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Saladax’s new chemotherapy assay receives CE mark

Saladax Biomedical has received CE mark registration in the EU for its 5-FU Personalized Chemotherapy Management assay on the Olympus AU400 clinical chemistry analyzer.

For European oncologists who prescribe 5-fluorouracil (5-FU) continuous infusion regimens alone or in combination (eg Folfox and Folfiri) for colorectal, stomach, breast, and pancreatic cancers, this simple, evidence-based blood test will show patients’s actual plasma 5-FU levels for individualized dosing.

Recently, results from a Phase III randomized study compared colorectal cancer patients who were dosed with 5-FU based on the current standard dosing method with patients whose dose was adjusted based on the actual concentration of 5-FU in the patients’ blood plasma.

The study showed that response rates among monitored patients doubled, two-year overall survival improved by 48%, Only 25% of body surface area dosed patients were in the target range to receive the optimal therapeutic benefit, 58% of patients were found to be under-dosed and had doses adjusted upward and 17% were found to be over-dosed, increasing the risk of severe side effects.

Salvatore Salamone, CEO of Saladax Biomedical, said: “Access to this simple blood test will arm oncologists with the ability to individualize 5-FU dosing to ensure patients receive the optimal benefit from their treatment.”