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.
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.
