TESTING GUIDELINES

Joint Guideline Issued for CRC Molecular Testing

A joint guideline from the American Society for Clinical Pathology, College of American Pathologists, Association for Molecular Pathology, and American Society of Clinical Oncology, published in the March issue of the Journal of Molecular Diagnostics, establishes evidence-based recommendations for mutational testing of EGFR signaling pathways for patients with colorectal cancer (CRC), as well as key steps laboratories can take to operationalize CRC molecular testing.

A systematic literature review found evidence supporting mutational testing to guide therapy of CRC with anti-EGFR monoclonal antibodies. Mutations in BRAF and MMR have “clear prognostic value,” while KRAS and NRAS have “relatively strong” evidence as negative predictors of benefit to anti-EGFR therapies. In addition to considerations for specific mutational analysis were recommendations for how laboratories can aid adoption of CRC molecular.

  • Laboratories should use CRC molecular biomarker testing methods that are able to detect mutations with at least 5% mutant allele frequency.
  • Laboratories should optimally utilize tissue specimens by using appropriate techniques (e.g., multiplexed assays).
  • Laboratories must use validated CRC molecular biomarker testing methods with sufficient performance characteristics and must incorporate these methods into their overall laboratory quality improvement program.
  • CRC molecular biomarker testing reports should include a results and interpretation section easily understandable by oncologists.
  • It is suggested that 90% of reports be available within 10 working days from date of receipt in the molecular diagnostics laboratory.
  • It is suggested that for laboratories requiring send-out testing, 90% of specimens should be sent out within three working days.

For more testing guidelines recently issued, see Testing Guidelines at a Glance.

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