Abbott's Fast, 15-Minute, Easy-to-Use COVID-19 Antigen Test Receives FDA Emergency Use Authorization

Abbott announced that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for its BinaxNOW™ COVID-19 Ag Card rapid test for detection of COVID-19 infection. Abbott will sell this test for $5. It is highly portable (about the size of a credit card), affordable and provides results in 15 minutes. BinaxNOW uses proven Abbott lateral flow technology, making it a reliable and familiar format for frequent mass testing through their healthcare provider. With no equipment required, the device will be an important tool to manage risk by quickly identifying infectious people so they don't spread the disease to others.

Abbott will also launch a complementary mobile app for iPhone and Android devices named NAVICA™. This first-of-its-kind app, available at no charge, will allow people who test negative to display a temporary digital health pass that is renewed each time a person is tested through their healthcare provider together with the date of the test result. Organizations will be able to view and verify the information on a mobile device to facilitate entry into facilities along with hand-washing, social distancing, enhanced cleaning and mask-wearing.

"We intentionally designed the BinaxNOW test and NAVICA app so we could offer a comprehensive testing solution to help Americans feel more confident about their health and lives," said Robert B. Ford, president and chief executive officer, Abbott. "BinaxNOW and the NAVICA app give us an affordable, easy-to-use, scalable test, and a complementary digital health tool to help us have a bit more normalcy in our daily lives."

In data submitted to the FDA from a clinical study conducted by Abbott with several leading U.S. research universities, the BinaxNOW COVID-19 Ag Card demonstrated sensitivity of 97.1% (positive percent agreement) and specificity of 98.5% (negative percent agreement) in patients suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset.

"The massive scale of this test and app will allow tens of millions of people to have access to rapid and reliable testing," said Joseph Petrosino, Ph.D., professor and chairman, Molecular Virology and Microbiology, Baylor College of Medicine, whose labs have been leading efforts to provide COVID-19 testing for the college and Harris County. "With lab-based tests, you get excellent sensitivity but might have to wait days or longer to get the results. With a rapid antigen test, you get a result right away, getting infectious people off the streets and into quarantine so they don't spread the virus."

Under FDA EUA, the BinaxNOW COVID-19 Ag Card is for use by healthcare professionals and can be used in point-of-care settings that are qualified to have the test performed and are operating under a CLIA (Clinical Laboratory Improvement Amendments) Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. Within these settings, the test can be performed by doctors, nurses, school nurses, medical assistants and technicians, pharmacists, employer occupational health specialists, and more with minimal training and a patient prescription.  

"Our nation's frontline healthcare workers and clinical laboratory personnel have been under siege since the onset of this pandemic," said Charles Chiu, M.D., Ph.D., professor of Laboratory Medicine at University of California, San Francisco. "The availability of rapid testing for COVID-19 will help support overburdened laboratories, accelerate turnaround times and greatly expand access to people who need it."

Currently, AdvaMed (The Advanced Medical Technology Association) estimates that test manufacturers are shipping about 1 million tests per day. Abbott will ship tens of millions of tests in September, ramping to 50 million tests a month at the beginning of October. The company has invested hundreds of millions of dollars since April in two new U.S. facilities to manufacture BinaxNOW at massive scale.

The BinaxNOW COVID-19 Ag Card can be used as a first line of defense to identify people who are currently infected and who should isolate themselves to help prevent the spread of the disease. It is intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in nasal swabs from individuals suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset.

As a near-person rapid antigen test, BinaxNOW was engineered for point-of-care settings, near-patient, and not for reference labs. Patient samples should be tested immediately and should not be diluted in viral transport media.

NAVICA mobile app will help facilitate return to daily activities

Abbott is also offering a mobile app at no charge that will allow people to display their results obtained through a healthcare provider when entering facilities requiring proof of testing. The NAVICA app is optional and an easy-to-use tool that allows people to store, access and display their results with organizations that accept the results so people can move about with greater confidence. The app is supported by Apple and Android digital wallets and will be available from public app stores in the U.S.

"While BinaxNOW is the hardware that makes knowing your COVID-19 status possible, the NAVICA app is the digital network that allows people to share that information with those who need to know," said Ford. "We're taking our know-how from our digitally-connected medical devices and applying it to our diagnostics at a time when people expect their health information to be digital and readily accessible."  

If test results are negative, the app will display a digital health pass via a QR code, similar to an airline boarding pass. If test results are positive, people receive a message to quarantine and talk to their doctor. As they're required to do for all COVID-19 tests, healthcare providers in all settings will be required to report positive results to the CDC and other public health authorities, regardless of whether they use the app. The digital health pass is stored in the app temporarily and expires after the time period specified by organizations that accept the app.

The app's user interface is supported by a back-end digital infrastructure that is cloud-based, scalable and secure. It's been designed to support a very large number of users and enable access from anywhere. The app is not for contact tracing and only collects a person's first and last name, email address, phone number, zip code, date of birth and test results.

About the BinaxNOW COVID-19 Ag Card Test

The BinaxNOW COVID-19 Ag Card is an assay for the qualitative detection of specific antigens to COVID-19 in the human nasal cavity. A simple nasal swab is used to collect specimens from people suspected of having an active infection. No equipment is required to process samples or read test results. In addition, minimal chemical reagents are required, which lessens exposure to biohazardous materials and improves safety for those administering the test.

The BinaxNOW COVID-19 Ag Card is the sixth test that Abbott is launching in the U.S. to help fight the coronavirus pandemic. Abbott's tests are performed on its high-volume m2000™ and Alinity® m molecular laboratory systems; its ID NOW™ rapid molecular point-of-care platform; antibody tests for its high-throughput ARCHITECT® i1000SR and i2000SR and Alinity™ i laboratory instruments.

Abbott has provided more than 27 million COVID-19 tests in the U.S. to date, including 14 million detection tests and 13 million antibody tests.  

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LumiraDx Receives FDA Emergency Use Authorization for Point of Care COVID-19 Antigen Test

The FDA has authorized its third antigen test for the novel coronavirus, designed to provide fast and cost-efficient results at the point of care and in community settings.

Developed by London-based LumiraDx, the diagnostic operates similar to rapid tests for the flu—it detects fragments of specific proteins found within the SARS-CoV-2 virus, as opposed to molecular diagnostics that match up sequences of the virus’s RNA or antibody tests that gauge the body’s natural immune response.

The LumiraDx SARS-CoV-2 Ag Test is a microfluidic immunofluorescence assay for direct and qualitative detection of nucleocapsid proteins in nasal swab specimens from patients suspected of COVID-19. Used with the LumiraDx Instrument the Test delivers rapid results at the point-of-care.

Using a nasal swab, chemical solution, testing strip and reader, LumiraDx’s assay aims to deliver results on-site within 12 minutes. The company’s clinical studies have shown it to be 97.6% as accurate as high-throughput molecular tests, which may require shipping samples to a centralized laboratory and waiting days for results.

“Actionable diagnostic results at the point of care lead to better health outcomes,” CEO Ron Zwanziger said. “Now that the FDA EUA has been received, we are working with health systems, major retail clinics and employers to get our platform to healthcare providers quickly to utilize in their testing programs.”

LumiraDx said it aims to produce 2 million tests during the month of September before ramping up manufacturing to 10 million tests per month by the end of the year. The company also plans to submit an antibody test, run on the same instrument, to the FDA for emergency review.

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Todos Medical Announces Positive Proof-of-Concept Data for Novel 10-Minute Point-of-Care Saliva-based Test Detecting Active SARS-CoV-2 Infection

Todos Medical Ltd., an in vitro diagnostics company focused on distributing comprehensive solutions for COVID-19 screening and diagnosis, and developing blood tests for the early detection of cancer and Alzheimer’s disease, today announced positive proof-of-concept data for its proprietary 10-minute rapid point-of-care saliva-based test for detecting active SARS-CoV-2 infections. Based on these data, the Company has initiated a multicenter clinical trial at Assuta Ashdod Hospital and Tel Aviv University in Israel to evaluate the clinical performance of the assay, and optimize product development prototypes for commercial scale-up.

This technology holds promise to provide a rapid result without the need for heating, expensive instrumentation, inconvenient sample collection or cold-chain logistics. As such, it may have applicability for self-testing at home, or where large numbers of people gather such as school, work, airports, etc.  Todos envisions developing both quantitative and qualitative tests based on the technology and intellectual property.  The Company is working to complete this initial clinical trial in the third quarter of 2020, with trial results and submissions to regulatory agencies worldwide in the fourth quarter of 2020.

“These data provide proof-of-concept for the 3C-Protease diagnostic approach in COVID-19 testing,” said Dr. Jorge Leon, consulting Chief Medical & Scientific Officer of Oncology and Infectious Disease for Todos. “The clinical trial in Israel will generate real-world data on how best to integrate this technology platform into products that can be deployed worldwide. We will now begin incorporating the software to analyze this assay into an application for use with mobile phones and various telemedicine platforms, so as to provide a more complete and efficient solution for COVID-19 testing and data reporting for all stakeholders.”

The proof-of-concept analytical performance data demonstrate that the assay is able to accurately detect the SARS-CoV-2 3C-Protease in human saliva samples spiked with recombinant 3C protease, and that the protease signal was specifically and significantly distinguishable from background protease activity present in normal saliva. The 3C-Protease is a coronavirus-derived protein that is required for viral replication and transmission to other cells and tissues. The 3C-Protease assay detects the presence of active viral replication specific to SARS-CoV-2, rather than host reactions to current or previous other coronavirus infections, or the detection of viral genetic fragments that continue to shed from patients who have recovered from COVID-19. As more people become infected and recover from COVID-19 worldwide, it is becoming increasingly important for a molecular assay to distinguish active, replicating SARS-CoV-2 virus from inactive, non-replicating SARS-CoV-2 genetic fragments.

Data on the importance of the 3C-Protease in coronaviruses was recently published in Science Translational Medicine, available here.  Patents covering the use of the 3C-Protease for the detection of the SARS-CoV-2 were filed in the first quarter in of 2020 by Todos’ joint venture partner NLC Pharma. The joint venture, named COVID Antigen Test Killer (CATK), is focused on the development of molecular diagnostic tests that are differentiated from currently available tests to enable point-of-care detection of the virus in its reproduction stage in minutes, as well as quantitative analysis of how quickly the virus is replicating, which is a measure of viral load. Assay data would give healthcare providers more meaningful information with which to triage patients with COVID-19.

“We are extremely pleased to have confirmed the usefulness of our 3C-Protease patented viral detection technology for COVID-19,” said Dr. Dorit Arad, Chief Scientific Officer of NLC Pharma. “With these data in hand, we see a clear path to apply our technology at large scale to provide widespread rapid, highly-sensitive molecular testing to make a difference in the rapid detection of active COVID-19. We believe this sets the stage for significant growth within our joint venture with Todos.”

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Quick and Affordable Saliva-based COVID-19 Test Developed by Yale Scientists Receives FDA Emergency Use Authorization

A saliva-based laboratory diagnostic test developed by researchers at the Yale School of Public Health to determine whether someone is infected with the novel coronavirus has been granted an emergency use authorization by the U.S. Food and Drug Administration (FDA).

 

The method, called SalivaDirect, is being further validated as a test for asymptomatic individuals through a program that tests players and staff from the National Basketball Association (NBA). SalivaDirect is simpler, less expensive, and less invasive than the traditional method for such testing, known as nasopharyngeal (NP) swabbing. Results so far have found that SalivaDirect is highly sensitive and yields similar outcomes as NP swabbing.  

 

With the FDA’s emergency use authorization, the testing method is immediately available to other diagnostic laboratories that want to start using the new test, which can be scaled up quickly for use across the nation — and, perhaps, beyond — in the coming weeks, the researchers said. A key component of SalivaDirect, they note, is that the method has been validated with reagents and instruments from multiple vendors. This flexibility enables continued testing if some vendors encounter supply chain issues, as experienced early in the pandemic.

 

“This is a huge step forward to make testing more accessible,” said Chantal Vogels, a Yale postdoctoral fellow, who led the laboratory development and validation along with Doug Brackney, an adjunct assistant clinical professor. “This started off as an idea in our lab soon after we found saliva to be a promising sample type of the detection of SARS-CoV-2, and now it has the potential to be used on a large scale to help protect public health. We are delighted to make this contribution to the fight against coronavirus.” The preprint on the development and validation of SalivaDirect was recently posted on medRxiv.

 

Development of SalivaDirect as a means of rapidly expanding SARS-CoV-2 testing was spearheaded this spring by Nathan Grubaugh and Anne Wyllie, assistant professor and associate research scientist, respectively, at Yale School of Public Health. After finding saliva to be a promising sample type for SARS-CoV-2 detection, they wanted to improve the method further. 

 

“With saliva being quick and easy to collect, we realized it could be a game-changer in COVID-19 diagnostics,” said Wyllie. With testing urgently needed, the Yale team was determined to decrease both testing times and costs, to make testing widely accessible.

 

“Wide-spread testing is critical for our control efforts. We simplified the test so that it only costs a couple of dollars for reagents, and we expect that labs will only charge about $10 per sample. If cheap alternatives like SalivaDirect can be implemented across the country, we may finally get a handle on this pandemic, even before a vaccine,” said Grubaugh. 

 

One of the team’s goals was to eliminate the expensive saliva collection tubes that other companies use to preserve the virus for detection. In a separate study led by Wyllie and the team at the Yale School of Public Health, and recently published on medRxiv, they found that SARS-CoV-2 is stable in saliva for prolonged periods at warm temperatures, and that preservatives or specialized tubes are not necessary for collection of saliva. 

 

The Jackson Laboratory for Genomic Medicine in Farmington, Connecticut, will partner with Yale to explore how to implement the test for a broader audience. The laboratory already analyzes patient samples for an RNA signature unique to that of SARS-CoV-2, the virus that causes COVID-19.  

 

“We must continue to invent and implement new ways to conduct SARS-CoV-2 testing faster, more economically and with greater accessibility, while maintaining acceptable test accuracy,” said Charles Lee, the laboratory’s director. “This method is an important next step toward this goal.”

 

Grubaugh and Wyllie said that they are not seeking to commercialize the method. Rather, they want the simplified testing method to help those most in need. Testing for SARS-CoV-2 has been a major stumbling block in the fight against the pandemic, with long delays and shortages of testing. Some experts have said that up to 4 million tests are needed per day; SalivaDirect provides one pathway toward that goal, the researchers said.

 

“Using SalivaDirect, our lab can double our testing capacity,” said Professor Chen Liu, chair of Yale Pathology, who oversaw the clinical validation of the study. 

 

“Dr. Liu and Yale Pathology Laboratory were instrumental in our application. We look forward to continuing to partner with them,” said Grubaugh. 

 

Liu will start offering SalivaDirect as a testing option in their CLIA-certified clinical laboratory in the coming days.

 

The related research was funded by the NBA, National Basketball Players Association, and a Fast Grant from the Emergent Ventures at the Mercatus Center, George Mason University.

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U of Arizona Aims to Provide Rapid Tests for Exposure to Biothreats, Including COVID-19

To better protect those serving on the front lines of battlefields or dealing with an event like the COVID-19 health crisis or potential future pandemics, scientists at the University of Arizona College of Medicine – Phoenix are leading an effort to develop a device that could easily, quickly and accurately detect pathogens and biological threats.

The college's Center for Applied Nanobioscience and Medicine is leading the effort, under an Other Transaction Agreement with the Defense Threat Reduction Agency, an agency within the U.S. Department of Defense. The contract, to provide about 3,000 devices, has a $9.5 million ceiling for three years.

Frederic Zenhausern, the center's director and interim co-chair of the Department of Basic Medical Sciences, and his team members, including associate professor Jian Gu, are creating the device in collaboration with scientists from the University of Nevada, Arizona State University, Duke University and Whitespace Enterprises, an Arizona-based startup founded by Zenhausern. The group is responsible for mass production of the technology.

"An individual in a combat zone or a first responder in the field could know within minutes if they have – or were exposed to – a serious pathogen or biothreat," Zenhausern said. "We want the brave individuals serving on the front lines to be safe, and this device potentially could prevent the next pandemic by providing rapid diagnostic testing for a broad range of threats, including coronaviruses."

The team is developing a vertical flow immunoassay diagnostic test that interfaces with a smartphone. Users would take a small finger prick of blood or a syringe of urine and then push the liquid onto a test strip. Essentially, the device would take a picture of that paper membrane, which would be analyzed and sent back to the users, telling them if they have been exposed to pathogens like anthrax, the plague-causing bacterium Yersinia pestis, or other bacteria and viruses.

Two major platforms for microbial diagnostics are available, including polymerase chain reaction tests, which look at the nucleic acid molecules of the organism, and antibody or immunoassay testing. The immunoassay test typically is color-coded, like a pregnancy test, and uses a lateral flow immunoassay method that involves a piece of paper upon which biofluid, such as blood or urine, is placed.

The biofluid would migrate along the paper and meet different antibodies to determine if an individual's body has produced an immune response to the virus, or if antigens could be detected. An antigen is a toxin or other foreign substance that induces an immune response in the body, especially production of antibodies. An interaction then occurs on the paper, signaling whether the individual has been exposed to the biothreat.

"Lateral flow immunoassay tests are limited to only a few antibodies and are not very sensitive or fast, but they are inexpensive and safe, which has made it a popular option in the past," Zenhausern said. "Through our device, we are combining the benefit of both platforms by increasing capabilities of looking at a much broader panel of disease signatures while significantly increasing the test sensitivity by orders of magnitude."

A vertical flow immunoassay test is when biofluids go toward and through the paper, not by capillarity along the surface of the test strip. This changes the mechanisms of fluidics and physics, which allows testing to look at multiple biomarkers for a wider range of pathogens, instead of just looking at one target biomarker.

"It's much faster and more sensitive," Zenhausern said, adding that this device would have more capabilities than currently available technology and could be applied to illnesses such as influenza, Ebola, COVID-19 or any other biological signature.

"Dr. Zenhausern's team at the University of Arizona Health Sciences and additional collaborators have worked tirelessly to take this idea from concept to production, and I am grateful for their dedication," said University of Arizona President Robert C. Robbins. "This research is an incredible example of how university research directly serves the community. By protecting first responders and others who have an increased likelihood of pathogen exposure, including those serving in combat zones, we can improve public health and prevent future outbreaks. I am immensely proud of our faculty who are spearheading this vital work and I am eager to see its impact."

Zenhausern said, due to the pandemic, a change in the health care delivery system will occur. "We will need to have rapid testing that is less invasive and more personalized."

A previous program, also sponsored by the Defense Threat Reduction Agency, successfully established design rules for the proposed vertical flow immunoassay platform technology, which will be scaled up for this product development project. This increase would encompass the U.S. Food and Drug Administration regulatory filing and delivery of thousands of devices. The Other Transaction Agreement contract also includes a subsequent production option for future commercialization and possible stockpiling through the Department of Defense.

The Other Transaction Agreement program is a partnership among several investigators and their teams, which have been collaborating for many years. These teams are led by world-renowned scientists such as David AuCoin at the University of Nevada Reno, Tuan Vo-Dinh at Duke University and Doug Montgomery at Arizona State University, as well as many industry partners.

The collaboration among most of these institutions began in 2016 after a $2 million Defense Threat Reduction Agency contract was awarded to study this technology and determine how it could be applied for the detection of Tier-1 bioagents in defense operations.

Source: University of Arizona 

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Singapore Scientists Develop COVID-19 Test Method that Delivers Results in 36 Minutes

Scientists at the Nanyang Technological University (NTU) have discovered a way to improve the speed of obtaining COVID-19 test results by up to four times.

The improved testing method for COVID-19 yields results in 36 minutes – about a quarter of the time required by existing gold-standard tests. The current testing method requires highly trained technical staff and can take a few hours before results are finalised.

NTU said the test can be done with portable equipment and could be deployed in the community as a screening tool.

Testing is a key part of the Singapore Government’s strategy to isolate and ring-fence COVID-19 cases to prevent large clusters from forming. Since Jul 1, individuals aged 13 and older who present with symptoms of acute respiratory infection will be tested for COVID-19 at first presentation to a doctor.

The new method, developed by scientists at NTU’s Lee Kong Chian School of Medicine, has demonstrated a way to improve “the speed, handling time and cost of COVID-19 laboratory tests”, the university said.

Currently, the most sensitive method of testing for the coronavirus is through a laboratory technique called polymerase chain reaction (PCR), where a machine amplifies genetic material by copying it over and over again so any trace of the coronavirus can be detected.

A big problem is purifying the ribonucleic acid (RNA) from other components in the patient sample – a process that requires chemicals that are now "in short supply worldwide”, NTU said.

“The method developed by NTU LKCMedicine combines many of these steps and allows direct testing on the crude patient sample, cutting down the turnaround time from sample-to-result, and removing the need for RNA purification chemicals,” the university added.

PCR tests have proven to be “a workhorse” for biological research but it has some drawbacks, said Mr Wee Soon Keong, who is the first author of the research paper that has been published in the scientific journal Genes.

“The process is fiddly and time-consuming. Our rapid COVID-19 test involves a single-tube reaction that reduces hands-on time and biosafety risk for lab personnel, as well as the likelihood for carryover contamination during the processing of samples,” he added.

The same method can also be used to detect other viruses and bacteria, including dengue. The number of dengue cases this year is set to surpass the 22,170 cases in 2013 – Singapore’s worst outbreak.

THE NEW METHOD

In PCR tests, the genetic material on the swab sample has to be extracted to remove substances in the sample that prevent the test from working. One example of an inhibitor is mucin, a main component of mucus.

The test designed by the NTU team uses the “direct PCR method”, but removes the need for RNA purification – a time-consuming and costly step.

“Instead, they added inhibitor-resistant enzymes and reagents targeting compounds that obstruct RNA amplification, such as mucin … these enzymes and reagents, which are commercially available, have high resistance to such compounds that otherwise inhibit PCR, rendering the test inaccurate," said NTU.

The biochemical mix of crude sample and inhibitor-resistant enzymes and reagents is placed into a single tube, which is inserted into a laboratory thermocycler, a machine used to amplify genetic material in PCR. After 36 minutes, results reveal whether there is any trace of COVID-19 “with confidence”.

The team also tested this method on a portable thermocycler, which can be deployed in low-resource settings and endemic areas, pointing to the possibility of having this test done in community healthcare settings by frontline healthcare workers.

Senior research fellow Dr Sivalingam Paramalingam Suppiah said: “By skipping the RNA extraction step with our direct-PCR method, we see cost savings on nucleic acid extraction kits, and avoid the problem of reagents in short supply when lab testing is ramped up and the demand increases globally.”

Associate Professor Eric Yap, leader of the research team, said the team is now trying to deploy such methods for routine diagnostics.

“We need to determine the actual utility and benefits in a real-world setting, and to understand if there are any trade-offs. When one bottleneck is removed, other challenges may emerge – like ensuring quality control, or reducing manual errors.

“Our goal is to develop ultrafast and automated tests that yield results in minutes, and that can be performed by healthcare workers in the clinic with similar accuracy and sensitivity as in specialised laboratories,” he added.

“This will allow us to take PCR testing out of conventional laboratories nearer to the point-of-care, and into the low-resource settings that need them the most.”

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Megna Health Announces FDA EUA Approval of COVID-19 Antibody Combo Test Kit

Megna Health, a medical technology company focused on the development and manufacturing of diagnostic and healthcare products, announced that the Company has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its Rapid COVID-19 IgG and IgM Combo Test Kit.

Serology testing for COVID-19 is at an increased demand to better understand COVID-19 infections especially in asymptomatic patients or those who have recovered and developed antibodies. IgM antibodies are generally detectable in blood samples a couple of days after initial infection, and IgG antibodies follow later, then stay in circulation longer. Antibody tests could be even more important to the reopening decision-making process since antibody tests indicate a certain degree of immunity for future infection. In contrast, diagnostic PCR tests can indicate the presence of viral material during infection and will not indicate if a person was infected and subsequently developed antibodies to prevent future infections.

Megna’s Rapid Antibody Test Kit is lateral flow based immune assay. It tests both IgM and IgG antibodies against the COVID-19 virus with only a drop of blood sample (less than 5uL) and reports result in less than 15 minutes. In addition to studies in 411 patients, Megna’s Rapid Antibody Test Kit has also been validated independently by NIH/NCI (National Cancer Institute). It demonstrated sensitivity of 100 percent both combined (IgM/IgG) and IgG antibody.

“Our antibody kit is a first among combo (IgM and IgG) antibody test kits approved and manufactured in U.S. with such sensitivity,” said Eric Hill, Head of Marketing at Megna Health. “Simultaneous detection of IgM and IgG provides more important information to assess stage of infection and degree of immunity than individual assay alone.” 

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Fluidigm Announces GnomeDX Files for FDA EUA for Rapid Turnaround RT-PCR COVID-19 Test Utilizing Biomark HD Platform

Fluidigm Corporation, an innovative biotechnology tools provider with a vision to improve life through comprehensive health insight, today announced that Gnome Diagnostics, LLC (GnomeDX), a leading pharmacogenomics testing company, is utilizing Fluidigm® microfluidics technology and reagents in a test developed to detect the SARS‑CoV‑2 virus, which causes COVID-19.

The Rapid Turnaround Real-Time RT-PCR™ COVID-19 Test, which can be performed via oropharyngeal, nasopharyngeal and nasal swab, is intended to meet growing testing needs for patients, health care workers and other critical populations across central Ohio. GnomeDX has filed for Emergency Use Authorization (EUA) for its extraction-free GnomeDX RT-PCR COVID-19 Test from the U.S. Food and Drug Administration (FDA).

“Supporting our first responders and their patients are among key goals of our test development program,” said Vicky Amann, Vice President for Lab Operations at GnomeDx. “Our CLIA certified genomics lab is ideally suited to this challenge, and we are committed to support our community in any way we can to respond to the pandemic.”

“GnomeDX selected the Fluidigm integrated fluidic circuit technology, reagents and workflow because they provide high-performance sample throughput that is unmatched by microwell plate-based PCR assays for the SARS-CoV-2 virus,” Amann added.

GnomeDX is a high-complexity lab certified under the Clinical Laboratory Improvement Amendments (CLIA) in the United States and eligible under FDA guidance to create its own diagnostic tests for COVID-19. GnomeDX has validated a workflow using assays developed by the Centers for Disease Control and Prevention designed to be run on the Fluidigm Biomark™ HD system.

Because sample collection methods for the test include oropharyngeal and nasal swabs, it does not require invasive nasopharyngeal collection.

COVID-19 testing on the Biomark HD platform provides throughput and cost advantages that reduce the impact of capacity‑constrained supply chains. Fluidigm’s microfluidics technology enables processing of more samples per batch and uses a fraction of expensive testing reagents per sample as compared to more traditional, microwell plate-based PCR technology.

“We believe a significant increase in testing capacity remains critical to an effective global response to the COVID-19 crisis,” said Chris Linthwaite, President and CEO of Fluidigm. “As governments, medical institutions and private labs look for solutions, speed, scale and automation are paramount. Since the beginning of the pandemic, we have been supporting labs around the world as they build out testing infrastructure that meets these important criteria.

“The Biomark HD platform can generate as many as 6,000 test results per day on a single instrument. More and more labs are adopting the Fluidigm model of COVID-19 testing, which offers much-needed high-throughput capability per system. We also support multiple approaches to sample collection, having recently filed for Emergency Use Authorization from the FDA for an extraction-free saliva-based test to detect COVID-19.

“We are honored to have been chosen by GnomeDX to provide a platform for its COVID-19 test to provide critically needed testing capacity in central Ohio.”

In early June, Fluidigm filed for Emergency Use Authorization with the FDA for an extraction-free saliva-based test to detect the SARS‑CoV‑2 virus. The test was developed in collaboration with scientists at the McDonnell Genome Institute and the Department of Genetics at the Washington University School of Medicine in St. Louis.

With respect to the Fluidigm test, Fluidigm has filed for Emergency Use Authorization with the FDA. The test has been validated by Fluidigm, but the FDA’s independent review of this validation is pending. The FDA may require additional data, validation and/or testing, and may not ultimately provide authorization for EUA requests. An EUA, if granted, does not constitute FDA clearance or approval, but would allow use by authorized laboratories only while the EUA is in effect.

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HelixBind Awarded $3MM Grant from NIH for New Rapid Test for the Early Detection of Lyme Disease

HelixBind, which is developing an innovative diagnostic platform to revolutionize care for patients afflicted with invasive microbial infections, announced today that it has been awarded a new $3MM grant from the NIH to support clinical studies evaluating the company’s early detection test for Lyme Disease.

Lyme Disease, caused by the tick-borne bacteria Borrelia burgdorferi, is a serious health concern in North America with approximately 300,000 cases annually. If diagnosed early and treated with appropriate antibiotics, recovery is generally rapid and complete. Delays in treatment, however, can result in debilitating complications such as arthritis, cardiac abnormalities, or neurological conditions. Unfortunately, definitive diagnosis of Lyme Disease is difficult today as early symptoms are often non-descript including headaches, muscle or joint pain, and fevers. While, the most telling indication of an acute infection is a localized rash often resembling a bullseye, this feature appears in only two-thirds of cases of which over half are atypical, making diagnosis both difficult and subjective.

HelixBind’s test detects DNA from Borrelia directly from a patient’s blood and has a limit of detection below 1 cell/ml, roughly 100x more sensitive than today’s best commercial PCR-based tests. Unlike frequently used serological tests, direct detection of DNA has the potential to detect an infection at the earliest timepoint, precisely when antibiotics are most effective.

“HelixBind’s novel diagnostic platform makes it possible for us to detect invasive infections early,” said Alon Singer, CEO of HelixBind. “Diagnosis of Lyme Disease today is limited by the sensitivity of existing tests. This new grant from the NIH will help us demonstrate whether the improved sensitivity of our test can improve diagnosis and help those afflicted with Lyme Disease.”

HelixBind has clinical studies planned for the 2021 tick season and is looking to sign up additional clinical partners.

About HelixBind 

HelixBind is developing an innovative diagnostic platform to revolutionize care for invasive infections such as sepsis. Its novel platform provides faster, more accurate, and more informative microbiology results, assisting clinicians in precisely identifying bloodstream infections and developing personalized antimicrobial interventions for infected patients. This approach can improve outcomes, save lives, and reduce the spread of antimicrobial resistance.

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Neogen Corp. Announces Launch of Advanced Soleris NG Microbial Testing System

Neogen Corporation announced that it has launched an advanced test system that automatically detects microorganisms in a fraction of the time of traditional testing methods.

Neogen's new Soleris® Next Generation (NG) can rapidly detect and enumerate a wide variety of microorganisms that can threaten the safety and quality of food and other consumer products. For example, Soleris NG can detect and enumerate yeast and mold in a sample in only 48 hours, as compared to the three to five days needed for traditional methods, and detects Alicyclobacillus, a bacterium of particular concern to the fruit juice industry, in only 48 hours, compared to the five days of other methods.

"Our improved system to detect microorganisms makes it even quicker and easier for our customers to test their products and environment — and even easier to protect their customers," said John Adent, Neogen's president and chief executive officer. "Our customers can now use a single automated system to screen consumer product and environmental samples for the presence of microorganisms — greatly simplifying that process. This important new system can be used to test for the microorganisms of most concern to the food, nutraceutical, cosmetic and cannabis industries."

Soleris NG offers all the features, benefits and ease of use of the previous generations of the company's automated microbial testing system, and adds enhanced hardware and software to make producing, analyzing and auditing test results even easier.

The Soleris NG system provides accurate and rapid microbiological answers in a complete system approach. The system features 32-vial incubating drawers integrated with a secure software package, and each ready-to-use vial rapidly and independently detects the presence or absence of microorganisms.

The advanced Soleris NG system is validated using United States Pharmacopeia (USP) methodology to test numerous sample types, including nutraceuticals, cosmetics and cannabis products. In addition, the Soleris vials have earned multiple AOAC validations and MicroVal certifications, which allows the Soleris NG system to provide proven testing solutions all along the food and consumer goods production cycle.

Available Soleris tests include: total viable count, yeast and mold, coliforms, E. coli, Enterobacteriaceae, Alicyclobacillus, and many more. Applications for the system include spoilage flora analysis, sterility testing, shelf-life prediction, the testing of raw materials and finished products, and others.

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AXIM® Biotechnologies Unveils First–in-Class COVID-19 Rapid Diagnostic Test for Neutralizing Antibodies

AXIM® Biotechnologies, Inc., an international healthcare solutions company targeting oncological research, today announced the development of NeuCovixTM, a rapid diagnostic test measuring levels of functional neutralizing antibodies that are believed to prevent SARS-CoV-2 from entering the host cells.

Unlike currently available serological COVID-19 tests that detect an antibody response to the virus, AXIM’s rapid 10-minute test measures a specific subpopulation of antibodies to block binding of the virus to host cell receptors. While there are expensive, time consuming laboratory tests that measure neutralizing antibodies, NeuCovixTM differs in that it is a portable, low cost, rapid point-of-care test with results in 10 minutes.

“We are hopeful our test fills an important need in these uncertain times. While other tests merely show whether someone was infected with coronavirus, we took it a step further by creating a test that stratifies individuals into those who have neutralizing antibodies, which are essential in preventing reinfection, and those who don’t. The test can be deployed for point of care use in convalescent plasma transfusions to severely ill patients and for evaluating efficacy of upcoming vaccines in generating protective antibodies,” said Sergei Svarovsky, PhD, MBA, AXIM’s CSO and co-inventor of NeuCovixTM.

An immediate application of NeuCovixTM, a point-of-care test, is to measure levels of neutralizing antibodies in convalescent plasma so that plasma with the highest levels of neutralizing antibodies can be identified and administered to patients fighting COVID-19.  Without this knowledge, many patients could be undertreated with non-neutralizing plasma and may not benefit from this treatment. 

Another application of NeuCovixTM is to help ensure that vaccines elicit high levels of neutralizing antibodies. When a vaccine is available, manufacturers can employ the NeuCovixTM rapid, point-of-care test to evaluate protective immune responses in vaccine recipients.

AXIM® Biotech CEO John W. Huemoeller II commented, “Our goal was to make this test, accurate, fast and relatively inexpensive so it could serve as an ‘Immunity Passport™’ for vaccine developers around the world as they begin larger Phase II and III clinical trials. We are optimistic that NeuCovixTM will be widely used, becoming the gold standard in assessing levels of immunity.”

Doug Lake, Ph.D. and co-inventor of NeuCovixTM commented, “Everybody who recovers from COVID-19 makes antibodies against the virus, but since all antibodies are not created equal, you really want to know if the antibodies you make neutralize the virus. People who recover want to make sure they are protected from re-infection and that they won’t infect others.”

AXIM also announced the filing of a pre-Emergency Use Authorization Application (EUA) and has already initiated dialogue with the FDA in order to finalize its EUA submission. The intellectual property relating to the novel serological test is the subject of Provisional Patent Application No. 63/023,646 “Convalescent Plasma Testing and Treatment” filed on May 12, 2020. 

About AXIM® Biotechnologies

Founded in 2014, AXIM® Biotechnologies, Inc. (AXIM) is a vertically integrated oncology company developing rapid diagnostic tests for the early detection of cancer and proprietary small molecules drugs to treat cancer and block metastasis. The Company is also developing novel antibodies for therapeutic and diagnostic uses for oncological therapeutics.

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Integral Molecular Expands its Reporter Virus Technology to Enable Broad Testing for Coronavirus Protection Against Emerging Strains Including D614G

Integral Molecular has launched an expanded panel of SARS-CoV-2 Reporter Virus Particles (RVP), which includes spike protein variants such as D614G and spike protein from other related coronaviruses. These variants will test the breadth of protection afforded by COVID-19 therapeutics and vaccines against newly emerging or resistant strains of the virus. Virus neutralization testing using RVPs is being adopted by vaccine companies for screening sera from clinical trials to provide rapid and safe testing under standard BSL-2 laboratory conditions.

Viruses mutate and change over time and these mutations can compromise the efficacy of drugs or vaccines through resistance. For example, the D614G variant of SARS-CoV-2, mutated at position 614 of the spike protein, has quickly become the dominant form of the virus in many parts of the world and may have a higher transmission rate than the original virus. As novel or resistant strains emerge, it is critical to keep pace with the changing virus, test for effectiveness against evolving strains, and adapt therapeutics and vaccines accordingly.

"To get ahead of this pandemic, we need to start planning now for how the virus will look tomorrow," said Benjamin Doranz, President and CEO of Integral Molecular. "Our reporter virus system is extremely agile and RVPs have been rapidly engineered to incorporate emerging sequence variants to provide timely support for drug and vaccine development."

SARS-CoV-2 is closely related to other coronaviruses that also cause severe illnesses, including SARS (severe acute respiratory syndrome) and MERS (Middle East respiratory syndrome) virus. Integral Molecular's suite of pseudotyped coronavirus RVPs enables neutralization tests against all three coronaviruses and can be used to identify broadly neutralizing vaccines or therapeutics that have the potential to protect against multiple pathogens.

About Integral Molecular

Integral Molecular is the industry leader in discovering and characterizing therapeutic antibodies against membrane proteins, an important group of drug targets found on the surfaces of cells and viruses. Integral Molecular's technologies have been integrated into the drug discovery pipelines of over 300 biotech and pharmaceutical companies to help discover new therapies for cancer, diabetes, auto-immune disorders and viral threats such as SARS-CoV-2, Ebola, Zika, and dengue.

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Luina Bio And XING Technologies Set To Manufacture New And Fast SARS-CoV-2 Diagnostic Kit

Luina Bio announced they have been selected to partner with XING Technologies (Brisbane) to co-develop and manufacture a Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) diagnostic kit. The COVID-19 detection technology is based on a temperature-stable molecule utilising Xing patented technology.

XING is looking to fast-track the development and regulatory approval of the diagnostic kit to meet customer needs in USA, Europe and the pan-Asian region. These customers have been looking for a fast and accurate point-of-care antigen test as a superior alternate to existing serology tests which measure immune response. The test being developed by XING and its partners is focussed on detecting the live virus itself, a reliable indicator of infectivity.

Luina Bio will be developing and implementing the manufacturing of key protein reagents in yeast. These proteins are central to the XING COVID-19 diagnostic test. “It is estimated time to GMP production using the Luina FMP™ systems will only take 24 weeks from project commencement to completion” says Luina Bio CEO Les Tillack. “Flexibility is key to being able to respond to important rapid development programs like this” he said.

Luina Bio and XING are proud Queensland companies, supporting Queensland jobs in the globally competitive life sciences sector. These reagent product’s will be entirely developed and manufactured in Queensland.

About Luina Bio

Luina Bio is one of Australia’s most experienced biopharmaceutical contract manufacturing organisations, offering an inclusive set of services including cGMP manufacture in TGA/APVMA-licensed facilities of recombinant proteins, vaccines, and synthetic molecules for human and veterinary uses. Luina Bio’s Flexible Bio-manufacturing Platform, Luina FMP ™ was developed from over three decades of contract manufacturing experience, knowledge and expertise. 

About XING Technologies

XING Technologies is an Australian healthcare biotechnology company using patented nanotechnology to develop, manufacture and commercialise novel, disruptive diagnostic and monitoring platforms with global distribution potential. The Company’s service and product lines currently span from cancer care to rapid nucleic acid and protein detection diagnostics as well as nanoparticle capture agents to identify and prevent spread of pathogens such as that of COVID-19.

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Purdue Team to Develop Rapid Sensor Technology for Cattle Disease

Bovine respiratory disease (BRD), one of the most prevalent and costly illnesses in the beef and dairy industries, accounts for about half of all feedlot deaths in North America and costs producers as much as $900 million a year. Quickly diagnosing the illness could improve the well-being of animals and save producers significant money. Current tests don’t offer results for four or more days.

Purdue University researchers, led by Mohit Verma, an assistant professor of agricultural and biological engineering, are developing technology to reduce diagnosis time to about 30 minutes. Their work is being funded by a $1 million U.S. Department of Agriculture National Institute of Food and Agriculture Inter-Disciplinary Engagement in Animal Systems (IDEAS) grant.

“Bovine respiratory disease can be triggered by a number of bacteria and viruses, making treatment decisions difficult. By the time a test comes back in four or five days, the disease may have killed the calf or spread to many others in the feedlot,” Verma said. “Over the next three years, we will develop a test that addresses the bacterial side and have a prototype to use in the field.”

Jennifer Koziol, a clinical assistant professor in Purdue’s College of Veterinary Medicine and co-investigator on the project, said veterinarians currently treat BRD with antibiotics that are effective against the most common bacteria that causes the disease. But it’s possible the bacteria is resistant to the chosen antibiotic, making  treatment ineffective. Expediting quick and accurate diagnoses while aiding in choosing the correct antibiotic the first time can save calf lives and reduce unnecessary antibiotic usage.

“When we have BRD going through multiple animals in the herd, we need to know exactly what bacteria we are up against and exactly which antibiotics will be useful quicker than four to five days so we can make good choices about the antibiotics we use the first time,” Koziol said. “Having a rapid test that we can use is good for the animals and good for antibiotic stewardship.”

Verma learned about the need for better BRD testing from Aaron Ault, a senior research engineer in Purdue’s School of Electrical and Computer Engineering, who farms 3,200 acres of corn and soybeans and manages 3,000 head of cattle near Rochester, Indiana. Ault, who will work with the team on engineering components of the technology, said he may spend weeks pulling two or three dozen sick calves per day from his herd for treatment during a bad BRD outbreak.

“The No. 1 struggle I have in farming is BRD. I believe it’s the biggest problem in the beef industry,” Ault said. “This technology can change that. But there’s also an opportunity to collect much better data about the health of our cattle through machine learning, looking at the types and amounts of bacteria normally present in a calf’s respiratory system and using that information to predict potential issues down the road.”

Verma believes the biosensor technology his team is developing for BRD could be the base technology for detecting other animal and human illnesses. Prior to receiving the USDA-NIFA IDEAS grant, Verma had started adapting the platform to identify the presence of SARS-CoV-2, the virus that causes COVID-19.

“To accurately diagnose a BRD infection, our sensors will need to be versatile enough to identify many bacteria and viruses,” Verma said. “It’s entirely possible we’ll be able to adapt these sensors rapidly to address other health issues, potentially even new viruses that require quick detection to prevent global pandemics.”

In addition to Verma, Koziol and Ault, the research team includes Jacquelyn Boerman, Candace Croney, Timothy Johnson and Jon Schoonmaker from the Purdue Department of Animal Sciences; Deepti Pillai from the Purdue Department of Comparative Pathobiology; and Hwanseok Song from Purdue’s Brian Lamb School of Communication.

The preliminary research Verma’s team conducted to obtain the $1 million USDA-NIFA grant was funded by a startup Agricultural Science and Extension for Economic Development (AgSEED) grant. AgSEED was established through Crossroads funding from the Indiana legislature to foster the state’s leadership in plant and animal agriculture and rural growth. Verma also received seed funding from the Disease Diagnostics INventors Challenge, created by the Purdue Institute of Inflammation, Immunology and Infectious Disease in partnership with the Department of Comparative Pathobiology, which contributed the funds to realize the pilot project, the Indiana Clinical and Translational Sciences Institute and the Indiana Consortium for Analytical Science and Engineering.

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3M and MIT Researchers Developing a Rapid Diagnostic Test for COVID-19

To help the world respond to COVID-19, 3M and researchers at MIT are testing a new rapid test that detects the virus. Accelerated research is underway to learn if a simple-to-use, diagnostic device can produce highly accurate results within minutes and is feasible to mass manufacture.

The U.S. National Institute of Health selected the rapid COVID-19 test for accelerated development and commercialization support, after rigorous review by an expert panel. The test is in the Rapid Acceleration of Diagnostics Tech (RADx Tech) program, an aggressively-paced COVID-19 diagnostics initiative from the NIH’s National Institute of Biomedical Imaging and Bioengineering.

“We are excited to collaborate with Professor Hadley Sikes and the team at MIT. Our approach is ambitious, but our collective expertise can make a difference for people around the world, so we owe it to ourselves and society to give it our best effort,” said John Banovetz, 3M Senior Vice President for Innovation and Stewardship and Chief Technology Officer. “This is another step demonstrating 3M’s leadership in the fight against COVID-19. We are seeking to improve the speed, accessibility and affordability of testing for the virus, a major step in helping to prevent its spread.”

The test would detect viral antigens and deliver highly accurate results within minutes via a paper-based device. The test could be administered at the point-of-care and would not need to be sent to labs for testing.

This effort draws on 3M’s deep technological expertise in biomaterials and bioprocessing along with the company’s expertise in global medical device manufacturing. The 3M team is led by scientists, manufacturing and regulatory experts from its corporate research laboratories and health care business group.

The research team at MIT is led by Professor Hadley Sikes at the Institute’s Department of Chemical Engineering. The Sikes lab specializes in the creation and development of molecular technologies to improve the performance of rapid, cellulose-based protein tests.

“There is a pressing need for a highly scalable rapid test,” Sikes said. “We are working with our colleagues at 3M to overcome the challenges to move this research from lab to impact, and find an innovative path forward to manufacture it at scale. Joining forces with 3M and the NIH has greatly enhanced our collective efforts toward swift detection of the virus, and a potential tool to help mitigate and contain this public health crisis.”

The teams at 3M and MIT believe a diagnostic test can be deployed once validated. Manufacturing equipment can be scaled to produce millions of units per day.

The team is prepared to collaborate with the government’s RADx Tech program to demonstrate the test’s capability and to deploy it as quickly as possible. RADx Tech’s phased innovation funnel is initially supporting a four-week period of intense research to demonstrate the test concept works and can be commercialized on a large scale. The project received $500,000 in validation funding from RADx Tech and is eligible for further investment in later stages of the development funnel.

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