On September 9, 2015 Myriad Genetics, Inc. (NASDAQ:MYGN) reported two posters on its myPlan Lung Cancer prognostic test at the International Association for the Study of Lung Cancer (IASLC) 16TH World Conference on Lung Cancer being held in Denver, Colo (Press release, Myriad Genetics, SEP 9, 2015, View Source [SID:1234507430]).

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The first study showed that the myPlan Lung Cancer test identified more patients with Stage IB lung cancer who are at risk for disease progression than were identified with National Comprehensive Cancer Network (NCCN) high-risk factors alone. The second study highlighted the successful analytical validation of the myPlan test, which demonstrated very high analytical precision.

"We use relatively crude categories of stage that were developed over 60 years ago to decide when to give chemotherapy. There is no routine assessment of the biology of the tumor, which we now know is a primary determinant of the risk of recurrence and cancer death," said Daniel Oh, M.D., Keck School of Medicine, University of Southern California. "Several validation studies from premiere cancer centers in this country have been presented and published that demonstrate the efficacy of myPlan Lung Cancer. I believe that the test is an important step forward in improving outcomes of lung cancer patients and allows a more rational approach to tailoring the treatment of our patients."

Below are details of the myPlan Lung Cancer studies that were highlighted at #WCLC2015.

Poster Presentation: P3.04-074.
Title: Prognostic Multigene Molecular Assay Might Improve Identification of Pathologic Stage IB Lung Adenocarcinoma Patients at Risk for Recurrence.
Date: Wednesday, Sept. 9, 2015: 9:45 to 10:45 a.m. and 3:45 to 4:45 p.m.

This study compared Stage IB patient risk as assessed by the myPlan Lung Cancer prognostic test score, which is a combination of cell cycle progression score and pathologic stage, versus NCCN high-risk features. Of the 279 Stage IB patients evaluated, 183 (65.6 percent) were designated high risk by the myPlan Lung Cancer test. Of these high-risk patients, less than 50 percent had three or more high-risk features as defined by NCCN guidelines. This study demonstrated that the myPlan Lung Cancer test can identify high-risk patients that would have been otherwise designated as low risk according to NCCN pathological features. Importantly, in the Stage IB population, the myPlan test provided quantitative risk information above that determined by current NCCN high-risk features. Patients with resected Stage I lung adenocarcinoma and a high myPlan Lung Cancer score may be candidates for adjuvant therapy to reduce cancer-related mortality.

Poster Presentation: P3.04-084.
Title: Analytical Validation of a Proliferation-Based Signature Used as a Prognostic Marker in Early-Stage Lung Adenocarcinoma.
Date: Wednesday, Sept. 9, 2015: 9:45 to 10:45 a.m. and 3:45 to 4:45 p.m.

This study successfully validated the analytical performance of the myPlan Lung Cancer test using formalin-fixed paraffin embedded (FFPE) tissue samples from patients with lung cancer by assessing precision, dynamic range and RNA input requirements. The results showed that the test had a standard deviation of 0.06 score units, which is only one percent of the clinical range of scores, and demonstrates that the myPlan Lung Cancer test is highly reproducible. The positive results from this study form an important component of the analytical validation section in our reimbursement dossier.

About Myriad myPlan Lung Cancer

Myriad myPlan Lung Cancer is a molecular prognostic test that measures the expression levels of cell cycle progression genes to provide an accurate assessment of cancer aggressiveness in patients with early-stage non-small cell lung adenocarcinoma. For more information visit: View Source