Microbix aids EMQN on genetic-test dosing program

Executive Summary

• Microbix Biosystems Inc. has partnered with EMQN CIC to launch a second-generation External Quality Assessment (EQA) program for point-of-care testing (POCT) of the CYP2C19 gene variant.
• The program aims to improve patient safety by ensuring accurate genotyping for patients taking Clopidogrel (Plavix), helping to prevent adverse events like bleeding or blood clots caused by incorrect dosing due to metabolic variations.
• Microbix is supplying proprietary Quality Assessment Products (QAPs) formatted on Copan FLOQSwabs to participating laboratories to validate their testing proficiency.

Key Details

• Partnership: Microbix Biosystems Inc. and EMQN CIC have arranged a go-live program for the new EQA scheme.
• Target Condition: The program focuses on detecting clinically-relevant variants of the Cytochrome P450 CYP2C19 liver enzyme gene.
• Clinical Significance:
  • Over 20% of persons carry gene variants affecting drug metabolism.
  • Slower metabolic clearance can lead to overdosing and life-threatening internal bleeding.
  • Faster metabolic clearance can lead to underdosing, reducing drug effectiveness and increasing the risk of life-threatening blood clots.
• Product Details:
  • Microbix-produced QAPs are formatted onto Copan FLOQSwabs.
  • Participants receive three samples every two months (18 samples per year).
  • The program code is POCT CYP2C19.
• Market Context:
  • Over 15 million prescriptions for Clopidogrel are written in the United States annually.
  • The program is available to U.K. and international labs.
• Company Status: Microbix notes this is their second entry into supporting genetic test accuracy, complementing their existing presence in infectious diseases and oncology.

Notable Quotes

• Sean Sales, Operations Director at EMQN: "It's been a pleasure to have Microbix's assistance in making QAPs for this groundbreaking and important new POCT EQA program. Physicians and pharmacists need information to be able to rapidly evaluate the risk-benefit of antiplatelet treatments, and no patient should be put at risk of life-threatening bleeding or clots due to inappropriate dosing."
• Sydney Rivers, Product Manager at Microbix: "We're pleased to help create EQA for this clinically important testing. Our expertise joins that of EMQN and Copan to ensure optimal treatment is available for patients worldwide. These QAPs are Microbix's second entry into supporting the accuracy of genetic tests, adding to our established presence in infectious diseases and emerging role in oncology."