Saturday, December 19, 2015

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.

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.”

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 G├Âttingen, 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.

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.

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.

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.

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.

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.

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.

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.

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™ .

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. Kremsm├╝nster, 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.