Seegene to Present Unique Random Access System at AACC

Seegene Inc., the world’s leading developer of multiplex molecular diagnostics technologies and assays, is to present its unique Seegene Random Access System (the “System”) at the 69th AACC Annual Clinical Lab Expo in San Diego, CA, from July 30 to August 3.

The ‘Seegene Random Access System’ is an innovative solution in molecular diagnostics (MDx), which can provide order-to-report on the same day by simultaneously performing high multiplex real-time PCR testing on a single platform, regardless of specimen type or assays.

The key advantage of MDx over conventional diagnostic methods is the ability to accurately diagnose diseases at their early stages. Rapid, accurate diagnosis and prompt treatment are especially critical for a successful treatment of infectious diseases such as tuberculosis, acute diarrhea, sepsis or meningitis. However, most existing MDx systems are unable to perform same-day reporting for same day treatment, because clinical laboratories typically perform testing after a sufficient number of specimens are collected. This is because generally, a single instrument cannot perform various types of MDx assays at the same time.

Each type of MDx assays requires different extraction methods, different reagent types, and different PCR conditions, making simultaneous testing on a single instrument impossible. The Seegene Random Access System, which is based on Seegene’s ‘One Platform’ with universal PCR condition and universal extraction protocol, provides a solution to all of these limitations.

Seegene Random Access System is made possible by more than 100 assays that can be tested under an identical, universal PCR condition on a single instrument platform. In addition, the System incorporates a universal nucleic acid extraction protocol which is applicable to all specimen types such as blood, urine, stool, and sputum.

Seegene’s proprietary PCR technologies in combination with bioinformatics and IT solutions enable the ‘Seegene Random Access System’, and allow laboratories to perform same-day testing and reporting.

Dr. Jong-Yoon Chun, founder and CEO of Seegene, said: “Despite the fact that MDx testing can provide rapid and precise test results, operational limitations in clinical laboratories such as lab space, instrumentation and human resources have made order-to-report on the same day almost impossible. Unfortunately the benefits of MDx tests do not reach the patients, as it takes several days for the physician to receive the test results. Seegene’s ‘Random Access System’ which overcomes all the operational limitations, makes same-day reporting possible and leads to prompt and personalized treatment. By incorporating same-day diagnosis and treatment, molecular diagnostics will be a breakthrough in achieving on-time customized patient care.”

So far, Seegene has successfully launched 12 Allplex products and plans to expand its product portfolio to more than 100 products by the end of 2018. Laboratories adopting the Seegene Random Access System will find themselves utilizing a single instrument system to simultaneously test more than 100 high-multiplex real-time PCR assays covering over 450 pathogenic targets.

Moving forward, Seegene will introduce the System to hospitals and clinical laboratories around the world, starting from the AACC Annual Clinical Lab Expo.

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Hygiena’s New SuperSnap Testing System Enables Accurate and Timely Verification of Endoscope Cleanliness

Hygiena, a leading provider of microbial detection, monitoring and identification solutions, has introduced its SuperSnap testing system, which provides high sensitivity, real-time verification of the cleanliness of endoscopes and other reusable medical instruments in just 15 seconds. This quick process highlights whether the initial cleaning steps have been effective, so the instruments can then be disinfected, sterilised and reused.

Operating on the powerful and proven adenosine triphosphate (ATP) bioluminescence technology, SuperSnap offers simple and dependable detection of ATP, a common component of all body fluids and bacteria. The system generates immediate, objective results, allowing for the rapid assessment of cleaning procedures and the timely undertaking of corrective actions. SuperSnap is a thousand times more sensitive than conventional protein detection systems, offering increased confidence in results. The system can be used  at multiple stages within the reprocessing workflow to facilitate the success of later disinfection and sterilisation procedures, which are dependent upon effective cleaning.

“Owing to their complex structure and design, endoscopes are very hard to clean. In addition, their high usage rate means that the available time for cleaning is short. Research has shown that more than 30 percent of endoscopes are inadequately cleaned, and even drying cabinets have been identified as sources of contamination. As such, diligent and thorough reprocessing is necessary to avoid cross-contamination and infection,” explains Dr Martin Easter, Chief Scientific Officer at Hygiena. “SuperSnap enables the quick and easy verification of cleaning on a daily basis, providing greater assurance of safety and containment of risk within the whole facility.”

SuperSnap is an integrated, all-in-one disposable device incorporating robust reagents and a swab for surface sample collection from the hand controls and distal end of the endoscope. A long swab is also available to collect samples from the internal channels.  AquaSnap is another integrated device designed to collect liquid samples and can be used on the same system to verify water quality. All of the test devices generate results in the sensitive EnSURE luminometer in 15 seconds. The systems also incorporate Hygiena’s SureTrend software package for the easy recording of test data and tracking of results. These data can be used to generate graphs and reports that detect cleaning issues, identify personnel training needs and monitor the overall cleanliness of an instrument inventory over time.

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Luminex Corporation Receives FDA Clearance for ARIES C. difficile Assay

Luminex Corporation (NASDAQ: LMNX) today announced that it has received FDA clearance for the ARIES®C. difficile Assay, a moderate complexity, sample to answer test for rapid detection of C. difficile. The ARIES®C. difficile Assay detects both toxin A and toxin B, which may reduce the probability of a false negative result from strains that only produce toxin A. This milestone continues the company's track record of a rapid succession of regulatory clearances for assays on the ARIES® Systems, such as Bordetella, GBS and Norovirus CE-IVD earlier this year.

The CDC has classified Clostridium difficile (C. difficile) as an 'Urgent' threat requiring more monitoring and prevention activities, in part because it has become the most common microbial cause of healthcare-associated infections in U.S. hospitals. A 2015 CDC study found that C. difficile caused almost half a million infections among patients in the United States in a single year. An estimated 15,000 annual deaths are directly attributable to C. difficile infections, making it a substantial cause of infectious disease death in the United States.

Dr. Ray Widen, Scientific Director, Esoteric Testing and R&D at Tampa General Hospital, commented: "C. difficile infections have become more frequent, severe and difficult to manage in recent years, increasing our need for better tools to diagnose and treat these debilitating and life threatening infections. This includes the ability to detect both toxin A and B genes of the bacterium. The ARIES®C. difficile Assay was easy to use and performed very well in our lab during the clinical trial. The combination of a simple workflow for ease of training, sample in/answer out capabilities for ease of use, rapid time to result, and flexible batch size, makes the ARIES® System a good fit for routine microbiology laboratories that may not have prior experience with molecular assays."

"With this regulatory approval, we are further broadening our infectious diseases testing portfolio and adding to our rapidly growing menu of targeted assays and customized panels," said Homi Shamir, President and Chief Executive Officer of Luminex. "We are very pleased to offer a new solution to hospitals and molecular testing labs that can help improve their ability to test for these serious infections. From GI to respiratory, blood culture to women's health, we are making a true difference in the delivery of healthcare with the rapid number of high quality products we are bringing to market, including four new tests for the ARIES® System already this year."

The ARIES® System is designed to run in multiple laboratory shifts and allows labs to simultaneously run both IVD and LDT assays in a sample to answer format when using a Universal Assay Protocol.  All aspects of testing are automated, from sample preparation through analysis, providing answers in less than 2 hours with minimal hands-on time while enabling easy implementation on weekends and night shifts. The ARIES®C. difficile Assay, a real-time polymerase chain reaction (PCR)-based qualitative in vitro diagnostic test, is part of Luminex's comprehensive gastroenterological testing menu that also includes the xTAG® Gastrointestinal Pathogen Panel (GPP), VERIGENE® Enteric Pathogens Test (EP), and the ARIES® Norovirus Assay CE-IVD.

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Nanopore Sequencing, PCR Platforms Evaluated for Rapid Pneumonia Diagnosis in UK Study

Researchers in the UK are testing three molecular diagnostics platforms for their potential to improve the speed of diagnosis of hospital-acquired or ventilator-associated pneumonia.

The five-year project, called Inhale, started in early 2016 and initially aims to assess the diagnostic performance of three respiratory disease tests — running on the Curetis Unyvero and BioMérieux's BioFire Diagnostics FilmArray, both PCR-based; and Oxford Nanopore Technologies' MinIon sequencer — to select the one that performs best for a prospectcive randomized controlled clinical trial comparing the platform against conventional cell culture.

Inhale is a collaboration between University College London (UCL), the University of East Anglia (UEA), and four hospitals — Norwich & Norfolk University Hospitals, University College London Hospitals, Great Ormond Street Hospital Children's Charity, and BUPA Cromwell Hospital — and is funded by the UK's National Institute for Health Research.

The original plan was to assess three PCR-based platforms, but after one of the manufacturers, Mobidiag, pulled out earlier this year, the project replaced that system with the Oxford Nanopore MinIon and started analyzing the first samples with nanopore shotgun metagenomic sequencing earlier this month.

"The ultimate goal here is to try to improve the treatment of patients, to look at a more personalized approach to antibiotic treatment," said Justin O'Grady, senior lecturer in medical microbiology at the University of East Anglia's Norwich Medical School, and one of the organizers of the project. "It's a move away from the guesswork that we currently use to diagnose and treat people."

Because pneumonia can be a life-threatening disease, especially in children, the elderly, and critically ill patients, doctors usually start treatment with antibiotics immediately. Two or three days later, when a microbiology lab has cultured the pathogen from the sample and determined its antibiotic resistances, treatment is often adapted to target the causative agent more specifically.

The idea is to shorten that timeframe to a few hours by using a molecular diagnostic test, O'Grady said, so patients can receive the most appropriate treatment more quickly.

For the clinical trial, "we will look at what drugs people got, when they were changed to a different drug, if they had the same outcomes, and if the antibiotic stewardship was better — if you were reserving the most potent antibiotics for those who really need it," he explained.

The trial will also have a health economics component to study the costs involved with moving to a molecular diagnostic platform, and a behavioral science part to look at whether doctors will actually act upon the results of a rapid molecular test.

For the first part of the project, which assesses the performance of the systems and whether they find the same pathogens and resistances as culture-based testing, the researchers plan to analyze about 600 samples on all three platforms. Samples come from the intensive care units of the participating hospitals and are from patients with hospital-acquired pneumonia, including patients on ventilators. Three sample types are being studied: bronchoalveolar lavage (BAL) samples, sputum, and endotracheal tube aspirates.

So far, the researchers have tested about 200 samples with the Curetis and BioFire platforms, some of which were frozen and will also be tested with the MinIon sequencer. The plan is to collect about 600 additional samples over the coming months for analysis with all three platforms, which are installed at the two testing laboratories at UCL and UEA.

About a year from now, one of the platforms will be chosen for the randomized controlled trial. O'Grady said the selection criteria will not only be the tests' specificity and sensitivity but also their cost and ease of use.

While the results of the initial evaluation will not be in for a while, in general terms, the three platforms have a number of pros and cons. For example, the Curetis test, which is already on the market, and the BioFire test, which is still in development, both run on "sample-in-answer-out" platforms that are simple to use and require little hands-on time, O'Grady said, whereas the MinIon metagenomic sequencing test, which his lab developed in house, is not as mature yet.

On the other hand, "the depth of information provided by metagenomics is vastly superior over what you get out of a PCR," he said. It includes the full genome of the pathogen and all resistance genes, for example, whereas the PCR tests only target selected organisms and resistances.

A shotgun metagenomics assay will also likely not miss any pathogen, he said, even unusual bacteria, whereas the PCR tests run panels that may cover 90 or 95 percent of the culprits, but not all of them.

In addition, metagenomic sequencing covers all organisms in a sample, pathogens and commensals, which O'Grady said is very useful because it provides an idea of whether a pathogen is a major or a minor component of a sample. Like a culture plate, a metagenomics test lets labs "see" quickly what is there, "whereas with PCR tests, you just pick out the pathogens and you don't know what else is possibly there," he said.

Being able to detect all resistances, even less common ones, is also an advantage, he said, but right now, bioinformatics pipelines are not ready yet to fully interpret genome sequence data for antibiotic susceptibility.

The platforms also differ in turnaround time. The Curetis test and the nanopore sequencing test currently take about six hours each to perform, whereas the BioFire test only takes about an hour.

What's important is to keep the turnaround time under eight hours, O'Grady said, because doctors usually put patients on a broad-spectrum antibiotic immediately and only need the test result before the patient takes the second dose about eight hours later.

It is not clear yet how the three tests will compare in price. The nanopore sequencing test currently costs the lab on the order of $120 per sample in consumables, including sample prep reagents, if six samples are combined on one flow cell, O'Grady said. This is less expensive than the Curetis test, which costs on the order of $230 per sample, but the price could be different if Oxford Nanopore decided to develop the test into a commercial offering, for example. The price of the BioFire test is not known yet since it has not been fully commercialized, he added.

Whichever test is chosen for the randomized clinical trial, where it would be used to guide patient treatment, will need to be approved by the study funders and an ethics board first. It is unclear yet whether this will require CE-IVD marking, US Food and Drug Administration approval, or whether it could be validated as a lab-developed test, O'Grady said.

Curetis submitted its Unyvero system and lower respiratory tract (LRT) panel to the FDA earlier this year and the BioFire FilmArray system is already FDA-cleared and CE-marked.

Prior to entering the nanopore respiratory test into the Inhale project, O'Grady's lab evaluated it in a proof-of-concept study, using about 50 sputum or BAL bacterial pneumonia samples. The analysis is still ongoing, but initial results look like the shotgun metagenomic approach has "excellent concordance with culture for pathogen identification," O'Grady said. The researchers plan to publish the results of the pilot in the near future, he added.

Sample prep for the test starts with a yet-unpublished depletion method the lab developed that removes human DNA. This is followed by DNA extraction and library preparation, using Oxford Nanopore's Rapid Low Input by PCR Barcoding Kit, which requires 1 to 5 nanograms of input DNA.  Depending on how much DNA is available from each sample — BAL samples, which are more dilute, generally yield less DNA than sputum or endotracheal tube aspirate — the lab usually performs 15, 20, or 25 cycles of PCR. Every five PCR cycles add about 30 minutes to the procedure, O'Grady explained, and the lab is working on ways to shorten the elongation step of the PCR.

At the moment, the lab multiplexes six samples per MinIon flow cell to keep costs down, but once Oxford Nanopore comes out with its Flow Cell Dongle, or Flongle, a low-cost MinIon flow cell adapter, the researchers plan to run a single sample per flow cell. Oxford Nanopore said previously that it intends to pursue regulatory approval for the Flongle, in a version to be called MinIon Dx, for use in diagnostics.

Right now, the team obtains 2 million reads on average in a 48-hour run, with average read lengths of 2 to 4 kilobases. The error rate of the nanopore reads is not a problem for pathogen identification, O'Grady said, but rapid identification of mutational resistance will require real-time consensus calling, which he believes Oxford Nanopore's team is working on.

To analyze the data, the lab currently uses real-time analysis workflows developed by Oxford Nanopore — 'What's In My Pot,' or WIMP, for taxonomic classification of microbial organisms and ARMA for antimicrobial resistance profiling.

Others have also been exploring shotgun metagenomics for infectious disease diagnostics.

Charles Chiu, an associate professor at the University of California San Francisco School of Medicine and director of the UCSF-Abbott Viral Diagnostics and Discovery Center, for example, said that his lab just completed a prospective clinical trial for meningitis and encephalitis diagnosis in which the team compared its clinical metagenomic next-generation sequencing (mNGS) assay to conventional testing, including culture and PCR testing, and evaluated clinical utility, cost-effectiveness, and patient outcomes. That test uses an Illumina sequencing platform and the patented SURPI algorithm for analysis.

The researchers are currently writing up the results for publication, Chiu said, and he plans to present them at a conference in September. Earlier this month, UCSF's CLIA-certified clinical microbiology laboratory launched the test, which analyzes cerebrospinal fluid, for patients with neurological diseases and said it was working on making testing available for patients with sepsis and pneumonia. The lab said it currently conducts the test in about 72 hours, and results are generally available within one or two weeks.

Also, PathoQuest, a spinout from the Institut Pasteur in France, has developed a metagenomic sequencing test for blood pathogens called iDTECT Blood, for which it obtained CE-marking last year. That test also uses an Illumina platform.

In addition, researchers at the University of Utah, Arup Laboratories, and bioinformatics firm IDbyDNA have also developed a metagenomic sequencing-based test for diagnosing respiratory and other diseases, presenting results earlier this year at the Biology of Genomes meeting.

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Valley Fever Test Submitted for FDA Approval

A patented assay to diagnose Valley fever, developed by Northern Arizona University Regents’ Professor of Microbiology Paul Keim, was recently submitted to the U.S. Food and Drug Administration (FDA) by DxNA LLC, the company that licenses the technology. This important milestone, a critical step in taking a new diagnostic technology to market, will pave the way for the assay to be used to help physicians diagnose patients more quickly and, as a result, save lives.

Valley fever, a potentially deadly, dust-borne fungal disease, is endemic to Phoenix and Tucson and is spreading throughout the arid regions of North and South America. It is an infection caused by the microscopic fungus Coccidioides, a pathogen that lives in desert soils and typically enters the body through the lungs. An estimated 150,000 Americans are infected annually by Valley fever, and as many as 500 die each year.

The assay represents a significant improvement in the rapid diagnosis of the disease. Testing for Valley fever is conducted by growing the fungus in a laboratory, which can take up to 21 days. Because the new test is performed directly on the patient specimen, it provides physicians with test results the same day, considerably reducing the time to begin treatment. This new genetics-based test can precisely identify both strains of Valley fever: Coccidioides posadasii, found in Arizona, New Mexico, Texas and much of Latin America; and Coccidioides immitus, found in California, Washington and Baja, Mexico.

NAU and the Translational Genomics Research Institute (TGen) were jointly awarded a U.S. patent for the technology in 2016, exclusively licensing it to Utah-based DxNA. DxNA incorporated the test into its proprietary GeneSTAT® System and GeneSTAT® Coccidioides Assay and successfully conducted clinical trials of the test at centers in Arizona, New Mexico and California. Keim worked closely with DxNA throughout the commercialization of the assay, providing clinical perspective and assisting with the clinical trials.

“Teaming scientists with top business entrepreneurs can lead to great products,” Keim said.

DxNA recently announced it submitted the GeneSTAT System and GeneSTAT Coccidioides Assay to the FDA as a 510(k) premarket notification. Once DxNA receives FDA clearance, the company plans to make the Valley fever test commercially available to hospitals and clinics.

“The FDA 510(k) application is the penultimate step in a long process that started in a business meeting at PathoGene, LLC, now part of DxNA,” Keim said.

Keim led development of the genomics approach by searching the Coccidioides genome for highly repeated DNA sequences, identifying a novel repeated DNA sequence and converting it to the Polymerase Chain Reaction-based diagnostic test for which DxNA is seeking FDA approval.

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Neogen Develops Fastest Listeria Test with No Enrichment

Neogen Corporation has developed an innovative test that detects Listeria in environmental samples in under 60 minutes — without the need to enrich samples.

Neogen’s new Listeria Right Now™ test system can detect all species of Listeria, including the pathogenic L. monocytogenes, in under 60 minutes through their ribosomal RNA (rRNA). The system’s effectiveness has been validated by NSF International to detect low levels of Listeria in environmental samples with greater sensitivity and speed than any other method available. The test is also under review for AOAC Performance Tested certification to further validate its accuracy.

“The advanced technology in Listeria Right Now truly changes everything about testing the environment for Listeria. Contamination of Listeria in the environment can now be determined, and cleaned as necessary, before food production begins and the quality and safety of a food product is compromised,” said Ed Bradley, Neogen’s vice president of Food Safety. “The new test system enables food safety professionals to very quickly implement corrective actions, which could include improving sanitation efforts or processes. Using Listeria Right Now also means that companies no longer have to grow potentially dangerous cultures in their facilities during the testing process, nor store test cultures for potential follow-up testing.”

The innovative Listeria Right Now process starts with taking an environmental sample to capture any Listeria present. The entire swab sample is placed in a tube that contains a lysis buffer that breaks up any bacteria present, and releases its rRNA. If Listeria is in the sample, the test’s reagents will amplify thousands of copies of its rRNA — and make the Listeria easily detectable by Listeria Right Now.

In the validation study of Listeria Right Now comparing the test against the reference cultural method, NSF International confirmed the effectiveness of this new test. The evaluation determined that under the conditions employed in this study, the enrichment-free Listeria Right Now method is as sensitive as the enrichment-based culture reference method.

The system employs an isothermal, amplified nucleic acid-based reaction to target rRNA. Amplification occurs through a polymerization mechanism by a specific endonuclease. Detection occurs in real-time using a fluorescent, molecular beacon.

Ribosomal RNA is present in much greater numbers in Listeria cells than the traditional DNA target (~1000 – 10,000 copies per cell vs. 1 copy per cell for DNA). This can result in a 1,000 – 10,000 fold increase in target analyte concentration.

The isothermal reaction within the instrument produces a constant cycle of molecular replication producing analyte copies much more quickly than traditional PCR reactions which run through a series of heating and cooling cycles.

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Revolutionary Bio-Contained, In-House Pathogen Detection System

The CERTUS system for rapid pathogen detection and environmental monitoring was launched at the 2017 International Association for Food Protection annual meeting in Tampa, FL.

This system raises the bar with a unique, bio-contained, in-house solution for pathogen detection for small and mid-size food processing plants. Unmatched in its unique approach to an industry dominated by outsourcing or complicated in-house testing, this system promises to make food safer by providing producers fast, easy and cost-effective ways to detect environmental pathogens in food processing environments and the food itself prior to reaching consumers.

Environmental testing and monitoring are translated into a “simple, safe and smart” process, greatly reducing time and cost by eliminating media preparation, sample preparation, courier expense and the risk of opening an enriched sample in the plant.

Anyone with minimal training can simply swab a surface, add media to the Bio-Lock™ Detection Tube and insert the tube into the detection unit to start getting rapid results during the enrichment cycle. There is no need for centrifuges, incubators, pipettes, stomachers, bags or many of the ancillary items and steps that current methods require.

The patented Grow, Read, Detect™ continuous monitoring process combines enrichment and high-sensitivity detection in a homogenous, no-wash format for real-time monitoring; it eliminates complex workflow; and it enables any food processor to conduct safe and easy on-site testing, receive instant alerts and take action to remediate. The first commercial system will be launched in 2018 for environmental monitoring and prevention of Listeria spp.

GROW: The detection unit features a thermal chamber optimized for growth of the selected pathogen once sealed in the detection tube.

READ: The detection unit deploys surface-enhanced Raman spectroscopy to monitor pathogen presence and growth.

DETECT: The system accurately detects the target pathogen continuously as enrichment is taking place.

This system contains everything you need for safe, in-house environmental monitoring.

The detection unit’s patented Grow, Read, Detect process provides real-time monitoring with simultaneous enrichment and detection. The control pad provides step-by-step directions, keeps records and sends instant alerts to key stakeholders through email and text. The detection kit includes sampling swabs, detection tubes with pathogen-specific dried reagent particles and pre-measured selective growth media.

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Point-of-Care Test for Active Hepatitis C Virus Infection

According to an observational cohort study conducted by researchers at the University of New South Wales in Sydney, Australia, a point-of-care test has high sensitivity and specificity for detecting hepatitis C virus (HCV) RNA. The findings were reported in The Lancet Gastroenterology & Hepatology.

With the increasing global burden of HCV, the World Health Organization (WHO) notes that improved testing and diagnosis are needed to facilitate access to treatment. This is an especially pressing need for marginalized populations such as homeless individuals and those with a history of injecting drugs. Many of the commonly used rapid diagnostic HCV tests only detect previous exposure via HCV antibodies rather than active infection as indicated by the presence of HCV RNA.

“Given that 25% of individuals spontaneously clear HCV infection, efforts to enhance diagnosis of chronic HCV infection and improve the HCV care cascade requires enhanced uptake of HCV RNA testing,” wrote the authors of the present research. They investigated the sensitivity and specificity of the Xpert® HCV Viral Load (Cepheid) point-of-care assay for detecting HCV RNA in plasma samples collected via venipuncture, as well as in fingerstick capillary whole-blood samples. The Abbott RealTime HCV Viral Load RNA assay was used for comparison.

The final analysis included 150 adults (median age: 44 years; 87% men) participating in drug recovery and homelessness programs across 5 sites. The findings show that HCV RNA was detected in 30% of participants (95% CI: 23%-38%). For plasma collected by venipuncture, sensitivity and specificity of the point-of-care test were 100% (95% CI: 92%-100%) and 99.1% (95% CI: 94.9%-100%), respectively. For the fingerstick samples, sensitivity and specificity were 95.5% (95% CI: 84.5%-99.4%) and 98.1% (95% CI: 93.4%-99.8%), respectively. No adverse events were reported.

The manufacturer of the Xpert HCV Viral Load point-of-care assay is now aiming to optimize the test to produce results within 60 minutes vs 108 minutes, as in this investigation. The reduced time to result is likely to lead to a commercially available fingerstick test to detect HCV RNA.

“The major advance of this point-of-care assay over previous antibody tests, which only indicate HCV exposure, is the ability to detect active HCV infection,” the authors stated. These results also indicate the need for additional “evaluation of the Xpert HCV Viral Load test for HCV RNA detection by finger-stick whole-blood collection as a strategy” to simplify sample collection and increase timely access to treatment. Such testing could vastly improve HCV testing and diagnosis, which is currently inadequate in many parts of the world.

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Bay Area Lyme Foundation Awards Grants to Researchers Exploring Novel Ways to Detect, Treat Lyme disease

Bay Area Lyme Foundation, the leading national nonprofit funder of innovative Lyme disease research, has announced that the winners of its 2017 Emerging Leader Award, are James J. Collins, PhD, Professor, Massachusetts Institute of Technology and Yuko Nakajima, PhD, Postdoctoral Fellow, Brandeis University. Dr. Collins was awarded a $250,000 grant to research an RNA direct detection diagnostic for early Lyme disease, while Dr. Nakajima received a $100,000 grant to investigate potential treatments to block immune evasion by the bacteria causing Lyme disease.

“Lyme disease receives little research attention compared to the scientific challenges it presents, so leveraging learnings from different diseases into the research of Lyme disease is critical,” added Laure Woods, president, Bay Area Lyme Foundation.

Because the most commonly used diagnostic for Lyme disease misses up to 60% of cases of early stage Lyme disease, Dr. Collins seeks to develop a more effective, rapid, inexpensive diagnostic for Lyme disease. His plan is to use RNA technology that has proven effective in developing diagnostics for antibiotic resistance markers, the Ebola virus, and the Zika virus. His lab recently developed a platform for direct detection of RNA that combines programmable molecular sensors called RNA toehold switches with an expression system that can be freeze dried onto paper discs; his goal is to apply this technology to better diagnose Lyme disease in early-stage patients.

“This award affords our team the opportunity to become actively engaged members of the Lyme disease research community as we try to unravel the mysteries of this illness and work to develop a rapid, inexpensive diagnostic test for early Lyme disease,” said James J. Collins, PhD, Termeer Professor of Medical Engineering & Science Professor, Department of Biological Engineering Massachusetts Institute of Technology. Dr. Collins is also affiliated with the Broad Institute of MIT and Harvard, as well as the Wyss Institute for Biologically Inspired Engineering, Harvard University.

Dr. Nakajima’s ELA project focuses on gene conversion. As in cancer, gene conversion was recently shown to be involved in the ability of B. burgdorferi, the bacteria that causes Lyme disease, to change its surface proteins and thus keep the immune system from manufacturing antibodies that match the currently expressed proteins. This ability to change its proteins is mediated by an unusual DNA structure called a G-quadruplex. A drug blocking G-quadruplex activity in cancer cells is currently in clinical trials. Dr. Nakajima will study the G-quadruplex in B. burgdorferi and then test different small molecules to detect which may be most able to block this coping mechanism.

“The bacteria that causes Lyme disease is very complex and I am determined to find a scientific solution that will stop its mechanisms,” stated Dr. Nakajima, a Postdoctoral Fellow in the lab of James E. Haber at Brandeis University. She also performed postdoctoral research at Rockefeller University and served as a research assistant at Lawrence Berkeley National Laboratory.    

The Emerging Leader Awards from Bay Area Lyme Foundation—made possible by a generous donation from the Steven & Alexandra Cohen Foundation —are given annually and designed to be awarded to promising scientists who have identified a defined approach to improved diagnostics or therapies for Lyme disease.

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TECHLAB Receives FDA 510(k) Clearance To Market TRI-COMBO PARASITE SCREEN™ To Detect Giardiasis, Cryptosporidiosis, And Amebiasis

TECHLAB®, Inc., a leading developer and manufacturer of rapid non-invasive diagnostic tests for gastrointestinal diseases, today announced that it received U.S. Food and Drug Administration (FDA) clearance for the TRI-COMBO PARASITE SCREEN™ test. The TRI-COMBO PARASITE SCREEN ™ test provides a complete analysis for Giardia, Cryptosporidium, and Entamoeba histolytica, the three most common intestinal protozoan parasites. It specifically detects pathogenic E. histolytica and does not cross react with non-pathogenic E. dispar.

Giardia, Cryptosporidium, and E. histolytica are the most common parasitic causes of diarrhea in the United States. The TRI-COMBO PARASITE SCREEN™ test is an enzyme immunoassay for the simultaneous qualitative detection of Giardia spp., Cryptosporidium spp., and/or E. histolytica antigen in human fecal specimens. It is indicated as an aid in the diagnosis of gastrointestinal infection when giardiasis, cryptosporidiosis and amebiasis is suspected. "This new and unique assay will make testing for the three most common causes of parasitic gastroenteritis more efficient and cost-effective," said David Lyerly, Ph.D., Chief Scientific Officer, TECHLAB®.

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Sepsis Lab-on-a-Chip Detects Infection in a Single Drop of Blood

A new portable device can quickly find markers of deadly, unpredictable sepsis infection from a single drop of blood.

A team of researchers from the University of Illinois and Carle Foundation Hospital in Urbana, Illinois, completed a clinical study of the device, which is the first to provide rapid, point-of-care measurement of the immune system’s response, without any need to process the blood.

This can help doctors identify sepsis at its onset, monitor infected patients and could even point to a prognosis, said research team leader Rashid Bashir, a professor of bioengineering at the U. of I. and the interim vice dean of the Carle Illinois College of Medicine. The researchers published their findings in the journal Nature Communications.

Sepsis is triggered by an infection in the body. The body’s immune system releases chemicals that fight the infection, but also cause widespread inflammation that can rapidly lead to organ failure and death.

Sepsis strikes roughly 20 percent of patients admitted to hospital intensive care units, yet it is difficult to predict the inflammatory response in time to prevent organ failure, said Dr. Karen White, an intensive care physician at Carle Foundation Hospital. White led the clinical side of the study.

“Sepsis is one of the most serious, life-threatening problems in the ICU. It can become deadly quickly, so a bedside test that can monitor patient’s inflammatory status in real time would help us treat it sooner with better accuracy,” White said.

Sepsis is routinely detected by monitoring patients’ vital signs – blood pressure, oxygen levels, temperature and others. If a patient shows signs of being septic, the doctors try to identify the source of the infection with blood cultures and other tests that can take days – time the patient may not have.

The new device takes a different approach.

“We are looking at the immune response, rather than focusing on identifying the source of the infection,” Bashir said. “One person’s immune system might respond differently from somebody else’s to the same infection. In some cases, the immune system will respond before the infection is detectable. This test can complement bacterial detection and identification. We think we need both approaches: detect the pathogen, but also monitor the immune response.”

The small, lab-on-a-chip device counts white blood cells in total as well as specific white blood cells called neutrophils, and measures a protein marker called CD64 on the surface of neutrophils. The levels of CD64 surge as the patient’s immune response increases.

The researchers tested the device with blood samples from Carle patients in the ICU and emergency room. When a physician suspected infection and ordered a blood test, a small drop of the blood drawn was given to the researchers, stripped of identifying information to preserve patient confidentiality. The team was able to monitor CD64 levels over time, correlating them with the patient’s vital signs. Researchers found that the results from the rapid test correlated well with the results from the traditional tests and with the patients’ vital signs.

“By measuring the CD64 and the white cell counts, we were able to correlate the diagnosis and progress of the patient – whether they were improving or not,” said Umer Hassan, a postdoctoral researcher at Illinois and the first author of the study. “We hope that this technology will be able to not only diagnose the patient but also provide a prognosis. We have more work to do on that.”

Bashir’s team is working to incorporate measurements for other inflammation markers into the rapid-testing device to give a more complete picture of the body’s response, and to enable earlier detection. They also have a startup company, Prenosis Inc., that is working to commercialize the device.

“We want to move the diagnosis point backward in time,” Bashir said. “The big challenge in sepsis is that no one knows when you get infected. Usually you go to the hospital when you already feel sick. So the goal is that someday you can be testing this at home, to detect infection even earlier if you can.”

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Luminex's ARIES Norovirus Assay Receives CE-IVD Marking

Luminex Corporation has announced that it has received CE-IVD marking for the ARIES Norovirus Assay, an easy to use, sample to answer test for rapid detection and differentiation of norovirus genogroup I and II from stool specimens of individuals with symptoms of acute gastroenteritis.

The CDC reports that norovirus is estimated to be the most common cause of acute gastroenteritis worldwide, and each year, norovirus causes over 200,000 deaths and a global economic burden of more than $60 billion.

As the fifth CE-marked assay for use on Luminex's ARIES Systems, the Norovirus Assay adds to a growing menu of tests for the ARIES platform. The system is designed to run in multiple laboratory shifts and allows labs to simultaneously run both IVD and LDT assays in a sample to answer format when using a Universal Assay Protocol.

"We are very excited to add the simple and cost-effective Norovirus Assay to our expanding menu of assays for ARIES," said Thomas Pracht, managing director of Luminex Europe. "The ARIES Norovirus Assay offers excellent performance for high confidence in results and reduced hands-on time compared to other molecular assays. Further, by enabling rapid and accurate diagnosis even outside office hours, the assay can expedite appropriate infection control measures."

ARIES Systems automate all aspects of testing, from sample preparation through analysis, providing answers in less than 2 hours with minimal hands-on time while enabling easy implementation on weekends and night shifts. The ARIES Norovirus Assay, a real-time polymerase chain reaction (PCR)-based qualitative in vitro diagnostic test, is part of Luminex's comprehensive gastroenterological testing menu that also includes the xTAG Gastrointestinal Pathogen Panel (GPP), VERIGENE Enteric Pathogens Test (EP), and the ARIES C. difficile Assay (RUO).

The ARIES Norovirus Assay is intended to aid in the diagnosis of norovirus infections when used in conjunction with clinical evaluation, laboratory findings, and epidemiological information. The assay also aids in the detection and identification of norovirus infections in the context of outbreaks.

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