Unfortunately Yahoo no longer allows the link to be posted.
Note that the biopsy samples in this study were all from radical prostatectomies. This may underscore the GHDX test being sensitive to sample volume and heterogeneity effects.
Myriad Genetics Publishes Prolaris(R) Data in the Journal of Urology
Tue February 18, 2014 7:05 AM|GlobeNewswire | About: MYGN
SALT LAKE CITY, Feb. 18, 2014 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (MYGN) today 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 (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.
This is the precursor to needle biopsy, prior to surgery, which is inevitable. The market is saying, via current share price, that the competitive landscape is changing. It's a race to see who gets the most market share in prostate testing. And, payers are all about cost containment, so reimbursement rates will favor less expensive tests that are nearly equivalent in predictive value.