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Test Directory

Test Directory Microsatellite Instability (MSI)

Microsatellite Instability (MSI)

Test Summary

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).

Aliases

Specimen Collection

Special Instructions

N/A

Preferred Specimen

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

Minimum Volume

1 tissue block • 0.03 mL extracted DNA

Instructions

Tissue: One formalin-fixed, paraffin-embedded 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.

Patient Preparation

N/A

Storage

N/A

Transport Temperature

FFPE block: Room temperature
DNA: Frozen

Specimen Stability

FFPE block
Room temperature: 5 years
Refrigerated: 5 years
Frozen: Unacceptable
DNA
Room temperature: Unacceptable
Refrigerated: Unacceptable
Frozen: See instructions

Limitations

N/A

Other Acceptable Specimens

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

Unacceptable Specimens

N/A

Order Code

MICINS

EPIC (Premier) Code

LAB3204

Includes

N/A

CPT Code

81301

Billing Code

670879

CPT Statement

Methodology

Capillary Electrophoresis • Polymerase Chain Reaction (PCR)

FDA Status

This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Physician Attestation of Informed Consent

N/A

Testing Laboratory

Quest Diagnostics Nichols Institute
33608 Ortega Highway
San Juan Capistrano CA, 92675

Department

Reference Testing

Reference Range

See Laboratory Report

Setup Schedule / Expected Turnaround Time

Wednesday, Saturday; Report available: 3 - 4 days