Cancer diagnostics: decision criteria for marker utilization in the clinic

Area of Science:

• Oncology
• Biotechnology
• Clinical Diagnostics

Background:

• New diagnostic tools require rigorous validation for clinical adoption.
• The Cancer Diagnosis Program (CDP) established the Program for the Assessment of Clinical Cancer Tests (PACCT) in 2000.
• PACCT aims to streamline the integration of new cancer technologies into clinical practice.

Purpose of the Study:

• To present an algorithm for evaluating and adopting new cancer diagnostic tests.
• To illustrate the successful application of the PACCT algorithm using the OncotypeDX assay.
• To discuss challenges in diagnostic tool development using examples like HER2 testing.

Main Methods:

• Development of a PACCT algorithm involving assay developers and end-users.
• Evaluation of the OncotypeDX assay, utilizing reverse transcription (RT)-PCR for 16 genes.
• Analysis of breast cancer recurrence risk in early-stage, hormone-responsive patients without lymph node involvement.

Main Results:

• The PACCT algorithm facilitates the efficient and effective integration of new diagnostic tools.
• The OncotypeDX assay is highly reproducible and provides valuable clinical decision-making information.
• A prospective trial is planned to assess OncotypeDX as a standalone treatment decision trigger.

Conclusions:

• The PACCT algorithm provides a robust framework for diagnostic test evaluation.
• The OncotypeDX assay exemplifies a successful translation of genomic research into clinical practice.
• Addressing common challenges is crucial for advancing cancer diagnostics and patient care.