Rapid Diagnostic Test Invention of Liberian-American Scientist Published in Nature

The rapid multiplex diagnostic test Invention of a US-Liberian infectious disease scientist, Dr. Dougbeh Chris Nyan’s, has been published in Nature Scientific Reports, an international peer-reviewed biomedical journal of the Nature Publishing Group. The invention is a portable rapid infectious diseases diagnostic system that detects and identifies multiple viruses in less than an hour. Announced earlier this year, Dr. Nyan’s invention addresses the need for speedy detection and identification of different viruses and for containing the spread of these infectious diseases in both developing and developed countries. The test simultaneously detects and identifies up to 7 or more different viruses, including HIV/AIDS, Dengue virus, Hepatitis viruses, Ebola, and West Nile virus that are common in Africa, Asia, and in the Americas. With the recent emergence of new cases of Ebola infection in Liberia, medical field workers could benefit from the Nyan-Test when produced. In the current Nature publication, Dr. Nyan and his research assistant, Mr. Kevin Swinson, reported their findings on simultaneous detection and identification of 6 medically important viruses. “In the next publication we will report on other pathogens such as Ebola, Chikungunya virus, Plasmodium (malaria), Leshmania, SARS, Trypanosoma, and Tuberculosis infection” said Dr. Nyan, a scientist in the US who is originally from Africa, the Republic of Liberia.

Earlier this year the world witnessed a severe global threat, as infection with the Ebola virus disease spread from Guinea in December 2013 to Liberia, Sierra Leone, Mali, Spain, United States of America, United Kingdom, Senegal, and Nigeria within 6 months. The lack of a rapid diagnostic test for Ebola virus was one of several challenges encountered by health care workers during the outbreak. “We are hopeful that this test will offer health care providers the ability to quickly detect and distinguish, for example, Ebola and Malaria infections which present similar clinical symptoms at the onset of infection and help in prompt clinical decision on specific treatment modalities”.

Asked when the test kits of his invention will be available, Dr. Nyan responded that “first, we have filed patent protections on our technology to protect our intellectual property and we are now seeking funding and collaborative partnership with institutions (such as the WHO, ECOWAS, Africa Union, US Department of Health), with philanthropists, and with private investors anywhere in the world so as to produce the diagnostic kits”. He further added that, “we want to ensure that simple-to-use and fast infectious pathogens diagnostic kits are accessible and affordable wherever they are needed anywhere in the world, particularly for the poorer countries and communities; I pray that this will contribute to ensuring global public health safety and also contribute to mitigating cross border transmission of infectious diseases and epidemics”, Dr. Nyan said.

The entry of this new diagnostic test into the health care arena is expected to impact diagnostics. According to Dr. Nyan’s Nature publication, the rapid multiplex diagnostic test is sensitive, specific, portable and simple to use. The test is of high quality and priced to be affordable than its competitors, while “serving humanity and addressing global health security”, he added.

Dr. Nyan’s research team plans to conduct field studies of the diagnostic test in Africa, Asia, and South America. When asked about what he made of the new Ebola cases in Liberia and Sierra Leone being declared Ebola free, the NIH and German-trained infectious disease specialist commented that, “we must be reminded of the epidemiological history of the Ebola virus; the virus (Ebola) seems to take permanent residence wherever it strikes; I would strongly urge these Ebola-affected countries to institute sustainable infectious disease control and prevention programs and technical collaboration”. In September 2014, Dr. Nyan, testified to US House Committee on Ebola and proposed the establishment of regional Centers for Disease Control and Prevention in Africa.

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OpGen's QuickFISH Rapid Pathogen ID Test Demonstrates Clinical Utility and Cost Effectiveness in Community Hospital’s Antimicrobial Stewardship Program

OpGen, Inc., a molecular diagnostics and bioinformatics company helping to guide antibiotic therapy and to assist healthcare providers in combatting multi-drug resistant infections, announced today that the American Journal of Clinical Pathology has published a study on the benefits of using the company’s rapid Staphylococcus QuickFISH test at Winter Haven Hospital in Winter Haven, Fla.

The study, entitled “The Impact of Implementation of Rapid QuickFISH Testing for Detection of Coagulase-Negative Staphylococci at a Community-Based Hospital”, demonstrated that when incorporating QuickFISH testing for Staphylococcus into its Antimicrobial Stewardship (AMS) program, the hospital calculated significant annual savings ($764,316) through a 30% reduction in length of stay. The hospital achieved this through use of the test as part of its AMS program that helped it to rapidly differentiate between Coagulase-Negative Staph (CoNS), a normal constituent of human skin, and a potentially life-threatening Staphylococcus aureus infection.

The study was published online on December 10, 2015 and will appear in the January, 2016 print edition of the Journal.

“True infections with Staphylococcus aureus present considerable clinical challenges to hospitals, such as increased mortality rates, prolonged hospital stays and additional costs,” says Denise L. Koncelik, Laboratory Supervisor and co-author of the study. “Whereas blood culture contamination with Coagulase-Negative Staph can lead to unnecessary coverage with broad-spectrum antibiotic therapy, extended length of stay and unnecessary hospital costs, QuickFISH reports the pathogen ID with the Gram stain result and helped us achieve substantial cost savings and reductions in vancomycin use.”

According to the study, the Winter Haven team reported:

• A 90% reduction in time to report pathogen identity (mean of 17.16 hours reduced to a mean of 1.35 hours).
• A 30% reduction in length of stay (mean of 4.89 days reduced to mean of 3.44 days).
• A 65% decrease in days on vancomycin (mean of 2.52 days to mean of 0.89 days).
• Savings from the use of QuickFISH with an antimicrobial stewardship program calculated to be $764,316 using the mean costs per day at a not-for-profit hospital in the state of Florida.
• QuickFISH was shown to be fast and easy to perform in a busy microbiology laboratory, requiring only 5 minutes of hands-on time.

“We believe QuickFISH is a significant breakthrough for community hospitals looking to launch effective antimicrobial stewardship programs,” says Kevin Krenitsky, M.D., President of OpGen. “QuickFISH is the only rapid diagnostic on the market that is fast enough to report pathogen identification along with the Gram stain result, which in turn provides impactful, measurable outcomes such as those documented in this study. QuickFISH is a simple and affordable test that can have a meaningful impact on a hospital’s AMS program and overall performance. We are looking forward to sharing these powerful study results as we market our rapid pathogen identification products and systems to hospitals throughout the U.S.”

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German Group Develops On-Chip RPA Arrays for Isothermal Detection of Viruses, Bacteria

Researchers in Germany have developed the first flow-through microfluidic microarray with automated detection using recombinase polymerase amplification (RPA) for on-chip amplification.

The isothermal method was able to detect and quantify a panel of three viruses and bacteria, but researchers said the array size might be virtually unlimited.

In a proof-of-principle study published earlier this month in Analytical Chemistry, researchers at Technical University of Munich, Georg-August-University Göttingen, and Brandenburg Medical School Theodor Fontane, created a water quality assay to detect DNA of Enterococcus faecalis, human adenovirus 41, and Phi X 174.

"If you have a PCR reaction where you know which gene sequence is interesting, then you can very easily adapt your primer for RPA," Michael Seidel, chair of analytical chemistry and of the institute of hydrochemistry at the Technical University of Munich, and a lead researcher on the work, told GenomeWeb in an interview.

"You can design ... and develop any kind of assay in a very short time," he said, noting that this is "a very simple and easy method."

The researchers employed established methods to create the arrays, using Scienion's sciFlexarrayer liquid handling technology to immobilize 500 micron dots of DNA on prepared glass slides.

In the RPA method, a complex made up of recombinase and primer scans the template, invading the double-stranded DNA at homologous sequences. From there, the displaced strand is bound by single-strand DNA-binding proteins, and primers are extended by a polymerase.

The group used biotinylated readouts for the water quality assay, and made the assay quantitative by calibrating it to dilutions of each organism. The total time to run the assay was 48 minutes, according to the study.

The RPA chemistry was originally developed by TwistDx, an Alere subsidiary. It is marketed as a kit for research use, but customers' creative uses of the technology may also inform internal R&D at TwistDx, according to CEO Niall Armes.

"We believe that continuing to supply RPA for research use will lead to developments like this," said Armes.

Seidel's team had previously created a microfluidic system, named MCR 3, which is being commercialized by GWK, a German firm specializing in heating and cooling instruments.

"We have an open-analysis platform, and so the idea is that researchers or industry can use the instrument and have their own application on it," Seidel said.

Over the past 10 years, the group has shown the platform can be used to process "any kind of immunoassay," for example, such as a six-minute chip-based assay to detect 13 different antibiotics in raw milk samples that the group developed.

"We normally use [MCR 3] for immunoassays, but now we have the chance to go to multiplex DNA amplification tests on our system," Seidel said.

Based on the current research, the group is developing a larger project in Germany to create "a fully automated hygiene monitoring system" for drinking water.

"The idea is, we have a system for the concentration of viruses and bacteria in water and our MCR 3 at the end, then you get a signal if there is any contamination," he explained.

The global environmental water quality monitoring market is projected to grow to $20.5 billion by 2020, according to one recent marketing report, due in part to environment-friendly policy changes and expansion of testing in emerging markets.

Meanwhile, the Analytical Chemistry study is "another good example of the promiscuity of the RPA method, showing its capacity to interface with a variety of possible consumables and methods, and to do so 'out-of-the-box'," TwistDx's Armes said.

In particular, the study draws attention to aspects of RPA that the firm sees in its own work as well as that of customers and collaborators.

Namely, the use of RPA on surfaces or in microfluidic devices is "made easy by the capacity of RPA to tolerate off-temperature environments and function on solid phase," Armes said.

Because RPA operates at typical body temperatures — and can even be run using body heat alone — the chemistry enables the use of biological reagents that might not tolerate the heat treatments usually needed for nucleic acid amplification.

"In this case, the authors use biotin-labeled primers and subsequent binding of the enzymes, but one could also readily conceive of how enzymes like [alkaline phosphatase] or [horseradish peroxidase] might be located directly on the oligonucleotides, or how reagents like antibodies might be employed directly," Armes said.

Off-the-shelf, RPA has been employed by a number of research projects and it is also purportedly the chemistry being used in Alere's second-generation influenza assay, as previously reported by GenomeWeb.

Armes said he believes the chemistry is the only rapid isothermal method to offer a broadly applicable alternative to PCR. The firm also recently showed that, in most cases, standard short PCR primers work well in RPA.

"The potential is so large that it cannot conceivably be exploited fully through innovations originating within TwistDx and Alere," he said. "It is, in my view, not only of commercial value but even our duty to make scientists and developers aware of this technology and hope that they will take the time to try it."

For his part, Seidel said that he is open to collaborators to develop more assays for the MCR 3 microfluidic platform. "We are a research institution, but we are interested in this principle getting into the market in the future," he said.

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3M Petrifilm Rapid Aerobic Count Plate Earns AOAC Official Methods of Analysis Distinction

3M Food Safety’s Petrifilm Rapid Aerobic Count Plate has been granted Official Method of Analysis status by AOAC International (OMA method number 2015.13). The 3M Petrifilm Rapid Aerobic Count Plate detects and accurately enumerates aerobic bacteria counts in just 24 hours for most food matrices and environmental samples. 3M introduced the plate in January 2015 as a faster and superior indicator test alternative to conventional agar methods, having received certification from the AOAC Performance Tested Methods program prior to its customer launch.

Food and beverage processors are constantly under pressure to make time-sensitive decisions, so the ability to efficiently and reliably detect and count aerobic bacteria is critical. Proven to be as effective as standard agar plating methods, the company said, the 3M Petrifilm Rapid Aerobic Count Plate uses proprietary indicator technology to facilitate swift counting of aerobic bacteria colonies, helping food companies maximize worker productivity, make smart cleaning decisions and improve the quality and safety of their products.

“We are proud to be taking yet another innovative step forward with the seventeenth addition to the 3M Petrifilm Plate portfolio and our tenth product offering that delivers results in 24 hours or less,” said Jason Semerad, global marketing manager, 3M Food Safety. “But an even greater source of pride is saving food and beverage processing plants time and capital and maintaining the highest degree of accuracy and reliability so that their hard-earned brand equity is protected.

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Oculer Rapid Milk-Spoiling Bacterial Test to Save Dairy €200m a Year

Tipperary dairy technology firm Oculer has developed microbiology testing which could save the Irish dairy sector up to €200m annually in reduced farmer penalties, superior product shelf-life, and enhanced protein concentration.

 Technopath Group spin-off, Oculer’s innovative system will cut detection of milk-spoiling bacteria from the current global standard of 72 hours to 24 hours, with an alarm to signal potential risk of bacteria triggered in as little as six hours. Oculer say this is the biggest breakthrough globally for dairy bacteria testing in the past 100 years.

Oculer chief executive Brian Byrne said: “Oculer also informs farmers where the source of the problem originated.

Thermoduric bacteria can only be effectively eliminated when the source is accurately and reliably identified.”

Thermoduric bacteria are naturally occurring bacteria that survive pasteurisation, and are responsible for downstream spoilage of finished dairy products, for reduced shelf-life and reduced protein concentrations.

Oculer is targeting a €150m annual bacteria testing market with its new test. The company will create at least 20 jobs in sales, R&D and engineering over the next two years.

Milk Test New Zealand, the independent laboratory that carries out thermoduric bacteria testing for 97% of the New Zealand dairy industry, is to receive an Oculer system in Hamilton in early 2016.

Oculer is already reporting very strong interest in the technology from several of the largest industry players around the world.

A Milk Test New Zealand spokesperson said: “We have been in dialogue with Oculer for over a year now regarding the development of a novel rapid high-volume assay for the detection and enumeration of thermoduric bacteria in raw milk.

"During the coming months Oculer will be installing the technology at our laboratory facilities in Hamilton, near Auckland for initial testing.

"We see strong potential for the Oculer system to deliver operational efficiencies to our labs in New Zealand and for the global dairy industry.”

The technology utilises a florescence sensor in a micro titer plate format. The principle of this sensor technology is based on its ability to emit light, indirectly proportional to the level of oxygen present.

As microorganisms grow, they consume oxygen and the florescence signal increases, therefore the higher the microbial load the greater the consumption rate of oxygen, resulting in an increased signal. This signal is captured in a purpose built system incorporating an automatic, high throughput incubator and florescence reader, utilising (Charged Couple Detection) CCD camera technology. The data captured by the camera is taken every 15 minutes allowing a kinetic read of the Microbial growth throughout the incubation period.

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Rapid Test for E. coli O157 Developed

Scientists at Western University have developed a new rapid-test system to detect E. coli O157 bacteria. This new test will help prevent recalls and outbreaks, since it can be used to discover contamination before the food leaves the plant and is shipped. The collaboration that developed this test is between Dr. Michael Rieder at the Robarts Research Institute at Western University and two London entrepreneurs.

Currently, it can take up to three weeks for testing conducted on foods, especially ground meat products. After the initial test, most facilities test again for confirmation. Most facilities do not test-and-hold foods; rather, they conduct tests, then the food is shipped to retail locations. That’s why recalls are so often issued. If a test comes back positive, a recall must be issued.

The food is sampled at the end of the day, and results come in the next morning. The test identifies proteins present in the pathogenic bacteria. Flow-through technology marks the protein with colloidal gold so it’s visible to the eye. The process is similar to the one used in pregnancy tests.
Dr. Rieder said, “the current method for developing battier like E. coli relies on culture and takes 3 or 4 days to get a result, so we thought we could do better than that. With this current system, two weeks of for  may need to be recalled to ensure against cross-contamination.”

In November 2015, All American Meats recalled more than 160,000 pounds of ground beef that was potentially contaminated with E. coli bacteria. Ground beef was recalled in September 2015 by Schrader Farms for E. coli contamination. In July 2015, veal products produced by Brown Packing Company were recalled after tests showed possible contamination. And also in July 2015, Lombardi Beef recalled tenderized steak and ground beef products because tests showed E. coli contamination.

The researchers have submitted an application to Health Canada for approval. They are going to work on a rapid test for Listeria monocytogenes next.

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Neogen Corp Announces Receipt of AOAC Approval for New E. coli Test

Neogen has received approval from the AOAC Research Institute for its new rapid and accurate test to definitively detect E. coli O157:H7 DNA.

Neogen's newly approved ANSR® for E. coli O157:H7 detects the bacteria after only 10 minutes of reaction time following sample preparation. Neogen's ANSR is an isothermal amplification reaction test method that exponentially amplifies the DNA of any target bacteria present in samples to detectable levels.

"Each time we receive a validation from an influential third party on any of our tests, it provides further assurance to our many customers that our tests perform as expected," said Ed Bradley, Neogen's vice president for Food Safety. "ANSR is the fastest DNA-definitive pathogen assay available — with results in only 10 minutes. Compared to the three hours other methods such as polymerase chain reaction, or PCR, take to produce DNA-level results, that's a huge difference in a laboratory's workflow, and the operations of a food producer as a whole."

Combined with ANSR's single-step enrichment, Neogen's new pathogen detection method for E. coli O157:H7 can provide definitive results in as little as 12 hours from the time the sample is taken. To date, the test has been validated for testing raw ground beef, raw beef trim, leafy greens and sprout irrigation water.

With the validation of ANSR for E. coli O157:H7, Neogen also announced a new program for its ANSR rapid pathogen detection system. The program is a limited-time, risk-free 30-day trial for an on-site evaluation of the ANSR system using any or all of Neogen's ANSR assays. The program is designed to show prospective, qualified food laboratories how easy rapid molecular pathogen testing can be.

Neogen's line of ANSR products also includes AOAC Research Institute-approved tests for Salmonella, Listeria and Listeria monocytogenes. The ANSR system was designed to combine molecular-level accuracy with a scalable, low-cost instrument and a methodology that can be easily incorporated into any testing laboratory's existing workflow.

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UM Baltimore Grants Pataigin Rights to Develop Rapid, Point-Of-Care Identification of Dangerous Pathogens

University of Maryland (UM) Ventures and Pataigin, LLC, announced today that the University of Maryland, Baltimore (UMB) has granted Pataigin worldwide, exclusive licensing rights to UMB patents and technology to develop a method to quickly and accurately identify dangerous pathogens. Robert Ernst, Ph.D., associate professor of microbial pathogenesis at University of Maryland School of Dentistry, and David Goodlett, Ph.D., professor of pharmaceutical sciences at University of Maryland School of Pharmacy, are patent inventors. The University of Washington is also a co-owner on one of the patents Pataigin (the Irish word for pathogen) is licensing. Erik Nilsson, who has headed software and mass spectrometry companies for nearly 20 years, will serve as Pataigin’s CEO and President.

Infectious diseases remain a major global killer, responsible for 18 million deaths worldwide every year. And yet, detecting potential infectious agents remains hampered by current technological methods that are slow, require cell culture and are expensive and labor-intensive. The licensed technology exploits the presence of lipids in the outer membranes of pathogens that are unique to each pathogen strain. A “barcode” for each lipid coating is created that allows laboratory staff to quickly use available mass spectrometry methods to identify specific strains of bacteria, fungi and yeast that cause disease. The technology will allow pathogen identification directly from tissues like blood, urine, and wounds, without the need for cell culture. And importantly, the technology can differentiate between drug-susceptible and drug-resistant variants; thereby allowing for quicker medical treatment decisions as well as containment of dangerous pathogens.

Phil Robilotto, D.O., M.B.A., Chief Commercialization Officer, UM Ventures, Baltimore, said, “We are delighted to license this promising technology to Pataigin, an exciting new startup with excellent scientific and business leadership. The Company is well situated to validate and commercialize this important diagnostic technology that has the potential to positively impact the treatment of infectious disease by significantly reducing the time required to accurately identify and treat specific pathogens.”

Erik Nilsson has 30 years of experience in software, mass spectrometry and biotechnology. He is currently CEO of Deurion, a software development company that developed new technologies for mass spectrometry, bioinformatics and microfluidics. He previously served as President of machine learning software company Insilicos, and previously held several leadership positions (including President) of software platform developer GraphiCode, which he sold in 1999.

“I’m proud to be part of the effort to transform this valuable technology into better methods for infectious disease pathogen detection,” said Mr. Nilsson. “Pataigin has created a library of chemically barcoded pathogens that can be checked to determine what type of an infection a patient has, making such detection faster, cheaper and more accurate.”

Pataigin’s leadership team will also consist of Dr. Goodlett and Dr. Ernst.

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3M’s Next Generation Molecular Detection Assay for Listeria Receives AOAC PTM Validation

3M Food Safety’s 3M Molecular Detection Assay 2 – Listeria has been approved by the AOAC Performance Tested MethodsSM program (Certification #111501). The approval certifies that this new second-generation test kit is equivalent or better than standard reference methods in the detection of Listeria spp. within a variety of food matrices and environmental surfaces.

“We’re pleased to be saving food processors and testing laboratories time in their efforts to detect Listeria in food,” said John David, global business manager with 3M Food Safety. “Having third-party validations reaffirms the robustness of the technology and further demonstrates our commitment to ensuring our products meet the highest performance standards.”

The latest Listeria assay is one of three test kits that were expanded on the innovative 3M™ Molecular Detection System platform. The 3M Molecular Detection System is designed around food processors’ needs for rapid pathogen detection and based on unique isothermal DNA amplification and bioluminescence detection technologies that provide a faster and simpler testing method with high accuracy. The new Listeria test kit now provides a reduced time-to-result – as little as 24 hours of enrichment – and features a streamlined workflow that is 30 percent faster than the first generation assay, originally launched with the platform in 2011.

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HiberGene Launches Meningitis Test

HiberGene Diagnostics, a company focused on the application of molecular technology to infectious disease testing, has completed CE marking of its first test, HG Meningococcus, a rapid test for a severe form of bacterial meningitis, Meningococcal disease (MD), caused by the bacterium Neisseria meningitidis.

The test meets a significant unmet clinical need and allows physicians to rapidly and accurately test for the presence of meningococcal bacteria, in a near patient setting, ensuring that suspected cases are rapidly diagnosed and the appropriate treatment administered earlier.

Current detection methods for MD include growing the bacteria in a culture medium which can take several days from sample to result, and lacks sensitivity and specificity. By comparison, HiberGene’s test uses LAMP (Loop Mediated Isothermal Amplification), a proven technology for the detection of infectious diseases, which provides results in under an hour.

The test can be performed using a sample of whole blood, cerebrospinal fluid or from a nasopharyngeal swab, and can detect all known pathogenic Neisseria meningitidis serogroups A, B, C, 29E, W135, X, Y, Z, at very low levels with a high degree of accuracy.

The test was developed in the Royal Victoria hospital Belfast with funding received from the Meningitis Research Foundation (MRF) in the UK, and the Health and Social Care (HSC) R+D Division in Northern Ireland. It was subsequently licensed exclusively by HSC Innovations to HiberGene from the Belfast HSC Trust.

Brendan Farrell, CEO of HiberGene, said: “The HG Meningococcus test meets a significant unmet clinical need using advanced and proven technology. Meningococcal disease can be a particularly devastating illness if not treated rapidly, but by utilising the HiberGene product, physicians now have a test which can ensure the best possible care for patients.”

Linda Glennie, Head of Research and Medical Information at MRF said: "this shows that long term investment in research pays off. This project began almost a decade ago and it's great to see it launched today. We hope it will help speed up diagnosis of this deadly disease. The 17,000 families affected by meningitis and septicaemia who MRF represents know only too well how important early detection and treatment are. We look forward to seeing how this test could help save lives in a hospital setting. It's important to remember, however, that such a test is not a substitute for national surveillance to direct public health action. "

Dr. David Brownlee, Innovation Advisor, HSC Innovations, said “this knowledge exchange and commercialization activity between HSC and HiberGene demonstrates the value of working with practicing clinicians to identify technology opportunities and to develop new products for healthcare. These products can help to secure real improvements in healthcare practices globally.”

The launch of the HG Meningococcus test is the first in a series of tests under development by HiberGene. The company is working on a pipeline of new tests for a range of infectious diseases, and plans to launch tests for Group B Streptococcus, C. Difficile and Norovirus in 2016.

Meningococcal disease is an extremely severe disease which, when untreated, can reach fatality rates as high as 15%. Although Meningococcal disease occurs in all age groups and during all seasons, the risk of death is highest among young infants and the elderly. Those who survive can suffer serious long-term deficiencies such as brain damage, hearing loss or learning disabilities.

The test is CE-IVD marked and will be available through a number of national distributors.

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Biocartis Announces Launch of Influenza-Respiratory Virus Panel on the Idylla Platform

Biocartis, an innovative molecular diagnostics company, announced the launch of its first infectious disease test on the Idylla™  platform. The Idylla™  Respiratory IFV-RSV Panel has been developed by Janssen Diagnostics and is intended for the detection of various strains of Influenza Virus (IFV) and Respiratory Syncytial Virus (RSV). The Idylla™  Respiratory IFV-RSV Panel received CE-IVD marking on 18 November 2015 and is being launched for commercial use in Europe and other geographies recognising the CE-mark. Janssen Diagnostics has appointed Biocartis as co-exclusive worldwide distributor of the test.

Respiratory viruses are one of the most important causes of morbidity and mortality throughout the world[1] with the influenza virus killing at least 50 million and up to 100 million people in the last century alone[2]. The majority of diagnostic tests currently used for this market are rapid immunoassays which are chosen due to their low cost and convenience. However, one of the key downsides of these rapid tests is their poor sensitivity. Negative samples are typically re-tested in a central lab with a more sensitive molecular test, delaying time-to-result by many hours. The new Idylla™  Respiratory IFV-RSV Panel, running on the Idylla™  platform, combines in one single product the speed of rapid tests with the quality and sensitivity standards of central lab tests.

The Idylla™  Respiratory IFV-RSV Panel is designed for the qualitative detection of nucleic acids of Influenza A, Influenza A subtype H1, Influenza A subtype H3, Influenza A subtype 2009 H1, H275Y mutation of Influenza A subtype 2009 H1, Influenza B and Respiratory Syncytial Virus (RSV) subtype A and RSV subtype B from nasopharyngeal swabs (NPS[3]) of adult and pediatric patients, using the Idylla™  molecular diagnostics platform to aid in the diagnosis of respiratory viral infection.

Thanks to the fully integrated workflow and outstanding ease-of-use of the Idylla™  platform, the Idylla™  Respiratory IFV-RSV Panel can be performed in as little as 50 minutes and requires less than one minute of hands-on time.

After Biocartis launched its solid biopsy BRAF Mutation Test for melanoma and solid biopsy KRAS Mutation Test for colorectal cancer, this Idylla™  Respiratory IFV-RSV Panel is the first of a series of infectious disease tests that Biocartis and its partners are developing for use on the Idylla™ platform.

Rudi Pauwels, CEO Biocartis, states: "Collaboration is a key aspect of the strategy that we outlined at the time of our Initial Public Offering, in order to accelerate our menu development and speed up our commercial reach. Janssen has been a long-standing and very supportive partner of Biocartis. We are therefore delighted with the launch of such a high performance quality Idylla™  Respiratory IFV-RSV Panel. The combination of oncology and infectious disease tests demonstrates the versatility of our Idylla™ platform, one of the reasons why Janssen Diagnostics chose to work with Biocartis."

Biocartis is planning to roll-out a range of infectious disease tests in the coming years. The Idylla™ Rapid Ebola Virus Triage Test, developed in association with Janssen Diagnostics and the Institute for Tropical Medicine in Antwerp (Belgium), is expected to be the next infectious disease test on Idylla™ .

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Scienion, Grenier Bio-One Collaborate on Rapid Multiplex Dx for Infectious Disease

European firms Scienion and Grenier Bio-One announced a collaboration to co-develop rapid, multiplexed diagnostic tests.

The partners said in a statement they would develop new tests for human pathogens that will yield test results within 75 minutes.

The deal brings together Scienion's sciFlexarrayer liquid handling technology and Grenier's PCR-based Genspeed pathogen detection platform. Kremsmünster, Austria-based Grenier has already launched a methicillin-resistant Staphylococcus aureus test, the Genspeed MRSA.

The agreement is the latest in a string of technology partnerships for Berlin-based Scienion this year. In September, the firm partnered with Australian firm Axxin to develop a multiplexed microarray analysis system. In July, it partnered with Australian reagent maker Anteo Technologies to improve the shelf life of protein microarrays. And in June, Scienion agreed to integrate sciFlexarrayer into QuantuMDx's nanowire array technology and commercialize the biosensor.

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BioFire Defense Ebola Test Fares Well in Sierra Leone, UK Evaluation

A research team from the UK has determined that a rapid molecular Ebola assay from BioMérieux subsidiary BioFire Defense is sufficiently sensitive and specific to be an attractive option for relatively low-throughput laboratories testing for the disease.

However, the assay and accompanying platform may not yet be suitable in outbreak situations or in labs with relatively high testing throughput, the researchers suggested.

Rapid and specific testing is critical for patient care in suspected cases of Ebola virus infection, but rigorous evaluation of the numerous molecular diagnostics that have received Emergency Use Authorization from the US Food and Drug Administration is ongoing.

Since August of 2014, eight molecular diagnostics for Ebola have been authorized. These include the FilmArray NGDS BT-E Assay and Biothreat-E test from BioFire Defense, which have been the subject of at least three peer-reviewed evaluations since mid-July of this year.

The most recent study of the BioThreat-E test, published online last week in the Journal of Clinical Microbiology, was a collaborative effort of the Defence Science Technology Laboratory, Public Health England, and the Centre of Defence Pathology in the UK.

The group tested samples as they became available during the Ebola crisis last year. These included 44 patients in Sierra Leone as well as 70 patients in the UK who had symptoms and had recently traveled to West Africa. During that period, the rare and imported pathogens lab at PHE saw a 10-fold increase in testing frequency, although the majority of patients were not infected with Ebola, the study noted.

Importantly, the evaluation deviated from the BioFire FilmArray protocol by adding a heating step prior to testing of 60 °C for 15 minutes. This was intended to inactivate the virus and enable the assays to be performed at lower biological safety levels.

According to Simon Weller, first author on the JCM study and a researcher at DSTL, the three agencies had different aims in conducting the evaluation.

"From a defense perspective, we have an interest in low operative and logistic burden diagnostic technologies — the FilmArray fits neatly into this area — and therefore the Ebola outbreak was an opportunity to test such a platform in a real-world setting," Weller told GenomeWeb in an email.

Meanwhile, from a public health perspective, there was a requirement to enhance the UK capability to rapidly test suspected patients closer to where they presented for diagnosis, Weller said, noting that most regional PHE labs didn’t operate an Ebola testing service prior to the outbreak.

"The FilmArray was a candidate for a means to rapidly put a safe and sensitive testing capability into these regional labs," he added.

The study compared the FilmArray Biothreat E-test to a published TaqMan-based real-time PCR assay. That assay had been optimized and validated previously by  for use in the UK and Sierra Leone, and included a bacteriophage internal control, Weller said.

The BioThreat-E test showed comparable performance to the validated PCR, with a sensitivity of 84 percent and specificity of 89 percent in the Sierra Leone samples, and a sensitivity of 75 percent and specificity of 100 percent in the samples from the UK.

This difference between the sites was likely a function of different prevalence of Ebola in the two countries and the relatively low sample numbers, rather than a performance or geographic characteristic, Weller said.

There were also nine discrepant results, potentially attributable to waning viral load and inhibitors present in whole blood.

Safely handling patient samples that could be infected with Ebola is always a concern. The comparator RT-PCR required a centrifugation step, which can potentially create aerosols.

"Within the small isolators in Sierra Leone — the only containment available there — there was a significant operative and temporal penalty in having to centrifuge," Weller explained.

"There was a lot of packaging in the isolators from unpacking samples; blood then had to be transferred to microtubes for centrifugation and then plasma had to be transferred to a fresh microtube for inactivation and RNA extraction — it took a while to do, even with practice."

The BioThreat-E test, on the other hand, used only 200 microliters of whole blood.

Disposal of waste and cleaning the platform is also important. In Sierra Leone, test pouches were double bagged and put into a clinical waste stream for immediate on-site incineration, Weller said, while in the UK they were autoclaved prior to incineration.

"How to disinfect a platform and then be able to subsequently use it is something we have an interest in," he said, adding, "We didn’t experience a pouch split in our testing and, in any case, put in an inactivation step prior to PCR."

And while the one-hour BioThreat-E test was found to be an "attractive option" for lower-throughput testing, it may not meet requirements for outbreak situations.

"When I was in Sierra Leone, we routinely had batches of 40 samples or more," Weller said. "These would be unsustainable to test on the FilmArray — it would be very costly and take too long."

He noted that in his experience of Ebola testing, there were bottlenecks in the unpacking of samples, generating plasma to test, and EBOV inactivation, all of which must be performed in a small isolator, as well as in the manual RNA extraction and PCR.

"An integrated platform [that performs] RNA extraction and PCR [and] which is able to test whole blood samples and run samples concurrently might be an interesting thing to evaluate," he said. A rapid diagnostic test that also included viral inactivation steps would be interesting as well, he suggested, although overall the researchers found the general microbiological screening capability of the FilmArray very useful in Sierra Leone.

In the future, the three labs will use whichever test or technology is best for the particular scenario they are faced with, as the FilmArray "is a very useful tool but only as part of a wider microbiological [and] virological testing capability," Weller said.

However, he said that he would hope the international community has now evaluated enough platforms and technologies for Ebola testing, and that it has enough experience to be able to rapidly deploy the best technologies and approaches in any future Ebola outbreak.

"Hopefully there will not be one on the same scale again," he said.

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Researchers Launch Bloodless Urine-based Malaria Test

Scientists working in Nigeria have developed a new test for malaria using urine which they hope will become mainstream soon in compliance with national guidelines to test before treating for malaria.

The urine malaria test (UMT), developed by Fyodor Biotechnologies, doesn’t require use of blood unlike existing rapid diagnostic test for malaria.

Speaking at the launch of UMT in Abuja, Dr Victoria Enwemadu, Fyodor’s global head of projects, told Daily Trust, “There are some challenges with adopting that [national malaria testing] guideline mainstream because of the invasiveness of trying to get blood for testing. Now we have made it easier by just using urine to test for malaria.”

The UMT includes a strip that is dipped into urine sample for 25 minutes to give results which can be read as positive, negative or valid, when compared against a control.

It is based on recombinant antibody technology which searches for malaria parasite in urine sample, and the strip indicates its presence or not, according to Dr Eddy Agbo, chairman of Fyodor.

“There should be no guesswork by any health provider as to whether a patient has malaria or not,” he added. “We have a game changer in our hands.”

UMT has taken seven years in the making, and involved Johns Hopskins University, University of Maryland and University of Nigeria, Nsukka in discovery, clinical development and analysis.

Researchers included partners at the National Malaria Elimination Programme recruited more than 2,000 people to take part in clinical trials for the test.

It is considered the “first full-scale clinical trial for a medical product ever undertaken in Nigeria,” according to Agbo.

Dr Bridget Okoeguale, director of public health at the federal health ministry, said FMOH would consider working with its Roll Back Malaria partners to push UMT as a do-it-yourself malaria test that does not require bleeding or pricking.

Fyodor has said it would use partnership with indigenous firm Geineth to make UMT available in hospitals, pharmacies, primary health centres and patent medicine stores around the country.

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Western University Scientists Develop New Test to Detect E. Coli in Contaminated Food

Scientists at Western University have developed new technology that they believe has the potential to drastically improve food safety.

The new rapid-test system, developed by Dr. Michael Rieder, would allow manufacturers to more quickly identify food contaminated with a strain of E. coli before it leaves the processing plant, and enters the grocery store.

“The current method for developing bacteria like E. coli relies on culture and takes about 3 or 4 days to get a result, so we thought we could do better than that,” said Dr. Rieder.

“By the time the bacteria are identified, the food has been shipped to grocery stores and may have already caused illness. With this current system, two weeks of food may need to be recalled to ensure against cross-contamination.”

Dr. Rieder’s rapid-test system would allow food to be sampled at the end of one day, and the results would be available before the food is shipped the next morning.

“This means that one day’s production is lost, not five days production,” he said. “This has the potential to save companies considerable money, and more importantly could save a lot of people from being exposed to food-borne disease.”

The system was developed over the past five years as a result of collaborations between Dr. Rieder, scientist at Robarts Research Institute at Western University, and London entrepreneurs, Michael Brock and Craig Coombe.

The rapid-test relies on targeting proteins identified by Dr. Rieder’s lab that are only present in the organisms that cause people to become ill. By collaborating with Toronto-based company, International Point of Care, the team was able to use flow-through technology to mark the protein with colloidal gold so that it is visible to the naked eye. The process is similar to that used in pregnancy tests – one line for negative, two lines for positive.

“I’d like to think that at Robarts we deliver, so now we’ve got this product that’s out there and let’s see where it goes,” he said. “Our next target, by the way, is going to look at Listeria, so now that we’ve got E. coli solved, we’re going to start looking at other bacteria.”

The rapid-test system has completed testing at Robarts and the Health Canada-certified Agriculture and Food Laboratory at the University of Guelph. The final application has been submitted to Health Canada for approval.

On average, 440 cases of E. coli 0157 infection in humans are reported annually to the Public Health Agency of Canada.

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Alere's SD BIOLINE HIV/Syphilis Duo is First Dual Test to Receive WHO Prequalification

Alere, a global leader in rapid diagnostics, announced that its Alere SD BIOLINE HIV/Syphilis Duo test has been awarded World Health Organization (WHO) prequalification, making it the first dual HIV/syphilis point-of-care test available for public sector procurement in resource-limited countries.

With WHO prequalification, global health organizations such as PEPFAR, UNAIDS and the Global Fund to Fight AIDS, Tuberculosis and Malaria can now deploy the HIV/Syphilis Duo test in national screening programs targeting those in greatest need. Utilization of the test will be focused on screening pregnant women for HIV and syphilis and linking those infected to care, in support of WHO's goal of eliminating mother-to-child transmission (EMTCT) of these serious diseases.

"Alere is committed to making our infectious disease diagnostics widely available to support prevention of mother-to-child transmission programs in resource-limited countries, and the WHO prequalification of HIV/Syphilis Duo test significantly advances this goal," said Avi Pelossof, Alere Global President of Infectious Disease. "With this broadened access, the full potential of the HIV/Syphilis Duo test in helping meet EMTCT goals can now be unlocked."

Her Excellency, Dr. Nana Lordina Dramani Mahama, First Lady of the Republic of Ghana and President of the Organisation of African First Ladies Against HIV/AIDS, said, "Alere has already provided test kits to help us screen 200,000 people for HIV and syphilis infections, and we are delighted that this productive relationship continues to grow and thrive."

About Alere SD BIOLINE HIV/Syphilis Duo

The Alere SD BIOLINE HIV/Syphilis Duo offers a simple, easy-to-use rapid diagnostic test for simultaneous detection of HIV and Syphilis. By enabling early detection of HIV, Syphilis or both in mothers, the Alere SD BIOLINE HIV/Syphilis Duo helps bridge the health equity gap and get patients onto treatment pathways faster. The test uses a solid-phase immunochromatographic assay for simultaneously qualitative detection of HIV-specific antigens (HIV-1 gp41, sub O, HIV-2 gp36) and recombinant Treponema pallidum antigen (17 kDa) in human serum, plasma, or whole blood.

About Mother-to-Child Transmission of HIV and Syphilis 

Globally, 1.4 million pregnant women have active syphilis and almost 1.5 million pregnant women are HIV infected. Both HIV and syphilis can be transmitted during pregnancy to the fetus. Additionally, syphilis infection during pregnancy increases the risk of mother-to-child HIV transmission by 180%.[1]  In sub-Saharan Africa, 260,000 African children are infected with HIV each year. Mother-to-child transmission occurs through pregnancy, labor, delivery and breast feeding. In fact, breast-feeding alone increases the risk of MTCT by 12%-43%.[2]  Maternal syphilis infection can cause stillbirth, neonatal death, prematurity, low birth weight or congenital syphilis. The impact of maternal syphilis can be prevented by testing early in pregnancy, treating seropositive pregnant women, and preventing re-infection.[3],[4]

Forty percent of pregnant women living with HIV have not received anti-retrovirals to reduce mother-to-child transmission during pregnancy.[5] Without any intervention, up to 45% of infants born to mothers living with HIV will become infected.[6]

In 2014, WHO and key partners published guidance on and recommendations for the dual elimination of mother-to-child transmission of syphilis and HIV, and a framework for countries to monitor progress and validate success.[7]

[1] Mwapasa V, Rogerson SJ, Kwiek JJ, et al. Maternal syphilis infection is associated with increased risk of mother-to-child transmission of HIV in Malawi. Aids 2006; 20(14): 1869-77.

[2] Maputle MS, Jali MN. Pregnant women's knowledge about mother-to-child transmission (MTCT) of HIV infection through breast feeding. Curationis. 2008;31(1):45-51.

[3] De Santis M, De Luca C, Mappa I, et al. Syphilis Infection during pregnancy: fetal risks and clinical management. Infectious diseases in obstetrics and gynecology 2012; 2012: 430585.

[4] Gomez GB, Kamb ML, Newman LM, Mark J, Broutet N, Hawkes SJ. Untreated maternal syphilis and adverse outcomes of pregnancy: a systematic review and meta-analysis. Bulletin of the World Health Organization 2013; 91(3): 217-26.

[5] 2013 Progress Report on the Global Plan. UNAIDS 2013.

[6] UNICEF, Unite for Children, Unite Against AIDS. Towards an AIDS-Free Generation, report highlights. Children and AIDS, Sixth Stocktaking Report 2013.

[7] World Health Organization (WHO). Global Guidance on Criteria and Processes for Validation: Elimination of Mother-to-Child Transmission of HIV and Syphilis. 2014. Available online at http://apps.who.int/iris/bitstream/10665/112858/1/9789241505888_eng.pdf?ua=1&ua=1.

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Researchers Successfully Test New Method for Rapid Diagnosis of Ebola in Guinea

An international team of researchers, including Ahmed Abd El Wahed, scientist at the University of Göttingen and the German Primate Center, has tested a new method for rapid diagnosis of Ebola in a field trial in Guinea. The test procedure was carried out using a portable suitcase laboratory. The mobile suitcase lab is operated with solar power and enables simple on-site diagnostics in remote areas without the need of an equipped laboratory. The new detection method, a recombinase polymerase amplification technique, shortly RPA, is based on the rapid identification of viral RNA in oral swabs of infected persons at 42 degrees. The comparison with two other currently available diagnostic methods revealed that the RPA is a very sensitive and rapid technique. An Ebola infection case was detected after 30 minutes. The results of the field study have been published in the current issue of the journal Eurosurveillance.

In the field study, which took place in Guinea from March to May 2015, oral swabs samples from persons suspected of dying of Ebola virus were analyzed. The scientists compared the new RPA with two variants of a currently available detection method, the so-called real-time polymerase chain reaction (PCR). "In the analysis we were able to determine two things", says Ahmed Abd El Wahed, currently in the Department of Microbiology and Animal Hygiene at the University of Göttingen and a guest scientist at the German Primate Center. "First, RPA works very well with oral swab samples, which greatly simplifies sampling in the future, because it is faster and less complicated than sampling blood. Second, we have demonstrated that RPA is as sensitive and specific as the gold standard, but technically much more simpler than the real-time PCR methods."

Nine hundred twenty eight oral swab samples were tested with RPA, one hundred twenty samples were positive and eight hundred eight negative. The reference real-time PCR method gave exactly the same results. "That is a 100 per cent accuracy", says Abd El Wahed. "In addition, we observed during the test that RPA even works better than a currently commonly used WHO approved real-time PCR for the detection of Ebola."

Both the PCR and RPA-tests are based on the identification of viral RNA in the serum or oral swabs of infected persons. In contrast to the real-time PCR, the RPA reagent can be shipped, stored and used at ambient temperature of Africa (up to 38 degrees), which makes them cold chain independent. After 30 minutes, the detection of Ebola with RPA is possible. In contrast, the real-time PCR usually takes several hours. This complicates the use of the method in remote areas. "In order to better control an Ebola epidemic, we must be able to prove infections on-site as early as possible", says Abd El Wahed.

In a previous project, Abd El Wahed, Manfred Weidmann and Frank Hufert of the former Department of Virology of the University Medical Center Göttingen (UMG) developed the laboratory suitcase. It now also contains all the necessary reagents and equipment needed for the Ebola virus detection by RPA and works up to 16 hours with solar power. A mobile glove box provides additional protection against infection with contaminated sample material.

"The mobile diagnostic kit facilitates detection of Ebola and other infectious diseases directly in the crisis areas", says Ahmed Abd El Wahed. "With the field study, we could now also demonstrate the effectiveness of the new tool. Speed, accuracy and ease of use are three important criteria that we were able to achieve with the new method. Thus, the procedure could contribute decisively to the management of future Ebola crises."

In future, the diagnostic kit is also to be used for the detection of other viral infections. For example, Dengue virus, Chikungunya virus and Rift Valley fever virus.

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Huntsville Biotech Company Reaches Important Milestone with Deadly Bacteria Detection

Leaders at HudsonAlpha associate company iCubate believe they are one step closer to having its gram positive bacteria rapid identification test used by hospitals.

According to findings published in "The Journal of Clinical Microbiology," the iCubate iC-GPC assay was proven effective in a hospital setting. The device can identify infections including Staphylococcus. Researchers say these are among the most common bacterial contaminants of blood.

“These findings are an important milestone for the company. We are one step closer to having this product available to help healthcare providers better treat their patients,” says iCubate CEO Carter Wells.

The findings, which were published online and will appear in the journal's December print publication, discussed benefits using the iCubate assay.

"A potential benefit of the iC-GPC assay is the use of a single, closed-system consumable cassette. This enables simplified assay set-up (< 5 min. hands on time) and also aids in reducing the risk of aerosolization of potentially infectious organisms and amplicon contamination. Furthermore, the iC- Processor is capable of random-access processing of up to 4 iC-cassettes simultaneously using an instrument that has a small footprint. Combined, these attributes may positively impact safety, workflow, and throughput when compared to other currently available FDA- cleared molecular platforms and assays for the direct identification of bacteria present in positive blood cultures.”
While this gives the company positive momentum, there is a major hurdle iCubate needs to clear before the assay is used in hospitals -- FDA approval.

iCubate founder and chairman Jian Han, M.D., Ph.D., told Tech Alabama in January 2015 he believes the privately-held company will be worth hundreds of millions of dollars once it obtains an FDA 510(k) clearance.

“Combining the innovative arm-PCR technology pioneered by Han, along with our talented team members, iCubate is positioned for success in this growing market,” Wells explains.

A timetable on FDA clearance is unknown at this time.

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New Tests Allow Quick Detection of Foodborne Bacteria

A new testing method developed by Abu Dhabi’s centralised laboratory will allow detection of foodborne and environmental bacteria much quicker, helping prevent and limit outbreaks of food-related diseases.

The Central Testing Laboratory (CTL) will now use a high-tech method with proteins that infect and multiply inside bacteria. This will enable the detection of some of the most common harmful foodborne pathogens, including Salmonella species, E. coli, Campylobacter species and Listeria.
The procedure will take less than 19 hours, compared to the four days required with traditional methods of detection.

“Pathogenic bacteria species such as these account for most food and water-related illnesses and outbreaks, resulting in many fatalities worldwide. The new capability puts CTL on par with the leading laboratories of the world and further augments Abu Dhabi’s capacity to control outbreaks of food borne diseases,” said Mohammad Al Baloushi, acting director for marketing and communication the Abu Dhabi Quality and Conformity Council (QCC). The QCC, which ensures the development of quality infrastructure in Abu Dhabi manages the CTL. The CTL itself is a merger of Abu Dhabi’s nine public laboratories.

The CTL’s current capabilities include testing of food, water, pharmaceuticals and construction materials.

Dr Krishna Murthy, director of Medeor 24x7 Hospital in the capital, said the new molecular testing method will allow for the rapid testing of foods and protect from possible pathogens being spread.
“With such advanced techniques, it is even possible to detect disease-causing bacteria that are present in very small quantities. So decisions to withdraw infected foods can be made accurately, thus keeping the community safe,” he explained.

The new detection method has also been accredited by the internationally accepted United Kingdom Accreditation Service.

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T2Bacteria Panel Achieves Rapid and Sensitive Detection of Six Clinically-Relevant Bacteria Species Directly From Whole Blood

T2 Biosystems, Inc., a company developing innovative diagnostic products to improve patient health, announced that data on its investigational T2Bacteria Panel will be presented today at the Association of Molecular Pathology (AMP) 2015 Annual Meeting in Austin, Texas. The data demonstrate the ability of T2Bacteria to provide the rapid and sensitive identification of six sepsis-causing bacteria, directly from whole blood, with limits of detection as low as 1 CFU/mL. The six clinically relevant bacteria included in the T2Bacteria Panel are: Staphylococcus aureus, Enterococcus faecium, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Acinetobacter baumannii.

"This is the first time study results demonstrate a rapid and sensitive bacterial species diagnosis direct from whole blood and without the need for blood culture," said Mike Pfaller, M.D., chief medical officer of T2 Biosystems. "The implications of these data are significant, enabling physicians to implement more timely targeted antibiotic therapy, potentially saving patient lives."

"The use of T2Candida and T2Bacteria, when combined with the practice of empirically administering broad spectrum antibiotics, may typically enable 95% of patients with sepsis to receive rapid and appropriate therapy," said John McDonough, chief executive officer of T2 Biosystems. "We are excited that the data in this study demonstrate the potential of T2Bacteria to enable the reduction in the current mortality rate of bacterial sepsis by 50%."

About the Study

The T2Bacteria Panel is being designed to run on the T2Dx instrument in conjunction with the T2Candida Panel. To achieve similar clinical performance to the T2Candida Panel, published data show that the T2Bacteria Panel will need to achieve a limit of detection (LoD) below 10 CFU/mL for each species. T2MR was able to demonstrate a high analytical sensitivity and high specificity for all bacterial targets. A LoD as low as 1 CFU/mL was observed for the targeted bacteria species spiked into healthy blood. The LoD for all bacterial species tested was determined by the cell concentration (CFU/mL) that resulted in a 95% or greater detection rate for 20 samples.

Key finding:

Data demonstrate the T2Bacteria Panel's ability to achieve limits of detection below 10 CFU/mL, and as low as 1 CFU/ml, similar to the performance demonstrated for the T2Candida Panel, in six clinically relevant bacteria species.

The six bacteria in the T2Bacteria Panel were selected because when combined with the use of T2Candida and the practice of empirically administering broad spectrum antibiotics, the rapid detection of these bacteria may enable 95% of patients with sepsis to receive rapid and appropriate therapy. These bacteria comprise 55% of all positive blood cultures and have growing resistance profiles.

About T2Bacteria Panel  

The T2Bacteria Panel is being developed to provide a species-specific result in three-to-five hours, direct from whole blood, with no need for blood culture. Similar to the FDA-cleared T2Candida Panel, the T2Bacteria Panel will run on the fully automated T2Dx Instrument. To date, the T2Candida Panel has demonstrated 91.1% sensitivity, 99.4% specificity and limit of detection as low as 1 CFU/mL. Species-specific results are obtained in three-to-five hours versus 120+ hours for blood culture. To achieve similar performance, published data indicates that the T2Bacteria Panel would need to achieve a limit of detection below 10 CFU/mL for each species, which was demonstrated in this study.

About Sepsis

Sepsis is one of the leading causes of death in the U.S. and the most expensive hospital-treated condition, with costs to the healthcare system exceeding $20 billion each year, according to the U.S. Department of Health and Human Services. The T2Candida Panel uses T2 magnetic resonance (T2MR) technology to detect the presence of five clinically relevant species of Candida, the most lethal form of common blood stream infections that cause sepsis, directly from a patient's blood sample in approximately three-to-five hours, enabling physicians to make timely treatment decisions to reduce adverse outcomes, patient mortality, and costs.

About The T2Candida Panel

The T2Candida Panel is the first sepsis pathogen diagnostic that provides species-specific results in three-to-five hours without the need for blood culture, which can take up to six days to provide a result. The rapid detection of Candida enables physicians to provide targeted treatment quickly, and research has shown this can reduce a positive sepsis patient's length of stay in the hospital by almost nine days at a cost savings of approximately $26,887. A rapid negative result can prevent unnecessary administration of antimicrobials, further reducing costs. In addition, a rapid negative result can prevent or reduce antimicrobial resistance, which the Centers for Disease Control and Prevention has designated a serious threat.

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Roche Expands cobas 4800 System menu with HIV-1, HCV and HCV Genotyping Tests

Roche announced the commercial availability of the cobas HIV-1, HCV and HCV Genotyping (GT) assays in countries accepting the CE mark1. These new molecular diagnostic assays increase the available menu on the cobas 4800 System, further improving efficiency and flexibility that allows laboratories to deliver results for rapid clinical decisions.

The new virology assays offer the latest generation of performance with dual target technology for HIV-1 and dual probe technology for HCV. All of the new virology assays can run simultaneously on the cobas 4800 System, with optimized sample processing volumes for streamlining workflow that increases flexibility for patient sample management. With these additions, the cobas 4800 System now has a menu of 12 high medical value IVD assays, making it the ideal solution for a highly efficient laboratory.

"With the addition of these assays to the cobas 4800 menu, more laboratories have access to advanced virology assays that provide reliable results for confident patient management," said Roland Diggelmann, COO, Roche Diagnostics." As the global market leader, we are also pleased to introduce cobas HCV genotype test which accurately identifies HCV genotypes and helps optimize treatment of hepatitis C patients."

The assays launched today will be followed in the coming months by the cobas HBV Test, which will complete the portfolio of viral load monitoring and genotyping assays for the cobas 4800 System.

About the cobas 4800 System

The cobas 4800 System offers improved automation of nucleic acid purification, PCR (polymerase chain reaction) set-up and real-time PCR amplification and detection to help laboratories achieve maximum efficiency. The system now has a comprehensive test menu including the cobas HIV-1 Test, cobas HCV Test, cobas HCV Genotyping Test, cobas MRSA/SA Test, cobas HSV 1 and 2 Test, cobas C.diff Test, cobas CT/NG Test (chlamydia/gonorrhea), cobas HPV Test, cobas BRAF V600 Mutation Test, cobas EGFR Mutation Test, and the cobas KRAS Mutation Test.

About the assays for the cobas 4800 System - assays for viral load monitoring and genotyping

The three new virology assays can run simultaneously on the cobas 4800 System with two different sample processing volumes for HIV-1 and HCV (200 µL and 400 µL) and only 400 µL for HCV GT streamlining workflow while increasing flexibility for patient sample management.

cobas HIV-1 is built upon the dual-target assay design from Roche. The test simultaneously amplifies and detects two separate regions of the HIV-1 genome, which are not subject to selective drug pressure, allowing for more reliable results to confidently and effectively quantify the amount of HIV-1 RNA in a patient's blood.

cobas HCV employs Roche's unique dual-probe approach to provide an extra layer of protection against mutations that can occur in the viral genome and is designed to accurately detect and quantify hepatitis C virus (HCV) ribonucleic acid (RNA) with state-of-the-art sensitivity in order to confirm active HCV infection or assess a patient's response to antiviral therapy.

cobas HCV Genotyping is a highly accurate and sensitive real-time PCR-based test for the qualitative identification of HCV genotypes 1 to 6 and genotype 1 subtypes a and b in human plasma or serum from individuals with chronic HCV infection. Identification of the infecting genotype is required before a patient is prescribed antiviral therapy as response to treatment correlates to the HCV genotype.

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Startup Qvella Gets Funding to Develop Rapid Pathogen Detection Test

It's been more than a decade in the making, but Qvella is close to the holy grail of diagnostics--a compact, inexpensive pathogen analyzer that identifies the precise culprit in only 30 minutes. The idea is to enable better infection treatment faster as well as to minimize the overuse of antibiotics, which leads to the development of resistance.

The company has gotten a $20 million Series A round that was co-led by RA Capital Management and Whitecap Venture Partners. Hatteras Venture Partners and Sands Capital Ventures also participated. The financing is intended to advance the development of its first test to detect pathogens, in whole blood, although the technology can also be used with other bodily fluids, as well as to build out its staff.

"Solutions that enable patients to receive the right treatment quickly will fulfill a key unmet need in microbiology," Parker Cassidy, Qvella board member and executive in residence at RA Capital Management, said in a statement. "Qvella has the perfect combination of technology, team, and potential to impact how antibiotics are delivered and developed." Cassidy was previously the VP of Continuous Glucose Monitoring at Becton Dickinson.

The development of the technology for the test started in 2003 at UCLA's David Geffen School of Medicine, with the establishment of Qvella following in 2009 and the in-licensing of the tech from UCLA shortly thereafter in 2010.

The test is based on the startup's Field Activated Sample Treatment (FAST) technology, which is a novel method of preparing the pathogen from the blood sample for subsequent amplification. FAST works via a tailored electric field that runs through a sample and releases the intercellular content. The field denatures and inactivates proteins such as nucleases and other contaminants that could inhibit the PCR amplification process, which subsequently occurs in a second chamber.

The process doesn't require traditional extraction and purification methods that use reagents or mechanical processes--or the hours that these can require. All this plays out on an E-Card, which houses all the processes from cell isolation and concentration to the neutralization of enzymes within the cells to reverse transcriptase and PCR amplification to data analysis.

"Qvella is on an accelerated path to significantly change how bacteriology is handled in the healthcare system," summed up Whitecap Partner Blaine Hobson in the announcement.

Source: http://www.fiercemedicaldevices.com

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Bibby Scientific’s Techne PCR-based Method Allows Rapid and Specific Detection of Flavour Spoilage Yeast

Bibby Scientific announced today that it has launched a Techne PCR-based method for reliable and highly specific detection of the yeast, Dekkera bruxellensis, which is a major cause of wine spoilage worldwide, causing large economic losses within the global wine industry.

Flavour-spoiling phenolic compounds released from this yeast lead to undesirable aromas, known as ‘Brett’ taints, that are normally associated with aromas of barnyard, burnt plastic, wet animal and horse-sweat. Detection of the yeast through traditional microbiological techniques can be time-consuming, costly and unreliable. In contrast, real-time or quantitative PCR-based detection methods allow for exceptionally rapid and highly specific identification of the yeast.

Testing for the presence of D. bruxellensis can be determined using the Techne Prime Pro 48 qPCR system in conjunction with the Techne qPCR test ‘Dekkera bruxellensis 26S ribosomal RNA’. The Techne qPCR Kit for D. bruxellensis is designed for the in vitro quantification of D. bruxellensis genomes. The kit is designed to enable the broadest detection possible whilst remaining specific to the D. bruxellensis genome. The kit is comprised of primers and probe sequences that have 100% homology with a wide range of D. bruxellensis sequences based on comprehensive bioinformatics analyses.

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Omega Diagnostics Identifies 'Stability Issue' in Long-Awaited HIV Test Kit

Omega notes in a progress report it has been working “since the last update” to resolve a “stability issue which manifested after five weeks storage at ambient temperature”

Medical diagnostics firm Omega Diagnostics has warned a “stability issue” has slowed progress in commercialising its long-awaited Visitect CD4 HIV testing kit.

Omega notes in a progress report it has been working “since the last update” to resolve a “stability issue which manifested after five weeks storage at ambient temperature”.

The company had noted in a July update is had brought manufacturing of Visitect CD4 back in-house after reporting “sub-optimal” field trials in Kenya.

The AIM-listed company reported a “manufacturing variability” issue with Visitect CD4 last October which had slowed commercialisation of the product.

Omega notes in a trading update today: “We have recently discovered an ambient temperature effect which manifests as a change in test line signal, with no corresponding change in reference line signal.

“We have identified the step responsible for this temperature effect, and our immediate focus now is to complete the testing needed to determine which component from this step causes it.

“Once the component is identified and replaced or adjusted, the verification and validation process will re-commence.

“We remain confident of resolving this, although the ultimate timing remains uncertain at this stage and we will provide further updates as soon as we can.”

Omega, which recently completed fit-out of a 20,000 sq.ft laboratory and manufacturing space in India as a second manufacturing site for Visitect CD4, said the manufacturing equipment installed is

“generic for most lateral flow rapid tests” and will “provide a low cost manufacturing base for a broader range of infectious disease tests”.

The company said it has selected a range of malaria tests to work on, “as soon as the equipment has completed validation”.

Omega which provides medical diagnostic test kits for allergies, food intolerance and infectious diseases, notes in a trading update it expects revenues will be up eight per cent in the six months to September 30 to £6.15 million for the period, (H1 2014: £ 5.69 million).

On a constant currency basis, Omega expected first half revenues are up 11 per cent.

The company said first half profits are “expected to be similar” to the £0.56 million reported for the first half of last year, as an increase in gross profit has covered a rise in management costs which Omega said is “in line with growth plans”.

Revenues from food intolerance activity are expected to be up 20 per cent to £3.34 million from “significant gains in business throughout the Americas and the Middle East plus a number of markets in Asia and the Far East”.

In infectious disease/other, first half revenues are expected to be up 13 per cent to £1.22 million as a result of growth in the UK and Africa.

Omega said it continues to make “good progress” with its allergy development programme, with a further four allergens optimised in the first half, taking the number of allergens whose performance matches with its IDS-iSYS assay test product to 36.

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Applied BioCode to Present Poster at AMP on 18-Plex GI Pathogen Panel with a High Throughput System

Applied BioCode announced today that its abstract for a poster on “18-Plex Gastrointestinal Pathogen Detection with a User Friendly, High Throughput System” has been accepted for presentation at the Association for Molecular Pathology meeting, November 5-7 in Austin, TX.

The poster will cover the development progress of Applied BioCode’s new high throughput, multiplex automated MDx system. The new BioCode platform utilizes Applied BioCode’s proprietary Barcoded Magnetic Beads (BMB) and fully automates the process of amplification, target capture and detection for molecular diagnostic assays.

The poster will also provide the latest analytical and performance data for the 18-plex Gastrointestinal Pathogen Panel that is currently in development. The BioCode 18-plex GI Pathogen Panel includes targets for the bacteria (Campylobacter, Clostridium difficile toxin A&B, Salmonella, Shigella, E. coli O157, Enterotoxigenic E. coli, Enteropathogenic E. coli, Shiga toxin producing E. coli, Enteroaggregative E. coli, Vibrio spp., Vibro parahaemolyticus, Vibro Vulnificus, Vibro Cholerae, Yersinia Enterocolitica), viruses (norovirus group I/II, adenovirus 40/41, rotavirus A), and parasites (Giardia, Cryptosporidium, Entamoeba histolytica).

Preliminary data generated for the Gastrointestinal Pathogen Panel with the automated system will be presented by Applied BioCode’s scientific personnel.

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MedMira Receives FDA Approval for the Reveal® G4 Rapid HIV-1 Antibody Test

MedMira Inc. has received approval from the U.S. Food and Drug Administration (FDA) for the next generation of the Company's rapid HIV test, Reveal G4 Rapid HIV-1 Antibody Test (Reveal G4). Reveal G4 adds new capabilities in testing fingerstick and venipuncture whole blood specimens which extends the Reveal product line into point-of-care settings and new market segments within the U.S. healthcare market.

With the approval of Reveal G4, MedMira is poised to capitalize on the rising demand for point-of-care whole blood HIV testing in the U.S., where today more than 1.2 million people are living with HIV, and as many as 168,000 remain unaware of their infection. Built on the motto of helping people know…®, MedMira has been employing its patented Rapid Vertical Flow Technology to deliver fast, accurate, high quality rapid HIV tests to healthcare providers and their patients in the U.S. since 2003, when the first generation of the Reveal rapid HIV test received FDA approval. With an initial focus on laboratories and hospitals where most of the HIV testing uses serum and plasma specimens, MedMira now moves to the front lines of healthcare with Reveal G4. Rapid tests are routinely being conducted in community based, point-of-care settings, where accessibility and convenience encourage more people to get tested during regular medical check-ups.

"With this FDA approval of Reveal G4, we are bringing the latest advancements in our Rapid Vertical Flow Technology platform to our U.S. customers. Reveal G4 delivers the same speed, performance, and quality that customers have come to know as hallmarks of our technology platform, and now we've added whole blood applications. This product is all about creating a rapid HIV testing solution that gives healthcare providers and their patients choices that make testing possible in any setting," said Hermes Chan, CEO, MedMira Inc. "Reveal G4 will make a significant contribution to increasing cost-effective, patient-focused HIV testing at the point-of-care, while continuing to serve the needs of our customers in laboratories and hospitals."

Reveal G4, like all MedMira tests, is built on the Company's patented Rapid Vertical Flow Technology platform which offers unique advantages unmatched by competitors. Users can obtain instant results from a Reveal G4 test following a simple 3-step testing procedure; add the specimen, process with the InstantGold™ cap, and read the results. This enables counselling, and if needed, initial treatment, to be delivered in a single patient visit. The streamlined testing approach and instant results that Reveal G4 facilitates translates to higher patient throughput for clinics and a reduction in the number of patients who are lost to follow-up, never returning for their results. As healthcare providers look for cost-efficient ways to integrate routine HIV testing in their practices and programs, a tool like Reveal G4 offers the speed and quality which will be critical to success.

In addition to its Reveal G4 test, MedMira is developing a broad range of rapid tests for major infectious diseases, as it continues to capitalize on the capabilities of its proprietary Rapid Vertical Flow Technology platform to create multiplex rapid tests that diagnose multiple infections on a single test with a single drop of specimen.

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Roche Gets FDA Approval for Cobas MDx Systems; HBV, HCV Viral Load Tests

Roche has received approval from the US Food and Drug Administration for its Cobas 6800 and Cobas 8800 molecular diagnostic platforms and associated hepatitis B and hepatitis C viral load assays.

The assays are the first approved by the FDA for use on the Cobas 6800 and 8800. These medium- and high-throughput PCR systems were unveiled in 2013, and allow for rapid, automated, mixed-batch processing.

Cobas HBV, a real-time PCR test for HBV genotypes A through H, was CE-marked in May. The Cobas HCV assay employs the firm's dual-probe approach to detect hepatitis C RNA and was CE-marked last December.

Roche noted in a statement that it currently has viral load tests under FDA review for HIV-1 and cytomegalovirus. When approved, these will complete a portfolio of viral load monitoring for the Cobas 6800/8800 systems, with further menu expansion plans including qualitative tests for donor screening, women's health, and microbiology.

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Ugandan Scientist Develops 5 Minute Ebola Test Kit

Ugandan scientist, Dr Misaki Wayengera has developed a rapid diagnostic test that can detect Ebola proteins in less than five minutes at the point of care in the community, a giant step in African medical innovation and in the fight against Ebola.

However, the process of developing the test kit has been marred by funding challenges and bureaucratic setbacks which threatened to derail the project.

According to New Times, Dr Wayengera did not receive financial support from the government although at the time, “the president’s office acknowledged the importance of his research for biodefence and pledged full support”.

Through Dr Wayengera’s efforts, his research team at Makerere University College of Health Sciences eventually secured funding from Grand Challenges Canada, a non-profit initiative funded by the Canadian government.

The team initially received $100,000 Canadian dollars (US$95,600) grant from the organisation before being offered a further $1.5 million by Grand Challenges Canada.

Dr Wayengera’s invention, “is the first rapid diagnostic test that is able to detect various strains of the Ebola and Marburg viruses.”

The inventor is reportedly to have applied for a patent with the African Regional Intellectual Property Organisation and the World Intellectual Property Organisation in 2013 and 2014.

“On average it takes about one year for a patent to be awarded by the World Intellectual Property Organisation and five years for it to be awarded by the African Regional Intellectual Property Organisation,” New Times reported.

The breakthrough is expected to reduce the Ebola death rate through quicker diagnosis of the diseases.

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Rapid Micro Biosystems Announces the Commercial Availability of the Growth Direct System for Sterility Testing

Rapid Micro Biosystems, the provider of automated, rapid, non-destructive detection and enumeration technologies in microbiology, today announced the launch of the sterility testing application for the Growth Direct(TM) System. The Growth Direct System automates the incubation, detection, and reporting steps for pharmaceutical quality control laboratories. The sterility test mirrors the compendial method sterility test, supporting both aerobic and anaerobic test conditions. Sterility testing joins the other application supported by the Growth Direct System, including environmental monitoring and bioburden testing. The technology is based on the detection of the natural auto-fluorescence of microorganisms, and can detect growing colonies in about half the time of the traditional 14-day sterility test, providing a significant time savings.

Developed in part with funds from the Biomedical Advanced Research and Development Authority (BARDA) as part of BARDA's Science and Technology Platforms Applied to Medical Countermeasure (MCM) Development program, the Growth Direct System for Sterility Testing revolutionizes pharmaceutical microbial quality control testing while adhering to the stringent regulatory requirements of the sterility test.

"BARDA has been a strong partner in the development of this technology," said Julie Sperry, Vice President of Marketing, Product Management and Services at Rapid Micro Biosystems. "Having the support of the Department of Health and Human Services indicates how critical a rapid sterility test is to both manufacturers and the regulatory community."

The technology supports testing of filterable samples and is designed for high and low volume sterility testing environments.

• Positive Results Starting in Hours:  The test provides early detection of a positive microbial contamination allowing faster response to contamination events.
• 7 Days Versus 14:  Final results of the sterility test are available in half the time of the traditional test.
• Discrete Colonies:  Growth occurs on the surface of a membrane and colonies can be "picked" directly, eliminating the time and labor necessary with a subculture step
• Closed Loop:  Sample preparation is closed looped and performed in an isolator or in a clean room, similar to the existing method.  The test replicates both anaerobic and aerobic test conditions.
• Non-Destructive:  No additional reagents are added. Samples with positive results can continue to grow.
• Complete Audit Trail:  A complete history of user activity as well as sample processing are available, ensuring compliance with 21 CFR Part 11.

"Saving manufacturers 7 days of sterility testing time delivers a significant financial benefit by accelerating product manufacturing and final product release," states Wendy Hinchey, Vice President of Sales. "Demand for the solution to this time consuming test has been very strong, as companies realize the resulting value the system provides their organizations."

"The release of our sterility application represents a significant milestone in Rapid Micro Biosystems' goal to automate key microbial tests in the manufacturing quality control lab," said Robert Spignesi, President and CEO of Rapid Micro Biosystems. "Our rapid sterility application, along with our environmental monitoring and bioburden applications, offers quality control labs options to improve productivity and streamline testing while closely aligning to traditional methods."

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Hema Diagnostic Systems Announces the Final Validation Process for a New Rapid Anthrax Ab Test

Hema Diagnostic Systems, LLC, a US based medical device company, announced today in Miramar, Florida, the final evaluation phase of its' new rapid, whole blood/serum tests, officially designated as the Rapid 1-2-3 Hema(R) Express(R) Anthrax Ab test.

According to Lawrence Salvo, President and CEO of Hema Diagnostic Systems, "The development and completion of the new Rapid 1-2-3 Hema Express Anthrax Ab diagnostic will make available, the very first rapid Anthrax Ab whole blood test that can deliver accurate, reliable and repeatable testing for the anthrax toxins of PA and LF, in the field and with a very high degree of sensitivity and specificity. Test results are read in 15 minutes from the start of the test process… the diagnostic can also be used with serum for laboratory processes." Additionally, Salvo said: "With the potential funding and partnership that HDS anticipates from Generex Biotechnology Corporation, we see a substantial opportunity to expand the commercialization of this product, especially here in the United States. Other current HDS products as well as those future devices presently in various stages of research and development, will also benefit from this growing relationship."

The new and novel Rapid 1-2-3 Hema Express Anthrax Ab has been developed to detect and differentiate the Anthrax Toxins of Protective Antigen (PA) and the Lethal Factor (LF) through either whole blood from a finger stick and capable of being performed in a clinic or in-field, as well as the use of serum in a laboratory procedure. Separate and individual Test ("T1 and T2") lines have been assigned to each of the two Anthrax Toxins for separate and individual confirmation of the presence of either/or, or both. Additionally, a Control ("C") line has been added on the test strip to confirm to the user that once the test process has started, the test is operational.

Sensitivity and specificity has been determined using existing in-house Quality Control ELISA panels. Following multiple test and batch evaluations, sensitivity was determined to be 100% and specificity at 99.6%. The device delivered continuing high performance, with significant repeatability.

Storage is set at 2°C-30°C with an initial designated shelf life of 18 months, and with the intention to increase shelf life as additional stability testing progresses over the next many months. Additional testing is being undertaken on a Real Time and Accelerated Stability basis, at higher temperatures.

The Rapid 1-2-3 Hema Express Anthrax Ab will be offered in the easy-to-use Rapid 1-2-3 Hema Express(R) housing which has been designed to be user-friendly and which reduces the opportunity of cross-infection through user-error and/or improper control of the potentially positive whole blood/serum sample.

Based upon the current timeline, it is anticipated that initial regulatory processes will be completed by January 2016.

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