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.

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.