FDA Clears First Point of Care Rapid Diagnostic Test Kit for Chagas Disease

InBios announced today that it received 510K Clearance from the FDA for its Chagas Detect Plus Rapid Test Kit (CDP). The product is a rapid immunochromatographic strip assay for the qualitative detection of human IgG antibodies to Trypanosoma cruzi (T. cruzi) in human serum and whole blood matrices (venous and capillary (finger prick) whole blood). CDP is a non-invasive diagnostic test for use in a primary care setting by personnel trained to obtain whole blood or serum samples. Reactive test results will be presumptive evidence of infection with T. cruzi.

This simple two-step rapid diagnostic test is offered in a convenient cassette format, and results can be obtained in 20 minutes. In several clinical studies, the CDP demonstrated greater than 95% sensitivity and specificity in both endemic and non-endemic populations. The kit can be stored at room temperature for up to 24 months.

This is the first point-of-care diagnostic test available in the United States for Chagas. Primary care settings now have a highly sensitive and specific reliable test to detect Chagas in minutes. The kit is also CE marked and available internationally.

Estela Raychaudhuri, President of InBios, said, “We are excited to bring this long awaited, fast and affordable point of care Chagas test to the US market. The CDP utilizes InBios’ proprietary multi-epitope recombinant antigen target in combination with a proprietary lateral flow system. The assay was developed in part through funding from the National Institutes of Health and in collaboration with the Infectious Disease Research Institute (Seattle, WA).”

About Chagas Disease:

In the United States, Chagas disease is considered one of the neglected parasitic infections, a group of five parasitic diseases that have been targeted by CDC for public health action. It is reportable in at least four states: Arkansas, Arizona, Texas and Tennessee.
Chagas disease is caused by the parasite Trypanosoma cruzi, which is transmitted to animals and people mostly by contact with feces or urine of triatomine bugs, known as 'kissing bugs”.

T. cruzi can also be transmitted by:

• consumption of food contaminated with T. cruzi
• blood transfusion from infected donors;
• the passage from an infected mother to her newborn during pregnancy or childbirth;
• organ transplants using organs from infected donors; and
• laboratory accidents.

About six to seven million people worldwide are infected, mostly in Latin America. It has been increasingly detected in the United States of America, Canada, and many European and some Western Pacific countries. This is due mainly to population mobility between Latin America and the rest of the world.

Signs, Symptoms and Complications:

Chagas disease has an acute and a chronic phase. If untreated, infection is lifelong.
Trypanosoma cruzi infection is curable if treatment is initiated soon after infection.

The initial, acute phase lasts for about two months after infection. During the acute phase, a high number of parasites circulate in the blood, but in most cases, symptoms are absent or mild. In less than 50% of people bitten by a triatomine bug, characteristic first visible signs can be a skin lesion or a purplish swelling of the lids of one eye. Additionally, they can present fever, headache, enlarged lymph glands, pallor, muscle pain, difficulty in breathing, swelling, and abdominal or chest pain.

During the chronic phase, the parasites are hidden mainly in the heart and digestive muscles. Up to 30% of patients suffer from cardiac disorders and up to 10% suffer from digestive (typically enlargement of the esophagus or colon), neurological or mixed alterations. In later years the infection can lead to sudden death or heart failure.

In people who have suppressed immune systems (for example, due to AIDS or chemotherapy), Chagas disease can reactivate with parasites found in the circulating blood. This occurrence can potentially cause severe disease.

About InBios International, Inc.

InBios International, Inc., located in Seattle, WA, USA, develops and manufactures high-quality proprietary diagnostic tests for infectious diseases. The facility is FDA registered, USDA licensed and ISO 13485:2003 Certified. InBios develops and markets a comprehensive range of diagnostic products affecting global public health including the only emergency use authorized commercial Zika IgM ELISA in the United States. InBios also offers FDA cleared ELISA kits for dengue and West Nile and rapid test kits for Visceral and Cutaneous Leishmaniasis. The company offers several CE marked products internationally including Chikungunya ELISA kits. All products are manufactured in the USA.

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Aeon Clinical Laboratories Launches MDx Advantage™ - an Innovative Women’s Health, qPCR-Based Diagnostic Test for STDs and Other Infections

Authentidate Holding Corp., a provider of diagnostic services including toxicology and genetic testing, Telehealth, and web-based software applications for healthcare organizations, today announced the launch of an innovative new Women’s Health diagnostic test, MDx Advantage™, which utilizes Molecular Microbiology to improve on the legacy testing methods.

Traditionally, vaginal infections are diagnosed using a combination of gynecological examinations including a vaginal pH test, a microscopic evaluation (gram-stain and/or wet mount), and an amine odor test. However, such procedures have approximately a 30% chance of failure and cannot detect common, mixed infections. According to the CDC, bacterial vaginosis (BV) is estimated to affect 21.2 million (29.2%) of women between the ages of 14-49. Further, vulvovaginal candidiasis caused by Candida sp. or other yeasts affects 75% of women at least once, and 40%-45% of women at least 2 or more times. Especially in cases of mixed infections, an accurate diagnosis is crucial for determining the best treatment plan.

Aeon’s innovative approach enables accurate and rapid detection and diagnosis of such infections, including sexually transmitted diseases such as chlamydia and gonorrhea, candidiasis, bacterial vaginosis (BV), and others. Aeon’s Molecular Microbiology approach facilitates broad coverage of vaginal flora by targeting thirty-four (34) different microbial organisms including bacteria, fungi, viruses, and protozoa.

This testing provides significant advantages over the use of the traditional diagnostics including improved accuracy (testing will distinguish microbes down to the species level), faster turnaround time, and an easy-to-read report.

“Our PCR-based DNA amplification techniques provide higher specificity and sensitivity compared to other methods,” commented Jillian Quiett, Head of the Pharmacogenomics Department at Aeon. “This new testing will provide our physician clients the ability to use a single test to detect the microorganisms responsible for the symptoms the patient is experiencing.”

Dr. Holly Carpenter, Chair of Aeon’s Scientific Advisory Board and Director of Business Development, added, “Our focus is on the future of healthcare, and it is our mission to provide our clients and their patients with revolutionary tools that are used to diagnose and treat diseases with actionable information. Aeon stands as an industry leader at the frontier of precision medicine and genetic testing with a focus on helping our physician clients to deliver accurate, patient-centric, and personalized medical care.”

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ReadCoor, Inc. Receives a Grant to Support a Novel Pathogen Detection System

ReadCoor, Inc. (“ReadCoor”) announced a multi-year grant from the Bill & Melinda Gates Foundation to apply their proprietary spatial sequencing technology to understand causes of childhood mortality. With this funding, ReadCoor will develop powerful methods using its FISSEQ platform – Fluorescent In situ Sequencing – to detect pathogens directly from their transcriptomes and genomes, which are ignored in traditional diagnostics. The research will take place at ReadCoor’s facilities in Cambridge, MA.

FISSEQ is a revolutionary sequencing platform that enables highly multiplexed analysis of RNA, DNA and other molecular features without removing cells from their tissue. Including infectious diseases, FISSEQ has demonstrated utility in a diverse range of applications including brain mapping, gene therapy, immuno-therapy, oncology, neurodegenerative diseases, regenerative medicine and others.

“It is a great privilege to partner with the Bill & Melinda Gates Foundation in this important effort to reduce childhood mortality in developing countries,” said Shawn Marcell, CEO and co-founder of ReadCoor. “We are committed to applying the FISSEQ platform for the benefit of humankind and we applaud the Gates Foundation for its vision and willingness to support innovative approaches to age-old problems.”

With this collaboration, the foundation will provide up to $2.5 million in funding over two years to develop FISSEQ-based diagnostics and analytical tools to investigate pathogens associated with early childhood diseases and epidemics. These contagion detection tools will enable the global health community to deliver the right intervention to the right children and save lives.

Stopping epidemics in the developing world is challenging because children are constantly exposed to numerous bacteria and viruses that remain in their systems and mask the actual deadly pathogen. Current molecular methods and pathological analyses laboriously and poorly distinguish the specific deadly pathogen from benign infections.

Because FISSEQ sequences tissue in situ it can identify each pathogen’s unique genetic sequence and location in the tissue. Each pathogen’s location is correlated with mortality markers, such as inflammation, to determine the deadly pathogen and the appropriate outbreak intervention.

The aim of this innovative epidemiological approach is to use FISSEQ’s comprehensive panomic view of interactions between cells and tissues to create a disease atlas that will aid contagion surveillance efforts and prepare for outbreaks.

ReadCoor is leading the next generation of “omics” by delivering the first panomic spatial sequencing platform to the global audience of researchers, clinicians, pharma and diagnostics companies, and ultimately patients. It is accomplishing this with FISSEQ, a fundamental new technology which simultaneously integrates high throughput sequencing, morphometric analysis, cellular location and three-dimensional spatial imaging. This uniquely powerful tool is the first and only implementation of “In-situ Sequencing” and will revolutionize the next phase in understanding the transcriptome, introducing vast new opportunities for important and meaningful clinical insight.

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Nanomix Advances Rapid Diagnostic Panel to Aid Emergency Evaluation of Sepsis

Nanomix, Inc. today revealed the first rapid diagnostic test panel designed to quickly evaluate patients affected by sepsis, which runs on the company's simple-to-use, handheld diagnostic system, the Nanomix eLab. Designed for emergency medical and other point-of-care needs, the new test employs a single patient blood, plasma, or serum sample to provide actionable results within 10 minutes. Currently screening tests for sepsis can take hours or days, are costly, and require the use of multiple instruments that are most often operated by skilled technicians within a central hospital laboratory. The company said it plans to initiate formal clinical trials of the sepsis panel by mid-2017, and if successful, seek both CE-mark and 510K approvals by 2018. Sepsis, characterized by the body's overwhelming response to infection potentially leading to tissue damage, organ failure, and death, is the third leading cause of death in the United States.

"Rapid diagnosis and aggressive clinical intervention is critical for patients to survive sepsis, and even short delays in sepsis identification and administration of treatment can negatively impact patient outcomes and increase mortality," said David Ludvigson, Nanomix President and Chief Executive Officer. "Our rapid sepsis panel, formatted into a disposable microfluidics test cartridge that the user inserts into our hand-held eLab, incorporates enzymatic and immuno-assays for three key sepsis markers. As such, it represents the first set of sepsis-related screening diagnostics that can be performed quickly at the first point of contact between a patient and the healthcare provider. Time matters in treating sepsis and we believe that the information provided by this novel diagnostic will enhance the clinician's ability to quickly and accurately assess patient status, enabling more timely and appropriate treatment, and improved patient outcomes."

"The Nanomix eLab system opens the door to many testing applications that can improve patient outcomes and potentially lower the cost of healthcare," said Mr. Ludvigson. "While sepsis-related diagnostic tests are a first step, over time, we believe the eLab System will enable point-of-care testing for many of the critical and routine tests now performed in hospital and reference laboratories."

About the Nanomix eLab System

The Nanomix eLab system is comprised of a mobile, handheld diagnostic device and a disposable microfluidics test cartridge. The device is simple to operate via an intuitive user interface on a color touch screen and incorporates a proprietary nano-biosensor for high quality, reliable performance. The single-use disposable test cartridge uses the patient's whole blood, without sample preparation. All test functions are controlled and automatically processed by the device. The robust system design supports use in almost any setting, inside or outside of the traditional laboratory environment. The eLab device is Bluetooth enabled for rapid communication of results. Internal testing by Nanomix scientists, their clinical partners, and other outside evaluators has shown the eLab to produce results equivalent to those produced by expensive central laboratory testing systems.

Economic Impact of Point of Care Testing

The National Academy of Medicine estimates that $750 billion – 30% of the U.S. annual healthcare budget -- is wasted on unnecessary medical services, inefficient delivery, excessive administrative costs and prevention failures. Testing patients at the point of first contact can help reduce a significant amount of these excess costs. In addition to reducing the time to diagnosis in the Emergency Department, portable, rapid testing technology could also be used outside the hospital to help determine if patients can be treated in place or if they need to be transported to a hospital for treatment. Nanomix envisions the eLab system finding usage in settings such as Skilled Nursing Facilities, Elderly Care Centers, Convalescent Centers, Urgent Care Clinics, or even the home for monitoring patients with chronic health conditions. Reducing the time to diagnosis and treating patients in place can not only increase patient satisfaction and improve outcomes, but could also lower costs by potentially more than a billion dollars.

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Curetis Acquires Real-Time qPCR Platform from Carpegen and Systec

Curetis N.V. (the "Company" and, together with Curetis GmbH, "Curetis"), a developer of next-level molecular diagnostic solutions, today announced the acquisition of the real-time qPCR-based Gyronimo Platform from Carpegen GmbH and Systec GmbH, joint owners of the platform.

The transaction allows Curetis to transform Unyvero into a uniquely broad platform offering with capabilities ranging from rapid 1 hour testing for 10+ diagnostic targets to highly multiplexed syndromic testing panels delivering results for over 100 diagnostic targets in 4 to 5 hours. Integrating Gyronimo into the Unyvero Platform for infectious disease testing will also allow Curetis to significantly expand its product portfolio into novel application in areas such as infection control, viral testing and CNS infections, as well as applications for immunocompromised patients.

Under the terms of the agreement, Curetis is acquiring all Gyronimo Platform assets, including fully functional prototype systems and the entire intellectual property portfolio comprised of several patent families pending and a key patent granted in the U.S., Canada and China already, and allowed in Europe. Curetis will also obtain exclusive Gyronimo know-how and a non-exclusive license to background intellectual property and know-how. Curetis will be granted exclusive worldwide rights to the platform, including the right to sublicense, partner or sell it, with an exemption for Carpegen and Systec in dental testing as well as in environmental and food safety testing.

Curetis will make a one-time upfront payment of EUR 5.0 million in cash. In addition, Carpegen and Systec are eligible for two discrete, one-time milestone payments upon platform and first cartridge CE marking and FDA clearance, respectively, totaling up to EUR 2.5 million. There will also be the potential for a royalty-based earn-out at an industry-typical mid-single digit percentage rate, up to a maximum of EUR 9 million.

Gyronimo offers rapid time to result (potentially as fast as 60 minutes), qualitative and, where needed, quantitative real-time PCR testing in a cartridge format that can provide up to 10 parallel multiplex qPCR reactions from one sample. As such, it lends itself to medium multiplexing applications ranging from 10 to 30 diagnostic targets. Curetis intends to fully and seamlessly integrate the Gyronimo Platform into its Unyvero Platform suite of products with respect to system architecture, design, software and handling. In particular, the new Unyvero Module will leverage the unique capabilities of the Unyvero Cockpit and Lysator for seamless workflow integration and flexible handling of very challenging and diverse native patient samples. In addition, all-in-one stand-alone modules are envisaged for certain future applications.

Curetis will take over functional prototype instruments and cartridges, and will complete the IVD development and industrialization as well as OEM manufacturing of systems and cartridge production. The Company expects completion of development and CE IVD marking not before late 2018. COGS of the Gyronimo cartridges are expected to be considerably lower than those for Unyvero Cartridges and other MDx multiplexing systems, opening up attractive commercial opportunities in the medium multiplexing infectious disease testing market segment.

"We are truly excited about the transaction which offers us an excellent opportunity to accelerate the growth and development of our Unyvero Platform with complementary and greatly expanding characteristics," said Dr. Oliver Schacht, CEO of Curetis. "Gyronimo's advanced product development stage, its speed, quantitation ability, low cost of goods and mid-range multiplexing features are unique. It is therefore a natural next step in the development of our Unyvero Platform and we do not intend to develop it as a separate system, but rather as an integral and modular part of our overall Unyvero Solution. It expands and provides our product portfolio with a remarkable competitive edge, i.e. an unmatched diagnostic bandwidth ideally suited for any particular clinical application from as few as 5 or 10, via 20 to 30, and up to over 100 markers. We believe that the platform will allow us to address additional infectious disease indications in hospitals. It will significantly expand our market opportunity and provide us with the opportunity to double our peak sales potential in the long run."

"With Curetis, we have found the ideal partner to take the Gyronimo Platform through the final stages of product development, industrialization, manufacturing and scale-up as well as global commercialization," said Dr. Antje Rötger, CEO of Carpegen GmbH. "We will benefit substantially from the ultimate commercial success of the platform and we have retained certain areas that are of direct commercial interest to us, such as dental testing and environmental and food safety testing. To this end, we have agreed that we may discuss a possible OEM partnership with Curetis at a future point in time to obtain Gyronimo instruments and cartridges for our own commercial purposes. We are excited to be working closely with Curetis on the smooth transfer of all assets and know-how in the coming months."

"We have developed the Gyronimo Platform from the first idea to its current stage as a fully functional and working prototype in a multi-year, close R&D collaboration and partnership with Carpegen," said Klaus-Gerd Schoeler, CTO of Systec GmbH. "Our teams are joint inventors of several core patents. We believe that putting the platform into the hands of a more mature, fully integrated IVD company such as Curetis offers us a faster and ultimately more successful and rewarding path to fully develop, leverage and commercialize the asset. We look forward to working closely with the Curetis team in the coming months as we hand over all system development projects."

At present, Curetis is marketing its Unyvero System and three application cartridges for pneumonia, implant and tissue infections, bacteremia and the company has a fourth Application Cartridge for intra-abdominal infections in late stages of development. Curetis' broad development pipeline of additional application cartridges further features applications to test for sepsis host response, urinary tract infections, cardiology-related infections and an extended panel for respiratory tract infections.

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Rapid Detection of Propionibacterium acnes in Shoulder Surgery

Propionibacterium acnes infection of the shoulder after arthroplasty is a scourge for patients and surgeons alike as it can involve serious complications. Current detection methods for P. acnes involve anaerobic cultures that require incubation periods of 7-14 days. Now, research that has won the 2017 Charles S. Neer Award from The American Shoulder and Elbow Surgeons society has resulted in a method to identify P. acnes within 24 hours.

David O’Gorman M.Sc., Ph.D. is co-director of Research at the Cellular and Molecular Research Laboratory, Roth McFarlane Hand and Upper Limb Centre at St. Joseph’s Healthcare in London, Ontario. A co-author on the study, Dr. O’Gorman stated, “The main reason this research was undertaken was to address a clinical problem, namely the extended time (typically weeks) required to grow cultures and confirm a P. acnes infection of the shoulder after surgery. The publication [“A rapid method for detecting Propionibacterium acnes in surgical biopsy specimens from the shoulder”] describes a methodology to detect and confirm the presence of P. acnes DNA in a shoulder tissue sample in a much shorter period of time (~24hrs) that does not require any cultures. The sooner a physician can confirm the presence of this organism in the shoulder, the sooner they can make clinical decisions about how to proceed.”

“As for the primers we designed, the technique we use requires small, single stranded pieces of DNA called ‘primers’ to ‘anneal’ (attach) to P. acnes DNA. We use these primers (2 different ones) to perform polymerase chain reaction (PCR), a technique where the DNA that lies between the annealing sites of the two primers can be amplified many thousands of times. The region we amplified is within a gene that all bacteria contain, but is quite variable between different bacterial species. This difference between species allows us to specifically amplify only P. acnes DNA and not the DNA of other bacteria. We also cut this amplified DNA into fragments using an enzyme (HaeIII, a ‘restriction’ enzyme to be precise) to check that the fragments are exactly the sizes we predict them to be. This is a ‘double check’ to ensure that we amplified DNA from P. acnes and not some other microbe by mistake.”

“With regard to plans for the future, we hope to enhance the technology to be able to ‘rank’ the P acnes we detect on a scale of least to most invasive/destructive by assessing their expression of virulence genes. We are also interested in developing a ‘point of care’ (POC) assay that would allow us to confirm the presence of P acnes within the time span of the operation itself. That will be technically challenging, but would also be a very valuable addition to the surgeons ‘toolkit’ to detect and treat P acnes infections of the shoulder in a timely manner.”

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First WHO Prequalified Hepatitis C Rapid Test Opens Door to Expanded Treatment

WHO has just prequalified its first hepatitis C virus (HCV) rapid diagnostic test, a tool that will aid diagnosis of HCV in low- and middle-income countries and improve access to treatment.

“The fact that we now have very effective new medicines for HCV needs to be bolstered by effective and affordable diagnostics,” said Dr Suzanne Hill, WHO Director for Essential Medicines and Health Products. “This new quality-assured test is good news for the many people awaiting diagnosis and treatment.”

The newly prequalified test, SD BIOLINE HCV, by Standard Diagnostics, Inc. (South Korea), is a point-of-care diagnostic, which makes it particularly appropriate for low-resourced countries, where testing laboratories and trained personnel may be scarce. Resembling a pharmacy pregnancy test, it does not require hospital facilities or electricity and can be performed by health workers with limited training. The test gives a result within 20 minutes.

WHO acceptance of the test comes at a time when direct acting antivirals (DAAs), new and highly effective medicines for HCV, are becoming increasingly affordable and available in low- and middle-income countries.

“The majority of people with chronic hepatitis C don’t know they have the infection and miss the opportunity to be cured,” said Dr Gottfried Hirnschall, WHO Director for the Department of HIV and Global Hepatitis Programme. “Making the first WHO prequalified test available in countries can greatly contribute to achieving the goal of eliminating hepatitis.”

There are only very few HCV rapid tests on the market, and they are either not quality-assured or too expensive for countries with limited resources. This means that patients may potentially be misdiagnosed – either as false positives or false negatives. The newly prequalified test is expected to be more affordable, as well as guaranteeing quality, safety and performance. Agencies that procure or purchase health products for low-resource countries, such as Médecins Sans Frontières and UNITAID, have been waiting for such a test in order to scale up diagnosis and treatment.

“One of the chief obstacles to effective testing and treatment of HCV has been a lack of suitable diagnostic tests, with the result that only a small minority of people infected with HCV are aware of their status,” said UNITAID Executive Director, Lelio Marmora. “We are therefore greatly encouraged by the news that a WHO-prequalified rapid diagnostic test for HCV can now be made available to those most in need.”

WHO has recently released normative guidance on care and treatment of viral hepatitis. DAAs have an over 90% cure rate and now provide the opportunity for addressing the HCV public health crisis. The emergence of DAAs has stimulated renewed interest in the establishment and expansion of testing services for HCV after a long period of stagnation. In addition, the new test will help key affected populations (e.g. injecting drug users), who have not been reached by existing HCV testing services that focus on blood screening.

Background

WHO prequalification is conducted in accordance with international standards of quality, safety and performance of in vitro diagnostic medical devices. Once a product has been prequalified by WHO, it is eligible for procurement by UN agencies. Countries and non-governmental organizations also rely on the WHO list of prequalified health products to guide their purchasing and procurement practices.

The SD BIOLINE HCV is a rapid assay that detects antibodies to HCV in human serum, plasma or whole blood. The assay is used as an aid to diagnosis of HCV infection; reactive specimens require additional testing to identify current HCV infection. The test contains a pre-coated nitrocellulose membrane strip; when the serum, plasma or whole blood specimen is applied, it moves along the membrane to the test region and forms into a visible line, which indicates a reactive result. The control line should always appear if the test procedure is performed properly and the reagents in the control line are working. The test result can be read between 5 and 20 minutes; as this is a visually-read device, no instrumentation is required to interpret the test result. The product has not been validated for infants or children.

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Vitas Pharma Receives Discovery Award for Developing Prototype Diagnostic Test

Vitas Pharma, an R&D driven company focused on developing drugs and diagnostics to detect and treat multidrug resistant infections, has received a Discovery Award, to develop its diagnostic product for the rapid detection of bacterial infections.

The Discovery Awards are small seed grants to help teams and individuals further develop their ideas for the Longitude Prize. The Awards ceremony, held at the Royal Society, London recently was presided over by Sir Martin Rees, Chair of the Longitude Prize committee and Dame Sally Davies, chief medical officer, England.

Vitas Pharma is incubated in the Technology Business Incubator, University of Hyderabad and IKP Knowledge Park. The company has prototyped a molecular test that detects the presence of bacteria with high specificity and sensitivity. This low cost, 45 minute assay is easy to perform and amplifies bacterial sequences without the need for expensive equipment. It is envisioned that the kit will ultimately consist of 3 tests per sample and will flag the presence of bacteria in 30 minutes. Unlike other currently available tests, this assay combines speed and accuracy combined with a low cost.

Dr Radha Rangarajan, CEO, Vitas Pharma said, “Infections caused by multidrug resistant bacteria are a major public health concern globally. To curb the spread of resistance, tests that enable the appropriate use of antibiotics, are a critical need. Our test will be simple, affordable and rapid, thus allowing physicians to make data-driven decisions on prescribing antibiotics.”

Antibiotics have played a vital role in improving human health: WHO estimates that antibiotics add an average of 20 years to an individual’s lives. However, the largely empirical use of antibiotics, has led to its inappropriate use, contributing to the emergence of drug resistance. Longitude Prize is a challenge with a £10 million prize fund to help solve one of the greatest issues of current times. The Longitude prize was instituted by the British Government to reward a team or individual that develops a diagnostic test for bacterial infections that is cost-effective, accurate, rapid and easy-to-use and allows health professionals worldwide to administer the right antibiotics at the right time.

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Automated Systems Launched by Beckman Coulter

Beckman Coulter has launched two automated systems in the UK to ease rapidly increasing workloads in microbiology and virology departments. The DxN VERIS Molecular Diagnostics system, for same-day molecular viral load testing, and the MicroScan Microbiology Systems for microorganism identification (ID) and antimicrobial susceptibility testing (AST), both rapidly and accurately identify therapeutic pathways for patient management.

This high-throughput testing significantly streamlines laboratory workflows, and reduces time to patient therapy diagnoses. The launch marks the advent of a significant investment in the UK microbiology market by Beckman Coulter with further product introductions scheduled.

The UK launch of the systems was celebrated with a showcase event - the first in a new series of educational events designed to provide a platform for interested parties to learn about new technologies. At the initial event, attendees had the opportunity to; speak to individuals using the new automated platforms, evaluate data in the form of presentations, and speak with technical experts to answer queries and gain a greater depth of understanding.

Duncan Whittaker, Laboratory Manager Virology at the Sheffield Teaching Hospital NHS Trust, spoke at the event about his experience with the DxN VERIS - which provides fast and accurate viral load assays by consolidating extraction, amplification and detection onto a single platform. “The DxN VERIS is the kind of instrumentation that will help the laboratory to meet long terms goals for improved services with faster turnaround times and greater productivity,” he commented.

The easy-to-use DxN VERIS system saves both hands-on time and space in the laboratory. Results are available rapidly - facilitating fast decision making and positively impacting patient treatment. Duncan confirmed, “Training staff is very quick and straightforward, taking just 20 minutes. Initial comments have been that faster results for certain viral load assays could be life-saving in some instances.”

Attendees also heard from Michael Dawson, Senior Biomedical Scientist, from the William Harvey Hospital where two MicroScan WalkAway 96 Plus systems are in use as part of the East Kent Microbiology Service.

The systems have improved workflow and streamlined processes through the rapid delivery of ID and AST with gold-standard accuracy. The easy-to-use walkaway systems allow simultaneous processing of conventional, rapid, and specialty panels. In addition, the MicroScan offers true Minimum Inhibitory Concentration (MIC) technology with visual read capability, which enables the detection of emerging resistance in real-time, without reliance on historical data.

Michael spoke about his Trust’s decision to move to the MicroScan platform for AST in particular. “For us the need to move to an automated microbial screening system was clear. Our previous multipoint testing methods, supported by disc diffusion testing, were non-reproducible, unreliable and inaccurate. In addition to the lack of standardisation, they were time consuming and whilst we screened for many agents, MIC determination required a further manual method.”

He went on to describe his experience of the MicroScan platform. “Time and accuracy are important factors for us as we screen over 160 isolates a day, seven days a week. We’ve found that the accuracy and reliability of MicroScan means that fewer isolates need further testing, reducing unnecessary manual work and delivering results in a predictable and consistent timeframe.

We are particularly impressed with the quick and very easy-to-use standardised PROMPT inoculation system and the fact that the MicroScan has the fewest clinically significant limitations in regard to antibiotic and micro-organism combinations.”

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FDA Completes Transfer of Emergency Use Authorization for ReEBOV Ebola Antigen Rapid Test to Zalgen Labs

Zalgen Labs LLC (Zalgen), a biotechnology and diagnostics company focused on high-impact, neglected infectious diseases, announced today that its ReEBOV® Antigen Rapid Test received U.S. Food and Drug Administration (FDA) emergency use authorization (EUA) on November 3, 2016. This marks the successful transfer of FDA EUA from Corgenix Medical to Zalgen.

The test is to be used for the presumptive detection of Ebola viruses (detected in the 2014 – 2016 West Africa outbreak) in individuals with signs and symptoms of Ebola virus infection in conjunction with epidemiological risk factors (including geographic locations with high prevalence of Ebola infection). The authorized ReEBOV Antigen Rapid Test is intended for circumstances when the use of a rapid Ebola virus test is determined to be more appropriate than use of an authorized Ebola virus nucleic acid test.

Ebola virus is indigenous to western and central Africa and is one of the deadliest viruses in the world, with mortality rates of between 30 and 90 percent. The ReEBOV Antigen Rapid Test for Ebola was the first rapid diagnostic test (RDT) and the first immunoassay authorized for emergency use by the FDA for the presumptive detection of Ebola virus, and also the first listed for procurement by the World Health Organization (WHO) under the Emergency Use Assessment and Listing procedure. Under the terms of a previously announced collaboration agreement, NOWDiagnostics Inc. (NOWDx) will manufacture the ReEBOV Antigen Rapid Test for Ebola virus as well as other Zalgen diagnostic products.

Unlike molecular testing, which in West Africa can still take days to return results from central testing laboratories, the Zalgen ReEBOV RDT is a point-of-care test that can be used in laboratories or facilities adequately equipped, trained and capable of such testing. That includes testing in treatment centers and public health clinics or in field laboratories with trained personnel capable of such testing. Instead of taking days for lab results, the ReEBOV RDT uses a drop of blood from a finger prick to deliver a presumptive detection of Ebola virus antigen in as little as 15 - 25 minutes, potentially allowing trained public health workers to rapidly screen, isolate and initiate care of suspect Ebola patients. Medical personnel will be able to quickly identify hotspots and may prevent resurgence of cases in future outbreaks.

The ReEBOV Antigen Rapid Test was developed in cooperation with additional members of the Viral Hemorrhagic Fever Consortium (VHFC), a collaboration of academic and industry members headed by Tulane University, including Autoimmune Technologies LLC, The Scripps Research Institute and the University of Texas Medical Branch at Galveston, as well as other collaborators in West Africa, particularly the Ministry of Health and Sanitation (MOHS) of the Republic of Sierra Leone and the medical personnel of the Kenema Government Hospital in Kenema, Sierra Leone, a number of whom died fighting the 2014-16 Ebola outbreak.

“This emergency use authorization from the FDA enables Zalgen and our distribution partners to continue providing this remarkable product worldwide to test suspected Ebola cases,” said Zalgen Managing Director, Luis Branco, PhD. “Zalgen and the VHFC are already working with NOWDx to develop next generation diagnostic tests for Ebola, Lassa and other hemorrhagic fevers as well as other tropical diseases.”

Development of the ReEBOV Antigen Rapid Test for Ebola was supported by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) (grants 1R43AI088843 and 2R44AI088843). Additional support was provided by The Bill & Melinda Gates Foundation and the Paul G. Allen Family Foundation.

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BITRI Develops Rapid Foot and Mouth Disease Test Kit

Botswana Institute of Technology Research and Innovation (BITRI) is developing the kits in collaboration with Botswana Vaccine Institute and Canadian Food Inspection Agency. Recently, BITRI held an FMD diagnostic tool kit research findings stakeholder engagement officiated by the Minister of Tertiary Education, Research, Science and Technology, Dr Alfred Madigele, at Maun Lodge.

Madigele said the rapid test kit promises to be a major breakthrough in the testing of FMD not just in Botswana, but Africa.  He explained that it would detect FMD in an animal within 25 minutes on site and immediately assist in monitoring the disease.   “If successful, this kit will significantly reduce waiting period for results to come back from the laboratories far away from cattle posts, thereby saving farmers the headache of anticipation,” he said. Madigele said accurate diagnosis of cattle infected with FMD is of prime importance to allow both control and eradication of FMD. Researcher at BITRI Boitumelo Madabuka explained that they are mandated to develop technologies to develop livelihoods across sectors of the economy. He said in 2014, they resolved to develop an FMD test kit similar to that used for HIV and pregnancy tests. She elaborated that Clearview technology (Patent No. 01291 194 B1, 1988) was introduced by Unipath Ltd (Bedford, UK) for the determination of pregnancy in women. Moreover, Lateral Flow Device (LFD) have since been adapted as diagnostic tools not only in human medicine, but also in veterinary medicine. She explained that “A rapid test would allow for on-site diagnosis to be made in a case of a suspected disease outbreak”.

Madabuka said most existing diagnostic methods require highly-trained laboratory personnel, special equipment thereby causing delays in the implementation of control procedures. Further, she explained that rapid and specific test for FMD at site permit suitable implementation of control measures. Madabuka explained that the role of test kits is to confirm suspected cases of FMD, substantiate absence of infection, demonstrate the efficacy of vaccination and for substantiating freedom from infection. She said BITRI plans to develop four sets of kits for FMD. Furthermore, Madabuka said after finalising the kits, they will hand them over to the Department of Veterinary Services for usage. However, the kits have to be approved by World Organisation for Animal Health before they are used.”

“As a research institute, our role is to develop the kits. For their commercialisation, expectation is that the private sector will invest in their production,” she said.

BITRI is a parastatal established in 2012 under the newly established Ministry of Tertiary Education, Research, Science and Technology. It is mandated to conduct needs based research and development in focused areas by identifying and developing appropriate technologies.

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Hygiena to Acquire Food Safety Diagnostics Business from DuPont, Including BAX and RiboPrinter Rapid Methods

DuPont Nutrition & Health and Hygiena, a Warburg Pincus portfolio company that specializes in rapid food safety and environmental sanitation testing, announced that Hygiena will acquire DuPont’s global food safety diagnostics business. The acquisition includes all of DuPont Diagnostics business assets, including the BAX® and RiboPrinter® Systems and associated test kits; a global and technically trained sales, R&D and manufacturing organization; and in-house production capacity. The business was formed by DuPont in 1992 as Qualicon, and Hygiena will retain the Qualicon name. The transaction is expected to close in the first quarter of 2017, pending customary closing conditions, including regulatory approvals.  Financial terms of the agreement were not disclosed.

DuPont Diagnostics provides innovative, science-based microbial detection and monitoring products that identify and characterize pathogens and other unwelcome organisms in food ingredients, finished products and production environments. Shortly after the formation of the business, DuPont pioneered Nobel-prize-winning PCR technology in commercial food safety testing with the BAX® System for pathogen detection.  Today, the BAX® System has been adopted as the leading detection method by food manufacturers, food quality laboratories and governments around the world. Hygiena plans to invest behind new product development to continue the DuPont Diagnostics history of market-leading innovation.

“The combination of DuPont Diagnostics and Hygiena will create a broad food safety diagnostics company that can better serve our customers,” said Steve Nason, chief executive officer of Hygiena.  “The combined company’s microbiology products will cover the full manufacturing process, from in-process environmental tests to finished product tests. In addition, the combination increases our customer service presence in the United States and internationally, which will allow us to further enhance our research and development efforts and support to our combined customer base.”

“This transaction is a strategic business decision that will allow DuPont Nutrition & Health to focus on growth opportunities that are more closely aligned with our core portfolio of specialty food ingredients,” said Matthias Heinzel, president, DuPont Nutrition & Health. “We believe that the Diagnostics business is an excellent strategic fit with Hygiena.  Together they will be better able to offer greater opportunities for growth and investment in innovative solutions for the global pathogen testing industry.”

Hygiena is a microbiology and life science company that serves industrial food processors, healthcare institutions, life science researchers and other industries. Hygiena manufactures and sells a broad range of rapid hygiene monitoring systems, environmental collection systems and rapid dilution devices, including its market leading ATP (adenosine triphosphate) testing system.  Its products are distributed in over 80 countries worldwide. Hygiena is committed to the mission of providing customers with innovative technologies that are simple, easy to use and reliable, with excellent customer service and support.

In 2016, Hygiena received an investment from Warburg Pincus, a global private equity firm focused on growth investing, to help further this mission.  Warburg Pincus’ investment in Hygiena was driven by the firm’s thesis that the company represents an excellent platform to consolidate the highly fragmented food and life sciences testing and environmental sanitation industry.  Stephanie Geveda, managing director, Warburg Pincus, said, “DuPont Diagnostics is a perfect fit within Hygiena’s growth strategy.  We are excited to invest in and build upon the business’ portfolio of leading diagnostic products and capabilities.”

Hygiena LLC is a microbiology and life science company that serves industrial food processors, healthcare institutions, life science researchers and other industries. Utilizing advanced technologies and patented designs, Hygiena manufactures a broad range of rapid hygiene monitoring systems, environmental collection systems, rapid dilution devices, and more. All products are made under strict GMP standards in its ISO-certified facility, ensuring excellent product quality and reliability.

Warburg Pincus LLC is a leading global private equity firm focused on growth investing. The firm has more than $40 billion in private equity assets under management. The firm’s active portfolio of more than 120 companies is highly diversified by stage, sector and geography.

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