Screening test for Lynch Syndrome. Determine potential eligibility for immunotherapy by identifying microsatellite instability-high (MSI-H) cancers.
Polymerase Chain Reaction/Fragment Analysis
DNA isolation: Sun-Sat
Assay: Sun, Tue, Thu
Tumor AND normal epithelial tissue. Also acceptable: DNA extracted by CLIA certified
Tissue: Formalin fix (10 percent neutral buffered formalin) and paraffin embed tissue. Protect from excessive heat. Tissue block will be returned after testing. Transport tissue block(s) or 10 unstained 5-micron slides (5 tumor and 5 normal epithelial). (Min: 3 tumor tissue and 3 normal epithelial tissue slides) Transport block(s) and/or slide(s) in a tissue transport kit (ARUP Supply #47808) available online through eSupply using ARUP Connect™ or contact ARUP Client Services at (800) 522-2787.
Extracted DNA: Transport 40 uL DNA with at least 50 ng/uL concentration. (Min: 40 uL)Transport DNA in a tissue transport kit (ARUP Supply #47808) available online through eSupply using ARUP Connect™ or contact ARUP Client Services at (800) 522-2787.
Room temperature. Also acceptable: Refrigerated. Ship in cooled container during summer months
Extracted DNA: Refrigerated.
Less than 25 percent tumor or less than 50 percent normal epithelial tissue. DNA extracted by a non-CLIA lab. DNA extracted without a corresponding circled H&E slide. Specimens fixed/processed in alternative fixatives (alcohol, Prefer) or heavy metal fixatives (B-4 or B-5). Decalcified specimens.
Include surgical pathology report.
Ambient: Indefinitely; Refrigerated: Indefinitely; Frozen: Unacceptable
Extracted DNA: Ambient: 1 month; Refrigerated: Indefinitely; Frozen: Indefinitely
Refer to report.
Compliance Statement B: For laboratory developed tests not using a RUO kit, and for FDA approved, cleared or 510(k) exempt assays with alterations. This test was developed and its performance characteristics determined by ARUP Laboratories. The U. S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.
|Component Test Code*||Component Chart Name||LOINC|
|0051741||Microsatellite Marker BAT-25|
|0051742||Microsatellite Marker BAT-26|
|0051743||Microsatellite Marker MONO-27|
|0051745||Microsatellite Marker NR-21|
|0051746||Microsatellite Marker NR-24|
|2001370||Microsatellite Instability Specimen||31208-2|
- BAT -25, BAT-26, MON-27, NR-21, NR-24 genotypes
- HNPCC MSI
- HNPCC tumor screening
- Lynch Syndrome MSI
- Lynch syndrome tumor screening
- microsatellite instability
- MSI Lynch syndrome