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.

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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.

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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.

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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."

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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.

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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.

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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).

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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."

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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.

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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.”

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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.

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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

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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.

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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.

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Sight Diagnostics Ltd. and the United States Army Announce a Joint Collaboration

Sight Diagnostics (SightDx) today announced a collaboration with the United States Army Medical Research Directorate Kenya (USAMRD-K) to develop and test the next generation of the SightDx malaria diagnostic technology. Sight Diagnostics will be developing and producing a portable malaria and complete blood count (CBC) reader that will be calibrated and tested in clinical trials at the USAMRD-K Field Station in Kisumu, Kenya.

Mr. Yossi Pollak, CEO of SightDx said, "We are very excited about the partnership with USAMRD-K. This award recognizes SightDx's success in bringing a high-throughput computer vision malaria diagnostic technology to the market and sets us on a path to launch a point of care version of the platform in remote locations and austere environments. USAMRD-K in Kisumu, Kenya serves as an ideal partner, given their extensive background in malaria clinical research and expertise in malaria diagnostics."

SightDx currently markets the Parasight device, a high-throughput malaria detection platform that uses computer vision technology to analyze blood samples for malaria parasites. The state-of-the-art digital cytometry technology combines cutting-edge computer vision algorithms, custom optics, and proprietary disposable cartridges, which allows for analyzing blood samples in a rapid, reliable and a completely automated fashion. The platform has shown ~98% sensitivity and ~98% specificity in clinical trials performed in Africa and India. The device is currently marketed throughout Europe, Africa and India with over 60 units having been placed in pathology laboratories and hospitals.

SightDx aims to develop and test a portable version of the malaria diagnostic technology which will also perform complete blood count, providing additional diagnostic information critical to health care providers operating in remote locations. In contrast to the current device that can hold 30 tests and features automated loading and scanning, the next generation device will scan a single cartridge of five tests and have significantly smaller dimensions, making it appropriate for smaller clinics in rural areas.

The project will be conducted in collaboration with Dr. John Waitumbi, senior scientist and chief of the Basic Science Laboratory at USAMRD-K, which is part of the Walter Reed Army Institute of Research (WRAIR). The USAMRD-K mission includes conducting regulated clinical trials for vaccines, drugs and diagnostic platforms for diseases of Africa and the world. In addition, USAMRD-K conducts surveillance, training, research and response activities related to emerging infectious disease threats as well being a partner in executing the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) and the President's Malaria Initiative (PMI).

"Malaria microscopy and rapid diagnostic tests (RDTs) have been the mainstay of malaria diagnosis for centuries and decades, respectively. If proven successful, the instrument from SightDx will help detect and quantify malaria parasites.  It will also provide the patient's blood count (anemic status), an important parameter in the management of patients diagnosed with malaria," said Waitumbi. "This collaboration recognizes the expertise and capability of USAMRD-K to evaluate the performance of potential diagnostic devices for diseases that are endemic to Kenya and the region."

In 2015, there were 214 million new cases of malaria worldwide resulting in 438,000 malaria deaths. The WHO estimates that nearly 500 million malaria tests are performed annually to combat the disease. While microscopy and RDTs are the main diagnostic approaches, there is recognition of the need to take improved diagnostics to the "point of need." Such devices need to be inexpensive, quick, consistent and highly accurate. The development and launch of the point-of-care device for malaria diagnosis, featuring complete blood count, will allow for wider use of the platform to enable better patient management.

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New Test to Detect Serious Bacterial Infections Including Meningitis and Sepsis

An international team of researchers, led by scientists at the Imperial College London have identified two genes that are switched on only when a child is suffering from a bacterial infection. This finding can let doctors easily distinguish between a viral or bacterial illness, which can help in identifying early cases of potentially deadly infections. The findings of the study were published recently in Journal of the American Medical Association (JAMA).

The researchers are now keen on developing a rapid test for use in hospitals and doctors’ surgeries. Conditions such as meningitis, septicemia or pneumonia caused by bacterial infections can be caught more rapidly with the help of such a rest. It will also prevent children with viral infections being unnecessarily prescribed antibiotics and hence aid in combating the threat of antibiotic resistance.

Presently, there is no quick method of distinguishing a viral and bacterial infection. In hospitals diagnosis is made by taking a sample of blood or spinal fluid, and seeing if bacteria grow in the sample. This process can take more than 48 hours and this time can be very crucial for a patient. Viral infections are more commons compared to bacterial infections, but the later can be deadlier in many cases.

Fever is one of the most common reasons why children are brought to medical care. But, sometimes a bacterial infection is thought to be a viral infection and this wrong diagnosis can be life threatening for them. Similarly, many children are admitted to hospital and receive antibiotics because there is no way to differentiate bacterial infection from a viral one,- but later it is confirmed that they are suffering from a virus.

Professor Michael Levin, from Department of Medicine at Imperial College London, who led the study opined that even though this research is at an early stage, the results show bacterial infection can be distinguished from other causes of fever, such as a viral infection, using the pattern of genes that are switched on or off in response to the infection. The next step is to transform our findings into a diagnostic test that can be used in hospital emergency departments or GP surgeries, to identify those children who need antibiotics.

For the study, 240 children with an average age of 19 months were studied by the researchers. These kids arrived at hospitals with fever across the UK, Spain, the Netherlands and the USA. Once it was determined Using traditional methods whether they were suffering from a viral or bacterial infection, the team studied the genes that had been switched on in the children’s white blood cells. A method known as RNA micro array which needs only a drop of blood to measure changes in 48,000 genes simultaneously was used. The team found two genes are switched on in bacterial infections. Further tests were carried out and it was found that these genes, called IFI44L and FAM89A, predicted a bacterial infection with 95-100 per cent accuracy.

Dr Jethro Herberg, senior lecturer in pediatric infectious diseases at Imperial, and co-author of the research remarked that since the threat of antibiotic resistant bacteria is larger than ever today, the need of today is to quickly distinguish a bacterial infection from a viral one. A rapid test based on the two genes identified in the study could transform pediatric practice, and allow doctors to use antibiotics only on those children who actually have a bacterial infection.

Vinny Smith, Chief Executive of Meningitis Research Foundation added that the latest development in the study is very exciting. Bacterial meningitis and septicaemia can kill in hours, and can leave survivors with life-changing after effects. Once we have a tool to rapidly determine whether an infection is bacterial or viral, it will enable faster detection and treatment of meningitis and septicemia.

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Rapid Test for Tuberculosis Developed

A rapid, accurate and inexpensive test for tuberculosis has been developed by a researcher based at the Texas A&M University Health Science Center. The test is called TB Read.

Tuberculosis cases are becoming more prevalent, leading the World Health Organization to place tuberculosis back on the list of the top ten killer diseases (a list of the diseases that kill the most people, globally, each year). There is also an increase in cases in countries like the U.S. In Texas alone, there were 1,334 cases reported in 2015.

Tuberculosis is a common, and in many cases lethal, infectious disease caused by various strains of mycobacteria, usually Mycobacterium tuberculosis. Tuberculosis may infect any part of the body, but most commonly occurs in the lungs.

The rise in incidences of tuberculosis means that considerable effort needs to be put into stopping the disease from spreading. Part of the control and containment strategy involves early detection. This is where the new Texas A&M University Health Science Center test comes in. The test has been designed by Dr. Jeffrey D. Cirillo.

The new test works by using a fluorescent substrate which targets an enzyme produced by Mycobacteria. The substrate causes the bacteria in the patient’s sample of sputum (the saliva and mucus coughed up from the respiratory system) to ‘glow.’ The fluorescence can then be detected using a tiny battery-powered reader.

The test kit is called TB Read and it is said to be able to detect up to 80 percent of cases that would be missed using conventional tests. The time to result with the new method is around ten minutes.
The test can also work without the need for a sputum sample. The test kit can detect very small amounts of the causative agent directly in the lungs. This is accomplished by using light and a compound delivered by aerosol straight to the site of infection and detecting it with the same system. This makes the test suitable for children. Children often struggle to produce sufficient sputum for standard tuberculosis tests.

Discussing the advantages in a research note, Dr. Cirillo explains: “This florescent substrate has many advantages over others we’ve tried. Most importantly, it has greater sensitivity than other methods and can reveal infections within organs deep inside the body.”

Details of the test and supporting data have been reported to the journal Angewandte Chemie. The research paper is titled “Fluorogenic Probes with Substitutions at the 2 and 7 Positions of Cephalosporin are Highly BlaC-Specific for Rapid Mycobacterium tuberculosis Detection.”

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