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.

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.