COLONSEQPlus Panel

COLONSEQPlus Panel

Test Code

36919
81457
36919
81457
Ordering Restrictions may apply. Please provide SERVICE AREA INFORMATION to find available tests you can order.
Not offered in Quest Diagnostics Nichols Institute (IFD) – San Juan Capistrano. Please provide SERVICE AREA INFORMATION to find available tests you can order.
In-home collection is not available in your area through Quest Mobile.

Clinical Significance

COLONSEQPlus Panel - 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.

Test Resources

None found for this test
Please visit our Clinical Education Center to stay informed on any future publications, webinars, or other education opportunities.

Test Details

Includes

  • APC, BRAF, CTNNB1, EGFR, ERBB2 (HER2), FBXW7, KRAS, MET, NRAS, PIK3CA, PTEN, SMAD4, TP53, and Microsatellite Instability (MSI) by PCR.

Methodology

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

Assay Category

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.

This test is not available for New York patient testing.

Reference Range(s)

See Laboratory Report

LOINC® Codes, Performing Laboratory

Service Area must be determined
APC, BRAF, CTNNB1, EGFR, ERBB2 (HER2), FBXW7, KRAS, MET, NRAS, PIK3CA, PTEN, SMAD4, TP53, and Microsatellite Instability (MSI) by PCR.

Methodology

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

This test is not available for New York patient testing.

Reference Range(s)

See Laboratory Report
Service Area must be determined

Preferred Specimen(s)

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

Collection Instructions

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

Transport Container

Sterile biohazard plastic bag

Transport Temperature

Room temperature

Specimen Stability

  • Room temperature: Indefinitely
  • Refrigerated: Indefinitely
  • Frozen: Unacceptable

Reject Criteria

Decalcified tissue specimen

Setup Schedule

Service Area must be determined
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
Specimen to be tested must contain a minimum of 10% tumor
Sterile biohazard plastic bag
Room temperature
Room temperature: Indefinitely
Refrigerated: Indefinitely
Frozen: Unacceptable
Decalcified tissue specimen
Service Area must be determined
Ordering Restrictions may apply. Please provide SERVICE AREA INFORMATION to find available tests you can order.
Not offered in Quest Diagnostics Nichols Institute (IFD) – San Juan Capistrano. Please provide SERVICE AREA INFORMATION to find available tests you can order.
In-home collection is not available in your area through Quest Mobile.
Test Details

Clinical Significance

Test Resources

Reference ranges are provided as general guidance only. To interpret test results use the reference range in the laboratory report.

The CPT codes provided are based on AMA guidance and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

This material contains content from LOINC® (http://loinc.org). The LOINC Table, LOINC Table Core are copyright © 1995-2019, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee and is available at no cost under the license at http://loinc.org/license.

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