Microsatellite Instability (MSI)

Microsatellite Instability (MSI)

Test Code

14989
81301
CPT Code is subject to a Medicare Limited Coverage Policy and may require a signed ABN when ordering.
14989
81301
CPT Code is subject to a Medicare Limited Coverage Policy and may require a signed ABN when ordering.
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

Microsatellite Instability (MSI) - Patients with early onset and family history of colon cancers are suggestive of hereditary nonpolyposis colon cancer (hnpcc) syndrome. Microsatellite instability analysis on tumor tissue is recommended as a screening test to identify individuals eligible for germline mutation analysis or mismatch repair genes. Microsatellite instability analysis can also be used to identify adult and pediatric patients with unrespectable or metastatic solid tumors who have failed frontline therapy and who would be candidates for targeted immune therapy with Keytruda (Pembrolizumab).

Test Resources

Test FAQ

PD-L1

Clinical Focus

Cutaneous Melanoma: Laboratory Support of Diagnosis and Management

Topic Brief

Colorectal Cancer: Laboratory Support of Diagnosis and Management

Test Guide

PD-L1: Test Selection Guide

Test Details

Methodology

Capillary Electrophoresis • Polymerase Chain Reaction (PCR)

Assay Category

This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Alternative Name(s)

Hereditary Nonpolyposis Colon Cancer (HNPCC),Lynch Syndrome,HNPCC Mismatch Repair Gene Mutation

LOINC® Codes, Performing Laboratory

Service Area must be determined

Methodology

Capillary Electrophoresis • Polymerase Chain Reaction (PCR)
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Alternative Name(s)

Hereditary Nonpolyposis Colon Cancer (HNPCC),Lynch Syndrome,HNPCC Mismatch Repair Gene Mutation
Service Area must be determined

Preferred Specimen(s)

Formalin-fixed, paraffin-embedded tissue collected in a paraffin block bag

Alternative Specimen(s)

0.03 mL extracted DNA collected in a sterile, leak-proof container

Minimum Volume

0.03 mL

Collection Instructions

Tissue:
One formalin-fixed, paraffin-emdedded tissue with representative tumor. Pathology report is required.

Extracted DNA:
Extracted DNA from CLIA-certified laboratory submitted in a sterile, leak-proof container. DNA is to be shipped frozen. Do not thaw. Minimum and absolute minimum volume is 0.03 mL. Ship DNA immediately after extraction is performed. DNA must remain frozen until testing.

Transport Container

Paraffin block bag

Transport Temperature

Room temperature

Specimen Stability

  • Formalin-fixed paraffin block:
  • Room temperature: 5 years
  • Refrigerated: 5 years
  • Frozen: Unacceptable
  •  
  • Extracted DNA:
  • Room temperature: Unacceptable
  • Refrigerated: Unacceptable
  • Frozen: See instructions

Reject Criteria

Avoid hemolysis

Setup Schedule

Service Area must be determined
Formalin-fixed, paraffin-embedded tissue collected in a paraffin block bag
0.03 mL extracted DNA collected in a sterile, leak-proof container

0.03 mL

Tissue:
One formalin-fixed, paraffin-emdedded tissue with representative tumor. Pathology report is required.

Extracted DNA:
Extracted DNA from CLIA-certified laboratory submitted in a sterile, leak-proof container. DNA is to be shipped frozen. Do not thaw. Minimum and absolute minimum volume is 0.03 mL. Ship DNA immediately after extraction is performed. DNA must remain frozen until testing.

Paraffin block bag
Room temperature
Formalin-fixed paraffin block:
Room temperature: 5 years
Refrigerated: 5 years
Frozen: Unacceptable

Extracted DNA:
Room temperature: Unacceptable
Refrigerated: Unacceptable
Frozen: See instructions
Avoid hemolysis
Service Area must be determined
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.

The tests listed by specialty and category are a select group of tests offered. For a complete list of Quest Diagnostics tests, please adjust the filter options chosen, or refer to our Directory of Services.

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