Ordering Recommendations

Screening test for Lynch Syndrome.  Determine potential eligibility for immunotherapy by identifying microsatellite instability-high (MSI-H) cancers.

Collect

Formalin-Fixed, paraffin-embedded tissue (FFPE) in microtainer: 3-5 10uM slices or >100K cells
Formalin-Fixed, paraffin-embedded tissue (FFPE) slides: 10 unstained slides with slices of 10uM, and an associated H&E slide with tumor cells marked.  Include surgical pathology report with tumor cellularity estimate in marked region.
Fresh tissue: min 0.1mL
Frozen tissue: min 100mg or 0.5cc / 0.5 cm3
Body Fluids: >200K cells
Fine needle aspirate slides: Minimum volume is dependent on the tumor size and cellularity.  Unfixed, ethanol fixed, or H&E stained – Soak slide in xylene to remove coverslip and dry before transporting to the lab.
 

Specimen Preparation

The tumor cellularity should be indicated by the pathologist. Usually, macrodissection is needed if tumor cellularity is less than 25%
 

Storage/Transport Temperature

20-25°C for several hours acceptable
Protect FFPE samples from heat exposure, especially in summer months.
Fresh tissue should be sent in saline soaked gauze, a tube with saline, or tissue culture medium. 
Frozen samples should be sent on dry ice.

Unacceptable Conditions

No tumor tissue. Specimens fixed/processed in alternative fixatives.

Remarks

All samples must be labeled with at least 2 patient identifiers.  The normal sample must be clearly differentiated from the tumor sample.  The specimens must be accompanied by the appropriate laboratory requisition containing the following information: patient’s name, date of birth, medical record number, sample type, test requested and the name of the ordering physician. Alternatively, this information is available from the laboratory information system. Include surgical pathology report with an estimate of tumor cellularity.
 

Stability (from collection to initiation)

Fresh samples: Ambient: 72 hours; Refrigerated: 1 week
FFPE samples: Ambient: 60 days
Protect FFPE samples from heat exposure, especially in summer months.  Fresh tissue should be sent in saline soaked gauze, a tube with saline, or tissue culture medium.  Frozen samples should e sent on dry ice.

Lab Section

Molecular Diagnostics

Methodology

Idylla Microsatellite Instability (MSI) Assay involving multiplex PCR followed by high-resolution melting curve analysis

Performed

Assay: Varies

Reported

Within 5 working days

Synonyms

  • HNPCC MSI
  • Lynch Syndrome MSI
  • microsatellite instability
  • MSI
  • MSI Lynch Syndrome

Interpretive Data

Microsatellite Instability - High (MSI-H): > 2 biomarkers shifted
Microsatellite Stable (MSS): 0 or 1 biomarker shifted
7 MSI loci analyzed: ACVR2A (2q22.3-q23.1), BTBD7 (14q32.12), DIDO1 (20q13.33), MRE11 (11q21), RYR3 (15q13.3-q14), SEC31A (4q21.22), and SULF2 (20q12.12)

CPT Codes

81301
88381 if microdissection performed

LOINC Mapping

43368-0

Order Type (Individual or Group)

G

Group Test Information

Result Test ID Reportable Result Test Name Result Type Type (Alpha or Numeric)
TYPMI Y SPECIMEN TYPE,MSI I A
CAS#M Y PATH CASE #,MSI I A
MSIR Y MSI RESULT I A
INTMI Y INTERPRETATION,MSI I A
REVMI Y REVIEWED BY I A
RRMSI Y MSI REVIEW I A

CPT Codes

81301
88381 if microdissection performed

LOINC Mapping

43368-0

Pricing

Refer to Lab Account Manager. email: labservicesoutreach@urmc.rochester.edu
Specimen Requirements

Ordering Recommendations

Screening test for Lynch Syndrome.  Determine potential eligibility for immunotherapy by identifying microsatellite instability-high (MSI-H) cancers.

Collect

Formalin-Fixed, paraffin-embedded tissue (FFPE) in microtainer: 3-5 10uM slices or >100K cells
Formalin-Fixed, paraffin-embedded tissue (FFPE) slides: 10 unstained slides with slices of 10uM, and an associated H&E slide with tumor cells marked.  Include surgical pathology report with tumor cellularity estimate in marked region.
Fresh tissue: min 0.1mL
Frozen tissue: min 100mg or 0.5cc / 0.5 cm3
Body Fluids: >200K cells
Fine needle aspirate slides: Minimum volume is dependent on the tumor size and cellularity.  Unfixed, ethanol fixed, or H&E stained – Soak slide in xylene to remove coverslip and dry before transporting to the lab.
 

Specimen Preparation

The tumor cellularity should be indicated by the pathologist. Usually, macrodissection is needed if tumor cellularity is less than 25%
 

Storage/Transport Temperature

20-25°C for several hours acceptable
Protect FFPE samples from heat exposure, especially in summer months.
Fresh tissue should be sent in saline soaked gauze, a tube with saline, or tissue culture medium. 
Frozen samples should be sent on dry ice.

Unacceptable Conditions

No tumor tissue. Specimens fixed/processed in alternative fixatives.

Remarks

All samples must be labeled with at least 2 patient identifiers.  The normal sample must be clearly differentiated from the tumor sample.  The specimens must be accompanied by the appropriate laboratory requisition containing the following information: patient’s name, date of birth, medical record number, sample type, test requested and the name of the ordering physician. Alternatively, this information is available from the laboratory information system. Include surgical pathology report with an estimate of tumor cellularity.
 

Stability (from collection to initiation)

Fresh samples: Ambient: 72 hours; Refrigerated: 1 week
FFPE samples: Ambient: 60 days
Protect FFPE samples from heat exposure, especially in summer months.  Fresh tissue should be sent in saline soaked gauze, a tube with saline, or tissue culture medium.  Frozen samples should e sent on dry ice.
Testing

Lab Section

Molecular Diagnostics

Methodology

Idylla Microsatellite Instability (MSI) Assay involving multiplex PCR followed by high-resolution melting curve analysis

Performed

Assay: Varies

Reported

Within 5 working days

Synonyms

  • HNPCC MSI
  • Lynch Syndrome MSI
  • microsatellite instability
  • MSI
  • MSI Lynch Syndrome
Result Interpretation

Interpretive Data

Microsatellite Instability - High (MSI-H): > 2 biomarkers shifted
Microsatellite Stable (MSS): 0 or 1 biomarker shifted
7 MSI loci analyzed: ACVR2A (2q22.3-q23.1), BTBD7 (14q32.12), DIDO1 (20q13.33), MRE11 (11q21), RYR3 (15q13.3-q14), SEC31A (4q21.22), and SULF2 (20q12.12)
Coding

CPT Codes

81301
88381 if microdissection performed

LOINC Mapping

43368-0
URM Labs Internal
Test Build

Order Type (Individual or Group)

G

Group Test Information

Result Test ID Reportable Result Test Name Result Type Type (Alpha or Numeric)
TYPMI Y SPECIMEN TYPE,MSI I A
CAS#M Y PATH CASE #,MSI I A
MSIR Y MSI RESULT I A
INTMI Y INTERPRETATION,MSI I A
REVMI Y REVIEWED BY I A
RRMSI Y MSI REVIEW I A

CPT Codes

81301
88381 if microdissection performed

LOINC Mapping

43368-0

Pricing

Refer to Lab Account Manager. email: labservicesoutreach@urmc.rochester.edu

Important Information

Lab Section
Molecular Diagnostics

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