Microbix & Aurevia Introduce Novel EQA Scheme

Core Insights - Microbix Biosystems Inc. and Aurevia Oy are launching a pilot external quality assessment program to enhance clinical laboratories' proficiency in diagnosing bacterial vaginosis using molecular diagnostic methods [1][3] - The program aims to provide definitive diagnoses for bacterial vaginosis and other vaginal infections, improving treatment plans and patient care [2][5] Company Overview - Microbix Biosystems Inc. specializes in creating proprietary biological products for human health, with a monthly sales target of C$ 2.0 million or more and a workforce of over 120 employees [6] - The company manufactures critical ingredients and devices for the global diagnostics industry, including antigens for immunoassays and laboratory quality assessment products [6][7] - Microbix is ISO 9001 & 13485 accredited and has a presence in over 30 countries through a network of international distributors [6] Industry Context - Bacterial vaginosis is a common condition affecting a significant percentage of women, traditionally diagnosed through less definitive methods [2] - Molecular diagnostic tests offer a more accurate means of diagnosis by distinguishing the organisms present in vaginal flora [2] - The EQA program will utilize simulated samples created by Microbix to emulate clinical specimens, ensuring safe and stable testing conditions [4][3] Program Details - The pilot program, titled "Bacterial vaginosis and vaginitis multiplex nucleic acid detection," will assess clinical labs' capabilities in diagnosing bacterial vaginosis and other vaginal infections [3] - Microbix has developed three quality assessment products (QAPs) specifically for this pilot, designed to emulate the workflow of molecular diagnostic tests [4] - Following the pilot study, an ongoing program for bacterial vaginosis is expected to be integrated into Aurevia's Labquality EQAS portfolio [3] Leadership Commentary - Aurevia's EQA Solutions Manager emphasized the importance of validating emerging molecular diagnostic tests to improve access to care and ensure accurate diagnoses [5] - The CEO of Microbix expressed pride in collaborating with Aurevia to validate next-generation diagnostic tests, aiming to support clinical labs in achieving high levels of accuracy and quality assurance [5]