Sample Requirements for Prolaris® Prostate Needle Biopsies Prolaris requires a small amount of quality tumor to run the test: 7 consecutive slides, that are 3 - 5 microns in thickness and tumor that is at least 0.5 mm in length. Several factors can affect the acceptance of a sample 1 Number of positive cores A greater number of positive cores increases the likelihood of sample acceptance, since tumor can be combined from multiple cores. With a single positive core, sample acceptance is most correlated with the percentage of tumor in the core (the higher the % the more likely the acceptance). 2 Percentage of core that is positive Cores with less than 10% involvement may not meet the 0.5 mm in length requirement. This can be overcome by combining tumor from multiple cores (core range in length from xx to xx). 3 Tissue remaining in the block The procedure for cutting tumor sections to diagnose cancer varies greatly by lab: • Labs vary in how deeply they face the block. These initial sections are all discarded. • Most labs cut between 2 and 6 levels. The greater the number of levels cut, the smaller the amount of tissue remaining in the block. • Many labs discard the intervening sections between the sections they use for diagnosis. • The percentage of the core remaining after slides are cut for diagnosis varies from 50% to 0% (no tissue). Example which leaves tissue in the block Example where very little tissue remains in the block Wasted facing the block Facing Discarded Remaining in the block Remaining tissue (Approximately 40%) (Approximately 15%) A1 A2 A3 A4 A5 B1 B2 B3 B4 B5 C1 C2 C3 C4 C5 D1 D2 D3 D4 D5 E1 E2 E3 E4 E5 F1 F2 F3 F4 F5 Discarded 4 Quality of Sample Samples must be at least 0.5 mm in length and 75% or greater tumor glands of macro dissectible tumor tissue. Often, prostate needle biopsies contain small foci of invasive cancer intermixed with normal tissue, which makes macro dissection of tumor difficult. Below are examples of acceptable and non-acceptable samples. Acceptable: This example show tumor foci that are near the tip of the biopsy. Acceptable: This example show tumor foci that are in an area that is easily identifiable during macro dissection. Unacceptable: This example shows small foci with large areas of intermixed normal or PIN. 5 Fixative The sample must be fixed in a formalin based fixative. For more information, call your local representative or visit www.prolaris.com PROL_BIOPSY_SAM_REQUIR_12_13_EN A prognostic medicine product for prostate cancer. Prolaris® testing assesses prostate cancer aggressiveness in conjunction with other clinical parameters. Prolaris® measures the expression level of genes involved with cell cycle progression (CCP) in tumor specimens to predict disease outcome. Myriad Genetics GmbH Leutschenbachstrasse 95 8050 Zurich Switzerland www.myriad.com Myriad, the Myriad logo, Prolaris and the Prolaris logo are either trademarks or registered trademarks of Myriad Genetics, Inc., in the United States and other jurisdictions. ©2013, Myriad Genetics, GmbH. Not for distribution in USA.
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