Microbix Biosystems rolls out QAPs for H3N2 flu testing

Executive Summary

• Microbix Biosystems Inc. has commercially launched new Quality Assessment Products (QAPs) and QUANTDx reference materials specifically designed to support antigen and molecular testing for H3N2 strains of seasonal influenza A.
• The launch addresses the emergence of the H3N2 subclade K variant, which is expected to dominate the 2025/2026 flu season and poses challenges for test accuracy due to antigenic drift.
• The new products include respiratory QAPs formulated with H3N2, available on Copan FLOQSwabs, which offer multiyear room-temperature stability and complement existing H1N1 formulations to create a comprehensive four-plex portfolio.

Key Details

• Product Launch: Commercial launch of QAPs and QUANTDx reference materials for H3N2 influenza A strains.
• Target Variant: Specifically formulated for the emerging H3N2 subclade K, which is linked to an early start of the 2025/2026 flu season in the northern hemisphere.
• Product Specifications:
  • QAPs: Available on Copan FLOQSwabs; provide multiyear room-temperature stability.
  • Variants: Users can select PROCEEDx (research use only) or REDx (in vitro diagnostic) variants.
  • Usage: Used for training personnel, validating new testing sites, and verifying instrument/assay performance.
• QUANTDx Reference Materials:
  • Well-characterized, accurately quantified, and fully traceable.
  • Enable assay developers to establish key analytical performance metrics including Limit of Detection (LoD), sensitivity (positive accuracy), and specificity (negative accuracy).
  • Essential for validation and regulatory submissions.
• Market Context: H3N2 is prone to antigenic drift, which can reduce the accuracy of antigen test assays and affect disease management and treatment decisions.
• Company Background: Microbix has over 120 employees, generated $25.4 million in revenue in fiscal year 2024, and holds ISO 9001, ISO 13485, FDA, TGA, and Health Canada registrations.

Notable Quotes

• "We believe it's critical that Microbix creates QAPs for emerging infectious diseases in a timely manner. Effective public health responses to all outbreaks are predicated on accurate and reliable, tracking, screening and diagnosis -- needs that are imperiled when quality management tools to support testing aren't readily available. It is Microbix's privilege to be a Canadian-led company that is improving health care outcomes worldwide with Ontario-made products." — Cameron Groome, CEO and President