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Examination and selection of retrieved archival (ie, previously diagnosed) tissue(s) for molecular analysis (eg, KRAS mutational analysis)

CPT4 code

Name of the Procedure:

Examination and Selection of Retrieved Archival Tissue(s) for Molecular Analysis (e.g., KRAS Mutational Analysis)

Summary

In this procedure, previously diagnosed tissue samples (archival tissues) are examined and selected for molecular analysis. The goal is to identify specific genetic mutations, such as KRAS mutations, which may guide treatment decisions.

Purpose

The procedure addresses the need to find genetic mutations in cancerous tissues which can determine the best treatment options. Identifying mutations helps personalize cancer therapy and may improve treatment outcomes.

Indications

  • Patients with cancer diagnoses where genetic profiling can influence therapy (e.g., colorectal cancer, lung cancer).
  • Recurrence of cancer or progression despite previous treatment.
  • Cases requiring confirmation of genetic mutations for targeted therapy eligibility.

Preparation

  • No specific preparation needed from the patient as the procedure involves existing tissue samples.
  • Ensure all prior pathology reports and related documents are available.
  • Confirm tissue sample availability from previous biopsies or surgeries.

Procedure Description

  1. Retrieval: Locate and retrieve the previously diagnosed tissue samples stored in pathology archives.
  2. Examination: Pathologists examine the tissue to confirm that it remains suitable for molecular analysis.
  3. Selection: Suitable tissue sections are selected based on quality and quantity considerations.
  4. Molecular Analysis: The selected tissues undergo molecular testing, such as PCR or sequencing, to detect specific genetic mutations (e.g., KRAS).

Duration

The entire process, from retrieval to the actual molecular analysis, generally spans a few days to a week.

Setting

The procedure is primarily conducted in a pathology laboratory equipped for molecular diagnostics.

Personnel

  • Pathologist
  • Molecular biologist or geneticist
  • Laboratory technicians

Risks and Complications

  • Rare risk of sample contamination.
  • Potential for tissue sample degradation, rendering it unusable for analysis.
  • Misinterpretation of molecular results, though highly unlikely with stringent protocols.

Benefits

  • Accurate identification of genetic mutations, facilitating personalized treatment plans.
  • Improved treatment outcomes through targeted therapy.
  • Non-invasive for the patient, using existing tissue samples.

Recovery

  • No recovery time for the patient since the procedure does not involve new tissue collection.
  • Follow-up involves discussing results with the oncologist and adjusting treatment plans as needed.

Alternatives

  • Fresh tissue biopsy: More invasive but may provide additional material for analysis.
  • Circulating tumor DNA analysis: Non-invasive, uses blood samples but may have lower sensitivity.

Patient Experience

  • No direct patient involvement during the procedure.
  • Patient may experience relief knowing that advanced molecular techniques are guiding their treatment.
  • Coordination with the healthcare team to review results and adapt the treatment plan accordingly.

Medical Policies and Guidelines for Examination and selection of retrieved archival (ie, previously diagnosed) tissue(s) for molecular analysis (eg, KRAS mutational analysis)

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