Microbix Collaborator Introduces New Lab Accreditation Program

Microbix Product Supporting Testing for Drug-Resistant Sexually-Transmitted Infection

MISSISSAUGA, Ontario, April 25, 2024 (GLOBE NEWSWIRE) -- Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix), a life sciences innovator, manufacturer, and exporter, announces that Labquality Ltd., a collaborator and customer, is presenting results of its use of Microbix Quality Assessment Products (“QAPs”) for accreditation of clinical labs for conducting molecular (“MDx”) tests for antimicrobial-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% 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 (e.g., 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 & 4 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 & 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.