Thursday, April 08, 2021

Israeli Company Develops Faster, More Comprehensive Tuberculosis Test

Israeli tech company BATM Advanced Communications Ltd. announced on Monday that they have received full funding to develop a new rapid molecular diagnostics test for Tuberculosis (TB), which is expected to begin its testing and validation phases in the second half of 2021.

The testing and validation phases will be fully funded by Stop TB Partnership, an international alliance which is comprised of over governmental and non-governmental organisations in more than 100 countries, all dedicated to eliminating the disease.

While current gold standard tests take days to return results and have issues determining antibiotic resistance, BATM's new test returns results within approximately two hours, identifying the strain and its resistance to antibiotics. 

It does this using a combination of a one-step PCR test, developed by BATM subsidiary Adaltis, with a NATlab instrument, which uses a new isothermal RCA process developed by BATM's associate company, Ador Diagnostics. 

The testing and validation of the test will take place at the University of Heidelberg, with BATM anticipating it will officially begin selling them next year.

BATM CEO Dr. Zvi Marom said the company was delighted about the new testing method and the funding and research announcements, saying they believe it "will be particularly crucial in preventing the spread of drug-resistant TB strains." 

"We also expect our solution to be more affordable and accessible than those used today," he said.

Dr. Marom elaborated, saying that "The devastating health, social and economic consequences of TB have been with us for centuries and are still here today. It is vital that we develop innovative solutions and systems that will enable this disease, which is a leading cause of death but is both preventable and curable, to be eradicated." 

He said that advances in molecular diagnostics have caused science to enter "a new era in the fight against infectious diseases." 

"I believe that BATM has an important role to play in this as we focus on developing new, innovative technologies while continuing to provide critical solutions to combat COVID-19," he concluded.

TB is one of the top 10 causes of death worldwide and the leading (non-pandemic) cause from a single infectious agent The WHO estimates that around three million cases go undiagnosed each year.

Drug-resistance, which can emerge through the prescription of incorrect treatment, in TB is an increasing public health issue and a health security threat.  TB can also cause other severe illnesses, such as meningitis, and can be an early indicator for HIV infection.

However, "with rapid and accurate diagnosis," BATM says, "TB is preventable, treatable and curable in most cases."

MatMaCorp Launches MYRTA, a New Hand-Held Real-Time PCR Device for POC and OTC Molecular Diagnostics

MatMaCorp (Materials and Machines Corporation), a developer of comprehensive molecular diagnostic systems, today announced the launch of its new hand-held device capable of conducting polymerase chain reaction (PCR) amplification and real-time fluorescent detection, anytime, anywhere. The device, called MYRTA™ (MY Real-Time Analyzer) was developed to provide portable, PCR-based molecular diagnostic solutions for human and animal health.

“The COVID-19 pandemic has highlighted the substantial need for over-the-counter and point-of-care testing to detect viruses, like SARS-CoV-2, and other disease-causing agents, at any time and any location in the world,” said Dr. Abe Oommen, MatMaCorp founder and President. “Almost all of the current handheld molecular diagnostic solutions have focused on isothermal amplification methods, but real-time PCR is still the gold standard for diagnostics that require high sensitivity and specificity.”

Real-time PCR is the primary method to reliably detect active infection of SARS-CoV-2 (the coronavirus that causes COVID-19) in patient samples. Efforts at developing easy-to-use and affordable over-the-counter (OTC) and point-of-care (POC) devices have been constrained by the fact that RNA or DNA isolation from samples must be integrated into the PCR amplification and detection steps. This has resulted in PCR-based methods for OTC and POC devices being side-lined, regardless of the fact that real-time PCR is the benchmark by which other molecular tests are measured. MatMaCorp successfully overcame these issues in the development of MYRTA, which can simultaneously conduct PCR amplification and rapid, real-time fluorescence detection.

“The ability to detect nucleic acids in real-time while running PCR amplification directly from the sample is a game changer in molecular diagnostics,” said Dr. Oommen. “Our flexible, robust, and portable MYRTA device will enable the use of PCR in numerous situations, making point-of-care and over-the-counter PCR-based testing possible in any part of the globe. Remote hospitals and clinics, as well as the military, can use this device to monitor disease causing pathogens.”

MatMaCorp has demonstrated accurate detection of SARS-CoV-2 and influenza A and B viruses directly from samples. In addition to human health applications, the MYRTA system could also be used in animal health, as shown by its ability to detect porcine reproductive and respiratory syndrome virus (PRRSV), a virus that causes major respiratory disease in pigs.

MatMaCorp plans to submit the MYRTA system to the U.S. Food and Drug Administration’s (FDA) for consideration of Emergency Use Authorization (EUA) for COVID-19 in the coming months. The FDA previously granted EUA to MatMaCorp’s COVID-19 2SF RNA test for the detection of SARS-CoV-2 on the company’s Solas 8 portable detection system.

binx health Receives FDA CLIA Waiver for Chlamydia and Gonorrhea Test

binx health, a population health technology company that provides convenient healthcare solutions, announced today that the US Food and Drug Administration (FDA) has granted Clinical Laboratory Improvement Amendments (CLIA) waiver for the binx io system, a first-of-its kind molecular point-of-care testing platform capable of delivering central laboratory quality results in about 30 minutes, for the detection of chlamydia (CT) and gonorrhea (NG). The platform was previously 510(k) cleared by the FDA for testing male and female samples in moderate and high-complexity locations.

"With ever increasing sexually transmitted infection (STI) rates, point-of-care and CLIA-waived platforms like the binx io are essential additions to our STI control toolbox, which will increase accessibility and decrease the burden on traditional healthcare settings," said Barbara Van Der Pol, PhD, MPH, Professor of Medicine and Public Health at University of Alabama at Birmingham.

CLIA waiver clearance allows binx to facilitate single visit testing for CT/NG in any of the more than 220,000 locations across the Unites States holding a CLIA certificate of waiver, including convenient and accessible locations such as OBGYN and primary care offices, urgent care facilities, community health clinics, STD clinics and retail settings. Single-visit diagnosis and treatment have the potential to improve treatment compliance and reduce STI transmission across communities.

"Clinicians on the front lines of sexual health and wellness have long needed options for rapid diagnostic tools to address the epidemic growth in STIs. In a healthcare landscape where consumer convenience and rapid answers are an imperative, the binx io is the first chlamydia and gonorrhea test to be used in near patient settings combining the features essential to meet these needs in a critically important area of sexual health," said Jeffrey Luber, binx Chief Executive Officer. "The io Instrument's demonstrated clinical effectiveness, ease of operation, and patient convenience make it a much-needed tool with transformative implications for public health, especially now during the COVID-19 pandemic where STI prevention services nationwide have been dramatically reduced or cut altogether as resources have been allocated to focus on the COVID response. We are grateful to the countless scientists, physicians, and key opinion leaders who played an important role in today's watershed event."

The CDC estimates that 1 in 5 people in the U.S.1 have an STI; based on CDC and USPSTF guidelines There are an estimated 108M people in the United States, for whom regular STI testing is appropriate.2 3

Today, nearly all CT/NG tests are processed at central laboratories, with a delay between diagnoses and treatment in many cases of several days or more, which often results in infected patients not returning for treatment. Data show that treatment delays may lead to onward transmission and serious health consequences particularly in women, with 10-15% of un-treated women experiencing Pelvic Inflammatory Disease and nearly 30,000 cases of infertility annually in the US related to undetected chlamydia4. Due to these delays, and potentially detrimental follow-on health effects, published data5 also show that clinicians are more likely to presumptively treat symptomatic patients with antibiotics while the patient is in the clinic rather than wait for central laboratory test results. Inappropriate antibiotic treatment can promote antimicrobial resistance and can contribute to the onward transmission of the untreated infection.

The CLIA waived status allows for expansion by permitting the binx io, through its national commercial distribution partnership with McKesson, to be placed in the over 220,000 CLIA-waived locations nationwide.

IIT Delhi Develops Handheld Device For Early And Rapid Diagnosis Of Dengue

Dengue is a serious global health concern with a large population around the world facing the risk of getting infected. Early diagnosis of dengue is the key to prevent deterioration of a patient’s health. However, conventional diagnostic tools like nucleic acid detection using Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) is a time taking proess and it also requires expensive equipments and reagents for the diagnosis of dengue.

These types of common diseases require a rapid, scalable and point-of-care diagnosis to be implemented at the community level and to reduce the workload of healthcare professionals. Understanding this, the GLancing Angle Deposition (GLAD) research group at IIT Delhi’s Physics Department has developed a handheld Surface Enhanced Raman Spectroscopy (SERS) based platform for early diagnosis of dengue virus. It also gives dengue test results within one hour (rapid diagnosis).

The handheld device has been succsessfully tested on the clinical blood samples collected from hundreds of individuals in collaboration with ICMR-National Institute of Malaria Research (NIMR), New Delhi.

Principal Investigator of the project and Professor in the Department of Physics, IIT Delhi, Prof. J.P. Singh’s research group is known for the synthesis of nanoscultptured thin films using a specialized technique called GLAD. This technique was employed to fabricate silver nanorods array based SERS active biosensors in order to detect pathogens. Only 2 microlitres of a diluted serum was dropcasted on the SERS substartes and Raman spectra were collected by flashing 785 nm laser beam through the device. All the data were fed in a statistical tool principal component analyzer (PCA) software. The intergrated device was able to clearly differentiate the three sets of blood samples; dengue positive, negative and healthy. This method provides a sensitive, rapid, and field deployable diagnosis of dengue at the early stage.

The research work was funded by IMPRINT India program of the Ministry of Education with New Age Instruments and Materials Pvt Ltd as the industry partner. The research was published in the journal Analytical Chemistry 92, 2527-2534 (2020).

The detection and distinction of human immunodeficiency virus (HIV-1) was also carried out in collaboration with ICMR-National AIDS Research Institute (NARI), Pune through the handheld SERS based platform. Binding of viruses directly on Ag nanorods without using antibodies or intermediate reagents was successfully demonstrated. The SERS platform was capable of distinguishing different tropic strains of HIV-1 suggesting tropism-based detection. The SERS based platform gives HIV-1 test results within an hour.

Speaking of the hand-held device, the project’s PI, Prof. J.P. Singh, IIT Delhi said, “This ultrasensitive and handy device has wide range of applications in the early-stage on-site detection of viral diseases and can produce the final report of investigation within an hour.” The research work was published recently in journal Colloids and Surfaces B: Biointerfaces 198, 111477 (2021)

Ultra-sensitive and Rapid Diagnostic Developed to Detect Ebola

An interdisciplinary team of scientists at Duke University has developed a highly sensitive and rapid diagnostic test for Ebola virus (EBOV) infection. In monkeys infected with Ebola, this diagnostic, called the D4-assay, proved to be 1000 times more sensitive than the currently approved rapid diagnostic test and capable of detecting the virus a full day earlier than the gold standard polymerase chain reaction (PCR) test.

This work, which appears in Science Translational Medicine on April 7, was done by biomedical engineers, molecular biologists, and immunologists at Duke University, and the University of Texas Medical Branch in Galveston and the Galveston National Laboratory.

Ebola virus gained global notoriety in early 2014 after an outbreak began spreading across the populous capital cities in Guinea, Liberia and Sierra Leone in Western Africa. By the time the pandemic was officially declared ended in 2016, more than 28,000 people had been infected and more than 11,300 people had died of the virus.

As of March 2021, there are two ongoing Ebola outbreaks in the Democratic Republic of the Congo that have resulted in more than 2,200 deaths, and Guinea declared a new outbreak of Ebola virus disease (EVD) after a cluster of cases appeared in February.

Early treatment and contact tracing of Ebola virus disease is critical for two reasons: First, patients are highly contagious once they begin showing symptoms, and early diagnosis can help contain the spread of EVD by make contact tracing and patient isolation easier. Second, the fatality rate of EVD can be as high as 90 percent if left untreated or treated late, but can be reduced to roughly 10 percent with monoclonal antibodies if patients are treated early in the infection.

The current gold standard for detecting Ebola virus is the reverse transcriptase polymerase chain reaction (RT-PCR) test, which identifies and amplifies viral RNA. Although RT-PCR has proven to be sensitive and capable of diagnosing Ebola infection much earlier than current alternatives, it has been difficult to implement in the remote settings where EVD outbreaks frequently originate.

Recent advances in RT-PCR test design have made it easier for untrained technicians to use the platform and reduced the need for expensive equipment. However, at $22.50 per test, the platform is expensive and, because it is lab-based, can be slow. In some studies, the median time required to confirm a diagnosis in the field is 6 days, making it a suboptimal tool when dealing with a highly contagious virus.

The current alternate diagnostic option is lateral flow assays, which detect antibodies or antigens that appear during an infection. These tests are cheaper, easy to use, and typically yield results in less than 30 minutes, but the trade-off is a greatly diminished sensitivity, so there is a greater possibility of the test missing an early infection.

To help address the shortcomings of both tests, the Duke team adapted the D4 assay, an ultrasensitive, point-of-care diagnostic previously developed by the Ahsutosh Chilkoti lab, to quickly and accurately detect secreted glycoprotein (sGP), a biomarker produced by the Ebola virus during the early stages of infection.

Besides Chilkoti, the Alan L. Kaganov Distinguished Professor of Biomedical Engineering, the team included Cassio Fontes, a former graduate student and now a senior research scientist in the Chilkoti lab, Michael Gunn, MD, a professor of medicine and immunology, and Barbara Lipes, an assistant professor of medicine at the Duke University School of Medicine.

"Prior studies suggested that Ebola virus produces secreted glycoprotein at high levels early in infection to act as a decoy and distract the immune system while the virus replicates and binds to the host cells," Fontes said. "We thought that if we could detect that, we could help facilitate earlier diagnosis, containment, and treatment during Ebola outbreak."

However, antibodies against sGP were not available, so Lipes, an antibody engineering expert in the Gunn lab, created a large library of antibodies that bind to sGP and screened for the antibodies that bound most strongly.

The two labs then worked together to identify the capture-detection antibody pair that provided the greatest sensitivity on the D4 platform.

The D4 assay for Ebola is made by inkjet printing these two antibodies against secreted glycoprotein onto a glass slide: detection antibodies, which are tagged with a fluorescent marker, and capture antibodies, which are primed to bind the target antigen. When a drop of blood or a throat or nose swab is placed on the slide, the detection antibodies separate from the array and bind to the target in the sample. These antibody-biomarker complexes then attach to the capture antibodies on the slide, which glow to indicate a capture.

To further improve sensitivity, the D4 assay is printed on a stealth polymer brush coating developed by the Chilkoti lab, which prevents non-target proteins from attaching to the slide's surface. This removes any 'background noise' on the chip, making it easier to detect very low levels of the target proteins, which makes the D4 assay very sensitive.

In parallel, the Chilkoti lab also developed a cheap but highly sensitive hand-held detector -- the D4Scope -- to read the results of the D4 assay.

"Jason Liu, a graduate student in my lab, worked to develop the D4Scope, which is a low-cost, battery-powered, compact, wide-field fluorescence reader that can image microarray spots with high sensitivity," Chilkoti said. "It was specifically designed using off-the-shelf components, so that parts could easily be replaced if the reader was damaged in the field."

To test their platform, the team worked with collaborators at the University of Texas Medical Branch in Galveston, where they showed that the D4 assay could detect EBOV in non-human primates a full day earlier than the RT-PCR.

"We've put the lateral flow assay to shame, sensitivity wise," said Fontes. "This is exciting because by understanding the biology of this virus, we've shown that there may be a target to look for where immunoassays like the D4 can outperform the PCR. It's really breaking new ground."

As the team moves forward, they aim to continue to refine their platform with the goal of shortening the time to results from 60 minutes to 30 minutes. Experiments are underway using molecular evolution to increase the sensitivity of the capture and detection antibodies.

They are also improving the design of the platform to make it a fully self-contained test. This would mean that users would only need to add a drop of blood to one port of a flow cell and a buffer solution to a second port to run the test under gravity flow. These changes would also allow for improved biocontainment and biosafety when handling potentially dangerous fluids.

Once these changes are made, the team hopes to coordinate clinical experiments in the field.

"I think it's a tremendous opportunity to really change the way Ebola testing works," Gunn said.

"When controlling an outbreak, it's key to identify the infected and be able to trace their contacts very quickly, and our hope is that test would allow you to do that," Gunn said. "With such a simple and rapid assay, you can also quickly screen people who are at risk of having contracted Ebola. It seems simple, but in the grand scheme of things could represent the difference between an outbreak and a pandemic."

This research was funded by the National Institutes of Health (NIH, R01AI150888; U19AI142785; UC7AI094660), the US Special Operations Command (w81XWH- 16C-0219), the National Council for the Improvement of Higher Education and the Science Without Borders project. Partial support was provided by the Department of Health and Human Services. The team also received the support of the Biosafety Level 4 (BSL-4) lab at the Galveston National Laboratory.

Competing Interests: The underlying technology of the D4 was developed by Angus Hucknall and Ashutosh Chilkoti, and was acquired by Immucor Inc (Norcross, GA) in 2014. The other authors declare no competing financial interests.

REFERENCE

"Ultrasensitive Point-Of-Care Immunoassay for Secreted Glycoprotein Detects Ebola Infection Earlier Than PCR," Cassio Fontes, Barbara Lipes, Jason Liu, Krystle Agans, Aiwei Yan, Patricia Shi, Daniela Cruz, Garrett Kelly, Kelli Luginbuhl, Daniel Joh, Stephanie Foster, Jacob Heggestad, Angus Hucknall, Maiken Mikkelson, Carl Pieper, Roarke Horstmeyer, Thomas Geisbert, Michael Gunn, Ashutosh Chilkoti. Science Translational Medicine, April 7, 2021. DOI 10.1126/scitranslmed.abd9696

Friday, March 19, 2021

Microtox® BT Evaluation of SARS-CoV-2 from Breath Test with Clinical Samples

DeepVerge, the environmental and life science AI company, announces initial data for ongoing Phase III clinical studies on the detection of SARS-CoV-2 on breath samples and identification of confirmed COVID19 positive patients.

Since Q3 2020, DeepVerge scientists have been working under laboratory conditions with the Spike Protein (“S-Protein”) of SARS-CoV-2 on the SARS-CoV-2 virus inside the Containment Level 3 (“CL3”) laboratories at the University of Aberdeen. In these studies, they have detected and identified the virus S-Protein in quantities at 40 femtogrami per millilitre (“Fg/mL”) at close to 100% sensitivity and specificity on DeepVerge’s Microtox® BTii nano-optofluidic chip.

In addition, under the clinical trial supervision of the Royal College of Surgeons, Ireland, 40 subjects, 16 of which were independently confirmed as COVID19 positive with PCRiii tests, provided breath samples that were tested on the Microtox® BT nano-optofluidic chip surface with Affimer® reagents (“Avacta Group”)iv and Optimers (“Aptamer Group”)v together the (“Binding Agents”).

The breath samples detected binding on the nano-optofluidic chip with a secondary antibody to the Spike Protein which was initially selected for the isolated spike protein work. Detection of the live virus was confirmed indicating 9 times increase in the digital spectrum signal on the Microtox® BT when compared to controls of nano-optofluidic chips with binding agent; and 19 times increase in signal with nano-optofluidic chips without binding agents. Additional digital background noise was indicated due to the non-specific binding of the antibody. Further data is required to confirm the same high sensitivity and specificity is achieved on breath test clinical trials which are underway.

Gerard Brandon CEO of DeepVerge plc commented:

“DeepVerge scientists have transformed its AI based water contamination detection system, developed over five years for e.coli, into the breath condensate Microtox® BT unit. Having successfully completed Phase I testing on the Spike Protein and Phase II studies with SARS-CoV-2 virus in the safety of CL3 laboratories, the initial results of Phase III real-world clinical studies in COVID19 patients have reached a major milestone with the demonstration that our Microtox® BT can deliver results in under 60 seconds from breath samples.

“The requirement for the UK Target Product Profile (“TPP”) Rapid Breath Test requires 150 confirmed positive samples and 250 confirmed negative samples. Additional supervised breath test clinical trials from a larger group is expected to provide sufficient data to meet the desired and acceptable criteria in the TPP to roll out the COVID19 and other pathogen breath tests later this year.”

Tracking progress of the stages of the infection

The Company notes the publicationvi by UK Medicines & Healthcare products Regulatory Agency (“MHRA”) of the “Target Product Profile Rapid Breath Tests for the direct and indirect detection of SARS-CoV-2”. Microtox® BT satisfies many of the “Desired” and “Acceptable” criteria within the document.

Subject to the limitations of the Binding Agents’ ability to capture the virus, the Microtox® BT breath test does or does not see the virus, eliminating false positives and enabling each test the potential to predict the following conditions:

• Asymptomatic and non-infectious,

• Asymptomatic and infectious,

• Symptomatic and infectious, and

• Symptomatic and non-infectious

Point-of-Care makes it possible to track and trace the progress of the stages of any infection, including COVID19, subject to the type of pathogen (bacteria, virus, fungi or parasite) or biomarker of a disease being targeted by the Binding Agents.

AI algorithms are designed to assess the risk of steric hindrance, in the case of SARS-CoV-2, by the capture of one S-Protein and one viral particle, blocking the binding of other viral particles in the immediate vicinity.

With ability to detect and identify the binding of individual S-Proteins at Fg/mL, the viral particle can be calculated to generate a bigger shift in the laser signal. Using AI, this relates back in Fg/mL of S-Proteins which indicates a viral load for each test subject.

The joint development program of work on the PBM-HALETM breath condensate device from PulmoBioMed is ongoing using multiplex bio-marker binding agents to analyse breath for 40 other diseases which include cancer, neurodegenerative, respiratory and metabolic conditions.

Winers Selected in XPRIZE Rapid Covid testing Competition

XPRIZE, the world’s leader in designing and operating incentive competitions to solve humanity’s grand challenges, is pleased to announce today the five winning teams in the $6M XPRIZE Rapid Covid Testing competition, with each winner creating high-quality, affordable COVID-19 testing to help society safely reopen and return to everyday activities. 

Chosen by an independent panel of judges, the grand prize winning solutions are radically affordable compared to what is currently available on the market; and are comparable to commercial offerings at measuring sensitivity, specificity and limit of detection, with a maximum turnaround time of 12 hours from sample to result

The winning teams are: 

Reliable LFC, LLC, Antigen Testing, Carlsbad, United States

ChromaCode, RNA Testing, Carlsbad, United States

Mirimus, RNA Testing, Brooklyn, United States

La Jolla Institute for Immunology, RNA Testing, La Jolla, United States

Alveo Technologies, RNA Testing, Alameda, United States

“We are thrilled to announce the winners of the XPRIZE Rapid COVID Testing, which awarded multiple winners with unique testing solutions to help prevent future supply chain problems,” said Anousheh Ansari, CEO of XPRIZE. “We started this journey to ensure communities across the globe have access to fast, affordable, and easy-to-use COVID-19 tests. We are grateful to have the best entrepreneurial and scientific teams on board to help bring their solutions to scale so we can properly reopen schools, businesses, and other vital institutions around the world.”

Following the December finalist announcements, the 20 teams sent their testing kits and protocols to two separate laboratories, for clinical validation. The independent judges, composed of diverse experts in the healthcare and COVID-19 space, reviewed each team’s lab results, testing concepts, and proposals before deciding on the winners. 

“While vaccines are important, we cannot rely on them alone to prevent the spread of the coronavirus and future outbreaks, especially not until they are provided around the world, en masse and at-scale,” said Jeff Huber, President & Co-Founder of OpenCovidScreen. “These technological breakthroughs in rapid covid testing are providing a safety net to ensure the spread of the disease is contained and to enable a safe return to work and school, and to protect hotspots like nursing homes. These advancements are key to helping underserved, under-resourced communities get access to affordable, accurate tests and to ultimately save more lives now and in the future.”

Additionally, four other teams were selected as winners in the Open Innovation Track, whose approaches demonstrated high potential for impactful screening solutions, but could not be categorized as polymerase chain reaction (PCR), Isothermal Amplification, Next Generation Sequencing, or Antigen Detection and could not be tested through the competition rounds. 

The four winning teams in the Open Innovation Track are: 

Steradian Technologies, Inc., Houston, United States

U-smell-it, Guilford, United States

Ram Global, Zweibr├╝cken, Germany

TeraGroup, Herzliya, Israel

The XPRIZE Rapid Covid Testing judges included:

Dr. Rick Bright, Ph.D, Immunology and Molecular Pathogenesis

Shawna Butler, R.N. M.D.A., Nurse Economist

Dr. Charity Dean, CEO and Co-Founder, The Public Health Company

Dr. Paul Drain, Associate Professor, Departments of Global Health, Medicine and Epidemiology at the University of Washington

Dr. Anita Goel, Physicist and Physician, Chairman and CEO, Nanobiosym

Dr. Michael Mina, Physician-Scientist and Assistant Professor, Epidemiology and Immunology and Infectious Diseases at the Harvard School of Public Health

Dr. Anne Wyllie, Associate Research Scientist, Yale School of Public Health

“The competition was open to all modalities of molecular testing, and the teams submitted an impressive range of ideas. The winners created innovative technologies in rapid PCR, novel antigens, and point-of-care LAMP as well as pioneering some of the first-ever olfaction and breathalyzer tests,” said Chris Mason, Leader of the Science Team and a Professor at Weill Cornell Medicine.

Launched this past July amid the COVID-19 pandemic, this prize comes out of the XPRIZE Pandemic Alliance to bring researchers, innovators, institutions, corporations, and governments together to share ideas and resources in the fight against the current and future pandemics. Since launch, 85 organizations have joined the Alliance, where they have been able to share ideas and research through its digital collaboration platform Exchange, as well as through the XPRIZE Data Collaborative, a unique platform for innovators to collaborate, share and learn from data in a broad spectrum of fields in their search for solutions. 

To amplify impact, a $50 million COVID Apollo Project led by experienced life sciences investors and company builders – including RA Capital, Bain Capital, Perceptive Advisors, Redmile Group, and Samsara Biocapital – will work with OpenCovidScreen, the XPRIZE community, and beyond to accelerate the best ideas, technologies, and innovations to market and scale them.

The Anthem Foundation and Anthem, Inc., serve as the Founding Anchor Partners of XPRIZE Rapid Covid Testing. Seven major national and regional health plans are collaborating as founding partners: Blue Shield of California, Cambia Health Solutions, Inc, Health Care Service Corporation, GuideWell Mutual Holding Corporation, Horizon Healthcare Services, Inc. (NJ), BlueCross BlueShield of South Carolina. Supporting partners include leading healthcare, laboratory and technology companies: Google, Amazon, Ilumina, Ancestry, Testing for America, Thermo Fisher Scientific, Exact Sciences, Centerview Partners, Twist Bioscience, Opentrons, HudsonAlpha Institute for Biotechnology, Weill Cornell Medicine , Biotia, Inc and Medical College of Wisconsin.

Teams will work the remainder of the year to accelerate the adoption of their solutions on a massive scale. XPRIZE will oversee the development of a multimedia playbook documenting the testing protocols,plans implemented and lessons learned at deployment sites where this incredible testing technology will be rolled out. XPRIZE is currently inviting communities like schools, offices, factories, nursing homes, homeless shelters, and other communities to apply to be part of this innovative roll-out. 

Scientists Evaluate Handheld DNA Sequencers for Microbial Monitoring of Food

Researchers have evaluated a handheld DNA sequencing device for use in environmental monitoring at food factories.

The study, by researchers from the Teagasc food research program and APC Microbiome Ireland’s Science Foundation Ireland Research Centre, tested portable DNA sequencers as a routine microbial monitoring tool in food production facilities. It was funded by the Department of Agriculture, Food and the Marine (DAFM).

Small, portable, DNA sequencers provide the first steps toward real-time industry paced microbial classification and analysis, said researchers in the journal npj Science of Food.

Microbes in food can cause spoilage and disease, so routine checks in production sites are necessary. Accurate identification of microorganisms in the food chain allows sources of contamination to be identified and control measures to be put in place. However, current techniques, while tried and tested, have some limitations, researchers reported.

Advancing microbiology

“Microbiology testing in the food chain has, and continues to, rely on older, classical microbiology testing such as the use of agar and petri dishes. This is a time-consuming approach and only microorganisms that are being specifically tested for are identified,” said professor Paul Cotter, the study’s senior author.

Instead of culturing bacterial samples in petri dishes, DNA sequencing can rapidly analyze bacterial DNA and identify the species in a sample. However, conventional sequencing involves expensive lab-based equipment and only highly trained technicians can do the procedure and analyze results. This means it isn’t a good fit for routine microbial surveillance in busy food production plants.

Professor Cotter and colleagues, led by Aoife McHugh, compared the performance of Oxford Nanopore Technologies and Illumina sequencing to culture-based methods for environmental monitoring of a dairy plant.

Oxford Nanopore’s MinION handheld device was similar to the larger lab-based sequencing system in terms of the number of bacterial species it could identify in samples, suggesting it has potential as a routine monitoring device in food production. However, the small device requires a minimum amount of DNA before it can function correctly.

A step toward non-experts using DNA sequencing tools

Eight locations in the facility were swabbed on three different days in October, November, and December 2018, after cleaning in place but before the next round of dairy processing.

In the cleaned dairy facility there weren’t enough bacteria in many of the samples, so researchers had to perform an extra step to amplify the bacterial DNA before there was enough to analyze. They said further development of the technology may help to overcome this issue.

Researchers previously determined the ability of MinION-based rapid sequencing to correctly classify a four-strain, mock community of related spore-forming microorganisms of relevance to the dairy processing chain including Bacillus cereus, which can cause infections in humans.

Cotter said the use of DNA sequencing technologies to enhance food quality and safety can have an impact on everyday life.

“This study represents a key step toward a day when non-experts can use DNA sequencing tools to carry out microbiology testing in the food chain.”

Reference:

McHugh, A.J., Yap, M., Crispie, F. et al. Microbiome-based environmental monitoring of a dairy processing facility highlights the challenges associated with low microbial-load samples. npj Sci Food 5, 4 (2021). https://doi.org/10.1038/s41538-021-00087-2

Source: Food Safety News

Tuesday, March 09, 2021

Rutgers Develops Rapid Test to Detect New Emerging Coronavirus Variants

Rutgers researchers have designed a new rapid test that can detect all three of the rapidly spreading variants of the coronavirus in a little over one hour – much shorter than the three to five days required by current tests, which can also be more technically difficult and expensive to perform.

Details and information on easily creating and running the rapid test – which is not being patented by Rutgers because researchers believe it should be widely available to the public -- are published on the pre-print online server, MedRxiv, and is available at no charge.

The Rutgers researchers designed and clinically validated the test, which is the first to use “sloppy molecular beacon probes,” which are highly sensitive and specific DNA sequences used to detect frequent mutations in organisms.

“This rapid test was developed and tested over a few weeks in a crash program to respond to a serious public health need,” said David Alland, director of the Rutgers New Jersey Medical School Public Health Research Institute and professor and chief of infectious disease at Rutgers NJMS. “Despite our hurry to get the test completed, it performed extremely well with clinical samples in our initial studies. We are very pleased with these results and we hope that this test will help in the control of the rapidly evolving COVID-19 pandemic.”

The new more contagious variants, isolated in the United Kingdom, South Africa and Brazil, appear to be more easily transmitted, cause more severe disease and may be more resistant to some of the approved COVID-19 vaccines.

The new rapid test is easy to set up and can be adapted for labs that use varying types of equipment and methods. The Rutgers researchers said users are free to use the test as described or modify it as needed, although they strongly suggest that additional validation be done for any test modifications.

Researchers are also working to expand their test to more precisely differentiate among the three main viral variants and they expect to release a new and larger test menu along with supporting evidence in the next several weeks. Additional test modifications will be released in the future as additional variants emerge.

David Alland, Padmapriya Banada, Soumitesh Chakravorty, Raquel Green and Sukalyani Banik were co-researchers at Rutgers who helped develop the test.