License From Saladax Biomedical Is Foundation Of New Molecular Oncology Test Launched By Myriad Genetics

Main Category: Cancer / Oncology
Article Date: 08 May 2009 - 5:00 PDT

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Saladax Biomedical, Inc. announced that Myriad Genetics, Inc. (NASDAQ:MYGN) has developed and launched its seventh molecular diagnostic product, OnDoseTM. OnDose™, which utilizes patent rights licensed from Saladax. OnDose provides a quantitative measure in blood of exposure of the patient to 5-Fluorouracil (5-FU), providing oncologists with a routinely available tool for personalizing infusion chemotherapy drug dosing to help optimize clinical efficacy and reduce toxic side effects.

5-FU is the foundation for colorectal cancer infusion chemotherapy regimens, and is also used for treating head and neck and metastatic breast cancer. With drug clearance varying by as much as 30-fold among different individuals, the traditional Body Surface Area (BSA) dosing methods result drug concentrations in the blood that vary widely. Studies have demonstrated a correlation of 5-FU treatment efficacy with blood concentration over time (Area Under the Curve) rather than dose. However, oncologists have previously not had a convenient way of measuring blood levels and as a result, many patients were over-dosed and many more were under-dosed.

"The introduction of OnDose™ is a new and vitally important advance in cancer care," said Dr. Edward Chu, M.D., Deputy Director of the Yale Cancer Center in New Haven, CT. "For the first time, a fast and accurate method of measuring and monitoring 5-FU blood levels will now be accessible to the practicing oncologist. OnDose™ will offer each oncologist who treats colorectal cancer patients an easy way to personalize their 5-FU regimen and help optimize their outcomes."

Myriad obtained from Saladax an exclusive North American license of patents arising from pioneering discoveries by Saladax. Under the terms of the patent license, Myriad has exclusive rights to develop, manufacture, sell and distribute products developed by Myriad for 5-FU in the United States and Canada. OnDose is being sold through Myriad's 150-person oncology sales force. Approximately 175,000 colorectal cancer patients are treated with 5-FU infusions annually in the United States. Myriad estimates that an average of eight OnDose measurements will occur during the full course of 5-FU infusion treatment and Myriad is offering the test for $300 per determination.

"We are very pleased that Myriad's development of a test based on licensed rights from Saladax's discoveries has resulted in a product now available to the US oncology community. Myriad Genetics is a reference lab of the highest quality and professionalism, with a broad reach in the US market," said Salvatore J. Salamone, Ph.D., Chief Executive Officer of Saladax Biomedical, Inc. "This is a win-win situation for all involved - Myriad, Saladax, doctors, payers, and most importantly, cancer patients."

About Saladax Biomedical, Inc.

Saladax Biomedical, Inc. is a personalized diagnostics company with its main R&D and manufacturing facilities based in Bethlehem, PA. Founded in 2004, Saladax is pioneering the development of an innovative line of proprietary Personalized Chemotherapy Management (PCM®) assays to test plasma levels of the most commonly used anti-cancer medicines. In the European Union, Saladax is marketing its 5-FU PCM Assay directly and has obtained a CE Mark for product distribution.

For more information about Saladax, visit http://www.saladax.com.

Source
Saladax Biomedical, Inc.

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