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EGFR Mutation Test Options at Disease Progression

Diagnostic EGFR T790M mutation tests at disease progression

There are 2 FDA-approved tests for detecting EGFR T790M mutations at progression.1

Company

Test Name

Sample Type

Turnaround Time

Roche2

cobas® EGFR Mutation Test v2

Tissue*/blood

7 days

Foundation Medicine3

FoundationOne CDx

Tissue*

<14 days

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Reminder: A new sample is required to test for EGFR T790M mutations at the time of progression.

LDTs for detecting EGFR T790M mutations

As you can see in the chart below, there are a number of commercially available laboratory-developed tests (LDTs) to identify the EGFR T790M resistance mutation at progression. While these LDTs are not FDA approved, they are validated and must adhere to specifications established by the Clinical Laboratory Improvement Amendments (CLIA) of 1988.4

Companies Offering CLIA-validated LDTs for Detecting EGFR T790M Mutations

Company

Test Name

Sample Type

Turnaround Time

Guardant Health5,6

Guardant360

Blood

14 days

Biodesix7,8

GeneStrat®

Blood

3 days

Sysmex Inostics9,10

OncoBEAM

Tissue/Blood

<10 days

Exosome Diagnostics11

ExoDx® Lung(T790M)

Blood

5 days

Biocept12

Biocept liquid biopsy

Blood

<7 days

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10 WORKING DAYS – The recommended turnaround time from the receipt of sample to reporting of EGFR mutation testing results according to guidelines from CAP, IASLC, and AMP.13

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When ordering an EGFR mutation test, it is important to verify turnaround time when the order is placed. If the test results are taking longer than expected, or exceed the recommended 10 days, it is recommended that you contact the laboratory.

*Formalin-fixed paraffin-embedded (FFPE) tissue samples are approved for testing.1

LDTs were developed and their performance characteristics determined by specific institutions in a manner consistent with CLIA requirements. They have not been cleared or approved by the Food and Drug Administration (FDA).14

Diagnostic EGFR T790M mutation tests at progression

There is only one FDA-approved test for detecting EGFR T790M mutations at progression6

cobas® EGFR Mutation Test v2 (Roche Diagnostics USA)

  • Able to detect the EGFR T790M mutation at progression in addition to EGFR activating mutations at diagnosis (eg, exon 19 deletions and the L858R mutation)
  • The test is approved to use DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue or circulating tumor DNA (ctDNA) from plasma6
Callout_1_CO1_Icon

Reminder: A new sample is required to test for EGFR T790M mutations at the time of progression.

LDTs for detecting EGFR T790M mutations

As you can see in the chart below, there are a number of commercially available LDTs to identify the EGFR T790M adaptive mutation at progression. While these LDTs are not FDA approved, they are validated and must adhere to specifications established by CLIA.5

Companies Offering CLIA-Validated LDTs for Detecting EGFR T790M Mutations

Company

Test Name

Sample Type

Turnaround Time

Guardant Health7,8

Guardant 360

Blood

14 days

Biodesix9,10

GeneStrat®

Blood

3 days

Sysmex Inostics11,12

OncoBEAMTM

Tissue/Blood

<10 days

Foundation Medicine13-15

FoundationOne/Act®

Tissue/Blood

14 days

Exosome Diagnostics16

ExoDxTM Lung

Blood

5 days

Biocept17

Biocept Liquid Biopsy

Blood

<7 days

Trovagene18,19

TroveraTM EGFR

Urine/Blood

10 days

Callout_2_CO2_Icon

10 WORKING DAYS - The recommended turnaround time from the receipt of sample to reporting of EGFR mutation testing results according to guidelines from CAP, IASLC, and AMP20

Callout_2_CO2_Icon

When ordering an EGFR mutation test, it is important to verify turnaround time when the order is placed. If the test results are taking longer than expected, or exceed the recommended 10 days, it is recommended that you contact the laboratory.

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Angie Carter, BSN, OCN
Cape Coral, Florida

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