Core Insights - Microbix Biosystems Inc. and Labquality Oy have launched a new external quality assessment (EQA) program aimed at improving the accuracy of clinical laboratories in identifying head and neck cancers associated with HPV [1][4] Group 1: Industry Context - Head and neck cancers (HNCs) are increasingly common, particularly in males, with over 300,000 cases diagnosed annually in North America and Western Europe, representing about 4% of all cancers [2] - Accurate identification of HPV-driven HNCs is crucial as these patients have better prognoses, influencing treatment decisions [2] Group 2: EQA Program Details - The EQA program was developed to address the lack of proficiency checks for clinical labs working with FFPE samples, which are used for diagnosing HNCs [3] - Microbix created QAPs™ that mimic HNC patient samples, containing both IHC and PCR targets, to support the EQA program [5] - A pilot study involving 32 clinical laboratories revealed significant discrepancies in p16 IHC staining protocols, highlighting the need for improved diagnostic accuracy through reflex testing [4] Group 3: Company Profiles - Microbix Biosystems Inc. specializes in creating biological products for human health, with revenues targeting C$ 2.0 million or more per month and a focus on the global diagnostics industry [7] - Labquality Oy provides EQA services to over 8,000 customers in more than 60 countries, emphasizing quality in clinical laboratories and point-of-care testing [9]

Core Viewpoint - Microbix Biosystems Inc. has entered into a multi-year agreement with the National Center for Infectious and Parasitic Diseases of Bulgaria (NCIPD) to develop new quality assessment products (QAPs™) using pathogen seedstocks supplied exclusively by NCIPD, aiming to enhance the accuracy of diagnostic tests for infectious diseases [1][2]. Company Overview - Microbix Biosystems Inc. is a life sciences innovator with nearly 40 years of experience in producing biological ingredients, particularly QAPs, which are critical for validating diagnostic tests [4][6]. - The company employs over 120 skilled workers and targets sales of C$ 2.0 million or more per month, exporting products to over 30 countries [6][8]. Partnership Details - The agreement with NCIPD includes a license fee, material-transfer fees, and royalties on net sales of related QAPs, allowing Microbix to commercialize multiple new QAPs that will support the accuracy of tests for diagnosing infectious diseases [2][5]. - NCIPD, established in 1881, is recognized as a leading institution in the field of infectious and parasitic diseases and has developed an extensive collection of characterized microorganisms [3][5]. Product Development - Microbix currently offers approximately 300 QAPs and expects to significantly increase this number through the collaboration with NCIPD, which will provide inactivated and stabilized mimetics of patient samples for test validation [4][2]. - The collaboration aims to ensure the accuracy of emerging tests for bacterial, parasitic, and viral infections, thereby improving global health outcomes [2][5].

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]