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Test ID: EGFRX    
Lung Cancer, EGFR with ALK Reflex, Tumor

Method Description Describes how the test is performed and provides a method-specific reference

All ordered specimens will undergo EGFR testing. The EGFR test is a PCR-based assay employing Scorpions real-time PCR and allele-specific PCR technologies that is used to test for 29 mutations within exons 18 through 21 of the EGFR gene:

 

G719A

2239_2256del8

G719S

2239_2248TTAAGAGAAG->C

G719C

2239_2258->CA

2235_2249del15

2240_2251del12

2235_2252->AAT

2240_2257del8

2236_2253del18

2240_2254del15

2237_2251del15

2239_2251->C

2237_2254del18

2307_2308ins9

2237_2255->T

2310_2311insGGT

2236_2250del15,

2319_2320insCAC

2238_2255del18,

S768I

2238_2248->GC

T790M

2238_2252->GCA

L858R

2239_2247del9

L861Q

2239_2253del15

 

 

A pathology review and macrodissection to enrich for tumor cells is performed prior to DNA extraction.

 

In patients with no detectable EGFR mutations, ALK FISH testing will be performed. The ALK FISH test uses an FDA-approved ALK dual-color, break-apart rearrangement probe kitset. The ALK probe consists of 2 probes that flank the ALK gene region at 2p23 (Abbott Molecular). Five micron sections of formalin-fixed, paraffin-embedded tissue specimens are cut and mounted on positively-charged glass slides. The selection of tissue and the identification of target areas on the hematoxylin and eosin-stained slide are performed by a pathologist. The probe set is hybridized to the appropriate target areas and 2 technologists analyze 25 interphase nuclei each (50 total). Results are reported based on the guidelines include with the probe kit and package insert with the results expressed as the percent abnormal nuclei.(Unpublished Mayo method)

Supplemental Report Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.

Monday through Friday; 10 a.m.

Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.

5 days (EGFR only) 10 days (if ALK is added on)

Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result

7 days (EGFR only) 14 days (if ALK is added on)

Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

Unused portions of blocks will be returned. Slides are stored indefinitely.

Performing Laboratory Location The location of the laboratory that performs the test

Rochester