Mr. Phil Casselli reports

MICROBIX & SEEGENE MEXICO COLLABORATE TO IMPROVE TEST ACCURACY

Microbix Biosystems Inc. and Seegene Mexico SAPI de CV, a firm focused upon transforming molecular diagnostics with innovative multiplex solutions, will use Microbix external third party quality assessment products (QAPs) to support the clinical use of the Allplex and Anyplex molecular multiplex assays of Seegene Mexico for detecting infection with high-risk types of the human papilloma virus (HPV).

HPV is a family of approximately 100 related viruses, and most people will be infected with one or more types over their lifetime. Infections with lower-risk types of HPV can lead to warts, while chronic infection with high-risk types of HPV can cause cancers, most notably cervical cancer. Molecular assays to detect infection with HPV provide important preventive health information years in advance of pathology-based methods such as the Pap test. However, molecular tests require rigorous and continuing quality management systems (including QAPs) to ensure the integrity of their workflows and resulting accuracy.

Core to Seegene Mexico are the Allplex and Anyplex HPV 28 detection assays -- real-time multiplexing PCR (polymerase chain reaction) tests that identify 19 higher-risk and nine lower-risk HPV genotypes. Using semi-quantitative data (that is, Ct values), the Allplex HPV 28 also provides information on infection status and genotype distribution. In turn, the HPV HR detection assays on the two systems enable the detection of each higher-risk HPV type.

Seegene Mexico is the national affiliate of Seegene Inc., a multinational diagnostics company based in South Korea that is a leader in the development and commercialization of multiplex PCR molecular tests. Seegene and its affiliates are deeply engaged with improving screening for HPV infection and resulting cervical cancers across Mexico, throughout Central and South America, and globally.

Use of HPV-focused QAPs will help ensure training and validation of new sites is rapid and optimal, while their ongoing use will enable Mexico's clinical labs to meet the highest international quality standards.

David Choi, chief executive officer at Seegene Mexico, commented: "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. Seegene remains committed to supporting clinical laboratories through continuous training and strengthening their quality management systems, not only for HPV testing but also for the diagnosis of a wide range of infectious diseases."

Phil Casselli, senior vice-president, business development, at Microbix, also commented: "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."

About Microbix Biosystems Inc.

Microbix creates proprietary biological products for human health, with over 120 skilled employees and revenues of $25.4-million in its latest fiscal year (2024). It makes and exports a wide range of critical ingredients and devices for the global diagnostics industry, notably antigens for immunoassays and its laboratory quality assessment products (QAPs) and reference materials (QUANTDx) supporting POCT (point-of-care testing) and clinical lab EQA (external quality assessment), enabling assay development and validation, or helping ensure the quality of clinical diagnostic workflows. Its antigens drive the tests of approximately 100 diagnostics makers, while QAPs or QUANTDx are sold to clinical lab accreditation organizations, diagnostics companies, and clinical labs. Microbix QAPs are now available in over 30 countries, supported by a network of international distributors. Microbix is ISO 9001 and ISO 13485 accredited, U.S. FDA (Food and Drug Administration) registered, Australian TGA (Therapeutic Goods Administration) registered and Health Canada establishment licensed, and it provides IVDR-compliant (In Vitro Diagnostic Medical Devices Regulation) CE-marked (Conformite Europeenne) products.

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