Specific Diagnostics Begins Clinical Demonstrations and Testing of the Reveal AST System

Specific Diagnostics today announced clinical demonstrations of the Reveal AST system will be conducted at a clinical laboratory in Amsterdam during the ECCMID conference April 13-16. The Reveal AST system delivers phenotypic AST in an average of 4 hours, directly from positive blood culture or isolate dilutions. The system provides minimum inhibitory concentration (MIC) with wide antimicrobial coverage for bacteria species responsible for bloodstream and other acute infections.

Current methodologies require 2 days to determine the effective antibiotic while Specific's Reveal AST solution provides antibiotic susceptibility results in hours, allowing same-shift impact. The demonstrations conducted during ECCMID for leading European clinical laboratory directors and partners will demonstrate this rapid AST performance with both spiked and clinical blood culture samples. The simple and rapid sample preparation workflow, just a 2- minute simple dilution of a positive blood culture fluid, will be demonstrated as well as the intuitive and elegant touch screen controller of the Reveal system. The demonstrations will allow customers to directly assess the simplicity and capability of the Reveal system in advance of its availability for adoption in Europe upon issuance of CE-IVD registration, expected in Q4 2019.

Bloodstream infection leading to sepsis is responsible for more than half of all deaths in hospitals and is the most expensive condition treated in hospitals. Mortality rate increases at more than 6% every hour from onset. Therefore, the same-shift susceptibility determination provided by Reveal can and will save lives.

“We are looking forward to demonstrating the clinical performance of the Reveal AST instrument and consumable assays during this year’s ECCMID conference. This is another major step towards commercial deployment. We consistently hear from clinical lab and infectious disease doctors that rapid, affordable AST is vital to patient outcome and of their desire to include this transformative solution in their labs. The world needs affordable, rapid susceptibility testing to treat time critical, acute infections and to combat growing antimicrobial resistance." said Ray Martino, Specific COO.

About Specific Diagnostics

Specific Diagnostics has developed in vitro diagnostic systems for the detection and identification of microorganisms while they grow in culture. The company’s unique patented technology leverages a low-cost printed chemical sensor array, enabling diagnostic products that simplify workflow and speed time-to-answer at low cost. During growth in culture, bacteria emit organism-specific small molecule metabolite mixtures. Specific’s products utilize inexpensive printed sensor arrays to obtain a profile of such mixtures, enabling detection of growth, determination of antibiotic efficacy, and microorganism ID with simple, automated, low-cost instruments and disposables. Specific and its founders have written almost 60 peer-reviewed publications, detailing the successful demonstration of the SMS array technology. The Company itself has independently authored over 20 scientific publications and conference abstracts detailing the SMS array powered detection, identification and antibiotic susceptibility testing.

Accuracies of minimum inhibitory concentration (MIC) determination meet those of gold standard broth microdilution methods, but with results obtained within four hours of a positive blood culture, directly from a diluted positive blood sample. The system will streamline lab workflow, reduce costs, and substantially shorten the time from sample arrival to selection of effective therapy, saving patients faced with fast-moving and deadly drug-resistant blood infections.

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FDA Classifies IVDs for Bacillus Detection

In vitro diagnostic (IVD) devices for the detection of the Bacillus species were assigned to class II on Friday, following the release of a US Food and Drug Administration (FDA) final rule.

The IVDs are prescription devices and indicated to aid in the diagnosis of diseases caused by the Bacillus species, including anthrax. They are intended for the detection and differentiation of the bacteria, such as Bacillus anthracis, and had been unclassified devices prior to FDA’s final classification regulation.

The final rule comes as the awareness of the anthrax bioterrorism threat has been raised since the 11 September 2001 events in the US and the anthrax letters. "Anthrax is a bioterrorism threat because the spores are resistant to destruction and can be spread by release in the air,” FDA Commissioner Scott Gottlieb said on Friday. “Exposure to anthrax can and has caused serious injury or death.”

Gottlieb noted device manufacturers have inquired about how the agency reviews tests that can detect Bacillus anthracis, citing the important role such devices play in a public health response to an anthrax attack. The final rule is the culmination of FDA’s “effort to provide a clear and predictable review pathway for these specific test developers” as it helps “understand the requirements, including testing criteria and how to address potential safety risks for lab workers using the devices,” Gottlieb added.

The decision to finalize the class II regulation resulted from recommendations made by the Microbiology Devices Advisory Panel in 2002. Rather than that of de novo classification requests, most unclassified devices have been classified under device classification panel procedures. The procedures involved a 2016 comment period, though the proposed rule for the IVDs did not receive any relevant comments.

The final rule will come into effect 30 days from its publication in the Federal Register. FDA clarified that manufacturers are not required to submit a 510(k) for IVDs legally marketed prior to the publication of the final rule. For such devices, the agency does not intend to enforce compliance with the special controls in sections VI, VII and IX of a new FDA guideline issued in conjunction with the final rule. Yet the final rule established a one-year grace period for such devices to comply with the labeling special controls set forth in section VIII of the guideline, after which FDA intends to consider taking enforcement actions.

The implementation strategy differs, however, for manufacturers required to submit a new 510(k) for devices undergoing significant changes or modifications. In addition to those that have not been legally marketed prior to the final rule, modified devices must comply with the new set of special controls.

The new class II special controls guideline on IVD devices for Bacillus species detection is partly based on the feedback from the device classification panel. Special controls identified in the guideline relate to device description requirements, performance studies and labeling, among other specific IVD requirements.

The requirements that will eventually apply to all devices, including those that are currently legally marketed, fall under labeling. Labeling special controls in the new guideline address IVD intended use, directions for use, precautions, performance characteristics as well as interpretation and reporting of assay results.

The final rule also restricts the use and distribution of IVDs for Bacillus species detection to laboratories that follow public health guidelines.

The class II assignment follows on the heels of the new Tri-Agency Task Force for Emergency Diagnostics’ launch to facility the rapid development and deployment of IVDs during public health emergencies.

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Five winners selected to receive $80,000 in Pathogen Monitoring Prize Competition from the Bureau of Reclamation

To optimize the design and operations of advanced water treatment facilities the Bureau of Reclamation completed a prize competition and has selected five submissions to share $80,000 in prizes in the Pathogen Monitoring Stage 1 Challenge, with half of the prize purse contributed by Xylem, Inc. The team of Hannah Safford and Heather Bischel, both of Davis, California, was selected to receive the top prize of $40,000 in this competition.

The demand for water is growing throughout the western United States and one of the ways the demand is being met is through water reuse, a method where wastewater is treated to be used again by the community. While advanced water treatment technologies exist to produce high quality, potable water from wastewater, improved pathogen detection and monitoring is needed.

Safford and Bischel’s idea used novel computational tools for quantifying waterborne viruses detected through flow cytometry. Their concept incorporates advanced data processing techniques to assist in the underlying signal to noise ratio problems that have prevented the use of this technology in the identification of viruses to this point. The proposed computational tool will use cluster analysis and diffusion mapping to facilitate rapid quantification of viruses in raw or treated wastewater.

In addition to the winning solution, another solver received a $10,000 prize for an idea that adapts an approach that is used clinically to identify pathogens in human patient specimens to detect viruses in wastewater.

Other winners in the prize competition each received $10,000.

• James Vickers of Separation Processes Inc., Carlsbad, California, for his idea use of automated conductivity profiles to verify reverse osmosis unit integrity in full-scale recycled water treatment facilities.
• John Newport, Chadds Ford, Pennsylvania, for his idea using microcapsules with external antibodies and internal nanomagnets and reporter molecules to quantify viruses in wastewater.
• David Wick, Stevensville, Montana, for his idea of identifying and quantifying viruses in raw and treated wastewater by sorting viruses by mass/charge ratio and quantifying them according to size.

The Bureau of Reclamation in partnership with Xylem, Inc., a global water technology provider and leader in digital water, The Water Research Foundation, and the Environmental Protection Agency sought ideas for the development of a rapid, accurate and preferably online/onsite monitoring techniques for various pathogens at advanced water treatment facilities.

To learn more about this and other prize competitions at Reclamation, please visit Reclamation's Water Prize Competition Center at: http://www.usbr.gov/research/challenges.

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IIT Develops AI-based Detector for TB

Very soon cost effective, time saving equipment to diagnose tuberculosis (TB) caused by the mycobacterium, malaria, intestinal parasite, and cervical cancer would be available as the researchers from Indian institute of Technology (IIT-D), Delhi have developed a low costing 'Artificial Intelligence (AI)-based low-power electronic hardware system', a device which is estimated to bring down the detection time of the deadly disease from two days to few milliseconds.

The device has been designed by the students of Department of Electrical Engineering: Khushal Sethi, Narayani Bhatia, Vivek and Shridu Verma. The team was headed by the Professor Manan Suri of the same department.

With detecting the disease in a few seconds, the device can also be used for healthcare access in resource-constrained areas with limited access to human specialists.

"While several software AI models exist for healthcare and diagnostic related applications, need of the hour is to efficiently map these models on portable dedicated low-power, low-cost hardware to enable edge-AI systems accessible to all in low resource environment," said professor Suri.

The researcher says that TB is one of the top10 causes of death worldwide and 39 percents of the population is at risk of malaria. "Rapid screening of TB is possible, but the service accessibility is still poor in rural areas and require specialized equipment that is not readily available," said Puri.

Further as per the data shared by the team, cervical cancer is the fourth most common cancer in women, and seventh overall, with an estimated 528,000 new cases and 266,000 reported deaths worldwide.

 Intestinal parasites infect the gastrointestinal tract of humans. They have a consistent external and internal morphology throughout the different stages of development that is egg, larva and adult stages.

The professor added that microscopy is particularly well adapted to low-resource, high disease burden areas, being both simple and versatile; even for diagnostic tasks for which newer technologies are available the cost of specialized equipment may render it impractical in such places.

"Such diagnosis requires skilled persons and there is a critical shortage of skilled technicians in our country. Thus, diagnoses are often made on the basis of clinical signs and symptoms alone, which are error-prone and lead to higher mortality, drug resistance, and the economic burden of buying unnecessary drugs. Hence, such alternatives will provide an access to quality diagnosis that is currently unavailable," said the professor.

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With 90% Accuracy, New Kit Can Detect TB Meningitis in 30 Minutes

Early detection and treatment are crucial to prevent spread, outbreaks of TB. Scientists at the Translational Health Science and Technology Institute and All India Institute of Medical Sciences, have jointly developed a diagnostic test kit for TB meningitis (the most severe form of TB) which has almost 91 percent accuracy in detecting disorder. The kit has been developed by a multi-institutional team led by Professor Jaya Sivaswami Tyagi from the Department of Biotechnology at AIIMS.

The performance of the diagnostic test was evaluated in approx 100 cerebrospinal fluid samples obtained from paediatric subjects, and for pulmonary over 300 tests have been conducted so far, said Dr. Tarun Kumar Sharma from the Centre for Biodesign and Diagnostics at Translational Health Science and Technology Institute (THSTI), Faridabad.

The diagnostic test is based on a derivative of a DNA aptamer (a small single-stranded DNA molecule that binds to a specific target molecule and is a chemical rival of antibodies) that shows high binding affinity in nanomolar range and high specificity to a TB antigen (HspX). Besides higher binding affinity, there is significantly higher load of the HspX antigen in cerebrospinal fluid samples, leading to higher sensitivity.

A rapid, point-of-care diagnostic test for TB meningitis that uses the DNA aptamer has already been adapted to a sensor format and is being evaluated on clinical samples. "It takes all of 30 minutes to get the result as we are using an electrochemical sensing platform. The test which will cost around Rs 300 only is being done in AIIMS and RML hospital in Delhi," says Prof. Tyagi.

The aptamer-based diagnostic test for TB meningitis has been patented by AIIMS and THSTI and licensed to AptaBharat Innovation Pvt Limited, a THSTI spin-off founded by Dr Sharma.

"The currently used diagnostic methods microscopy and culture of cerebrospinal fluid suffer from huge limitations in terms of poor sensitivity and long turnaround time of up to eight weeks, said the official.

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Bruker Announces Improved Assay for Tuberculosis Diagnostics in Novel Liquid Array™ Format for Improved Multiplexing

In time for the World Tuberculosis (TB) Day 2019 on Sunday, March 24th (www.who.int/campaigns/world-tb-day/world-tb-day-2019), Bruker announced the launch of an important further innovation in the field of tuberculosis diagnostics.

According to the World Health Organization (WHO), TB is among the most dangerous infectious diseases worldwide, ranking alongside HIV/AIDS (https://www.who.int/tb/en/) as a cause for death. One of the targets of the United Nations' Sustainable Development Goals for 2030 is to end the tuberculosis epidemic (https://www.un.org/pga/73/event/fight-to-end-tuberculosis/), which demands a global effort to tackle the rise of multi-drug-resistant TB (MDR-TB) and extensively-drug-resistant TB (XDR-TB). MDR-TB is resistant to the first-line drugs isoniazid (INH) and rifampicin (RIF), and XDR-TB in addition has developed resistance to fluoroquinolone and the injectable compounds used. The rapid diagnosis and appropriate treatment of both MDR-TB and XDR-TB is therefore essential to prevent significant morbidity, mortality and further transmission of the disease.

In recent years an increased spectrum of anti-mycobacterial resistance, and therefore an increased number of MDR and XDR cases has been observed. Conventional antibiotic susceptibility testing (AST) methods for TB can take an extremely long time to yield results, require significant laboratory infrastructure and training, and are potentially biohazardous. As a result, there is still under-diagnosis and a gap between acute TB cases and TB notifications.

The new PCR-based FluoroType MTBDR 2.0 assay identifies tuberculosis pathogens, as well as several important antibiotic resistance characteristics in only three hours. The novel assay detects TB pathogens directly from patient samples, without the need for any culture. In addition, it can be used to detect MDR-TB, i.e. resistance against rifampicin and isoniazid, the two most important first line TB drugs. This novel TB test relies on the innovative Bruker-Hain Liquid Array technology to analyze a multitude of mutations in the associated TB resistance genes.

The new FluoroCycler XT is a novel, high-performance thermal cycler and optical reader that enables the Liquid Array assay technology. The FluoroType MTBDR 2.0 assay can detect more than 60 mutations in the TB genes, leading up to 522 resistance patterns with relevant information to guide therapy. This level of genetic specificity normally can only be achieved with sequencing.

Dr. Jaime Esteban from the Depto. Microbiología Clínica at the Universidad Autónoma de Madrid stated: "We will implement the new high-resolution FluoroType MTBDR 2.0 test together with the newly developed, high-performance optical FluoroCycler XT to improve our ability to diagnose acute TB with greater specificity and as quickly as possible."

The FluoroCycler XT PCR system and the FluoroType MTBDR 2.0 assay were CE-IVD registered in January 2019. With their combined launch, the fight against TB has a new tool for advanced testing to provide superior diagnostic information.

David Hain, Managing Director of Bruker-Hain Diagnostics, said: "With introduction of the FluoroType MTBDR 2.0 Liquid Array assay for in-depth tuberculosis testing on our innovative FluoroCycler XT platform, Bruker supports the multinational healthcare objective to improve diagnosis for improved personalized therapy of acute tuberculosis."

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Academic Institutions Grant Commercial License for CRISPR-based SHERLOCK Diagnostic Technology in Developed World

A group of academic institutions has granted a license for SHERLOCK™, the highly-sensitive, low-cost CRISPR-based diagnostic, for commercial uses in the developed world, while reserving rights to enable its broad use by organizations to serve developing nations as well as unmet public health needs in the developed world.

First unveiled in 2017, SHERLOCK lifts a barrier to rapid deployment of diagnostics in outbreak zones. The system (which stands for Specific High-sensitivity Enzymatic Reporter unLOCKing), allows clinicians to quickly and inexpensively diagnose disease and track epidemics, such as Ebola and Zika, without the need for extensive specialized equipment. SHERLOCK can detect the presence of viruses with an unmatched degree of sensitivity in clinical samples like blood or saliva.

Under an agreement announced today, the institutions — Broad Institute of MIT and Harvard, Massachusetts Institute of Technology, Harvard University, Massachusetts General Hospital (MGH), Rutgers, The State University of New Jersey, Skolkovo Institute of Science and Technology (Skoltech), Wageningen, and University of Tokyo — have granted a license to Sherlock Biosciences Inc., a biotechnology company.

The license provides a limited exclusive right, under the Broad Institute’s inclusive innovation model, to deploy SHERLOCK diagnostic tools for commercial applications in the developed world.

“Because SHERLOCK is simple and inexpensive, it holds impressive potential for transforming how we detect disease,” said Issi Rozen, chief business officer at the Broad Institute. “It is therefore important to ensure creative commercial innovation while at the same time protecting access to new diagnostic tools in the developing world, and for public health applications in the developed world, where they are desperately needed. We designed our licensing strategy to accomplish this.” (Rozen will serve as an academic representative on the board of directors of Sherlock Biosciences, but will receive no personal compensation.)

The licensing agreement announced today does not cover SHERLOCK’s use in the developing world. In addition, the license is not exclusive for certain public health applications in the developed world — for example, the licensing structure is designed to make SHERLOCK available to help health care professionals quickly diagnose a host of circulating bacterial and viral infections such as malaria, tuberculosis, Zika, and rotavirus, among others. For such purposes, the academic coalition will ensure SHERLOCK is made widely available. In addition, SHERLOCK tools, knowledge, and methods will continue to be made freely available for academic research worldwide.

The technology was developed by a team of scientists from the Broad Institute, the McGovern Institute for Brain Research at MIT, the Institute for Medical Engineering & Science at MIT, the Wyss Institute for Biologically Inspired Engineering at Harvard University, MGH, Rutgers, and Skolkovo Institute of Science and Technology. It is a rapid, inexpensive, highly sensitive diagnostic tool with the potential for a transformative effect on research and global public health.

“Skoltech is proud to be working with Broad Institute and the international academic community to address important medical challenges facing humanity, save lives and improve health and well-being for the world’s citizens,” said Professor Alexander Kuleshov, President of Skoltech, and Member of the Russian National Academy of Sciences.

Broad Institute of MIT and Harvard was launched in 2004 to empower this generation of creative scientists to transform medicine. The Broad Institute seeks to describe all the molecular components of life and their connections; discover the molecular basis of major human diseases; develop effective new approaches to diagnostics and therapeutics; and disseminate discoveries, tools, methods, and data openly to the entire scientific community.

Founded by MIT, Harvard, Harvard-affiliated hospitals, and the visionary Los Angeles philanthropists Eli and Edythe L. Broad, the Broad Institute includes faculty, professional staff, and students from throughout the MIT and Harvard biomedical research communities and beyond, with collaborations spanning over a hundred private and public institutions in more than 40 countries worldwide. For further information about the Broad Institute, go to http://www.broadinstitute.org.

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RSSL Introduces UK's First Same Day Mycoplasma Testing Service for Biologics

Reading Scientific Services Ltd (RSSL), a leading provider of scientific and technical solutions to the global pharmaceutical and biopharmaceutical sectors, has introduced the United Kingdom’s first same-day mycoplasma testing service for manufacturers of biologic medicines.

Traditionally, the testing required to confirm biologics are free from mycoplasma, a genus of small, hard-to-detect bacteria that lack cell walls, took 28 days and used an agar and broth method. The European Pharmacopoeia now accepts a faster, PCR-based method but other limits on turnaround times mean manufacturers still typically need to wait two or more days to receive results.

RSSL has used its established processes for sample handling and tracking to eliminate the constraints that have kept turnaround times above 48 hours. If a manufacturer gets a sample to RSSL by 9:30am, it will receive mycoplasma testing results by 5pm.

RSSL has reduced the time it takes to execute this process to serve the UK’s fast-growing advanced therapy medicinal products (ATMPs) sector. Production of ATMPs such as autologous cell and gene therapies entails taking a sample from a patient, processing it and re-administering it back into the same patient within 15 days, making speed a priority.

The highly trained and professional team at RSSL initially use automated technology to extract DNA for testing, followed by real-time PCR for mycoplasma using regulator-accepted commercial analysis kits such as  the Roche MycoTOOL Mycoplasma Real-Time PCR Kit.  RSSL is offering clients a choice of Real-Time PCR based kits based on their individual requirements.

Multiple sample types can be used for the analysis although spent culture media is preferred, as this is easily available and will contain any mycoplasma that may have contaminated the process. Some preliminary sample validation is still required to ensure there are no components within the test material that will interfere with the PCR technique.

“Speed of service is critical to manufacturers of autologous cell and gene therapies. These companies have a window of 10 to 15 days to execute the entire supply chain and manufacturing process. They simply don’t have time to wait for traditional mycoplasma testing methods,” Phil Kuhlman, Biomolecular Analysis Laboratory Manager at RSSL, said.

RSSL offers longer turnaround times that may be more suitable for producers of traditional biologics but, with the UK emerging as a leader in ATMPs, it saw an unmet need for a one-day service. With 64 developers of ATMPs, the UK has more companies in the sector than any other European country.1 The manufacturing capacity in place to serve these companies increased by 60% in the year preceding November 20182.

RSSL, which collaborates closely with commercial kit suppliers, offers the mycoplasma testing service as part of a broader suite of ATMP support. ATMP companies rely on RSSL for tests of raw materials, process and product related impurities, host cell protein and DNA and pharmaceutical microbiology. RSSL also provides GMP training, product issue troubleshooting and contaminant identification.

Whatever your testing requirements, contact the RSSL customer services team to discuss your requirements further on +44 (0)118 918 4076 or email enquiries@rssl.com.

Roche CustomBiotech regarding the MycoTOOL kit in Europe on +49 621 759 8580 or mannheim.custombiotech@roche.com, in North America Phone +1 800 428 5433, custombiotech.ussales@roche.com in Asia +65 6371 6638 or apac.custombiotech@roche.com.

References

Annual Review 2018 highlights work of the CGT Catapult. Available at: https://ct.catapult.org.uk/news-media/general-news/annual-review-2018. (Accessed: 3rd January 2019)

Research Shows UK’s Growing Cell and Gene Manufacturing Industry. Available at: https://ct.catapult.org.uk/news-media/manufacturing-news/research-highlights-uk-growing-manufacturing-industry. (Accessed: 3rd January 2019)

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New Promega Water-Glo™ System Combines ATP Detection and Bioluminescence Technologies for Quick, Highly Sensitive Water Quality Testing

Promega Corporation’s new Water-Glo™ System offers water plant operators a rapid, highly sensitive and flexible measurement tool for monitoring microbial contamination in freshwater, process water, seawater or wastewater samples. The Water-Glo™ System, launched by Promega this week, uses bioluminescent technology to measure adenosine triphosphate or ATP, the "energy currency" of all living cells that degrades rapidly when a cell dies. Even the slightest change in ATP levels acts as an early warning system to assess the presence of live microbes and possible dangerous pathogens in water.

Water-Glo™ reagents were used in recent research by scientists at the world renowned IHE Delft Institute for Water Education based in Delft, the Netherlands demonstrating the first “direct method” of measuring ATP in seawater. The paper “ATP measurement in seawater reverse osmosis systems: Eliminating seawater matrix effects using a filtration-based method” is published in the March 2019 issue of the international journal Desalination.

ATP detection provides technicians a number of advantages compared to other methods for detecting microbes in water such as heterotrophic plate count (HPC), flow cytometry and indirect methods such as turbidity or pressure drop. Benefits include:

• Sensitivity to directly assess living cells from any type of microbe even in samples with low microbial load, facilitating early intervention, or high biomass load, allowing technicians to monitor the effectiveness of biocide treatments or biological filtration processes.
• Rapid results from ATP detection provides an immediate indication of microbial contamination that does not require waiting for microbes to grow in media.
• Flexibility to use in the field, floor or lab since the reagent is stable for six months at 4°C or two weeks at room temperature.
• Higher throughput to measure up to 96 samples at once using the large format option.
• Promega, a leading manufacturer of reagents, leveraged the company’s expertise in bioluminescence technology developed over the last 25 years to develop the Water-Glo™ System, one of the most sensitive tools in ATP detection in the environmental and water testing industry.

Water-Glo™ Chemistry is also available as part of a fully automated system. The AppliTek EZ-ATP® Analyzer with the Water-Glo™ Chemistry provides a total solution for online microbial analysis of water samples.

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New Tool Detects Cholera in 15 Minutes

Scientists at the International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), in partnership with Incepta Pharmaceuticals, have  developed a low-cost device which can detect cholera in only 15 minutes.

Called Cholkit, the tool has generated hopes of better management of cholera and if commercially produced, it will reduce dependence on imported testing kits and might be exported as well, scientists said.

“Presently, in addition to the laboratory culture of stool samples, imported rapid diagnostic test kits are being used for cholera detection,” said Dr Firdausi Qadri, the lead scientist in the project who works in the Infectious Diseases Division at icddr,b.

An estimated 1.3 billion people globally are at risk of cholera, with South Asia constituting the largest share, which makes the device export-worthy.

More importantly, Cholkit comes as a blessing for many in Bangladesh where at least 66 million people are at risk of cholera.

Moreover, nearly 110,000 cases are reported annually, according to a statement of icddr,b yesterday.

Scientists said the rapid diagnostic test (RDT) went through a rigorous three-year research and development process and successfully met requirements and guidelines for tests capable of detecting Vibrio cholerae from stool.

To use it, the device is dipped into a tube with stool specimen and then in 15 minutes it provides qualitative result (coloured band) which is readable by the naked eye.

A field evaluation of Cholkit has recently been published in the scientific journal “PLOS Neglected Tropical Diseases” which showed the sensitivity and specificity of the dipstick to be similar to the commercially available rapid diagnostic test (RDTs) for detecting Vibrio cholerae from stool specimens.

A total of 7,720 stool samples were tested during the evaluation. Cholkit demonstrated a sensitivity of 76 percent and specificity of over 90 percent, while other RDTs showed around 72 percent and 86.8 percent respectively.

The gold standard for detecting cholera is laboratory confirmation by stool culture, which is sensitive to several factors, including the quality of sampling, delays in shipment, laboratory equipment, skilled human resources.

It also needs longer period of time (24 to 72 hours) and costs $6 to 8 per sample, icddr,b says.

Cholkit is priced around $3, said icddr,b. Officials, however, said they could not specify its commercial price or when it would go into production but added it would be soon.

The kit has been found to be highly effective in detecting V cholerae serogroup O1 and has received official licensure, said icddr,b.

From a public health perspective, cholera outbreaks need immediate and early detection as the pathogen can spread and cause epidemics in a short period of time, it said.

“Thus, the need for simple and easy to use RDTs, which are quickly interpretable, require simple storage facilities, and are reasonably priced is a clear choice,” icddr,b said.

It has the potential to be used at the primary health care level for cholera surveillance, for early outbreak detection and as a tool for an initial alert for monitoring of seasonal peaks in highly endemic areas and in peripheral health care facilities, it said.

The Incepta-produced Cholkit is now being used in 22 cholera sentinel surveillance sites across Bangladesh. The sites are managed jointly by icddr,b and Institute of Epidemiology Disease Control And Research.

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Shield Diagnostics Announces Launch of Target-NG Test for Antibiotic Susceptibility in Neisseria gonorrhoeae

Shield Diagnostics, an Andreessen Horowitz-backed clinical laboratory tackling antibiotic resistance by bringing precision medicine to infectious disease, announced the launch of Target-NG, a rapid molecular test for antibiotic susceptibility in Neisseria gonorrhoeae.

A common sexually transmitted infection, Gonorrhea has quickly become resistant to most major classes of antibiotics and resistance has now been reported in the final class of antibiotics we have left, requiring those patients to be hospitalized and treated with broad spectrum antibiotics in order to be cured. With 820,000 cases of Gonorrhea each year in the US, the CDC has named antibiotic resistant gonorrhea (dubbed "Super Gonorrhea") a top 3 urgent public health threat.

To slow the rate of antibiotic resistance, the last line of defence must only be used when strictly necessary. First line antibiotics can be used in the majority of patients if a precision medicine approach is taken to identify the specific resistance patterns of an infection & the appropriate drug then prescribed. Such an approach is being taken by the British Association for Sexual Health and HIV, who recently announced revised treatment guidelines to recommend treating with ciprofloxacin if susceptibility results are available prior to treatment.

"Rapid molecular testing for ciprofloxacin resistance allows for smarter medicine," said Dr. Jeffrey D. Klausner, a professor of infectious disease medicine at the University of California, Los Angeles. "Right now we're treating gonorrhea with a sledgehammer, we're treating everything with the same exact regime. And it's not a surprise that the organism will become resistant to what we're currently using."

Ciprofloxacin can be used to treat 80% of infections, and is 99.8% effective when susceptibility has been determined. Because it is administered as a single oral dose, rather than the current injectable treatment, clinicians can prescribe antibiotics for the patient to give to their partners, ensuring that they are treated as well.

"Shield has launched Target-NG to help clinicians adopt a precision medicine approach to Gonorrhea treatment," said lead scientist on the project Dr. Nidhi Gupta.

"Target-NG can determine if a given gonorrhea infection is susceptible to ciprofloxacin with the same turnaround time as regular gonorrhea screening tests," said Fred Turner, the company's CEO. "This is enabling prescription of a single-dose pill (ciprofloxacin) as an effective treatment for gonorrhea." The test is available from urine, rectal & pharyngeal samples, ensuring that complete care is provided for higher risk groups.

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Redberry Unveils Red One®, its New Rapid Microbiology Technology at Forum Labo Paris from March 26th to 28th 2019

Redberry, founded in 2017, announced today that it will present its new Rapid Microbiological analysis platform, Red One®, for the first time at Forum Labo Paris 2019. Redberry will offer live demonstrations at its dedicated booth. “Red One® can detect microorganisms instantaneously and deliver a quantitative result. The workflow is fully automated, which makes it very easy to use.

Visitors will be able to experience it themselves,” says Jonathan Macron, CEO of Redberry.

First applications are water microbiological tests, for the water industry (potable & industrial) and the pharmaceutical industry. Other developments are ongoing for the food and cosmetics industries. “Our technology shows potential beyond the field of industrial microbiology with applications in Research and Diagnostics,” says Dr. Joseph Pierquin, Founder and CTO of Redberry.

Fully automated, Redberry technology detects single cells but also micro-colonies at very early stages of growth. Using advanced image treatment techniques, the patented system tracks and analyzes the assimilation of staining agents by the targeted cells. This real time analysis enables differentiation of targeted cells from non-viable particles with a high level of reliability.

In the field of industrial microbiology, Red One® delivers instantaneous results in most cases, while traditional methods, requiring a phase of culture and growth, will deliver typically in a few days. “Our product is fast, easy to use, and reliable. As a complement to classical tests in labs, it sets the path for routine testing, closer to our customers’ processes.” explains Macron.

Redberry is preparing a test campaign on potable water in the Paris area by end of 2019, in collaboration with a specialized laboratory. “We will compare with other methods and test our system in the real world,” says Dr. Pierquin. “It is also an important step in our development as we are working on an automated online control solution that we could launch in 2020.”

About Redberry SAS

Redberry is a private company specializing in instrumentation and devices for Life Sciences and Health, located in the East of France (Strasbourg area). The six-person team develops and commercializes a new range of fully automated systems for Rapid Microbiology applications. Red One® is its first available product.

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New Rapid Blood Test for TB Enters Clinical Trials

A new blood test for tuberculosis (TB) could, for the first time, enable screening of patients at an early stage of infection. The simple Actiphage® blood test is being investigated in a clinical trial by researchers from the University of Leicester and PBD Biotech - with results due to be announced later this year.

Despite recent reductions, the UK has one of the highest rates of TB in Western Europe. While TB cases have been declining overall in the UK, the rate of TB in some of the most deprived areas remains more than 7 times higher than in the least deprived. TB is a serious bacterial infection, which can be life-threatening if not properly treated with antibiotics. Pulmonary TB of the lungs or throat is contagious, but TB can affect any part of the body.

One of the biggest challenges in human TB is rapid early diagnosis. No blood tests currently exist to help with TB diagnosis. Traditional tests rely on sputum to detect the infection, but almost half of all people with pulmonary TB are unable to produce sputum, particularly in early disease. This contributes to delays in diagnosis and starting treatment, and promotes transmission within communities.

Actiphage®, developed by PBD Biotech, is an alternative to bacterial culture. The test’s underlying biotechnology was originally used for the detection of human TB - under the FastPlaque brand - but was only suitable for use on sputum. Now the phage-based diagnostic has been optimized, so it can detect the presence of the mycobacteria in blood in just six hours. This means it may help to improve the speed and reliability of diagnosis for TB patients and avoid the need for some patients to have more invasive tests performed.

The clinical trial of the new Actiphage® test will involve a cohort of patients with both latent and active TB at Leicester’s Hospitals.

Dr Pranab Haldar from the University of Leicester, one of UK’s leading TB research groups, is the lead clinician on the trial and commented:

“Many think of TB as a disease of the past and yet it is continuing to affect people, particularly in vulnerable communities across the country.

“Despite having a modern and well-equipped NHS, a third of patients still wait more than three months after symptoms begin to have a diagnosis made and treatment started. Through this trial, we are keen to explore the potential of Actiphage to provide better insights into M. tuberculosis infection and determine how the test can support and contribute to tackling this public health problem in the UK as well as internationally.”

Dr Berwyn Clarke, CEO of PBD Biotech, said:

“Actiphage is the first sensitive, specific and speedy blood test for Mycobacteria. Its effectiveness has been proven in TB trials with other species, so it is an incredibly exciting opportunity to be working with one of the world’s leading human TB research groups to investigate its potential as a transformational tool in human health.”

Clinical trial findings will be announced at the American Thoracic Society (ATS) International Conference, Dallas, in May 2019.

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PathSensors Breaks New Ground Into Detecting Pathogens for the Potato Testing Industry

PathSensors is excited to break some new ground and expand their pathogen detection capabilities to work closely with the potato industry. The Baltimore-based biotechnology company is focused on delivering highly rapid and sensitive pathogen detection solutions to the agriculture, food safety, and biodefense industries and is currently working to employ their technologies to save time and money for potato seed growers.

VP of Product Development, Dr. Andrew Flannery, recently attended the National Potato Expo in Austin, Texas on January 9-10th. The expo was a gathering of leaders in the potato industry, from grower associations to chip manufacturers and marketing associations. PathSensors attended as a company creating diagnostic solutions for potato disease and received valuable insights from other attendees about challenges they face.

The current potato testing process is long and arduous. Potato farmers generally grow tubers in their home states before shipping these tubers to seed certification labs, which then ship the tubers to be grown out into sprouts in Hawaii so that the leaves may be tested for plant disease. This process involves large amounts of sample processing time, months of waiting, and has the added expense of shipping and testing outside of the continental United States. Wouldn’t it be great to make testing simpler? That’s why PathSensors is working to develop a high throughput potato tuber testing assay.

To achieve this goal, PathSensors scientists have started working to create assays for the most common viruses that can infect potatoes. They are first focusing on potato virus Y, a Potyvirus which is commonly tested for in seed potatoes. This proof-of-concept assay will be developed in collaboration with two USDA-ARS scientists, Dr. Ramon Jordan and Dr. John Hammond, who are experts on Potyviruses and developed monoclonal antibodies for their detection. “Potato virus Y causes one of the major potato diseases wherever potatoes are grown worldwide, causing losses of up to 60%; necrotic strains are especially important,” they commented. By creating a novel Potyvirus biosensor, PathSensors instruments can be used to detect to rapidly detect PVY in the required high testing volumes to help growers know they are producing high quality seed.

PVY will be the first of many pathogens afflicting potato crops detected by PathSensors technology. The biotech company has licensed antibodies from organizations like Science and Advice for Scottish Agriculture (SASA), and Fera Science Limited in the United Kingdom in order to do further research into developing assays for the detection of other viruses, like potato mop-top and potato leafroll.

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Rapid and Accurate Diagnosis of the Respiratory Disease Pertussis on a Point-of-Care Biochip

Pertussis is a highly contagious respiratory disease caused by the bacterium Bordetella pertussis (B. pertussis). The infection is difficult to diagnose especially in underserved or resource-limited areas. Scientists at the University of Texas, University of Southern California and Children's Hospital Los Angeles have developed a low-cost and instrument-free diagnostic method for rapid and accurate detection of B. pertussis on a point-of-care (POC) testing device.

The technology employs a paper/polymer hybrid microfluidic biochip integrated with loop-mediated isothermal amplification (LAMP) method for the rapid and accurate detection of B. pertussis. This microfluidic approach was validated by testing 100 de-identified remnant clinical nasopharyngeal swabs and aspirates, which were confirmed to be either positive or negative for B. pertussis by a validated real-time PCR assay at the Children's Hospital Los Angeles.
Findings

The instrument-free detection results could be successfully read by the naked eye within 45 min with a limit of detection (LOD) of 5 DNA copies per well. Our optimized bacterial lysis protocol allowed the direct testing of clinical samples without any complicated sample processing/preparation (i.e. DNA extraction) or the use of any equipment (e.g. centrifuges). The validation of the microfluidic approach was accomplished by testing 100 clinical samples. High sensitivity (100%) and specificity (96%) with respect to real-time PCR were achieved.
Interpretation

This microfluidic biochip shows great potential for point-of-care disease diagnosis in various venues including schools and physician's offices, especially in low-resource settings in developing nations.

The full study (and a link to the publication in PDF format) has been published in the online version of The Lancet.

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New Biological Detection System Can Provide Faster, Less Expensive Results for Veterinarians

Veterinarians and agricultural inspectors who seek to detect and contain the spread of animal diseases can now turn to a newer, faster and less expensive biological detection system.

Known as the Axiom™Microbiome Array, or AMA, the new biological detection system is the most comprehensive microorganism detection platform built to date and the first high-throughput microarray.

The AMA is the commercialized successor to Lawrence Livermore National Laboratory’s earlier microarray, called the Lawrence Livermore Microbial Detection Array (LLMDA).

The LLMDA was licensed in 2016 to Waltham, Massachusetts-based Thermo Fisher Scientific and went on sale later that year as Applied Biosystems™ AMA.

In a yearlong evaluation, published in the online scientific journal PLOS ONE, a team of researchers from LLNL, Kansas State University and Thermo Fisher Scientific concluded that the microbiome array “is an efficient tool to rapidly analyze large numbers of clinical and environmental samples for the presence of multiple viral and bacterial pathogens.”

“Two of the array’s advantages are that it’s faster and cheaper,” said Raymond “Bob” Rowland, professor of diagnostic medicine and pathobiology at Kansas State’s College of Veterinary Medicine. “I live in the world of veterinary medicine and cost is critical.

“If we were to do a test using the LLMDA, it would have cost us about $250 just for the reagents; now with the AMA we can do the same tests for $40.”

When LLNL biologists and computer scientists first unveiled the versatile LLMDA in 2010, it could analyze samples for nearly 3,000 bacteria and viruses, all within 24 hours. But it could only analyze four samples a day.

With the 96-well AMA, the new detection system can analyze 96 samples in three days. Additionally, each of the 96 wells contain about 1.4 million probes, so samples are analyzed by about 132 million probes.

“One of the most important conclusions of our study is that this is the first high-throughput microarray that has been developed,” said LLNL biologist Crystal Jaing, who heads the LLMDA/AMA efforts. “It increases the throughput by 10- to 20-fold and decreases the cost by five-fold.”

As LLNL and Thermo Fisher Scientific researchers moved to a higher throughput microarray, one of the team’s prime goals has been to maintain a high-resolution and sensitivity of detection.

In their PLOS ONE paper, researchers from the three institutions note that with the new array, they were able to detect both Shigella, a food-borne bacterial pathogen, and Aspergillus, a fungal pathogen, at 100 genome copies, as well as vaccinia virus DNA, a genetic relation to smallpox, at 1,000 genome copies.

In veterinary tests with pigs, the microbiome array detected two viruses – porcine reproductive and respiratory syndrome virus and porcine circovirus type 2 – as well as other common viral and bacterial microbiome species.

During their evaluation, the researchers conducted tests with 14 veterinary samples and 30 environmental samples, finding that the AMA performed at a resolution similar to the LLMDA, according to Jaing.

Because of the microbiome array, veterinarians can now conduct multiple tests on a single animal in Rowland’s view.

“This is a technology that is meant for the veterinary technician to use. It’s the everything test for everything.

“We base our testing on pathology. When we see a change in the tissue of an organ, that’s where your pathogen can usually be found. If we see changes in multiple organs and multiple tissues, now we can sample them all,” Rowland said.

According to the PLOS ONE paper authors, “Rapid detection and characterization of bacterial and viral pathogens is important for clinical microbiological diagnostics, public health, veterinary diagnostics, drug and food safety, environmental monitoring and biodefense.”

The current version of the AMA has the capability to detect more than 12,000 microorganisms and can identify 6,901 bacteria, 4,770 viruses and a combined total of 842 archaea, fungi and protozoa.

The new arrays, which come in 24- and 96-well formats, can analyze a variety of different sample types and can be used for nutrigenomics, agrigenomics, plus animal research and modeling.

In addition to Rowland and Jaing, the paper’s lead author, other paper co-authors are LLNL biologists James Thissen and Nicholas Be, LLNL bioinformaticists Kevin McLoughlin and Shea Gardner (deceased), retired LLNL computer scientist Tom Slezak and Thermo Fisher Scientific biologists Paul Rack and Michael Shapero.

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Researchers Use Health Data Tools to Rapidly Detect Sepsis in Newborns

Automated programs can identify which sick infants in a neonatal intensive care unit (NICU) have sepsis hours before clinicians recognize the life-threatening condition. A team of data researchers and physician-scientists tested machine-learning models in a NICU population, drawing only on routinely collected data available in electronic health records (EHRs).

"Because early detection and rapid intervention is essential in cases of sepsis, machine-learning tools like this offer the potential to improve clinical outcomes in these infants," said first author Aaron J. Masino, PhD, who led the study team's machine-learning efforts. Masino is an assistant professor in the Department of Anesthesiology and Critical Care Medicine and a member of the Department of Biomedical and Health Informatics at Children's Hospital of Philadelphia (CHOP). "Follow-up clinical studies will allow researchers to evaluate how well such systems perform in a hospital setting."

The research team published its findings in the retrospective case-control study in PLOS ONE.

A major worldwide cause of infant mortality and morbidity, sepsis begins with a bacterial invasion of the bloodstream. An aggressive immune response can unfortunately cause a progression to septic shock, a severe systemic condition causing multiple organs to fail, sometimes fatally. While relatively rare in healthy, full-term infants, sepsis rates are 200 times higher in premature or chronically hospitalized infants. Survivors of infant sepsis may suffer long-term problems such as chronic lung disease, neurodevelopmental disabilities, and prolonged hospital stays.

Rapid diagnosis of sepsis is often difficult in hospitalized infants, due to ambiguous clinical signs and inaccuracies in screening tests. Delays in recognizing sepsis cause delays in intervention, including antibiotic treatment and supportive care. However, unnecessary use of antibiotics carries its own risks and increases antibiotic resistance, so a clear-cut early diagnosis is important.

The current study aimed to develop a machine-learning model able to recognize sepsis in NICU infants at least four hours before clinical suspicion. "To our knowledge, this was the first study to investigate machine learning to identify sepsis before clinical recognition using only routinely collected EHR data," said Masino.

Machine learning uses computational and statistical techniques to train computational models to detect patterns from data, then perform a desired task. In this case, the study team evaluated how well eight machine-learning models were able to analyze patient data to predict which infants had sepsis. Because the data came from a retrospective sample of NICU infants, the researchers were able to compare each model's predictions to subsequent findings--whether or not an individual patient was found to develop sepsis.

The study team drew on EHR data from 618 infants in the CHOP NICU, from 2014 to 2017. Many of the infants in the patient registry were premature; the cohort had a median gestational age of 34 weeks. Co-occurring conditions included chronic lung disease, congenital heart disease, necrotizing enterocolitis (a severe intestinal infection) and surgical conditions.

Among the co-authors were pediatrician and biomedical informatics expert Robert W. Grundmeier, MD, and neonatologist and sepsis expert Mary Catherine Harris, MD. Both drew on their clinical experience and knowledge of medical literature to help develop groups of sepsis-related features available in EHR data. Masino, Grundmeier and Harris, in addition to their CHOP positions, also are faculty members of the Perelman School of Medicine at the University of Pennsylvania.

Grundmeier and Harris, the study's lead clinical investigators, developed a list of 36 features associated or suspected to be associated with infant sepsis. Those features, grouped under vital signs, laboratory values, co-morbidities and clinical factors, such as whether an infant was on a ventilator, were extracted from EHR entries, and provided input data for the machine-learning models. "The biomedical informatics specialists like myself collaborated with our clinician colleagues to select relevant features from the EHR data," said Masino.

Six of the eight models performed well in accurately predicting sepsis up to four hours before clinical recognition of the condition.

The team's findings, said Masino, are a preliminary step toward developing a real-time clinical tool for hospital practice. The researchers plan to follow up this study with further research to refine their models and investigate the software tools in a carefully designed prospective clinical study. "If research validates some of these models, we may develop a tool to support clinical decisions and improve outcomes in critically ill infants," he added.

Reference: Aaron J. Masino, et al, Machine learning models for early sepsis recognition in the neonatal intensive care unit using readily available electronic health record data, PLOS ONE, published Feb. 22, 2019. http://doi.org/10.1371/journal.pone.0212665

Source: Children's Hospital of Philadelphia

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AU Researchers Develop 10-Minute Genetic Test to Detect Antimicrobial Resistance

Researchers at American University have developed a new, highly sensitive rapid genetic test that can determine whether bacteria carries a gene that causes resistance to two common antibiotics used to treat strep throat and other respiratory illnesses. The scientists show that the new method works as accurately as culture-based methods but gives results in minutes, not hours or days. The research has been published in BMC Infectious Diseases.

The new rapid test developed by the AU team determines if a person harbors bacteria carrying the Macrolide efflux gene A, or mef(A), which causes resistance to two antibiotics: erythromycin and azithromycin. Azithromycin (also known as Zithromycin or a Z-Pak) is among those commonly used to treat strep throat and is one of the most highly prescribed antibiotics in the United States.

"The test is able to detect the gene within 10 minutes of assay run-time," said John R. Bracht, assistant professor of biology at American University and corresponding author on the study. "Standard antibiotic testing requires at least an overnight culture and often isn't performed in routine diagnostic work. Instead, physicians guess which antibiotic to prescribe based on past experience and recommendations, and patients have to return if the treatment fails. We simplified the process of detecting antimicrobial resistance so a physician can determine whether or not a patient will be resistant to a prescribed drug while that patient is still in the waiting room. We think this is a game-changer for treating common illnesses."

It's common knowledge in the medical community that there's widespread resistance in people to azithromycin and erythromycin, but in spite of that, the antibiotics are still used a lot in the treatment of strep throat and other respiratory illnesses, said the paper's lead author Megan M. Nelson, a graduate of AU's biotechnology master's program.

"Our rapid genetic test can help doctors better assign medication on site, and improve point-of-care diagnostics, potentially leading to better outcomes without having prescribed a patient a useless antibiotic," she added. "There's a lot of trial and error with antibiotic use, so this is trying to take out some of the error."

The rise of antibiotic-resistant bacteria is a growing problem in the United States and the world. In the U.S. annually, more than 2 million people get infections that are resistant to antibiotics and at least 23,000 people die as a result, according to the Centers for Disease Control and Prevention. The U.S. National Institutes of Health, CDC, World Health Organization, and United Nations have prioritized the issue. However, tracking antimicrobial resistance is a significant challenge, the researchers write in the paper, precisely because the available culture-based methods are so slow and expensive.

The new rapid test addresses this challenge, making tracking antibiotic resistance quick, easy, and routine. It offers scientific researchers a way to monitor the prevalence and movement of antimicrobial drug resistance. The next step for the AU team to getting the test into doctors' offices is to seek approval of the test from the U.S. Food and Drug Administration.

Reference: Megan M. Nelson, Christopher L. Waldron and John R. Bracht. 2019. Rapid molecular detection of macrolide resistance. BMC Infectious Diseases. https://doi.org/10.1186/s12879-019-3762-4.

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