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February 18, 2014
07:19 EDTMYGNProlaris test predicted which men would develop BCR after prostate surgery
Myriad Genetics announced it has published data in the Journal of Urology demonstrating that its Prolaris test accurately predicted, based on biopsy specimens, which men would develop biochemical recurrence, or BCR, or metastatic disease following radical prostate surgery. Prolaris is a 46-gene molecular diagnostic test that has been evaluated in more than 5,000 patients across 11 clinical studies. The study evaluated biopsy specimens in 582 men who were treated by radical prostatectomy. In the study, biopsy samples were evaluated from three cohorts of contemporary patients in the United States and Germany. The clinical endpoints were metastatic disease and BCR. In all cohorts, the Prolaris test was a statistically significant predictor of BCR and was the single strongest predictor of metastatic disease when compared to Gleason Score or PSA. In the pooled analysis, each one-unit increase in the Prolaris score translated into a fivefold increased risk of metastases and a 1.6-times increased risk of BCR.
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May 15, 2015
10:28 EDTMYGNMAC updates positive for NanoString, Myriad, Invitae, QIAGEN, says Leerink
Leerink said that coverage updates posted yesterday by Medicare Administrative Contractors were favorable for NanoString (NSTG), Myriad Genetics (MYGN), Invitae (NVTA) and QIAGEN (QGEN). The firm has Outperform ratings on NanoString and Invitae and Market Perform rating on the other two stocks listed.
07:09 EDTMYGNMyriad Genetics presents clinical data for Prolaris test
Myriad Genetics presented clinical data for its Prolaris test at the 2015 American Urological Association, or AUA, Annual Meeting being held May 15-19 in New Orleans, La. The results highlighted and underscored the significant ability of the Prolaris test to help physicians improve care for men diagnosed with prostate cancer. In this pioneering study, Myriad presented important new clinical validation data that establishes an active surveillance, or AS, threshold for men with localized prostate cancer. Specifically, the AS threshold is a composite of the Prolaris test score and clinicopathologic features. In the validation data featured at AUA, the pre-defined AS threshold was evaluated in 765 conservatively managed men, and the clinical endpoint was 10-year risk of prostate cancer mortality. The results showed that at the AS threshold, the predicted 10-year survival rate of prostate cancer patients was 97%. Conversely, there was a three percent risk of 10-year, prostate-specific mortality. Importantly, however, there were no observed prostate cancer-specific deaths over 10 years among men whose scores fell below the AS threshold. Additionally, a separate analysis of 4,218 patients was performed to determine what percentage of patients who were clinically tested with Prolaris would be candidates for active surveillance based on the validated AS threshold. Of this commercial cohort, 36% qualified for active surveillance based on their clinical features alone. However, when the Prolaris test was added to the clinical risk assessment, 60% of these patients fell below the AS threshold, representing a significant increase in the total number of candidates who may be eligible for active surveillance.

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