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Oxford University’s Covid-19 vaccine shows promise in animal study

Oxford University's Covid-19 vaccine shows promise in animal study

The University of Oxford in the UK has reported positive findings of its Covid-19 vaccine candidate in a small preclinical study involving six monkeys.

This preliminary data of the vaccine, currently in human trials, has been published on the preprint website bioRxiv, noted Reuters.

According to the publication, some monkeys administered with a single shot of the vaccine generated antibodies against the virus within 14 days while all monkeys developed antibodies within 28 days, prior to being exposed to high virus doses.

Following exposure to the coronavirus, the vaccine candidate was prevented damage to the lungs and blocked the virus from replication. However, the virus was found to be actively replicating in the nose.

London School of Hygiene & Tropical Medicine pharmacoepidemiology professor Stephen Evans said that the animal data was โ€˜good newsโ€™. Evans was quoted as saying: โ€œIt is one of the hurdles to be passed by the Oxford vaccine and it has cleared it well.โ€

The professor also noted that no evidence of immune-enhanced disease, where a vaccine makes the disease worse, was reassuring.

Evans added: โ€œThis was a definite theoretical concern for a vaccine against SARS-CoV-2 and finding no evidence for it in this study is very encouraging.โ€

Last month, the University of Oxford signed an agreement with AstraZeneca to develop and distribute its Covid-19 vaccine candidate, a recombinant adenovirus vaccine in development by Jenner Institute and Oxford Vaccine Group at the university.

Results from the human trial are expected next month, with plans to start late-stage trials by the middle of this year. As part of the deal, AstraZeneca will carry out the development and global manufacturing and distribution of the vaccine.

Single Use Surgical support Cavell Nurses Trust by donating 5p from every product sold in the UK

Single Use Surgical support Cavell Nurses Trust by donating 5p from every product sold in the UK

Single Use Surgicalwill donate 5p from the sale of every disposable surgical instrumentsold in the UK to Cavell Nursesโ€™ Trust to help supportthe nursing family in their time of need.

Cavell Nursesโ€™ Trust is the national charity which provides support to UK nurses, midwives and healthcare assistants when they are facing personal or financial hardship.

This may be as a result of illness, disability, domestic abuse and more recently the impact of COVID-19. Since the beginning of the Coronavirus outbreak, the charity has provided record levels of support to nursing professionals.

The partnership withCavell Nursesโ€™ Trust comes in recognition of International Nursesโ€™ Day 2020, celebrated globally each year to commemorate the birth of Florence Nightingale, the founder of modern nursing. It also reinforces the companyโ€™s support for the NHS during these challenging times.

Sales Director Jon Blastland said: โ€œI am delighted to be a part of this new collaboration with Cavell Nursesโ€™ Trust, itโ€™s very important in these times of COVID-19, but my wish is โ€“ to continue to support our fantastic NHS nurses long after the virus has been beaten. Nurses are the heart of our NHS and they should receive the support and gratitude they deserve.โ€

Cavell Nurses’ Trust was founded in 1917 in memory of British nurse Edith Cavell, who is celebrated for her work in World War I. Edith is believed to have saved the lives of over 200 soldiers thanks to her bravery.

Today, the charity transforms lives by supporting frontline workers when they need it most โ€“ from simple, essential support like money to repair a broken cooker or boiler, to vital life-changing aid like helping a family flee their home from domestic abuse.

John Orchard, Chief Executive at Cavell Nursesโ€™ Trust added: โ€œEdith Cavell continues to inspire people a century on and Cavell Nursesโ€™ Trust is proud to support nurses, midwives and healthcare assistants in her name. Weโ€™re incredibly grateful to the team at Single Use Surgical for getting behind us in this way and helping us support the nursing family in the UK.โ€

Established in 2001, Single Use Surgical was formed as a direct response to UK hospitalsโ€™ concerns over the cleaning practices involving fine lumen instruments. The companyโ€™s ethos is simple โ€“ to produce instruments that are sterile, efficient and manufactured to the highest standards, all carefully designed to put patients first and reduce the risk of cross-contamination.

Asia Pacific countries fast track review processes benefits Clinical Trial clients

Asia Pacific countries fast track review processes benefits Clinical Trial clients

Asia-Pacific’s largest specialist biotech CRO Novotech said many countries in the region were now fast-tracking their COVID-19 clients’ clinical trials with expedited review processes for treatment and vaccine candidates.

A Novotech Client COVID-19 trial was just approved in under 9 days in South Korea.

The South Korean Ministry of Food and Drug Safety (MFDS) has announced “GO-expedite” program where they are expediting the review process for COVID-19 treatment and vaccine trials with specific timelines.

Other Asia Pacific countries are also fast-tracking COVID-19 trial reviews including:

  • India: review/approval in 10 working days
  • Thailand: review/approval in 15 working days
  • Malaysia: review/approval in 20 working days

Novotech Executive Director, Asia Operations, Dr. Yooni Kim said she was pleased to see such a rapid response in the region to support vital research.

“We are seeing an increase in demand from biotechnology sponsors for studies in the Asia-Pacific region because of the speed and quality available here. This expedited review process will further support the race for COVID-19 treatments.”

EKF & Tosoh Europe N.V. distribution agreement expands HbA1c POC testing reach in Middle East & Africa

HbA1c POC testing reach in Middle East & Africa

EKF Diagnostics, the global in vitro diagnostics company, announces that it has signed a three-year distribution agreement with Tosoh Europe N.V. for the distribution of its Quo-Testยฎ HbA1c point-of-care (POC) analyzer in the Middle East and Africa. Tosoh Bioscience division is one of the largest global manufacturers of high-performance liquid chromatography (HPLC) equipment for glycated hemoglobin (HbA1c) analysis predominantly in core laboratories. As a desktop analyzer designed for simple and reliable HbA1c measurement for monitoring and managing diabetes in POC settings, such as diabetes clinics and doctorsโ€™ surgeries, EKFโ€™s Quo-Test analyzer complements Tosohโ€™s HPLC technology.

Tosoh Europe has seen a growing need for point-of-care HbA1c analysis alongside its traditional laboratory market and has identified EKF Diagnostics as an important partner to work with in order to provide this to its customers. As a leading HPLC manufacturer, Tosohโ€™s analyzers are frequently used to benchmark and validate POC devices such as Quo-Test. This agreement will allow both EKF and Tosoh Europe to work in markets they have previously been unable to access and provides Tosoh Europe with the opportunity to offer new services to suit changing customer requirements.

โ€œWe are delighted to partner with Tosoh Europe as they expand their need for point-of-care HbA1c analysis in a time where those suffering from diabetes are at greater risk,โ€ commented Julian Baines, CEO of EKF. โ€œTosoh is a leading HPLC brand and its analysers are considered to be the gold standard when validating POC products such as EKFโ€™s Quo-Test. For them to choose our analyzer to complement their lab-based HPLC analyzers for HbA1c testing is a great endorsement of our technology.โ€

Quo-Test is fully automated and quantifies HbA1c from a 4ฮผL sample taken from a finger prick or venous whole blood. Unaffected by most hemoglobin variants, lab-quality results are available within four minutes and reported in IFCC and DCCT standard units. Also facilitating its use as a POC analyzer, step-by-step instructions are displayed on Quo-Testโ€™s multi-lingual display, minimizing staff training time and minimizing user-related errors.

After the initial three-year term for the Middle East and Africa, EKFโ€™s Quo-Test distribution agreement with Tosoh Europe has a rolling one-year renewal with the option to extend the agreement into EU countries as required.

About EKF Diagnostics
EKF Diagnostics Holdings plc, which includes the EKF Diagnostics, Stanbio Laboratory and DiaSpect brands, specializes in the development, production and worldwide distribution of point-of-care analyzers for use in the detection and management of diabetes and anemia, and also in sports and maternal medicine. EKF products are sold in more than 100 countries around the globe, through a network of specialist distributors.

Point-of-care diagnostics: EKF Diagnostics designs and manufactures world-class diagnostic devices, as well as distributing rapid test kits for infectious diseases and pregnancy. The EKF analyzer range is used widely in GP surgeries, pharmacies, blood banks, sports clinics, hospitals and laboratories for glucose, lactate, hemoglobin, hematocrit and HbA1c measurement.

Central laboratory: EKF, through its wholly owned subsidiary, Stanbio Laboratory (Boerne, Texas, USA), manufactures a comprehensive range of clinical chemistry reagents, as well as associated analyzers. In addition, EKF Life Sciences (Elkhart, Indiana, USA) manufactures enzymes used in reagent development and also provides contract fermentation facilities.

About Tosoh Europe N.V.
Tosoh Europe N.V. is a part of Tosoh Corporation, headquartered in Tokyo, Japan. The parent company was established in 1935 and is listed on the First Section of the Tokyo Stock Exchange. In the 80 years that we have been in business, we have built balanced product lines of commodity chemicals for industry and of specialty products and materials for high technology and niche markets.

Tosoh Bioscience is a leading supplier of chromatographic columns, media, and sophisticated diagnostic systems. Bringing the best in quality products and services from complete in-house bio-separation and diagnostic portfolios.

Tosoh’s diagnostic systems feature advanced immunoassay technologies such as the AIA series of automated immunoassay analyzers, G series of glycohemoglobin analyzers, and molecular testing solutions that support the monitoring of such life-threatening disease as diabetes, certain cancers, and microbial infections. They also feature integrated essential hardware and software uncompromising value through global customer support that includes ensuring the ready availability of the systems’ consumable items, namely AIA-PACK reagent cups.

Adaptive Biotechnologies and Microsoft launch virtual Immune RACE study to inform novel COVID-19 diagnostics to address unmet needs in testing

Adaptive Biotechnologies and Microsoft launch virtual Immune RACE study to inform novel COVID-19 diagnostics to address unmet needs in testing

Adaptive Biotechnologies Corp. announced that it has begun enrolling a virtual clinical study, ImmuneRACE, as part of a broader effort it has undertaken with Microsoft Corp. to rapidly map and measure the immune response to the COVID-19 virus to inform improved diagnostics to fulfill the need for more reliable testing. The study calls for 1,000 participants in select U.S. metropolitan areas impacted by COVID-19. De-identified data will be made freely available to public health officials, academia and industry to help accelerate solutions to the pandemic. LabCorp, through its Covance drug development business, will manage the collection of blood samples and nose/throat swabs from participants in the comfort and safety of their own homes.

There are currently two types of tests for COVID-19. PCR tests indicate the presence of live virus from a nose or throat swab, and serology tests indicate exposure to and potential immunity against the virus by measuring the presence of antibodies in the blood. Adaptive and Microsoft believe a third type of test can potentially help address current challenges with testing, resulting in the following scenarios:

  • Complementary or alternative diagnostic testing for individuals with known exposures or symptoms
  • Ability to triage patients and inform treatment strategies based on risk
  • Ongoing immunity surveillance testing of the population to inform decisions on restrictions

โ€œWeโ€™ve spent the past decade learning how the adaptive immune system naturally detects and treats all disease, and we are well-positioned to apply our immune medicine platform specifically to COVID-19. Weโ€™re hopeful that we can contribute important information that will become part of an immune scan to help reopen society,โ€ said Chad Robins, CEO and co-founder of Adaptive Biotechnologies. โ€œAs many are sheltering in place wondering how they can help, we wanted to launch ImmuneRACE with Microsoft and give people an opportunity to participate. These efforts are complementary to many global initiatives underway to study the virus itself.โ€

As part of the study, the partners will measure the presence of specialized cells of the immune system in the blood, called T cells, that identify the disease early on and proliferate to combat the infection. Together, Adaptive and Microsoft are mapping and measuring the immune response of T cells specific to many diseases and are now applying their combined capabilities to COVID-19.

โ€œWe are dedicated to being part of the solution against COVID-19,โ€ said Peter Lee, corporate vice president, AI and Research, Microsoft. โ€œImmune response data may augment what we have been learning to date to help determine who is at greater risk of developing more severe symptoms and may help with future containment efforts. Anyone who has been affected by COVID-19 holds key information that can help contain and manage the virus.โ€

In March, the companies announced an expansion of their existing partnership to use machine learning to map the immune system response to many different diseases, including infectious diseases, autoimmune disorders and cancer, at scale to study COVID-19. The information obtained from study participants, including how the immune system identifies the virus and how people are responding to the virus, will be integrated with data obtained from samples provided by hospitals and other institutions across the globe. The accuracy of the immune response signature will be continually improved and updated online in real time as more study samples are sequenced and by using Microsoftโ€™s hyperscale machine learning capabilities and the Azure cloud platform.

Other industry leaders, including Illumina and Providence, have also joined forces with Microsoft and Adaptive to accelerate this critical effort against COVID-19.

How to join ImmuneRACE

ImmuneRACE will enroll 1,000 individuals from more than 20 metropolitan areas in the U.S. You can be part of the solution if you are between the ages of 18 and 89 and:

  • Currently have COVID-19
  • Have recently recovered from COVID-19
  • Were exposed to someone diagnosed with COVID-19

If you decide to participate and qualify for the study, you will be asked to provide relevant information about your medical history, symptoms and previous diagnostic tests.

Patients who qualify for the study can schedule a blood draw and swab collection in the convenience of their own home. The phlebotomist completing sample collection will be using appropriate personal protective equipment to safely conduct the visit when entering participantโ€™s homes.

About the Adaptive and Microsoft partnership

Adaptive and Microsoft partnered in 2018 to create a TCR-Antigen Map, an approach to translating the genetics of the adaptive immune system to understand at scale how it works. Together we are using immunosequencing and machine learning to map T-cell receptor (TCR) sequences to diseases and disease-associated antigens. Using these data, we aim to develop a blood test for the early and accurate detection of many diseases, translating the natural diagnostic capability of the immune system into the clinic. In 2019, we confirmed clinical signals in two diseases, and established our first proof of concept in Lyme Disease. Adaptive expects to submit our first clinical application to the FDA in 2020.

About Adaptive Biotechnologies

Adaptive Biotechnologies is a commercial-stage biotechnology company focused on harnessing the inherent biology of the adaptive immune system to transform the diagnosis and treatment of disease. We believe the adaptive immune system is natureโ€™s most finely tuned diagnostic and therapeutic for most diseases, but the inability to decode it has prevented the medical community from fully leveraging its capabilities. Our proprietary immune medicine platform reveals and translates the massive genetics of the adaptive immune system with scale, precision and speed to develop products in life sciences research, clinical diagnostics, and drug discovery. We have two commercial products, and a robust clinical pipeline to diagnose, monitor and enable the treatment of diseases such as cancer, autoimmune conditions and infectious diseases. Our goal is to develop and commercialize immune-driven clinical products tailored to each individual patient.

About Illumina

Illumina is improving human health by unlocking the power of the genome. Our focus on innovation has established us as the global leader in DNA sequencing and array-based technologies, serving customers in the research, clinical, and applied markets. Our products are used for applications in the life sciences, oncology, reproductive health, agriculture, and other emerging segments.

About LabCorp

LabCorp, an S&P 500 company, is a leading global life sciences company that is deeply integrated in guiding patient care, providing comprehensive clinical laboratory and end-to-end drug development services. With a mission to improve health and improve lives, LabCorp delivers world-class diagnostics solutions, brings innovative medicines to patients faster, and uses technology to improve the delivery of care. LabCorp reported revenue of more than $11.5 billion in 2019. To learn more about LabCorp, visit www.LabCorp.com, and to learn more about LabCorpโ€™s Covance drug development business, visit www.Covance.com.

About Providence

Providence is a national, not-for-profit Catholic health system comprising a diverse family of organizations and driven by a belief that health is a human right. With 51 hospitals, 1,085 physician clinics, senior services, supportive housing and many other health and educational services, the health system and its partners employ more than 119,000 caregivers serving communities across seven states โ€“ Alaska, California, Montana, New Mexico, Oregon, Texas, and Washington, with system offices in Renton, Wash., and Irvine, Calif.

About Microsoft

Microsoft enables digital transformation for the era of an intelligent cloud and an intelligent edge. Its mission is to empower every person and every organization on the planet to achieve more.

Mayo Clinic collaborates with Ultromics to rapidly assess patients diagnosed with COVID-19

Mayo Clinic collaborates with Ultromics to rapidly assess patients diagnosed with COVID-19

A joint UK-US research team is applying a pioneering artificial intelligence system to map for the first time how the COVID-19 virus attacks the heart with such deadly impact.

The coronavirus has been found to kill more than one in ten victims with heart disease and also to significantly weaken the hearts of other sufferers.

This week, British health-tech company Ultromics and Mayo Clinic in the US will use AI software, EchoGo Core, to analyze echocardiograms of COVID-19 victims, for clues about how the virus affects the human cardiovascular system.

Their findings will produce, for the first time, a map of the โ€˜novel cardiac featuresโ€™ of COVID-19 and help physicians rapidly triage and treat high-risk patients, potentially saving countless lives.

CEO of Ultromics, Ross Upton said: โ€œTo date, there is no way of linking the impact of the virus to predicted patient outcomes. By applying our technology to the evaluation of COVID associated echocardiograms, we can help understand the characteristics of cardiac involvement. We hope that by discovering a way to do this, patient management can be optimized โ€“ this is incredibly important where resources are scarce. Most importantly, we can give physicians the gift of time to treat those most in danger.โ€

Mayo Clinic is one of the worldโ€™s leading centers of cardiology and its extensive cardiac knowledge will assist Ultromics in the development of an image analysis application to help clinicians in the fight against COVID-19. The collaboration will be led by Gary Woodward, CTO of Ultromics and Patricia A. Pellikka, M.D. cardiologist and clinical researcher at Mayo Clinic.

The COVID-19 coronavirus has considerable potential for cardiovascular impact including COVID induced microvascular disease and myocarditis and also side-effects from some treatments, known as therapy-associated cardiotoxicity.

The multi-site study will look at 500 COVID-19 positive men and women, aged between 18 and 89. These participants will have undergone a clinically indicated echocardiography exam during a three-month period. The primary objective is the assessment of automated cardiac measurements, ejection fraction and Global Longitudinal Strain, for the classification of COVID-19 patient outcomes.

EchoGo Core has the opportunity to provide physicians with an alternative streamlined solution for monitoring and identifying heart disease, enabling healthcare providers, no matter what experience level, to perform analysis with ease. This could be hugely important in giving physicians freed time to provide high quality, patient-centric care.

Echocardiograms have a proven role in the identification and assessment of virtually all cardiac disease entities. The non-invasive method is cost-effective and widely available, ideal for bedside assessment of patients with suspected cardiac complications of COVID-19.

Quantum Medicine: A Return to Our “self”

Quantum Medicine: A Return to Our "self"

What if a doctor told you to tap into your vital energy in order to heal your body; how would you react? This is what quantum medicine suggests in a nutshell. But what does it mean and how does it work?

Quantum Medicine and Nanotechnology

Quantum medicine is considered energy medicine. It is based on the idea that the body is not only matter but also vital energy. If that vital energy is disturbed or blocked, it will not only cause discomfort but can also bring diseases into the body. How does it work? Todayโ€™s medicine is based on cellular biochemical exchange. In quantum medicine, it is the communication of electromagnetic information between the cells that determines our health.

This may be a difficult concept to integrate, but quantum medicine is also very real. Through the use of quantum dots, it is possible to detect intracellular events, track cell migration, map tissue and demarcation to name but a few of their capabilities. Thanks to the advent of nanotechnology, which is used to create the quantum dots, there are new ways to detect diseases and treat them.

Can we understand Our Self and heal it?

Quantum medicine implies that our vital energy carries information and that this information is intelligent in nature. In other words, if we are able to connect to our higher Self, we can understand what is going on inside our body to help heal it. How? By unblocking the flow of information which is causing the disease.

It is a proven scientific fact that all matter is energy. The field of electromagnetic frequencies has been studied for over a century now and scientists have found that everything has its own vibrational frequency and it can be measured precisely (in hertzes). As technology evolves, the vital energy inside us can be measured more and more clearly.

Adopting quantum medicine will take time as it will force us to think of a disease not only as a biological problem anymore but also as a lack or blockage of information running through the body. Suddenly we will become more than just organs and tissues. We will reconnect with our own vibrating electromagnetic field where our information resides, so we can maintain homeostasis (find equilibrium and stability).

Conclusion

Meanwhile, science is bringing more and more quantum elements to our lives. As we saw earlier, the use of quantum dots is becoming more frequent and not just for medicinal purposes. Thanks to quantum physics, we now have products like iPhone, smart televisions and many more. No doubt that the quantum knowledge will keep growing in the years to come.

Master Lock announces product donation to help protect frontline workers and small business amid pandemic

Master Lock is donating up to 1,000 Bluetooth Lock Boxes โ€“ a more than $250,000 investment โ€“ to help frontline workers and small business owners safeguard their critical personal protective equipment and important supplies and assets amid the COVID-19 pandemic.

Beginning Tuesday, May 12, those representing a healthcare facility as well as either from police force, fire department or ambulance service provider in America and event the owners and workers of small business, can request a free Portable Lock Box or Wall Mounted Lock Box by completing the designated submission form and agreeing to the terms and conditions.

As demand for PPE continues in the COVID-19 environment, so does the need for facilities and frontline workers to safeguard their equipment. Ensuring security solutions for myriad valuables โ€“ from employee PPE to irreplaceable business documents โ€“ also extends to small business owners as sectors of the economy reopen. Equipped with the ability to track and manage access to storage areas via smartphone, the Bluetooth Lock Box donation is designed to help protect frontline workers from potential theft, while minimizing physical contact with the device.

โ€œWe couldnโ€™t be more grateful for those on the frontlines making sacrifices each day to support the fight against coronavirus,โ€ said, David Youn, President at The Master Lock Company. โ€œWhile no donation amount could ever express our full appreciation, we at Master Lock hope the offering provides relief for those needing reliable security solutions for their facilities, businesses and essential equipment.โ€

The Bluetooth Lock Box donation is an extension of Master Lockโ€™s spring program where the company offered 250 smart locks and lock box units, a $50,000 product investment, to healthcare workers and facilities nationwide. After receiving positive responses from the healthcare community and exhausting fulfillments in roughly eight days, Master Lock committed to expanding inventory and extending donations to support first responders and small business owners.

Vitagene Launches The First FDA Authorized Saliva based “Zero Contact” COVID-19 At Home Test

Vibra Health Laboratory Scales its Operation to Support COVID-19 Testing with Rapid Turnaround Time

Vitagene, the precision health company, announced the immediate availability of 50,000 FDA authorized โ€œZero Contactโ€ at home COVID-19 test kits for use during the current public emergency. Vitagene is using the 1Health.io platform to facilitate compliance with FDA requirements for assessment of symptoms, telehealth and electronic tracking of the test kit.

Simple At-Home Testing: Currently, consumers who are showing symptoms of COVID-19 infection are expected to drive or take mass transit to a clinic or stay for hours in a drive-through testing line. With the Zero Contact COVID-19 test, patients will get a kit at home eliminating the need to drive or be at risk going to a clinical setting.

โ€œOur mission as a team is to help our customers improve their health and wellness,โ€ said Mehdi Maghsoodnia, CEO at Vitagene. โ€œOur customerโ€™s number one need right now is access to COVID-19 testing. That is why our team, alongside our partners, have been working day and night to bring this test to market with physician approval, telehealth supervision and a clear chain of custody tracking.โ€

Protect Healthcare Providers: The current COVID-19 tests require that the healthcare provider be in the same room as the patient with symptoms, creating risk of infection for the healthcare provider. Once the traditional specimen collection is conducted, the provider then needs to disinfect their garments to minimize the risk of cross contamination. With Zero Contact, both patients and healthcare workers need not be in the same place while the test is being administered.

Saliva vs. Nasal Testing: Saliva test kits are readily available today; in fact, Vitagene is committed to providing 50,000 tests in the first month of service and scaling that number to 300,000 tests per month beginning in middle of May 2020. Additionally, Vitagene has partnered with supply chain manufacturers to provide the kits, which are manufactured in the U.S., supporting our economy and providing local employment.

โ€œOur new, efficient, and self-contained saliva collection kits using the EUA approved SDNA-1000 device, makes not only sample collection easy but sample transport as well,โ€œ said Stephen Fanning. CEO of Spectrum Solutions. โ€œ The proprietary preservation solution inactivates the virus once a biosample is collected to the point that we are able to suspend and stabilize the viral RNA transcripts for sensitive and specific qPCR testing by the lab. Another incredible benefit of our process is that we can help limit undue exposure making the testing for COVID-19 safer for everyone involved.โ€

Convenient Access to Testing: Today, many communities do not have convenient access to hospitals or other testing facilities. This – combined with limited nasal test availability – has led to only ~1 percent of people being tested in the U.S. to date. In order to decrease and manage the health and economic risks of COVID-19, we need access to widespread testing. Now, anyone who thinks that he or she might have been exposed can go to Vitagene.com and start the process of being tested.

โ€œOur saliva-based test kit makes it possible for patients across the United States to have access to testing, not just those located near a hospital, clinic or testing facility.โ€ said Andrew Brooks, chief operating officer and director of technology development at the university’s RUCDR Infinite Biologics lab. โ€œMillions of Americans, who until now might have to travel hours to their nearest testing location, can be sent a test by their doctor or clinic.โ€

ABOUT VITAGENE

Headquartered in San Francisco, California, Vitagene Incorporated and its platform division 1health.io are focused on helping consumers improve their health and lifestyle. Vitagene leverages the latest science in machine learning and data analytics, as well as genomics, to provide actionable health plans to consumers. Vitagene keeps all data private and secure and does not share or sell data to third parties. Vitagene has a team of accomplished engineers, scientists and physicians dedicated to improving the health of its customers.

ABOUT RUCDR

RUCDR Infinite Biologics, which is part of Rutgers’ Human Genetics Institute of New Jersey, is the world’s largest university-based cell and DNA repository. Its mission is to understand the genetic causes of common, complex diseases and to discover diagnoses, treatments and cures for them. The organization collaborates with researchers in the public and private sectors throughout the world, providing the highest quality bio-banking services and biomaterials, as well as scientific and technical support.

Quidel Receives Emergency Authorization for Rapid Antigen COVID-19 Diagnostic Assay

Vela Diagnostics Receives CE mark for COVID-19 Detection Test

Quidel Corporation, a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced that Quidel has received EUA from the U.S. FDA to market its Sofiaยฎ 2 SARS Antigen FIA, a rapid point-of-care test to be used with the Sofia 2 Fluorescent Immunoassay Analyzer for the rapid detection of SARS-CoV-2 in nasal or nasopharyngeal specimens from patients meeting the Centers for Disease Control and Preventionโ€™s (CDC) criteria for suspected COVID-19 infection.

Sofia 2 is Quidelโ€™s next-generation version of its best-selling Sofia instrumented system. Sofia 2 utilizes the original Sofia fluorescent chemistry design while improving upon the graphical user interface and optics system to provide an accurate, objective and automated result in 15 minutes. The next-generation Sofia 2 system also comes connected to Virenaยฎ, Quidelโ€™s data management system, which provides aggregated, de-identified testing data in near real-time.

The Sofia 2 instrument also offers 2 distinct workflows: depending upon the userโ€™s choice, the Sofia 2 SARS Antigen FIA cartridge is placed inside Sofia 2 for automatically timed development (WALK AWAY Mode); or test cartridges can be placed on the counter or bench top for a manually timed development and then placed into Sofia 2 to be scanned (READ NOW Mode), allowing the user to markedly increase testing throughput per hour.

โ€œIn the fight against COVID-19, our employees are truly making a difference, and I am tremendously proud of our organizationโ€™s ability to quickly develop and mobilize an accurate rapid antigen test,โ€ said Douglas Bryant, president and chief executive officer of Quidel Corporation. โ€œThe EUA for our Sofia 2 SARS Antigen FIA allows us to arm our healthcare workers and first responders with a frontline solution for COVID-19 diagnosis, accelerating the time to diagnosis and potential treatment of COVID-19 for the patient.โ€

The assay is currently available for sale in the United States under EUA, and Quidel is now shipping the product to its customers. Quidel offers several other Sofia assays for sale, which are FDA cleared and CLIA waived, including tests for Influenza A and B, Respiratory Syncytial Virus (RSV), Group A Strep, and a 12-minute finger-stick whole blood test for Lyme Disease. In addition, Quidel also markets Sofiaยฎ tests for Lyme Disease, Legionella and S. pneumoniae in Europe.

Healthcare professionals can purchase the Sofia 2 SARS Antigen FIA through distribution representatives for Cardinal Health, Fisher Healthcare, Henry Schein, or McKesson.

About Quidel Corporation

Quidel Corporation serves to enhance the health and well-being of people around the globe through the development of diagnostic solutions that can lead to improved patient outcomes and provide economic benefits to the healthcare system. Marketed under the Sofiaยฎ, QuickVueยฎ, D3ยฎ Direct Detection, Thyretainยฎ, Triageยฎ and InflammaDryยฎ leading brand names, as well as under the new Solanaยฎ, AmpliVueยฎand Lyraยฎ molecular diagnostic brands, Quidelโ€™s products aid in the detection and diagnosis of many critical diseases and conditions, including, among others, influenza, respiratory syncytial virus, Strep A, lyme, herpes, pregnancy, thyroid disease and fecal occult blood. Quidel’s Triageยฎ system of tests comprises a comprehensive test menu that provides rapid, cost-effective treatment decisions at the point-of-care (POC), offering a diverse immunoassay menu in a variety of tests to provide diagnostic answers for quantitative BNP, CK-MB, d-dimer, myoglobin, troponin I and qualitative TOX Drug Screen. Quidelโ€™s research and development engine is also developing a continuum of diagnostic solutions from advanced immunoassay to molecular diagnostic tests to further improve the quality of healthcare in physiciansโ€™ offices and hospital and reference laboratories.

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