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New York State Health Department Approves Busulfan Testing By Memorial Sloan-Kettering Cancer Center

Posted on: Wednesday, 12 December 2007, 12:00 CST

The State of New York Department of Health has approved the testing protocol submitted by the Department of Clinical Labs at Memorial Sloan- Kettering Cancer Center (MSKCC) for the measurement of busulfan, commonly used as a preparative regimen prior to allogeneic hematopoeitic stem cell transplant (HSCT) in patients suffering from chronic myelogenous leukemia. Busulfan can be quite toxic and even lethal, particularly in pediatric patients for whom dose management by blood level monitoring is recommended. Current testing methods require long lead times, often yielding results too late to adjust dose and reduce toxic side-effects of the treatment.

The busulfan test developed and offered by MSKCC is based upon antibodies rather than physical methods such as gas chromatography-mass spectroscopy (GC-MS). It utilizes critical raw materials (or Analyte Specific Reagents [ASRs]) supplied by Saladax Biomedical, Inc., and enables more timely and cost-effective management of busulfan dosing.

"Clinical data confirms that dose management of busulfan significantly impacts the success of treatment of CML patients. By providing clinicians with timely and accurate testing services for busulfan concentrations, Memorial Sloan-Kettering Cancer Center is providing patients the highest level of care to enhance treatment response and their quality of life," said Dr. Martin Fleisher, Chairman, Department of Clinical Laboratories & Chief of Clinical Chemistry Service at Memorial Sloan- Kettering Cancer Center.

According to Saladax Chief Executive Officer Dr. Salvatore J. Salamone, Saladax is the first company to generate monoclonal antibodies to busulfan. "Our patented antibodies are ideally suited for blood level monitoring, providing high quality test results with quick turn-around time. We are very pleased to be collaborating with Memorial Sloan-Kettering Cancer Center to make available this clinically important service to cancer patients."

MSKCC will be the first laboratory in the State of New York to offer a busulfan blood level monitoring test, and the New York State Health Department Agency indicated that it will now refer New York healthcare providers seeking busulfan testing for their patients to MSKCC.

About Saladax Biomedical

Saladax Biomedical, Inc. is a research-based, health care diagnostics company with its main R&D and manufacturing facilities based in Bethlehem, PA. Founded in 2004, Saladax is developing and marketing Personalized Chemotherapy Management (PCM) assays to test plasma levels of the most commonly used anti-cancer medicines. Final assay development is underway for the highest volume anti-cancer drugs. For more information about Saladax, please visit www.saladax.com.

About Memorial Sloan-Kettering Cancer Center

Memorial Sloan-Kettering Cancer Center is the world's oldest and largest private institution devoted to prevention, patient care, research and education in cancer. Our scientists and clinicians generate innovative approaches to better understand, diagnose and treat cancer. Our specialists are leaders in biomedical research and in translating the latest research to advance the standard of cancer care worldwide. For more information, go to www.mskcc.org.

Source: Business Wire

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