Ordering Recommendations

Qualitative detection of specific gene fusions for ALK, ROS1, and RET, as well as MET exon 14 skipping and 3'-5' expression imbalance for ALK, ROS1, and RET.
The Idylla GeneFusion Assay was optimized using FFPE tissue from non-small cell lung cancer (NSCLC).

Collect

Formalin-Fixed, paraffin-embedded tissue (FFPE) slides: 3 - 5 unstained slides with slices of 10 um, together with an H&E stained slide.  The tumor cellularity should be indicated and the tumor area should be circled by the pathologist.  The tumor cellularity should be more than 25% in the circled area.
When ordering as a reflex from STMP, 12 unstained slides with an H&E should be collected for the two tests combined, or if appropriate, a microtube with FFPE curls and 2 unstained slides with a stained H&E

Unacceptable Conditions

Specimen identity is in doubt.
No tumor tissue
Frozen tissue

Stability (from collection to initiation)

Ambient (20 - 25°C): 60 days; Refrigerated: Indefinitely: Frozen: Unacceptable
Protect FFPE samples from heat exposure, especially in summer months.

Lab Section

Molecular Diagnostics

Methodology

Real-Time PCR

Performed

3 - 4 times per week

Reported

3 - 5 working days

Performing Laboratory Website (click below)

CPT Codes

81479

CPT Codes

81479
Specimen Requirements

Ordering Recommendations

Qualitative detection of specific gene fusions for ALK, ROS1, and RET, as well as MET exon 14 skipping and 3'-5' expression imbalance for ALK, ROS1, and RET.
The Idylla GeneFusion Assay was optimized using FFPE tissue from non-small cell lung cancer (NSCLC).

Collect

Formalin-Fixed, paraffin-embedded tissue (FFPE) slides: 3 - 5 unstained slides with slices of 10 um, together with an H&E stained slide.  The tumor cellularity should be indicated and the tumor area should be circled by the pathologist.  The tumor cellularity should be more than 25% in the circled area.
When ordering as a reflex from STMP, 12 unstained slides with an H&E should be collected for the two tests combined, or if appropriate, a microtube with FFPE curls and 2 unstained slides with a stained H&E

Unacceptable Conditions

Specimen identity is in doubt.
No tumor tissue
Frozen tissue

Stability (from collection to initiation)

Ambient (20 - 25°C): 60 days; Refrigerated: Indefinitely: Frozen: Unacceptable
Protect FFPE samples from heat exposure, especially in summer months.
Testing

Lab Section

Molecular Diagnostics

Methodology

Real-Time PCR

Performed

3 - 4 times per week

Reported

3 - 5 working days

Performing Laboratory Website (click below)

Result Interpretation
Coding

CPT Codes

81479
URM Labs Internal
Test Build

CPT Codes

81479