20/20 Launching First COVID-19 Rapid Antibody Test Authorized by FDA for Point-of-Care Use

20/20 BioResponse, a business unit of 20/20 GeneSystems, Inc., announced today that it is now accepting orders for the Assure COVID-19 IgG/IgM Rapid Test kits. These kits were the first to receive an emergency use authorization (EUA) from the FDA for point-of-care (POC) use with fingerstick blood samples on September 23. According to the FDA announcement “this authorization means that fingerstick blood samples can now be tested in POC settings like doctor’s offices, hospitals, urgent care centers and emergency rooms rather than having to be sent to a central lab for testing.” “Authorizing POC serology tests will enable more timely and convenient results for individuals who want to understand if they have previously been infected with the virus that causes COVID-19,” said FDA Commissioner Stephen M. Hahn, M.D.

The company is now accepting orders from pharmacies, urgent care centers, and doctor’s offices, especially those servicing first responders.

The test kits are rapid chromatographic immunoassays (configured like a home pregnancy test) to detect IgM and IgG antibodies to COVID-19 SARS-CoV-2 in blood, which is the cause of COVID-19. IgM antibody generally begins to rise within 1 week of initial infection and IgG typically appears about 14 days after infection.

“As vaccines begin to enter the market over the coming months, we believe there will be increasing demand by individuals and their healthcare providers for antibody tests,” said Michael Lebowitz, Ph.D., 20/20’s Chief Scientific Officer. “The presence of serum antibodies against an infectious agent may be an indicator of immunity against said agent. Until such time as the durability of the immune response is established, it will be important for both those who have had a prior infection as well as those who have received a vaccine to be monitored on a regular basis for the presence of antibodies. Such information can be used to suggest that an individual may benefit from a boost with the vaccine”.

20/20 also plans to conduct studies to validate the use of an at-home fingerstick blood collection device together with a quantitative antibody test awaiting an EUA from the FDA. Quantitative tests permit individuals to monitor changes in their antibody levels over time and may help assess susceptibility to future infections. The company, which specializes in developing machine learning algorithms associated with laboratory tests, will seek to build algorithms to help predict and quantify the strength and durability of immune response.

About 20/20 GeneSystems: 

20/20 GeneSystems, Inc. is a Rockville, MD based company focused on innovative diagnostics and detection products. In addition to the company’s blood tests for early cancer detection, 20/20 has also commercialized its patented BioCheck® detection kit to help fire departments and other emergency response organizations screen suspicious powders.

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Vox Biomedical Receives NIH Award for Rapid COVID-19 Diagnostic Development

Vox Biomedical announced that it has received a supplemental award from the National Institute on Drug Abuse, part of the National Institutes of Health, to expand upon the breath analyzer technology, which it is developing for the detection of marijuana and opioids, to include a rapid, sensitive and accurate breath diagnostic test for COVID-19.  

The award calls for a biomarker discovery effort to determine the exhaled breath molecular species most suitable for use as a COVID-19 biomarker and methods of capture that can be implemented within the safety paradigm governing COVID-19 testing.  

Exhaled breath is a rich matrix of volatile organic compounds, or VOCs, originating from human metabolism as well as aerosol condensates and bacterial and viral species suspended in micro-water droplets and inflammatory products. Towards the end of developing a breath-based COVID-19 diagnostic, Vox Biomedical scientists will investigate biomolecules associated with the inflammatory and metabolic changes caused by COVID-19 infection. In addition, Vox Biomedical scientists will consult with Dr. Scott Lukas of McLean Hospital and Harvard Medical School to determine substance abuse molecules that can be simultaneously captured along with a COVID-19 biomarker in the exhaled breath. This effort will allow future studies to determine the effect of COVID-19 infection on substance abuse communities.

Upon identification of potential COVID-19 breath-based biomarkers detection, efforts will concentrate on breath collection and virus detection utilizing Vox’s current portable instrument design. An FDA regulatory approval strategy for such a COVID-19 diagnostic technique will be developed to aid in the rapid deployment of this diagnostic technique once validation of a COVID-19 biomarker has been established.

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Diagnostic Tool for Coronavirus Being Developed by University of Warwick

Scientists at the University of Warwick have demonstrated that a potential diagnostic tool for detecting COVID-19 using sugars will work with a virus rather than just its proteins, a significant step in making it a viable test in future.

Coronavirus diagnostics currently require centralised facilities and collection/distribution of swabs and results are ‘next day’. A new diagnostic tool being developed by the University of Warwick and its partner Iceni Diagnostics may allow on-the-spot detection of Coronavirus infection, without facilities using a simple disposal device.

The researchers detailed their technique in a preprint paper announced earlier this year, but have now presented additional results in a paper for the journal ACS Central Science, published by researchers from the University of Warwick, University of Manchester and Iceni Diagnostics ltd based in Norwich. The new diagnostic tool uses glycans (sugars) to detect the virus, using a tool very similar to a home pregnancy test.

There is an urgent need for new diagnostics, especially those which give rapid results for screening of healthcare professions or for getting transportation, education and manufacturing hubs running again.

The diagnostic proof of principle has been demonstrated in initial studies, but the partnership is now searching for investment or philanthropic donors to take the concept forward.

Professor Matthew Gibson who holds a joint appointment between the Department of Chemistry and Warwick Medical School comments:

“Our team has now been able to show that this detection technique works with a ‘pseudotyped virus’; a safer to handle alternative which mimics SARS-COV-2. This further demonstrated that the diagnostic format can detect actual viruses not just the isolated proteins from its surface.

“The additional results have allowed us to fine-tune the system more, and learn more about how we can optimise the detection limits and exactly how a sample needs to be introduced to the device, which is crucial. Our next stage is patient samples and understanding how sensitive the device is and really thinking how it might be used alongside existing diagnostic tools.

“The rapid detection of the virus, for both healthcare and to enable society to return to normal is crucial. Our technology, developed through joint PhD student work with our industry partners, makes use of glyco-nanomaterials to detect a specific portion of the coronavirus. The technology is straightforward, and extremely low-cost as the kit is paper-based. The University retained lab-capacity for essential COVID research such as this ensuring we could fulfil the University’s mission to create new knowledge and innovative solutions.”

Professor Robert Field, co-founder and CEO of Iceni diagnostics, comments:

”It is great working with the fabulous talent in the Gibson team at Warwick. Combining our expertise has enabled us to move this project along rapidly - including initial clinical evaluation. We look forward to extending our working relationship with Warwick to explore diagnostics for other infectious diseases based on carbohydrates and glycopolymers”

Dr James Lapworth, Warwick Innovations, who is working with Professor Gibson to commercialise the technology, said:

“There is an urgent, global need to increase diagnostic testing capacity for Covid-19 infections. This new approach potentially offers significant benefits because it delivers a very rapid result and requires no specialist lab equipment or training to complete. The result is that people could determine very quickly whether they have a current infection and take appropriate action, for example to self-isolate.”

‘The SARS-COV‑2 Spike Protein Binds Sialic Acids and Enables Rapid Detection in a Lateral Flow Point of Care Diagnostic Device’ is published in ACS Central Science, DOI: 10.1021/acscentsci.0c00855 Link: https://dx.doi.org/10.1021/acscentsci.0c00855

The research and development of the new tool has been supported by grants from the BBSRC (BB/M01116X/1 and BB/S506783/1), EPSRC (EP/R511808/1), the University of Warwick and Iceni.

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Evaluation of LamPORE Rapid Covid-19 Tests Show High Levels of Diagnostic Sensitivity

A team of scientists, including researchers from the University of Sheffield, have published their evaluation of a rapid, new Covid-19 testing technology, which has the potential to expand the type and scale of testing available.

LamPORE, a novel diagnostic platform for detecting SARS-CoV-2RNA, combines loop-mediated isothermal amplification with nanopore sequencing, meaning it has the potential to analyse thousands of samples per day on a single instrument.

Although preliminary, the results suggest high levels of diagnostic sensitivity in LamPORE which could mean an expansion to the scale of testing that could be offered in the future to help control the SARS-CoV-2 pandemic.

The collaboration between the University of Sheffield and colleagues at Public Health England Porton Down (PHE), Sheffield Teaching Hospitals NHS Foundation Trust and the University of Oxford, including support from the NIHR Oxford Biomedical Research Centre, evaluated the performance of LamPORE against RT-PCR - the most commonly-used laboratory test for Covid-19.

The team used RNA (Ribonucleic acid which is a polymeric molecule essential in various biological roles in coding, decoding, regulation and expression of genes) extracted from two types of samples. Initially, mock samples formed of saliva from people without infection that had a known quantity of virus added to it, and subsequently nose and throat swabs from real Covid-19 patients collected during routine care at two UK hospitals - Oxford University Hospitals NHS Foundation Trust and Sheffield Teaching Hospitals NHS Foundation Trust.

The positive clinical specimens came mostly from patients with symptomatic infection, and among these LamPORE had a diagnostic sensitivity of 99.1 per cent (i.e. it was positive in 226 of 228 samples positive by RT-PCR).

Among negative clinical specimens, including 153 with other respiratory pathogens detected, LamPORE had a diagnostic specificity of 99.6 per cent (i.e. it was negative in 278 of 279

samples negative by RT-PCR). Overall, 1.4 per cent of samples produced an indeterminate result on first testing, and repeat LamPORE testing on the same RNA extract had a reproducibility of 96.8 per cent.

These results indicate that LamPORE has a similar performance to RT-PCR for the diagnosis of SARS-CoV-2 infection in symptomatic patients.

Dr Thushan de Silva, from the University of Sheffield’s Department of Infection, Immunity and Cardiovascular Disease, said: “These are preliminary but promising data that suggest LamPORE has the potential to expand the type and scale of SARS-CoV-2 testing that could be offered in the future.

“We are delighted to have partnered with collaborators in Oxford and Public Health England to help evaluate this novel diagnostic platform for SARS-CoV-2.”

Dr Cariad Evans, Consultant Virologist at Sheffield Teaching Hospitals NHS Foundation Trust and joint senior author of the published evaluation, said: “We are pleased to have contributed to this important evaluation. These are encouraging early findings and we are proud to have supported Public Health England and our academic partners in this essential Covid-19 research.”

Professor Helen McShane, Director of the NIHR Oxford BRC, said: “This is an excellent example of how NIHR funding to support academic–industrial collaborations can lead to the development of new tools to help us control the SARS-CoV-2 pandemic.”

Dr Steve Pullan, from Public Health England, Porton Down, said: “Our early data indicates LamPORE to be a credible alternative to conventional PCR -based diagnostics, which has the potential to provide further high-throughput testing capacity.”

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TU Dublin Team to Develop Rapid Saliva-Based COVID Test

Researchers at Technological University (TU) Dublin have been awarded funding to develop a saliva-based COVID-19 test, which can detect the virus in a matter of minutes.

The project, known as AptaGold, will focus on developing a test that is suitable for use in a number of settings, is cost effective and is readily scalable.

According to AptaGold lead and medical scientist, Dr Steve Meaney of TU Dublin, current diagnostic tools are expensive as they rely on the use of genetic approaches and require equipment, reagents and trained diagnostic staff.

"The capacity of such laboratory-based test systems will always be a challenge. Our solution meets the urgent need for a cheap, on-the-spot and sample-to-result screening option, using an easily obtainable saliva sample.

"As specialised training or equipment is not required to complete the proposed new test, it might find use in workplaces, airports and other travel hubs, as well as in low-resource environments where there are insufficient laboratory services," he explained.

It is already well established that viral particles from SARS-CoV-2, the virus that causes COVID-19, are present in the saliva of infected individuals.

According to AptaGold co-lead and biochemist, Dr Niamh Gilmartin of TU Dublin, AptaGold is based on mixing patient saliva samples with specially selected DNA strands called aptamers.

"These strands are linked to tiny gold particles, and if COVID-19 virus proteins are present, these particles bunch up, leading to a visible colour change in minutes. Aptamers can be produced at a much lower cost than antibodies, so the production can be easily scaled up to meet demand in Ireland and abroad," she explained.

She emphasised that testing, isolating and contact tracing are all vital to stopping COVID-19 and timely, accurate results will significantly reduce these timelines and save lives.

"AptaGold is designed to be a first-line screening system for those who require immediate treatment and isolation, both in the healthcare sector and in the general population. By providing a simple and inexpensive near-patient test system, this approach will significantly reduce wait times for sample collection and test results," Dr Gilmartin noted.

The researchers believe that the rapid identification of infected patients will improve clinical decision making.

"The system can support rapid intervention and therefore, reduce the spread of infection. This is really relevant as we continue to open up the economy and society. Employees could take the test each morning to quickly find out if they should self-isolate or not and it could be helpful for people to manage their travel plans," Dr Meaney said.

AptaGold is a multi-agency project led by TU Dublin in collaboration with Dublin City University, Trinity College Dublin, St James's Hospital, Beaumont Hospital, the Royal College of Surgeons in Ireland and the National Clinical Programme for Pathology.

The funding was awarded as part of a rapid research response funding call published jointly by Science Foundation Ireland, Enterprise Ireland and the IDA.

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New COVID-19 Diagnostic Test in French Clinical Trial

C4Diagnostics, Bertin Technologies, and Enalees announce the launch of their clinical trial of BEC-SARS-CoV-2 for humans, a diagnostic test for COVID-19, developed jointly with Pasteur Institute.

The BEC-SARS-CoV-2 for humans test has been submitted to the authorities in accordance with French regulations, the detection process has been validated and a clinical trial has been launched by the consortium in order to obtain CE-IVD marking by the end of September. In the meantime, the test is available as RUO. This diagnostic test relies on two technologies for the extraction of viral RNA and its rapid detection using RT-LAMP. Due to its portable format, it can detect SARSCoV-2 in human on site within 25 minutes (from collection to result) from a nasal or nasopharyngeal swab, with an endogenous control and two different target genes (in line with the World Health Organisation and the French Health Authority (HAS) recommendations).  

Laurent Thiery, CEO and co-founder of Enalees, said: "The BEC-SARS-CoV-2 for humans test kit is based on the Enalees test concept that we have been using for two years to detect and curtail the transmission of respiratory diseases, on site, in domestic animals such as horses. In particular, our rapid viral RNA extraction technique validated previously on test kits for animal diseases is at the core of this new test kit. In addition, this test also uses a rapid molecular diagnostic technology based on RTLAMP, used in all Enalees test kits and during previous health crises such as Ebola or Zika by Pasteur Institute. We have adapted our standardised and optimised sample preparation and analysis procedures for human SARS-CoV2 diagnostic test in time to help manage the current health crisis. BEC-SARS-CoV-2 for humans therefore provides a proven solution both in terms of performance and ease of use. This integrated approach highlights the benefits of the One Health approach, combining the best of human, animal, and environmental health."

Younes Lazrak, CEO of C4Diagnostics, added: "While waiting for an effective vaccine against COVID-19, we must expand and facilitate population screening. To cope with the current health crisis, a diagnostic test kit such as BEC-SARS-CoV-2 for humans is particularly suitable for scenarios where access to a diagnostic laboratory is difficult or even impossible, and/or where test results must be determined immediately for on-site testing of asymptomatic individuals who may be potential COVID-19 carriers. The ability to carry out field testing of people in a rapid, easy, and robust way is a major step forward for COVID-19 rapid screening campaigns. The results we have obtained are currently being tested in a prospective clinical trial led by Pasteur Institute in several clinical centres. The clinical data will confirm the sensitivity and specificity of our diagnostic test and we expect that BEC-SARS-CoV-2 for humans will receive its CE-IVD marking by the end of September.” 

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Health Canada Approves Portable Human COVID-19 Testing Device that Delivers Results in 90 Minutes

Health Canada has granted approval for the Hyris bCUBE to be used as a medical device for COVID-19 human testing. As a portable device, the Hyris bCUBE provides onsite and accurate results in minutes. This timely approval arrives as Canadians face rising COVID-19 cases and it supports the testing capabilities of provincial programs to meet demand.

The Hyris bCUBE is a portable DNA-testing laboratory in a box, offering Point of Care (POC) testing wherever people are—anytime, anywhere. Controlled by any device with an internet connection, including a smartphone, the scientifically validated bCUBE analyzes test samples through a cloud-based platform that delivers accurate results in minutes.

The bCUBE was previously approved and used for surface testing. Now, with Health Canada's approval for human testing, more Canadians and businesses can access testing that is accurate, quicker and less invasive—wherever they are in the country. This is particularly significant for vulnerable or remote communities, businesses or industries, where access to onsite rapid testing is key.

Considered the "gold standard" according to the CDC and WHO's effective testing guidelines, the bCUBE deploys PCR (Polymerase Chain Reaction) technology that has demonstrated a 95%+ accuracy rate in clinical trials. Similar trials are currently underway with the FDA.

"The bCUBE is a small, portable genomic biotechnology that is ideal for onsite, immediate test results," confirms Dr. Steven Newmaster, University of Guelph Genomics Professor. "We have validated the bCUBE after using it for several years in the food and natural products industry to identify pathogens, microbes, animal and botanical species ingredients."

Songbird Life Science is the exclusive Canadian distributor of the Hyris bCUBE. Along with several DNA/RNA-identification technologies that Songbird can deploy to suit a space or community's specific requirements, the bCUBE is a key component to Songbird's risk-management consultancy services.

"Health Canada's approval of the Hyris bCUBE addresses big gaps in testing capability and accessibility for Canadians," says Deleo de Leonardis, co-founder of Songbird Life Science. "This is key to keeping the economy running and people safe, despite the ongoing pandemic. Test results in minutes is a game changer."

Hyris is a UK-based company producing bCUBEs in Italy and Germany in accordance with the strictest quality and engineering requirements. Interested businesses can purchase bCUBEs through the Songbird Life Science website. Songbird is currently working with government officials at all levels to assess how this technology can be best deployed to remote communities and other locations where the need for onsite COVID-19 testing with rapid results is especially urgent.

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FDA Authorizes First Point-of-Care Antibody Test for COVID-19

The U.S. Food and Drug Administration recently issued an emergency use authorization (EUA) for the first serology (antibody) point-of-care (POC) test for COVID-19.

The Assure COVID-19 IgG/IgM Rapid Test Device was first authorized for emergency use by certain labs in July 2020 to help identify individuals with antibodies to SARS-CoV-2, indicating recent or prior COVID-19 infection.

That EUA has been reissued to authorize the test for POC use using fingerstick blood samples. This authorization means that fingerstick blood samples can now be tested in POC settings like doctor’s offices, hospitals, urgent care centers and emergency rooms rather than having to be sent to a central lab for testing.

“Authorizing point-of-care serology tests will enable more timely and convenient results for individuals who want to understand if they have previously been infected with the virus that causes COVID-19,” said FDA Commissioner Stephen M. Hahn, M.D.

“Until today, serology test samples were generally only able to be evaluated in a central lab, which can be time-consuming and use additional resources to transport samples and run the test. As more and more point-of-care serology tests are authorized, they will help conserve those resources and may help reduce processing time for other types of COVID-19 tests, as less time is spent on serology tests.”

Nearly 50 serology tests have been granted an EUA since the start of the pandemic. The Assure test is a lateral flow assay and is authorized for use with venous whole blood, serum, plasma and fingerstick whole blood. This serology POC test, unlike POC COVID-19 diagnostic tests, uses a blood sample from the fingertip to run the test.

The FDA wants to remind patients that it is unknown how long antibodies persist following infection and if the presence of antibodies confers protective immunity, so they should not interpret results from a serology test as telling them they are immune, or have any level of immunity, from the virus.

Due to these unknowns, the FDA is cautioning patients against using the results from these tests, or any serology test, as an indication that they can stop taking steps to protect themselves and others, such as stopping social distancing, discontinuing wearing masks or returning to work.

The FDA also wants to remind the public that serology tests should not be used to diagnose an active infection, as they only detect antibodies the immune system develops in response to the virus – not the virus itself. It is also important to remember that in a population with low prevalence, even high-performing antibody tests may produce as many or more false results as true results because the likelihood of finding someone who has been infected is very small. Thus, it is necessary to consider that the results from two serology tests may be needed to generate reliable results.

The Assure COVID-19 IgG/IgM Rapid Test Device is currently the only FDA authorized COVID-19 POC serology test and is available by prescription only. The FDA continues to work with test developers to expand access to COVID-19 testing.

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Bosch Develops “World’s Fastest” PCR-Based Coronavirus Test

Bosch has developed a new rapid test for its Vivalytic analysis device to detect the SARS-CoV-2 pathogen. The test provides a reliable result in 39 minutes and is currently the fastest polymerase chain reaction (PCR) test worldwide. Bosch’s new rapid test is predestined for decentralized use in mobile test centers at freeway service stations or in airports. People who take the test can obtain a reliable result while at the testing site. Available now in Europe, the CE-approved test helps avoid time in quarantine, relieve laboratories, and make travel and work safer again. “One of the keys to fighting the coronavirus pandemic is to rapidly identify sources of infection. That’s why we focused on following up on our first coronavirus test with an even faster one,” says Dr. Volkmar Denner, chairman of the board of management of Robert Bosch GmbH. “This will now enable us to put people’s minds at ease even more quickly.”

The development of the new Bosch PCR singleplex test is part of a research and development project funded by the German Federal Ministry of Education and Research (BMBF). As the federal minister for education and research Anja Karliczek says, “I believe it’s important that people have clarity about their state of health as quickly as possible. In this respect, insights from science and research can bring people huge benefits. Over the next few months, we will be confronted with the particular challenge of having to test more people. The improved testing procedure developed by Bosch with the BMBF’s support has the potential to be a tremendous help with this complex job. The rapid improvement of our technological capabilities shows what innovative achievements German companies can deliver in times of crisis.”

The test has a sensitivity of 98 percent and a specificity of 100 percent. To develop it, the Bosch subsidiary Bosch Healthcare Solutions joined forces with the German biotechnology company R-Biopharm – a leading provider of highly sensitive manual PCR tests. PCR tests are considered the gold standard of test methods.

Bosch launched the first rapid test for its Vivalytic analysis device at the end of March, after just six weeks’ development. As a multiplex test, it simultaneously checks samples for the SARS-CoV-2 virus and nine other respiratory diseases in two and a half hours. The new, accelerated test is exclusively for SARS-CoV-2. “With our different coronavirus tests and variable analysis strategies, we open up a range of testing scenarios with a Vivalytic device – from screening all the way to supporting differential diagnosis for diseases with similar symptoms,” says Marc Meier, president of Bosch Healthcare Solutions GmbH. And development work is still in full swing at Bosch: As of early October 2020, it will be possible to simultaneously evaluate five samples in one test cartridge and at a comparable speed – a world first, according to the company. Bosch is thus increasing available testing capacity, enabling fully automated processing of more than 160 samples a day using a Vivalytic device. In addition, optimized software will in the next few weeks further reduce the time to result of the SARS-CoV-2 test on positive samples.

The advantages of Bosch’s rapid test lie not only in speedy analysis, but also in ease of use. A sample is taken from the patient’s nose or throat using a swab, and placed in the test cartridge. Then the test cartridge, which already contains all the reagents required for the test, is inserted into the Vivalytic device for automated analysis. The Vivalytic analysis device is designed to be user-friendly; medical staff require only brief training on how to operate it. The development of the Vivalytic system, which consists of an analysis device and test cartridges, grew out of a long-standing collaboration between Bosch’s corporate research and advance engineering and Bosch Healthcare Solutions.

By the end of the year, Bosch wants to reach capacity for one million tests. As demand for the analysis device and the rapid tests remains high, the company is working closely with its suppliers to maximize capacity and further increase supply.

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