In this free webinar, learn about the importance of expertise at all stages of infectious disease diagnostics development. The featured speakers will discuss the value of bioinformatics in the development of infectious disease diagnostics. Attendees will learn how to successfully navigate regulatory pathways to gain market access.
TORONTO, Feb. 14, 2024 /PRNewswire-PRWeb/ -- The need for rapid, accessible and portable infectious disease diagnostics for seasonal respiratory diseases like influenza, respiratory syncytial virus (RSV) and SARS-CoV-2 is critical to saving lives. Join an informative webinar focused on in vitro diagnostic development to meet this need, ranging from assay design, the use of bioinformatics in identifying emerging pathogens and optimizing assays, and securing the necessary regulatory approvals that support market access.
Advancing novel, highly sensitive diagnostic assays for infectious diseases requires extensive research and development experience. In a post-pandemic world, as consumers expect these technologies available at point-of-care, this experience has never been more valuable. Because the symptoms of diseases like influenza, RSV and SARS-CoV-2 can be very similar, there is significant benefit in a single diagnostic that tests for the presence of multiple respiratory pathogens.
A critical early-stage step in diagnostic development is the identification of genetic markers that can be leveraged for the accurate identification of the disease. Bioinformatic analyses play a vital role in early-stage diagnostic development for broad-spectrum infectious disease diagnostics and aid in the identification of common genetic markers across various pathogens. The use of a computational approach that includes metagenomic analysis, machine learning and biomarker discovery accelerates the response to emerging infectious threats, ensuring diagnostics keep pace with evolving pathogens.
Defining the market pathway for an in vitro diagnostic device is a critical activity that should be started as early as possible in the process. Engagement with regulatory authorities can help identify special requirements that may be considered during design and verification and validation study planning, including for clinical comparator testing. This in turn can help clarify the submission and review process as well as the regulatory requirements for quality management, labeling and analytical and clinical testing that is necessary to demonstrate the safety and efficacy of the diagnostic assay.
Register for this webinar to learn how to effectively take an infectious disease diagnostic assay from initial design stages through regulatory approvals that support market access.
Join experts from MRIGlobal, Jennifer Stone, MS, Principal Scientist; Joe Russell, PhD, Principal Scientist, Group Leader — Applied Biology & Bioinformatics; and Yvette Girard, MPH, PhD, Principal Science Advisor, for the live webinar on Tuesday, March 5, 2024, at 12pm EST (5pm GMT/UK).
For more information, or to register for this event, visit Infectious Disease Diagnostics for Influenza, RSV and SARS-CoV-2.
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