Thursday, June 13, 2013

Prolaris® Technical Specifications Myriad Genetic Laboratories, Inc. 2012


Clinically Reportable Ranges
Based on observed scores in the 779 FFPE postprostatectomy tumor samples from the two patient cohorts, a clinically reportable Prolaris Score range of -1.6 to 3.7 was established. Based on analysis of the 413 samples in the more contemporary validation cohort, individuals with a Prolaris Score of 1.2 or higher have a predicted probability of biochemical recurrence by 10 years of greater than 50% (95% CI: 37-65%). Prolaris Scores outside the range of -1.6 to 3.7 will be reported but will be qualified with the information that they lie outside the range of the prediction model  Similarly, based on observed scores in 766 out of
779 FFPE post-prostatectomy tumor samples from the two patient cohorts, a clinically reportable Prolaris Combined Score range of –0.9 to 4.5 was established. Based on analysis of the 413 samples in the more contemporary validation cohort, individuals with a Prolaris Combined Score of 2.0 or higher have a predicted probability of biochemical recurrence by 10 years of greater than 50% (95% CI: 40-61%). Prolaris Combined Scores outside of this range will be reported, but a biochemical recurrence risk estimate will not provided as these scores lie outside of the range of the prediction model.

Detection Limit/Linearity
Prolaris Scores between -8 and 8 are technically  detectable by this assay. Linearity was established within this range as follows: The 31 cell cycle genes were preamplified, diluted to different concentrations and spiked into a cDNA sample of known concentration. Each spiked sample was assayed in triplicate, and the resulting 3 data points were averaged for each concentration to generate a Recurrence score. Linearity was established for Prolaris Scores ranging from 0 to 8 using this method. Linearity for Prolaris Scores ranging from -8 to 0 was similarly  established. The 15 housekeeping genes were pre-amplified,  diluted to different concentrations and spiked into a cDNA  sample of known concentration. Each spiked sample was  assayed in triplicate, and the resulting 3 data points were averaged for each concentration to generate a ProlarisScore.

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