IDEXX Pseudalert Test Accepted as Global ISO Standard

IDEXX Laboratories, Inc., the global leader in rapid microbiological testing for water, today announced that the IDEXX Pseudalert® method has been published as the International Organization for Standardization (ISO) worldwide standard 16266-2 for the 24-hour detection of Pseudomonas aeruginosa in water. P. aeruginosa can cause life-threatening infections in hospitals and is a frequent cause of skin, ear, and eye infections from pool and spa water. Public and private laboratories and healthcare and hospitality industry facilities count on the Pseudalert method to monitor their water for this pathogen.

ISO is a global, widely recognized organization focused on ensuring that products and services are safe, reliable, and of good quality. Becoming an ISO standard requires a rigorous process and passing scrutiny of experts from all over the world. More than 160 national standards bodies are ISO members.

Listed under ISO 16266-2:2018, Water Quality—Detection and Enumeration of Pseudomonas aeruginosa–Part 2: Most Probable Number Method, the Pseudalert method detects P. aeruginosa in 24 hours, less than half the time of other commercially available methods. It also has high sensitivity and specificity, requires no confirmation steps, and can be more easily used with water samples that have high levels of background flora. Turnaround time is especially critical in the healthcare and hospitality industries, where receiving test results sooner enables facility managers to act more quickly to clean their water systems and protect the safety of patients and visitors. Faster turnaround time for retesting after remediation also reduces the costs of clinical downtime and closed facilities.

"King's College Hospital strives to maintain a bacteria-free environment, and part of ensuring a clean facility is regular testing for contaminants including Pseudomonas aeruginosa," said Paul Balaam, Senior Estates Officer, King's College Hospital NHS Foundation Trust, one of London's largest and busiest teaching hospitals. "The IDEXX Pseudalert method's acceptance as an ISO standard further validates that we are using the best solution on the market for our testing needs."

The Pseudalert method is also included in country-specific standards in Germany, France, Italy, and the United Kingdom, and was shown to be as accurate as or more accurate than the traditional method in two independent studies published in peer-reviewed journals.1,2

"IDEXX Water is the global leader in water microbiology, committed to innovation in diagnostic technologies to improve the safety of water worldwide," said Jonathan Ayers, Chairman and Chief Executive Officer of IDEXX Laboratories. "Regular testing is critical to ensuring harmful bacteria such as Pseudomonas aeruginosa stay out of the water, and we hope the acceptance of the Pseudalert method as an ISO standard helps ensure safe water and clean facilities for more people."

The Pseudalert method's acceptance as an ISO standard marks the second such ISO milestone for an IDEXX Water diagnostic. The IDEXX Colilert®-18 method was published as an ISO standard (ISO 9308-2) in 2012 and was included as one of the two reference methods for coliforms and E. coli in the revised European Union Drinking Water Directive in 2015.

Ares Genetics Initiates Development of AI-Powered Infectious Disease Test

Curetis N.V., a developer of next-level molecular diagnostic solutions, today announced that its wholly-owned subsidiary Ares Genetics GmbH ("Ares Genetics") has initiated the development of its ARESupa Universal Pathogenome Assay. The assay for the diagnosis of microbial infections and antimicrobial drug response is based on the Company's proprietary ARES Technology Platform and genetic antimicrobial resistance database ARESdb.

ARESupa is intended to cover nearly any pathogen in a broad array of sample types and to predict antimicrobial drug response to a wide variety of treatment options using a single, uniform laboratory workflow. While planning to launch the test as a laboratory-developed test first, Ares Genetics ultimately aims to seek regulatory approval as an in vitro diagnostic ("IVD") test, which it will eventually seek to commercialize. For in-house test development and initial commercialization of a laboratory-developed test in Europe, Ares Genetics is in the process of establishing a dedicated R&D and diagnostic service lab at the Vienna BioCenter Campus in Vienna, Austria. Supported by the Austrian Economic Chambers ("WKO") as a winner of the Austrian "GoSiliconValley" competition earlier this year, Ares Genetics is further exploring fast-track options to launch ARESupa as a laboratory-developed test in the U.S., once development of a first-generation ARESupa has been completed.

Microbial Infections and antibiotic resistance have become a major healthcare challenge, with antimicrobial resistance estimated to have caused 700,000 deaths globally in 2016, a number that is projected to dramatically increase to 10 million deaths annually by 2050 if no countermeasures are taken (Ref. 1). Ares Genetics seeks to address this challenge with a disruptive approach using high-resolution Next Generation Sequencing ("NGS") technology in combination with a proprietary, artificial intelligence ("AI") curated genetic pathogen reference database, ARESdb, to interpret results. Pursuing a partnership-oriented approach, Ares Genetics and Curetishave entered into an agreement with MGI, a BGI Group Company, located in Shenzhen, China, to develop an integrated and fully automated solution for analyzing diverse human samples for microbial infections using NGS. Discussions with other NGS technology providers to utilize their platforms for the deployment of ARESupa are ongoing.

"We are excited to announce the development program for our ARESupa Universal Pathogenome Assay for broadly detecting microbial infections and antibiotic resistances," said Dr. Andreas Posch, Managing Director of Ares Genetics. "With this assay, we are not only building on ARESdb, which we believe is the world's most comprehensive database on the genetics of antibiotic resistance, but also leverage our extensive IP portfolio covering antibiotic resistance biomarkers, sample preparation technologies, bioinformatics and artificial intelligence methods. We are therefore convinced that Ares Genetics is well positioned to advance the development of next-generation rapid molecular testing for microbial infections and drug response with the goal to improve patient outcomes and counteract rapidly spreading antibiotic resistance."

"Founded in 2017, Ares Genetics provides data intelligence for the design and continuous optimization of test panels and interpretation of test results for Curetis' core business of rapid multiplex PCR testing based on the Unyvero Platform," said Dr. Achim Plum, also Managing Director of Ares Genetics GmbH and CBO of Curetis N.V. "With ARESupa, we intend to take molecular testing for microbial infections to the next level, leveraging the anticipated adoption of NGS technology in clinical diagnostics. With the support of the WKO we are now exploring how we can implement this solution commercially in the U.S. once development of a first-generation ARESupa has been completed."

With initial seed funding of Ares Genetics provided by Curetis and support from the WKO, Ares Genetics is currently identifying U.S. strategic partners and exploring options for accessing U.S. venture capital funding to accelerate the development of ARESupa and its commercial deployment in the U.S. market.

This initiative is part of Curetis' ongoing assessment of strategic and tactical financing options to secure appropriate funding and cash for continued operations for at least the next 12 months, a strategy that was previously communicated in the publication of the FY 2017 results on  April 30, 2018. While no firm decisions have been taken, the Company is considering making use of the shareholder resolutions authorizing the management board to raise additional capital from institutional investors through the non-preemptive issuance of shares. These resolutions were approved at the AGM on June 21, 2018 for up to 50% of issued capital for strategic financing(s).

FreshDetect to Receive EU Support

As part of its Horizon 2020 research and innovation program, the European Union has agreed to support the high-tech start-up FreshDetect GmbH headquartered in Pullach, Germany (Munich). The grant is intended to help the company expand its BFD-100, a portable device for rapid and precise quality control of food products, across Europe. The project will also support enhancements designed to fully exploit the potential of the technology in food manufacturing.

Around the world, currently two of the most important issues for food manufacturers are waste and safety during production. Behind this backdrop, FreshDetect GmbH will receive support from the European Union beginning September 2018. The support will come from phase 2 of the EU’s Horizon 2020 SME financial instruments program and will specifically target enhancements to and expansion of the FreshDetect technology within Europe.

“Each year, 88 million tons of food valued at €143 billion are wasted in the EU alone,” explains Oliver Dietrich, Managing Director of FreshDetect GmbH. “With the BFD-100, the first portable measurement device for rapidly determining the microbiological quality of food, our aim is to help address this issue. The BFD-100 is the first device that enables hygiene quality control across the entire production process and creates a new dimension in food safety. It furthermore lays an important foundation for optimizing the manufacturing process and minimizing food waste.”

Horizon 2020 is the EU’s framework program for research and innovation that aims to establish a knowledge- and innovation-based society and secure Europe’s global competitiveness, while at the same time contributing to long-term economic growth.

The EU created a special instrument to increase the participation of small- and medium-size enterprises (SMU) in the Horizon 2020 program. While it focuses on application-based research and demonstration, the SMU instrument also has its eye on the marketing innovation phase. With the chances for being selected for such support at a very low 5 percent, these types of grants are a distinction for the company and its growth.

Technology

The BFD-100 is the world’s first handheld device for determining bacterial contamination in raw meat. The non-invasive, fluorescence spectroscopy measurement ascertains the total viable count (TVC) within seconds, but with a level of accuracy similar to standard microbiological methods. The result is displayed in CFU/cm² . The device can handle up to 2,000 measurements before the data has to be transferred to a PC. The TVC results are output and saved together with the temperature, date and time of the measurement and a sequential test number.

The technology relies on emitting an intense blue light onto the surface of the meat under evaluation. Fluorescent signals from bacteria and the meat matrix are detected by a spectrophotometer.  Algorithms specific for the meat matrix and bacteria are used to determine the bacterial count in that sample.

Quidel Receives FDA Clearance, CLIA Waiver for Its Point-of-Care Sofia® 2 Lyme Fluorescent Immunoassay

Quidel, a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that it has received 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver from the United States Food and Drug Administration (FDA) to market its Sofia 2 Lyme FIA to be used with the Sofia 2 Fluorescent Immunoassay Analyzer for the rapid differential detection of human IgM and IgG antibodies to Borrelia burgdorferi from finger-stick whole blood specimens from patients suspected of B. burgdorferi infection. The test is intended for use with the Sofia 2 analyzer to aid in the diagnosis of Lyme disease.

Sofia 2 is Quidel’s next-generation version of its best-selling Sofia instrumented system. Sofia 2 utilizes the original Sofia’s fluorescent chemistry design while improving upon the graphical user interface and optics system to provide an accurate, objective and automated result in as few as 3 minutes. Sofia 2 also integrates wireless connectivity and its barcode scanner within a smaller footprint than the legacy Sofia instrument. The next-generation Sofia 2 system also comes connected to Virena®, Quidel’s data management system, which provides aggregated, de-identified testing data in near real-time.

Lyme disease is the most common tickborne disease in North America and Europe [1]. In the United States, Lyme disease is caused by the bacterium, Borrelia burgdorferi, transmitted through the bite of an infected blacklegged tick [1,2]. Patients infected with B. burgdorferi may experience symptoms associated with three stages: early localized disease, early disseminated disease, and late persistent disease [1]. The most characteristic symptom of early localized disease is the appearance of erythema migrans (EM) on the skin [1,3]. EM may also be accompanied by flu-like symptoms days or weeks after infection [3]. In the second stage, early disseminated disease, untreated patients may begin to see neurological and rheumatological manifestations, and less commonly, dermatological, cardiac, or ophthalmological manifestations. These symptoms generally appear weeks to months after infection [1]. If the disease continues to be left untreated, late persistent disease may also follow months or years later with continued progression of manifestations in the joints, heart, skin, and nervous system [2,3].

Early detection and treatment of Lyme disease can help resolve symptoms and prevent progression of the disease [1]. The primary means of identifying B. burgdorferi infection is detection of the body’s IgM and IgG antibody response by way of immunoassay [3]. Detection of IgM antibodies to B. burgdorferi is generally most significant in the earlier stages of the disease. Conversely, detection of IgG antibodies has proven to be significant for longer periods, as the antibodies may remain detectable years after infection.

The Sofia 2 Lyme FIA uses a bi-directional test strip format to detect both IgM and IgG antibodies to B. burgdorferi from a single finger-stick whole blood sample. One side of the test strip detects IgM antibodies to B. burgdorferi and the other side of the test strip detects IgG antibodies to B. burgdorferi.

The Sofia 2 Lyme FIA is also novel in that it can process samples from less invasive finger-stick whole blood specimens instead of blood samples collected though venipuncture, the traditional method of sample collection for Lyme testing. The assay’s whole blood sample processing technology speeds the time to diagnosis, is less invasive to the patient, and allows the test to be CLIA waived by the FDA.

CLIA waiver for the Sofia 2 Lyme FIA markedly expands the available market for the Sofia 2 test system, which allows the test to be run in physician offices, as well as in several thousand hospitals, medical centers, smaller clinics, and alternate sites (e.g., urgent care centers, free standing emergency departments, retail clinics, etc.) in the United States.

“The Sofia 2 Lyme FIA’s 510(k) clearance and CLIA Waiver for use on the Sofia 2 instrument will allow healthcare workers to generate a result in a single office visit, accelerating the time to diagnosis and potential treatment of Lyme Disease for the patient. This is another example of our ability to provide simple, cost-effective solutions for physician offices and hospitals that previously had to wait several days for send-out results,” said Douglas Bryant, president and chief executive officer of Quidel Corporation. “We expect that this new product introduction will increase the value of our Sofia 2 platform, and could create incremental instrument placement opportunities in traditional healthcare institutions that are closer to the patient, as well as in the rapidly growing alternate site segment of point of care.”

The Sofia 2 Lyme FIA is the fourth Sofia test for use on the Sofia 2 system that has been 510(k) cleared and CLIA waived by the FDA: the Sofia Influenza A+B FIA, the Sofia RSV FIA, and the Sofia Strep A+ FIA were 510(k) cleared and CLIA waived by the FDA in 2017. Quidel also markets the moderately complex Sofia Lyme FIA in the US, as well as Sofia Legionella FIA and Sofia S. pneumoniae FIA in Europe.

References

1. Wormser, G. P., Dattwyler, R. J., Shapiro, E. D., Halperin, J. J., Steere, A. C., Klempner, M. S., Nadelman, R. B. (2006). The Clinical Assessment, Treatment, and Prevention of Lyme Disease, Human Granulocytic Anaplasmosis, and Babesiosis: Clinical Practice Guidelines by the Infectious Diseases Society of America. Clinical Infectious Diseases, 43(9), 1089-1134.
2. CDC. http://www.cdc.gov/lyme/diagnosistesting/LabTest/TwoStep/index
3. Aguero-Rosenfeld, M. E., Wang, G., Schwartz, I., & Wormser, G. P. (2005). Diagnosis of Lyme Borreliosis. Clinical Microbiology Reviews, 18(3), 484-509.

HP is "Printing" Drugs for the CDC to Speed up Antibiotic Testing

HP Inc. announces its participation in a pilot program run by the Centers for Disease Control and Prevention (CDC) that aims to accelerate the testing of new antibiotics designed to fight antimicrobial resistant bacteria. The pilot uses HP technology to “print” pharmaceutical samples. As part of the pilot, CDC will deploy new HP D300e Digital Dispenser BioPrinters to four regional labs in the Antibiotic Resistance (AR) Lab Network, to develop antimicrobial susceptibility test methods for new drugs. For the first time, regional labs will be able to conduct rapid susceptibility testing for health departments and hospitals nationwide.

“Bacteria continuously develop new ways to resist antibiotics—once a drug is approved for use, the countdown begins until resistance emerges. In fact, resistance has even been detected before FDA approval,” said Jean Patel, PhD, D (ABMM), science team lead of the Antibiotic Resistance Coordination and Strategy Unit at the CDC. “To save lives and protect people, it is vital to make technology accessible to hospital labs nationwide. We hope this pilot will help ensure our newest drugs last longer and put gold-standard lab results in healthcare providers’ hands faster.”

Antimicrobial resistance is an international public health issue. New antibiotics for resistant bacteria can help save lives, but hospitals often do not have access to antimicrobial susceptibility testing to know if the new drug might be effective. The HP printer helps to speed up testing availability at the local level by “printing” the gold standard test plates in a few minutes. When testing is not available, new drugs can be either over-utilized, contributing to antimicrobial resistance, underutilized, not helping patients in need, or mis-utilized, which can lead to side effects or prolonged treatment.

How it Works

The BioPrinter accurately dispenses or “prints” volumes from picoliters to microliters for faster, more reliable dispensing of small molecules and biomolecules to enable drug discovery, genomics, and proteomics research. The following labs within the AR Lab Network will use this technology to develop and perform antimicrobial susceptibility testing for new drugs: New York, Minnesota, Tennessee and Wisconsin. This new capacity can be used by healthcare providers for patient care while commercial methods commonly used in hospital laboratories are developed and implemented.

Testing through CDC will be implemented in the regional laboratories in the first quarter of FY19. CDC will prioritize testing for highly resistant bacteria, with pan-resistant bacteria being the top priority. HP will coordinate with CDC to evaluate the pilot in the regional laboratories of the AR Regional Lab Network, refine the system, and explore and support a larger roll-out of inkjet printing technology in labs nationwide.

Purdue Researchers Take on Mosquito Diseases Like Zika and West Nile with New Device

The number of cases in the continental U.S. of mosquito-borne diseases, such as Zika, dengue, West Nile, and chikungunya, has climbed over the past two decades.

To help combat these tropical diseases, a team of researchers at Purdue University has created a startup company — SMK Diagnostics — that is developing a device to rapidly detect and monitor various mosquito-borne diseases.

Many current methods take days or weeks to determine whether a virus is present in a sample. Even then, these techniques often can detect that a flavivirus — a strain of virus often carried by mosquitoes — is present, but cannot discern whether it is Zika, dengue, or chikungunya.

Now Purdue biologists and material scientists are working together to create a biosensor that they hope will improve the speed, specificity, sensitivity, and portability of current testing techniques for a range of mosquito-borne viruses.

“Our device responds within 30 minutes and doesn’t require trained people,” said Lia Stanciu, a material scientist who helped develop the device. “It’s fast and portable.”

How does it work?

To develop their sensor, the researchers take advantage of the fact that many of these mosquito-borne viruses are composed of single-stranded ribonucleic acids, or RNAs. Like DNA, each unit in the RNA sequence can bind to just one other complementary unit — like two puzzle pieces coming together.

The researchers can then create new biomolecule “probes” composed of specific sequences that will match and bind only to a given target RNA virus, for example, Zika or dengue virus. The biomolecule probe acts like a lock that can only be opened by a specific virus key.

The biomolecule probe is attached to an electrode and when a target virus is present, it binds to the probe — opening the door, so to speak — which the electrode senses and alerts the device’s user to the presence of that virus.

“It’s remarkable in that it is very specific and you can control the specificity by your design of your probes,” said Richard Kuhn, co-founder of SMK Diagnostics and a biologist at Purdue University who recently determined the structure of the Zika virus. “It’s incredibly sensitive in that it picks up very low level signals.”

The electrodes are printed on a film that will ultimately be connected to a portable electronic reader. Ideally, multiple electrodes could be printed on a single film, meaning each biosensor unit could be used to look for multiple viruses at a time.

“In any area of technology, we want to do things better and faster,” Kuhn told IndyStar. “What we have here is a fairly rapid and fairly precise assay that out-competes what’s currently being used.”

Rapid identification of certain viruses can support earlier delivery of life-saving treatments. And for viruses such as Zika and dengue that don’t currently have specific anti-viral treatments, identification of the viral infection can still aid in patient care. For example, Zika infection is known to cause serious birth defects. Thus, women testing positive for Zika could make more informed decisions about future or current pregnancies.  

In addition to these diagnostic tests, the researchers envision that their biosensor can be used to ensure blood transfusion safety at blood banks and hospitals, to track or contain disease movement, and to manage mosquito populations.

“If you find infected mosquitoes in one area, you can communicate with the local authorities in that area, and say there is a problem,” Stanciu said. “We can spray there before they go and infect other people or areas.”

Scaling up the manufacture to join the Internet of Things

So far, the startup has patented their biosensor creation technique, and they are now working to optimize the device’s portability and to scale up manufacturing with printing through the Scalable Manufacturing of Aware and Responsive Thin films (SMART) consortium at Purdue University.

This research initiative combines the expertise of industry partners, including Indianapolis-based Eli Lilly and Co. and United Technologies, and university researchers to help fledgling companies, such as SMK Diagnostics, develop scalable, low-cost manufacturing techniques for new sensing technologies.

The mosquito-borne disease sensor created by SMK Diagnostics is just one example of a device that will become part of the burgeoning “Internet of Things.” Often referred to as IoT, it is a network that interconnects sensors embedded in everyday objects that send and receive information among devices.

Just as Silicon Valley revolutionized the computing world, many believe that IoT technology will transform data collection, measurement and optimization for product use and safety in our daily lives.

At Purdue’s Birck Nanotechnology Center, various companies and researchers are creating biosensors with wide-ranging applications: a soil-nitrogen sensor for agriculture, smart packaging for food safety, and human performance monitors for health care, among others.

“Most of our manufacturing today is the conventional type — parts of cars and so on — but if we can bring some of these new factories and technologies for sensors and IoT to the region, we could become the manufacturing hot bed in the U.S. and for the world,” said Ali Shakouri, director of the Birck Nanotechnology Center. “If we keep that here, then the design and new ideas will be here. Who knows, we could be the IoT Plains of the United States.”

By creating a common platform for multiple sensor applications, the SMART consortium will lower the cost of producing this technology for all types of sensors, making it easier for SMK Diagnostics to rapidly make the large numbers of sensors that are required for future stages of field testing of their mosquito-borne disease sensor.

The SMART consortium leaders hope that their efforts will push Indiana to become a global leader and manufacturer in the IoT revolution, giving Silicon Valley a run for its money.As for the founders of SMK Diagnostics, they are excited that their device to detect mosquito-borne diseases could improve human health, both globally and locally.

“People working at companies and universities in Indiana (are) partners in global health. Global health always turns at some point into local health,” said Kuhn, SMK’s co-founder. “Things that might work in India or Thailand (now), probably are going to have a positive impact on people in Indiana at some point.”

Source: Indystar.com

Neogen’s One-Hour Listeria Right Now™ Receives AOAC Approval

Neogen’s revolutionary Listeria Right Now™ environmental pathogen detection system has officially achieved AOAC approval, license number #081802.

The approval adds another level of assurance to the food safety community, as the product has now been validated by one of the industry’s leading third-party accreditation groups.

“It’s extremely gratifying to receive this approval,” said John Adent, Neogen’s president and chief executive officer. “It comes as the result of a lot of hard work and ingenuity on the part of Neogen’s R&D and validation groups. The Listeria Right Now system is truly revolutionary, and having this approval validates this new technology platform.”

Listeria Right Now is a complete system for taking environmental Listeria tests with molecular-level accuracy that requires no enrichment, so there’s no need for processors to grow bacteria cultures on-site. The system provides results in under one hour, much faster than traditional methods, which can take up to several days.

The system works so quickly thanks to a technology that targets rRNA, which is present in much greater numbers than the traditional DNA target. An isothermal reaction also causes the replication and amplification to occur at a constant rate instead of the normal thermal-cycle technology from traditional PCR systems. The technology allows food production and processing facilities to seek and eliminate Listeria more quickly, which can reduce the risk of cross-contamination of food products — keeping consumers safe.

Listeria Right Now has now been validated by AOAC and NSF International, and is the winner of the 2018 Innovation Award from the French organization Carrefour des Fournisseurs de l’Industrie Agroalimentaire.