Microbix to provide QAPs to Seegene for HPV assays

Executive Summary

• Microbix Biosystems Inc. and Seegene Mexico SAPI de CV have entered into a collaboration to improve the accuracy and clinical adoption of Seegene’s molecular multiplex assays for detecting high-risk human papillomavirus (HPV) in Mexico.
• Microbix will provide its external third-party quality assessment products (QAPs) to support the clinical use of Seegene’s Allplex and Anyplex HPV 28 detection assays.
• The partnership aims to facilitate rapid training and validation of new clinical sites, ensuring Mexico’s clinical laboratories meet international quality standards for HPV testing and cervical cancer surveillance.

Key Details

• Parties Involved: Microbix Biosystems Inc. (provider of QAPs and reference materials) and Seegene Mexico SAPI de CV (affiliate of South Korean diagnostics leader Seegene Inc.).
• Product Integration: Microbix QAPs (specifically REDx and PROCEEDx brands) will be used to validate and monitor the performance of Seegene’s Allplex and Anyplex HPV 28 assays.
• Assay Capabilities: The Allplex and Anyplex systems are real-time multiplexing PCR tests that identify 19 higher-risk and nine lower-risk HPV genotypes using semi-quantitative data (Ct values) to determine infection status and genotype distribution.
• Strategic Goals:
  • Ensure rigorous quality management systems for molecular HPV tests.
  • Support the launch and broad adoption of Seegene’s assays across Mexico, Central and South America.
  • Enable clinical labs to meet high international quality standards.
• Future Scope: While initially focused on HPV, Microbix intends to support Seegene assays for respiratory, sexually transmitted, and other infectious diseases.
• Company Context: Microbix reported revenues of $25.4 million in its latest fiscal year (2024) and serves approximately 100 diagnostics makers with its antigens and QAPs, which are available in over 30 countries.

Notable Quotes

• David Choi, CEO, Seegene Mexico: "We believe that expanding access to Seegene's Allplex and Anyplex HPV tests across Mexico will substantially improve public-health efforts for cervical cancer surveillance. We're pleased to collaborate with Microbix and its REDx and PROCEEDx brand QAPs to ensure the smooth implementation and broad adoption of our assays."
• Phil Casselli, SVP, Business Development, Microbix: "We're delighted to be helping Seegene Mexico with the launch and adoption of the Anyplex and Allplex platforms and their assays. Although we've initially focused on HPV molecular assays, Microbix also intends to support Seegene assays for respiratory, sexually transmitted and other infectious diseases."