Tuesday, December 20, 2016

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.

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.”

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.

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.

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.

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.”

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.


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.

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.

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.”

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.

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.

Monday, December 19, 2016

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.

Monday, November 21, 2016

New, Rapid Diagnostic Test for Malaria Wins $100,000 Grand Challenges Explorations Grant

An interdisciplinary team of scientists and engineers at Vanderbilt University headed by Stevenson Professor of Chemistry David Wright has designed a new kind of rapid diagnostic test for malaria that has received a $100,000 Grand Challenges Explorations grant which is designed to support innovative global health and development research projects. It is one of 56 such grants announced today by the Bill & Melinda Gates Foundation.

The innovative aspect of the "Origami Diagnostics to Accelerate Malaria Elimination" project is its use of "paper microfluidics" to produce a malaria test that is one hundred times more sensitive than commercially available tests while retaining the low cost and simplicity required for real world application.

"In order to eradicate malaria, we must be capable of detecting the individuals that carry the malaria parasite but don't show any symptoms," said Wright. "Current commercial malaria tests are not capable of doing this. That is why we have engineered our origami test with the sensitivity required to identify these individuals. At the same time, we have designed it so it will be extremely inexpensive to make and so it will be as easy to operate as current lateral flow detectors like the pregnancy test."

One of the factors that limit the sensitivity of current rapid malaria tests is the small amount of blood that they can process: a single drop. To address this problem, the origami detector consists of a relatively large well that is capped with a porous membrane. The membrane has a special coating that selectively catches proteins produced by the malaria parasite, called biomarkers. Users dilute a few milliliters of blood in a special liquid and pour it through the membrane, which snags the biomarkers as the mixture percolates through. This allows it to collect a much larger number of biomarkers than commercial tests. Once that is done, the users detach the well and throw it away. Then they fold the membrane onto an attached sheet of paper printed with special inks. These inks contain sensor molecules that change color when they bind with parasite biomarkers. Next they wet down the membrane/paper sandwich with a special liquid that releases the biomarkers from the membrane so they will come in contact with the sensor molecules, causing them to change color.

To receive funding, Wright and other Grand Challenges Explorations winners described a "bold idea" in a two-page online application in one of six critical global heath and development topic areas.

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

Zalgen Labs LLC, 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.

OpGen, Merck Enter Rapid Diagnostics, IT Products Development Collaboration

OpGen, Inc. announced it has entered into a research collaboration with Merck to develop new rapid diagnostics and information technology products to help combat the threat of antimicrobial resistance. The companies will collaborate to support OpGen’s development of rapid DNA tests and a genomic knowledgebase of antibiotic-resistant pathogens for predicting antibiotic susceptibility based on test results.

Under the terms of the agreement, Merck will provide access to its archive of over 200,000 bacterial pathogens gathered over the last 15 years through the Study for Monitoring Antimicrobial Resistance Trends (SMART), one of the world’s largest surveillance studies of antimicrobial resistance supported by Merck in collaboration with International Health Management Associates (IHMA). OpGen will perform genomic analysis, microbiology testing for drug resistance, and incorporate this information into its Acuitas® Lighthouse Knowledgebase and the development of rapid DNA tests. This new molecular testing and informatics approach is being developed to help transform antibiotic decision making for doctors managing acute care patients with blood, respiratory, urinary tract, and soft tissue infections. In addition to identifying resistance determinants to predict antibiotic failures, the OpGen technology is being evaluated as the foundation for utilizing molecular diagnostic tests to predict pathogen susceptibility and guide patient management choices to improve patient outcomes.

“This collaboration builds upon the promise of our DNA-based genetic tests, Lighthouse Knowledgebase and antibiotic resistance decision making tools to make a significant impact on hospital infections,” said Evan Jones, chairman and CEO of OpGen. “Access to Merck’s SMART surveillance network data has the potential to greatly accelerate our internal development efforts in validating our rapid diagnostic tools and bolster data acquisition for our Lighthouse Knowledgebase.”

Recent studies have indicated that antimicrobial resistant infections currently claim 50,000 lives each year across the United States and Europe alone, with many hundreds of thousands more dying in other areas of the world. In September, world leaders at the United Nations called rising antimicrobial resistance a fundamental threat to human health, development, and security. As a result, for the first time, Heads of State committed to taking a broad, coordinated approach to combat rising antimicrobial resistance including the development of new medicines and rapid diagnostics.

“Rapid diagnostics for pathogen identification and antibiotic susceptibility testing are central to developing global solutions for antimicrobial resistance,” said Dr. Eliav Barr, senior vice president, Infectious Diseases and Vaccines Clinical Development, Merck Research Laboratories. “By providing OpGen with access to our archive of bacterial pathogens, we hope to expedite the development of rapid diagnostic tests and enable prompt and informed antibiotic prescribing to improve patient outcomes.”

OpGen will initially perform molecular analyses on up to 10,000 pathogens to identify markers of resistance to support rapid decision making using the Acuitas Lighthouse® MDRO Management System (“Lighthouse Portal”), and to speed development of OpGen’s rapid diagnostic platforms. OpGen’s Lighthouse Portal and Knowledgebase are being developed to provide antibiotic stewardship and tracking information for drug resistant pathogens in hospitals and health systems. Merck will gain access to the high-resolution genotype data for the SMART isolates as well as access to OpGen’s Lighthouse Portal to support internal research and development programs.

About the SMART Study

The Study for Monitoring Antimicrobial Resistance Trends (SMART) was initiated by Merck in 2002 to monitor the in vitro susceptibility of clinical isolates to 12 commonly used antibiotics in different regions of the world to survey changing trends in antibiotic susceptibility. SMART currently monitors antibiotic activity against gram-negative bacteria isolated from two common types of infection: intra-abdominal and urinary tract infections. Isolates have been collected from patients with complicated intra-abdominal infections since 2002 and from patients with complicated urinary tract infections since 2010. In 2016, Merck anticipates that more than 41,000 isolates will be collected.

This research agreement is executed between OpGen and Merck Sharp & Dohme Corp., a wholly-owned subsidiary of Merck & Co. Inc. The Merck Global Health Innovation Fund, a venture capital arm of Merck, is an investor in OpGen Inc.

Researchers Exploring New Platform for Detecting Pathogenic Bacteria Using Bacteriophages

Bacterial pathogens pose serious health risks, especially for infants, young children, elderly and those with compromised immune systems. The evolution of drug-resistant bacteria is particularly concerning in the fight against disease. A research team in Canada is exploring a new platform for detecting pathogenic bacteria using bacteriophages, viruses that use bacteria as their host.

During the AVS 63rd International Symposium and Exhibition being held November 6-11, 2016, in Nashville, Tennessee, Stephane Evoy, an applied physicist from the University of Alberta, will explain how the team recognized the limited reliability of antibodies in providing bacteria detection with specificity. Instead they used phage-derived proteins, proteins developed from the bacteria-invading viruses, for detection of pathogenic bacteria to address this deficiency. This work has implications not only in disease diagnosis, but also in food and water safety.

"The high specificity of phages offers a potent alternative for the targeting of pathogens," Evoy said. "More specifically, recombinant phage-receptor-binding proteins (RBPs) responsible for phage-host specificity can be used as biological probes and present numerous advantages over the use of a whole phage."

The study used skim cow milk spiked with different phages or combinations of phages, such as mycobacteria (MAP) and Escherichia coli cells, and a unique process to capture the DNA after incubation. The entire process took less than 24 hours and resulted in significantly better sensitivity of detecting targeted DNA.

"The use of phage-derived proteins in such a manner was quite unique when we started that work back in 2005, but since then the approach thrived, and multinational companies integrated this into their product line," Envoy said. "However, there is still a lot of work to be done in terms of applying the technology to diseases such as tuberculosis and staphylococcus infections."

In addition to demonstrating this capture technique, the research team designed and developed a sophisticated bacteria detector comprised of an array of microresonators, able to enumerate bacteria over a large area and detect the attachment of a single cell anywhere on the array. The devices were prepared with their phage proteins, adding this high specificity of detection to the spatial precision offered by the array design.

"We are looking forward to adapting this technology for the rapid diagnosis of drug-resistant bacteria," Evoy said. "It could go a long way toward make microbial testing methods both more rapid and affordable."

Sekisui Diagnostics Announces OSOM® Ultra Flu A&B Test is now CLIA Waived

Sekisui Diagnostics announces the U.S. Food and Drug Administration (FDA) has granted Clinical Laboratory Improvement Amendments (CLIA) Waiver status for the OSOM® Ultra Flu A&B Test using swab samples.  

The OSOM® Ultra Flu A&B Test delivers fast, accurate results in 10-15 minutes by utilizing a simple procedure across multiple sample types, including nasal swabs, nasopharyngeal swabs, and in moderate settings, nasopharyngeal aspirate/wash.  The performance of the OSOM® kit by users at CLIA waived sites was measured against the preferred standard of polymerase chain reaction (PCR), with a Positive Percent Agreement of 89.2% for Flu A and 86.4% for Flu B and Negative Percent Agreement of 99.4% for Flu A and 99.0% for Flu B.

According to the CDC Foundation, there are approximately 31.4 million outpatient visits and 200,000 hospitalizations each year related to influenza.[1] An estimated 20 million rapid tests have been performed in the U.S. each year since 2013, with a projected 4.5% CAGR through 2019. ]2,3]

CLIA waiver designation will enable healthcare providers to perform the OSOM® Ultra Flu A&B Test using nasal or nasopharyngeal swabs, to deliver simple and accurate test results in locations such as the emergency room, community-based settings, urgent care and physician offices. By using the OSOM® Ultra Flu A&B Test healthcare practitioners will provide patients with a rapid, accurate diagnosis while on site, thereby helping prevent unnecessary antibiotic prescriptions, reduce hospitalization, and minimize influenza transmission. [4]

"The excellent performance benefits of the CLIA Waived OSOM® Ultra Flu A&B Test will aid in the fast, accurate  detection of influenza through an easy to use product that provides physicians and patients the convenience of rapid results and treatment in one visit," says Robert Schruender, President and Chief Operating Officer of Sekisui Diagnostics.  "The test complements our other OSOM® CLIA waived rapid diagnostic tests and is another example of meeting our promise to our customers to deliver the products they need."

Along with influenza, Sekisui Diagnostics provides a broad line of OSOM® rapid tests for Strep A, Mononucleosis, Trichomonas, Bacterial Vaginosis, Helicobacter pylori, hCG and Fecal Occult Blood.  Sekisui's expanding Point-of-Care product line also includes the FastPack® IP System, which offers a convenient, rapid, decentralized testing solution for Vitamin D, Testosterone, PSA, Free PSA, TSH, Free T4, and hCG.

Point-of-Care Testing (POCT) is a highly relevant and growing area of diagnostics, particularly due to the increased focus on cost efficiency through rapid and appropriate treatment. Market analysis and consulting firm Enterprise Analysis Corporation estimated the global market for POC testing at $5,924 million in 2015. [5]

1. http://www.cdcfoundation.org/businesspulse/flu-prevention-infographic
2. GHX data
3. Kalorama 2014 Physician Office Laboratory Markets
4. Theocharis, George.Vouloumanou, Evridiki et al."Evaluation of a direct test for seasonal influenza in outpatients", European Journal of Internal Medicine, Vol. 21(2010) 434-438.
5. Enterprise Analysis Corporation, IVD Market Research 2016.

Miacom Diagnostics and MetaSystems: First Ultra-Rapid Phenotypic MRSA/MSSA Differentiation Assay

As a joint effort, Miacom Diagnostics GmbH and MetaSystems GmbH announced the development of an ultra-rapid super bug assay that allows the 30 minute differentiation of multiple resistant strains (MRSA) and normal, sensitive strains (MSSA) of the clinically most prominent pathogen S. aureus directly from samples without need for sample preparation or costly target amplification. The assay has now entered the clinical trial phase and will be introduced to the European market to offer a novel solution to physicians to initiate proper antibiotic treatment to patients suffering from a hospital acquired infection such as sepsis or pneumonia. For the first time, it doesn´t detect genetic mutations responsible for resistance but instead shows a resistant phenotype of the organism. As there are frequently new mutations observed, this approach is independent of new genetic variations of resistant strains as the outcome of such mutations will always result in the same phenotypic variations, giving this approach a great advantage over the existing PCR based approaches.

The new assay follows the path MetaSystems and Miacom Diagnostics have chosen and will be initially available to be used on the Metafer RPI Platform allowing an automated, high-throughput slide analysis directly after the samples are prepared using Miacom’s standard Direct Multiplex Imaging procedure. The MRSA/MSSA differentiation will be available as either a stand-alone assay for screening species of Staphyloccus for MRSA or as a combined multiplex assay detecting more than 10 important Gram positive and Gram negative bacteria in a sepsis. As all of miacom’s assays, this assay relies on the FDA-approved Direct Multiplex Imaging (DMI) technology which allows to test patient materials directly without the need for amplification in a multiplex fashion differentiating up to 14 pathogens in one single test. The identification of the bacterial strains is made possible via detection of fluorescent light given by the molecular probes used when they find their specific target molecules.

The launch of this addition to Miacom’s existing test kits is expected to take place in 2017 and will offer physicians to improve their treatment strategies. ”In the long run this will result in the reduction of the use of broadband antibiotics, reduce patient morbidity and mortality and also help clinics to save time and resources”, stated Dr. Mirko Stange, CEO Miacom Diagnostics.

Light Sensor Spots Deadly Bacteria in Minutes

Outbreaks of Legionnaire’s Disease, a respiratory infection that can cause pneumonia, and in severe cases organ failure or septic shock, are more common than we might think. With anyone being susceptible, more than 100 cases are reported each week both in America and in Europe, with a fatality rate of around 10%.

Naturally occurring in freshwater lakes and rivers, the Legionella bacterium is harmless in small enough quantities, but problems start when it multiplies in plumbing systems, air conditioning units, Jacuzzis, decorative fountains or in a public water supply. Here it can be transmitted to humans when it condenses into droplets of fine mist which are inhaled and then settle in the lungs.

Roughly 5,000 cases are reported in the United States every year, while 2013 saw 5,851 cases reported by 28 EU Member States and Norway, according to the European Centre for Disease Prevention & Control (ECDC).

The European group POSEIDON, (or ‘Plasmonic-based automated lab-on-chip sensor for the rapid in-situ detection of Legionella’) intends to change all this, having developed their scanner to spot the deadly Legionella bacteria in under one hour, a process that normally takes 10 days of cultivation and analysis.

Equipped with tiny sensors, the device works by using the photonics technique of Surface Plasmon Resonance (SPR), a procedure that reads information from a refracted laser beam, allowing fast, highly sensitive, inexpensive detection from a small sample without the need for ‘labelling’, the process of binding to a protein in order to be detected.

SPR occurs when polarized beams of light hit a metal film at the interface of two media. A charge density oscillation of free electrons (or “surface plasmons”) at the metal film occurs, reducing the intensity of reflected light. The scale of the reduction depends on the substance on the metal at the interface. Information then gathered from the refracted can then be analysed, and a pre-programmed pathogen confirmed, resulting in an unambiguous detection of the bacteria in situ.

“Detection and investigation of viruses, bacteria and eukaryotic cells is a rapidly growing field in SPR bio sensing, but the detection has only been achieved in laboratory settings. With our unique innovative SPR sensing architecture, POSEIDON provides reliable measurement readouts of legionella bacterial cells that are driven and entrapped on a custom sensing surface specifically designed with opportune positive and negative controls.”

Surviving and flourishing at temperatures between 25º to 45º C, Legionella bacteria are normally prevented by heating water units above 70º C in order to kill them off. However new bacteria can form quickly, and not all of the pathogens are necessarily removed. The POSEIDON project aims to remove the uncertainty involved. Scientific coordinator, Roberto Pierobon explains:

“POSEIDON is a first for detecting Legionella with light and provides an inexpensive, user-friendly, state of the art early warning system on an air-conditioning unit. We aim to reduce the time involved in a diagnosis from 10 days to less than 1 hour. In order to prevent outbreaks at critical times of the year, we should be talking about a matter of minutes, rather than days.”

“Cells remain intact throughout the whole fluid transportation system in the device, and do not adhere to the fluidic piping and microfluidic channels. Virtually all of the bacteria cells in the sample are delivered to the sensing unit, giving extremely high sensitivity and specificity,” said Pierobon.

Hoping to have these revolutionary new pathogen detectors ready within 3 years, Bruno Bellò, project coordinator and CEO of Clivet, is excited about the implications for the future,

“The exciting feature of this device is that with future development, it could be recalibrated to look for other pathogens, which would provide incredible safety options for the environmental, medical or food industries,” Bellò said.

Earlier last year the POSEIDON consortium received funding of €4,068,781 from the Photonics Public Private Partnership, via the European Commission’s H2020 program for a three year research project. Coordinated in Italy, POSEIDON is comprised of a number of European partners, including Protolab, Clivet, A.R.C (Italy), Catlab (Spain), Metrohm Applikon (Netherlands), and Uppsala University(Sweden).

Bruker Acquires NAT Assay Lab Infrastructure and IP; Hires R&D Team

Bruker announced a technology acquisition in support of its microbiology business and its world-leading MALDI Biotyper microbial identification platform. Financial details were not disclosed.

Bruker has acquired selected assets in Glasgow, UK for the development, validation and commercialization of molecular assays for applications in microbiology. Bruker has acquired laboratory infrastructure and IP in the NAT assay field, including real-time PCR assays for microbiology. In parallel, Bruker has hired an experienced R&D, operations and commercial team in Glasgow to drive PCR-based syndromic panel development for Bruker's MALDI Biotyper platform.

The MALDI Biotyper offers fast, highly accurate and cost-efficient microbial identification with exceptionally broad species coverage, based on proteomic fingerprinting. Molecular multiplex and syndromic panel testing is another growing field in clinical microbiology. When a rapid, targeted answer is required without prior microbial cultivation, multiplex PCR assays for the identification of selected bacterial, fungal and viral species, and for the fast detection of resistance genes, are highly complementary to broad-coverage, untargeted proteomic identification from isolates after overnight culture. Such proteomic assays and NAT assays are expected to be both performed on the same MALDI Biotyper platform. Applications for targeted multiplex PCR assays arise in early screening, confirmation testing and broader syndromic testing.

Dr. Wolfgang Pusch, Executive Vice President for Clinical MALDI Solutions at Bruker Daltonics, commented: "In addition to conventional, targeted real-time PCR assays, Bruker sees further advantages in combining multiplexed syndromic PCR assays with a read-out on the MALDI Biotyper platform. Bruker intends to validate and launch the real-time PCR assays which have been acquired, and develop new multiplex PCR panels on the MALDI Biotyper platform in order to expand its assay menu to rapid targeted bacterial, fungal and viral identification, to fast antibiotic resistance testing, as well as to syndromic panels. With over 2,000 MALDI Biotypers already installed worldwide for fast, highly accurate and untargeted microbial identification, we are excited to bring new NAT multiplex assay and syndromic panel capabilities to our customers over time."

Cepheid Rapid Flu/RSV Test Receives CE Mark

Cepheid has received CE marking on a rapid test for influenza and respiratory syncytial virus, the firm announced today, and the new test is available immediately in all countries recognizing the CE mark.

The Xpert Xpress Flu/RSV runs on the firm's GeneXpert platform and provides results in about 30 minutes. The assay features a novel design employing multiple targets for each virus, with redundancy providing high sensitivity and mitigating the impact of seasonal drift, the firm said.

"With the arrival of fast molecular tests like Xpert Xpress Flu/RSV, patients and their healthcare providers can now expect an accurate diagnosis, and access to targeted therapies substantially more quickly," David Persing, Cepheid's chief medical and technology officer, said in a statement. "This supports clinical efforts to improve the patient experience, and further streamlines workflow in the laboratory, which can be particularly challenging in the midst of a busy respiratory virus season."

The assay is the first rapid test in a proposed line which will use the same GeneXpert platform and cartridge design but take advantage of new, faster chemistries. The proposed menu of Xpress tests was previously reported to include Group A Strep, Group B Strep, human papillomavirus, pertussis, chlamydia and gonorrhea, and vaginitis/vaginosis.

Cepheid received US Food and Drug Administration clearance and CLIA waiver in December for a one-hour test called Xpert Flu+RSV Xpress. The firm now intends to bring the rapid version to the US for CLIA waiver, where it could compete with the likes of the Roche Liat and Alere i Flu/RSV tests in the point-of-care market.

The firm noted in its first quarter 2016 earnings report that, based on early market feedback and changing clinical practices, it had identified an opportunity to broaden its penetration in the US point-of-care market by leveraging its broad test menu and accelerating the development of certain Xpert Xpress tests. At that time Cepheid said it was targeting the 2017/2018 flu season to deliver the first Xpert Xpress tests for the CLIA-waived market, and that waiver of the Xpert Flu+RSV Xpress test helped guide the change in course, enhancing confidence that the firm could bring other Xpress tests through the regulatory process as well.

Zalgen and NOWDiagnostics Announce Strategic Collaboration to Advance Novel Rapid Diagnostic Tests for Tropical Diseases

Zalgen Labs LLC, a biotechnology and diagnostics company focused on high-impact, neglected infectious diseases, announced that it has entered into a series of agreements with NOWDiagnostics Inc. (NOWDx), an innovator in rapid diagnostic tests (RDT), to collaborate in the development, manufacturing and commercialization of infectious disease diagnostic products.

Under the terms of the agreements, the parties will collaborate in bringing new rapid infectious disease tests to the global market, primarily using the patented NOWDx ADEXUSDx® test system. NOWDx will also manufacture existing Zalgen products, including the ReEBOV® Antigen Rapid Test for Ebola virus and the ReLASV™ Antigen Rapid Test for Lassa fever. The ReEBOV® Antigen Rapid Test for Ebola was the first 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.

Zalgen is a partner of the Viral Hemorrhagic Fever Consortium (VHFC), an academic and industry partnership lead by Tulane University, developing state-of-the-art diagnostic and immunotherapeutic products for biothreat agents and emerging pathogens. The NOWDx alliance expands the VHFC portfolio with an advanced diagnostic RDT platform for additional products currently in development.

“The new alliance with NOWDiagnostics significantly enhances our diagnostic product capability worldwide,” said Zalgen Managing Director, Luis Branco, Ph.D. “Zalgen and the VHFC plan to continue building on our portfolio of diagnostic products for hemorrhagic fevers and other tropical diseases, and the ADEXUSDx cassette is the ideal immunodiagnostic platform to address the market demands.”

“High risk diseases have a devastating impact on communities across the globe. We are excited to leverage VHFC’s world-class science with our platform to try and address the need for fast and accurate diagnoses, even in the remotest of places,” said Kevin Clark, CEO of NOWDiagnostics. “We look forward to developing future assays in our format and value the collaboration with the VHFC and Zalgen.”

Bill & Melinda Gates Foundation gives $3.6m grant to Atomo Diagnostics

The Bill & Melinda Gates Foundation has awarded $3.6 million to Sydney's Atomo Diagnostics, increasing its support to the company developing an affordable HIV self-test for resource-poor countries to almost $14 million.

The self-test kit delivered under the grant should be much cheaper than that which Atomo has already developed for sale in rich countries, which includes a digital interface and Bluetooth functionality.

Atomo and the Gates' foundation have agreed a target of 20 million of the cheap kits be produced over the next three years.

The grant follows a $2.6 million investment from the Gates-backed Global Health Innovation Fund (GHIF) in August as part of an equity raising, and a $7.8 million loan from GHIF in January.

GHIF owns 8.4 per cent of Atomo, and the largest shareholders remain the founding team led by chief executive John Kelly; property development billionaire Lang Walker's Walker Group owns 23 per cent, while Macquarie Bank founder Allan Moss also is a backer.

"We have sought always to develop simple, low-cost solutions that remove errors common with the current generation of 'bits in a box' test kits," Mr Kelly said.

"This grant is an endorsement of our innovative user-friendly approach to testing and our commitment to making a positive impact on global health."

The grant money will be used to develop and launch a HIV self test in countries most affected by the disease, which involves liaising with their public health systems, Mr Kelly said.

More than 120 million HIV rapid diagnostic tests are used annually in resource-poor countries and, according to the World Health Organisation, demand for testing is projected to increase significantly until 2020.

Self-testing will support the United Nations' 'AIDS goal' under which it is aiming to have 90 per cent of HIV-positive people know their status by 2020, Mr Kelly said.

Atomo is working towards approval for its existing HIV self-test to be sold in Australia. It won a grant from the NSW Medical Devices Fund last year and all of the development and design work is done in Leichhardt in Sydney's inner west.

It also has offices in South Africa and the UK.

Its manufacturing partner IDE also is Sydney-based, although it oversees a global supply chain – for instance, the diagnostic strips are made in South Africa.

In the meantime, Atomo's revenue comes from sales of its HIV test kits for professional use in hospitals, as well as white-labelling of its self-diagnosis platform by medical companies wanting to use it for tests on other diseases.

The $US108 million GHIF was established in 2013 by the Bill & Melinda Gates Foundation and JP Morgan, and Mr Gates' foundation nominates an advisor to the fund and is one of several investors.

FDA Clears Quidel Rapid MDx Strep Test

Quidel Corporation, a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) to market Quidel's new Solana® Strep Complete Assay for the rapid and qualitative detection and differentiation of Streptococcus pyogenes (Group A beta-hemolytic Streptococcus) and Streptococcus dysgalactiae (pyogenic Group C and G beta-hemolytic Streptococcus) nucleic acids isolated from throat swab specimens obtained from symptomatic patients. Specimens identified as negative by the Solana assay do not require additional testing by culture.

Group A Streptococcus are Gram-positive bacteria, primarily residing in the nose, throat and skin; they are responsible for several illnesses, ranging from strep throat or skin infections to severe illnesses (necrotizing fasciitis, or streptococcal toxic shock syndrome). (1) Strep throat, or streptococcal pharyngitis, is the most common illness from Group A Streptococcus infections. These bacteria are spread through contact with airborne droplets from an infected person's cough, sneeze or via contaminated items such as eating utensils. (2) Streptococcus dysgalactiae is a species of pyogenic beta-hemolytic Streptococcus C/G commonly isolated from humans. (3) Most infections are treated with penicillin or other beta-lactams.

The Solana Strep Complete Assay accurately differentiates pyogenic Group A from pyogenic Group C or G. Non-group A strains, especially Group C&G, are found in a significant number of Group A negative symptomatic patients (≥20%) and treatment appears to shorten the symptomatic period of the disease. (4)

The Solana Strep Complete Assay is an easy-to-use, rapid molecular diagnostic test that has superb clinical accuracy and does not require culture confirmation of negative results, an industry first for Streptococcus dysgalactiae (pyogenic Group C and G beta-hemolytic Streptococcus). The assay requires no upfront extraction of DNA and generates an accurate result in approximately 25 minutes.

The Solana molecular platform leverages the Helicase-Dependent Amplification (HDA) technology that is resident in Quidel's AmpliVue® molecular product line to generate a fast and accurate test result. Solana can process up to 12 patient samples in each 25-minute run, thereby providing time-saving workflow advantages to healthcare professionals in moderately complex settings.

"We are very pleased to receive FDA clearance for a definitive, comprehensive diagnostic for Streptococcal infections, and along with our recently-cleared Solana Influenza A+B Assay, comes just in time for the upcoming respiratory disease season," said Douglas Bryant, president and chief executive officer of Quidel Corporation. "With the Solana system, we've given moderately complex labs what they want: a platform that provides definitive test results quickly, and in a scalable connected format with a low total cost of ownership. We believe that Solana's utility and value will continue to increase with the launch of each additional assay."

Solana® Strep Complete is Quidel's fourth molecular diagnostic test to receive 510(k) clearance from the FDA in the scalable and versatile Solana format. Solana® Influenza A+B received 510(k) clearance in September, Solana® Trichomonas assay received 510(k) clearance in August, and Solana® Group A Strep assay was cleared in June 2015.

With the Solana franchise, Quidel has grown its number of molecular platforms that are FDA cleared and available commercially: non-instrumented AmpliVue® for lower-volume moderately complex labs; and Lyra® reagents for higher throughput, highly complex laboratories with existing PCR infrastructure.

1. http://www.cdc.gov/groupastrep/diseases-hcp/strep-throat.html
2. http://www.cdc.gov/Features/strepthroat/
3. Vieira V, Teixeira L, Zahner V, et al. Genetic relationships among the different phenotypes of Streptococcus dysgalactiae strains. Int J Syst Bacteriol 1998; 48:1231-43.
4. Zwart, S. et al BMJ 2000;320:150-4

Pitt State Researchers Use Nanosensors to Detect E. coli in Water, Food

The chemistry department at Pittsburg State University (Pittsburg, KS) have come up with a new way to detect foodborne bacteria in food and water in less than an hour.

PSU chemist Tuhina Banerjee, assistant professor Santimukul Santra, professor and biochemist James McAfee and six chemistry students were able to combine magnetic resonance imaging (MRI) and fluorescence to create a device that enables scientists to detect the presence of dangerous bacteria in food and water. The team’s research was inspired by widespread news stories of food related E. coli outbreaks in the U.S. As a result, they began pondering way to use nanosensors to try to detect common pathogens, first in water.

The nanosensors are made up of iron oxide particles combined with an optical dye and antibodies that latch onto the E. coli cells. The nanosensors clump around the bacteria and this can be detected by MRI, for very small amounts, and fluorescence, for large amounts. The method was initially tested using water from PSU’s University Lake, along with other water resources. The nanosensor was “very good” at picking up contamination, according to researchers.

The next step, in order to make a rapid detection system available in the field, is miniaturization.

“The next step is to work with engineers to develop a chip that can take the process out of the lab and into the field,” says Banerjee. In the meantime, the researchers are exploring ways the technique they’ve developed could be used for the rapid detection of other pathogens, such as influenza and Zika.

As a result of this work, one student--Tyler Shelby--was awarded with the Star Trainee Award from the Kansas IDeA Network of Biomedical Research Excellence and he is following up the research on E. coli with a paper that explores how nanosensors may be used for the rapid detection of the influenza virus.

PSU’s research was recently published in the American Chemistry Society’s journal Infectious Diseases. Since publishing their work, the team has been getting calls from researchers around the world.

Turnkey Detection: Rapid Diagnostics in the Field

Viruses can live on surfaces, such as counters and doorknobs, for more than two hours making them highly contagious when in confined quarters. As warfighters are frequently in these types of environments, identifying viral threats rapidly is vital to treatment and halting transmission. However, a versatile, user-friendly detection and diagnostic device for multiple pathogens does not currently exist.

In an effort funded by the Defense Threat Reduction Agency’s Joint Science and Technology Office, Dr. Steven Benner from the Foundation for Applied Molecular Evolution (FfAME), is working to change this by developing a turnkey, adaptable and cost-effective device to test for several pathogens in a single assay. The device will not require laboratory diagnostic tools and can be used with minimal training.

This research represents a significant improvement in available diagnostics and surveillance kits that rely on polymerase chain reactions which require skilled interpretive analysis, specialized equipment and laboratory testing environments. DTRA’s new capability will address the existing need for increased warfighter protection from known and emerging viral pathogens at the point of infection.

Diagnosis cannot rely solely on symptoms since indicators of emerging diseases are difficult to identify. Further, a patient’s antibody response can present weeks after an active infection and persist long after the infection is resolved. Also, diagnostic tools that require laboratory analysis waste valuable time, making quarantines ineffective.

Instead, health care providers need an assay that detects the nucleic acids, the DNA or RNA from the pathogen, in both biological and environmental samples at the point of care, offering a flexible “single source” solution. A tool that can detect multiple diseases would be valuable not only in terms of warfighter protection, but in terms of affordability. Costing upwards of $200 a test, traditional diagnostic tools are expensive.

In addition, the nucleic acid-targeted diagnostic must be adaptable. As new pathogens emerge, the diagnostic capability needs to be incorporated into the existing kit. This has been a challenge to scientists working diligently to create a solution.

Recently reported in the Journal of Virological Methods article “Standard and AEGIS Nicking Molecular Beacons Detect Amplicons from the Middle East Respiratory Syndrome Coronavirus,” the on-site reporting capability showed the adaptability of the diagnostic tool to detect a coronavirus (CoV) that causes the Middle East Respiratory Syndrome (MERS).

Dr. Benner utilized a previously discovered DTRA-supported tool, the artificially expanded genetic information system (AEGIS), to create the new, high sensitivity diagnostic tool with low noise. AEGIS works by adding nucleotides to the four found in standard DNA and RNA, pairing orthogonally to the A:T and G:C pairs.

Molecular beacons containing AEGIS then generate florescent light signals, detectable at points of sampling, where it can be read on the spot or captured by a cell phone camera for transmission to a remote site for evaluation and epidemiological use. Placing AEGIS components in the stems of molecular beacons lowers noise (thus reducing the ‘signal to noise’ ratio) by preventing unwanted cross-reaction with natural DNA that is abundant in natural environmental and human diagnostic samples.

As a further innovation, the diagnostic kit engineers the beacon so that a single target molecule turns over multiple copies of the beacon, allowing it to amplify the signal, increasing the sensitivity of the assay.

Combining these technologies allows the detection of as few as 50 copies of MERS-CoV RNA in the form of a green glow visible to the human eye, significantly stronger than existing point-of-sampling kits. In addition to detecting MERS, it provides accurate results in detecting influenza A and B, severe acute respiratory syndrome (SARS) and human respiratory syncytial virus (RSV); all viruses easily confused with the symptoms generated by MERS.

This new diagnostic device will allow quicker point-of-care testing of infected warfighters allowing for more rapid treatment and troop safety. After analytical comparisons with current CDC kits, the next step will be to gain ‘Emergency Use Authorization.’ This will accelerate the FDA development process, allowing the diagnostic tool to reach the warfighter sooner.