CPT® Code 81327

Official Description

SEPT9 (Septin9) (eg, colorectal cancer) promoter methylation analysis

Common Language Description

The CPT® Code 81327 refers to a laboratory test specifically designed to analyze the methylation status of the SEPT9 gene, which is associated with colorectal cancer (CRC). This test detects circulating methylated SEPT9 gene DNA in plasma, providing valuable information regarding the presence of colorectal cancer. The SEPT9 gene is located on the long arm of chromosome 17 at position 25 (17q25) and plays a crucial role in cellular processes such as cytoplasmic division, growth regulation, and tumor suppression. In the early stages of tumor development, particularly in colonic mucosal tissue, the V2 region of the SEPT9 promoter undergoes methylation. This hypermethylation leads to the silencing of DNA transcription, resulting in the inactivation of the gene's tumor suppression properties. Consequently, this allows for tumor cell migration and invasion, which are critical steps in the progression of colorectal cancer. During the carcinogenesis of CRC, SEPT9 DNA is released into the bloodstream from necrotic and apoptotic cancer cells, making it a significant biomarker for the disease. The sensitivity and specificity of the SEPT9 promoter methylation analysis are comparable to traditional stool sample tests for occult blood or fecal immunochemical testing. This test is particularly useful for screening adults aged 50 and older who are at average risk for colorectal cancer, especially in cases where patients have opted out of recommended colonoscopy or fecal testing. The procedure involves obtaining a blood sample through a separately reported venipuncture, followed by testing the plasma for methylated SEPT9 gene DNA using real-time polymerase chain reaction (RT-PCR) with a fluorescent hydrolysis probe. The results are reported as quantitative, indicating either a positive or negative result based on the level of SEPT9 DNA methylation detected in the blood sample. A positive result typically leads to a referral for further evaluation via colonoscopy.

1. Indications

The SEPT9 (Septin9) promoter methylation analysis, coded as CPT® 81327, is indicated for the following:

Colorectal Cancer Screening This test is utilized to screen for colorectal cancer in adults aged 50 and older who are at average risk for the disease, particularly in situations where patients have declined or avoided recommended colonoscopy and/or fecal testing.

2. Procedure

The procedure for conducting the SEPT9 promoter methylation analysis involves several key steps:

Step 1: Blood Sample Collection A blood sample is obtained from the patient through a venipuncture, which is reported separately. This step is crucial as it provides the plasma needed for subsequent analysis.
Step 2: Plasma Preparation After the blood sample is collected, the plasma is separated from the cellular components. This is essential to isolate the circulating methylated SEPT9 gene DNA that will be analyzed.
Step 3: Methylation Analysis The prepared plasma is then subjected to real-time polymerase chain reaction (RT-PCR) testing. This method employs a fluorescent hydrolysis probe specifically designed for the methylation detection of the SEPT9 DNA target. The RT-PCR process amplifies the DNA, allowing for the detection of methylated SEPT9 gene sequences.
Step 4: Result Interpretation Following the analysis, a quantitative result is generated, indicating either a positive or negative finding based on the level of SEPT9 DNA methylation present in the blood sample. A positive result suggests the presence of colorectal cancer, prompting further investigation.

3. Post-Procedure

After the SEPT9 promoter methylation analysis is completed, the patient receives the results, which are interpreted in the context of their clinical history and risk factors. If the result is positive for methylated SEPT9 DNA, the patient is typically referred for a colonoscopy to further evaluate the presence of colorectal cancer or any precancerous lesions. It is important for healthcare providers to discuss the implications of the test results with the patient and to outline the next steps in their care plan. Additionally, patients should be monitored for any symptoms or changes in their health status following the test.

Short Descr	SEPT9 GEN PRMTR MTHYLTN ALYS
Medium Descr	SEPT9 GENE PROMOTER METHYLATION ANALYSIS
Long Descr	SEPT9 (Septin9) (eg, colorectal cancer) promoter methylation analysis
Status Code	Statutory Exclusion (from MPFS, may be paid under other methodologies)
Global Days	XXX - Global Concept Does Not Apply
PC/TC Indicator (26, TC)	9 - Not Applicable
Multiple Procedures (51)	9 - Concept does not apply.
Bilateral Surgery (50)	9 - Concept does not apply.
Physician Supervisions	09 - Concept does not apply.
Assistant Surgeon (80, 82)	9 - Concept does not apply.
Co-Surgeons (62)	9 - Concept does not apply.
Team Surgery (66)	9 - Concept does not apply.
Diagnostic Imaging Family	99 - Concept Does Not Apply
CLIA Waived (QW)	No
APC Status Indicator	Service Paid under Fee Schedule or Payment System other than OPPS
Type of Service (TOS)	5 - Diagnostic Laboratory
Berenson-Eggers TOS (BETOS)	T2D - Other tests - other
MUE	1

90	Reference (outside) laboratory: when laboratory procedures are performed by a party other than the treating or reporting physician or other qualified health care professional, the procedure may be identified by adding modifier 90 to the usual procedure number.
GA	Waiver of liability statement issued as required by payer policy, individual case
GZ	Item or service expected to be denied as not reasonable and necessary