First Light Biosciences Develops a Novel Method for Rapidly Determining Effective Antibiotics for Treating Infections

First Light Biosciences, a provider of innovative diagnostic tests for fighting life-threatening infections and combating the spread of antibiotic resistance, today announced they will be presenting a scientific poster detailing their novel MultiPath™ technology for rapidly detecting infections, identifying pathogens, and determining the optimum antimicrobial therapy at IDWeek in San Francisco next week.

"IDWeek is the premier, international, scientific meeting of healthcare professionals in infectious diseases and healthcare epidemiology and prevention, including researchers, clinicians, quality and patient safety practitioners, epidemiologists, and public health officials, as well as those who see HIV and pediatric patients."  With more than 6000 attendees and hosted by internationally recognized organizations such as the Society for Healthcare Epidemiology of America (SHEA), the Infectious Disease Society of America (IDSA), The HIV Medicine Association (HIVMA), and the Pediatric Infectious Diseases Society (PIDS), IDWeek provides a unique opportunity for practitioners in the industry to gather and learn from each other's knowledge and experiences.

During the poster session, Lauren Priess, Senior Research Associate from First Light, will be discussing the poster entitled, "A New Method for Rapid Phenotypic AST Directly from Patient Samples." The poster highlights a study demonstrating the value of MultiPath technology for addressing important drawbacks of current infectious disease diagnostics.

The pathogens causing life-threatening infections are frequently resistant to antibiotics. Because current culture-based antimicrobial susceptibility tests (ASTs) take days to identify the appropriate targeted antimicrobial therapy, broad-spectrum therapies are generally prescribed initially. This empiric therapy may be medically sub-optimal or even ineffective and often results in treatment of uninfected patients, which accelerates the spread of antibiotic resistance.

The poster introduces the MultiPath technology and demonstrates its potential for detecting infections, identifying pathogens, and determining the appropriate targeted therapy in 4 hours rather than several days as required by current methods. The study demonstrates the method's unique potential to determine the effective antibiotic directly from patient samples including samples infected by multiple pathogens and samples containing large numbers of contaminating non-pathogenic microbes.

"We are excited to have the opportunity to present the results of this study at IDWeek," said Don Straus, Founder and Chief Scientific Officer at First Light Biosciences. "The results of this study demonstrate MultiPath technology's unique potential to determine the optimum treatment for life-threatening syndromic infections in any type of sample in just a few hours."

First Light will be presenting their poster on Friday, October 5th from 12:30 PM - 1:45 PM, and will be happy to answer questions throughout the event.

About First Light Biosciences

First Light Biosciences is developing and preparing to commercialize, innovative diagnostic products for rapid, sensitive and cost-saving detection of life-threatening infections, and combating the spread of antibiotic resistance.  Don Straus is the company's Founder and primary inventor of the company's core scientific technology. Based on its proprietary MultiPath™ detection technology, First Light's products combine the clinical performance of the most advanced commercial laboratory tests with speed, cost-effectiveness, and ease-of-use. The tests rapidly detect infections, identify infectious agents, and determine effective targeted antibiotic therapy. This will improve patient outcomes, reduce healthcare costs, and prevent inappropriate use of powerful antibiotics.

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HHS Partners to Develop Faster Tests to Identify Bacterial Infections

A test that may reduce, from days to hours, the time needed to diagnose patients with bacterial infections and determine how well an antibiotic will work against specific infections will receive advanced development support from the U.S. Department of Health and Human Services’ (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR).

The Biomedical Advanced Research and Development Authority (BARDA), part of ASPR, will sponsor the advanced development of the new testing technology under an 18-month, approximately $9.3 million contract with SeLux Diagnostic, Inc of Charlestown, Massachusetts.

SeLux is developing a phenotypic test; it identifies bacteria based on observable physical or biochemical characteristics of the bacteria. Based on the characteristics, the test identifies the class of bacteria and which antibiotics are best for treating that particular bacterial infection.

Faster information to select the best antibiotic can speed a patient’s recovery, which means fewer days spent in a hospital and better outcomes for patients. The ability to match bacteria more precisely to the drugs that will combat the infection also could curb antibiotic resistant infections.

“Antibiotic resistance is a growing threat to public health and to the health security of the United States,” said BARDA Director Rick Bright, Ph.D. “In a bioterrorism incident, antibiotic resistant infections could be devastating. We will need innovative tools for precision medicine to save lives.”

BARDA is sponsoring the development of two test systems from SeLux.  The company’s first-generation test system may be able to provide results using bacteria isolated from patient samples 24 hours faster than current state-of-the-art methods and may be able to provide results from blood samples three days faster than the current methods. The company’s second-generation test system may be able to provide results the same day that the test is started.

The tests are designed to be used in hospital and commercial laboratories. Rapid information on bacteria and how susceptible they are to antibiotics would help doctors make earlier, better-informed decisions about how best to treat infections.

BARDA funding will support necessary work for the company to apply for U.S. Food and Drug Administration (FDA) approval. The agreement can be extended to fund additional work up to a total of approximately $36 million through 2023.

In addition to SeLux’s diagnostic test systems, BARDA is supporting development of other antibiotic susceptibility tests that can distinguish between bacterial and viral infections. BARDA also is working with federal partners to develop other tests that identify bacterial infections and the bacteria’s susceptibility to specific antibiotics. These efforts are part of the HHS commitment to combat antimicrobial resistance and to support antibiotic stewardship. To encourage antimicrobial stewardship further, ASPR provides hospitals and health care coalitions with guidance and the latest information on antibiotic resistant infections and new tools to combat them.

About HHS, ASPR and BARDA

HHS works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. The mission of HHS’s Office of the Assistant Secretary for Preparedness and Response (ASPR) is to save lives and protect Americans from 21st century health security threats. Within ASPR, BARDA invests in the advanced research and development, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products needed to combat health security threats.

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Nigeria Government to Deploy GeneXpert Systems to Improve TB Diagnosis

As Part of national efforts to improve the diagnosis of tuberculosis (TB), the Minister of Health, Prof. Isaac Adewole said that the Federal Government plans to deploy GeneXpert machines in 774 local government council areas across the federation.

Adewole disclosed this plan at the Public Private Mix (PPM) Summit for Tuberculosis (TB) Control in Nigeria, which took place in Lagos recently.

According to Adewole, a total of 391 GeneXpert machines have so far been installed at 310 sites across the country for this purpose of improving the diagnosis of TB and to make the diagnosis rapid.

However, to ensure universal access to TB diagnosis, the Federal Government targets to have at least one machine per LGC area across the federation.

The GeneXpert diagnostic technology is a a diagnostic tool that has high sensitivity in diagnosing TB.

TB is an infectious disease usually caused by bacterium Mycobacterium (MTB). TB generally affects the lungs, but can also affect other parts of the body. Most TB infections do not have symptoms, in which case it is known as latent TB.

About 10 per cent of latent infections progress to active disease which, if left untreated kills about half of those infected. The classic symptoms of active TB are a chronic cough with blood-containing sputum, fever, night sweats and weight loss.

The PPM summit was organised by the Federal Ministry of Health (FMOH) in collaboration with the World Health Organisation (WHO), Stop TB Partnership Nigeria and the Tuberculosis Control Programme in Lagos State.

Giving the background to some of the challenges in tackling TB, it was said that inadequate Gene Expert machines meant for the diagnosis of the killer disease remains a huge challenge to curbing the high prevalence of TB in communities.

However, bringing the Gene Expert machine closer to various communities would therefore remove the hindrance obstructing rapid diagnosis of the medical condition.

Nigeria has the 2nd highest burden of TB in Africa.Nigeria has a country is among the 14th countries considered by the WHO as being high burden not only for Tb, but also for TB/HIV and multi-drug resistance ( MDR-TB).

Country Representative of the WHO in Nigeria, Dr. Wondimagegnehu Alemu who was represented by Dr. Lynda Ozor, said expanding quality TB diagnostic coverage nationwide was necessary as a measure to stop the spread of new TB infections.

He also called for the optimisation of the existing Gene EXpert diagnostic machine (390).
According to him, involving the private sector in tackling TB would ensure that the vision of reaching more Nigerians that were affected by TB and those at risk of infection, could be reached this 2018 and beyond.

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OpGen Partners with NY State Department of Health and Merck’s ILÚM Health Solutions to Detect Antimicrobial-Resistant Infections

OpGen, Inc. announced a groundbreaking collaboration with the New York State Department of Health (“DOH”) and ILÚM Health Solutions, LLC (“ILÚM”), a wholly owned subsidiary of Merck’s Healthcare Services and Solutions, to develop a state-of-the-art research program to detect, track, and manage antimicrobial-resistant infections at healthcare institutions statewide. OpGen will work together with DOH’s Wadsworth Center and ILÚM to develop an infectious disease digital health and precision medicine platform that connects healthcare institutions to DOH and uses genomic microbiology for statewide surveillance and control of antimicrobial resistance.

The DOH, ILÚM and OpGen will work collaboratively to build a sustainable, flexible infectious diseases reporting, tracking and surveillance tool for antimicrobial resistance that can be applied across New York State. The goal of this project is to improve patient outcomes and save healthcare dollars by integrating real-time epidemiologic surveillance with rapid delivery of resistance results to care-givers via web-based and mobile platforms. ILÚM is leading the project with the implementation of its technology platform. OpGen is providing its Acuitas® AMR Gene Panel for rapid detection of multidrug-resistant bacterial pathogens along with its Acuitas Lighthouse® Software for high resolution pathogen tracking.

“We are proud to be a part of this groundbreaking initiative throughout the State of New York, and to collaborate with Wadsworth and ILÚM to help develop the blueprint for how governments and healthcare facilities can detect, track, and manage antimicrobial-resistant infections,” said Evan Jones, CEO, OpGen. “As part of the collaboration, OpGen will receive a $1.5 million contract for the 12-month demonstration portion of the project, with the potential for full implementation during the next five years, should certain milestones be achieved by all parties involved. We look forward to working with the Wadsworth Laboratories and to serving the people of the State of New York.”

The precision medicine solutions provided by OpGen and ILÚM to accomplish the goals of the project are:

• The OpGen Acuitas AMR Gene Panel u.5.47, a distributed, rapid diagnostics platform capable of detection and identification of multidrug-resistant bacterial pathogens in under three hours and for use with the Acuitas Lighthouse Software.  Together, these products can rapidly identify and locate antibiotic resistance threats in healthcare institutions and networks.  Both systems are commercially available for Research Use Only (RUO) and are anticipated to be submitted for FDA clearance after completion of ongoing and planned clinical trials. In future iterations, OpGen’s Acuitas technologies are anticipated to provide custom testing solutions to supplement evolving Wadsworth Laboratory testing and New York State’s DOH surveillance needs.
• The OpGen Acuitas Lighthouse Software includes Acuitas Lighthouse epidemiology dashboards with high-resolution pathogen tracking through healthcare facilities, to cities, regions, as well as the entire state. 
• ILÚM’s technology platform, a Commercial Off The Shelf (COTS) solution which assembles and streams analyzed health data from across locations and health care systems. This data includes laboratory test results, pharmacy, orders, and ADT (admissions, discharges, transfers). The platform offers patient and program-specific data analytics and visualization capabilities to users via a web application and a mobile device application.  Also, it enables case browsing, patient monitoring, detection and prioritization and performance monitoring and reporting for disease management, including actionable insights in support of quality improvement efforts, disease surveillance, pathway adherence, and ultimately impacting outcomes.

New York State Health Commissioner Dr. Howard A. Zucker said, "Under Governor Cuomo's leadership, New York State is setting the standard in addressing the threat of antimicrobial resistance.  New York's Wadsworth Center is uniquely qualified to partner with OpGen and ILÚM Health Solutions as part of our response to this public health concern."

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Mylan Extends Commitment to Fight HIV/AIDS; Partners with Atomo Diagnostics to Expand Access to HIV Self-Testing

Global pharmaceutical company Mylan N.V. and medical device company Atomo Diagnostics today announced a strategic partnership to commercialize CE-Marked in vitro HIV rapid diagnostic tests for self-testing in low- and middle-income countries. The tests will allow individuals to confidently screen themselves in the privacy of their own homes with a device engineered for simplicity and accuracy. The tests are designed to detect the presence or absence of HIV antibodies in a single drop of blood obtained from a fingertip. Results are delivered in just 15 minutes, which is essential for access to early treatment and care.

A third of the 36.7 million people living with HIV are not aware of their status. While HIV testing rates have improved, many countries still face obstacles in expanding access to testing, such as patients being hard-to-reach or socially isolated due to stigma and discrimination. Deploying point-of-care self-tests in community-based settings that deliver prompt and accurate results is vital to increasing the proportion of people who know their HIV status. The sooner an individual is tested, the sooner counseling can be offered and prevention options or treatment can be initiated, which is critical to halting further transmission of the virus.

Mylan CEO Heather Bresch commented, "Today's announcement is another great example of our work to support the HIV/AIDS community, especially those living in low- and middle-income countries. I am proud of Mylan's efforts to fight HIV/AIDS around the world, which is part of our long-standing commitment to increase access to treatment to address some of the world's most significant public health issues. Today, 40% of all people living with HIV who are receiving treatment depend on antiretrovirals that we produce. But our work is far from over, with too many new infections each year and too many people not receiving the care they need. Our partnership with Atomo to supply HIV rapid diagnostic tests for self-testing is an important step in our collective goal of preventing HIV infections and expanding treatment."

Founder and CEO of Atomo Diagnostics John Kelly said, "We are delighted that our innovative HIV self-tests have been chosen by Mylan, the global health leader in HIV treatment and the largest supplier of ARVs. This strategic partnership will mean that the products designed by Atomo can be introduced to more than 100 countries, so that millions of people will have access to award-winning rapid tests.  We believe that Mylan is the ideal partner to ensure that our HIV self-test products have maximum impact in the fight against HIV/AIDS."

While in some countries, like the U.S. and in Europe, HIV self-tests are readily available in pharmacies, HIV testing in low- and middle-income countries remains dependent on the diagnostic test being conducted in formal settings by trained professionals. Scaling up self-testing globally requires a simple and reliable product. Atomo is partnering with Mylan to supply all-in-one test devices that offer improved functionality and ease-of-use compared to current multi-component rapid diagnostic tests.

Atomo products are highly accurate. In laboratory and in-field evaluations, Atomo diagnostic tests demonstrated an aggregated 99.6% for sensitivity and specificity. Atomo HIV self-test products are CE-marked and are being evaluated by the World Health Organization for prequalification.

Under the terms of the agreement, Mylan has exclusive rights to commercialize the products in more than 100 countries in Africa, Asia, the Middle East, the Commonwealth of Independent States (CIS) and Latin America. Mylan plans to launch the Mylan HIV Self-Test in global markets in early 2019.

Mylan's Commitment to the HIV/AIDS Patient Community

Mylan is the world's largest supplier by volume of HIV/AIDS therapies. More than 40% of the 20 million patients on treatment worldwide depend on a Mylan product every day. For more than a decade, Mylan has been a leader in providing access to quality, dependable and affordable ARVs in 100 countries around the world. This includes introducing in 2009 the first generic one-tablet-once-a-day combination for developing countries – only three years after the originator product launched in the U.S. Since that time, Mylan has been the first to market with nearly half of the new products tentatively approved by the FDA under PEPFAR. Mylan was also the first generic drug maker to develop a heat-stable version of a drug critical for second-line regimens and has consistently developed innovative pediatric formulations for children in developing countries. Mylan has long been a supporter of the patient community through the sponsorship of free community HIV/AIDS testing and clinical research. Learn more about Mylan's work with infectious disease here. Watch this video to learn more about Mylan's commitment to people living with HIV/AIDS.

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Smartphone Kit can ID Pathogens in Under an Hour

In a potential game changer for the health care industry, a new cell phone app and lab kit now allow a smartphone to identify bacteria from patients anywhere in the world. With the new app, doctors will be able to diagnose diseases and prescribe the appropriate antibiotic within a one-hour office visit, meaning faster recovery — and lower treatment costs — for patients.

Developed by a research team of UC Santa Barbara scientists and colleagues, the study “Smartphone-based pathogen diagnosis in urinary sepsis patients” was published in the journal EbioMedicine.  The detection system succeeded in achieving rapid diagnosis of urinary tract infections — among the most common type of infection globally. The app uses a smartphone’s camera to measure a chemical reaction and determines a diagnosis in about an hour — and the simple, low-cost test can be performed in the world’s most remote locations.

The project was led by professors Michael Mahan of UC Santa Barbara and Tom Soh of Stanford University, along with Santa Barbara Cottage Hospital physicians Jeffrey Fried, M.D. and Lynn Fitzgibbons, M.D. Additional collaborators include UCSB scientists Lucien Barnes, Douglas Heithoff, Scott Mahan, Gary Fox and Jamey Marth — who is also also a professor at Sanford Burnham Prebys Medical Discovery Institute (SBP) — as well as Cottage Hospital scientists Andrea Zambrano, M.D., and Jane Choe.

“This simple test for urinary tract infections can be conducted in a fraction of the time and cost of clinical diagnostics — one hour versus 18 to 28 hours,” lead author Mahan explained. “We believe that this lab test holds exciting potential to bring state-of-the-art diagnostics within easy reach of non-expert users.”

The process is simple and straightforward. A small volume of the patient’s urine sample is collected and analyzed by the smartphone app using the phone’s camera and the diagnostic kit. No additional specialty materials are required.

“This is a great example of an interdisciplinary collaboration between biologists and engineers to solve important biomedical problems,” said Soh. “We hope technologies like this offer new ways of providing better healthcare around the globe."

The multi-institution collaboration was launched to develop rapid, low-cost diagnostics that can be used by healthcare providers anywhere in the world to diagnose bacterial infections.  The test can be performed rapidly and the lab kit can be produced for less than $100. And it requires little more than a smartphone, a hot plate, LED lights and a cardboard box.

“Urinary tract infections are particularly harmful to pregnant women and can cause miscarriage,” explained Fitzgibbons, an infectious disease physician. “Thus, there is a medical need for rapid, low-cost, on-site testing — particularly in resource-limited settings.”

The simple lab test works on a variety of pathogens and diverse patient specimens (blood, urine and feces), enabling clinical utility for a number of infectious diseases. Additionally, the test can be modified to detect emerging pathogens that pose an ongoing threat to human health.

“The app enables early-stage diagnosis and intervention, which is particularly important in the context of multidrug-resistant pathogens for which treatment options are highly limited,” said Fried, a clinical care physician. “Such early treatment also reduces the risk of the emergence of multidrug-resistant pathogens.”

The free, custom-built app was developed for the Android operating system and can be downloaded and installed from the Google Play Store. Upon opening the app, the user is presented with an option for a step-by-step tutorial prior to running test samples.

This research was funded by grants from the National Institutes of Health’s National Heart, Lung, and Blood Institute. Additional support was provided by the Chan-Zuckerberg BioHub and by the Bill and Melinda Gates Foundation.

Source: UC Santa Barbara 

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Cepheid Receives CE-IVD Clearance for Xpert Hepatitis C Fingerstick Test

Cepheid announced the CE-IVD marking of Xpert HCV VL Fingerstick, the first molecular test to detect and quantify hepatitis C Virus (HCV) RNA levels directly from a fingerstick blood sample. Currently, the clinical care pathway for detection of hepatitis C faces many barriers, including complicated multi-step diagnostic algorithms based on antibody screening and RNA confirmation [1]. These algorithms currently require centralized testing technologies that may result in treatment delays and loss to follow up, and could discourage at-risk populations from accessing testing and receiving care.

"Over the past few years, Cepheid, with its collaborators at the Kirby Institute and FIND have been able to demonstrate that a rapid and accurate test for active HCV infection can be performed on a drop of blood," said David H. Persing, M.D., Ph.D., Cepheid's Chief Medical and Technology Officer. "This is the first HCV RNA detection technology sensitive enough for both active case finding and use as a potential test of cure at the point of care."

Cepheid's Xpert HCV VL Fingerstick test allows for a simplified diagnostic pathway. From blood collected into a capillary tube via fingerstick, the simple to use test detects and quantifies a wide range of HCV genotypes within 58 minutes.  This enables diagnosis of HCV and initiation of direct acting antiviral treatment within a single clinic visit [2], and with this, the potential for curing more people with HCV.

The new test is now available in the EU and all countries recognizing the CE-mark.

References

1. Grebely et al. Hepatitis C point-of-care diagnostics: in search of a single visit diagnosis. Expert Rev Mol Diagn. 2017 Dec;17(12):1109-1115. doi: 10.1080/14737159.2017.1400385. Epub 2017 Nov 8.
2. Lamoury et al. Evaluation of the Xpert HCV Viral Load Fingerstick point of care assay. J Infect Dis. 2018 May 25;217(12):1889-1896. doi: 10.1093/infdis/jiy114.

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Thermo Fisher Launches qPCR-based Kit for Rapid Detection of Mastitis Pathogens in Dairy Herds

About 40 percent of clinically abnormal milk samples tested with traditional bacterial culture come back with a “no growth” result, leaving farmers exactly where they started – with a mastitic cow and no diagnosis. To overcome this reoccurring dilemma, Thermo Fisher Scientific has launched the Applied Biosystems VetMAX MastiType Multi qPCR Kit. The new diagnostic test quickly identifies the most common mastitis-causing pathogens, enabling dairy farmers and veterinarians to take immediate and informed action.

The new kit is designed to detect 15 mastitis-causing bacteria and an antibiotic resistance gene with just one diagnostic test. It provides reliable results with individual cow samples or bulk milk samples, which can be fresh, frozen or preserved.

The VetMAX MastiType Multi qPCR Kit detects the following: Staphylococcus aureus, Staphylococcus spp., Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus uberis, Escherichia coli, Enterococcus spp., Klebsiella oxytoca, Serratia marcescens, Corynebacterium bovis, Trueperella pyogenes and/or Peptoniphilus indolicus, Staphylococcal β-lactamase gene (penicillin-resistance gene), Mycoplasma bovis, Mycoplasma spp., yeast and Prototheca spp.


Real-time PCR kits, such as the new VetMAX MastiType Multi Kit, offer laboratory results in two and a half to three hours, enabling same-day results even for Mycoplasma species. Mycoplasma mastitis, which can be difficult to culture, can take up to 10 days with traditional bacterial culturing. The pathogen can spread swiftly, making rapid diagnosis critical for the health, welfare and productivity of the herd.

Laboratories also benefit from VetMAX MastiType Multi Kit’s fast and convenient new workflow using the MagMAX CORE nucleic acid extraction. It uses the Applied Biosystems QuantStudio 5 instrumentation which employs cloud-based software solutions.

“Dairy farmers and veterinarians want better, faster diagnostic solutions,” said Martin Guillet, global head and general manager for AgriBusiness at Thermo Fisher Scientific. “VetMAX MastiType Multi qPCR Kit joins the recently launched VetMAX MastiType Micro4 Kit and VetMAX MastiType Myco8 Kit to complete our mastitis veterinary diagnostic portfolio. It offers an additional qPCR solution for mastitis detection to our portfolio that will help veterinarians and farmers take fast, well-informed action toward eliminating mastitis in the dairy herd.”

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QIAGEN and NeuMoDx Announce Strategic Partnership for Next-Gen Molecular Diagnostic Testing

QIAGEN N.V. and NeuMoDx Molecular, Inc. announced a strategic partnership to commercialize two new fully integrated systems for automation of PCR (polymerase chain reaction) testing. These next-generation systems are specifically designed to help clinical molecular diagnostic laboratories process increasing test volumes and deliver more rapid insights on a broad range of diseases.

Under the agreement, QIAGEN will initially distribute the NeuMoDx™ 288 (high-throughput version) and NeuMoDx™ 96 (mid-throughput version) in Europe and other major markets worldwide outside of the United States. NeuMoDx will cover the United States directly. Additionally, the companies are collaborating to implement certain QIAGEN chemistries on the NeuMoDx systems.

QIAGEN began commercialization of the NeuMoDx systems at the European Society of Clinical Virology (ESCV) congress (September 23-26 in Athens, Greece) with an initial assay menu based on the first two CE-IVD marked assays for Group B Streptococcus (GBS) and Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) infections. The NeuMoDx systems offer a growing menu of relevant in vitro diagnostic (IVD) tests and the ability to process both commercial and laboratory-developed tests (LDTs) in the most flexible and efficient manner. LDTs, which account for an important number of test requests and volumes, are IVD tests designed by clinical labs for their own use.

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UK-India Project Aims to Combat Infections Threat with Rapid Diagnostics

A £3 million interdisciplinary research project is to address the growing threat of drug-resistant infections in India. The project will develop innovative diagnostics to curb antimicrobial resistance (AMR), one of the biggest threats to global public health.

AMR describes the situation when infections agents - including bacteria and parasites such as malaria - become resistant to the medicines used to treat them. The DOSA programme - Diagnostics for One Health and User Driven Solutions for AMR - brings together nine leading academic institutions, five from India and four from the UK.

Medical researchers, diagnostic innovators, economists and social scientists will create cutting edge, rapid diagnostic solutions to fight AMR in settings as diverse as community healthcare, dairy farms and aquaculture. AMR is of particular concern in India, where the levels of infectious diseases are high but public knowledge of diseases and appropriate treatments is low. In India, and across the globe, antibiotic use is regularly carried out without appropriate diagnostics, thereby fuelling the AMR crisis.

Rapid diagnostic tools are either unavailable, too expensive or do not fit people's needs, which leads to antibiotics being used in a trial and error fashion. The three-year DOSA programme will begin with a meeting of the project group on 24-25 September at the Indian Institute of Technology Delhi.

The project is jointly funded by UK Research and Innovation/Economic and Social Research Council, the Newton Fund, and Government of India's Department of Biotechnology.

Indian partners include the Indian Institute of Technology Delhi; the Centre for Cellular and Molecular Platforms Bangalore; ICAR-Central Institute of Fisheries Technology, Cochin, Kerala; ICAR-National Dairy Research Institute, Karnal, Haryana; Silchar Medical College and Assam University, Silchar, Assam.

UK partners include the Universities of Edinburgh, Bradford and Southampton and University of the Arts London.

Lead researcher Dr Till Bachmann, of the University of Edinburgh's Division of Infection and Pathway Medicine, said: "DOSA gives us the exceptional possibility to create a deep understanding between user needs and diagnostics innovation.

"The project will focus on community settings in India. It is here where the big drivers of AMR are located, where AMR is a huge burden and where it is exceptionally difficult to implement rapid diagnostics."

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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.

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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).

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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.

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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.

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