Outbreaks such as the COVID-19 coronavirus and other emerging infectious diseases represent both challenges in protection and containment, and opportunities for innovation and technology development.
The Emerging Trends in Infectious Disease Interactive Infographic is a living resource, staying current with diagnostic, protective, and therapeutic developments in the vitally important area.
This post serves as a chronology of the interactive infographic, citing ongoing developments in the areas of: Detection and Containment, Diagnosis and Treatment, Laboratory Equipment, and Prevention and Surveillance.
Detection and Containment
PCR and DNA Technologies
The FDA has fast-tracked Emergency Use Authorization (EUA) of Molecular-Based Laboratory Developed Tests for COVID-19 detection. These are essential tools for research and disease surveillance efforts, and will provide important platforms for future contagion detection kit development.
- 4/24/20 – The FDA has now granted EUA for a total of 18 Laboratory Developed Tests (LDTs) developed by CLIA certified laboratories for use in hospitals and clinics.
- 4/29/20 - A new technology has been developed based on Reverse Transcribed Loop-Mediated Isothermal Amplification (RT-LAMP) for onsi-site detection of SARS-CoV-2 by color change monitoring.
- 5/4/20 - The complete SARS-CoV-2 genome has been cloned into Yeast using Transformation Associated Recombination (TAR).
- 5/6/2020 - The FDA has issued an EUA to Sherlock BioSciences for the Sherlock CRISPR SARS-CoV-2 Kit, the first of its kind employing CRISPR technology for an infectious disease test.
- 5/25/20 - EUA have now been issued for 32 high-complexity Laboratory Developed Tests (LDTs) for CLIA-certified laboratories.
In Vitro Diagnostics
ISO 134485:2016 designated manufacturers of in vitro molecular technologies are now able to produce medical devices and in vitro diagnostics for immediate human pathogen detection. The FDA Emergency Use Authorization (EUA) program is streamlining deployment of commercial diagnostics for clinical use.
- 4/24/20 – The FDA has now approved a total of 40 In Vitro Diagnostics kits based on molecular analysis for commercial use.
- 4/29/20 - The NIH has launched a $1.5 billion Rapid Acceleration of Diagnostics (RADx) initiative to infuse funding into early innovative technologies to speed development of rapid COVID-19 testing and move more advanced diagnostic technologies through the development pipeline toward commercialization.
- 5/25/20 - The FDA has now approved a total of 80 In Vitro Diagnostics kits based on molecular analysis for commercial use.
- 5/22/20 - Nimble Therapeutics is collaborating with Roche Diagnostics to discover and develop novel peptide-based molecules for diagnostics of SARS-CoV-2.
Masks and Safety Equipment
The design and accessibility of protective masks and containment equipment provide valuable barriers to infectivity and disease spread. Such equipment continues to be important aspects of first-line public preparedness in the onset of an outbreak.
- 4/24/20 – Through the EUA program, the FDA has now approved 10 ventilators and other medical devices for use in patient care and clinical settings.
- 4/24/20 – The FDA has granted EUA to 10 Personal Protection Equipment (PPE) products including sterilization systems, face-shield, and respirators for emergency use.
- 5/25/20 - Through the EUA program, the FDA has now approved 21 ventilators and other medical devices for use in patient care and clinical settings.
- 5/25/20 - The FDA has granted EUA to 14 Personal Protection Equipment (PPE) products including sterilization systems, face-shield, and respirators for emergency use.
Diagnosis and Treatment
Serology Analysis and Immunity Tests
The development and deployment of serology and antibody detection kits offer critical measures in tracking infection and immunity. This is especially important in determining the extent of the human immune response following infection and the generation of long-term protective immunity.
- 4/24/20 – Four serological diagnostic kits have received authorization based on IgM, IgG, IgM and IgG, and total antibody analysis.
- 4/27/20 - Seven serology test kits have received emergency use authorization, although the FDA has begun to investigate unvalidated or suboptimal kits on the market.
- 5/2/2020 - The FDA has created a new policy pathway to support the emergency authorization of tests for SARS-CoV-2 antibodies.
- 5/22/20 - The FDA has released a list of antibody tests that no longer meet criteria for EMU under the new policy pathway.
- 5/28/20 - Two published studies now show that monkeys infected with COVID-19 develop immunity, a positive sign for vaccines.
- 5/28/20 - A recent study showed an antibody first identified in a blood sample from a patient who recovered from Severe Acute Respiratory Syndrome in 2003 inhibits related coronaviruses, including the cause of COVID-19.
Companies are focusing on coronavirus therapeutic development using a variety of approaches including: monoclonal antibodies directed towards virus antigens, small molecule virus receptor inhibitors, repurposed anti-HIV and Influenza drugs, and more.
- 4/24/20 – There are currently a total of 155 drugs under development for treating COVID-19, many of which have been previously approved for other viral infections – an indication they are safe for human use.
- 4/29/20 - A NIH clinical trial shows Remdesivir accelerates recovery from advanced COVID-19.
- 5/1/20 - The structural basis for Remdesivir mode of action in humans has been resolved.
- 5/14/20 – The NIH begins clinical trials of hydroxychloroquine and azithromycin to treat COVID-19.
- 5/15/20 - According to the World Health Organization and ClinicalTrials.gov, there are currently 1,114 ongoing clinical studies of treatments for COVID-19.
- 5/22/20 – The FDA has issued new actions to accelerate development of novel prevention, treatment options for COVID-19.
Vaccine Research Tools
Subunit vaccines can now be developed quickly due to advances in synthetic gene design. Isolation and use of antigen-presenting viral genes and peptides avoids the needs for handling live viruses and the associated safety hazards in vaccine development.
- 4/24/20 – A total of 79 vaccine candidates are under development with at least five in Phase 1 clinical testing.
- 4/24/20 – The NIH has announced the launch of Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV), a public/private partnership between government, industry, and non-profit groups to speed COVID-19 vaccine and treatment options.
- 4/24/20 – The Coalition for Epidemic Preparedness Innovations (CEPI) and the Biomedical Advanced Research and Development Authority (BARDA) are funding numerous advanced vaccine technologies, several already in human trials.
- 4/24/20 – Moderna, developer of a novel mRNA nanoparticle vaccine and the first to enter clinical testing in humans, has reached a milestone and is moving into the second round of dosing.
- 4/29/20 - There are over 90 vaccines in development and six currently in patient clinical trials
- 5/1/20 - There are now 102 vaccines in development, eight in clinical trials, and two that have shown protection against SARS-CoV-2 in non-human primates.
- 5/7/20 - Moderna has received FDA clearance to advance its COVID-19 vaccine candidate mRNA-1273 into a Phase II trial.
- 5/28/20 - AstraZeneca has partnered with the University of Oxford’s COVID-19 vaccine efforts and announced that the U.S. Biomedical Advanced Research and Development Authority (BARDA) has paid more than $1 billion to support the development, production and delivery of the vaccine
Mobile Lab Supplies
Remote point of care diagnostic kits and equipment are addressing the need for rapid testing and hospitals and clinics. Swabs, testing reagents, gowns, and personal protective equipment are all necessary for remote care.
- 4/24/20 – The development of mask disinfection devices aims to extend the life of key protective equipment, such as N-95 masks, particularly in areas in which personal protective equipment (PPE) is vitally needed for healthcare workers and essential employees.
- 4/26/20 - Studies have identified that saliva samples offer high sensitivity than traditional nasal swabs for detection of SARS-CoV-2 by RT-PCR.
- 5/8/20 - The FDA has approved the first at-home saliva collection test for coronavirus.
- 5/15/20 – Ionican PTR-TOF instruments for VOC detection by mass spectrometry are being evaluated for testing COVID-19 in breath.
- 5/28/20 - The FDA has now granted 15 EUA approvals for personal protective equipment to assist in medical care and remote triage.
- 5/28/20 - EUAs for 22 ventilators and other medical assist devices have now been granted.
Virology Lab Equipment
Research-grade PCR, RT-PCR, light and electron microsopes, microscopes accessories, sample preparation equipment and reagents, fume hoods, and more are necessities for laboratories engaged in basic virology research.
- 4/24/20 – Cutting-edge instrumentation and innovative technologies have led the way in solving the structures of key SARS-CoV-2 virus proteins, integral to novel therapeutic and vaccine development efforts.
- 5/28/20 - New targeted next-generation sequencing (NGS) technology enables a streamlined research workflow for complete viral genome sequencing and variant detection for epidemiological studies of SARS-CoV-2.
Pathogen Biosafety Tools
Handling pathogens in clinical and research settings requires the appropriate protective gear: including face shields, masks, respirators, clean suits, fume hoods, gloves, and depending on the level of security, biosafety containment equipment.
- 4/24/20 – Companies have stepped up production and availability of laminar flow workstations, microscope enclosures, and other containment devices fitted with air filtration and sterilization measures required for pathogen handling.
- 4/24/20 – The CDC has posted interim guidelines for laboratories including resources for: Sample collection and handling, real-time RT-PCR, and biosafety practices.
- 5/28/20 - The FDA issued new guidance and updated guidance to address potential shortages of face masks, surgical masks, respirators and face shields during the COVID-19 pandemic.
Prevention and Surveillance
Proper protective measures include: knowledge of virus reservoirs, early warning signs, and awareness of the most susceptible which in the case of COVID-19 include: older individuals with sepsis and chronic diseases such as hypertension, diabetes, and blood clotting disorders.
- 4/24/20 – The COVID-19 outbreak has shown that collaboration between scientists and the use of international networks are requirements for early detection and rates of disease progression.
- 4/24/20 – A new strategic plan from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, details the institute’s plan for accelerating research to diagnose, prevent and treat COVID-19.
- 5/28/20 - Researchers at Mount Sinai have developed a platform that uses artificial intelligence (AI) combined with imaging, and clinical data to analyze patients with COVID-19.
Increased disease surveillance through optimized real-time network communications will help identify initial outbreaks, and inform early responders to enact containment, social distancing, diagnostics, and treatment protocols.
- 4/24/20 – Modelling COVID-19 disease spread has been a challenge for epidemiologists, as the data and accuracy of infection reporting has been unreliable. Efforts are focused on improving the data collection process so future projections can be more accurate and informative.
- 5/4/20 - Researchers have developed a wearable device that can detect early signs and symptoms of coronavirus.
- 5/28/20 - ProMIS Neurosciences has received a Digital Technology Supercluster award from the Government of Canada for $1.8 million (CAN) for their project, “Predicting the evolution of COVID-19.”
Understanding risks and actions tied to outbreaks will allow strict avoidance and legal parameters to be defined, thereby limiting the chances for contagions to infect and spread through the population. Medical preparedness and prophylaxis will be essential for these goals.
- 4/24/20 – Preparedness is a top priority that includes no only outbreak detection and surveillance, but stockpiles of PPE, medical care infrastructure, and predictive modelling technologies to stay ahead of the infection progression.
- 5/13/20 – A recent study reviewed measures government ought to implement in order to prevent future outbreaks, including technologies designed for mass testing, contract tracing, and case isolation.
- 5/19/20 - The CDC has updated "Interim U.S. Guidance for Risk Assessment and Work Restrictions for Healthcare Personnel with Potential Exposure to COVID-19"