Diagnostic Test That Measures 5-Fluorouracil Now Available in Spain, Portugal

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(Chemotherapy Advisor) – Measuring blood levels of the widely-used anti-cancer drug 5-fluorouracil (5-FU) just got a lot easier for oncologists in Spain and Portugal. Bethlehem, Pennsylvania–based Saladax Biomedical, Inc., announced on March 12 that it had just reached a distribution agreement with INyDIA Labs (Madrid, Spain) to distribute its test for 5-FU called My5-FU. INyDIA Labs, which specializes in producing in vitro diagnostic reagents and instrumentation, will be the exclusive provider of the test in Spain and Portugal; the test is already available in North America under the name OnDose, and in the European Union. 5-FU is used to treat many solid tumors, including colorectal cancer.

The test is composed of a competitive, homogeneous, nanoparticle-based immunoassay method, followed by quantitative, spectrophotometric readout on an automated clinical chemistry analyzer. There are two reagents in the assay kit, with the first being a 5-FU conjugate and the second, a 5-FU-directed, antibody-conjugated nanoparticle. Free 5-FU in the patient's serum competes with reagent 1, thereby inhibiting aggregation of the two assay reagents. Amount of light absorbance upon readout is related to the amount of free 5-FU in the patients' serum.

The agreement between Saladax Biomedical and INyDIA Labs will enable oncologists in Spain and Portugal to provide more personalized treatment to their cancer patients. My5-FU is Saladax's first commercially available test for the determination of optimal therapeutic dose. This determination enables oncologists to determine not only the optimal dose of 5-FU to use in their patients, but also to minimize the risk of toxicity and severe side effects.

OnDose Technical Specifications (PDF)

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