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New Data Demonstrates 5-FU Personalized Chemotherapy Management (PCM(R)) Assay Provides Similar Performance to More Complicated Liquid Chromatography-Mass Spectrometry (LC-MS/MS)
Date:6/23/2008

BETHLEHEM, Pa., June 23 /PRNewswire/ -- A new blood test may make it easier for oncologists to accurately measure and personalize 5-fluorouracil (5-FU) dosing for patients undergoing continuous infusion chemotherapy regimens. Data from a multicenter trial showed that a nanoparticle-based immunoassay from Saladax Biomedical, called 5-FU Personalized Chemotherapy Management (PCM(R)), performed as well as high performance liquid chromatography (HPLC) or LC-MS/MS, but was easier to use, more rapid and more amenable to widespread clinical use. The data was presented at the 2008 Hematology/Oncology Pharmacy Association and the International Society of Oncology Pharmacy Practitioners' (HOPA/ISOPP) annual meeting in Anaheim, Calif.

5-FU is a cornerstone treatment regimen for colorectal cancer; the third leading cause of cancer deaths in the United States.(i)

"This evidence-based tool for monitoring the actual drug concentrations of 5-FU in the blood will enable simplified, personalized dose management with the goal of minimizing toxicity and maximizing the therapeutic benefit of 5-FU treatment," said Salvatore Salamone, Ph.D., CEO of Saladax Biomedical. "This is important because a significant amount of scientific evidence over the last decade demonstrates that the effectiveness of the 5-FU regimen is burdened by potentially severe and life-threatening side effects."

To date, analysis of 5-FU blood plasma levels could only be performed by complex, labor-intensive, expensive, and physical analytical methods such as HPLC that have insufficient capacity to be used in high volume clinical settings. The 5-FU PCM assay could provide the same HPLC or LC-MS/MS-like performance, while offering advantages of automation, small sample size, and improved turn-around time for oncologists.

The multicenter study evaluated 5-FU blood plasma levels at three sites, according to the Clinical and Laboratory Standards Institute (CLSI) protocol. 5-FU blood plasm
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SOURCE Saladax Biomedical
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