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January 1, 2013BMC Genomics343 citationsOpen Access

Analytical validation of the Oncotype DX prostate cancer assay – a clinical RT-PCR assay optimized for prostate needle biopsies

DKDejan KnezevicNofimaAGAudrey D. GoddardOntario Institute for Cancer ResearchNNNisha NatrajGenomic Health (United States)

Key Points

  • To validate the analytical performance and reliability of the Oncotype DX RT-PCR assay using small RNA inputs from prostate needle biopsy samples.
  • Evaluated the analytical requirements and performance of the clinical reverse transcription-polymerase chain reaction (RT-PCR) assay designed for prostate needle biopsy specimens.
  • Assessed assay functionality across limited RNA input quantities.
  • Successfully demonstrated analytical validation of the assay when utilizing very limited RNA inputs.
  • Established robust and reliable analytical performance intended to guide clinical treatment decisions in early-stage prostate cancer.

Abstract

The Oncotype DX Prostate Cancer Assay, a clinical RT-PCR assay specifically designed for use with prostate needle biopsies, has been analytically validated using very limited RNA inputs. The assay requirements and analytical performance will provide physicians with test results from a robust and reliable assay which will enable improved treatment decisions for men diagnosed with early-stage prostate cancer.

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Cite This Study

Knezevic et al. (2013) studied this question.

synapsesocial.com/papers/69dd438427c48be1bb40c84ehttps://doi.org/10.1186/1471-2164-14-690
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