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.

BD, BioGX Announce FDA Emergency Use Authorization Submissions for New COVID-19 Diagnostics for Use in US

BD (Becton, Dickinson and Company), a leading global medical technology company, and BioGX Inc, a molecular diagnostics company, today announced that the companies have submitted Emergency Use Authorization requests to the U.S. Food and Drug Administration (FDA) for new diagnostic tests that, if authorized, would increase the potential capacity to screen for COVID-19 (coronavirus) by thousands of tests per day.

The tests would help fill an urgent need across the U.S. for laboratories to access an easy-to-use, rapid diagnostic test to screen patients for COVID-19. The tests will be run on the BD MAX™ Molecular Diagnostic Platform, which is already in use in nearly every state across the U.S. at hundreds of laboratories, with each unit capable of analyzing hundreds of samples per day. The system is fully automated, reducing the opportunity for human error and increasing the speed to result. Samples are capable of being analyzed start to finish in two to three hours. Each BD MAX™ System can process 24 samples simultaneously.

"The collaboration with BioGX to deliver a COVID-19 diagnostic in the U.S. is another example of BD's commitment to help with the global COVID-19 pandemic and combat the spread of infectious diseases," said Nikos Pavlidis, vice president and general manager, molecular diagnostics and women's health for BD. "Our BD MAX System is a versatile molecular platform that enables us to rapidly deliver molecular solutions across our laboratory customers and help communities in need during times of high anxiety."

BioGX developed the assay for the BD MAX™ System in their Sample-Ready™ ready-to-use format to detect the presence of the SARS-CoV-2 virus, the cause of COVID-19. The assay is based on the same viral RNA targeting sequences and real-time PCR detection method as the test developed by the U.S. Centers for Disease Control and Prevention (CDC).

"These are challenging times for all of us, more so for our laboratory partners who have an urgent need for an easy to use, reliable test to detect the SARS-CoV-2 to determine if patients have contracted COVID-19," said Shazi Iqbal, Ph.D., chief executive officer of BioGX. "The foundation of BioGX firmly stands on its team's ability to step up and address such unmet needs with speed.  Authorization to use our test would increase access across the U.S. to an automated, highly reliable SARS-CoV-2 test."

The companies submitted the Emergency Use Authorization requests to FDA today. The Emergency Use Authorization authority allows FDA to help strengthen the nation's public health protections against chemical, biological, radiological and nuclear threats by facilitating the availability and use of medical countermeasures needed during public health emergencies.

WuXi Diagnostics' Integrated Testing Solution for COVID-19 Epidemiological Investigation and Diagnosis

WuXi Diagnostics has successfully developed a series of COVID-19 detection products, including 2019-nCoV IgM Detection kit (Enzyme-linked Immunoassay, ELISA), 2019-nCoV IgM/IgG Detection Kit (Enzyme-linked Immunoassay, ELISA) and 2019-nCoV Nucleic Acid Detection Kit (PCR-Fluorescent Probe Method). All these products, as a set of "integrated detection" solution, assist medical institutions to diagnose COVID-19 infection quickly and accurately, and improve epidemic prevention and control capabilities for disease control centers at all levels.

IgM/IgG and IgM antibody detection, an effective measure for community preparedness

Immunoglobulin antibodies appear after the 2019-nCoV infection and initiate an immune response. IgM antibody is an indicator of current infection and IgG antibody is an important indicator of recent and past infection.

WuXi Diagnostics 2019-nCoV IgM/IgG and IgM Detection Kits can specifically detect IgM and IgG antibodies of COVID-19, covering the entire course of infection and recovery period of patients. This integrated approach improves the overall diagnosis of COVID-19 in both acute and recovery phases of illness.

Our two serological kits utilize enzyme-linked immunoassays, and provide an easy workflow, short turnaround time, and rapid diagnosis of COVID-19 suspected patients. Our kits can detect COVID-19 specific IgM and IgG antibodies in serum samples within 60 minutes with high reproducibility. Both methods do not require expensive medical instruments and consumables, and offer a favorable solution in primary medical institutions compared to other detection methods.

Nucleic acid detection, a "gold standard" for the diagnosis of COVID-19

Nucleic acid testing is considered to be the "gold standard" for the diagnosis of COVID-19. WuXi Diagnostics 2019-nCoV Nucleic Acid Detection Kit (PCR-Fluorescent Probe Method) is based on the latest COVID-19 sequence variation studies. Our Kit utilizes fluorescence quantitative PCR combined with a TaqMan probe with high specificity to ensure accurate identification of ORF1ab and N genes of 2019-nCoV. The kit offers a highly sensitive test with a limit of detection as low as 1000 copies/ml. Our assay is optimized with an internal control to exclude false-negative results from sample inhibitors and amplification failures. The kit can be used for the detection of 2019-nCoV infection in different types of samples, such as nasopharyngeal swabs, alveolar lavage fluid, sputum, etc. Our assay can provide the result as soon as two hours from processing a sample.

Coupling serological testing with nucleic acid detection provides a high-quality, multi-dimensional and cost-effective diagnostic solution

Performing just one type of test to diagnose COVID-19 could lead to a false-negative result or misdiagnosis due to complex medical conditions of the patients. Therefore, implementation of a combined diagnostic workflow by integrating serological and molecular tests using the three 2019-nCoV viral detection kits developed by WuXi Diagnostics, will provide a comprehensive diagnosis for clinicians.

We are at a critical moment for prevention and control of the COVID-19 epidemic. WuXi Diagnostics' integrated solution, which combines both serology and molecular tests, can meet the detection needs for early disease prevention and control, differential diagnosis, and epidemiological investigations. Our kits provide a high-quality, multi-dimensional and cost-effective solution for disease control departments and medical institutions.

"WuXi Diagnostics is devoting every effort with all healthcare providers to building a reliable line of defense against COVID-19", says Jason Liu, Ph.D., Chief Executive Officer of WuXi Diagnostics. "We will leverage advanced technology, continuously launch high-quality diagnostic solutions, and contribute in winning this battle against of COVID-19."

MyEG Introduces COVID-19 Rapid Testing Kit for Malaysia and the Philippines

My E.G. Services Berhad (MyEG) has a rapid testing kit for the COVID-19 coronavirus (2019-nCoV) and is ready to deploy this in Malaysia and the Philippines. The testing kit, developed by a leading diagnostics company, is approved by the health authorities in China where it is presently widely used. MyEG is currently awaiting approval by local authorities for the use of the kits in Malaysia.

The MyEG rapid testing kit is a one-step test that allows for the qualitative detection of the 2019-Novel Coronavirus IgM antibody in serum, plasma, fingertip blood or whole-body samples of pneumonitis patients or suspected cases.

MyEG intends to sell the testing kit for MYR99 (~USD23) or MYR990 (~USD230) for a pack of 10. This is affordable compared to other available options including the home screening service from DoctorOnCall that is priced at MYR700. Besides that, IHH Healthcare’s Gleneagles and Pantai hospitals also provide on-demand screening for MYR950, as does KPJ Healthcare Bhd’s Lablink and Qualitas Medical Group.

According to MyEG, the test uses an anti-human IgM antibody conjugated with colloidal gold and recombinant 2019-nCoV nucleocapsid protein (N protein) and spike protein (S protein) coated on different test lines respectively.

When a person is infected by 2019-nCoV, their immune system produces specific antibodies for the viral antigen. This usually happens within three to seven days after infection.

After the samples have been applied to the test strip, the gold-labelled anti-human IgM antibody will bind with IgM in the sample and form marked antigen-antibody complexes.

These complexes move to the test card detection zone by capillary action. Then, the marked antigen-antibody complexes will be captured on different test lines by recombinant 2019-nCoV N protein and S protein resulting in purplish red streaks on the test line. The colour intensity of each test line increases in proportion to the amount of 2019-nCoV IgM antibody in the sample.

A positive result is indicated by two purplish red bands at the control area (C) and the test region (T). If only one purplish-red band appears at the control area (C), it indicates the result is negative. On the other hand, if no band appears on the control area (C), the test result is invalid. The test should then be repeated.

MyEG claims the kit is able to accurately detect the COVID-19 coronavirus within a span of 30 minutes without the need for nose or throat swabs, or for samples to be sent to external diagnostic laboratories.

The company is said to be collaborating with approved medical facilities to offer on-site testing with these kits.

Monday, March 16, 2020

Curetis Begins Offering BGI’s CE-IVD Rapid Test Kit for Coronavirus in Europe

Curetis N.V., a developer of next-level molecular diagnostic solutions, announced that it started offering a CE-IVD certified real-time PCR test kit for SARS-CoV2 (also known as 2019-nCov), the causal pathogen of Corona Virus Disease 2019 (Covid-19). The test kit was developed and is manufactured by Curetis’ strategic partner BGI (Shenzhen, China) and was cleared by Chinese authorities in January 2020. In compliance with European regulations for in-vitro-diagnostics (IVD) tests, the test kit was CE-IVD certified on February 28, 2020.

The BGI 2019-nCoV RT-qPCR Kit enables diagnostic laboratories to perform SARS-CoV2 testing of nasopharyngeal swabs and bronchoalveolar lavage fluid of patients suspected to suffer from Covid-19. The test kit is compatible with standard methods for extracting the virus’ nucleic acid from the sample such as the QIAamp Viral RNA Mini Kit (QIAGEN) and can be performed on standard real-time PCR instruments such as the Applied Biosystems 7500 Real-Time PCR System (ThermoFisher Scientific) that are available in many molecular diagnostic laboratories in Europe. The test kit includes all necessary reagents and controls to test up to 48 patients in just a few hours.

The test will be made available to diagnostic laboratories in Europe through Curetis network of distribution partners but - owing to the special circumstances of the global SARS-CoV2 outbreak - also directly by Curetis in countries where Curetis’ distribution partners are not set up to supply the test kit themselves at short notices.

Offering the BGI 2019-nCoV RT-qPCR Kit is highly synergistic with Curetis’ Unyvero product line as patients hospitalized with Covid-19 are at risk of co-infections with bacterial pathogens that are often resistant to one or more antibiotics. The Unyvero HPN Panel for pneumonia allows for rapid testing of a broad spectrum of bacterial or fungal pathogens commonly involved in lower respiratory tract infections such as severe and life-threatening cases of pneumonia. It also provides key information on genetic resistance markers often carried by such pathogens and thereby allows for earlier and better informed treatment decisions for hospitalized patients suffering from severe pneumonia.    

“The strong synergies in offering BGI’s SARS-CoV2 test alongside our Unyvero HPN application make it an obvious move to leverage our sales channels to make coronavirus testing available as broadly as possible in Europe,” said Oliver Schacht, PhD, CEO of Curetis. “We sincerely hope that in this way we can contribute to containing the outbreak and improving the outcomes of Covid-19 patients by way of a comprehensive offering of diagnostic solutions for severe and life-threatening respiratory tract infections.”

FDA Issues Emergency Use Authorization to Thermo Fisher Scientific for Diagnostic Test Used to Detect COVID-19

Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, announced today that the U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for its diagnostic test that can be used immediately by CLIA high-complexity laboratories in the U.S. to detect nucleic acid from SARS-CoV-2, the virus that causes COVID-19, and not for any other viruses or pathogens.

The authorized test uses Applied Biosystems TaqPath Assay technology and is designed to provide patient results within four hours of a sample being received by a lab. The estimated time-to-result also includes time for sample preparation and instrument analysis.

"The authorization of our diagnostic test for COVID-19 will help to protect patients and enable medical staff to respond swiftly to treat those who are ill and prevent the spread of infection," said Marc N. Casper, chairman, president and chief executive officer of Thermo Fisher Scientific. "At Thermo Fisher, our Mission is to enable our customers to make the world healthier, cleaner and safer. In partnership with the FDA and regulatory authorities around the world, we are committed to expanding the availability of diagnostic testing to prevent the spread of this disease."

The EUA test is optimized for use on the company's Applied Biosystems 7500 Fast Dx Real-time PCR instrument, which is covered under the EUA and already used in clinical laboratories worldwide.

This test has not been FDA cleared or approved, however, the FDA can issue an EUA to permit use of certain medical products that may be effective in diagnosing, treating or preventing a disease or condition, as in the case of the novel coronavirus when the secretary of the U.S. Department of Health and Human Services (HHS) declares a public health emergency. HHS Secretary Alex Azar declared an emergency for COVID-19 on January 31. The test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

For more information about the test, visit www.thermofisher.com/COVID19EUA

Saturday, March 14, 2020

Mologic, Institut Pasteur to Develop and Manufacture COVID-19 Diagnostic Test in Senegal

Mologic Ltd, a leading developer of lateral flow and rapid diagnostic technologies, announced that it has been awarded circa £1 million as part of the UK government’s £46 million international coronavirus (COVID-19) prevention and research funding package. The funding will be used by Mologic and global partners, to develop a point-of-need diagnostic test for the virus, in addition to supporting the Company to initiate research for novel vaccine candidates.

Mologic will build on their experience developing a rapid test kit for Ebola, which was jointly funded by UK aid and the Wellcome Trust, to create a new hand-held diagnostics device to detect COVID-19. This will allow health officials to test for the virus at home or in the community, providing results in 10 minutes, without the need for electricity or a laboratory. Rapid identification of the virus enables quicker quarantine and access to care, to support global efforts in preventing further spread – especially in vulnerable countries that have limited specialist facilities. Alongside their work on diagnostics, UK aid is also supporting Mologic in the development of a COVID-19 vaccine candidate for further evaluation.

The company is working in close partnership with the Institut Pasteur de Dakar to validate and manufacture the COVID-19 test at a new manufacturing site, DiaTropix, in Senegal. This will be the first time that a diagnostics kit created in the UK will be jointly manufactured in Africa, to ensure its immediate availability, to manage any potential outbreaks on the continent, and further international spread. Global validation partners include; Liverpool School of Tropical Medicine and St George’s, University of London in Europe; the Wuhan Institute of Virology and the University of Malaya in Asia; and for Latin America, Fiocruz.

Professor Paul Davis, Co-Founder and Chief Scientific Officer, Mologic, commented: “As seen with the COVID-19 outbreak, viruses can quickly transmit between populations, however, our knowledge to tackle this threat has also grown exponentially. For rapid epidemic preparedness and response, we need to develop a platform that is readily modified according to a novel pathogen, as we are demonstrating through our accelerated programmes for Ebola and COVID-19.”

Dr Joe Fitchett, Medical Director, Mologic, said: “The COVID-19 outbreak is at a critical juncture, and to bring it to an end, we need next generation diagnostics for use at the point-of-need – at home or in the community, in limited and well-resourced settings. Rapid detection of the virus is important to stop its spread – we are pleased that the UK government has acknowledged this, supporting Mologic and the work of our partners to prevent further outbreaks internationally.”

Dr Amadou Sall, Director of Institut Pasteur de Dakar, said: “The COVID-19 epidemic highlights an unprecedented level of seeding of cases to vulnerable locations. We are proud of this partnership working with UK aid to support all countries to have responsive and resilient diagnostics to control COVID-19. With Mologic, we are already applying support from the UK government and Wellcome Trust to develop successful diagnostics tests to detect and combat the spread of Ebola, which is close to being controlled in the Democratic Republic of the Congo. DiaTropix’s remit is to responsively manufacture diagnostics for epidemics both for Africa and wherever they surface.”

Hospitals are Starting to Deploy Their Own Coronavirus Tests

On Friday, Johns Hopkins University announced it had successfully developed a test for COVID-19. The health system says it is currently able to process 50 tests per day. It plans to handle 180 a day by Monday, and hopes to ramp up to 1,000 a day over the next three weeks.

Two weeks ago, the Food and Drug Administration began allowing approved laboratories to create their own coronavirus tests.  Those facilities are now deploying and ramping up their testing abilities.  On Thursday, the Mayo Clinic announced it had developed a 24-hour test to detect the virus that causes Covid-19, Severe Acute Respiratory Syndrome Coronavirus-2.

At the University of Washington’s virology lab, researchers have been at work on a test since January. Once the FDA opened up test creation to sophisticated laboratories like UW’s, it was already ready to go. By March, 5, the lab was processing 100 tests a day, according to NPR. It plans to be able to do 4,000 per day.

For the John Hopkins test, a doctor takes a swab of a patient’s mouth that is then analyzed for the presence of the virus. At the moment, it’s able to get a diagnosis within 24-36 hours, about the same rate as sending it out to a public health laboratory. However, Dr. Heba Mostafa, director of the university’s molecular biology lab, says that as testing scales up, her team may be able to turn around tests in 12 hours. The test will be available to five hospitals within the Johns Hopkins network in Maryland.

Dr. Mostafa says that all labs able to develop their own tests are in the process of validating them now. Her colleague, Dr. Karen C. Carroll, director of the division of microbiology at Hopkins, says that several manufacturers of rapid diagnostic tools are also working on their own tests: Within 2-4 weeks,  “many laboratories that cannot develop their own test from scratch,” will still be able to assemble them by buying the necessary components, she says.

Having the test be widely available isn’t just important so that epidemiologists can better manage people who have contracted the virus. It also matters because treatment may be on the way. “I do believe there will be a clinical trial for a novel antiviral medication,” says Dr. Carroll. “So being able to diagnose people who may qualify for the clinical trial for the drug would be another advantage of having a quick turnaround for a test.”

Source: Fast Company