Epi proColon®, Septin 9 Gene Methylation Detection

CPT: 81327
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Test Details

Use

Epi proColon® is a qualitative in vitro diagnostic method for the detection of methylated Septin 9 DNA in EDTA plasma derived from patient whole blood specimens. Methylation of the target DNA sequence in the promoter region of the SEPT9_v2 transcript has been associated with the occurrence of colorectal cancer (CRC).

The Epi proColon® test is indicated to screen adults of either sex, 50 years or older, defined as average risk for CRC, who have been offered and have a history of not completing CRC screening. Tests that are available and recommended in the USPSTF 2008 CRC screening guidelines should be offered and declined prior to offering the Epi proColon® test. Patients with a positive Epi proColon® test result should be referred for diagnostic colonoscopy.

The Epi proColon® test results should be used in combination with physician's assessment and individual risk factors in guiding patient management.

Limitations

The clinical performance of Epi proColon® was reported with a sensitivity range of 68.2%, 73.3%, and 72.2% and a specificity range of 78.8%, 81.5%, and 80.8% in the package insert for Trial One and in Trial Two (all plasma specimens, and paired Fecal Immunochemical Test specimens) respectively when compared to colonoscopy. (See package insert, Table 12, 14a, and 14b, p27-28).

Methodology

DNA is isolated from plasma specimen and treated with bisulfite. Real-time polymerase chain reaction (PCR) is performed on ABI 7500 Fast Dx to detect methylated form of Septin 9 DNA.

Specimen Requirements

Specimen

Plasma, frozen

Volume

Two plastic transport tubes (containing at least 3.5 mL each) of frozen plasma

Minimum Volume

One plastic transport tube (containing at least 3.5 mL) of frozen plasma. Note: This volume does not allow for repeat testing.

Container

4-mL BD® purple-top (K2 EDTA) tube. Collect six tubes of whole blood in accordance with the collection procedure specified below.

Collection

Please label each final plasma collection tube with the word "Plasma". Testing will be delayed if the tube is not labeled properly.

Blood Collection

• Blood should be collected according to your laboratory's procedure for venipuncture using only a 4-mL BD® purple-top (K2 EDTA) tube. Plasma preparation should be performed within four hours after blood is collected. Store, transport, and ship plasma at frozen condition only. The plasma sample can be stored frozen at -15°C to -25°C for 14 days.

• Do not freeze whole blood samples.

Plasma Specimen Preparation

• Immediately following specimen collection, label all tubes with appropriate patient information (two patient identifiers, minimum).

• The brake setting of the Drucker 642e at LabCorp is 3 or 4 (manufacturer setting).

• Centrifuge the six BD purple-top (K2 EDTA) tubes for 10 minutes at 1600±90 rcf. (For conversion of RPM [revolutions per minute] to rcf [relative centrifugal force], refer to the centrifuge manufacturer's user manual.)

• Remove blood collection tubes from the centrifuge. (Plasma sample will be rejected if it is hemolyzed. Patient will be contacted.)

• Using a fresh, six-inch disposable transfer pipette, transfer plasma from three 4-mL tubes to one 8.5-mL Sarstedt centrifuge tube (55.598.006).

• Repeat this process with the second set of three 4-mL tubes. Two 8.5-mL tubes will be collected from six 4-mL tubes.

• Centrifuge plasma in the 8.5-mL centrifuge tube for 10 minutes at 1600±90 rcf.

• Using a fresh, six-inch disposable transfer pipette or serological pipette, transfer 3.5 mL of plasma from one 8.5-mL centrifuge tube into a labeled 7-mL Sarstedt screw-cap, flat-bottom purple frozen transport tube (62.550.019).

• Repeat this process with the second 8.5-mL centrifuge tube.

• Two 7-mL tubes will be collected.

• Ship and store plasma at -15°C to -25°C. Stable for 14 days.

• Take care not to disturb or transfer the buffy coat (white blood cells) layered above the red blood cells in the blood collection tube after the first centrifugation or sedimented at the bottom of the centrifuge tube after the second centrifugation.

Storage Instructions

Freeze. The plasma sample could be stored frozen at -15°C to -25°C for 14 days.

Causes for Rejection

Hemolyzed specimen; plasma not frozen; volume <3.5 mL per tube; leaking or broken tubes

Clinical Information

References

Instruction for Use, Epi proColon®. IFU0008, rev10 [package insert]. Berlin, Germany: Epigenomics AG; April 2016.
Warren JD, Xiong W, Bunker AM, et al. Septin 9 methylated DNA is a sensitive and specific blood test for colorectal cancer. BMC Med. 2011 Dec 14; 9:133. 22168215

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
481160 Epi proColon(R), Septin 9 481161 Septin 9 Result: 65810-4
481160 Epi proColon(R), Septin 9 481166 Indications: 42349-1
481160 Epi proColon(R), Septin 9 481167 Specimen Type: 31208-2
481160 Epi proColon(R), Septin 9 481162 Background: 77202-0
481160 Epi proColon(R), Septin 9 481163 Methodology: 49549-9
481160 Epi proColon(R), Septin 9 481164 References: 75608-0
481160 Epi proColon(R), Septin 9 481165 Director Review: 72486-4
481160 Epi proColon(R), Septin 9 481467 Septin 9 N/A
481160 Epi proColon(R), Septin 9 481483 Septin 9 N/A

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