Healthcare Industry News: BRACAnalysis
News Release - March 2, 2010
Myriad Genetics Launches PROLARIS(TM): First Diagnostic Test to Predict Prostate Cancer RecurrenceSALT LAKE CITY, March 2, 2010 -- (Healthcare Sales & Marketing Network) -- Myriad Genetics, Inc. (Nasdaq:MYGN ) today announced the launch of PROLARIS(TM), a 46-gene prognostic test which quantitatively determines the risk of recurrence in patients who have undergone prostatectomy surgery. For the first time, physicians now have a direct molecular measure of a prostate tumor's capacity to divide and grow by examining the mechanics of growth at the molecular level. PROLARIS is the Company's eighth molecular diagnostic product and the first of two that are planned to be launched this year.
PROLARIS is a molecular diagnostic assay that offers urologists a more accurate way of determining a prostate cancer patient's risk of recurrence. The new molecular diagnostic test is based on cell growth and tumor biology and provides rigorous, quantitative measures of the expression levels of multiple genes related to progression of the cell cycle.
The test identifies patients at low risk of disease recurrence with 95% certainty giving these men confidence that additional aggressive treatment with the accompanying toxicity and adverse events is likely unwarranted. Conversely, men with high PROLARIS scores would be considered for more intensive screening and adjuvant therapy to address their more aggressive disease.
The Company is performing additional clinical validation studies to expand the utility of PROLARIS. In one such recently completed study of 365 prostate cancer patients, 98.5% of prostate cancer patients with a low (favorable) PROLARIS score survived their disease after 10 years, compared to 57.6% of the patients receiving a high (unfavorable) score who died of prostate cancer within 10 years.
"PROLARIS is a valuable additional tool that will enable urologists to provide an accurate, individualized recurrence risk score to men who have undergone a radical prostatectomy," stated Mark C. Capone, President, Myriad Genetic Laboratories, Inc. "We view PROLARIS as the first of a strong emerging stable of RNA signature tools based on fundamental tumor biology which Myriad will offer to the urology/oncology community."
In the United States, 192,000 men are diagnosed with prostate cancer each year and 80,000 men will undergo a radical prostatectomy, a surgical procedure that removes the prostate gland and some surrounding tissue. Approximately 35% of these men will eventually have a biochemical recurrence indicating the return of their prostate cancer. Current models based on clinical variables cannot effectively predict in which of these men the disease will recur.
Myriad will introduce PROLARIS to urologists and oncologists through its established oncology sales force and new urology sales team in the coming weeks. The cost for PROLARIS is $3,400.
Clinical Data on PROLARIS to be Presented
The clinical validation and scientific data supporting PROLARIS will be presented at the 2010 Genitourinary Cancers Symposium on March 5-7, 2010 in San Francisco. The abstract of the presentation entitled: "Cell Cycle Genes Predict Recurrence After Radical Prostatectomy" by Dr. Gregory P. Swanson and colleagues will be publically released on the American Society of Clinical Oncology's website, www.asco.org on Wednesday, March 3, 2010 at 6:00 pm Eastern.
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.
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 timing and manner of the launch and introduction of PROLARIS to urologists and oncologists; the planned launch of a second molecular diagnostic product this year; the degree of certainty in identifying patients at low or high risk of disease recurrence with PROLARIS; the consideration or role of the PROLARIS score or results in subsequent medical management decisions; the timing, completion and results of additional clinical validation studies to expand the utility of PROLARIS; the value and utility of PROLARIS to provide accurate individualized recurrence risk scores to men who have undergone radical prostatectomy; the Company's anticipated offering of a strong emerging stable of RNA signature tools based on fundamental tumor biology; the initial cost for PROLARIS of $3,400; and the presentation of clinical data on PROLARIS at the 2010 Genitourinary Cancers Symposium on March 5-7, 2010 in San Francisco. 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.
Source: Myriad Genetics
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