Development and Validation of A Cell Cycle Progression Signature for Decentralized Testing of Men with Prostate Cancer
Vanessa Kuhl, Wyatt Clegg, Stephanie Meek, Lauren Lenz, Darl D. Flake, Tracy Ronan, Max Kornilov, Deborah Horsch, Marsel Scheer, Daniel A. Farber, Hillary Zalaznick, Olivier Cussenot, Éva Compérat, Géraldine Cancel‐Tassin, Peter J. Wild, Felix K.‐H. Chun, Philipp Mandel, Farid Moinfar, Todd Cohen, Sylvette Delee, Ralf Kronenwett, Jennifer Doedt
Abstract
Aim: The 46-gene Prolaris® cell cycle progression test provides information on the risk of prostate cancer progression. Here we developed and validated a 16-gene kit-based version. Methods: RNA was extracted from prostate cancer biopsy tissue. Amplification efficiency, minimum tumor content, repeatability, reproducibility and equivalence with the 46-gene test were evaluated. Results: Amplification efficiencies for all genes were within the acceptable range (90–110%), and samples with ≥50% tumor content were appropriate for the 16-gene test. Results were repeatable (standard deviation: 0.085) and reproducible (standard deviation: 0.115). Instrument, operator and kit lot had minimal impact on results. Cell cycle progression scores from the 46- and 16-gene tests were highly correlated (r = 0.969; bias = 0.217). Conclusion: The 16-gene test performs consistently and similarly to the 46-gene test.