Thursday, August 28, 2014

Portable Device Tests for TB Faster and Cheaper

A new test for tuberculosis (TB) could dramatically improve the speed and accuracy of diagnosis for one of the world’s deadliest diseases, enabling health care providers to report results to patients within minutes, according to a study published in the journal Angewandte Chemie. Jeffrey Cirillo, professor at the Texas A&M Health Science Center College of Medicine and investigators at Stanford University, have identified a new chemical compound to spot the bacteria that cause TB with a level of sensitivity that currently takes months to produce; and results of the first human clinical trial data are promising.

Findings show the test can determine that a patient has tuberculosis with 86 per cent sensitivity and 73 per cent specificity. Smear microscopy, the most widely used test in the world, has asignificantly lower ability to detect TB, ranging between 50 to 60 per cent sensitivity. Although preventable, TB claims three lives every minute, making it the second leading cause of mortality from an infectious disease in the world.

Spread through the air when an individual with active TB infection coughs or sneezes, reports show that if left untreated, a person with active TB infects an average of 10 to 15 people each year, leaving a need for reliable testing. Cirillo’s latest breakthrough perfects the technology behind the test. Using a fluorescent substrate, the device targets BlaC – an enzyme produced by the bacteria that cause TB – as an indicator of the bacteria’s presence. Until now, it has not been possible to target a specific TB enzyme for diagnosis. Once sputum samples are combined with the reactive substance, a batterypowered, portable tabletop device, the TB REaD, is then used to detect any fluorescence and deliver the diagnosis in as little as 10 minutes.

“It’s simple. Take a sputum sample, treat it with the solution and put it inside the reader,” Cirillo said. “A camera inside looks for a reaction between the sample and solution that produces light. No light, no infection.” Currently, there is no diagnostic tool comparable to this and while others exist, they take several months to produce the same level of sensitivity; and come with a high price tag. The target price tag on Cirillo’s test is less than $1000 for the reader and less than $5 per test. Additionally, the one-step test will require little technical expertise or resources, should take less than 30 minutes to carry out, and is easily transportable, making it an ideal candidate for field diagnosis in developing countries.

The device significantly undercuts current diagnostic methods, important, given the staggering statistic that if left untreated – a common scenario in countries lacking infrastructure or resources to efficiently screen and follow up with patients – a person with active TB has only a 50 per cent chance of survival, Cirillo notes. “Interrupting disease transmission will require early and accurate detection paired with appropriate treatment,” Cirillo said. “Our new, rapid point-of-care TB test dramatically reduces the current delays in diagnosis with incredible accuracy, accelerating appropriate treatment and reducing the death rate of the disease. We’re looking at a low-cost, easy-to-use test that has the potential to eradicate TB.” The test is currently in the later stages of clinical trials with plans to go to market in 18 months.

Wednesday, August 27, 2014

Ohio State, Nationwide Children’s Hospital Partner with ENTvantage Diagnostics to Develop Rapid Bacterial Sinusitis Diagnostic Test

The Ohio State University, through the Ohio State Innovation Foundation, and Nationwide Children’s Hospital announced the signing of an exclusive, world-wide agreement with ENTvantage Diagnostics Inc. licensing a technology for rapid diagnosing of bacterial sinusitis. The jointly-created technology will be the foundation for ENTvantage Diagnostics Inc. to develop a diagnostic kit based on this technology to better equip physicians with additional information when making a bacterial sinusitis diagnosis.

The technology was developed as a result of the research collaboration between The Ohio State University and Nationwide Children’s Hospital. Subinoy Das, M.D. and Lauren O. Bakaletz, Ph.D., joined forces to create the diagnostic technology. Das is the former Director of The Ohio State University Sinus and Allergy Center and is now an adjunct Assistant Professor at The Ohio State University. In addition, he is a Research Associate of the Center for Microbial Pathogenesis in The Research Institute at Nationwide Children’s Hospital. Bakaletz is the Director of the Center for Microbial Pathogenesis in The Research Institute at Nationwide Children’s. She is a Professor in the Departments of Pediatrics and of Otolaryngology at The Ohio State University College of Medicine.

Determining the primary cause of sinusitis remains a clinical challenge for physicians. Different kinds of medication are often given to a patient until a specific medication is effective in improving the sinusitis condition. The diagnostic kit will enable physicians to take a sample swab from a patient’s nose, perform a rapid analysis, and have the results of the infection available the next day.

“Many patients are being prescribed antibiotics that they do not need or do not optimally treat the underlying pathogenic bacteria because there is a lack of definitive office-based diagnostic tests for this infection,” said Das. “This assay kit will help physicians understand the underlying bacterial cause of sinusitis in their office and allow better selection of antibiotics to treat patients. In addition to more efficient treatment, the diagnostic kit will also aid in reducing the number of antibiotic resistant infections and complications.”

“Our research serves as the foundation for this diagnostic test by demonstrating the specific bacterial protein profiles associated with chronic sinusitis. With the identification of these biomarkers, tests now can be developed to determine the presence and type of pathogenic bacteria in the upper respiratory tract,” Bakaletz explained. “Seeing our research result in a
positive impact on physician practice, and more importantly on patient health, is the aspiration of every medical scientist.”

Nationwide Children’s Hospital and Ohio State have a long-standing collaborative history and continue to work together on several fronts, one of which includes commercializing technologies. Both organizations have an equity position in ENTvantage Diagnostics Inc.

ENTvantage was founded by serial medical device entrepreneurs Joe Skraba and Rick Hawkins who bring more than 50 years of collective experience in commercialization of a broad range of medical devices, pharmaceuticals and biotech products.

“Dr. Das and Dr. Bakaletz are thought leaders in their disciplines and the technology they created will truly change the diagnostic capabilities for bacterial sinusitis,” said Skraba. “Collaborating with Nationwide Children’s Hospital and Ohio State was a logical decision for ENTvantage.”

Austin-based ENTvantage plans to commercialize diagnostic tests to improve the diagnosis of illnesses of the ear, nose and throat by providing rapid, in-office diagnostic test kits to physicians world-wide.

“The lack of diagnostic tools has led physicians to over prescribe antibiotics to treat sinusitis when they are not needed, we know that we can provide physicians with timely information to better diagnose the underlying cause of these illnesses and lead to better management of sinusitis,” said Joe Skraba, the President & CEO of ENTvantage.

The implications of ENTvantage’ s diagnostic kit go well beyond bacterial sinusitis.
“The same pathogens that cause bacterial sinusitis, also cause illnesses in other areas of the body, we believe we can extend this technology to identify these bacterial pathogens and lead to improved patient care, reduction of treatment costs and a reduction in the growing worldwide epidemic of antibiotic resistant infections,” said Skraba.

Rapid MDR-TB Test Improved Clinical Outcomes

A rapid molecular diagnostic test significantly reduced the time to treatment initiation in patients with multidrug-resistant tuberculosis, new data suggest.

 “In a setting with high rates of MDR-TB, implementation of a rapid diagnostic test for drug-resistant TB into routine clinical care significantly decreased time to initiation of MDR-TB treatment, to culture conversion and improved timely cohorting of patients with MDR-TB,” the researchers wrote in Clinical Infectious Diseases.

Researchers from Emory University and the National Center for Tuberculosis Lung Diseases in Tbilisi, Republic of Georgia, conducted a quasi-experimental study of patients with sputum culture-positive MDR-TB. Georgia implemented a rapid molecular diagnostic test, the MTBDRplus assay, in 2009-2010. The researchers compared the clinical outcomes of 80 patients diagnosed with MDR-TB after the test’s implementation with the clinical outcomes of 72 patients diagnosed by conventional culture and drug-susceptibility testing before the rapid test implementation.

Patients in the pre-implementation group had a longer delay to start a second-line drug regimen (83.9 days) than the post-implementation group (18.2 days). Although all 152 patients were hospitalized and placed in a drug-resistant TB ward, 39 patients were hospitalized before their drug-resistant status was known. Among those 39 patients, people in the pre-implementation group spent 58.3 days in a drug-susceptible TB ward compared with patients in the post-implementation group, who spent 10 days in the ward.

The study included 119 patients with at least 24 weeks of follow-up time, and among those, 82% achieved sputum conversion and 73% achieved culture conversion by 6 months. Patients in the post-implementation group were more likely to have culture conversion by 24 weeks compared with patients in the pre-implementation group: 86% vs. 63%. There also was higher, but nonsignificant, rates of smear conversion in the post-implementation group.

“These findings are some of the first to demonstrate improved clinical outcomes following implementation of a rapid molecular diagnostic test to detect drug-resistant TB,” the researchers wrote. “Other National TB Programs in low- and middle-income countries, especially those with high rates of drug-resistant TB, should explore implementation of such a test in order to improve patient care and enhance TB infection control efforts.”

Tuesday, August 26, 2014

Ebola Diagnostic Device Prototype Is Rapid And Inexpensive

Historically, the physical separation of communities has played a critical role in confining the spread of disease. In the modern age, however, frequent inter-continental travel makes the risk of pandemic disease outbreaks a possibility of great concern. To help prevent such a scenario, PositiveID, a company in the San Francisco Bay area, has been developing a rapid, on-site test system that will help public health and transportation officials screen for disease at ports of entry.

In addition to screening for people who may be ill when coming into the country, this technology may help contain a disease at the site where it develops.

“If you can test early on in remote locations, you can essentially quarantine that area sooner, therefore reducing the spread of [the disease],” Lyle Probst, president of PositiveID, stated in a recent interview with KTVU in San Francisco. “Even now as people go through, some airports are scanning to see who’s running a temperature and who’s not and if they’re running a temperature they can go and take a sample from them, but they’re not going to get results for several hours.”

According to the KTVU report, the test kit from PositiveID is currently under development, and it is capable of analyzing a sample in about 15 minutes. The speed of this device combined with its design, which is highly focused on ease-of-use, makes it possible for just about anyone to operate.

The system makes use of a disposable cartridge with a small hole in the center where the biological sample is placed. To perform the analysis, there is a single button that gets pushed by the operator. Each test costs $25 to perform, while the test device itself has a target cost between $3,000 and $5,000.



The core technology for this device was developed about a decade ago by Probst and was funded by the Department of Homeland Security, reports KTVU. What was once contained in an 800 pound machine is now being deployed in a handheld device that can be used in areas where traditional laboratories are not available.

As the cost of electronic devices continues to decrease, the ability to provide tools to healthcare providers in third world countries becomes greater. In addition to helping prevent the spread of disease, handheld devices for clinical diagnostics are also being developed for more conventional medical practices.

Corgenix Ramps up Efforts on Ebola Diagnostic Test

As the current Ebola outbreak grows more dire in West Africa, a greater urgency has been placed on efforts underway locally to develop a commercial test to rapidly detect the onset of the deadly virus.

However, it's too soon to tell how much the work being done by Corgenix Medical Corp. could be accelerated, officials for the Broomfield-based diagnostics products maker said Monday.

In late June, Corgenix Medical Corp. was awarded a $2.9 million grant from the National Institutes of Health to further develop a prototype diagnostic test for the Ebola virus. The project's timeline is three years.

"There's a lot of urgency, a lot of interest in it," said Douglass Simpson, chief executive officer of Corgenix. "We're assembling our team, we're growing our team."

The deaths attributed to the Ebola outbreak in West Africa climbed to 1,013 on Monday, according to the World Health Organization.

Corgenix has commenced work under the grant, but it is premature to say whether the company would be able to accelerate that work and shave a couple months or a year off that three-year timetable, Simpson said.

"We'll try to accelerate this if we can," he said. "It takes a bit of time."

Corgenix, founded in 1990, develops a variety of diagnostic products that range from tests to determine aspirin's effectiveness in individual humans to assays that can rapidly detect viral hemorrhagic fevers such as Lassa.

The work on a Lassa diagnostic test — which resulted in Corgenix's ReLASV Antigen Rapid Test gaining a CE Mark, allowing for sale in the European Union — has made for an easier roadmap for the Ebola test, Simpson said.

"There are different antibodies, and it's detecting a different virus, but we're building on the knowledge we established under Lassa," he said. " ... I see no indication that it's not going to be successful. We're using the same model for Lassa products, and they're very effective."

The Ebola test resulted from a 2010 to 2012 research program conducted in partnership with the Viral Hemorrhagic Fever Consortium and funded with nearly $600,000 from the NIH.

Corgenix officials have said the Ebola assay identified potential indications of the deadly virus in 15 minutes after an initial screening and confirmed the diagnosis in a little more than an hour. Other testing methods can take a few hours.

The rapid test for Ebola has not been cleared or approved by any worldwide agency.

The latest $2.9 million grant is designed to take the test to a point where it could be commercialized, Simpson said.

The initial work on the tests will take place in Broomfield and in Viral Hemorrhagic Fever Consortium partner labs in places such as Galveston, Texas. The tests locally do not involve any live samples of the virus

The latter end of the work would involve additional research and testing in the areas where Ebola is endemic, he said.

Earlier this year, Corgenix shipped out hundreds of its prototype Ebola rapid tests as part of a "first line of defense" attempt to detect the virus in a matter of minutes.

Those prototype test supplies have since been exhausted and are no longer in use in the "hot zone" areas.

"Because of the severity of the outbreak, they shifted from screening," Simpson said. "Now anyone who shows symptoms (is brought in for medical care)."

No Corgenix officials are operating out of West Africa, although some other researchers within the Viral Hemorrhagic Fever Consortium remain in the area, he said.

"The people over there right now are MDs and they're just trying to help in the overall epidemic control; the research is really postponed," Simpson said. "We've got to take care of the people first. What we expect is once they get it cleaned up, it'll get back to business as usual."

Thursday, August 7, 2014

Quidel Receives FDA Clearance for Its Hand-Held Molecular Diagnostic Test for Group A Strep

Quidel Corporation, a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced that it has received clearance from the United States Food and Drug Administration (FDA) to market its AmpliVue GAS Assay for the qualitative detection of Group A β-hemolytic Streptococcus (Streptococcus pyogenes) nucleic acids isolated from throat swab specimens obtained from patients with signs and symptoms of pharyngitis, such as sore throat.

The AmpliVue GAS Assay is an easy-to-use, handheld disposable molecular diagnostic test that has superb clinical accuracy and does not require culture confirmation of negative results. The assay requires no upfront extraction of DNA and generates an accurate result in less than one hour. Like other previously FDA-cleared AmpliVue assays, the AmpliVue GAS Assay does not require the customer to invest in either expensive thermocycling equipment, or any other upfront testing costs. Using AmpliVue can therefore significantly lower a laboratory's cost to adopt and maintain molecular testing methods.

Group A streptococci are Gram-positive bacteria, primarily residing in the nose, throat and skin; they are responsible for several illnesses, ranging from mild illnesses (strep throat or skin infections) to severe illnesses (necrotizing fasciitis, or streptococcal toxic shock syndrome).(1) Strep throat, or streptococcal pharyngitis, is the most common illness from Group A streptococcal infections. These bacteria are spread through contact with airborne droplets from an infected person's cough, sneeze or via contaminated items such as eating utensils.(2)

"We are very pleased with the rapid pace of our AmpliVue assay development. Our AmpliVue assay for Group A Strep is our third AmpliVue product to be 510(k)-cleared by the FDA in the last seven months," said Douglas Bryant, president and chief executive officer of Quidel Corporation. "Our sales force now has a broader suite of fast and accurate molecular assays that offer a compelling value, especially among smaller labs that generally do not test using molecular methods. With respect to diagnosing Group A streptococcal infections, Quidel now has a breadth of diagnostic offerings ranging from the Sofia immunofluoresence-based test to the hand-held AmpliVue molecular assay to the Lyra Strep A + C/G molecular product for higher throughput labs."

Quidel's AmpliVue platform now enables laboratories of all sizes to perform highly sensitive and specific molecular tests. The AmpliVue GAS Assay is Quidel's fourth molecular infectious disease assay to receive 510(k) clearance from the FDA in this hand-held, disposable AmpliVue format. Quidel now offers 510(k)-cleared, in vitro diagnostic products on this novel platform for the diagnosis of five pathogens: C. difficile, Group A Strep, Group B Strep, HSV1 and HSV2.

1. http://www.cdc.gov/ncidod/dbmd/diseaseinfo/groupastreptococcal_g.htm

2. http://www.cdc.gov/Features/strepthroat/

About Quidel Corporation

Quidel Corporation serves to enhance the health and well being of people around the globe through the development of diagnostic solutions that can lead to improved patient outcomes and provide economic benefits to the healthcare system. Marketed under the QuickVue(R), D3(R) Direct Detection and Thyretain(R) leading brand names, as well as under the new Sofia(R), AmpliVue(R) and Lyra(TM) brands, Quidel's products aid in the detection and diagnosis of many critical diseases and conditions, including, among others, influenza, respiratory syncytial virus, Strep A, herpes, pregnancy, thyroid disease and fecal occult blood. Quidel's research and development engine is also developing a continuum of diagnostic solutions from advanced lateral-flow and direct fluorescent antibody to molecular diagnostic tests to further improve the quality of healthcare in physicians' offices and hospital and reference laboratories.

Wednesday, August 6, 2014

Invisible Sentinel’s Veriflow Technology Is Adopted For Use By R-Biopharm And Trilogy Analytical Laboratory

Invisible Sentinel Inc., a life-sciences company that develops rapid diagnostics for the food and beverage industries, announced today that its first-in-class Veriflow diagnostic technology has been adopted for use at North American locations of R-Biopharm AG and Trilogy Analytical Laboratory.

R-Biopharm, based in Darmstadt, Germany, is a worldwide leader in the development and implementation of reliable tests for food, beverage, and feed analysis. Trilogy, based in Washington, MO, is majority-owned by R-Biopharm.

Invisible Sentinels Veriflow assays have been approved by the Association of Analytical Communities (AOAC), a globalstandardization organization, to detect bacterial contamination in a wide variety of food types, and on various environmental surfaces. Additionally, the Veriflow product suite now includes spoilage-organism assays for the wine industry.

Nick Siciliano, Chief Executive Officer and co-founder of Invisible Sentinel, commented: It is gratifying that Veriflow technology has earned acceptance by 3rd-party labs with deep experience and stringent standards. R-Biopharm and Trilogy are highly respected in their diagnostic fields, and were delighted to work with them to offer the advantages of our expanding Veriflow product line to their clientele.

Kurt Johnson, President of R-Biopharm North America, added: Veriflow technology is a truly innovative addition to the diagnostic tests we employ for our clients in the food and beverage industries. Adding Veriflow assays to our analytical capabilities is yet another step we are taking to offer pioneering solutions of the highest quality.

About Invisible Sentinel

Invisible Sentinel is the inventor of Veriflow technology, a patented, molecular flow-based technology that draws from the companys core competencies in molecular diagnostics, antibody design, and immunoassays. Veriflow test kits are finding applications across multiple industries. Invisible Sentinel helps the food industry to detect foodborne pathogens. The company works with winemakers and beer artisans to cost-effectively improve the quality of their products. And it can apply Veriflow technology to challenges in other industries, too, designing custom solutions for healthcare, veterinary services, biodefense, and environmental testing.

Tuesday, August 5, 2014

Micro Imaging Technology and Northern Michigan University to Investigate MIT 1000 Enhancement for Rapid Pathogen Testing

Micro Imaging Technology, Inc. announced that it has funded the collaboration with Northern Michigan University (NMU) to investigate an alternative preparation method that could provide a specimen test turnaround time of 4 to 5 hours.

Dr. Amit Morey, an expert food microbiologist and a consultant to Micro Imaging Technology (MIT), proposed the new sample preparation method. He said, "This method will revolutionize the MIT 1000 System and significantly broaden its appeal in the clinical health, and food safety markets, as well as other pathogen testing arenas."

Dr. David Haavig, Chief Scientist of MIT, said, "Even though the MIT 1000 System is the fastest and least expensive bacterial pathogen test today, it still requires bacteria taken from culture plates. This new method will significantly simplify the bacterial isolation step and completely eliminate the culture plate growth time of 16-24 hours. If successful, this new method will reduce the entire specimen identification turnaround time to 4 to 5 hours."

Dr. Josh S. Sharp, Ph.D., assistant professor at the Northern Michigan University Department of Biology in Marquette, Michigan, has been spearheading the collaboration between MIT and NMU since October of 2013. He is researching clinical applications of the MIT 1000 System, particularly the pathogens Staphylococcus aureus (S. aureus) and Methicillin Resistant S. aureus (MRSA). "It has been shown that rapid identification of bacterial pathogens has the potential to improve successful patient outcomes," said Dr. Sharp. "However many of the current agar plate based identification methods require 16-24 hours of growth before identifications can be made," he continued. "To decrease the time for organism identification, the Sharp lab at NMU will be working in collaboration with MIT to develop a method to capture S. aureus bacteria directly from a specimen. Using the MIT 1000, this would decrease the total time for S. aureus identification to 4 to 5 hours. Our goal is to reduce the time from specimen to pathogen identification resulting in the ability to quickly implement proper antimicrobial therapy to patients."

"Preliminary results by the Sharp lab are very encouraging and very exciting," said Jeff Nunez, President of MIT. "If Dr. Sharp's efforts are successful, and we are highly confident they will be, this will be a major game changer since this new method can easily be extended to other significant clinical and food safety pathogens. Additionally, this method can be fully accomplished well within an eight hour lab technicians work shift. When this is combined with today's lowest bacteria pathogen per test cost, the MIT 1000 System should be the obvious choice for clinical and food safety diagnostic laboratories."

MIT 1000 has been certified by the AOAC for identification of Listeria spp. The Company recently announced that it had also added Staphylococcus (Staph) and Salmonella enterica serotype Choleraesuis (S. Choleraesuis) to its catalog of identifiers. It is continuing development of, a series of Salmonella Identifiers including Salmonella spp, S. heidelberg, S. enteritidis and S. typhimurium.

Monday, August 4, 2014

Luminex Is Supporting U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) in Research Efforts to Control African Ebola Outbreak

Luminex Corporation today announced that U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) Diagnostics Division is working on rapid diagnostics for the Ebola virus using Luminex xMAP® Technology. Luminex's MAGPIX® system was recently deployed to Africa to support research efforts to control the current outbreak.

The recent Ebola outbreak has so far claimed 729 lives across Guinea, Liberia, Nigeria, and Sierra Leone according to the World Health Organization . Ebola virus disease is a severe, often fatal illness in humans characterized by the sudden onset of fever, intense weakness, muscle pain, headache and sore throat. Early diagnosis is critical for proper management of the illness and prevention of spread.

Developed by USAMRIID Diagnostics Division and run on the MAGPIX system, the assays test serum samples for the presence of viral antigens (proteins) as well as antibodies directed at these antigens. Results of the assays provide information about replication of the virus and the immune response of the host, respectively. In a study conducted in rhesus macaques, Dr. Abbe Ames and colleagues showed that some animals may be able to limit the replication of the virus, and thus have a better chance of survival.1 Understanding the pathophysiology of the Ebola virus may assist in the development of countermeasures against the disease that could save lives.

"Our open architecture instruments provide researchers a flexible tool for assay development that can advance their research goals," said Patrick J. Balthrop, president and chief executive officer of Luminex. "Understanding the functional progression of a virus is extremely valuable information. Luminex is proud to support researchers, clinicians and biosurveillance professionals and their important work in the global effort to combat infectious diseases."

About Ebola Virus Disease (EVD)

Ebola virus disease is a severe, often fatal illness in humans. Outbreaks have a case fatality rate of up to 90% and occur primarily in remote villages in Central and West Africa, near tropical rainforests. The virus is transmitted to people from wild animals and spreads in the human population through human-to-human transmission. Fruit bats of the Pteropodidae family are considered to be the natural host of the Ebola virus. Severely ill patients require intensive supportive care. No licensed specific treatment or vaccine is available for use in people or animals. 2 Because of the potential for human-to-human transmission, it is important to quickly identify infected individuals so proper precautions can be taken to limit spread of the disease.

About Luminex Corporation

Luminex is committed to applying its passion for innovation toward creating breakthrough solutions to improve health and advance science. The company is transforming global healthcare and life-science research through the development, manufacturing and marketing of proprietary instruments and assays utilizing xMAP® open-architecture multi-analyte platform, MultiCode® real-time polymerase chain reaction (PCR), and multiplex PCR-based technologies, that deliver cost-effective rapid results to clinicians and researchers. Luminex's technology is commercially available worldwide and in use in leading clinical laboratories, as well as major pharmaceutical, diagnostic, biotechnology and life-science companies. Luminex is meeting the needs of customers in markets as diverse as clinical diagnostics, pharmaceutical drug discovery, biomedical research including genomic and proteomic research, personalized medicine, biodefense research and food safety.

Whole-Genome Sequencing Expected to Revolutionize Outbreak Investigations

From Food Safety News. For decades, food safety experts have lived with the reality that roughly one-third of foodborne illness outbreak investigations ended without finding the source.

But with the wide proliferation of new laboratory technology on the horizon, outbreak investigations could soon become more accurate, more efficient and more complete, according to researchers at Cornell University, the New York State Department of Health and the U.S. Food and Drug Administration.

The new technology is known as rapid whole-genome sequencing, a process of analyzing the complete DNA sequence of organisms, included foodborne pathogens such as Salmonella and E. coli. It’s the same technology used to generate the human genome, but in epidemiology, the process grants investigators the ability to much more precisely identify organisms causing outbreaks, right down to their DNA.

Older forms of bacterial subtyping, such as pulsed-field gel electrophoresis (PFGE), are still important for the detection and investigation of outbreaks, but they lack the level of detail needed for outbreak detection. In other words, it’s been impossible until the advent of genome sequencing to truly know whether two people infected with the same strain of pathogen were genuinely sickened by the same food source.

By letting investigators identify a bacterium down to the DNA, genome sequencing allows much more certainty when matching clusters of illnesses and narrowing down the list of potential food sources. For example, two people in the same area might both be sick with Salmonella Heidelberg from two different sources, but investigators could only know that the illnesses were unrelated by looking at the bacteria’s DNA.

The technology has been in use at a select number of laboratories around the country for a little more than a year now. Earlier this year, a deadly outbreak of Listeria in Maryland was traced back to Delaware-based dairy manufacturer Roose Foods through genome sequencing. Health officials were then able to shut the facility down.

“What genome sequencing allows us to do with food traceback is unprecedented. It’s like upgrading from an old backyard telescope to the Hubble,” said Dr. Eric Brown, director of the Division of Microbiology at FDA’s Office of Regulatory Science.

Brown and FDA colleagues recently collaborated with researchers from Cornell University and the New York State Department of Health to demonstrate the feasibility of using whole-genome sequencing to investigate foodborne illness outbreaks in a state health laboratory.

Their study, published in the August 2014 edition of Emerging Infectious Diseases, consisted of two parts. The first was an analysis of bacterial samples from a known Salmonella outbreak occurring in 2010. Using whole-genome sequencing, the researchers were able to attribute additional cases to the outbreak that were not — and could not have been — attributed when the original investigators relied on PFGE.

The second part of the study involved the real-time use of genome sequencing in conjunction with PFGE technology to analyze incoming Salmonella cases in 2012. In that test, genome sequencing found more cases connected to an outbreak than could be determined using PFGE.

The conclusion: Whole-genome sequencing “vastly improved” the detection of outbreak cases and the amount of detail available to investigators.

“Using PFGE, we couldn’t find much meaningful differences between strains. But by using whole-genome sequencing, we can establish much better relationships between bacteria in the population,” said Dr. Henk den Bakker, research associate at Cornell’s Department of Food Science and lead author of the study.

As whole-genome sequencing becomes more widespread, there will be less reason to use PFGE, den Bakker added.

Until recently, whole-genome sequencing technology was simply too costly for most public health laboratories to use, although the technology is quickly becoming more cost-effective. Part of that cost is due to labs needing someone on staff who can translate the genetic information into information epidemiologists can use in their investigations.

Right now, the field of epidemiology is entering a transition period where genome sequencing is replacing PFGE. A vast amount of historic PFGE data exist on outbreak networks, however, and epidemiologists are now working to sequence historic pathogenic samples to enhance new whole-genome databases.

One such database is FDA’s Genome Trakr Network, a pilot database for state and federal laboratories to collect and share genomic data on foodborne pathogens. The network currently consists of seven state health department labs and 10 FDA field labs, according to FDA.

“It’s clear that we’re going to be adopting and expanding genome sequencing to many more state labs. State labs are the boots on the ground,” said Dr. Marc Allard, research area coordinator for genomics for the Division of Microbiology at FDA’s Office of Regulatory Science.

Beyond the states, the Genome Trakr database will network with international databases under the umbrella of the Global Microbial Identifier. In the future, every new outbreak sample will be compared with global records to track the sources of outbreaks and determine when or where new pathogens are emerging.

And, ultimately, the researchers say it should lead to a system that prevents more illnesses worldwide by tracking down the sources faster and more accurately.

“What’s the cost of not finding the food source?” Allard asked. “More people getting sick and potentially dying, along with larger recalls and more litigation. [Whole-genome sequencing] will have a such a broad impact on public health that it’s difficult to estimate.”

Source: Food Safety News

Saturday, August 2, 2014

Corgenix Rapid Diagnostic Ebola Test Research Earns Divisional Best Abstract Award at AACC Meeting

Corgenix Medical Corporation has been recognized for outstanding research presented at the American Association for Clinical Chemistry (AACC) Annual Meeting and Clinical Lab Expo 2014 in Chicago. Corgenix earned the award for its poster abstract "Development of a Point-of-Care Diagnostic for Ebola and Sudan Virus Detection," presented at the conference by Corgenix Research Associate Abby Jones, M.S.

The Best Annual Meeting Abstract Award is given by the AACC Critical and Point of Care Testing Division in recognition of outstanding research for abstracts submitted and posters presented at the AACC annual meeting.

"We're pleased to accept this prestigious award, and we must also recognize our academic, research and industry partners at the Viral Hemorrhagic Fever Consortium who have helped to make this possible," said Douglass Simpson, Corgenix President and CEO. "We are continuing with our efforts to develop breakthrough diagnostic products for detecting Ebola, Lassa and other biologic agents. Rapid, accurate testing for these agents in difficult environments is critical to global public health and defense against bioterrorism threats."

Corgenix and the VHFC were recently awarded a three-year, $2.9 million National Institutes of Health grant to continue work on the development of an Ebola rapid diagnostic test kit. Corgenix and the consortium have already developed and CE marked the ReLASV(R) rapid diagnostic test for the Lassa fever virus.

Given the current Ebola outbreak in West Africa, the largest ever recorded, Simpson said it's clear that point-of-care testing will be needed in the future for the rapid identification and treatment of viral hemorrhagic fevers, including Lassa, Ebola and Marburg.

On Thursday, July 31, 2014, Corgenix also presented an oral abstract titled "Suspected Lassa Fever (LF) Case Outcomes: A Comparison to a Non-Febrile Population in Sierra Leone." This first-ever oral abstract for Corgenix was discussed during the AACC morning symposia titled "Infected: Innovative Ideas in Laboratory Medicine for Acute and Chronic Infections."

The study was conducted to better identify and treat patients with Lassa, which can be difficult to distinguish from other illnesses such as malaria. Study results were presented by Corgenix Regulatory and Clinical Affairs Specialist Bethany Belote and will be published in the October issue of Clinical Chemistry.