Olympus and Saladax co-develop first personalised chemotherapy management (PCM) assay

Olympus Life and Material Science Europa, GMBH ??Diagnostics (Olympus) and Saladax Biomedical Inc. (SBI) have entered into a development agreement to accelerate introduction of a blood test expected to help oncologists more effectively dose 5-fluorouracil (5-FU), a widely used chemotherapy agent. The 5-FU test will enable more timely and cost-effective dosing, thereby optimising therapeutic effects and minimising toxicity among the 1.5 million patients treated annually around the world.

Pursuant to this agreement, SBI will adapt the first of a line of Personalised Chemotherapy Management (PCM) assays for quantifying the concentration of 5-FU (Rubex/Efudex/Adrucil) in cancer patients to the Olympus AU400 clinical chemistry system, while the parties finalise the terms of the non-exclusive multi-year distribution agreement.

5-FU is indicated primarily for colorectal, gastrointestinal, breast and head & neck cancers. In addition to the typically associated toxic side-effects of 5-FU such as soreness of the mouth, difficulty swallowing, diarrhoea, stomach pain, neutropenia and neuropathy, some patients face life threatening consequences from 5-FU treatment. Three to five percent of the population have an enzyme deficiency (DPD Deficiency) that is crucial for the metabolism and deactivation of 5-FU. Such patients suffer from severe side effects, even death, with smallest doses and often with the very first dose of 5-FU.

??here is a large body of published clinical evidence that managing 5-FU dosing by measuring blood concentration has a significant positive impact on response to therapy and reduction of toxic side-effects. However, today doctors have no clinical relevant tool by which to get this information. Saladax plans to launch a simple 5-FU test within the year and we are pleased by the prospect of having it offered by a highly respected and quality partner such as Olympus,??said Dr. Salvatore J. Salamone, Chairman and Chief Executive Officer of Saladax.