SARS-CoV-2

CDC Traveler-based Genomic Surveillance Program to Expand to Two New US International Airports in Miami and Chicago

Retrieved on: 
Tuesday, March 12, 2024
Miami International Airport, Genomics, Federation, Traveler, Pneumonia, JFK, Mycoplasma pneumoniae, Partnership, COVID-19, DNA, MIA, Bacteria, SARS-CoV-2, RSV, Ginkgo Bioworks, Biosecurity, Mycoplasma, CDC, Airport, TGS, Collection, Federal, Vaccine

This expanded funding will also bring the number of airports in the program to a total of nine active sites: Los Angeles, San Francisco, New York (JFK), Washington Dulles, Newark, Boston, Seattle, Miami, and Chicago.

Key Points: 
  • This expanded funding will also bring the number of airports in the program to a total of nine active sites: Los Angeles, San Francisco, New York (JFK), Washington Dulles, Newark, Boston, Seattle, Miami, and Chicago.
  • Since its inception in September 2021, the TGS program has demonstrated its ability to serve as an early detection mechanism for new pathogens and fill gaps in global biosurveillance.
  • In October 2023, the program expanded to cover a list of more than 30 viral and bacterial targets.
  • “We are thrilled to have the opportunity to take the TGS program to the next level.

QuidelOrtho Receives FDA 510(k) Clearance for Its QuickVue® COVID-19 Test

Retrieved on: 
Tuesday, April 2, 2024
Medical Supplies, FDA, Health, Infectious Diseases, COVID-19, General Health, VZV, Ageing, Food and Drug Administration, Research, Sale, Virus, SARS-CoV-2, Laboratory, CLIA, Multimedia, Data, Marketing, QuidelOrtho, Food

QuidelOrtho Corporation (Nasdaq: QDEL) (“QuidelOrtho" or the “Company”) has received U.S. Food and Drug Administration (“FDA”) 510(k) clearance for its QuickVue COVID-19 test.

Key Points: 
  • QuidelOrtho Corporation (Nasdaq: QDEL) (“QuidelOrtho" or the “Company”) has received U.S. Food and Drug Administration (“FDA”) 510(k) clearance for its QuickVue COVID-19 test.
  • This clearance allows the test to be used with accuracy and convenience in home and medical facility settings with CLIA certificates of waiver.
  • For healthcare providers, comprehensive instructions for use accompany the QuickVue COVID-19 test, facilitating seamless integration into existing diagnostic protocols.
  • QuidelOrtho secured FDA 510(k) clearance in December 2023 for its Savanna PCR platform and Savanna HSV 1+2/VZV PCR assay.

Syndromic Multiplex Panels Market Research Report 2024: Global Analysis, Strategies, Trends and Forecasts to 2028 with Executive Guides - ResearchAndMarkets.com

Retrieved on: 
Friday, March 29, 2024
Medical Supplies, Medical Devices, Health, Technology, Infectious Diseases, Health Technology, PCR, Disease, POCT, SARS-CoV-2, RSV, DTC, BioMérieux, STI, Live

5.2.3 Infectious Disease is Declining But..

Key Points: 
  • 5.2.3 Infectious Disease is Declining But..
    5.2.5 Economic Growth improves Living Standards.
  • 5.3.14 Syndromics drives POCT adoption.
  • 6.2 BioMerieux Submits Application for Respiratory, Sore Throat Panel
    6.8 Altratech to Enter MDx, POC Space by Supplanting PCR
    6.21 Quidel Gains CE Mark for Savanna Analyzer, Respiratory Panel
    6.26 Binx Health Targeting Clinics, DTC & OTC With STI Tests
    6.27 Luminex Lands BARDA Grant to Develop Test for SARS-CoV-2, Flu, RSV
    6.29 MiRxes Receives Approval for Multiplex SARS-CoV-2, Flu Test

Tevogen Bio Reports Its Investigational SARS-CoV-2 Specific T Cell Therapy, TVGN-489, Retains Activity Against the Dominant JN.1 Variant

Retrieved on: 
Wednesday, March 20, 2024
COVID-19, Research, Clinical Trials, Biotechnology, Health, Pharmaceutical, General Health, Other Science, Science, TVGN, COVID, Mutation, Immunotherapy, Patient, DNP, SARS-CoV-2, Genome, Peptide

Tevogen Bio Holdings ('Tevogen Bio') ( Nasdaq : TVGN ), today announced TVGN 489, its investigational allogeneic SARS-CoV-2 specific Cytotoxic CD8+ T lymphocytes (CTLs) immunotherapy for treatment of COVID-19 in high-risk patients and Long COVID, retains activity against the currently dominant and highly mutated JN.1 strain based on a review of this variant’s protein sequences.

Key Points: 
  • Tevogen Bio Holdings ('Tevogen Bio') ( Nasdaq : TVGN ), today announced TVGN 489, its investigational allogeneic SARS-CoV-2 specific Cytotoxic CD8+ T lymphocytes (CTLs) immunotherapy for treatment of COVID-19 in high-risk patients and Long COVID, retains activity against the currently dominant and highly mutated JN.1 strain based on a review of this variant’s protein sequences.
  • TVGN 489 contains Cytotoxic T lymphocytes that recognize multiple SARS-CoV-2 proteins, or peptides.
  • TVGN 489’s peptide targets have been preserved in all previously studied COVID strains.
  • Continuing surveillance by Tevogen Bio of SARS-CoV-2 variants, including the currently dominant JN.1 strain and newer JN.1 strains, show that 96% of these CTLs remain active against the current circulating variants.

Dr. Jody Douglas Berry Joins NOWDiagnostics as Chief Scientific Officer

Retrieved on: 
Thursday, March 14, 2024
Infectious Diseases, Biotechnology, Health, COVID-19, De novo, DPA, Growth, RBD, OraSure Technologies, Syphilis, Cangene, Research, Public Health Agency, HHS, SARS-CoV-2, National Microbiology Laboratory, Infection, Congenital syphilis, Therapy, CSO, FDA, Government, Pharmaceutical industry

NOWDiagnostics (NOWDx) today announced the appointment of Jody Douglas Berry, Ph.D. as chief scientific officer (CSO).

Key Points: 
  • NOWDiagnostics (NOWDx) today announced the appointment of Jody Douglas Berry, Ph.D. as chief scientific officer (CSO).
  • Dr. Berry, a distinguished scientific leader with over two decades of experience in infectious diseases, brings a wealth of expertise in diagnostics and therapeutics to the role.
  • A recognized international expert in immunoassay development, antibody technology, and infectious diseases, Dr. Berry has over two decades of commercial, government and academic experience.
  • Dr. Berry earned international recognition for his contributions to immunoassay development, antibody technology, and protein design.

Inhalon Biopharma Announces Two Publications Advancing its Inhaled Antibody Treatment Platform for Acute Respiratory Infections

Retrieved on: 
Thursday, March 14, 2024
Health, Infectious Diseases, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Human, Infection, Bronchiolitis, Risk, Viral load, COVID-19, Inflammation, Lung, PIV, SARS-CoV-2, RSV, IND, Antibody, Omicron, Biological engineering, Translational medicine, Vaccine, Animal, Advanced Science

Inhalon Biopharma (Inhalon), a clinical-stage company advancing a proprietary inhaled antibody platform for treating acute respiratory infections, today announced the publication of preclinical data showcasing the advantages and efficacy of its “muco-trapping” technology in animal models of respiratory syncytial virus (RSV) and SARS-CoV-2 infections.

Key Points: 
  • Inhalon Biopharma (Inhalon), a clinical-stage company advancing a proprietary inhaled antibody platform for treating acute respiratory infections, today announced the publication of preclinical data showcasing the advantages and efficacy of its “muco-trapping” technology in animal models of respiratory syncytial virus (RSV) and SARS-CoV-2 infections.
  • “Inhalon’s approach rethinks the use of antibodies for the treatment of acute respiratory infections by delivering antibodies directly to the site of the infection,” said John Whelan, president and chief executive officer, Inhalon Biopharma.
  • “Our studies in Advanced Science and in Bioengineering and Translational Medicine demonstrate the exceptional effectiveness of our inhaled antibody platform, which offers the potential to treat a wide array of acute respiratory infections.
  • With the support of the USAMRDC, Inhalon has begun preclinical activities and manufacturing to advance this candidate into the clinic in 2025.

FDA Roundup: March 22, 2024

Retrieved on: 
Friday, March 22, 2024
Health, Capecitabine, PFAS, FCN, Dietary supplement, OCE, Risk, COVID-19, Patient, Warning, Tablet, Public, RNA, DNA, Animal, News, Plasma protein binding, Emergency Use Authorization, Human services, Role, System, SARS-CoV-2, Physical examination, Plasmodium vivax, Plasmodium falciparum, Highlight, Malaria, Heated tobacco product, CFR, Vaccination, Safety, DPD, Cosmetics, Growth, Vaccine, Plasmodium ovale, Marketing, Food, FDA, Multimedia, Ponatinib

On Thursday, the FDA updated the Breakthrough Devices Program webpage to update the device designations data and the marketing authorizations list.

Key Points: 
  • On Thursday, the FDA updated the Breakthrough Devices Program webpage to update the device designations data and the marketing authorizations list.
  • From launch of the Breakthrough Devices Program through December 31, 2023, in total, the FDA granted 933 Breakthrough Devices designations and authorized 95 Breakthrough Devices for marketing.
  • On Thursday, the FDA approved safety labeling changes for fluorouracil injection products.
  • These changes also enable the FDA to more effectively respond to new information on the safety and use of food contact substances.

Circadia Health, Cleveland Clinic Research Collaboration Shows Predictive Power of Continuous Respiratory Monitoring in Prediction of Clinical Deterioration in COVID-19

Retrieved on: 
Wednesday, March 13, 2024
Research, COVID-19, Vital signs, Respiratory rate, Patient, C100, University, SARS-CoV-2, Infection, Cleveland Clinic, Outcome, LOS, FDA, Outcomes research, Health, Frontiers in Medicine

LOS ANGELES, March 13, 2024 /PRNewswire-PRWeb/ -- Continuous monitoring of respiratory rate of patients admitted with Covid-19 using contactless technology demonstrates the ability to predict those at high risk of clinical deterioration up to 24 hours in advance, in a study recently published in Frontiers in Medicine (https://doi.org/10.3389/fmed.2023.1243050).

Key Points: 
  • The study, conducted in collaboration with the Cleveland Clinic, demonstrates Circadia Health's C100 system's ability to offer continuous, contactless respiratory monitoring, predicting clinical deterioration 24 hours in advance and enhancing patient care.
  • In a landmark study, a collaboration between Circadia Health, Cleveland Clinic, and the University of Barcelona utilised the Circadia Health C100 system to monitor patients with respiratory symptoms of SARS-CoV-2 (COVID-19) severe enough to warrant admission to hospital.
  • The C100 system provides continuous respiratory rate monitoring without the need for patient contact, providing respiratory rate data every three seconds.
  • The standard vital sign relating to respiratory function, intermittent respiratory rate measurement, was not predictive of subsequent decline.

Study Links Key Gene to Protection from Severe Illness and Death From Covid Infections in Men Under Age 75

Retrieved on: 
Wednesday, March 13, 2024
Inflammation, Gene, Brain, Letter, Internal medicine, Rheumatoid arthritis, COVID-19, NYU Langone Health, Infection, Disease, Abramson, Risk, Patient, APG system, Journal, Research, IL1, Factorization of polynomials, Canakinumab, NYU, Death, Doctor of Philosophy, SARS-CoV-2, Attur, Salem, Arthritis, Woman, Male, MPH, National Institutes of Health, IL1RN, Vasopressin receptor 2, Bangladesh Technical Education Board, Fatigue, Blood, Viral, Hospital, Pharmaceutical industry

NEW YORK, March 13, 2024 /PRNewswire/ -- A certain variant of a key anti-inflammatory gene protects men under age 75 from severe illness and death when hospitalized from Covid-19, a genetic analysis of their blood shows.

Key Points: 
  • NEW YORK, March 13, 2024 /PRNewswire/ -- A certain variant of a key anti-inflammatory gene protects men under age 75 from severe illness and death when hospitalized from Covid-19, a genetic analysis of their blood shows.
  • According to the study authors, the protective gene in question, an interleukin-1 receptor antagonist (IL1RN) variant, appears to tamp down inflammation.
  • Overall, more men than women (240 men, at 60.5%; and 157 women, at 39.5%) died from their disease, with women 20% less likely to die than men.
  • Funding support for this study was provided by National Institutes of Health grants P30CA016087 and R21AR078466.