.

"We are looking at partnerships that bring the experience, dedication and the vision to address critical world health issues, like tuberculosis," stated Mr. Bernardo Chavarria, President of Nano Labs. "We expect that new research areas and biosensor solutions will emerge from this project and therefore present a much larger scope of practical applications that need to be further investigated. This technology has enormous potential and will bring exciting new opportunities to our company."

Tuesday, March 05, 2013

EnviroLogix Launches Rapid Molecular Test Kit for Salmonella

EnviroLogix Inc. has introduced the DNAble® Salmonella Rapid Screening Kit, a pioneering testing solution for live poultry production.

At a luncheon during the International Production and Processing Expo in Atlanta, EnviroLogix was joined by poultry industry leaders to unveil the new technology and present performance data.

Kathy S. Hensley, General Laboratory Manager at Perdue Farms, shared the results of a field validation showing comparable performance to other standard Salmonella detection methods, such as culture and PCR. 

Hensley described how these DNAble results could be obtained overnight, compared to the several days required for current methods.

Dr. Nick Evans, a Research Scientist from Virginia Tech, presented a field study that demonstrated the versatility of the DNAble test system. His findings highlighted a novel approach for predicting the level of ground-meat contamination by determining Salmonella load on poultry transport trucks prior to processing.

"This technology represents a significant advancement in how Salmonella test results can be used to make pathogen-management decisions in the poultry industry," says Jennine Cannizzo, Director of Veterinary Business for EnviroLogix. "The DNAble system, with minimal enrichment, can give our customers results today, allowing for immediate intervention and process improvement."

The new DNAble Salmonella test system generates same-day results that can be used to make intervention decisions when managing Salmonella in live production. The DNAble testing system uses a proprietary molecular-detection technology that requires minimal sample preparation but provides sensitive and specific results. Testing can be performed quickly and without expensive equipment, making DNAble an ideal solution for Salmonella management in the production process. 

EnviroLogix is seeking both NPIP and AOAC approval for the DNAble Salmonella Rapid Screening Kit. Additional pathogen and infectious disease tests are in development, and will be part of a comprehensive DNAble product portfolio.

Sunday, March 03, 2013

Thermo Fisher Scientific Announces SureTect PCR System for Food Pathogen Detection

Thermo Fisher Scientific Inc., the world leader in serving science, today announced the launch of SureTect PCR System that delivers test efficiencies for food safety laboratories that are testing for the most common bacterial pathogens. With the new system, results for all targets and matrix types can be obtained in less than 24 hours of the food sample being received, leading to faster food release.

The SureTect System combines a real-time PCR instrument with bespoke software and convenient pre-filled reagent components that together with a single PCR protocol for a range of common targets and sample types, streamline the test workflow.

“Over time, we’ve seen our customers’ needs develop as they strive to meet increasing consumer and legislative demands, while continuing to gain cost efficiencies,” says Sumi Thaker, VP Global Marketing, Microbiology, Thermo Fisher Scientific. “The need to streamline test workflow and reduce time to result means that speed, ease-of-use, reliability and value for money are primary considerations in today’s pathogen test selection.

“With the SureTect System, food testing laboratories get easy set-up and result-reading, and flexible throughput, from fewer than 10 to several hundred tests per day. In addition, they have access to a team of microbiological experts to help them with evaluation, implementation as well as for day-to-day support.”

Assays for Salmonella species and Listeria monocytogenes are available now. Assays for Listeria species and Escherichia coli O157:H7 will be released towards the end of quarter one this year with further tests already in development.

San Diego Considering Faster System for Testing Water Quality at Beaches

The San Diego County Board of Supervisors is scheduled to consider a faster system for testing water quality at beaches.

Under a proposal by Supervisor Greg Cox, the board chairman, the county would start a yearlong study of a system that gives results on bacteria and other pollutants within four hours of testing.

The current system, which involves growing cultures, sometimes requires up to two days to get results.

The state-funded water quality testing program has been run by the county Department of Environmental Health since 1999.

When the testing finds contaminated water after sewage spills or rain storms, the DEH posts warning signs at affected beaches.

If approved, the trial run would start on April 1 and cost $59,000, according to Cox.

"Residents and visitors deserve quick notification if the water quality at local beaches is unsafe, and our tourism economy depends on healthy beaches," Cox said in a memo to fellow board members. "By moving towards rapid detection methods for our beach water monitoring program, the county of San Diego will use the latest in science to protect the public and deliver reliable information."

An earlier trial of the quantitative polymerase chain reaction testing system by the U.S. Environmental Protection Agency found that it works scientifically, but should be "deployed systematically to fit local needs," Cox said.

Blood Culture Medium Affects Bacterial Detection, Recovery

The choice of which blood culture medium to use in detecting possible sepsis in trauma and emergency patients can make a difference in time to bacterial detection and recovery, according to an article published in the March 15 issue of Clinical Infectious Diseases.

Rebecca Zadroga, MD, from the Department of Infectious Disease, University of Minnesota, and Hennepin County Medical Center, Minneapolis, and colleagues conducted a head-to-head comparison of 2 widely used blood culture media at a 462-bed acute care trauma center and emergency department between February 1 and September 30, 2011.

They compared the Becton Dickenson Bactec Plus (Bactec) with the bioMériux BacT/Alert FAN (BacT/Alert) in the collection of 9395 cultures. Of those cultures, 831 were included in the analysis, 524 (33%) of which contained pathogens. Exclusion criteria included pediatric patients and a difference in the amount of bottles drawn.

The researchers found that Bactec yielded a 4.5-hour faster bacterial detection time (P < .0001) than BacT/Alert and isolated exclusively 182 (35%) of 582 pathogens (P < .001). They also found that Bactec isolated 136 (39%) of 345 of the gram-positive cocci (P < .001), 48 (27%) of 175 gram-negative rods (P = .02), and 101 (52%) of 195 Staphylococcus aureus (P < .001) and identified 59 (49%) of 120 septic events (P = .004).

"If active antibiotics had been dosed 0–4 or 4–48 hours prior to culture collection, the odds of that culture growing in BACTEC were 4.8- and 5.2-fold greater, respectively, than of growing in BacT/Alert (P < .0001)," the researchers write. "Both were equivalent in the recovery of yeast and when no antimicrobials were dosed."

Time is critical in the diagnosis of sepsis, the researchers write, and guidelines recommend that antimicrobials be initiated within 1 hour of sepsis recognition.

"The reality of this paradoxical relationship between rapid treatment initiation and potential impact on diagnostics is exemplified in our study, as 50% and 82% of patients seen in our wards and [intensive care unit] environments, respectively, had a an antimicrobial administered [prior to culture collection]," the researchers write.

Previous studies have not detected differences among blood culture media in a hospital setting, and it is unclear why this study did show differences, the researchers note. "[D]ifferences in the recovery and [time to detection] for S. aureus is a key finding in our study that has not been previously described," they write.

They conclude, "[T]he diagnosis of sepsis remains both a clinical and laboratory diagnosis."