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Microsatellite Instability (MSI)
Test Code14989
CPT Codes
81301
Preferred Specimen
Formalin-fixed, paraffin-embedded tissue collected in a paraffin block bag
Minimum Volume
0.03 mL
Other Acceptable Specimens
0.03 mL extracted DNA collected in a sterile, leak-proof container
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 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
Room temperature: 5 years
Refrigerated: 5 years
Frozen: Unacceptable
Extracted DNA:
Room temperature: Unacceptable
Refrigerated: Unacceptable
Frozen: See instructions
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 FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Setup Schedule
A.M. Sets up 2 days a week.
Report Available
Reports in 3 to 4 days.
Clinical Significance
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).
