Sunday, August 02, 2020

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.

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.


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.”

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.” 

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.

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.

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.

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.

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.

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.

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.

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.

Sunday, July 05, 2020

Lab-on-a-Chip (LoC) COVID-19 Test Advances to Clinical Trials

In July, Dr. Pantelis Georgiou’s research group from Imperial College London will begin testing the accuracy of a “lab-on-a-chip” COVID-19 diagnostic test in clinical trials at Charing Cross Hospital in London. This inexpensive test provides a result in 20 minutes, relies on smartphone technology and can be used in remote locations without access to electricity. The only reliance on electricity is for charging the internal battery.

The test involves loading extracted DNA and RNA from a nasal or throat swab onto a single-use disposable cartridge. The cartridge is loaded onto the LoC device, which contains an array of ion-sensitive field-effect transistor (ISFET) sensors integrated on a complementary metal-oxide semiconductor (CMOS). The single-use cartridge with the CMOS is plugged into the main device. The main device contains a microcontroller, similar to a small computer, that acquires and processes the data. The microcontroller also transfers the data retrieved from the test via Bluetooth to a smartphone app and secure cloud server.

Each ISFET sensor measures ion concentrations in solution. When the ion concentration changes, the current in each sensor or pixel varies as well. An ISFET is similar to a metal-oxide-semiconductor field-effect transistor (MOSFET). The difference is that in an ISFET, the gate connection is tied to a reference electrode in contact with the solution. Also, the gate oxide is replaced with an ion-sensitive insulating layer.

CMOS is a technology that enables microchips to acquire, store and transmit large amounts of information. The CMOS for this particular test contains over 4,000 electrochemical sensors.

The sensors allow ion imaging of the reaction on the surface of the chip. If the sample contains the RNA of the active virus, the device performs an amplification reaction and protons are released in the solution. When the concentration of hydrogen ions increases, the pH drops. Thus, the solution becomes more acidic.

“One of the benefits of using smartphone technology is that everyone has such a device in their pocket,” said Dr. Nicolas Moser, research associate at the Department of Electrical and Electronic Engineering at Imperial College London and a member of the team.  “With a custom app, a smartphone can be used to implement advanced algorithms to process the data.”

Moser added that a handheld device is cheaper than using a computer. With only a single battery, a doctor could administer multiple tests at once.

“Each lab-on-chip (LoC) cartridge contains a control sample to ensure that the result from the swab is accurate,” Moser said. “During our clinical validation, we will also measure the results of the validation with an analysis from a quantitative polymerase chain reaction machine (qPCR machine), which amplifies and detects DNA. In addition, we will use other gold-standard methods of virus detection to validate the performance of our LoC test.”

The team is currently working to ensure the chip’s seal is reliable. A tight seal will prevent contamination of the sample.

“We’ve switched to 3D printing from our previous manufacturing technology and adopted a new design,” said Matthew Cavuto, a graduate student and research assistant on the team. “Luckily our 3D printer, the Figure 4 from 3D Systems, can print our microfluidic chips very quickly. Between March and June of 2020, we went through probably 30 versions of the design. That’s been our primary troubleshooting technique, iterating and experimentally testing as rapidly as possible.”

The current test was developed from technology the team started researching two years ago. The technology was originally designed to address outbreaks of the Zika virus.

“The LoC has the advantage of offering versatility to a wide range of infectious diseases,” Moser said. “It was designed to detect dengue and trialed in Taiwan and, later, malaria and trialed in Ghana. In March 2020, we adapted the test to detect the novel coronavirus.”

Moser and Cavuto said Imperial College London has allowed the team access to the lab through the pandemic. Work conditions have been similar to those under normal circumstances, except for new requirements to socially distance and wear masks and gloves at all times.

“At times, we had difficulty obtaining printed circuit boards and electronics from China,” Cavuto said. “Their manufacturing facilities were closed.”

The team has been able to continue research because the project is deemed essential to the current COVID-19 pandemic.

Moser said that during and after the clinical trials, the team will develop training to teach healthcare providers how to administer tests. The team is also determining how to synchronize data from tests and store them on a secure cloud server.

“We further hope to take the anonymous information retrieved from the tests and synchronize it onto a global map that we’ve developed,” Moser said. “That will track the evolution of data in a completely automated way. It will give countries reliable information to make decisions regarding public health.”

The current members of the research group are Georgiou, Dr. Jesus Rodriguez Manzano, Moser, Cavuto, Ivana Pennisi, Kenny Malpartida Cardenas, Ahmad Moniri and Luca Miglietta. To learn more about the Imperial College London team’s research, read their published papers on rapid detection and mobile detection system.

GenMark Diagnostics Announces Launch of its ePlex® Respiratory Pathogen Panel 2 (RP2)

GenMark Diagnostics, Inc., a leading provider of automated, multiplex molecular diagnostic testing systems, announced that its ePlex® Respiratory Pathogen 2 (RP2) Panel is now available for U.S. commercial distribution and clinical use. The ePlex RP2 Panel is one of the first rapid-result multiplex panel tests that can identify 21 pathogens, including SARS-CoV-2, to be made available for clinical use. The company also submitted an Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration for the ePlex® Respiratory Pathogen 2 (RP2) Panel earlier this month.

The ePlex RP2 Panel is designed to provide results for SARS-CoV-2 – the virus that causes COVID-19 – in addition to a number of other common respiratory pathogens, including influenza, adenovirus, rhinovirus and respiratory syncytial virus (RSV), in under two hours. The panel also includes a new, simplified workflow making it even easier for labs to run the test. The ability to quickly determine the cause of infections will be vital in the fall and winter when many of these respiratory pathogens are likely to be circulating, along with SARS-CoV-2.

Incorporating the SARS-CoV-2 assay into the existing ePlex RP Panel is intended to streamline the diagnostic process for hospitals by allowing them to check for multiple pathogens with a single test, saving time and resources and improving bed management. A study at two acute large tertiary care hospitals demonstrated that using the ePlex RP panel in the Emergency Department led to earlier patient results which resulted in an 8.4% reduction in hospital admissions.1

“The ePlex RP2 Panel is designed to enable clinicians to quickly determine the cause of infection and the best course of treatment. This is especially vital for individuals who are vulnerable, such as the elderly, people with compromised immune systems, and children, and therefore at increased risk for the new coronavirus and other common and often serious respiratory illnesses,” said Scott Mendel, President and CEO of GenMark. “One recent study highlighted that about 20% of COVID-19 patients are also infected with other respiratory pathogens.2 Syndromic panels that provide broad coverage of viruses and bacteria from one patient sample will be critical this flu season, which is expected to coincide with continued SARS-CoV-2 infections.”

Incorporating the SARS-CoV-2 test into the existing ePlex RP Panel is expected to improve GenMark’s manufacturing efficiency and output and increase the number of respiratory panels (including COVID-19 tests) the company can supply. GenMark continues to invest in manufacturing capacity improvements to scale and meet future testing demand.

The ePlex RP2 Panel is designed for use with the company’s ePlex system, which has been cleared by the FDA for use with the ePlex Respiratory Pathogen (RP) Panel and Blood Culture Identification (BCID) Panels (Gram-positive, Gram-negative and Fungal pathogens). In March, GenMark received EUA for its ePlex SARS-CoV-2 Test. Certified by the FDA under the Clinical Laboratory Improvement Amendments (CLIA) as moderately complex, the ePlex system is easy to operate and can be used in a wide variety of hospital and reference lab settings.

Tangen Biosciences Awarded a Contract for Point-of-Care Detection of Candida auris

Tangen Biosciences, Inc. announced that it was awarded a contract by the New York State Department of Health’s Wadsworth Center in conjunction with Health Research Inc. to develop a point-of-care device for detection of Candida auris, a “superbug” that is resistant to anti-fungal drugs and is emerging as a public health threat. According to the CDC, New York State has the most Candida auris cases in the United States. Tangen™ was selected as one of the three awardees for this contract to join forces with the Wadsworth Center to fight against this drug resistant fungus. Tangen will independently develop a skin-swab based Candida auris assay running on its portable GeneSparkTM instrument and will also develop a swab-based Candida auris test for environmental surveillance.

Tangen has developed a molecular diagnostic platform called TangenDx™ – a small footprint, rapid, highly sensitive, and low-cost system. TangenDx is composed of an assay kit and a GeneSpark analyzer. The TangenDx has been developed for rapid diagnosis of bloodstream candida infections, bacterial infections including Bacillus anthracis, and an antimicrobial-resistant panel directly from whole blood in less than one hour. During the COVID-19 pandemic, Tangen has focused on developing a point-of-care SARS-CoV-2 assay and intends to submit an Emergency Use Authorization notification to FDA within the next month. Tangen’s new contract with Wadsworth Center is expected to further expand Tangen’s product pipeline to include a clinical as well as an environmental Candida auris test. The high sensitivity, portability, and speed provided by the TangenDx platform is expected to facilitate a faster and more accurate diagnosis of Candida auris, allowing for an improved response to outbreaks of this threat.

The current Tangen bloodstream candida panel used on the TangenDx can detect fewer than 5 CFU/ml of the five most prevalent Candidiasis species in less than one hour from a whole blood sample without culture. “We are building upon the foundation of Tangen’s existing Candida Bloodstream Infection diagnostic assay, and predict we can rapidly develop a Candida auris test for both blood and skin swab samples with very low risk and achieve high sensitivity and specificity,” Dr. John Davidson, Chief Scientific Officer of Tangen and the Principle Investigator of this contract, stated. “Rapidly detecting Candida auris is crucial to control its spread in hospitals and the community, including nursing homes, which have been identified as incubators for this superbug. We are excited to work with the Wadsworth Center to address this very important public health issue."

“New York State’s continued support continues to advance the nation’s efforts to control this fungus that predominantly affects an already vulnerable population, including those in nursing homes and people with compromised immune systems,” said Jill Taylor, Ph.D., Director of the Wadsworth Center. “We look forward to working with Tangen to bring this important tool to frontline health care settings.”

T2 Biosystems Announces U.S. Launch of COVID-19 Diagnostic Test

T2 Biosystems, Inc., a leader in the rapid detection of sepsis-causing pathogens, today announced the completion of validation of its COVID-19 molecular diagnostic test, the T2SARS-CoV-2 Panel. The test was developed by T2 Biosystems under a license agreement with the Center of Discovery and Innovation at Hackensack Meridian Health and is being commercially distributed after validation meeting requirements for an Emergency Use Authorization (EUA) request to FDA.

The T2SARS-CoV-2 Panel is designed to detect SARS-CoV-2, the virus that is responsible for COVID-19 infections. The T2SARS-CoV-2 Panel provides sample-to-answer results in less than two hours, utilizing a nasopharyngeal swab sample. Clinical testing on known positive and negative patient samples showed a sensitivity of 95% and specificity of 100%. The T2SARS-CoV-2 Panel runs on the Company’s FDA-cleared T2Dx® Instrument, which is a fully-automated, random access system capable of performing seven tests simultaneously.

“We are proud to announce the U.S. launch of our molecular diagnostic test, the T2SARS-CoV-2 Panel, which has demonstrated excellent clinical performance. Adding this test to our existing sepsis-related portfolio illustrates our commitment to transformative diagnostics that improve the lives of patients,” said John Sperzel, President and Chief Executive Officer of T2 Biosystems. “Given the susceptibility of critically-ill COVID-19 patients to develop bacterial or fungal co-infections and secondary infections that can lead to sepsis, we believe our platform can be used to identify acute COVID-19 infections, and optimize outcomes for patients under intensive care.”

The T2Dx Instrument can also run the Company’s FDA-cleared T2Bacteria® Panel and T2Candida® Panel. These panels can detect sepsis-causing pathogens, both bacterial and fungal respectively, directly from whole blood in three to five hours, without the need to wait for a blood culture, which typically takes days to provide results and is not as sensitive. By providing quicker results, the panels enable clinicians to target therapy faster than ever for their patients suspected of sepsis, leading to better patient outcomes, improved antibiotic stewardship, and reductions in length of stay in the hospital.

Sherlock Biosciences and binx health Announce Global Partnership to Develop First CRISPR-based Point-of-care Test for COVID-19

Sherlock Biosciences and binx health today announced the companies have entered into a strategic partnership to develop the world’s first rapid, point-of-care diagnostic test for COVID-19 leveraging CRISPR technology. The organizations will combine the binx io diagnostic platform with SHERLOCK™ CRISPR technology to create a test that is robust and simple to use. This unique solution is designed to provide rapid and accurate results in a single patient visit across many diverse CLIA-waived settings, such as clinics, doctors’ offices, assisted living centers, pharmacies and other easily accessible consumer venues, which will assist in broadening ways of managing potential resurgences of the pandemic. The combination of technologies also portends strong positioning for other viral threats as they emerge.

The binx io is the fastest molecular platform in the world that has U.S. Food and Drug Administration (FDA) clearance for chlamydia and gonorrhea testing. The Company’s platform is based on a proprietary detection method that makes it suitable for broad application across infectious diseases. The platform has a demonstrated ability to rapidly detect complex infectious disease targets from bodily fluids with very high accuracy. The binx io molecular platform consists of an easy-to-use, desktop-sized instrument and single-use cartridge with multiplex capacity of up to 24 targets. Once a patient sample is added to the cartridge and loaded into the io instrument, the process is fully automated, requires no interpretation of data, and is designed to produce a clearly indicated onscreen “detected” or “not detected” result.

“We are pleased to partner with Sherlock Biosciences to help bridge a gap in COVID-19 testing—the need for highly accurate point-of-care diagnostic testing in CLIA-waived and near-patient settings,” said Jeff Luber, chief executive officer of binx health. “In April of this year, binx health made history with the first 30-minute, FDA-cleared molecular diagnostic instrument for chlamydia and gonorrhea in both men and women that for the first time delivers same-visit diagnoses. Our proprietary platform will now leverage Sherlock’s CRISPR-based assay combined with binx’s electrochemical detection for rapid viral detection of SARS-CoV-2 without the need for additional instrumentation. This union of technologies is designed to enable physicians, clinicians and other healthcare workers on the front lines of the global COVID-19 pandemic to make on-the-spot care decisions and to control and prevent further infections. We also have a unique alignment of vision with Sherlock for solutions that support ‘everywhere’ testing in near-patient retail and clinical settings.”

“This collaboration with binx health to advance our SHERLOCK diagnostic platform and offer an accurate, point-of-care test is the next critical step in combating the global COVID-19 crisis,” said Rahul Dhanda, co-founder, president and CEO of Sherlock Biosciences. “We are also excited to explore with binx how to utilize the io platform to bring accurate and affordable testing to hospitals, urgent care centers and other healthcare facilities for a range of diagnostic tests beyond COVID-19. We agree with the binx strategy that ‘everywhere care’ depends on highly accurate in-clinic and easy-to-use at-home solutions. Through both our SHERLOCK- and INSPECTR™-based platforms, we hope to serve as part of the solution to addressing the COVID-19 pandemic by making accurate, affordable diagnostics available everywhere they are needed: in the lab, point-of-care locales, low-resource settings and the home.”

The currently available Sherlock™ CRISPR SARS-CoV-2 kit uses the SHERLOCK (Specific High-sensitivity Enzymatic Reporter unLOCKing) method to program a CRISPR molecule to detect the presence of a specific SARS-CoV-2 genetic signature in specimens collected from patients suspected of COVID-19 by their healthcare provider. The kit is intended for use in CLIA laboratories to assay nasal swabs, nasopharyngeal swabs, oropharyngeal swabs or bronchoalveolar lavage (BAL) specimens. When the signature is found, the CRISPR enzyme is activated and releases a detectable signal, yielding results in about an hour. The kit is the first CRISPR-based diagnostic test to receive EUA from the FDA for qualitative detection of nucleic acid from SARS-CoV-2. Sherlock is also pressing forward in developing its INSPECTR at-home testing platform to create an instrument-free, handheld test – similar to that of an at-home pregnancy test – for the rapid detection of the SARS-CoV-2 virus.

European Pharmacopoeia Publishes New Chapter Regarding BET Testing and the Use of Recombinant Factor C

The European Pharmacopoeia has released a supplement containing a new general chapter that describes an alternative bacterial endotoxins (BET) test to the classic limulus amoebocyte lysate (LAL)-based method.

The new chapter 2.6.32. Test for bacterial endotoxins using recombinant factor C describes how recombinant factor C (rFC) based on the gene sequence of the horseshoe crab and fluorimetric detection can be used to quantify endotoxins from gram-negative bacteria.

Supplement 10.3 also contains the revised chapter 5.1.10. Guidelines for using the test for bacterial endotoxins, which has been updated to reflect the new status of rFC-based methods and give prerequisites for their deployment by users of the pharmacopoeia.

According to the Council of Europe (EDQM), chapter 2.6.32 has the potential to become a standardised method, which will become official in the 39 signatory countries to the European Pharmacopoeia convention.

BET tests using rFC can be used in the same way as LAL-based methods once they have been demonstrated as fit for purpose with the specific substance or product. The use of rFC for BET testing does not need to be validated, making its implementation easier; however, the replacement of an LAL-based method by an rFC-based method is considered as the use of an alternative method by the EDQM.

BET testing currently relies on two species of horseshoe crab as the sole source of lysate. Both Limulus polyphemus and Tachypleus tridentatus are endangered species and so a more sustainable option has been the topic of controversy. It was said the new chapter marks a significant step towards alleviating the need for these animal resources.

The EDQM’s Director, Susanne Keitel, explained: “When used under appropriate conditions, rFC-based methods provide the same guarantee of a product’s compliance with the test for bacterial endotoxins – and therefore, of its safety for use in patients – as LAL-based methods”.

The new general chapter 2.6.32 and the revised general chapter 5.1.10 will become effective on 1 January 2021.

Sources: EDQM and European Pharmaceutical Review

Sekisui Diagnostics Announces FDA Clearance and CLIA Waiver of the OSOM Ultra Plus Flu A and B Test

The test utilizes traditional lateral flow technology with performance near or exceeding sensitivity of other reader-based tests without using an instrument. It is intended for the qualitative detection of influenza type A and type B nucleoprotein antigens directly from nasal or nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection.

The clearance of the OSOM Ultra Plus Flu A&B Test heightens the performance of our flu portfolio allowing us to provide a more accurate rapid influenza test kit to many different institutions including nursing homes, chronic care facilities, and hospitals which the CDC acknowledges is useful for public health purposes to detect influenza outbreaks, said Robert Schruender, President and CEO of Sekisui Diagnostics. Accurate diagnosis of influenza is critical to rule in or rule out the flu and can help guide healthcare professionals when trying to diagnose other respiratory infections. This is especially important in our current situation where SARS-CoV-2 Tests are not widely available. We are proud to be able to provide another diagnostic tool which can help protect patients and our communities.

Sekisui Diagnostics offers all three commonly used modalities in the CLIA Waived environment via four different tests OSOM Ultra Plus Flu A&B Test (lateral flow dipstick), OSOM Ultra Flu A&B Test (lateral flow cartridge) Acucy Influenza A&B Test (point-of-care reader) and the Silaris Influenza A&B Test (molecular point-of-care). Sekisui Diagnostics offers more options to address the varying needs of customers to help improve patient outcomes, maximize clinical efficiencies, and reduce operational budgets. Reflecting on the unprecedented respiratory season this year, we have seen the value of tests that can respond to high volume clinical demand no matter where testing occurs, said David Morris, PhD, Sr. Product Manager. Rapid, point-of-care testing continues to be an essential tool in the healthcare system's ability to respond to surges in testing demand and to reduce the spread of respiratory infections.

Testing patients provides valuable information to clinicians that enables treatment decisions and reduces the risk of prescribing unnecessary antivirals, antibiotics or allows them to be referred on for more extensive testing if needed.

Monday, June 22, 2020

Virginia Commonwealth University Researchers Develop Extremely Rapid Experimental COVID-19 Test

Early diagnosis and isolation of patients with COVID-19 is a keystone for controlling the pandemic. While testing capacity has grown, quick turnaround for patient results remains critical.

To address this need, Rebecca Martin, Ph.D., a research member at VCU Massey Cancer Center, developed an extremely rapid experimental molecular diagnostic assay that decreases the amount of time required to diagnose COVID-19.

"When results can be obtained in just a few minutes, diagnosis and treatment can be provided on the initial care visit without sending samples to a central lab," said Martin, an assistant professor in the Department of Microbiology and Immunology at the VCU School of Medicine. "This methodology could provide accurate disease diagnostics on-site."

The project was enabled by a grant from the VCU COVID-19 Rapid Research Funding Opportunity, sponsored by the Office of the Vice President for Research and Innovation and the C. Kenneth and Dianne Wright Center for Clinical and Translational Research. The initiative was established to quickly pivot or expand research addressing the impact of the COVID-19 pandemic on the health system and the community.

Martin worked with VCU M.D.-Ph.D. students Jared Farrar and Joseph Lownik to develop the test by using recent methods of fast nucleic acid amplification to screen for SARS-CoV-2, the causative virus for COVID-19.

Their method is combined with rapid RNA extraction to allow for a total detection time of 3.5 minutes from swab to diagnosis. Compared to conventional testing, this new methodology is significantly faster, making the turnaround time minutes rather than hours.

"[Polymerase chain reaction], a common methodology in research and clinical laboratories, is slow, but sensitive," Martin said. "Antigen-based testing is fast, but not very sensitive. Our technique is both fast and sensitive."

Martin's work builds on research previously conducted by Farrar and Carl Wittwer, M.D., Ph.D., at the University of Utah that demonstrated that PCR—which can produce many copies of a DNA sequence from a small sample—can be performed in 15 to 60 seconds.

"By utilizing the principles of Extreme PCR, our test is currently the fastest described molecular diagnostic test for COVID-19 to our knowledge," Martin said. "Additionally, our technology can be easily multiplexed unlike other rapid molecular diagnostic methods."

Martin has filed provisional patent applications for this technology. She will also need to obtain Food and Drug Administration approval before the tests can be used on patients.

Her laboratory prototype is currently not practical for testing with patients at the point of care but proves that molecular diagnostic testing for COVID-19 can be done much faster than what current modalities are capable of doing.

For the next steps in their research, Martin and her team will work with the VCU Health System to test their prototype on patient samples as well as apply for funding for building a point-of-care prototype.

"We look forward to collaborating with the industry to develop an implementation for use in the clinic for COVID-19 diagnostics, as well as syndromic pathogen panels that can be used in testing for many different respiratory pathogens," she said.

Genetworx Laboratories Announces New COVID-19 Antibody Test with 99.8 Percent Specificity

Genetworx Laboratories, a leading innovative molecular diagnostic testing laboratory, announced today that the company is now performing COVID-19 antibody testing, in addition to diagnostic testing, for the virus. The Virginia-based company stated that it is providing the new antibody blood test in response to the demand from physicians' offices, emergency management providers, government, assisted living entities, and employers all over the United States. The Genetworx Total Antibody (IgM & IgG) test is 99.8% specific and 100% sensitive.

In addition to the new antibody test, the company further announced a comprehensive instant notification system implemented recently in which patients (who opt in) are notified of their test results immediately – for both antibody and diagnostic testing clients. Once Genetworx receives a patient's sample, the test is performed, and results are available through a patient or physician portal, or via text and voice messaging, within 24-48 hours.

Test results were previously sent directly to providers or third-party contractors. However, now, patients themselves can choose to receive their Genetworx COVID-19 test results automatically by text message or through a new interactive voice response telephone messaging system using a personal cellphone. Additionally, test results can be provided online through a patient portal. A certificate of proof of a test result will also be able to printed through the new online portal for employees as they return to work.

"We understand how important COVID-19 test results are to our patients so Genetworx invested in a system allowing rapid notification so that patients can have a diagnosis in the soonest time possible -- immediately after the Laboratory reads the results—usually within 24-48 hours of receipt of the sample," explained William Miller, CEO of Genetworx and a 20-year veteran of the molecular diagnostic laboratory testing industry. "Like all laboratories in the US, we saw a significant increase in volume recently and have worked tirelessly to implement the new system and be as responsive as possible to our patients and providers," he said.

The Genetworx antibody test, like the diagnostic test, is in the 99th percentile for accuracy and has emergency use authorization from the U.S. Food and Drug Administration. COVID-19 antibody tests utilize a patient's blood sample to detect the presence of specific antibodies to show a past infection with the virus. Nearly all immune competent individuals will develop an immune response following SARS-CoV-2 infection. Like infections with other pathogens, a COVID-19 infection creates IgM and IgG antibodies, which are the most useful for assessing antibody response. A patient's physician and the Centers for Disease Control guidelines will help determine the appropriate response to antibody test results.

Miller says that the last few months have been a once-in-a-lifetime experience for him and his staff.

"It's been very exciting for us to work together and play an important role in battling the coronavirus pandemic. Our company is proud that we pivoted quickly and repurposed part of our facilities back in March in order to conduct widespread COVID-19 testing with a 99 percent accuracy rate. Although it was challenging to keep up with the demand and to innovate in order to get both physicians and patients the information they need at the accuracy level required by the pandemic, Genetworx invested in our patients and, with this new rapid notification system and antibody test for our clients, we can assist the nation in moving forward through the pandemic and back to work."

Genetworx was founded to provide pharmacogenomic DNA genotyping to help provide patients with the right medications, at the right dose, and lower overall healthcare expenditures while delivering the best health outcome. The company is a fully integrated CAP/CLIA certified high complexity molecular diagnostic laboratory.

In 2017, the company was purchased by the national substance use disorder treatment network, Recovery Centers of America ("RCA"). Recovery Centers of America operates seven evidence-based addiction treatment facilities in Massachusetts, Pennsylvania, New Jersey and Maryland and is expanding to Chicago, Indianapolis, and Pittsburgh to meet the growing need for substance use disorder services.

InDevR Delivers Commercial Multiplex Coronavirus SeroAssay Kit and Testing Services for Vaccine Development

InDevR, Inc., a leader in novel analytical technologies that support the development and production of vaccines and biotherapeutics, announced commercial availability of its COVID-19 serology test kits. InDevR's VaxArray Coronavirus SeroAssay leverages the Company's established VaxArray platform to deliver a rapid quantitative test that can simultaneously screen for antibody responses to the spike proteins of SARS-CoV-2, SARS-CoV-1, MERS, and all four endemic coronaviruses in both animal and human samples. The serological test kit is designed to streamline the development of SARS-CoV-2 vaccine candidates by enabling measurements of pre-immunization status of clinical study participants, post-immunization antibody levels, and any potential induced cross-protection against other coronaviruses. The VaxArray Coronavirus SeroAssay uses ~200x less antigen per test than a typical ELISA, which is critical during a time when supplies of antigens are limited.  

Based on a clinical validation study involving over one hundred specimens and conducted in collaboration with Children's Hospital in Denver, the assay exhibits 100% clinical specificity and 98% sensitivity. Quantitative results with low limits of detection and multiple answers from a single <10 ยตL aliquot are more informative. This new tool will undoubtedly enable higher quality research and provide a deeper understanding of immunity.  InDevR also offers Testing Services to alleviate additional vaccine development bottlenecks.

Kathy Rowlen, CEO of InDevR, further noted that "In addition to the improvements in speed, usability, and information content relative to traditional ELISA immunoassays, we believe our VaxArray CoV SeroAssay can be used as a standardized benchmarking tool for the many organizations pursuing SARS-CoV-2 vaccine candidates. Higher quality comparisons of baseline antibody levels and immune responses across thousands of clinical study samples collected during the coming months will help accelerate the identification of the most promising vaccine candidates."

"The InDevR Coronavirus SeroAssay helped us to rapidly gain insight into various formulations of our COVID-19 vaccine candidates, providing us with an understanding of IgG response to SARS-CoV2 spike antigen produced from various sources and cross-reactivity with other CoVs. The information provided from the assay helped to guide decisions in our continuing work on development of a SARS-CoV-2 candidate vaccine. We found the correlation with our microneutralization measurements interesting and we look forward to pursuing this link further," noted Kentucky BioProcessing President, Hugh Haydon.

The VaxArray CoV SeroAssay is based on InDevR's VaxArray platform, a microscale multiplexed immunoassay that is already used by the world's largest vaccine manufacturers to streamline development and characterization of seasonal influenza vaccines, with applications to a range of other vaccines currently under development in collaboration with the Bill & Melinda Gates Foundation. The portfolio of VaxArray products delivers highly sensitive and quantitative measurements in a fraction of the time required for traditional characterization methods, thus reducing vaccine development timelines and manufacturing costs.

Thursday, June 18, 2020

FDA Revokes Emergency Use Authorization for Chembio Antibody Test

On June 17, 2020, the U.S. Food and Drug Administration revoked the emergency use authorization (EUA) of the Chembio Diagnostic System, Inc. (Chembio) DPP COVID-19 IgM/IgG System, a SARS-CoV-2 antibody test, due to performance concerns with the accuracy of the test. Antibody tests, a type of serological test, can help provide information on a person’s and population’s exposure to COVID-19.

As such, has deleted this serology test from its comprehensive list of EUAs.

“Since the beginning of the COVID-19 public health emergency, the FDA has balanced the urgent need for access to diagnostic and antibody tests with providing a level of oversight that helps to ensure accurate tests are being deployed,” said Jeff Shuren, M.D., director of FDA’s Center for Devices and Radiological Health. “By continuing to monitor authorized tests and emerging scientific evidence, we are able to make changes when appropriate – including taking action when a test’s benefits no longer outweigh its risks. Through these efforts, we are able to help assure that FDA-authorized tests meet the needs of the American public.”

The Chembio antibody test was one of the first antibody tests authorized by the FDA during the COVID-19 public health emergency. At the time of authorization, based on the information that Chembio submitted to the FDA at that time, the agency concluded that the test met the statute’s “may be effective” standard for emergency use authorization, and that the test’s known and potential benefits outweighed its known and potential risks.

As the FDA has learned more regarding the capability for performance of SARS-CoV-2 serology tests during the pandemic, and what performance is necessary for users to make well-informed decisions—through both the continued review and authorization of serology tests as well as through a research partnership with the National Institutes of Health’s National Cancer Institute (NCI)— the FDA was able to develop general performance expectations for these tests, which are listed in our serology templates.

Data submitted by Chembio as well as an independent evaluation of the Chembio test at NCI showed that this test generates a higher than expected rate of false results and higher than that reflected in the authorized labeling for the device. Under the current circumstances of the public health emergency, it is not reasonable to believe that the test may be effective in detecting antibodies against SARS-CoV-2 or that the known and potential benefits of the test outweigh the known and potential risks of the test, including the high rate of false results. Moreover, the risk to public health from the false test results makes EUA revocation appropriate to protect the public health or safety. As such, the FDA decided to revoke the emergency use authorization of the Chembio test, and this test may not be distributed.

The FDA will continue to monitor the performance of tests marketed in the U.S. and take actions, as appropriate, including modifying its policies.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Thursday, June 04, 2020

Digid Seeks FDA Approval for its Rapid Coronavirus Antigen Test Based on Cantilevers and Monoclonal Antibodies

At the Helmholtz Centre for Infection Research (HZI), scientists have succeeded for the first time in detecting SARS-CoV-2 viruses using the revolutionary Cantisense(TM) technology from Digital Diagnostics AG. Application for approval of the Digid Cantisense(TM) SARS-CoV-2 Test by the FDA has been submitted. Delivery of the first point-of-care tests is planned for July.

At the high-security laboratory of the Helmholtz Centre for Infection Research (HZI) in Braunschweig, Germany, the revolutionary Cantisense(TM) technology of the German health technology company Digital Diagnostics AG was used for the first time to successfully detect SARS-CoV-2 viruses in high measuring accuracy in test liquids.

In contrast to PCR testing, the new test provides a clear electronic "YES" or "NO" information within a few minutes, saving precious time in the diagnosis. What's more, the Digid Cantisense(TM) SARS-CoV-2 Test directly detects the presence of the virus while other rapid tests only recognize antibodies.

Konstantin Kloppstech, CTO at Digital Diagnostics, says: "Recent test series at the HZI high-security laboratory have shown that SARS-CoV-2 viruses can be detected directly using our Cantisense technology and without the need for PCR or further sample processing. This is a scientific breakthrough. We have coated cantilevers with a capture layer of highly specific monoclonal antibodies, which can reliably bind SARS-CO-2 viruses in the test fluid."

Constantin von Gersdorff, CEO of Digital Diagnostics, said: "The next step will be to initiate clinical studies with patient samples. To this end, we have already established international collaborations with leading hospitals."

With Digid's test kit, the measurement results are transmitted wirelessly from a sensor hub to a mobile device. By connecting to a secure analytics platform, the sensor data can be augmented with further data and processed anonymously for research and diagnostic applications.

Due to its measurement speed and the highly reliable results, the test is particularly suitable to support the containment of the current SARS-CoV-2 pandemic. The test offers the possibility of simple and rapid testing of patients and medical staff as an alternative to laboratory tests and enables reliable identification of infected persons within minutes. The possible areas of application therefore also include screening for access control at airports and railway stations, hospitals and specially protected areas (such as retirement homes) as well as for companies who want to ensure that their production runs smoothly and safely.

Digital Diagnostics has applied for approval of the Digid Cantisense(TM) SARS-CoV-2 Test by the US Food and Drug Administration (FDA). Digid aims to provide millions of units by July 2020. A further scaling of capacities is planned in the short term. The experts at Digital Diagnostics are also working at full speed to further develop the technology and to adapt the point-of-care testing procedure for use by consumers at home.

Atrys is Developing a Point of Care Graphene Technology-Based Biosensor to Detect COVID-19

Atrys Health, in collaboration with researchers from the Complutense University of Madrid and the University of Granada, is already working on the development of a portable diagnostic device “Point of Care” (tests from which the result is obtained immediately) based on graphene technology, which will allow detection with high reliability and in less than 15 minutes of COVID-19.

This kit, called RAP-ID19 will combine the advantages of the two techniques that have been most used so far for the diagnosis of the disease: on the one hand, the high specificity and sensitivity of the PCR (Polymerase Chain Reaction) technique; and, secondly, the speed of diagnosis and the need for specialized personnel of the RADTs (rapid antigen detection tests).

This will be achieved thanks to the graphene technology (GFET) used in its development, which allows making highly sensitive and instantaneous measurements using small amounts of sample thanks to the high electronic conductivity of graphene. In this sense, GFET-Point of Care biosensors represent a complete alternative for the massive, fast and reliable detection of COVID-19 due to its high sensitivity, specificity, speed, easy use, handling safety, as well as portability.

Another advantage of this Atrys device will be that end users will not be limited to testing by highly qualified professionals of the Health System, so it could be implemented as a detection tool in nursing homes; work and educational centers; airports, railway and bus stations.

Finally, by using a quantitative method, RAP-ID19 will allow quantifying the amount of virus, that is, the patient’s viral load, a factor potentially influencing the evolution of patients.

Financing of the SUPERA COVID-19 Fund

The project, which has an estimated duration of nine months, has been one of the seven selected within the SUPERA COVID-19 Fund of the Banco de Santander and Conference of Rectors of Spanish Universities.

The consortium that will carry out the RAP-ID19, with extensive experience in all the scientific aspects of this proposal and close prior collaboration, will receive financial assistance from the SUPERA COVID-19 Fund to develop the project and achieve a potentially marketable device.

Researchers Develop 1-Minute Electro-Optical Test to Identify COVID-19 Carriers

Ben-Gurion University of the Negev's Prof. Gabby Sarusi has developed a one-minute electro-optical test of nose, throat, or breath samples that will identify both asymptomatic and affected carriers of the COVID-19 virus in under one minute with greater than 90% accuracy.

Each test kit will cost approximately $50, which is far less costly than standard, laboratory-based polymerase chain reaction (PCR) tests. The BGU test is based on an electro-optical system that detects and identifies biological samples.

It does not require a lab environment so it can be deployed at critical locations such as airports, border crossings, stadiums, and other environments, as well as healthcare facilities where rapid testing is required.

Initial clinical trials completed with the Israel Defense Ministry on more than 150 Israelis had a better than 90% success rate. The ongoing trials will compare samples from COVID-19 patients with samples of patients with other diseases to detect the presence as well as the specific stage of COVID-19 infection.

"Right from the beginning of the trials, we received statistically significant results in line with our simulations and actual PCR tests that were conducted in parallel," says Prof. Sarusi, deputy head of research at the School of Electrical and Computer Engineering and a faculty member of the Electro-Optical Engineering Unit at BGU.

"We are now validating the robustness of the test and preparing to submit for FDA accelerated approval."

How does the test work?

"We asked ourselves, since this virus is just like a nano-particle or a quantum dot with a diameter between 100nm to 140nm in terms of its size and electrical properties, can we detect it using methods from the world of physics, photonics and electrical engineering," says Prof. Sarusi. "We discovered that the answer is yes; this virus resonates in the THz frequency, and spectroscopy in these frequencies reveals it promptly."

PCR coronavirus test kits are based on amplifying and identifying the viral RNA/DNA sequences and therefore depend on costly reagents in short supply and biochemical reactions that can be affected by heat and humidity.

PCR-based kits take hours, and in many cases days, to yield results and require logistically complicated shipping and handling of sensitive and infectious biological samples and can only be performed at points of care.

The new method is based on the change in the resonance in the THz spectral range imposed by the coronavirus through THz spectroscopy performed on the electronic chip designed by Prof. Sarusi and his team. This spectral range has been employed in recent decades for the fast detection and identification of biological samples.

Particles from a simple breath test or throat and nose swabs, currently used for other tests, are placed on a chip with a dense array of tens of thousands of metamaterial sensors that were designed specifically for this purpose.

The system then analyzes the biological sample and provides an accurate positive/negative result within a minute via a cloud-connected system.

The point-of-care device automatically records the results into a database that can be shared by authorities, making it easier than ever to track the course of the virus, as well as triage and treat patients.

"The world needs rapid, less expensive and widespread COVID-19 detection and this one will be ready to deploy in Israel in just weeks," says Doug Seserman, chief executive officer of the New York City-based American Associates, Ben-Gurion University of the Negev.

"BGU is working in many areas from vaccines to psychological support to mitigate the effects of this pandemic."

The new test is just one of more than 50 initiatives funded with grants as part of the BGU COVID-19 Response Effort. These each require financial support, and AABGU has announced its commitment to raise emergency funds, enabling BGU to participate fully in the world's efforts at mitigation and containment.

Source: American Associates, Ben-Gurion University of the Negev