Ordering Recommendation

Recommended test to distinguish between Lynch syndrome and sporadic noncolorectal tumors with loss of MLH1.

Mnemonic
MLH1PCR
Methodology

Real-Time Polymerase Chain Reaction/Fluorescence Resonance Energy Transfer

Performed

DNA isolation: Sun-Sat
Assay: Sun, Tue, Thu

Reported

7-12 days

New York DOH Approval Status
This test is New York DOH approved.
Specimen Required
Patient Preparation
Collect

Tumor tissue. Also acceptable: DNA extracted by CLIA certified lab with corresponding client-circled H&E slide.

Specimen Preparation

Tumor 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 or 5 unstained 5-micron slides. (Min: 3 slides) Transport block 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.

Storage/Transport Temperature

Room temperature. Also acceptable: Refrigerated. Ship in cooled container during summer months.
Extracted DNA: Refrigerated.

Unacceptable Conditions

Less than 25 percent tumor. 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.

Remarks

Include surgical pathology report.

Stability

Ambient: Indefinitely; Refrigerated: Indefinitely; Frozen: Unacceptable
Extracted DNA: Ambient: 1 month; Refrigerated: Indefinitely; Frozen: Indefinitely

Reference Interval
Interpretive Data

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.

Note
Hotline History
N/A
CPT Codes

88381; 81288

Components
Component Test Code* Component Chart Name LOINC
0051749 MLH1 Promoter Methylation
2002148 Block ID 57723-9
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.
Aliases
  • HNPCC screening
  • Lynch syndrome screening
MLH1 Promoter Methylation, Paraffin