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Saladax Gets Canadian Approval for Chemotherapy Monitoring Test

NEW YORK — Saladax Biomedical, a developer of therapeutic drug monitoring technologies, said Tuesday that its 5-fluorouracil (5-FU) assay has been approved by Health Canada.

5-FU is a chemotherapeutic used to treat a range of malignancies including breast, colon, rectum, and stomach cancers that can cause various adverse effects that require patient monitoring such as neutropenia, pulmonary embolism, and thrombocytopenia.

According to Saladax, 5-FU infusions are dosed using a method — developed more than 100 years ago — based on body surface area, which does not account for individual differences in patients or measure blood levels of the drug.

Saladax's test measures blood levels of 5-FU using a single blood sample obtained during a chemotherapy cycle and can run on existing clinical laboratory analyzers, the Bethlehem, Pennsylvania-based company said. In addition to Canada, it is cleared for use in the EU, China, the UK, and Israel.

"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," Saladax CEO Salvatore Salamone said in a statement. "The use of real-time blood levels to guide 5-FU therapy management is a critical step forward."