COLONSEQ Panel

Test Code

36918

CPT Codes
81445, 81301

Preferred Specimen

Paraffin-embedded tissue accompanied by a circled H&E slide indicating the area to be examined collected in a sterile biohazard plastic bag or
15 formalin-fixed paraffin-embedded tissue slides and H&E slide (or 1 additional slide) collected in a slide holder

Instructions

Specimen to be tested must contain a minimum of 10% tumor

Transport Temperature

Room temperature

Specimen Stability

Room temperature: Indefinite
Refrigerated: Indefinite
Frozen: Unacceptable

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)

Decalcified tissue specimen

Methodology
Next Generation Sequencing • Polymerase Chain Reaction (PCR) • MSI

FDA Status
This test was developed and its performance characteristics determined by med fusion. It has not been cleared or approved by the U.S. Food and Drug Administration (FDA). The FDA has determined that such clearance or approval is not necessary. This test is used for clinical purposes. It should not be regarded as investigational for research. This laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as qualified to perform high complexity clinical laboratory testing.

Setup Schedule

Set up: Mon, Thurs; Report available: 8-10 days

Clinical Significance

This test is intended to be used as a disease specific solid tumor panel to aid the oncologist in prioritizing standard of care therapy choices for their patients with Colorectal Cancer.

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.