Mr. Cameron Groome reports

MICROBIX COLLABORATOR INTRODUCES NEW LAB ACCREDITATION PROGRAM

Labquality Ltd., a collaborator and customer of Microbix Biosystems Inc., will release results of its use of Microbix quality assessment products (QAPs) for accreditation of clinical labs for conducting molecular (MDx) tests for anti-microbial-resistant (AMR) strains of M. genitalium (Mgen), a common sexually transmitted infection (STI).

The poster presentation of results will be made at ECCMID 2024, the European Congress of Clinical Microbiology and Infectious Diseases, taking place in Barcelona, Spain, from April 27 to 30, 2024. The poster is titled "Mycoplasma genitalium, Drug Resistance, Nucleic Acid Detection; Introducing a New External Quality Assessment Scheme" and was authored by scientists from both Labquality and Microbix.

Mgen is a common STI in both men and women who have been sexually active. Left untreated, Mgen is known to cause chronic health problems in women, such as chronic pain, ectopic pregnancy, infertility and pelvic inflammatory disease, and non-gonococcal urethritis in men. As many as 50 per cent of Mgen infections can be resistant to first-line antibiotic treatments. Tests for Mgen were not commonly conducted until the past several years, in part due to the unavailability of controls (such as QAPs) to assess and validate the accuracy of tests for antibiotic-susceptible and AMR strains of this bacteria.

As testing for Mgen and AMR Mgen infections becomes more widespread, external quality assessment (EQA) programs are needed to evaluate the proficiency of clinical labs and provide them accreditation to test patient samples. The poster presents results of a Labquality program evaluating the proficiency of 38 clinical labs in their use of 16 different MDx assays (12 commercial and four lab-developed). Each clinical lab was evaluated for its ability to detect (i) Mgen, and (ii) an Mgen-related marker of resistance to macrolide antibiotics. It was found that (i) the Microbix Mgen QAPs (positives and negatives) were well suited for this usage; (ii) the performance of labs and assays was excellent; (iii) specific reporting guidelines are needed to avoid errors; and (iv) there is a need for such an EQA program to support Mgen testing.

Microbix developed its Mgen QAPs to resemble patient specimens, support the whole testing process and contain all possible MDx test targets -- buffered and desiccated onto a Copan FLOQSwab to ensure multiyear product stability at room temperature. The pilot EQA program confirmed the performance of these QAPs across all clinical labs, instrument platforms and assays. These Mgen QAPs are now available from Microbix as part of its PROCEEDx FLOQ (RUO) or REDx FLOQ (IVD) catalogue of products.

Enquiries regarding the EQA program being developed by Labquality to qualify and support clinical laboratories in molecular testing for Mgen and AMR Mgen should be directed to Kati Luiro, EQA co-ordinator, at kati.luiro@labquality.com, info@labquality.com or via its website. Purchase enquiries for these or other Microbix QAPs can be e-mailed to customer.service@microbix.com.

About Microbix Biosystems Inc.

Microbix Biosystems creates proprietary biological products for human health, with over 100 skilled employees and annualized revenues approaching $2-million per month. It enables the worldwide commercialization of diagnostic assays by making a wide range of critical ingredients and devices for the global diagnostics industry, notably antigens for immunoassays and its laboratory quality assessment products (QAPs) that support clinical lab proficiency testing, enable assay development and validation, or help ensure the quality of clinical diagnostic workflows. Its antigens drive the antibody tests of approximately 100 diagnostics makers, while QAPs 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 13485 accredited, U.S. Food and Drug Administration registered, Australian Therapeutic Good Administration registered, and Health Canada establishment licensed, and provides CE marked products.

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