The blood test is now approved in Canada, China, the European Union, the UK, and Israel. Credit: Salov Evgeniy/Shutterstock.com.

Saladax Biomedical has received approval from Health Canada for the 5-Fluorouracil (5-FU) therapeutic drug monitoring (TDM) test, known as My5-FU Assay, for use in Canada.

Completed in six days, this rapid approval emphasises the critical need for precise dosing in chemotherapy treatments using 5-FU.

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The test aims to optimise patient care by ensuring accurate drug dosage, thereby improving efficacy and reducing toxicity.

The medical community has expressed concerns over the traditional dosing method for 5-FU, which is based on Body Surface Area (BSA), and does not account for individual patient differences.

Studies have shown that this can lead to incorrect dosing for most patients.

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Currently in use in several countries, the My5-FU test allows for patient-specific dose adjustments, aligning with pharmacology guidelines that advocate for TDM in 5-FU treatments.

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Saladax’s My5-FU Assay enables healthcare professionals to measure and adjust 5-FU levels with a single blood sample during a chemotherapy cycle. It is compatible with existing clinical laboratory analysers.

This test is now approved in Canada, China, the EU, the UK, and Israel.

Saladax CEO Salvatore Salamone said: “It’s imperative that we move away from the assumption that a patient receives the appropriate 5-FU dose based on a one-size-fits-all approach, which is often not the case.

“The use of real-time blood levels to guide 5-FU therapy management is a critical step forward.”

Saladax Biomedical is engaged in developing, manufacturing, and marketing assays that provide rapid therapeutic drug levels for essential and life-saving medicines, which are prescribed by psychiatrists and oncologists.