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News Breaks
June 2, 2014
07:10 EDTMYGNMyriad presents myPath Melanoma clinical validation study results
Myriad Genetics presented results from a pivotal clinical validation study of the Myriad myPath Melanoma test at the 2014 American Society of Clinical Oncology annual meeting. The Myriad myPath Melanoma test has now shown reproducible results in two large cohorts. Last November, Myriad presented results from its verification study at the American Society of Dermatopathology annual meeting. Data from that verification study of 464 lesions showed that the Myriad myPath Melanoma test had greater than a 90 percent diagnostic accuracy in differentiating malignant melanoma from benign skin lesions in a variety of subtypes. Additionally, an analysis of a prospective clinical utility study was highlighted at ASCO and initial findings from that study are consistent with earlier findings from a retrospective clinical utility study that was presented at the United States & Canadian Academy of Pathology's annual meeting in March. The USCAP data demonstrated a 33% change in medical management based upon the Myriad myPath Melanoma test result.
News For MYGN From The Last 14 Days
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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.
May 13, 2015
18:47 EDTMYGNMyriad Genetics to present data from 19 studies at 2015 ASCO meeting
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May 11, 2015
18:29 EDTMYGNAffordable Care Act guidance says insurers must cover BRCA1, BRCA2 testing
The United States Department of Labor issued updated Affordable Care Act guidance, which mandates that health insurers must cover testing for breast and ovarian cancer through analysis of the BRCA1 and BRCA2 genes. Myriad (MYGN), Foundation Medicine (FMI), and Genomic Health (GHDX) compete in the genetic testing space. Reference Link

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