Tuesday, March 31, 2020

Indiana University Develops Real-Time COVID-19 Diagnostic Tests

Indiana University researchers from the School of Informatics and Computing at IUPUI and the School of Medicine, in collaboration with Indiana University Health, are developing new diagnostic tests that combine speed and sensitivity for rapid detection of the viral strain.

These tests can eventually be employed for faster diagnosis of health care workers and others who are on the front lines and exposed to COVID-19 patients.

Benchtop and palm-held sequencing-based approaches being developed by IU principal investigator Sarath Janga and colleagues provide solutions for real-time detection of viral infections in clinical samples and further means to control the outbreaks.

"The issue with current accepted approaches for COVID-19 tests is that, while effective at detection, they are slow, with results taking up to a day or longer. We are testing our benchtop sequencing approach, which can potentially be done in two to three hours or even less," Janga said.

An additional advantage of this novel approach is that testing may be performed at point-of-care in the clinic, rather than transferring samples to the lab, further reducing time and the risk of more infections.

Given these challenges, the team hopes to leverage the findings from these new rapid tests to generate quantitative or semi-quantitative data that can be used to identify the COVID-19 strains prevalent in Indiana and reconstruct the development and evolution of the virus to inform surveillance, public health strategy and potential vaccine design going forward.

Janga's lab is also supporting current ongoing COVID-19 testing by providing personnel and necessary reagents to the clinical pathology lab at IU Health.

"Viral outbreaks such as COVID-19 need real-time detection of the status of infection in patients to control the spread," Janga said. "Since there are currently no specific treatments for coronavirus infections, and strains of these RNA viruses evolve rapidly, it is crucial to develop novel techniques that can provide rapid diagnostics and therapeutic intervention."

Like coronavirus, several viral strains are pathogenic in nature, difficult to detect and easy to transmit, leading to the emergence of pandemics. In the case of an outbreak, it is important to have a method to detect the virus as quickly and accurately as possible in order to prevent its transmission and efficiently treat infected patients.

Currently, most clinical diagnostic tests for viruses depend on either detecting viral antigens or on PCR amplification of viral nucleic acids. These two approaches offer trade-offs and benefits. Antigen tests are typically rapid but have low sensitivity, while PCR is more time-consuming and more sensitive.

Janga and his team are employing a commercially available Oxford Nanopore Technologies sequencing platform that generates full-length DNA or direct RNA virus sequences from clinical samples.

Janga, an associate professor in bioinformatics and data science in the School of Informatics and Computing at IUPUI, and visiting research associate Quoseena Mir, from the Department of Biohealth Informatics in the School of Informatics and Computing, are collaborating with Ryan Relich, head of the IU Health Clinical Pathology Laboratory and assistant professor of clinical pathology and laboratory medicine at IU School of Medicine, and Dr. Raj Vuppalanchi, director of the clinical hepatology division in the IU School of Medicine's Department of Medicine.

Source: Indiana University News

Battelle and Wexner Medical Create New COVID-19 Diagnostic Test

Battelle and The Ohio State University Wexner Medical Center have jointly developed a new rapid, sensitive diagnostic test for COVID-19. The Ohio State Wexner Medical Center will administer the new test under its existing FDA certification permits. This will increase and improve test processing in Ohio according to existing state clinical guidelines.

The new rapid test will allow for faster turnaround time on test results, which will help “flatten the curve.”

Battelle researchers spent several weeks working in the company’s West Jefferson labs to develop a diagnostic assay and complete a validation process, with early results suggesting exceptionally high sensitivity.

Since March 14, more than 100 Ohio State Wexner Medical Center researchers and clinicians have worked with Battelle researchers nights and weekends to stand up the lab that will support COVID-19 testing. After enough data was gathered by researchers at both institutions, Ohio State processed its first 91 tests for diagnosis Wednesday using cutting-edge Battelle and Ohio State equipment in a Centers for Medicare & Medicaid Services (CMS)-certified pathology lab at Ohio State.

Battelle is now working to bring a second lab online in West Jefferson, with the intent of making more test processing available. Battelle is in the process of receiving a Clinical Laboratory Improvement Amendment (CLIA) from CMS to begin its own clinical testing.

“Ohio State and Battelle teams have shown incredible leadership and ingenuity in moving this project forward so rapidly,” said Ohio Gov. Mike DeWine. “With this collaboration, we will increase testing right here in Ohio to better help health care professionals and public health officials understand, treat and prevent the spread of the virus.”

Results of the test can be available in as few as five hours. Initially, the system can process approximately 200 tests per day, but when the infrastructure is fully built over the coming weeks, the goal is to process more than 1,000 test swabs per day.

“Battelle has decades of experience in infectious disease research and has worked with virtually all federal health and national security agencies to respond to emerging health threats,” said Lou Von Thaer, Battelle’s president and CEO. “I am incredibly proud of the Battelle team, the speed at which it was able to work around the clock to quickly get this operational, and our collaboration with The Ohio State University.”

Battelle’s infectious disease, genetic and virology experts teamed up with researchers and scientists across Ohio State’s College of Medicine, including immunologists, microbiologists, pathologists, epidemiologists and data analytics researchers for this project.

“We’re proud of the partnership of our dedicated scientists with Battelle researchers to help find innovative solutions for the coronavirus pandemic sweeping the world,” said Dr. Hal Paz, executive vice president and chancellor for health affairs at Ohio State and CEO of the Ohio State Wexner Medical Center. “Our physicians and nurses are eager to start administering these tests that will greatly increase our capacity to diagnose more people and assist us in finding solutions for this disease. Testing is just one of more than 50 new research areas aimed at combatting COVID-19 underway at the Wexner Medical Center. We are working hand in hand with Battelle on many of these critical projects.”

Battelle is contributing its expertise and using its specialty facilities, including the largest, private BSL-3 laboratory in the United States, and is actively working on several other solutions related to the COVID-19 pandemic.

COVID-19 testing requires an order from a physician or other advanced practice provider. Based on feedback from the Ohio Department of Health, testing is prioritized for inpatients in hospitals and other facilities, outpatients who are moderately ill but who are at high risk for serious illness (e.g, elderly, immune compromised, underlying lung disease, etc.), health care providers and first responders. Asymptomatic patients do not need to be tested.

People who believe they need to be tested should contact their primary care provider, local hospital or your local health department for further direction.

Monday, March 30, 2020

Philippines FDA Approves Five COVID-19 Rapid Test Kits Despite Accuracy Concerns

The Philippines Food and Drug Administration (FDA) announced on Monday that it has approved COVID-19 rapid test kits despite the Department of Health’s preference for real-time polymerase chain reaction (RT-PCR) based test kits.

FDA Director General Eric Domingo said they have approved the use of 5 brands of rapid test kits. "We approved kits that are registered and used in countries with advanced technology and wide experience with COVID-19,” he said in a statement.

These are the Nanjing Vazyme 2019-nCoV IgG/IgM Detection Kit, the Novel Coronavirus (2019-NCOV) IgM/IgG Antibody Detection Kit (Colloidal Gold Method), the Diagnostic Kit for IgM/IgG Antibody to Coronavirus (Sars-CoV-2) (Colloidal Gold), the 2019-nCoV Antibody Test (Colloidal Gold) and the SARS-CoV-2 Antibody Test (Lateral Flow Method). The test kits are from China and Singapore.


Domingo also announced the FDA’s approval of the SARS Cov2 kit of Gene Xpert, as well as their coordination with Abbott Laboratories, which invented a test that can detect the COVID-19 virus within 5 minutes.

“Both tests were recently approved by the US FDA and can detect the virus in just a few minutes,” Domingo said in Filipino. He said they are awaiting for the production of the said test kits.

Unlike the rapid test kits, this one is PCR-based like the 17 other test kits already approved by FDA for commercial use.

For the past weeks, the FDA has only been approving PCR-based test kits, which the Department of Health considers the “gold standard” for COVID-19 testing. PCR-based test kits are used in laboratories to extract genetic material from throat and nose swab samples to compare it with the COVID-19 virus.

Rapid test kits, on the other hand, only measure the antibodies from a patient’s blood samples.

Domingo said that while the DOH does not believe that rapid test kits can be used for mass screening, it will yield a faster result, making it useful in some cases, such as when there is an immediate need to test a patient with severe symptoms or for communities where there is an outbreak. However, it is not as accurate as PCR-based kits.

During a televised briefing, Doming explained in Filipino that the results of rapid test kits must be interpreted by a health professional.

FDA is requiring all rapid test kits to have the following label: “This product is strictly for medical professional use only and not intended for personal use. The administration of the test and interpretation of results should be done by a trained health professional. Confirmatory testing is required.”

“The body takes time to develop antibodies and this might give a negative result for patients who have been infected but have not yet developed antibodies,” Domingo said. “A positive result due to cross reaction with other bacteria or viruses is also possible, which is why a confirmatory PCR based test is still required,” he added.

He emphasized that the rapid test kits cannot be used at home as it requires the preparation of a solution and the proper handling of the drug samples. “This is important because blood can be used to transmit diseases like hepatitis or HIV,” Domingo said.

Because of the backlogs due to limited test kits and laboratories, it takes 5 to 7 days to get COVID-19 test results. But the DOH said it will soon go back to 24 to 48 hours once they are done testing backlog samples.

The FDA reminded local government units to be careful with the test kits they are using.

Recently, one mayor posted a photo of the rapid test kits that his LGU purchased for his city. However, the FDA said it cannot be used yet because it has not been approved.

It also called on the DOH to increase the number of laboratories for the PCR-based tests.

“We are also calling on doctors to help and guide in the use of test kits and to properly explain the results to patients,” Domingo said.

The FDA official also warned against fake or unregistered medicine and medical devices.

Head of NanoBio Lab Develops 5-Minute Coronavirus Test

Professor Jackie Ying, who heads the NanoBio Lab at the Agency for Science, Technology and Research (A*Star), and her team have come up with a rapid test that can tell if a person has Covid-19 in as little as five minutes. When approved, this would be about the fastest test out there for Covid-19.

They hope to submit the test for approval in a month's time. The test looks for the genetic material of the virus in a patient's secretions collected from a swab.

This sample is then put in a portable device that will give the result in about five to 10 minutes, using an extremely rapid amplification method that they have named Cepat.

"We have done some preliminary clinical validation at the KK Women's and Children's Hospital using real patients' samples, and found the test to be very sensitive and accurate," said Prof Ying.

Once it is approved, the technology can be used to make such kits for use in hospitals. It will also be adapted for use in general practitioner clinics, said Prof Ying.

She and her team are among the researchers here and around the world who are racing to come up with point-of-care tests that can tell you if you have Covid-19 much faster than the current standard lab test. The challenge, Prof Ying said, is to develop rapid and accurate diagnostics that can be done without the use of expensive machines.

As the pandemic grows, the spotlight is increasingly falling on testing as a way to contain the spread - for the lack of it has potentially been hiding a large number of cases.

The World Health Organisation has emphasised the need to "test, test, test", as it allows cases to be picked up earlier and promptly isolated, before they spread it to more people.

Some countries are able to do widespread testing; others, like the United States, are experiencing a shortage of tests.

In Singapore, testing started in January at the National Centre for Infectious Diseases, where the National Public Health Laboratory is based. By the end of January, all of Singapore's public hospitals could test for Covid-19, said the group director of medicine at the National University Health System, Professor Dale Fisher. Singapore then tested anyone coming to a hospital with a respiratory illness and anyone who had been in contact with a Covid-19 patient.

"Less than 1 per cent of tests are positive, which reflects the large number being done," he said. These are the standard lab tests that look for the genetic material of the virus in the patient's secretions, often collected with a nasopharyngeal swab.

The test takes at least two to three hours to show results and requires the use of specialised machines. If samples need to be transported, the turnaround time is even longer.

These tests work by first converting the coronavirus' RNA to DNA in a method known as reverse transcription (RT). Then, the polymerase chain reaction (PCR) technique is used to amplify the genetic material of the virus so that it can be easily detected. It is called the RT-PCR test. "It is essentially a molecular photocopier. PCR was invented in 1984, and even in today's machines, about 60 per cent of the time is spent waiting for the PCR machine to heat up and cool down," said Prof Ying.

The latest invention by her and PhD student Muhammad Nadjad Abdul Rahim is a new method to amplify specific DNA/RNA at a single temperature. Just like PCR, their method can "photocopy" the genetic material of the virus millions of times. The difference in their new method is that they can hit a rate of millions of copies within a minute.

One key reason is that unlike PCR, their approach does not require any heating and cooling between each controlled amplification step. This is enabled by a special enzyme developed in Prof Ying's lab.

Prof Ying said she and her team of scientists have been working tirelessly for around six weeks to come up with the fast test, after A*Star's chief executive Frederick Chew gave them the challenge of coming up with rapid tests for Covid-19. Earlier, A*Star had developed PCR test kits for use here and overseas, and has passed the baton to local firm MiRXES, which can mass produce them.

Another local biotech firm Veredus Laboratories developed a three-hour PCR test kit that is being used at checkpoints here.

Associate Professor Hsu Li Yang, the programme leader for infectious diseases at the National University of Singapore's Saw Swee Hock School of Public Health, said that there are many diagnostic tests and kits being developed in China and the US, as well as those by local companies such as MiRXES and Veredus Laboratories, and it is a matter of time before the ones from overseas are available here.

US firm Cepheid has received emergency authorisation from the US Food and Drug Administration for its rapid molecular test, which can be used at the point of care for patients and gives a result in 45 minutes. It makes use of machines to run the test, which are already available in Singapore hospitals.

Other types of tests done to find Covid-19 in patients are the sero-logical tests. These look for immunoglobulins, which are the antibodies made by the immune system to fight the virus - in patients' blood.

These antibodies take a few days to show though, and will not appear in the early stage of the disease. Hence, a blood test will not detect Covid-19 if someone has just been infected with it.

Duke-NUS Medical School was the first in the world to develop a serological test that was put to good use last month to trace two people who were the source of infection of two clusters here. The two had mild symptoms, were not hospitalised and had recovered, but the test found they had antibodies against the coronavirus.

As serological tests pick up such mild cases, they can be done to ascertain the extent of community spread, as well as asymptomatic spread. Such tests, however, take several hours to show results. Fast test kits solve the problem but it is very important to note the sensitivity of the tests, said Prof Ying.

There is little point using a very fast test kit when it cannot detect the virus in you most of the time. Or, worse, it may tell you that you are not sick, even though you are infected with Covid-19. The latter is what is called a false negative, and it can happen, for instance, when the test kit is unable to pick up the virus in a person with a low viral load.

People infected with Covid-19 are believed to shed large quantities of the virus early in their illness (high viral load) and less later on. Hence, it would be best if a fast test can pick up the infection from a patient at various stages of the disease, regardless of whether he has a high or low viral load, said Prof Ying.

On Saturday, the US Food and Drug Administration said it is already beginning to see unauthorised fraudulent test kits that are being marketed to test for Covid-19 in the home.

Fraudulent health claims, tests and products may keep some patients from seeking care or delay necessary medical treatment, it said. "When you run a test, you must know what you are testing for," said Prof Ying.

An RT-PCR test should be able to detect the disease in someone who is in the earlier stage of the disease, when he is shedding more of the virus, and, therefore, likely more infectious.

On the other hand, a serological test can find antibodies in someone who is at the late stage or recovered, when he is shedding less or none of the virus, she said.

"This crisis has forced Singapore to re-examine whether we have the ability to do the various things needed to fight it and we do," she said. "We can do the science and we can also develop our own tests."

Source: The Straits Times 

Fluxergy Submits Request For FDA Emergency Use Authorization (EUA) For One-Hour COVID-19 Test At Point-Of-Care

Fluxergy LLC, a research and medical diagnostic test company based in Irvine California, has submitted an Emergency Use Authorization (EUA) request to the U.S. Food and Drug Administration (FDA) Center For Devices and Radiological Health, seeking an authorization that would permit medical professionals to begin using the company's high-speed Research Use Only (RUO) test system as a COVID-19 diagnostic at the point-of-care (POC).

The Fluxergy Analyzer system, which utilizes state-of-the-art PCR and microfluidics technology, has been shown to accurately identify the SARS-CoV-2 virus in under one hour in bench lab tests performed by the company and in follow-up validation tests with patient samples completed this week by researchers at University of California San Diego (UC San Diego). The UC San Diego physician-scientist research team that conducted the validation, completed on March 27, 2020, has been led by Dr. Davey Smith, Professor of Medicine and Head of the UCSD Division of Infectious Diseases and Global Public Health. Dr. Smith is a member of the Fluxergy Medical Advisory Board.

Advanced rapid point-of-care PCR tests for COVID-19 like the Fluxergy Analyzer system may have the potential to save significant time compared to standard lab tests that must be shipped to centralized laboratories for processing. Fluxergy's on-site sample-to-answer test for COVID-19 requires a very small sample, typically a nasal swab. This swab is mixed with a reagent solution, loaded onto the Fluxergy card and inserted into the Fluxergy Analyzer in a convenient two-step procedure.

"The worldwide shortage and inaccessibility of COVID-19 tests have been major impediments to containing the pandemic in the U.S. and globally," said Dr. Ali Tinazli, Chief Commercial Officer at Fluxergy. "We are gratified to be progressing toward the next important milestone in the development of our point-of-care diagnostic technology."

About Fluxergy

Fluxergy, launched in 2013 with funding support of investor John Tu, co-founder of Kingston Technologies, seeks to provide a portable, highly sophisticated and easy to use sample-to-answer POC platform that enables clinicians to cost-effectively conduct a wide range of multiplex and multimodal in vitro diagnostic tests (different types of tests all at once, up to 30 targets). Fluxergy's solution is a portable testing platform based on three core elements: the single-use consumable Fluxergy Card, the Fluxergy Analyzer, and its user interface Fluxergy Works. The Fluxergy Analyzer and the single-use consumable Fluxergy Cards (lab-on-chip) are designed to be very cost-effective and scalable, using proprietary printed circuit board (PCB) manufacturing and microfluidics technologies. Leveraging Fluxergy Works Software, as many as 256 Fluxergy Analyzers can be managed with one local server and linked to the Cloud to provide powerful access to help manage patient data.

Friday, March 27, 2020

Abbott Launches 5-Minute COVID-19 Isothermal Point-of-Care Test

Abbott announced today that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for the fastest available molecular point-of-care test for the detection of novel coronavirus (COVID-19), delivering positive results in as little as five minutes and negative results in 13 minutes. The test will run on the company's ID NOW™ platform, providing rapid results in a wide range of healthcare settings such as physicians' offices, urgent care clinics and hospital emergency departments.

The ID NOW platform is small, lightweight (6.6 pounds) and portable (the size of a small toaster), and uses molecular technology, which is valued by clinicians and the scientific community for its high degree of accuracy. ID NOW is already the most widely available molecular point-of-care testing platform in the U.S. today.

ID NOW features a unique isothermal nucleic acid amplification technology targeting COVID-19 RdRp gene, all within a self-contained test cartridge. Instead of thermal cycling, the system uses enzymes to rapidly drive the amplification process.

"The COVID-19 pandemic will be fought on multiple fronts, and a portable molecular test that offers results in minutes adds to the broad range of diagnostic solutions needed to combat this virus," said Robert B. Ford, president and chief operating officer, Abbott. "With rapid testing on ID NOW, healthcare providers can perform molecular point-of-care testing outside the traditional four walls of a hospital in outbreak hotspots."

Abbott will be making ID NOW COVID-19 tests available next week to healthcare providers in urgent care settings in the U.S., where the majority of ID NOW instruments are in use today. The company is working with the Administration to deploy tests to areas where they can have the greatest impact.

Abbott is ramping up production to deliver 50,000 ID NOW COVID-19 tests per day, beginning next week, to the U.S. healthcare system.

The arrival of the Abbott ID NOW COVID-19 test comes a week after the company launched its Abbott m2000™ RealTime SARS-CoV-2 EUA test, which runs on the m2000™ RealTime System located in hospital and reference labs around the world. Between the two platforms, Abbott expects to produce about 5 million tests per month.

When not being used for COVID-19 testing, ID NOW is the leading molecular point-of-care platform for Influenza A&B, Strep A and respiratory syncytial virus (RSV) testing. Our platform holds the largest molecular point-of-care footprint in the U.S. and is already widely available in physicians' offices, urgent care clinics, and hospital emergency departments across the country.

"Through the incredible work of teams across Abbott, we expect to deliver 50,000 COVID-19 tests per day to healthcare professionals on the front lines, where testing capabilities are needed most," said Chris Scoggins, senior vice president, Rapid Diagnostics, Abbott. "Portable molecular testing expands the country's capacity to get people answers faster."

Bosch and Randox Develop Rapid Test for the Simultaneous Detection of COVID-19 and Nine Other Respiratory Viruses with Similar Symptoms, Including Influenza and Other Human Coronaviruses

Bosch Healthcare Solutions, together with Randox Laboratories Ltd., has developed one of the world’s first fully automated molecular diagnostic tests for COVID-19. The rapid molecular diagnostic test runs on the Vivalytic analysis device from Bosch Healthcare Solutions.

Developed in just six weeks, the rapid test can detect a SARS-CoV-2 coronavirus infection in patients in under two and a half hours, measured from the time the sample is taken to the time the result arrives. Another advantage of the rapid test is that it can be performed directly at the point of care. This eliminates the need to transport samples, which takes up valuable time. It also means patients quickly gain certainty about their state of health, while allowing infected individuals to be identified and isolated immediately. With the tests currently in use, patients must usually wait one to two days for a result.

Bosch’s rapid test is one of the world’s first fully automated molecular diagnostic tests that can be used directly by all medical institutions. What’s more, it allows a single sample to be tested not just for COVID-19 but also for nine other respiratory diseases, including influenza A and B, simultaneously.

The new test utilises Randox Biochip Technology, reporting 540 results in less than 5 hours on the Randox Evidence Investigator, a semi-automated analyser that is capable of processing 54 patient samples simultaneously.

Randox Laboratories have developed a game-changing point of care coronavirus test. The Vivalytic Viral Respiratory Tract Infection (VRI) Array can identify SARS-CoV-2 (COVID-19) and differentiate it from nine other respiratory infections with similar symptoms, including influenza and all known coronaviruses.

The newly developed test will be available in Germany starting in April, with other markets in Europe and elsewhere to follow.

In various laboratory tests with SARS-CoV-2, the Bosch test delivered results with an accuracy of more than 95%. The rapid test meets the quality standards of the World Health Organization (WHO). A sample is taken from the patient’s nose or throat using a swab. Then the cartridge, which already contains all the reagents required for the test, is inserted into the Vivalytic device for analysis. During the analysis, medical staff can devote themselves to other tasks, for example treating patients.

The Vivalytic analyzer is designed to be so user-friendly that even medical personnel who have not been specially trained on it can reliably perform the test. A Bosch Vivalytic analyzer can perform up to ten tests in the space of 24 hours. This means it takes just 100 devices to evaluate up to 1,000 tests per day. Given the dynamic spread of the coronavirus SARS-CoV-2, laboratories are already working beyond capacity. The Bosch Vivalytic will thus help to increase available testing capacities.

UConn Researchers Working on Simple, Low-Cost CRISPR-based Diagnostic Test for COVID-19

Researchers in the Department of Biomedical Engineering— a shared department in the schools of Dental Medicine, Medicine, and Engineering—have been working to develop a new, low-cost, CRISPR-based diagnostic platform to detect infectious diseases, including the novel coronavirus (SARS-CoV-2).

With the recent outbreak of the SARS-CoV-2, the causative agent of COVID-19, Changchun Liu, associate professor, developed the “All-In-One-Dual CRISPR-Cas12a” (AIOD-CRISPR) method to enable simple, rapid, ultrasensitive, visual detection of SARS-CoV-2 and HIV viruses, intended for use at home or in small clinics.

Liu’s lab has long focused on developing simple diagnostic technologies for infectious disease detection.

“The recent outbreak of novel coronavirus has spread rapidly all over the world,” Liu says. “Rapid and early detection of the SARS-CoV-2 virus​ will facilitate early intervention and reduce disease transmission risk. Our method has a great potential for developing next-generation point-of-care molecular diagnostics.”

The Polymerase chain reaction (PCR) method is currently considered the “gold standard” for disease diagnostics. However, the PCR method relies on expensive equipment and well-trained personnel. Liu’s method, unlike the PCR, is isothermic (~37°C), and unlike other isothermal amplification technologies, has better sensitivity and specificity.

In Liu’s lab, his AIOD-CRISPR system was successful in detecting the DNA and RNA of SARS-CoV-2 and HIV. Additionally, the method was evaluated by detecting HIV-1 RNA extracted from human plasma samples, achieving comparable results to the PCR method.

“We will further integrate the AIOD-CRISPR assay into our microfluidic diagnostic device to develop a rapid point-of-care diagnostic platform for SARS-CoV-2 detection,” Liu says. “We envision that such simple, affordable, and mobile diagnostics technology can be widely used for rapid diagnostics of the SARS-CoV-2.”

This isn’t the first time Liu responded to an outbreak with innovative diagnostic technology. During the 2015-2016 Zika outbreak, Liu’s lab at the University of Pennsylvania developed an instrument-free point-of-care molecular diagnostic platform for Zika virus detection.

Postdoctoral researchers Xiong Ding and Kun Yin, along with PhD student Ziyue Li, collaborated with Liu on this study. UConn has recently filed a patent application on this technology.

The manuscript for this study is available on the BioRxiv preprint platform.

The work was supported, in part, by R01EB023607, R01CA214072, and R21TW010625.

UK Scientists Develop Rapid Smart Testing Device for Coronavirus

Incorporating artificial intelligence, image processing, molecular virology and vast experience in the applied technologies, researchers at Brunel University London, Lancaster University and University of Surrey have developed an innovative device to detect CoVID-19 in 30 minutes using an intelligent smartphone application.

The science behind the device has been tested in the Philippines to check chickens for viral infections. The team has adapted it to detect CoVID-19 in humans and is talking with backers to get it urgently mass-produced.

The current system is capable to perform diagnostics at any location with very minimal training. The researchers believe that the device would be operated by ambulatory care professionals, nurses, and biomedical scientists. It would also let people self-isolating test themselves and health care workers test patients to help slow the spread of the pandemic and ease the burden on the NHS.

“Now we have access to multiple genomes (blueprint) of SARS-CoV-2 virus, we can develop reliable molecular assay in a week and have them up and running on the device in three or four weeks,” said Brunel University London’s Professor Wamadeva Balachandran.  He added, “We are confident it will respond well, and we rapidly need industrial partners to come on board. It will have a huge impact on the population at large.”

“The team strongly believes that with our combined expertise, we will be able to make this device and its associated system available for adoption within a few weeks and take a step closer to beating Covid-19,” said Molecular Virologist Dr Muhammad Munir at Lancaster University.

The battery-operated and hand-held smart phone-linked device is highly cost effective (£100/device) and easy to use. Developed in collaboration with Lancaster University and University of Surrey, it works by taking nasal or throat swabs, which are put into the device. Then in 30 minutes, it can determine if someone has CoVID-19. The samples don’t need to go to a laboratory and the same device can test six people at once at a cost of around £4 per person.

The team is also working on adding a tele-medicine functionality to the mobile app which can control the device, track the user’s movement with government permission and contact anyone who has had a close interaction with the person diagnosed to suggest the next steps to do, in order to reduce the CoVID-19 infection and spread to others.

“Normally, anything like this would have to go through clinical trials,” said Professor Balachandran. “But this is not a normal situation. According to the Imperial College model, this pandemic might last for 18 months. And cases will rise over the next few months. Everyone is crying out for these tests, and many will take a long time. We have limited time to stop the virus spreading, so anything like this is going to help. Speed is essential. With local hospitals’ help we aim to do a limited number of tests with available positive and negative samples.”

The idea is to try and make it cheaper than other tests so it can be used worldwide at home, in GP surgeries, hospitals and workplaces. Once infection is identified, the intelligent system will track down all people who had close contact with the newly identified patient in the last 14 days, alert them about the threat of having CoVID-19 and advise them what to do via the mobile phone app.

Professor Roberto La Ragione, Deputy Head of the School of Veterinary Medicine at the University of Surrey, said: “We are delighted to be involved in the development of rapid diagnostic tools for CoVID-19. With a rapid response from manufacturers, we could deliver a point-of-care test kit to support mass-scale testing within the NHS and globally."

“The team firmly believe that both identifying CoVID-19 infection and minimising the spread of infection are important. Once infection is identified using this device, the app will automatically update the database and the intelligent system will track down all individuals who have been in close contact with the newly identified patient, alert them about the threat of having CoVID-19 and make recommendations regard further steps”, said Dr Anil Fernando, University of Surrey.

Thursday, March 26, 2020

T2 Biosystems Announces Worldwide Licensing Agreement of COVID-19 Assay from Hackensack Meridian Health’s Center

T2 Biosystems, Inc., a leader in the rapid detection of sepsis-causing pathogens, today announced that it has entered into a worldwide licensing agreement for a rapid COVID-19, novel coronavirus test developed by the Center of Discovery and Innovation at Hackensack Meridian Health, New Jersey’s largest and most comprehensive health network.

The licensed coronavirus assay has been used by healthcare professionals within the Hackensack Meridian Health network, under the U.S. Food and Drug Administration’s Emergency Use Authorization guidance, to test and treat patients suspected of having coronavirus. Under terms of the agreement, T2 Biosystems will adapt the coronavirus test to run on its T2Dx® Instrument, the same instrument used for the FDA-cleared T2Bacteria® and T2Candida® Panels. Hackensack Meridian Health will also adopt the T2Dx® Instrument and test panels within its Center of Discovery and Innovation.

“This agreement combines our FDA-cleared T2Dx platform with our joint scientific expertise to benefit patients at risk for both primary coronavirus infections, as well as associated secondary infections that may lead to sepsis,” said John Sperzel, President and Chief Executive Officer of T2 Biosystems. “Data from prior flu pandemics indicated bacterial co-infection rates as high as 29%, and sepsis rates above 30% among patients admitted to hospital intensive care units. The ability to detect coronavirus and associated secondary bacterial or fungal infections that may lead to sepsis, without the need to wait days for a diagnostic result, allows clinicians to achieve targeted therapy faster, and can lead to reduced length of stay in the intensive care unit, freeing up beds for incoming patients.”

By adding this complementary test to the T2Dx platform, capable of detecting SARS-CoV-2 (novel coronavirus), T2 Biosystems will be able to provide a comprehensive assessment of patients suspected of primary or secondary infections associated with coronavirus, when timely results are most critical. These results will enable clinicians to rapidly quarantine and treat patients suspected of having coronavirus, effectively allocate critical resources, and in the case of a negative result, spare the patient unnecessary time in the hospital, thus reducing risks to additional exposure.

“Our scientists at the Center for Discovery and Innovation have given our health network a crucial tool to treat patients in real-time,” said Robert C. Garrett, FACHE, Chief Executive Officer of Hackensack Meridian Health. “We are pleased to license the technology to T2 Biosystems and also adopt the T2Dx platform.”

The ongoing pandemic has accelerated the need for worldwide testing. The World Health Organization (WHO) has confirmed nearly 335,000 cases globally and the most recent reports indicate a death toll of more than 14,500. In the United States, more than 33,400 cases have been reported across all 50 states, with 400 deaths, according to the Centers for Disease Control and Prevention (CDC).

“We developed a highly sensitive and accurate coronavirus test that provides rapid, definitive results by combining the best elements found in the coronavirus tests developed by CDC and WHO,” said David S. Perlin, Ph.D., Chief Scientific Officer and Senior Vice President of the CDI. “The T2Dx® Instrument is the perfect vehicle to expand our innovation to customers around worldwide.”

While the majority of confirmed cases have been mild to moderate in severity, nearly 14% of patients have suffered from severe disease, exhibiting signs and symptoms that also meet SIRS criteria, putting those patients at high risk for sepsis. Additionally, 6.1% of patients were found to be critical, suffering from respiratory failure, septic shock, and/or multiple organ dysfunction/failure. These patients are treated in the ICU, where they are exposed to additional risk factors as well as countless antimicrobial agents.

About T2 Biosystems

T2 Biosystems, a leader in the rapid detection of sepsis-causing pathogens, is dedicated to improving patient care and reducing the cost of care by helping clinicians effectively treat patients faster than ever before. T2 Biosystems’ products include the T2Dx® Instrument, T2Candida® Panel, the T2Bacteria® Panel, and the T2ResistanceTM Panel and are powered by the proprietary T2 Magnetic Resonance (T2MR®) technology. T2 Biosystems has an active pipeline of future products, including products for the detection of additional species and antibiotic resistance markers of sepsis pathogens, and tests for Lyme disease.

About Hackensack Meridian Health

Hackensack Meridian Health is a leading not-for-profit health care organization that is the largest, most comprehensive and truly integrated health care network in New Jersey, offering a complete range of medical services, innovative research and life-enhancing care. Hackensack Meridian Health comprises 17 hospitals from Bergen to Ocean counties, a behavioral health hospital, and two rehabilitation hospitals. Additionally, the network has more than 500 patient care locations throughout the state which include ambulatory care centers, surgery centers, home health services, long-term care and assisted living communities, ambulance services, lifesaving air medical transportation, fitness and wellness centers, rehabilitation centers, urgent care centers and physician practice locations. Hackensack Meridian Health has more than 34,100 team members, and 6,500 physicians and is a distinguished leader in health care philanthropy, committed to the health and well-being of the communities it serves.

Wednesday, March 25, 2020

PathSensors Develops a SARS-CoV-2 Biosensor

PathSensors Inc, a Baltimore biotechnology company, announced today that they are developing a CANARY ™ biosensor to detect the Novel SARS Coronavirus (SARS-CoV-2), the causal agent for the coronavirus disease COVID–19. The biosensor will be available for research purposes in May 2020 and validation data on the new SARS-CoV-2 product will be available June 2020.

CANARY ™ technology provides a unique opportunity to reduce the impending public health impact of COVID-19 with rapid results and high specificity. The initial application for this PathSensors product will be for testing of environmental swabs and air monitoring in sensitive spaces such as hospitals, offices, food services, etc. PathSensors will continue to advance the assay’s capabilities as the novel virus is further characterized. As the SARS-CoV-2 biosensor is commercialized, PathSensors expects new uses to emerge, such as rapid specimen screening.

Third-party laboratory validations have demonstrated that commercially available CANARY ™ products are highly sensitive and specific. PathSensors offers three instrumentation platforms that are easy to use and typically generate test results in less than 5 minutes. PathSensors expects the SARS-CoV-2 product to be a valuable tool for fighting the spread of COVID-19.

An expert in virology and biological threats, Dr. David Hodge was involved in commissioning and overseeing a third-party evaluation of CANARY ™ technology while working at the Department of Homeland Security as the Senior Program Manager for Basic Research and Assay Development. “Our evaluation of CANARY™ technology resulted in promising sensitivity of detection data," said Dr. Hodge, PathSensors’ Scientific Advisor. "A SARS-CoV-2 assay would be a powerful solution to a critical problem."

“PathSensors has a long history of manufacturing rapid and highly sensitive detection kits for dangerous biologic agents such as anthrax, orthopox, ricin, listeria, and many others. We expect this new SARS-CoV-2 assay to dramatically expand the tools available to public health agencies fighting this pandemic” said Ted Olsen, PathSensors’ President.

About COVID-19

A novel coronavirus was discovered in late 2019 in China before spreading around the world. The disease, COVID-19, causes severe pneumonia-like symptoms and can be spread via human-to-human transmission prior to any symptoms. Coronaviruses are a family of viruses that cause diseases including Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS). There is still much to learn about the novel coronavirus and the impacts of COVID-19 on global health.

About CANARY Technology

CANARY ™ is a biosensor technology that delivers extremely rapid detection of pathogens with high sensitivity and specificity. Originally developed by scientists at MIT–Lincoln Laboratory to combat bioterrorism threats, CANARY ™ technology has been licensed and commercialized by PathSensors, Inc.

About PathSensors, Inc.

PathSensors is a leading environmental testing company, built on CANARY ™ technology which is exclusively licensed from MIT-Lincoln Laboratory. CANARY ™ offers cutting-edge pathogen detection capabilities to a variety of industries including food safety, agriculture, and bioterrorism. The company’s mission is to make the world a safer place by detecting pathogens that can cause sickness or worse while creating high technology jobs in the state of Maryland.

Monday, March 23, 2020

Heat Biologics Developing Quick Point-of-Care COVID-19 Antibody Test

Heat Biologics, a publicly traded North Carolina biotechnology company, is adding a rapid point-of-care COVID-19 diagnostic test to its product development pipeline.

The new test is in addition to the provisional patent application the Morrisville company filed March 3 to apply its immune system activating technology to prevent and/or treat COVID-19.

The company has focused mainly on treating cancer, but recently shifted toward coronavirus.

NCBiotech recruited Heat Biologics to North Carolina from Miami in 2011 and awarded the business a $225,000 Strategic Growth Loan. Heat is one of several companies supported by funding from NCBiotech that are now racing to develop products to deal with the COVID-19 pandemic.

Heat reported today that it is collaborating with the University of Miami to develop a proprietary patient-friendly COVID-19 point-of-care diagnostic test. The new test will require a simple pharyngeal throat swab to deliver on-the-spot results on a paper strip in less than 30 minutes.

In contrast, current tests for COVID-19 usually rely on the use of expensive thermal-cyclers, with results in five to six hours or require blood samples to detect antibodies to show the body’s defense against a previous exposure.

Heat says its preliminary research suggests the new test is specific to the novel coronavirus, with no cross-reaction to previous coronavirus subtypes such as the common cold. The test is designed to enable cost-effective manufacturing amenable for mass production and deployment around the world.

The test was developed by Sylvia Daunert, PharmD, MS, PhD, chair of biochemistry and molecular biology at the University of Miami Miller School of Medicine, along with Sapna Deo, MS, Ph.D., and Jean-Marc Zingg, Ph.D., both also faculty at the Miller School.

“Our lab has tremendous experience developing accurate and easily usable tests for infectious diseases such as HPV and Zika,” said Daunert. “Unlike tests that detect antibodies (IgG and IgM method), which can take weeks to manifest, our test is being developed to utilize molecular recognition and amplification of the target virus. This should allow for much-earlier detection, within a couple days of exposure, providing critical and time-sensitive information to help curb the spread of the disease.”

Daunert added, “Additionally, our test is designed to provide a read-out in a fraction of the time required for most other tests, has no technical hardware requirements, and offers high sensitivity and a simple binary paper readout that can tell the healthcare provider if the patient is positive for a disease within 30 minutes. I am very excited to collaborate with Heat Biologics in order to bring our expertise to bear in fighting this pandemic.”

Heat CEO Jeff Wolf added, “We are honored to work with Dr. Daunert and the University of Miami to develop this exciting new platform for early and quick diagnosis of COVID-19. Her lab has developed multiple bioassays against similar diseases, and we are eager to utilize these tools in the war against COVID-19. Importantly, we believe this point-of-care diagnostic will address many of the challenges facing existing tests, including time to readout and cost. We look forward to providing further updates on this platform in the near future.”

NxGen MDx Announces the Launch and Availability of Their COVID-19 Test

To combat the lack of availability of tests, NxGen MDx announces the immediate launch and availability of their COVID-19 test.

The rise in U.S. cases of COVID-19, a highly contagious and sometimes fatal respiratory illness, has concerned health officials and spurred calls from lawmakers for action to expand testing capacity to slow its spread.

"Like the CDC-built kits, ours will be conducted on QuantStudio qPCR instrumentation and will be able to process 2000 samples per day with tests being resulted in 24-48 hours," said Dr. Jacqueline Peacock, Director of Laboratory Operations.

The test will help meet a major U.S. shortfall of diagnostic capabilities that has severely limited the nation's ability to track the spread of the outbreak.

"COVID-19 is a global challenge and we are committed to providing people on the frontlines of this pandemic with critical tests to help ensure proper care," said Alan Mack, CEO of NxGen MDx.

To ensure providers can give their patients the most comprehensive diagnostic results, NxGen MDx is also working to validate a 40+ respiratory pathogen panel to identify the cause of respiratory symptoms in a single test. This test is slated for launch in July 2020.

About NxGen MDx

NxGen MDx LLC is a leading women's health company delivering highly accurate and precise genetic testing. NxGen MDx's history of whole-gene sequencing combined with advanced technology allows us to provide accessible, high-quality testing options to families as they plan for the future. NxGen MDx employs state-of-the-art technology, including rapid molecular diagnostics for infectious disease and genetic screening technology that examines the entire gene rather than parts of the gene, giving women and families a comprehensive assessment of their health. NxGen MDx is based in Grand Rapids, Michigan. To learn more, visit the company's website at www.nxgenmdx.com.

Sunday, March 22, 2020

Chembio Diagnostics To Send COVID-19 IgM/IgG System to Brazil

Chembio Diagnostics, Inc., a leading point-of-care diagnostic company focused on infectious diseases, announced its receipt of a $4 million order from Bio-Manguinhos for the purchase of Chembio’s DPP COVID-19 IgM/IgG System, to support the urgent needs of Brazil’s Ministry of Health. Bio-Manguinhos is a subsidiary of the Oswaldo Cruz Foundation (Fiocruz) that is responsible for the development and production of vaccines, diagnostics and biopharmaceuticals, primarily to meet demands of Brazil’s national public health system. Chembio has a long-standing relationship with Bio-Manguinhos, having supplied multiple products for point-of-care detection of HIV and other infectious diseases. Chembio’s Brazilian subsidiary has filed for ANVISA approval of the DPP COVID-19 IgM/IgG System under the emergency use authorization program.

The DPP COVID-19 IgM/IgG System is a single-use rapid point-of-care test for the detection and differentiation of IgM and IgG antibodies to COVID-19 in whole blood, via fingerstick using Chembio’s handheld analyzer, which achieved ANVISA approval and CE Mark during 2019. The System is intended for use in clinical and point-of-care settings to aid in the diagnosis of SARS‑CoV-2 infection.

“We are pleased to deepen our relationship with Bio-Manguinhos to address the serological testing needs surrounding COVID-19,” said Javan Esfandiari, Chembio’s Executive Vice President and Chief Science & Technology Officer. “Recent studies reiterate that both molecular and serological tests are needed to definitively confirm a virus carrier, and the strength of our DPP platform technology enabled our team to develop a high quality test for SARS‑CoV‑2 efficiently and rapidly. Our serology test will detect the presence of antibodies in blood indicating that a person had an immune response to SARS-CoV-2, regardless of whether symptoms developed from infection or if the infection was asymptomatic.”

In the United States, Chembio will begin testing the DPP COVID-19 IgM/IgG system at multiple sites. The testing program has been designed to generate the clinical validation data that Chembio needs in order to submit the DPP COVID-19 IgM/IgG System for Emergency Use Authorization by the FDA and to commercially launch the System under new FDA guidelines.

Georgia Researchers Develop 2-hour Antibody Coronavirus Test

The Georgia Esoteric and Molecular Laboratory at the Medical College of Georgia Department of Pathology has developed a novel, accurate coronavirus test that can tell patients if they are infected within about two hours instead of waiting typically days to hear from remote testing facilities.

“We want patients and physicians in our community to have timely access to information that will ultimately benefit us all by helping limit spread of the virus,” says Dr. Ravindra Kolhe, director of the GEM Lab, chief of the Section of Molecular and Genetic Pathology and vice chair for translational research in the MCG Department of Pathology at Augusta University.

“More rapid identification of individuals who are infected will help ensure they get help as needed and that the risk of exposure to others is significantly reduced,” Kolhe says of the test rapidly developed by the GEM Lab team over recent days.

“We completed our COVID-19 assay validation on Sunday and immediately submitted the documentation to the FDA for their approval. This was a nonstop 90-hour effort by the phenomenal team in the GEM lab to develop this test, but we all felt a commitment to our community to make this test available here,” Kolhe says. While Food and Drug Administration approval is pending for the new test, the FDA released new guidance this week that its approval is no longer required for COVID-19 testing in a CLIA-certified laboratory like the GEM Lab. CLIA is a Centers for Medicare and Medicaid Services certification.

“As we have all seen in the news, identifying individuals infected with this virus within a few hours and initiating the quarantine protocol can have a huge impact on infection spread and potentially patient outcomes,” says Kolhe. “We are now running tests around the clock.”

The GEM Lab team includes Dr. Ashis Mondal, lab supervisor; Kimya Jones, lab manager; research associates Sudha Ananth and Yasmeen Jilani; postdocs Drs. Pankaj Ahluwalia, Nikhil Sahajpal and Meenakshi Ahluwalia; and molecular pathology fellow Dr. Allan Njau.

While the priority is providing quick, accurate results to local residents, Kolhe says his lab also would like to test samples from outside the immediate area when requested, but those details are still being worked out. At the moment, the test is for patients whose samples are taken at the AU Health System.

To quickly meet demand, the GEM Lab team is now working around the clock to increase their testing capacity, which started at 72 tests in a 24-hour period and which they want to expand to 500 in coming weeks. The MCG GEM Lab also will work with other CLIA-certified labs interested in offering their new test.

Their new test, which works on the Luminex ARIES laboratory platform, is based on modified testing recommendations from the Centers for Disease Control and Prevention, Kolhe says, and focuses on two unique genetic markers for the virulent virus.

“For testing, we are looking at a conserved region that is unique for coronavirus 2019, has not been changed in this virus and is fundamental to its survival” says Kolhe of the two genetic markers, N1 and N3. Genetic markers are DNA sequences that are distinctive points of variation that can be used to identify a human or a disease.

The MCG lab’s own AI-driven genetic analysis, called in silico testing, also showed that N1 and N3 were distinctive for coronavirus 2019, and now the GEM team is looking for additional markers that also might qualify as unique to this virus.

“Everybody is looking at these targets and everybody has a different way of looking at them,” Kolhe says. “The biggest game changer in this is the turnaround time for patients because we are able to provide the test locally.” The test also indicates the viral load present, and higher loads increase that person’s chance of infecting others.

“We want to identify patients with a high viral load and who can spread the virus rapidly. We want to prevent #patient31 in Augusta,” Kolhe says, referencing a woman in South Korea who is believed to have significantly increased the virus’ spread there by coming in contact with many others in large crowds, including two large church services and dining at a buffet, before being tested. She had been in a minor car wreck a few days before which brought her to a hospital but she was not tested there for the coronavirus.

Until now, a patient sample from the Augusta area would be taken, put on a plane to a reference lab, where it may take three to four hours to process, he says, but the real issue is proximity and travel time to that lab.

For the first real-time test run this past weekend, the GEM Lab team began analyzing the sample at 10 p.m. and was reporting the status shortly after 2 a.m. to physicians at AU Health System. These first tests ultimately confirmed the first cases of infection reported in the Augusta area.

While the coronavirus test is in serious short supply because of rapidly escalating and unexpected demand, the individual components needed to make a test are not yet as in demand, so the GEM Lab team’s work included finding needed parts like the extraction cassettes they put the patient sample in.

“The GEM Lab team has worked 24/7 to complete validation and implementation in absolutely record time,” says Dr. Amyn Rojiani, chair of the MCG Department of Pathology. “Kudos to the entire team for their uncompromising dedication and expertise that has now made this test directly available for the first time to the Augusta community,”

The coronavirus has been around for at least 40 years but we are hearing and worrying so much about it now because there are changes in the virus’ structure that have made it more virulent and contagious, Kolhe says.

Coronaviruses are a large group of viruses that cause disease in animals and humans, according to the National Foundation for Infectious Diseases. Human coronaviruses were first identified in the 1960s and the novel COVID-19 surfaced in China in 2019. Most people get infected with one of the common human strains at some point in their lives. Symptoms of COVID-19 infection may occur two to 14 days after exposure and include fever, cough, difficulty breathing and shortness of breath.

Source: Augusta University News 

Cepheid Receives Emergency Use Authorization from FDA for Rapid SARS-CoV-2 Test

Cepheid announced it has received Emergency Use Authorization (EUA) from the U.S. Food & Drug Administration (FDA) for Xpert® Xpress SARS-CoV-2, a rapid molecular diagnostic test for qualitative detection of SARS-CoV-2, the virus causing COVID-19. The test has been designed to operate on any of Cepheid's more than 23,000 automated GeneXpert® Systems worldwide, with a detection time of approximately 45 minutes.

"During this time of increased demand for hospital services, Clinicians urgently need an on-demand diagnostic test for real-time management of patients being evaluated for admission to health-care facilities. An accurate test delivered close to the patient can be transformative — and help alleviate the pressure that the emergence of the 2019-nCoV outbreak has put on healthcare facilities that need to properly allocate their respiratory isolation resources," said Dr. David Persing, MD, Ph.D., Chief Medical and Technology Officer at Cepheid. "By leveraging the design principles of our current Xpert Xpress Flu/RSV cartridge technology, in which multiple regions of the viral genome are targeted to provide rapid detection of current and potential future variants of SARS-CoV-2, we have developed a test that provides reference lab-quality results in multiple settings where actionable treatment information is needed quickly."

"Cepheid currently has nearly 5,000 GeneXpert® Systems in the US capable of point-of-care testing and for use in hospitals," said Cepheid President Warren Kocmond. "Our automated systems do not require users to have specialty training to perform testing — they are capable of running 24/7, with many systems already doing so today."

The test will begin shipping next week. For more information about Cepheid's Xpert Xpress SARS-CoV-2 test, please visit www.cepheid.com/coronavirus.

Friday, March 20, 2020

Rheonix to Launch Rapid, Fully Automated COVID-19 Assay

Rheonix Inc., a leader in highly automated molecular diagnostics, announced it is developing a coronavirus (COVID-19) test kit for use on its Encompass MDx ® workstation. Upon Rheonix’s receipt of emergency use authorization (EUA) from the Food and Drug Administration (FDA), the new test will allow for the fully automated detection of SARS-CoV-2 in respiratory specimens, facilitating testing at small and medium-sized labs in distributed locations.

The Rheonix system is a fully automated, sample-to-answer microfluidic system that provides test results in four hours and requires no technician involvement after the sample is loaded. The workstation automatically introduces clinical specimens directly from their barcoded collection tubes into the wells of the microfluidic Rheonix CARD ® cartridges, and processes all virus detection reactions on the cartridge within the closed workstation. Once the test is completed, all biological waste remains enclosed in the disposable cartridge and is destroyed. The fully enclosed, self-contained workstation and cartridge system eliminate the technician’s need to handle the sample and reduce the possibility for spread of the highly communicable virus.

Due to its relatively low workstation size and cost, low per-sample test cost, and the ability for the assay to be performed by a single technician with no special training, the Rheonix test is easy to implement. It can be rapidly deployed to a broad range of low- and medium-throughput laboratories, including regional hospital labs, physician offices, public health testing sites and clinics.

“A fully automated sample-to-answer testing solution that can be reliably run by small and medium-sized labs will be critical in mobilizing local and regional health networks to fight the COVID-19 public health emergency,” said Richard Montagna, Ph.D., FACB, senior vice president for scientific and clinical affairs, Rheonix. “We are grateful that the FDA is providing the flexibility necessary for innovative companies like Rheonix to act quickly to put testing in the hands of those most in need of rapid and dependable methods to control the spread of this virus.”

Rheonix is working with a consortium of leading New York state collaborators to test and validate the assay. Inactivated samples of the coronavirus are being provided by ZeptoMetrix, a Buffalo-based company that manufactures biological material for diagnostics development. A leading New York health care network is providing clinical samples and expertise, and Gregory Wilding, Ph.D., chair of the biostatistics department of the University at Buffalo School of Public Health and Health Professions, will validate the results. Rheonix anticipates submitting an emergency use authorization (EUA) to the FDA on the Rheonix COVID-19 MDx assay for the detection of SARS-CoV-2 as soon as validation is complete.

Rheonix has developed the suite of Encompass workstations, fully automated systems that provide highly multiplexed sample-to-answer molecular testing for use in clinical, research and applied testing laboratories. With minimal hands-on time, the Encompass systems offer true walkaway simplicity. Rheonix’s growing portfolio offers multiplexed testing solutions including the Beer SpoilerAlert™ assay, the most comprehensive beer spoilage panel available; the Listeria PatternAlert™ assay, a rapid method for Listeria strain typing; and the NGS OnePrep™ solution, a fully integrated and automated DNA extraction and library prep solution. The Rheonix STI TriPlex™ Assay and Rheonix Encompass MDx ® workstation are currently undergoing FDA 510(k) review.

Avellino Expands Production of Genetic Test Kits for Coronavirus Detection

Avellino announced today that it is adding additional production shifts for its newly developed coronavirus diagnostic, the Avellino SARS-CoV-2/COVID-19 Test (AvellinoCoV2, for short). The AvellinoCoV2 ultra-rapid genetic test is in increasing demand by health systems, public health services, and first-responders because of its speed, accuracy, and ability to detect coronavirus in patients who are asymptomatic. In order to meet growing public health demand, the company is temporarily suspending sequencing operations of its AvaGen genetic test that identifies the risk of developing keratoconus and the presence of corneal dystrophies.

Operations for the AvellinoCoV2 test will expand into the genetic diagnostics lab as used for the company’s newly released AvaGen™ test used by ophthalmologists and optometrists to diagnose and monitor patients with keratoconus and other corneal dystrophies. The AvellinoCoV2 test helps clinicians diagnose COVID-19, the disease caused by a SARS-CoV-2 virus infection, by identifying and isolating the genetic markers as approved by the CDC and the FDA.

Avellino Group Chairman Gene Lee said, “We appreciate the support from eye care professionals who are now using the AvaGen genetic test to care for their corneal patients. We understand the breakthrough importance of the AvaGen test in treating patients with complex corneal conditions. Avellino will restart production of the AvaGen genetic test as soon as we have fulfilled our public health obligation surrounding the coronavirus pandemic.

About The Avellino SARS-CoV2/COVID-19 Genetic Test

On March 5, 2020, Avellino completed the validation process for AvellinoCoV2 according to the FDA issued guidance, “Policy for Diagnostics Testing in Laboratories Certified to Perform High-Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency.” The test must be ordered by a physician and cannot be made available directly to the public. The test is performed in the physician’s office or at a public collection facility by collecting cell samples from the back of the patient’s throat and the nose via swabs. Samples are then sent by the healthcare provider to Avellino’s CLIA certified high-complexity molecular testing laboratory facility in Menlo Park for testing. Tests take approximately 1.5 to 3 hours to perform. Negative results are sent back immediately to the physician and/or public health officials who ordered the test. Positive results are subject to secondary confirmation testing. Results may be available in as little as six hours or the next day in most cases.

The AvellinoCoV2 patent pending test identifies two N gene markers that test the SARS-CoV-2 virus expression. Original CDC guidance specified that coronavirus testing required three specific genetic parts. Avellino has confirmed through its validation process that only two of these parts are necessary in identifying COVID-19. As a result, the company has the technology today to quickly identify the two genetic parts required to confirm the presence of COVID-19.

Conventional COVID-19 diagnostics face many issues, including the difficulty in identifying patients where only few antibodies are present. Therefore, a genetic test such as the AvellinoCoV2 test provides clinicians and public health officials with a valuable diagnostic tool. That said, while a positive result from the AvellinoCoV2 test is indicative of an active infection, it does not necessarily rule out a bacterial or other viral infection. Similarly, a negative result from the AvellinoCoV2 test does not necessarily preclude the presence of the COVID-19 virus – in that potential issues with sample collection and other factors common to all diagnostic tests can affect results. Clinicians are strongly recommended to use clinical observation, patient history, and their best medical judgment in making a final diagnosis and treatment decisions.

Scanwell Health to Launch First Clinical-Grade Rapid At-Home COVID-19 Antibody Test

Scanwell Health, a developer of smartphone-enabled, at-home diagnostics, announced today that it has secured exclusive rights to license and distribute a SARS-CoV-2 rapid serology test from INNOVITA for at-home use. The test takes 15 minutes to complete using the Scanwell Health app, and within hours a doctor or nurse practitioner will reach out with results and next steps.

This type of test can be used to identify large numbers of infected patients and asymptomatic carriers, ultimately supporting containment efforts and slowing the spread of the virus. Currently, the test is the only rapid serology test cleared by China's FDA, the National Medical Products Administration (NMPA), that detects and displays both IgM and IgG antibodies in the blood. To distribute the tests to individuals in the U.S., Scanwell will leverage its existing partnership with telehealth partner Lemonaid Health.

The SARS-CoV-2 test is manufactured by the Chinese biotechnology company INNOVITA and has been used extensively in China for aiding in the diagnosis of COVID-19. The test detects IgM and IgG antibodies against novel coronavirus SARS-CoV-2 in the blood, which indicates that a person has been exposed and developed antibodies against the virus.

"We recognized that a number of healthcare organizations are struggling to evaluate patients for COVID-19 due to testing constraints," said Stephen Chen, Founder and CEO of Scanwell Health. "While the gold standard for diagnosis is still the PCR test, given the growing shortage of swabs and reagents, a rapid serology test is beneficial in that it allows for wide-scale testing."

"We hope that these home-use test kits will ease the burden on healthcare centers, so that they can focus on the highest severity cases," added Chen.

How the Scanwell Health SARS-CoV-2 Rapid Test will work:

- Patient completes online intake questionnaire to be evaluated by a Lemonaid doctor or nurse practitioner.
- If appropriate, the Lemonaid doctor or nurse practitioner will order a test for the patient (following guidelines established by the CDC) and an at-home test kit will be mailed out to the patient via next business day delivery.
- Once received, patient performs at-home test and securely shares results with a doctor or nurse practitioner via the Scanwell app. This process takes 15 minutes, and the patient can expect to hear back from the doctor or nurse practitioner within hours.
- Patient receives follow-up consultation with a Lemonaid doctor or nurse practitioner, who will advise on next steps (self-quarantine, confirmatory testing, in-person care, etc.).

The clinical trial of the IgM and IgG rapid serology test for SARS-CoV-2 from five institutions in China demonstrated 87.3% sensitivity and 100% specificity when compared to traditional tests. Though the presence of IgM and IgG antibodies can take time to develop, antibody tests are especially helpful for tracking the spread of the virus as they also identify asymptomatic carriers (the World Health Organization reports that 80% of infections are mild or asymptomatic) and those who may have been previously infected.

While U.S. protocols for COVID-19 testing have been initially limited to PCR tests, the FDA on 3/16/2020 updated its guidance to include the use of serological tests.

"The advantage of collaborating with INNOVITA is that they have firsthand clinical data showing how effective their IgM and IgG tests have been in managing disease outbreak in China," said Chen. "Furthermore, making this test available to U.S. patients in the home via Lemonaid Health will allow patients to receive personalized guidance from a doctor or nurse practitioner in a safe environment while limiting exposure."

"The option of having an at-home test mailed next day to your door gives Americans nationally a new option for how to get tested without putting others at risk of infection by driving to a lab or doctor's office," said Paul Johnson, CEO and co-founder of Lemonaid Health.  "Our medical team will order the test, convey the results to the patient, and help the patient understand what the test result means in terms of both the result and what to do next. The result of the test could have immediate implications for not just the patient, but their family and friends, too."

Scanwell is anticipating that the SARS-CoV-2 rapid test kits will be available within 6 to 8 weeks after Scanwell obtains Emergency Use Authorization (EUA) from the FDA for at-home use of serology tests. The service will be provided at cost ($70 including next business day delivery, no insurance required), and will first rollout in WA, CA, NY and other severely affected states. Scanwell is investigating options to provide the service for free to patients unable to pay.

20/20 BioResponse to Launch Antibody-Detecting Rapid Coronavirus Test Kits in U.S.

20/20 BioResponse, a business unit of 20/20 GeneSystems, Inc. announced today that it will begin taking orders for its CoronaCheck ™ COVID-19 Rapid Antibody Test Kit. (The test is intended to identify persons having an immune response against SARS-CoV-2.) The company's action follows discussions with officials from the U.S. Food & Drug Administration (FDA) this week after the agency's March 16 Guidance issued to "expand the number and variety of diagnostic tests" as the "severity and scope of the current COVID-19 situation around the globe necessitates greater testing capacity than is currently available."

The test kits are rapid chromatographic immunoassays (configured like a home pregnancy test) to detect IgM and IgG antibodies to COVID-19 SARS-CoV-2 in blood, which is the cause of COVID-19. IgM antibody generally begins to rise within 1 week of initial infection. IgG appears about 14 days after infection. According to the March 16 FDA Guidance, antibody blood tests of this nature are "less complex" than the nucleic acid testing that the CDC and laboratories throughout the U.S. have been running since the start of this emergency.

Advantages of these types of tests, approved by the Chinese FDA and compliant with medical device regulations in Europe, include the following:

- Rapid results (under 15 minutes)
- Accurate: High sensitivity (~97%) and specificity (~92%)
- Well-validated on numerous cohorts in China
- CE approved and widely used in many European countries
- Whole blood testing likely remedies some false negatives inherent in respiratory swab samples
- Low cost
- Ease of use; no need for laboratory personnel, equipment or sample transport
- Can be easily mass produced to over 200,000 per day
- CoronaCheck was evaluated in China using 760 clinical samples. In this cohort, 286 samples were confirmed positive. Our manufacturers report a sensitivity of 97.2% and specificity of 92%.

Furthermore, in a soon to be published manuscript from a group of over 20 medical practitioners who were on the front lines fighting the corona virus outbreak in China, (including Wuhan), the physicians concluded that IgM / IgG rapid tests "have great potential benefit for the fast screening of COVID-19 infections and it has already generated tremendous interest and increased clinical usage after a short time testing in Chinese hospitals."

20/20 will immediately make this test available to U.S. based public health providers, hospitals, urgent care centers, and occupational health providers, especially those serving first responders. It will also request from FDA an Emergency Use Authorization to make these kits available to consumers through retail and internet purchase.

GenMark Receives FDA Emergency Use Authorization for its ePlex® SARS-CoV-2 Test

GenMark Diagnostics, Inc., a leading provider of automated, multiplex molecular diagnostic testing systems, today announced that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for the company’s ePlex SARS-CoV-2 Test.

GenMark’s test was developed for the qualitative detection of SARS-CoV-2 virus in nasopharyngeal swab samples for patients suspected of COVID-19 by their health care provider. Rapid and easy detection of SARS-CoV-2 is becoming increasingly critical and customers are adopting the ePlex test based on the workflow and ease-of use to address this urgent need. The test is exclusively for use on the company’s ePlex system, which had a global installed base of more than 500 analyzers as of December 31, 2019. The ePlex sample-to-answer system provides an automated solution to the diagnostic process and provides results in under two hours with the capacity to process up to 96 tests per 8-hour shift. The ePlex system’s modular and expandable design enables near-patient COVID-19 testing to be widely accessible to meet the needs of various types of laboratories, from small decentralized sites, to large central hospitals and laboratories.

“Because ePlex enables near-patient testing and is available in hospitals and labs across the United States and in more than 30 countries, results can be returned to doctors and patients more rapidly than with other platforms. Our unique ability to quickly diagnose and begin treatment of critically ill patients addresses the challenges associated with the coronavirus pandemic. We are proud of our team’s ability to rapidly respond to this urgent public health crisis,” said Scott Mendel, Interim Chief Executive Officer. “The FDA’s Emergency Use Authorization of our test supports GenMark’s commitment to provide critical and actionable diagnostic information to healthcare providers so that they can better manage their patients.”

Initial customer validations of the ePlex® SARS-CoV-2 (RUO) Test were met with positive laboratory customer feedback, including from both existing customers and new sites. GenMark is one of the first companies to commercialize a rapid sample-to-answer test to help meet the critical testing need during this public health crisis and has provided nearly ten thousand tests to customers since the beginning of March.

“GenMark reached out to us several weeks ago to ask for our help to run the first patient samples on their RUO ePlex SARS-CoV-2 Test,” said David T. Pride, MD, PhD, director of the Clinical Molecular Microbiology Laboratory and associate director of the Microbiology Laboratory at UC San Diego Health. “We completed the validation and were the first lab in the U.S. to go live with the ePlex test.”

GenMark is continuing to invest in additional manufacturing capacity with current capability to supply approximately 100,000 ePlex tests per month to support near patient testing. “Demand for our tests has been extraordinary, especially as centralized testing supply has been limited. Our team is working 24/7 to fight this global pandemic and we are taking every step possible to continue this pace, including consulting with local, state, and federal agencies. The COVID-19 outbreak highlights the value of rapid, near-patient multiplex molecular diagnostics to the global healthcare ecosystem that enables better patient triage, bed management, and patient care decisions,” concluded Mendel.

The ePlex SARS-CoV-2 Test can be used to test nasopharyngeal swab (NPS) specimens. The ePlex SARS-CoV-2 Test should be ordered for the qualitative detection of SARS-CoV-2 in individuals suspected of COVID-19 by their health provider. The ePlex SARS-CoV-2 Test is authorized for use in qualified laboratories designated by CDC and in the U.S., certified under CLIA to perform high complexity tests. A positive test result for COVID-19 indicates that RNA from SARS-CoV-2 (formerly 2019-nCoV) was detected, and the patient is presumptively infected with COVID-19 and presumed to be contagious. Laboratory test results should always be considered in the context of clinical observations and epidemiological data in making a final diagnosis and patient management decisions. Patient management should follow current CDC guidelines. All laboratories using this test must follow the standard confirmatory testing and reporting guidelines according to their appropriate public health authorities. Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities. A negative test result for this test means that SARS-CoV-2 RNA was not present in the specimen above the limit of detection. However, a negative result does not rule out COVID-19 and should not be used as the sole basis for treatment or patient management decisions. A negative result does not exclude the possibility of COVID-19. If COVID-19 is still suspected based on exposure history together with other clinical findings, re-testing should be considered in consultation with public health authorities.

Wednesday, March 18, 2020

XCR Diagnostics Validates its XCR® COVID-19 Assay

Molecular diagnostics company XCR Diagnostics has successfully completed the verification and validation of its XCR® COVID-19 assay and can now petition the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA). The company’s faster COVID-19 test leverages its patented rapid chemistry format to enable laboratories to double or even triple the number of patients tested per day for the disease caused by the SARS-CoV-2 coronavirus.

Currently, it takes one to three hours to complete a single coronavirus test on existing laboratory equipment. The Xtreme Chain Reaction (XCR®) test from XCR Diagnostics takes approximately 30 minutes on the same standard laboratory equipment, accelerating the laboratory’s testing capabilities.

The XCR test advantage derives from the company’s unique intellectual property, which dramatically improves the reaction kinetics and therefore reduces the reaction time. The ability for any laboratory to use XCR technology on its existing molecular testing equipment is key to early detection of the COVID-19 disease. XCR Diagnostics can deploy its XCR test across an existing laboratory’s installed base of machines, allowing even small laboratories to significantly improve patient testing output.

1. XCR Diagnostics Inc. is not affiliated with Roche, Hologic, ABI, or DiaSorin.
2. Based on XCR Diagnostics Inc. using XCR chemistry with reverse transcription RNA, amplification and detection steps in its laboratory.
3. Based on XCR Diagnostics Inc. running reverse transcription RNA, amplification and detection steps in its laboratory.
4. The Roche 6800 and Hologic Panther includes onboard sample preparation resulting in longer test times.

“Every healthcare system can easily adapt existing equipment to accept the XCR COVID-19 test, immediately achieving heretofore unprecedented speed in patient testing,” said Dr. Daniel Kolk, vice president of clinical development at XCR Diagnostics. “We have compared a number of influenza-like tests to our XCR test. Our test was completed in about 35 minutes while other tests took 60 minutes or longer to complete. When time is of the essence, switching to the COVID-19 test from XCR Diagnostics could immediately double any facility’s daily patient test volume.”

“We have verified XCR capabilities on a variety of systems deployed in laboratories today,” said Mark Powelson, CEO of XCR Diagnostics. “As an example, the two most widely used systems —Hologic’s Panther and Roche’s 6800 instruments— reported time to first results are 2.5 to 3.5 hours*, respectively. In that same period, we can provide 480 to 672 XCR COVID-19 test results.”

He added, “When lives are at risk in a pandemic, it’s critical to make our technology available as soon as possible so laboratories can begin community surveillance programs rather than continuing in their dangerously reactive mode of the past few months. We are collaborating with BIOLYPH to leverage their large-scale capacity and maximize the performance, shelf-life and ease-of-use of our XCR COVID-19 test. By supercharging testing volumes, we can proactively screen for COVID-19 at the population level, rather than having only the capacity to test patients already presenting symptoms.”

“At BIOLYPH, we are committed to providing the highest-quality lyophilization services and have been successfully doing so since 1993,” said Timothy Pearcy, founder and CEO of BIOLYPH. “Our team is committed to supporting XCR Diagnostics in supplying large volumes of tests to healthcare providers. We have the expertise and capacity in place to act once the XCR COVID-19 test gains EUA status.”

On the horizon …

While currently focused on alleviating the COVID-19 pandemic, XCR Diagnostics is also developing a proprietary portable instrument system called the Pyramid. This portable nucleic acid testing system will take full advantage of patented XCR technology to perform on-demand testing in ways conventional Polymerase Chain Reaction (PCR) systems cannot. The Pyramid will be smaller, lighter, and faster than comparable PCR systems, providing actionable results in less than 10 minutes. Because of its compact size and flexible power requirements, it can be more easily and cost-effectively deployed in the field, making it invaluable during a disease outbreak in hard-to-reach or medically underserved areas. Three tests have been developed for the Pyramid, with the first test entering FDA clinical trial in 2020.

* Times published by Hologic and Roche

Covid-19 Diagnostic Based on MIT Technology Might be Tested on Patient Samples Soon

As more Covid-19 cases appear in the United States and around the world, the need for fast, easy-to-use diagnostic tests is becoming ever more pressing. A startup company spun out from MIT is now working on a paper-based test that can deliver results in under half an hour, based on technology developed at MIT’s Institute for Medical Engineering and Science (IMES).

Cambridge-based E25Bio, which developed the test, is now preparing to submit it to the FDA for “emergency use authorization,” which would grant temporary approval for using the device on patient samples during public health emergencies.

Elsewhere around MIT, several other research groups are working on projects that may help further scientists’ understanding of how coronaviruses are transmitted and how infection may be prevented. Their work touches on fields ranging from diagnostics and vaccine development to more traditional disease prevention measures such as social distancing and handwashing.

Faster diagnosis

The technology behind the new E25Bio diagnostic was developed by Lee Gehrke, the Hermann L.F. von Helmholtz Professor at IMES, and other members of his lab, including Irene Bosch, a former IMES research scientist who is now the CTO of E25Bio.

For the past several years, Gehrke, Bosch, and others in the lab have been working on diagnostic devices that work similar to a pregnancy test but can identify viral proteins from patient samples. The researchers have used this technology, known as lateral flow technology, to create tests for Ebola, dengue fever, and Zika virus, among other infectious diseases.

The tests consist of strips of paper that are coated with antibodies that bind to a specific viral protein. A second antibody is attached to gold nanoparticles, and the patient’s sample is added to a solution of those particles. The test strip is then dipped in this solution. If the viral protein is present, it attaches to the antibodies on the paper strip as well as the nanoparticle-bound antibodies, and a colored spot appears on the strip within 20 minutes.

Currently, there are two primary types of Covid-19 diagnostics available. One such test screens patient blood samples for antibodies against the virus. However, antibodies are often not detectable until a few days after symptoms begin. Another type of test looks for viral DNA in a sputum sample. These tests can detect the virus earlier in the infection, but they require polymerase chain reaction (PCR), a technology that amplifies the amount of DNA to detectable levels and takes several hours to perform.

“Our hope is that, similar to other tests that we’ve developed, this will be usable on the day that symptoms develop,” Gehrke says. “We don’t have to wait for antibodies to the virus to come up.”
If the U.S. Food and Drug Administration grants the emergency authorization, E25Bio could start testing the diagnostic with patient samples, which they haven’t been able to do yet. “If those are successful, then the next step would be to talk about using it for actual clinical diagnosis,” Gehrke says.

Another advantage of this approach is that the paper tests can be easily and inexpensively manufactured in large quantities, he adds.