Analytical Validation of a 12-Gene Molecular Test for the Prediction of Distant Recurrence in Breast Cancer | Zendy

M. Bryan Warf | Zendy; Saradha Rajamani | Zendy; Kristin Krappmann | Zendy; Jennifer Doedt | Zendy; Jared Cassiano | Zendy; Krystal Brown | Zendy; Julia Reid | Zendy; Ralf Kronenwett | Zendy; Benjamin B. Roa | Zendy

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Analytical Validation of a 12-Gene Molecular Test for the Prediction of Distant Recurrence in Breast Cancer

Author(s) -

M. Bryan Warf,

Saradha Rajamani,

Kristin Krappmann,

Jennifer Doedt,

Jared Cassiano,

Krystal Brown,

Julia Reid,

Ralf Kronenwett,

Benjamin B. Roa

Publication year - 2017

Publication title -

future science oa

Language(s) - English

Resource type - Journals

SCImago Journal Rank - 0.825

H-Index - 23

ISSN - 2056-5623

DOI - 10.4155/fsoa-2017-0051

Subject(s) - breast cancer , oncology , medicine , computational biology , gene , cancer , biology , medical physics , bioinformatics , genetics

Aim: To validate the analytical performance of a 12-gene molecular assay that predicts distant recurrence for early-stage ER+/HER2- invasive breast cancer as run within a central reference laboratory. Materials & methods: Formalin-fixed paraffin-embedded breast resections were evaluated by quantitative reverse transcription polymerase chain reaction for the expression of eight target genes, three housekeeper genes and one control gene to assess for DNA contamination. Results: The assay results were highly correlated with a validated reference laboratory. The assay had a broad linear range for input RNA, with similar amplicon efficiencies for target and housekeeper genes. The assay test was highly reproducible, with comparable inter- and intrabatch precision to the reference laboratory. Conclusion: These studies demonstrate that the 12-gene molecular assay is highly robust and accurate.

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