Microbix Teams Up with EMQN for Improved Genetic Testing
In a significant collaboration, Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF), a frontrunner in life sciences innovation, is joining forces with EMQN CIC, a leader in laboratory external quality assessment (EQA) schemes for genomic testing. Together, they are rolling out an essential program aimed at aiding healthcare professionals in identifying patients who possess gene variants affecting the metabolism of the widely-used antiplatelet medication Clopidogrel.
Understanding the Importance of Genetic Testing
This innovative EQA program focuses on the proficiency of Point-of-Care Tests (POCTs) that screen for three critical variants of the Cytochrome P450 CYP2C19 liver enzyme gene – specifically *2 or *3 loss-of-function and *17 enhanced-function variants. These genetic variations play a pivotal role in determining how efficiently a patient metabolizes Clopidogrel, with over 20% of the population carrying these variants.
Implications of Genetic Variants in Medication Response
Correct dosing of Clopidogrel is vital for patient safety. Individuals with variants leading to slower metabolism may experience an increased risk of life-threatening internal bleeding if overdosed. Conversely, those with faster metabolism may not receive enough of the medication, heightening the likelihood of serious cardiovascular events, such as blood clots. As clinical decisions often hinge on timely diagnosis, the role of POCT-based genotyping becomes critical in managing antiplatelet therapy effectively.
The Scope of Antiplatelet Therapy
Antiplatelet drugs like Clopidogrel are routinely prescribed to individuals at risk of serious conditions such as heart attacks, strokes, and pulmonary embolisms. In the United States alone, over 15 million Clopidogrel prescriptions are issued each year. As such, pharmacogenomic POCTs are essential tools for managing medication dosing, ensuring that patients receive the right amount of the drug, thereby mitigating the risks related to improper dosing.
Quality Assessment Products in Action
The quality assessment products (QAPs™) manufactured by Microbix play a fundamental role in this EQA initiative. Delivered on Copan FLOQSwabs, these QAPs facilitate ongoing monitoring of proficiency and accuracy in genetic testing laboratories participating in the EMQN EQA program. Each subscription provides three samples bi-monthly, totaling 18 samples annually, to help ensure laboratories maintain high testing standards.
Expert Insights on the EQA Program
Sean Sales, Operations Director at EMQN, expressed enthusiasm for the partnership, stating, “Microbix's contributions in developing QAPs for this groundbreaking POCT EQA program are invaluable. Rapid access to precise information is crucial for healthcare providers to assess the risks and benefits associated with antiplatelet treatments effectively.”
Similarly, Sydney Rivers, Product Manager at Microbix, noted, “We are thrilled to support EMQN in enhancing the accuracy of this essential testing. Our teamwork ensures optimal treatment options are available for patients worldwide, marking Microbix's continued commitment to supporting the genetic testing field alongside our work in infectious diseases and oncology.”
Joining the EQA Program
Laboratories across the UK and internationally are welcome to enroll in this vital EQA program (code POCT CYP2C19) via EMQN CIC. This initiative highlights Microbix's dedication to quality in genetic testing while providing labs with the resources necessary to deliver safe and effective patient care.
About EMQN CIC
Located in Manchester, EMQN specializes in offering quality assurance tools and expert guidance within the human genomic testing domain through established EQA schemes. Their focus on quality helps to enhance molecular diagnostic procedures and ensures high levels of analytical performance. The organization's commitment to excellence is reflected in their accreditation by the UK Accreditation Service.
About Microbix Biosystems Inc.
Microbix is dedicated to creating proprietary biological products aimed at improving human health. With a skilled team of over 120 employees generating revenues of C$ 2 million or more monthly, it produces critical components for the global diagnostics industry, including antibodies for immunoassays and QAPs supporting clinical lab EQA. Microbix is ISO 9001 & 13485 accredited and its products are compliant with various international health standards, reinforcing its commitment to quality and safety in diagnostic testing.
Frequently Asked Questions
What is the purpose of the new EQA program by Microbix and EMQN?
The EQA program is designed to support accurate identification of patients with gene variants that affect their metabolism of Clopidogrel, ensuring safer and more effective treatment decisions.
How often do laboratories receive test samples in this program?
Participating laboratories will receive three test samples bi-monthly, totaling 18 samples each year for proficiency assessment.
What are the implications of genetic variants related to Clopidogrel metabolism?
Genetic variants can significantly affect how patients metabolize Clopidogrel, leading to risks of overdosing or under-dosing, which can cause serious health issues.
Who can enroll in the EQA program?
Both UK and international laboratories are eligible to enroll in the EQA program to enhance their testing accuracy and efficacy.
What distinguishes Microbix in the diagnostics industry?
Microbix stands out for its innovative quality assessment products and commitment to supporting clinical labs, bolstered by strong international distribution and compliance with health standards.
