Healthcare Industry News:  Myriad Genetics 

Diagnostics Oncology

 News Release - October 28, 2013

Myriad myPlan(TM) Lung Cancer Test Meets Primary Endpoint in Validation Study

Data to Be Presented at the IASLC 15th World Conference on Lung Cancer

SALT LAKE CITY, Oct. 28, 2013 -- (Healthcare Sales & Marketing Network) -- Myriad Genetics, Inc. (MYGN) today announced that validation data for the Myriad myPlan Lung Cancer test showed that it significantly predicted patients' risk of death from early-stage lung adenocarcinoma within five years of being diagnosed. A key finding of the validation study is that patients with a high-risk myPlan prognostic score had approximately twice the number of lung cancer related deaths compared to patients with a low-risk score.

Myriad is presenting these results and another myPlan clinical study this week at the International Association for the Study of Lung Cancer (IASLC) 15th World Conference on Lung Cancer in Sydney, Australia. myPlan Lung Cancer is the only prognostic test on the market today that can assess a patient's risk of lung cancer mortality and thereby guide the physician in determining which patients may benefit from post-surgical chemotherapy.

"The Myriad myPlan Lung Cancer test provides new information that can identify people at high risk of lung cancer recurrence and will enable us to offer these patients additional therapy to improve their survival," said Raphael Bueno, M.D., Associate Chief of Thoracic Surgery at Brigham and Women's Hospital and Harvard Medical School. "Once we know a patient's risk profile, we can align our clinical management strategies to achieve better medical outcomes and save more lives."

The two studies being presented at the IASLC annual meeting are:

Validation of a Proliferation-based Expression Signature as Prognostic Marker in Early Stage Lung Adenocarcinoma. [Bueno et al., Poster: Oct. 28, 2013, 3:30 p.m. -- 4:15 p.m. AEDT]

This study evaluated the association of cell cycle progression (CCP) genes with five-year lung cancer mortality in 650 patients diagnosed with stage 1 or 2 lung adenocarcinoma. In this clinical validation study, patients with a high-risk Myriad myPlan Lung Cancer prognostic score had a significantly higher average five-year mortality rate (35 percent) than patients with a low-risk score (18 percent). The prognostic score (CCP + tumor stage) segregated stage 1A to 2B patients with five-year risk estimates ranging from 11 percent to 68 percent. This study demonstrated that the myPlan Lung Cancer prognostic score was statistically significant in predicting five-year lung cancer mortality, and was significantly more predictive than tumor staging information alone. These data strongly support the use of the Myriad myPlan Lung Cancer test to help stratify patients' risk profiles and determine which patients are candidates for conservative management with surgery alone versus more intensive therapy based on a higher personal risk profile.

Integrated Prognosis in Early-Stage Resectable Lung Adenocarcinoma. [Kim et al., Poster: Oct. 30, 2013, 3:30 p.m. -- 4:15 p.m. AEDT]

This study evaluated a prognostic model that combines a cell cycle progression (CCP) score with tumor stage in order to maximize the prognostic utility of both predictive markers. The primary outcome measure was cancer specific death within five years of surgery. The results for this study show that both tumor stage and CCP score are statistically significant independent predictors of lung cancer death. However, the combination of tumor stage and the CCP expression score was a more powerful predictor of post-surgical risk of cancer-specific death than tumor stage alone. Myriad myPlan Lung Cancer is a prognostic test that combines CCP score and tumor stage and offers clinicians a more precise risk assessment of patients with early-stage lung cancer, which may improve medical management of these patients.

About Myriad Genetics

Myriad Genetics is a leading molecular diagnostic company dedicated to making a difference in patients' lives through the discovery and commercialization of transformative tests to assess a person's risk of developing disease, guide treatment decisions and assess risk of disease progression and recurrence. Myriad's molecular diagnostic tests are based on an understanding of the role genes play in human disease and were developed with a commitment to improving an individual's decision making process for monitoring and treating disease. Myriad is focused on strategic directives to introduce new products, including companion diagnostics, as well as expanding internationally. For more information on how Myriad is making a difference, please visit the Company's website:

Myriad, the Myriad logo, myRisk 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 relating to the Myriad myPlan Lung Cancer prognostic test as a valuable tool for selecting early-stage patients; the Myriad myPlan Lung Cancer test being an important new molecular diagnostic tool that will help physicians in predicting the aggressiveness of early-stage lung adenocarcinoma in conjunction with conventional clinical parameters; and the Company's strategic directives under the caption "About Myriad Genetics". These "forward-looking statements" are management's present 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 described in the forward-looking statements. These risks include, but are not limited to: the risk that sales and profit margins of our existing molecular diagnostic tests and companion diagnostic services may decline or will not continue to increase at historical rates; risks related to changes in the governmental or private insurers reimbursement levels for our tests; the risk that we may be unable to develop or achieve commercial success for additional molecular diagnostic tests and companion diagnostic services in a timely manner, or at all; the risk that we may not successfully develop new markets for our molecular diagnostic tests and companion diagnostic services, including our ability to successfully generate revenue outside the United States; the risk that licenses to the technology underlying our molecular diagnostic tests and companion diagnostic services tests and any future tests are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with operating our laboratory testing facilities; risks related to public concern over our genetic testing in general or our tests in particular; risks related to regulatory requirements or enforcement in the United States and foreign countries and changes in the structure of the healthcare system or healthcare payment systems; risks related to our ability to obtain new corporate collaborations or licenses and acquire new technologies or businesses on satisfactory terms, if at all; risks related to our ability to successfully integrate and derive benefits from any technologies or businesses that we license or acquire; risks related to increased competition and the development of new competing tests and services; the risk that we or our licensors may be unable to protect or that third parties will infringe the proprietary technologies underlying our tests; the risk of patent-infringement claims or challenges to the validity of our patents; risks related to changes in intellectual property laws covering our molecular diagnostic tests and companion diagnostic services and patents or enforcement in the United States and foreign countries, such as the Supreme Court decision in the lawsuit brought against us by the Association for Molecular Pathology et al; 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 of our most recent Annual Report on Form 10-K 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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