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.

UGA Researchers Develop New Rapid Test for Fusarium Watermelon Disease

Fusarium wilt, caused by a soilborne fungus, is one of the most damaging diseases of watermelons worldwide. Since it was discovered in 1894, it’s been a battle for producers to manage through crop rotation and chemical fungicides.

The fungus is persistent in both seedless and seeded varieties, and its spores can last for many years in the soil. While there are some watermelon varieties with known resistance, they are not resistant to all strains of the pathogen.

University of Georgia researchers have now developed a faster way to detect the disease’s presence and determine the races, or groups of strains, of the pathogen Fusarium oxysporum f. sp. niveum (FON) that cause the disease.

“At the microscopic level, you can diagnose Fusarium, but you can’t differentiate the races,” Emran Ali in the Department of Plant Pathology at the College of Agricultural and Environmental Sciences said. “Traditional bioassay methods have been used for this, but it takes weeks to grow watermelon plants and evaluate the disease, and watermelon cultivars used for the bioassay can be difficult to source. This method is not only inefficient, it is also sometimes inaccurate.”

The new molecular detection method, published in the International Journal of Molecular Sciences, allows differentiation of the different races of the pathogen.

Ali, who is head of the Plant Molecular Diagnostic Laboratory at the UGA Tifton campus, worked with Pingsheng Ji, a professor of plant pathology, and Owen Hudson, a graduate student in the department, as well as faculty at the University of Florida and Clemson University to identify more than 160 Fusarium samples collected from Georgia, Florida and South Carolina. Most of the results matched those done with the traditional bioassay method for the same samples.

The new process should improve the speed and accuracy of current diagnostic ability for FON races and facilitate research in related areas — especially breeders who are developing new varieties — to develop options such as host resistance against the disease.

“The whole process takes about three hours to diagnose races; traditional bioassay takes more than a month, at least,” Ali said.

Determining the races can help farmers better mitigate the issue and make the right management decisions. So far, four races of FON have been identified. Some commercial watermelon varieties are resistant to races zero and one, but not races two and three.

“Resistant watermelon varieties are effective against some races but not others,” Ali said. “If you quickly diagnose, growers can have more time in advance to know what’s going on in their fields. It’s good to know what’s going on. Watermelon varieties resistant to races zero and one are available, so you may grow resistant varieties to control disease caused by these races; other races are more destructive and more difficult to control.”

Georgia is continually a national leader in watermelon production, ranking second or third each year. The crop’s farm gate value was $180 million in 2019 and, with already thin profit margins, finding more efficient ways to battle diseases like Fusarium wilt could make a big difference for farmers.

Ali and his team at the Plant Molecular Diagnostic Laboratory also have developed faster tools for tracking other pathogens, including cucurbit leaf crumple virus in vegetables, dollar spot in turfgrass, citrus greening disease, root-knot nematodes in pecans, and irrigation water molds that can cause root rot. They say they hope these new detection methods will not only save time but also reduce pathogen prevalence in the field.

Coronavirus-like Particles Could Ensure Reliability of Simpler, Faster COVID-19 Tests

Rapid COVID-19 tests are on the rise to deliver results faster to more people, and scientists need an easy, foolproof way to know that these tests work correctly and the results can be trusted. Nanoparticles that pass detection as the novel coronavirus could be just the ticket.

Such coronavirus-like nanoparticles, developed by nanoengineers at the University of California San Diego, would serve as something called a positive control for COVID-19 tests. Positive controls are samples that always test positive. They are run and analyzed right alongside patient samples to verify that COVID-19 tests are working consistently and as intended.

The positive controls developed at UC San Diego offer several advantages over the ones currently used in COVID-19 testing: they do not need to be kept cold; they are easy to manufacture; they can be included in the entire testing process from start to finish, just like a patient sample; and because they are not actual virus samples from COVID-19 patients, they do not pose a risk of infection to the people running the tests.

Researchers led by Nicole Steinmetz, a professor of nanoengineering at UC San Diego, published their work in the journal Biomacromolecules.

Journal Reference:

Soo Khim Chan, Pinyi Du, Caroline Ignacio, Sanjay Mehta, Isabel G. Newton, Nicole F. Steinmetz. Virus-Like Particles as Positive Controls for COVID-19 RT-LAMP Diagnostic Assays. Biomacromolecules, 2021.


This work builds on an earlier version of the positive controls that Steinmetz's lab developed for the RT-PCR test, which is the gold standard for COVID-19 testing. The positive controls in the new study can be used not only for the RT-PCR test, but also for a cheaper, simpler and faster test called the RT-LAMP test, which can be done on the spot and provide results in about an hour.

Having a hardy tool to ensure these tests are running accurately -- especially for low-tech diagnostic assays like the RT-LAMP -- is critical, Steinmetz said. It could help enable rapid, mass testing of COVID-19 in low-resource, underserved areas and other places that do not have access to sophisticated testing equipment, specialized reagents and trained professionals.

Upgraded positive controls

The new positive controls are essentially tiny virus shells -- made of either plant virus or bacteriophage -- that house segments of coronavirus RNA inside. The RNA segments include binding sites for both of the primers used in the PCR and LAMP tests.

"This design creates an all-in-one control that can be used for either one of these assays, making it very versatile," said first author Soo Khim Chan, who is a postdoctoral researcher in Steinmetz's lab.

The team developed two types of positive controls. One was made from plant virus nanoparticles. To make them, the researchers infected cowpea plants in the lab with cowpea chlorotic mottle virus and then extracted the viruses from the plants. Afterwards, the researchers removed the virus' RNA and replaced it with a custom-made RNA template containing specific yet non-infectious sequences from the SARS-CoV-2 virus. The resulting nanoparticles consist of coronavirus RNA sequences packaged inside plant virus shells.

The other positive control was made from bacteriophage nanoparticles. It involved a similar recipe. The researchers infected E. coli bacteria with custom-made plasmids -- rings of DNA -- that contain specific fragments of sequences (which are also non-infectious) from the SARS-CoV-2 virus, as well as genes coding for surface proteins of a bacteriophage called Qbeta. This process caused the bacteria to produce nanoparticles that consist of coronavirus RNA sequences packaged inside bacteriophage shells.

The plant virus and bacteriophage shells are key to making these positive controls so sturdy. They protect the coronavirus RNA segments from breaking down at warmer temperatures -- tests showed that they can be stored for a week at temperatures up to 40 C (104 F). The shells also protect the RNA during the first step of the PCR and LAMP tests, which involves breaking down cells in the sample -- via enzymes or heat -- to release their genetic material for testing.

These protections are not present in the positive controls currently used in COVID-19 testing (naked synthetic RNAs, plasmids or RNA samples from infected patients). That's why existing controls either require refrigeration (which makes them inconvenient to handle, costly to ship and store) or have to be added at a later stage of the test (which means that means scientists will not know if something went wrong in the first steps).

As a next step, the researchers are looking to partner up with industry to implement this technology. The positive controls can be adapted to any established RT-PCR or RT-LAMP assay, and using them would help negate false readouts, Steinmetz's team said. Plus, these positive controls can be easily produced in large quantities by molecular farming in plants or microbial culture fermentation, which is good news for translating them to large-scale manufacturing.

"With mutants and variants emerging, continued testing will be imperative to keep the population safe," Steinmetz said. "The new technology could find utility in particular for at-home tests, which may have a higher rate of false readouts due to the less controlled experimental conditions."

This work was funded in part by the National Science Foundation (RAPID CBET-2032196 and RAPID CMMI-2027668) and the University of California (UCOP-R00RG2471 and a Galvanizing Engineering in Medicine Award).

Liquid Crystal Sensor Offers Breakthrough for Rapid COVID-19 Diagnostic Test

The global outbreak of COVID-19 has prompted scientists to focus their research on rapid and robust diagnostic tests. Reverse-transcription polymerase chain reaction (RT-PCR) assays – the ‘gold-standard’ for molecular clinical diagnostics – became available quickly, however this provides relatively long characterisation times and the need for specialised equipment.

Researchers at OSU have subsequently designed a liquid crystal (LC) based diagnostic kit and a smartphone-based application to enable automatic detection of SARS-CoV-2 ssRNA, which could be used for reliable self-test of SARS-CoV-2 at home without the need for complex equipment or procedures.

Prof Xiaoguang (William) Wang, PhD led the research team at OSU, and commented on his decision to consider LCs as a prospective diagnostic technology to meet the need: “It is well known that thermotropic LCs are ultrasensitive to small chemical modulations, and we felt that we could use this property to develop a rapid LC-based detection method for SARS CoV-2 virus that could be contained in a portable and economical sensor.”

A series of experiments were required to prove this concept and develop a prototype sensor, which included three key steps. 

1. The characterisation of a substrate layer that had been ‘functionalised’ with a liquid crystal mixture.

2. Validation of the reliable binding of an ssDNA ‘probe’ to this layer.

3. The detection and quantitation of ssRNAcov extracted from the virus as it bound to the probe.

Important for this last step was holding the temperature of the system at precisely 48.7°C, the melting temperature of ssRNA. The Linkam PE120 stage was integral to this phase and gave the team at OSU the reproducible control of the temperature of the sensor they needed during the process.

The PE120 Peltier system is straightforward to integrate with microscopes and other equipment, and ensures precise control of the temperature of microscope slides to +/-0.1°C at temperatures between  25°C to 120°C. 

Prof Wang’s research has recently been published, and it has shown that LC-based sensors offer a highly sensitive, reproducible and robust method of detection of target ssRNAcov – with detection limits in the nanomolar to femtomolar range.

Commenting on the work, Robert Gurney PhD, Marketing and Applications Specialist at Linkam Scientific, said: “What Prof Wang and his colleagues have achieved is extremely exciting. It’s great that one of the Linkam temperature control stages has played a key part in the team’s proof-of-concept studies, and I’m looking forward to seeing the results of the next stage – trials of the sensor with patient samples.”

Mobidiag Receives CE-IVD Marking for Amplidiag® RESP-4 for Simultaneous Detection of COVID-19, Flu A, Flu B and RSV

Mobidiag Ltd. today announces that it has received CE-IVD marking for its Amplidiag® RESP-4 molecular diagnostic test for the rapid and simultaneous detection of some of the most prevalent respiratory viruses: SARS-CoV-2 (responsible for COVID-19 infection), Influenza A, Influenza B and RSV.

These viruses present similar symptoms, making it difficult for physicians to determine accurately which virus a patient has. The Amplidiag® RESP-4 assay can rapidly and simultaneously determine an accurate diagnosis from one patient sample using nasopharyngeal swabs, helping to guide clinicians to the relevant treatment decision for each patient. The test runs on the Mobidiag Amplidiag® Easy platform, which provides clinicians with an optimized sample screening process, with automated DNA/RNA extraction and PCR plate setup. Based on well-established high-throughput PCR technology, the platform can process 46 samples in approximately three hours.

This new test further broadens Mobidiag’s already available portfolio of diagnostics tests.

Tuomas Tenkanen, CEO of Mobidiag said, “We are very pleased to announce the CE-IVD marking for the Amplidiag® RESP-4 assay, which is highly relevant to both the traditional flu season and COVID-19. Symptoms caused by these viruses [SARS-CoV-2, Influenza A, Influenza B and RSV] can be very similar, and it is imperative that healthcare professionals are able to rapidly distinguish between them, in order to start the appropriate treatment for the benefit of patients.

In response to the growing need for fast and reliable diagnostics, at Mobidiag we are putting all our efforts into maintaining a high degree of autonomy in the production of our Amplidiag® tests by securing critical components to provide continuous support for our customers, as we all work together to control the spread of COVID-19.”

Mobidiag is currently developing Novodiag® RESP-4, a molecular diagnostic test using its Novodiag® platform for the rapid and on-demand detection of SARS-CoV-2, Influenza A, Influenza B and RSV. This test will complement Amplidiag® RESP-4 and enable clinicians to detect respiratory viruses to support early decisions in managing efficiently epidemiological and infection control measures, isolate patients in a timely manner, and ultimately improve patient care and outcomes.

Please note that Mobidiag tests are not home testing kits. They are only available for healthcare professionals, and not for patients directly. Please follow the recommended processes and guidance for your location if you have any symptoms of respiratory infections.

About Mobidiag

Mobidiag is a fast-growing molecular diagnostics company whose rapid, cost-effective, widely applicable and robust technology makes the power of molecular diagnostics available to address the spread of infectious diseases and antimicrobial resistance (AMR) by rapid detection of pathogens and their potential resistance to antibiotics. Through its Amplidiag® and Novodiag® solutions, Mobidiag offers a comprehensive range of molecular diagnostic solutions for the detection of infectious diseases to laboratories of all sizes.