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Oncology (prostate), mRNA, gene expression profiling by real-time RT-PCR of 17 genes (12 content and 5 housekeeping), utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as a risk score

CPT4 code

Name of the Procedure:

Oncology (prostate), mRNA, gene expression profiling by real-time RT-PCR of 17 genes (12 content and 5 housekeeping), utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as a risk score.

Summary

This procedure involves analyzing the expression of 17 specific genes in a prostate tissue sample to assess the risk and aggressiveness of prostate cancer. It uses a technique called real-time RT-PCR on tissue that has been preserved in formalin and embedded in paraffin. The results are used to generate a risk score that can help guide treatment decisions.

Purpose

This test is used to evaluate prostate cancer risk and the likelihood of disease progression. It helps doctors determine the most appropriate treatment plan, whether it involves active surveillance, surgery, radiation, or other therapies.

Indications

Patients with a diagnosis of prostate cancer or those with suspicious biopsy results may benefit from this test. It’s particularly useful for those who need more information to decide between treatment options.

Preparation

There are no special preparations required from the patient for this test. The tissue sample needed is typically obtained during a prior biopsy procedure.

Procedure Description

  1. Tissue Sample: The procedure starts with a previously collected prostate tissue sample that has been preserved in formalin and embedded in paraffin.
  2. RNA Extraction: RNA is carefully extracted from the sample.
  3. RT-PCR: The RNA undergoes real-time RT-PCR to measure the expression levels of 17 specific genes.
  4. Data Analysis: An algorithm analyzes the data and generates a risk score based on the gene expression profile.

Tools and technology include real-time PCR machines and specialized software for data analysis. No anesthesia or sedation is required as the biopsy is taken beforehand.

Duration

The entire analysis process typically takes several hours in the lab, but the patient’s active involvement is minimal, occurring only during the initial biopsy.

Setting

The test is conducted in a specialized laboratory equipped for gene expression analysis.

Personnel

Lab technicians and molecular pathologists are primarily involved in performing and analyzing the test. The patient's urologist or oncologist will review and discuss the results.

Risks and Complications

The risks are minimal since the procedure deals with an already obtained biopsy sample. There could be a slight risk of sample contamination, though this is rare.

Benefits

The main benefit is a more accurate assessment of prostate cancer risk, which can lead to better-informed treatment decisions. Results can typically be provided within a few days to a week after analysis starts.

Recovery

There is no recovery time for the test itself, as it uses a pre-existing biopsy sample. Recovery considerations pertain to the initial biopsy.

Alternatives

Alternative tests could include other gene expression profiling tests, imaging tests, or additional biopsies. Each option has different accuracy levels, invasiveness, and costs, making this procedure a valuable option for precision.

Patient Experience

The patient may experience some anxiety while waiting for the results but will not feel any pain or discomfort related to the testing process itself. Pain management and comfort will have been addressed during the initial biopsy procedure.

Medical Policies and Guidelines for Oncology (prostate), mRNA, gene expression profiling by real-time RT-PCR of 17 genes (12 content and 5 housekeeping), utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as a risk score

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