SALT LAKE CITY, April 27, 2010 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (Nasdaq:MYGN) today announced a significant improvement in the sample collection kit for OnDoseTM, its 5-Fluorouracil (5-FU) dose optimization product. Patient sample handling can now be conducted at room temperature, eliminating the need for frozen sample handling. Myriad said that it believes the simplified process should increase physician acceptance and utilization of OnDose.
The new OnDose sample handling protocol employs a chemical stabilizer that is injected into the blood collection test tube immediately following the patients' blood draw. The stabilizer effectively inhibits any enzyme degradation of 5-FU in the patient's blood sample. Previously this was accomplished by chilling the blood, freezing the plasma sample overnight, and shipping the frozen sample on ice in special insulated containers. The chemical stabilizer allows physicians to handle, prepare and ship the patient's sample all at room temperature, eliminating the need to employ these extra measures for maintaining very cold temperatures during sample preparation and shipping. In market research surveys conducted following the launch of OnDose, physician practices greatly preferred this simplified sample process over the current frozen sample approach.
"This is an important step forward in greater utilization of OnDose," said Mark C. Capone, President of Myriad Genetic Laboratories. "More rapid adoption as a result of this exciting new technology, which permits easier and quicker patient sampling, is very significant for colon cancer patients who frequently receive sub optimal 5-FU therapy and would benefit greatly from OnDose testing."
About OnDose™
OnDose™ is a simple blood test that for the first time 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. A phase 3, multicenter, randomized study in 208 colon cancer patients published in the Journal of Clinical Oncology established that the OnDose™ approach of monitoring 5-FU exposure combined with dose adjustment to an optimal 5-FU exposure range significantly improved drug efficacy and reduced toxicity. Objective response rates for these patients were nearly double that of conventionally dosed patients (33.6% versus 18.3%; p = 0.0004) and grade 3-4 toxicity events were 83% higher in the conventionally dosed patients versus those that were monitored using the OnDose approach (p = 0.003). Importantly, patients dosed using the OnDose approach survived 6 months longer than those dosed using the Body Surface Area (BSA) dosing, the current standard of care.
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, 175,000 colon cancer patients may benefit from OnDose optimization of 5-FU infusion therapy each year.
OnDose is performed under patents licensed from Saladax Biomedical, Inc.
About Myriad Genetics
Myriad Genetics, Inc. is a leading molecular diagnostic company focused on developing and marketing novel predictive medicine, personalized medicine and prognostic medicine products. Myriad's news and other information are available on the Company's Web site at www.myriad.com.
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Myriad, the Myriad logo, BRACAnalysis, Colaris, Colaris AP, Melaris, TheraGuide, Prezeon, OnDose, and Prolaris are trademarks or registered trademarks of Myriad Genetics, Inc. in the United States and foreign countries. MYGN-G
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the expectation and belief that the simplified handling process should increase physician acceptance and utilization of OnDose testing; the importance of this step forward in greater utilization of OnDose testing; the significance of more rapid adoption of OnDose testing as a result of this new exciting technology for colon cancer patients who would greatly benefit from OnDose testing; and the number of colon cancer patients in the United States that may benefit from OnDose optimization of 5-FU infusion therapy each year. 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 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 our products; risks related to regulatory requirements or enforcement in the United States and foreign countries and changes in the structure of healthcare payment systems; uncertainties about our ability to obtain new corporate collaborations and acquire new technologies on satisfactory terms, if at all; 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 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, 2009,which has been 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.