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OnDose(R) Study Demonstrates Need for Improved Dosing Approach for Colorectal Cancer Patients

/ Source: GlobeNewswire

SALT LAKE CITY, June 9, 2011 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (Nasdaq:MYGN) announced today that a study published in Clinical Colorectal Cancer entitled "Body Surface Area-based Dosing of 5-Fluoruracil Results in Extensive Inter-individual Variability in 5-Fluroruracil Exposure in Colorectal Cancer Patients on FOLFOX Regimens" demonstrated Body Surface Area (BSA) dosing in colorectal cancer patients receiving FOLFOX treatment regimens resulted in a wide range of drug plasma concentrations, with most patients falling well outside the target range.   

"These findings demonstrate the importance of providing physicians with a diagnostic that can help optimize dosing in FOLFOX therapy," stated Mark Capone, President of Myriad Genetic Laboratories, Inc. "Myriad's OnDose® product aids physicians in determining the most efficacious therapeutic dose for FOLFOX treatment for colorectal cancer patients, all while minimizing toxic side effects." 

The study analyzed 5-FU plasma concentrations of 357 patients who had been dosed by BSA. Only 21.3% of patients were found to have plasma 5-FU in the target range (20-24 mg·h/L) while 51% of patients fell below and 27.7% were above the target range. The authors concluded BSA dosing failed to achieve optimal efficacy and reduced toxicity when administering FOLFOX chemotherapy in adjuvant and metastatic disease settings. BSA dosing does not account for many of the factors that impact drug metabolism, including genotype, age, gender, disease state, drug-drug interactions, organ function, and co-morbidities.  

In the study, 62 patients received at least 4 OnDose measurements and had at least one dose adjustment following OnDose measurement. Prior to these OnDose titrations, less than 5% of patients in this cohort were in the target range and more than 50% were wide outliers. But after four drug administrations, at least one of which was preceded by an OnDose measurement, drug plasma levels in over 37% of these patients were in the target range and less than 14.5% were wide outliers. These findings demonstrate the benefit of using the OnDose product after each treatment so that the optimal therapeutic dose is provided to colorectal cancer patients.

About OnDose®

OnDose is a simple blood test that provides oncologists with a practical means to optimize infusional 5-FU therapy for colon cancer patients by measuring a patient's actual exposure to the chemotherapeutic drug 5-FU. In a clinical study presented at the ASCO 7th Annual Gastrointestinal Cancers Symposium in January 2010, 150 U.S. colon cancer patients received FOLFOX6 or FOLFOX6 plus Avastin® treatments under BSA dosing protocols. Drug exposure was analyzed using OnDose, and a startling 81.3% of the patients exhibited suboptimal exposure to 5-FU, with 28.7% of the patients having too much drug exposure and 52.6% of the patients having too little drug exposure. The study showed greater than a 12-fold improvement in drug exposure using OnDose to help optimize dosing.

In the United States alone, 179,000 colon cancer patients may benefit from OnDose optimization of 5-FU infusion therapy each year.  

About Myriad Genetics

Myriad Genetics, Inc. (Nasdaq:MYGN) is a leading molecular diagnostic company dedicated to developing and marketing novel predictive, personalized and prognostic medicine products to assess a person's risk of developing disease and guide treatment decisions. Myriad's portfolio of nine molecular diagnostic products are based on an understanding of the role genes play in human disease and were developed with a focus on improving an individual's decision making process for monitoring and treating disease. With fiscal year 2010 annual revenue of over $360 million and approximately 1,000 employees, Myriad is working on strategic initiatives, including new product introductions, companion diagnostics, and international expansion, to take advantage of significant growth opportunities. For more information on how Myriad is making a difference, please visit the Company's website: . 

Myriad, the Myriad logo, BRACAnalysis, COLARIS, COLARIS AP, MELARIS, TheraGuide, PREZEON, OnDose, prolaris and PANEXIA are trademarks or registered trademarks of Myriad Genetics, Inc. in the United States and foreign countries. 

Safe Harbor Statement

This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements related to the OnDose study demonstrating a need for improved dosing approach for colorectal cancer patients; the study findings demonstrating the importance of providing physicians with a diagnostic that can help optimize dosing in FOLFOX therapy; and the ability of the Company's OnDose product to aid physicians in determining the most efficacious therapeutic dose for FOLFOX treatment for colorectal cancer patients, all while minimizing toxic side effects.   These "forward-looking statements" are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that sales and profit margins of our existing molecular diagnostic products may decline or will not continue to increase at historical rates; the risk that we may be unable to expand into new markets outside of the United States; the risk that we may be unable to develop or achieve commercial success for additional molecular diagnostic products in a timely manner, or at all; the risk that licenses to the technology underlying our molecular diagnostic products and any future products are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with manufacturing our products or operating our laboratory testing facilities; risks related to public concern over genetic testing in general or our products in particular; risks related to regulatory requirements or enforcement in the United States and foreign countries and changes in the structure of healthcare payment systems; risks related to our ability to obtain new corporate collaborations and acquire new technologies or businesses on satisfactory terms, if at all, and risks related to our ability to successfully integrate and derive benefits from any technologies or businesses that we acquire; the development of competing products and services; the risk that we or our licensors may be unable to protect the proprietary technologies underlying our products; the risk of patent-infringement and invalidity claims or challenges of our patents; risks of new, changing and competitive technologies and regulations in the United States and internationally; and other factors discussed under the heading "Risk Factors" contained in Item 1A in our Annual Report on Form 10-K for the year ended June 30, 2010, filed with the Securities and Exchange Commission, as well as any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. All information in this press release is as of the date of the release, and Myriad undertakes no duty to update this information unless required by law.

CONTACT: Rebecca Chambers Director, Investor Relations and Corporate Communications (801) 584-1143